01-IMS-04 F07 (Department Wise)

ADVICS North India Pvt Ltd Format No. : 01-IMS-04 F07 Rev. No.
: 00
Clause Requirements
ISO / TS:16949 RESPONSIBLE
DEPT.
ADSNI procedure name or number
Is Procedure effective? Procedure is
followed on same area? ( Y/N )
If your answer is: "No" , please describe the
corrective action to close the gap´.
Target Date Comments
Eff. Date : 02.01.2017
Control of documents. Documents required by the quality management system shall be controlled. ALL
Records are a special type of document and shall be controlled according to the requirements given in 4.2.4
ALL
A documented procedure shall be established to define the controls needed ALL

a) to approved documents for adequacy prior to issue, ALL
b) to review and update as necessary and re-approve documents ALL ADSNI- Procedure for
4.2.3 4.2.3 Control of documents
control of documents
c) to ensure that changes and the current revision status of documents are identified, ALL
d) to ensure that relevant versions of applicable documents are available at points of use, ALL
e) to ensure that documents remain legible and readily identifiable. ALL
f) to ensure that documents of external origin are identified and their distribution controlled, and ALL
g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are
ALL
retained for any purpose
Records established to provide evidence of conformity to requirements and of the effective operation of the quality
management system shall be controlled. ADSNI - Procedure for
4.2.4 4.2.4 Control of records The organization shall establish a documented procedure to define the controls needed for identification, storage, ALL
control of records
protection, retrieval, retention and disposition of records.
Control of records. Records shall be established and maintained to provide evidence of conformity to requirements
and of the effective operation of the quality management system. ALL
Records shall remain legible, readily identifiable and retrievable. ALL ADSNI- Procedure for record
4.2.4.1 4.2.4.1 Records retention retention
A documented procedure shall be established to define the controls needed for the identification, storage,
protection, retrieval, retention time and disposition of records ALL
The control of records shall satisfy regulatory and customer requirements. ALL
Top management shall ensure that the quality policy ALL
a) is appropriate to the purpose of the organization, ALL
b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality
ALL
5.3 5.3 Quality policy management system
c) provides a framework for establishing and reviewing quality objectives, ALL ADSNI - Procedure for
management review
d) is communicated and understood within the organization, and, ALL meeting
e) is reviewed for continuing suitability. ALL
Top management shall ensure that quality objectives, including those needed to meet requirements for product are
ALL
5.4.1 5.4.1 Quality objectives established at relevant functions and levels within the organization.
The quality objectives shall be measurable and consistent with the quality policy. ALL
Top management shall ensure that appropriate communication processes are established within the organization ADSNI- Procedure for
5.5.3 5.5.3 Internal communication and that communication takes place regarding the effectiveness of the quality management system. ALL Internal & External
Communication
The organization shall provide on-the-job training for personnel in any new or modified job affecting product quality,
ALL
including contract or agency personnel. ADSNI- Procedure for
6.2.2.3 6.2.2.3 Training on the job Personnel whose work can affect quality shall be informed about the consequences to the customer of Training & Development
nonconformity to quality requirements ALL
The organization shall determine and manage the work environment needed to achieve conformity to product ADSNI - Procedure for
6.4 6.4 Work environment ALL
Kaizen Activity
requirements
The organization shall maintain its premises in a state of order, cleanliness and repair consistent with the product
6.4.2 6.4.2 Cleanliness of premises and manufacturing process needs. ALL
The organization shall ensure the confidentiality of customers-contracted products and projects under development,
7.1.3 7,1,3 Confidentiality ALL
and related product information
ADVICS North India Pvt Ltd Format No. : 01-IMS-04 F07 Rev. No. : 00
Clause Requirements
DEPT.
Eff. Date : 02.01.2017
a) The organization shall plan and carry out production and service provision under controlled condition. PRODUCTION /
QA
The controlled conditions shall include:
a) The availability of information that describes the characteristics of the product.
7.5.1 Control of production and b) The availability of work instructions. ADSNI - Procedure for
7.5.1 service provision Production Management
c) The use of suitable equipment. PRODUCTION /
d) The availability and use of monitoring and measuring devices QA
e) The implementation of monitoring and measurement, and
f) The implementation of release, delivery and post-delivery activities.
7.5.1.2 Work Instructions PRODUCTION

a) The organization shall prepare documented work instruction for all employees having responsibilities for the
PRODUCTION ADSNI - Procedure for
7.5.1.2 7.5.1.2 Work Instructions operation of processes that impact product quality.
Production Management
b) The instruction shall be derived from sources such as the quality plan, the control plan and the product
PRODUCTION
realization process.
7.5.1.6 Production scheduling PPC & PROD.
ADSNI- Procedure for
a) Production shall be scheduled in order to Meet customer requirements, such as just in time supported by an Production Management,
7.5.1.6 7.5.1.6 Production scheduling information system that permits access to production information at key stages of the process. ADSNI - Procedure for
PPC & PROD. production planning &
control and dispatches.
Instructions for rework, including re-inspection requirements, shall be accessible to and utilized by the appropriate
8.3.2 Control of reworked personnel
8.3.2 product
PROD./ QA
The organization shall determine, collect and analyse appropriate data to demonstrate the suitability and
effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness
of the quality management system can ALL
This shall include data generated as a result of monitoring and measurement and from other relevant sources.
ALL ADSNI - Procedure for
8.4 8.4 Analysis of data
COPQ
The analysis of data shall provide information relating to ALL
a) customer satisfaction ALL
b) conformity to product requirements ALL
c) characteristics and trends of processes and products including opportunities for preventive action and ALL
d) suppliers ALL
Trends in quality and operational performance shall be compared with progress toward objectives and lead to action
ALL
to support the following:
a) development of priorities for prompt solutions to customer-related problems ALL
8.4.1 8.4.1 Analysis and use of data b) determination of key customer-related trends and correlation for status review, decision-making and longer term ADSNI- Procedure for COPQ
ALL
planning
c) an information system for the timely reporting of product information arising from usage ALL
The organization shall continually improve the effectiveness of the quality management system through the use of
8.5.1 8.5.1 Continual improvement the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and ALL
management review. ADSNI- Procedure for
The organization shall define a process for continual improvement continual improvement,
8.5.1.1 Continual improvement ADSNI - Procedure for
8.5.1.1 of the organization
ALL
kaizen activity.
8.5.1.2 Manufacturing process Manufacturing process improvement shall continually focus upon control and reduction of variation in product
8.5.1.2 improvement ALL
characteristics and manufacturing process parameters.
The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence. ALL
Corrective actions shall be appropriate to the effects of the nonconformities encountered. ALL
A documented procedure shall be established to define requirements for: ALL
a) reviewing nonconformities (including customer complaints), ALL
8.5.2 8.5.2 Corrective action b) determining the causes of nonconformities ALL
c) evaluating the need for action to en sure that nonconformities do not recur ALL
d) determining and implementing action needed ALL
e) records of the results of action taken and ALL
f) reviewing corrective action taken ALL
The organization shall have a defined process for problem solving leading to root cause identification and ADSNI- Procedure for
ALL
8.5.2.1 8.5.2.1 Problem solving elimination corrective & preventive
If a customer-prescribed problem-solving format exists, the organization shall use the prescribed format. ALL action
8.5.2.3 Corrective action The organization shall apply to other similar processes and products the corrective action, and controls ADSNI- Procedure for
8.5.2.3 impact implemented, to eliminate the cause of a non conformity ALL warranty analysis
The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their
ALL
occurrence
Preventive actions shall be appropriate to the effects of the potential problems. ALL
A documented procedure shall be established to define requirements for a) determining potential nonconformities
ALL
8.5.3 8.5.3 Preventive action and their causes
b) evaluating the need for action to prevent occurrence of nonconformities, ALL
c) determining and implementing action needed, ALL
d) records of results of action taken and ALL
e) reviewing preventive action taken ALL
Clause Requirements
DEPT.
Eff. Date : 02.01.2017
ALL

b) to review and update as necessary and re-approve documents ALL ADSNI - Procedure for
ALL
management system shall be controlled. ADSNI- Procedure for
control of records
ALL
c) provides a framework for establishing and reviewing quality objectives, ALL ADSNI- Procedure for
management review
ALL
Communication
ALL
a) buildings, workspace and associated utilities, HR / MANT. / OM

6.3 6.3 Infrastructure
b) process equipment (both hardware and software), and HR / MANT.
The organization shall prepare contingency plans to satisfy customer requirements in the event of an emergency
6.3.2 6.3.2 Contingency plans MAINT.
such as utility interruptions, labour shortages, key equipment failure and field returns.
The organization shall determine and manage the work environment needed to achieve conformity to product ADSNI- Procedure for
6.4 6.4 Work environment
requirements
ALL
Kaizen Activity
Clause Requirements
DEPT.
Eff. Date : 02.01.2017
7.5.1.4 Preventive and predictive maintenance MAINTENANCE

a) The organization shall identify key process equipment and provide resources for machine/equipment
MAINTENANCE
maintenance and develop an affective planned total preventive system.
b) The system shall include: ADSNI - Procedure for
7.5.1.4 Preventive and Planned maintenance activities.
7.5.1.4 predictive maintenance Preventive & Predictive
Packaging and preservation of equipment, tooling and gauging. MAINTENANCE Maintenance
Availability of replacement parts for key manufacturing equipment.
Documenting, evaluating and improving maintenance
c) The organization shall utilize predictive maintenance methods to continually improve the effectiveness and the
MAINTENANCE
efficiency of production equipment.
7.5.1.5 Management of production tooling PE & MAINT.
a) The organization shall provide resources for tool and gauge design, fabrication and verification activities. PE & MAINT.
b) The organization shall establish and implement a system for production tooling management including:
7.5.1.5 Management of Maintenance and repair facilities and personnel. ADSNI- Procedure for New
7.5.1.5 production tooling Set-up. Tooling & Maintenance
PE & MAINT.
Tool- change programmes for perishable tools.
Tool design modification document
c) The organization shall implement a system to monitor these activities if any work is outsourced. PE & MAINT.
ALL
8.4 8.4 Analysis of data ADSNI- Procedure for COPQ
d) suppliers ALL
ALL
8.4.1 8.4.1 Analysis and use of data b) determination of key customer-related trends and correlation for status review, decision-making and longer term ADSNI- Procedure for COPQ
ALL
planning
management review. ADSNI- Procedure for
8.5.1.1 Continual improvement ADSNI- Procedure for kaizen
ALL
activity.
ALL
ALL
occurrence
ALL
Clause Requirements
DEPT.
Eff. Date : 02.01.2017
ALL

ALL
control of records
ALL
management review
ALL
Communication
ALL
6.4 6.4 Work environment ALL
Kaizen Activity
requirements
Acceptance criteria shall be defined by the organization and, where required by the costumer. QA ADSNI- Procedure for
7.1.2 7,1,2 Acceptance criteria Inspection & Testing
For attribute data sampling, the acceptance levels shall be zero defects (see 8,2,3,1). QA
The organization shall determinated and implement effective arrangements for communicating with customers in
SALE & QA
relation to
a) Product information, SALE & QA
7,2,3 Customer
7.2.3 communication. b) enquiries, contracts or order handling, including amendments, and SALE & QA ADSNI- Procedure for
c) customer feedback, including customers complaints customer complaint
SALE & QA handling process
The organization shall have the ability to communicate necessary information, including data, in a customer
7,2,3,1Customer
7.2.3.1 communication -supplemental specified language and form. SALE & QA
7.4 Purchasing process PURCHASING /

SQA
ADSNI-Procedure for
7.4 7.4 Purchasing process
supplier selection,
ADSNI - Procedure for
supplier development &
upgradation
Clause Requirements
DEPT.
Eff. Date : 02.01.2017
a) The organization shall be ensure that purchased product conforms to specified purchase requirements.} PURCHASING /
SQA
b) The type and extent of control applied to the supplier and the purchased product shall be dependent upon the PURCHASING /
effect of the purchased product on subsequent product realization or the final product. SQA
c) The organization shall evaluate and select supplier based on their ability to supply products in accordance with PURCHASING /
the organization´s requirements. SQA
7.4.1.1 Regulatory conformity PURCHASING /
SQA
a) All purchased product or materials used in product shall conform to applicable regulatory requirements. PURCHASING / ADSNI-Procedure for
supplier selection,
SQA
7.4.1.2 Supplier quality management system development PURCHASING / supplier development &
SQA upgradation
a) The organization shall perform supplier quality management system development with a goal of supplier PURCHASING / controlling special control
conformity with technical specification. SQA parts
ADSNI-Procedure for
7.4.1.3 Customer - approved sources PURCHASING / controlling special process
SQA
a) The organization shall be purchase products, materials or service from approved sources. PURCHASING /
SQA
PURCHASING /
7.4.2 Purchasing Information SQA
a) Purchasing information shall describe the product to be purchased including:
Requirements for approval of product, procedures, processes and equipment. PURCHASING /
7.4.2 7.4.2 Purchasing Information Requirements for qualification of personnel. SQA
Quality management system requirements.
b) The organization shall be ensure the adequacy of specified requirements prior to their communication to the PURCHASING /
supplier. SQA
7.4.3 Verification of purchased product. QA
7.4.3 Verification of purchased a) The organization shall establish and implemented the inspection or other activities necessary for ensuring that QA
7.4.3 product. purchased product meets specified purchase requirements.
b) The organization shall state the intended verification arrangements and method of product release in the
QA
purchasing information. ADSNI- Procedure for
7.4.3.1 Incoming Product quality QA Inspection & Testing
a) The organization shall have a process to assure the quality of purchased product utilizing one or more of the
7.4.3.1 Incoming Product
7.4.3.1 quality
following methods:
Receipt of, and evaluation of, statistical data by the organization. QA
Receiving inspection and/or testing
7.4.3.2 Supplier Monitoring QA
a) Supplier performance shall be monitored through the following indicators:
Delivered product quality.
Customer disruptions including field returns. ADSNI- Procedure supplier
7.4.3.2 7.4.3.2 Supplier Monitoring QA
development & up gradation
Delivery schedule performance.
Special status customer notifications
b) The organization shall promote supplier monitoring of the performance of their manufacturing processes. QA
a) The organization shall plan and carry out production and service provision under controlled condition. PRODUCTION /
QA
7.5.1 Control of production and b) The availability of work instructions.
7.5.1 service provision c) The use of suitable equipment. PRODUCTION /
d) The availability and use of monitoring and measuring devices QA
7.5.1.3 Verification of job set-ups QA ADSNI- Procedure for pre-

a). Job set-ups shall be verified whenever performed , such as an initial run of a job, material changeover or job production control,
7.5.1.3 Verification of job set- QA ADSNI - Procedure for
7.5.1.3 ups change.
b) Work instructions shall be available for set-up personnel. QA Making boundary sample
c) The organization shall use statistical methods of verification where applicable. QA
7.5.2 The organization shall validate any processes for production and service provision where the resulting output
cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies
become apparent only after the product is in use or the service has been delivered. QA
7.5.2 Validation of processes QA

Validation shall demonstrate the ability of these processes to achieve planned results.
7.5.2 for production and service
QA
provision. The organization shall establish arrangements for these processes including, as applicable
a) defined criteria for review and approval of these processes, QA
b) approval of equipment and qualification of personnel, QA
c) use of specific methods and procedures, QA
d) requirements for records (see 4.2.4), and QA
e) revalidation. QA
The requirements of 7.5.2 shall apply to all processes for production and service provision. ADSNI - Procedure for
7.5.2.1 Validation of processes
Inspection & Testing
7.5.2.1 for production and service QA
provision - Supplemental
ADVICS North India Pvt Ltd ADSNI - Procedure for Format No. : 01-IMS-04 F07 Rev. No. : 00
ISO / TS:16949 RESPONSIBLE Inspection & Testing Is Procedure effective? Procedure is If your answer is: "No" , please describe the Eff. Date : 02.01.2017
Clause Requirements DEPT.
followed on same area? ( Y/N ) corrective action to close the gap´.
Where appropriate, the organization shall identify the product by suitable means throughout product realization.
QA
The organization shall identify the product status with respect to monitoring and measurement requirements. QA
7.5.3 Identification and Where traceability is a requirement, the organization shall control and record the unique identification of the product
7.5.3 traceability
QA
(see 4.2.4).
NOTE: Inspection and test status is not indicated by the location of product in the production flow unless inherently
obvious, such as material in an automated production transfer process. Alternatives are permitted, if the status is QA
clearly identified, documented and achieves the designated purpose.
7.5.3.1 Identification and The words "Where appropriate" in 7.5.3 shall not apply.
7.5.3.1 traceability - Supplemental QA
The organization shall determine the monitoring and measurement to be undertaken and the monitoring and
measurement devices needed to provide evidence of conformity of product to determined requirements (see 7.2.1). QA
The organization shall establish processes to ensure that monitoring and measurement can be carried out and are
carried out in a manner that is consistent with the monitoring and measurement requirements. QA
Where necessary to ensure valid results, measuring equipment shall: QA

a) be calibrated or verified at specific intervals, or prior to use, against measurement standards traceable to
international or national measurement standards; where no such standards exist, the basis used for calibration or QA
verification shall be recorded
b) be adjusted or re-adjusted as necessary; QA ADSNI - Procedure for
7.6 Control of monitoring and
7.6 measurement devices c) be identified to enable the calibration status to be determined; QA controlling monitoring &
d) be safeguarded from adjustments that would invalidate the measurement result; measuring devices
QA
e) be protected from damage and deterioration during handling, maintenance and storage. QA
In addition, the organization shall assess and record the validity of the previous measuring results when the
QA
equipment is found not to conform to requirements.
The organization shall take appropriate action on the equipment and any product affected. QA
Records of the results of calibration and verification shall be maintained (see 4.2.4). QA
When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy
the intended application shall be confirmed. QA
This shall be undertaken prior to initial use and reconfirmed as necessary. QA

NOTE: Confirmation of the ability of computer software to satisfy the intended application would typically include tis QA
verification and configuration management to maintain its suitable for use.
QA
Statistical studies shall be conducted to analyze the variation present in the results of each type of measuring and
QA
test equipment system.
7.6.1 Measurement system This requirement shall apply to measurement systems referenced in the control plan. QA
7.6.1 analysis
ADSNI- Procedure for MSA
The analytical methods and acceptance criteria used shall conform to those in customer reference manuals on
measurement system analysis. Other analytical methods and acceptance criteria may be used if approved by the QA
customer.
Records of the calibration/verification activity for all gauges, measuring and test equipment, needed to provide
evidence of conformity of product to determined requirements, including employee- and customer-owned QA
equipment, shall include
- equipment identification, including the measurement standard against which the equipment is calibrated,
QA
7.6.2 Calibration/verification
7.6.2 records - revisions following engineering changes, QA controlling monitoring &
measuring devices
- any out-of-specification readings as received for calibration/verification, QA
- an assessment of the impact of out-of-specification condition, QA
- statements of conformity to specification after calibration/verification, and QA
- notification to the customer if suspect product or material has been shipped. QA
An organization's internal laboratory facility shall have a defined scope that includes its capability to perform the
QA
required inspection, test or calibration services.
This laboratory scope shall be included in the quality management system documentation. QA
The laboratory shall specify and implement, as a minimum, technical requirements for QA
- adequacy of the laboratory procedures, QA
- competency of the laboratory personnel, QA
7.6.3.1 7.6.3.1 Internal laboratory
- testing of the product, QA
- capability to perform these services correctly, traceable to the relevant process standard (such as ASTM, EN, etc.),
and QA
- review of the related records. QA

NOTE: Accreditation to ISO/IEC 17025 may be used to demonstrate the organization's in-house laboratory
conformity to this requirement but it is not mandatory. QA
External/commercial/independent laboratory facilities used for inspection, test or calibration services by the
organization shall have a defined laboratory scope that includes the capability to perform the required inspection, QA
test or calibration, and either
- there shall be evidence that the external laboratory is acceptable to the customer, or QA
- the laboratory shall be accredited to ISO/IEC 17025 or national equivalent. QA
7.6.3.2 7.6.3.2 External laboratory NOTE1: Such evidence may be demonstrated by customer assessment, for example, or by customer-approved
second-party assessment that the laboratory meets the intent of ISO/IEC 17025 or national equivalent. QA
NOTE2: When a qualified laboratory is not available for a given piece of equipment, calibration services may be
performed by the equipment manufacturer. In such cases, the organization should ensure that the requirements QA
listed in 7.6.3.1 have been met.
Clause Requirements
DEPT.
Eff. Date : 02.01.2017
8.2.2.2 Manufacturing process The organization shall audit each manufacturing process to determine its effectiveness.
8.2.2.2 audit QA
The organization shall audit products as appropriate stages of production and delivery to verify conformity to all Process & Product Audit
8.2.2.3 8.2.2.3 Product audit specified requirements, such as product dimensions, functionality, packaging and labeling, at a defined frequency. QA
The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality
QA
management system processes.
8.2.3 Monitoring and
8.2.3 measurement of processes These methods shall demonstrate the ability of the processes to achieve planned results. QA
When planned results are not achieved, correction and corrective action shall be taken, as appropriate, to ensure
QA
conformity of the product.
The organization shall perform process studies on all new manufacturing (including assembly or sequencing)
QA
processes to verify process capability and to provide additional input for process control
The results of process studies shall be documented with specifications, where applicable, for means of production,
QA
measurement and test, and maintenance instructions.
These documents shall include objectives for manufacturing process capability, reliability, maintainability and
QA
availability, as well as acceptance criteria
The organization shall maintain manufacturing process capability or performance as specified by the customer part
QA
approval process requirements.
The organization shall ensure that the control plan and process flow diagram are implemented, including adherence
QA
to the specified:
a) measurement techniques, QA
8.2.3.1 8.2.3.1 Monitoring QA
b) sampling plans,
c) acceptance criteria, QA
d) reaction plans when acceptance criteria are not met. QA
Significant process events, such as tool change or machine repair, shall be recorded QA
The organization shall initiate a reaction plan from the control plan for characteristics that are either not statistically
QA
capable or are unstable.
These reaction plans shall include containment of product and 100% inspection as appropriate. QA
A corrective action plan shall then be completed by the organization, indicating specific timing and assigned ADSNI - Procedure for
QA
responsibilities to assure that the process becomes stable and capable. Inspection & Testing
The plans shall be reviewed with and approved by the customer when so required QA
The organization shall maintain records of effective dates of process changes. QA
QA
The organization shall monitor and measure the characteristics of the product to verify that product requirements
QA
have been met.
This shall be carried out at appropriate stages of the product realization process in accordance with the planned
8.2.4 Monitoring and QA
8.2.4 arrangements
measurement of product
Evidence of conformity with the acceptance criteria shall me maintained QA
Records shall indicate the persons authorizing release of product QA
Product release and service delivery shall not proceed until all the planned arrangements have been satisfactorily
completed, unless otherwise approved by a relevant authority, and where applicable by the customer. QA
A layout inspection and a functional verification to applicable customer engineering material and performance
standards shall be performed for each product as specified in the control plans. QA
8.2.4.1 Layout inspection and
8.2.4.1 functional testing
Results shall be available for customer review. QA
For organizations manufacturing parts designated by the customer as "appearance items", the organization shall
QA
provide:
a) appropriate resources including lighting for evaluation, QA
8.2.4.2 8.2.4.2 Appearance items
b) masters for colour, grain, gloss, metallic brilliance, texture, distinctness of image (DOI), as appropriate, QA
c) maintenance and control of appearance masters and evaluation equipment, and QA
d) verification that personnel making appearance evaluations are competent and qualified to do so. QA
The organization shall ensure that product which does not conform to product requirements is identified and
QA
controlled to prevent its unintended use or delivery.
The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a
QA
documented procedure.
The organization shall deal with nonconforming product by one or more of the following ways: a) by taking action to
QA
eliminate the detected nonconformity,
b) by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by
8.3 Control of nonconforming QA
8.3 the customer,
product
c) by taking action to preclude its original intended use or application QA
ADSNI-Procedure for
Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall Control of Non-conforming
QA
be maintained Product
When nonconformity product is corrected it shall be subject to re-verification to demonstrate conformity to the
QA
requirements
When nonconforming product is detected after delivery or use has started, the organization shall take action
QA
appropriate to the effects, or potential effects, of the nonconformity
8.3.1 Control of Product with unidentified or suspect status shall be classified as nonconforming product
8.3.1 nonconforming product- QA
supplemental
8.3.2 Control of reworked Instructions for rework, including re-inspection requirements, shall be accessible to and utilized by the appropriate
8.3.2 product
PROD./ QA
personnel
Clause Requirements
DEPT.
Eff. Date : 02.01.2017
Customers shall be informed promptly in the event that nonconforming product has been shipped. ADSNI -Procedure for
8.3.3 8.3.3 Customer information QA Control of Non-conforming
Product
ALL
d) suppliers ALL
ALL
ADSNI812 - Procedure for
8.4.1 8.4.1 Analysis and use of data b) determination of key customer-related trends and correlation for status review, decision-making and longer term COPQ
ALL
planning
management review. ADSNI - Procedure for
ALL
kaizen activity.
The organization shall have a defined process for problem solving leading to root cause identification and
ALL
8.5.2.1 8.5.2.1 Problem solving elimination
If a customer-prescribed problem-solving format exists, the organization shall use the prescribed format. ALL
8.5.2.3 Corrective action The organization shall apply to other similar processes and products the corrective action, and controls ADSNI - Procedure for
8.5.2.3 impact implemented, to eliminate the cause of a non conformity ALL corrective & preventive
action
The organization shall analysis parts rejected by the customers manufacturing plants, engineering facilities and ADSNI - Procedure for
QA
dealerships. warranty analysis
8.5.2.4 Rejected product The organization shall minimize the cycle time of this process. QA
8.5.2.4 test/analysis
Records of these analysis shall be kept and made available upon request QA
The organization shall perform analysis and initiate corrective action to prevent recurrence QA
ALL
occurrence
ALL
Clause Requirements
DEPT.
Eff. Date : 02.01.2017
4.2.1 General. The quality management system documentation shall include

QMS
a) documented statements of a quality policy and quality objectives

QMS
4.2 Documentation
4.2 requirements b) a quality manual
QMS
c) documented procedures required by this International Standard

QMS
0.1 QMS Manual
d) documents needed by the organization to ensure the effective planning, operation and control of its processes QMS
and
4.2.2 Quality manual. The organization shall establish and maintain a quality manual that includes QMS
a) The scope of the quality management system, including details of and justification for any exclusions (see 1.2)
QMS
4.2.2 4.2.2 Quality Manual b) The documented procedures established for the quality management system, or reference to them, and
QMS
e) a description of the interaction between the processes of the quality management system
QMS
ALL

ALL
The organization shall have a process to assure the timely review, distribution and implementation of all customer
engineering standards/specifications and changes based on customer-required schedule. NPD / ENG ADSNI - Procedure for new
product design &
4.2.3.1 Engineering development,
4.2.3.1 specifications Timely review should be as soon as possible, and shall not exceed two working weeks. NPD / ENG ADSNI - Procedure for
The organization shall maintain a record of the date on which each change is implemented in production, Product & Engineering
implementation shall include updated documents. NPD / ENG change
control of records
Records shall remain legible, readily identifiable and retrievable. ALL ADSNI - Procedure for
4.2.4.1 4.2.4.1 Records retention record retention
ALL
c) provides a framework for establishing and reviewing quality objectives, ALL ADSNI107 - Procedure for
management review
ALL
Communication
ALL
including contract or agency personnel. ADSNI - Procedure for
6.2.2.3 6.2.2.3 Training on the job Training & Development
Personnel whose work can affect quality shall be informed about the consequences to the customer of
requirements
ALL
Kaizen Activity
Clause Requirements
DEPT.
Eff. Date : 02.01.2017
The organization shall plan and develop the processes needed for product realization. NPD
Planning of product realization shall be consistent with the requirements of the other processes of the quality
NPD
management system (see 4.1)
In planning product realization, the organization shall determine the following, as appropriate: a) quality objectives
NPD
and requirements for the product
7.1 Planning of product b) the need to establish processes, documents and provide resources specific to the product, NPD
7.1 realization ADSNI - Procedure for
c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for Product and engineering
NPD change
product acceptance
d) record needed to provide evidence that the realization processes and resulting product meet requirements (see
NPD
4.2.4)
The output of this planning shall be in a form suitable for the organization's method of operations NPD
7,1,1 Planning of product Customer requirements and references to its technical specifications shall be included in the planning of product
7.1.1 realization- supplemental
NPD
realization as a component of the quality plan.
The organization shall have a process to control and react to changes that impact product realization. NPD
The effects of any change, including those changes caused by any supplier, shall be assessed, NPD
and verification and validation activities shall be defined, to ensure compliance with the customer requirements.
NPD
7.1.4 7,1,4 Change control Product & Engineering
change
Clause Requirements
DEPT.

Eff. Date : 02.01.2017
7.1.4 7,1,4 Change control Changes shall be validated before implementation NPD
Product & Engineering
change
For proprietary designs, impact on form, fit and function (including performance and/or durability) shall be reviewed
NPD
with the costumer so that all effects can be properly evaluated.
When required by the costumer, additional verification/identification requirements, such as those required for new
NPD
product introduction, shall be met.
7.3.7 Control of design and development changes NPD & ENG
a) Design and development changes shall be identified and records maintained. NPD & ENG ADSNI- Procedure for
7.3.7 Control of design and
7.3.7 development changes b) The changes shall be reviewed, verified and validated and approved before implementation. NPD & ENG Product & Engineering
change
c) Design and development changes shall include evaluation of the effect of the changes on constituent parts and
NPD & ENG
product already delivered.
a) Production shall be scheduled in order to Meet customer requirements, such as just in time supported by an Production Management,
7.5.1.6 7.5.1.6 Production scheduling information system that permits access to production information at key stages of the process. ADSNI - Procedure for
PPC & PROD. production planning &
control and dispatches.
The organization shall preserve the conformity of product during internal processing and delivery to the intended
PPC ADSNI- Procedure for
destination.
7.5.5 7.5.5 Preservation of product production planning &
The preservation shall include identification, handling, packaging, storage and protection. PPC control and dispatches
Preservation shall also apply to the constituent parts of a product. PPC
In order to detect deterioration, the condition of product in stock shall be assessed at appropriate planned intervals.
PPC
7.5.5.1 7.5.5.1 Storage and inventory The organization shall use an inventory management system to optimize inventory turns over time and assure stock material procurement
PPC
rotation, such as "first-in-first-out" (FIFO).
Obsolete product shall be controlled in a similar manner to nonconforming product. PPC
8.1.1 Identification of statistical Appropriate statistical tools for each process shall be determined during advance quality planning and included in
8.1.1 tools
PE / NPD
the control plan.
Basic statistical concepts, such as variation, control (Stability), process capability and over-adjustment shall be statistical technique
8.1.2 Knowledge of basic
8.1.2 statistical concepts
understood and utilized throughout the organization. PE / NPD
The organization shall obtain a customer concession or deviation permit prior to further processing whenever the
NPD
product or manufacturing process is different from that which is currently approved.
The organization shall maintain a record of the expiration date or quantity authorized
NPD
The organization shall also ensure compliance with the original or superseding specifications and requirements ADSNI- Procedure for
8.3.4 8.3.4 Customer waiver NPD deviation approval
when the authorization expires.
Material shipped on an authorization shall be properly identified on each shipping container. NPD
This applies equally to purchased product. The organization shall approve any requests from suppliers before
submission to the customer NPD
COPQ
d) suppliers ALL
ALL
ADSNI812 - Procedure for
ALL
planning
ALL
kaizen activity.
The organization shall have a defined process for problem solving leading to root cause identification and ADSNI - Procedure for
ALL
corrective & preventive
ADVICS North India Pvt Ltd action Format No. : 01-IMS-04 F07 Rev. No. : 00
Clause Requirements
DEPT.
ADSNI- Procedure
ADSNI procedure namefor
warranty analysis
or number
Eff. Date : 02.01.2017
ALL
occurrence
ALL
Clause Requirements
DEPT.
Eff. Date : 02.01.2017
ALL

ALL
control of records
ALL
management review
ALL
Communication
ALL
The organization shall use a multidisciplinary approach for developing plant, facility and equipment plans. ADSNI - Procedure for New
6.3.1 Plant, facility and Tooling & Maintenance
6.3.1 equipment planning
PE / OM
equipment qualification
requirements
ALL
Kaizen Activity
7,2,1,1 Customer-designated The organization shall demonstrate conformity to customer requirements for designation, documentation and
7.2.1.1 ENG / PE
special characteristics control of special characteristics
The organization shall use a multidisciplinary approach to prepare for product realization, including
7,3,1,1 Multidisciplinary
7.3.1.1 approach -development/finalization and monitoring of special characteristics, - development and review of FMEAs, including PE
actions to reduce potential risks, and
Clause Requirements
DEPT.
Eff. Date : 02.01.2017
the organization shall identify, document and review the manufacturing process design input requirements, including
7,3,2,2 Manufacturing process -product design output data - targets for productivity, process capability and cost, -customer requirements, if any
7.3.2.2 design input PE
and -experience from previous developments,
The organization shall identify special characteristics [see 7,3,3 d)] and -include all special characteristics in the
7.3.2.3 7,3,2,3 Special Characteristics control plan, -comply with customers-specified definitions and symbols, and -identify process control documents PE & ENG
including drawings, FEMAs
The outputs of design and developments shall be provided in a form that enables verification against the design and
PE & ENG
development input and shall be approved prior to release
a) Met the input requirements for design and development, PE & ENG
7,3,3 Design and development
7.3.3 outputs b) provide appropriate information for purchasing, production and for service provision, PE & ENG
c) contain or reference product acceptance criteria, and PE & ENG
b) specify the characteristics of the product that are essential for its safe and proper use. PE & ENG
the product design output shall be expressed in terms that can be verified and validated against product design
PE & ENG
input requirements.
7,3,3,1 Product design outputs
7.3.3.1 - supplemental The product design output shall include -design FMEA, reliability results, -product special characteristics and
specifications, -product error-proofing, as appropriate, -product definition including drawings or mathematically PE & ENG
based data, -product design revision
The manufacturing process design output shall be expressed in terms that can be verified against manufacturing
PE & ENG
process design input requirements and validated.
7,3,3,2 Manufacturing process
7.3.3.2 design output the manufacturing process design output shall include - specifications and drawings, -manufacturing process flow ADSNI- Procedure for new
chart/layout, -manufacturing process FMEAs, -control plan (see 7,5,1,1), -work instructions, -process approval PE & ENG product design &
acceptance criteria, -data for development,
a) to evaluate the ability of the results of design and development to meet requirements, and PE & ENG ADSNI - Procedure for
Implementing product
b) to identify any problems and propose necessary actions. PE & ENG verification
7.3.3.4 review Participants in such reviews shall include representatives of functions concerned with the design and development ADSNI - Procedure for
PE & ENG initial control
stage(s) being reviewed.
records of the results of the review and any necessary actions shall be maintained (see 4,2,4) PE & ENG
Measurements at specified stages of design and development shall be defined, analysed and reported with
7.3.4.1 7,3,4,1 Monitoring PE & ENG
summary results as an input to management review.
7.3.5 Design and development a) Verification shall be performed in accordance with planned arrangements. PE & ENG
7.3.5 verification. b) The results of the verification and any necessary actions shall be maintained. PE & ENG
a) Design and development validation shall be performed in accordance with planned arrangements. PE & ENG
7.3.6 Design and development b) Validation shall be completed prior to the delivery or implementation of the product.
7.3.6 validation.
PE & ENG
c) Records of the results of validation and any necessary actions shall be maintained. PE & ENG
7.3.6.1 Design and a) Design and development validations shall be performed in accordance with customer requirements including
7.3.6.1 development validation - program timing. PE & ENG
Supplemental
a) The organization shall have a prototype programme and control plan. PE & ENG
b) The organization shall use, the same supplier, tooling and manufacturing processes as will be used in production.
PE & ENG
c) All performance- testing activities shall be monitored for timely completion and conformity to requirements. PE & ENG
7.3.6.2 7.3.6.2 Prototype programme d) The organization shall be responsible for the outsourced services, including technical leadership. PE & ENG
7.3.6.3 Product approval process PE & ENG
a) The organization shall conform to a product and manufacturing process approval procedure recognized by the
PE & ENG
customer.
b) The product and manufacturing process approval procedure shall also be applied to suppliers. PE & ENG
7.5.1.1 Control Plan PE
a) The organization shall:
Develop control plans at the system, subsystem, component and/or material level for the product supplied,
including those for processes producing bulk materials as well as parts, and PE
Have a control plan for pre-launch and production that takes into account the des
b) The Control Plan shall: ADSNI- Procedure for
List the controls used for the manufacturing process control. control plan
7.5.1.1 7.5.1.1 Control Plan Include methods for monitoring of control exercised over special characteristics (see 7.3.2.3) defined by both the ADSNI - Procedure for
customer and the organization. manufacturing process
PE planning
Include the customer-required information. If any, and
Initiate the specified reaction plan (see 8.2.3.1) when the process becomes unable or not statistically capable.
c) Control Plans shall be reviewed and updated when any changes occurs affecting product, manufacturing
PE
process, measurement, logistics, supply sources or FMEA (see 7.1.4).
Clause Requirements
DEPT.
Eff. Date : 02.01.2017
7.5.1.5 Management of production tooling PE & MAINT.

a) The organization shall provide resources for tool and gauge design, fabrication and verification activities. PE & MAINT.
7.5.1.5 Management of Maintenance and repair facilities and personnel. ADSNI- Procedure for New
7.5.1.5 production tooling Set-up. Tooling & Maintenance
PE & MAINT.
c) The organization shall implement a system to monitor these activities if any work is outsourced. PE & MAINT.
8.1.1 Identification of statistical Appropriate statistical tools for each process shall be determined during advance quality planning and included in
8.1.1 tools
PE / NPD
the control plan.
Basic statistical concepts, such as variation, control (Stability), process capability and over-adjustment shall be statistical technique
understood and utilized throughout the organization. PE / NPD
ALL
d) suppliers ALL
ALL
ALL
planning
continual improvement,
The organization shall define a process for continual improvement
8.5.1.1 Continual improvement
8.5.1.1 of the organization ALL ADSNI - Procedure for
kaizen activity.
ALL
8.5.2.1 8.5.2.1 Problem solving elimination ADSNI- Procedure for
If a customer-prescribed problem-solving format exists, the organization shall use the prescribed format. ALL corrective & preventive
The organization shall use error-proofing methods in their corrective action process. action
8.5.2.2 8.5.2.2 Error-proofing PE
8.5.2.3 Corrective action The organization shall apply to other similar processes and products the corrective action, and controls warranty analysis
8.5.2.3 impact implemented, to eliminate the cause of a non conformity ALL
ALL
occurrence
ALL
Clause Requirements
DEPT.
Eff. Date : 02.01.2017
ALL

ALL
control of records
ALL
management review
ALL
Communication
ALL
6.4 6.4 Work environment requirements ALL continual improvement
Kaizen Activity
Clause Requirements
DEPT.
Eff. Date : 02.01.2017
7.4 Purchasing process PURCHASING /

SQA
a) The organization shall be ensure that purchased product conforms to specified purchase requirements.} PURCHASING /
SQA
b) The type and extent of control applied to the supplier and the purchased product shall be dependent upon the PURCHASING /
effect of the purchased product on subsequent product realization or the final product. SQA
c) The organization shall evaluate and select supplier based on their ability to supply products in accordance with PURCHASING /
the organization´s requirements. SQA
7.4.1.1 Regulatory conformity PURCHASING /
SQA
a) All purchased product or materials used in product shall conform to applicable regulatory requirements. PURCHASING /
ADSNI -Procedure for
SQA
supplier selection,
7.4.1.2 Supplier quality management system development PURCHASING / ADSNI - Procedure for
SQA supplier development &
upgradation
a) The organization shall perform supplier quality management system development with a goal of supplier PURCHASING / ADSNI - Procedure for
conformity with technical specification. SQA Prequerment of material
7.4.1.3 Customer - approved sources PURCHASING /

SQA
a) The organization shall be purchase products, materials or service from approved sources. PURCHASING /
SQA
PURCHASING /
7.4.2 Purchasing Information SQA
Requirements for approval of product, procedures, processes and equipment. PURCHASING /
7.4.2 7.4.2 Purchasing Information Requirements for qualification of personnel. SQA
b) The organization shall be ensure the adequacy of specified requirements prior to their communication to the PURCHASING /
supplier. SQA
COPQ
d) suppliers ALL
ALL
ALL
planning
management review.
8.5.1.1 Continual improvement continual improvement,
8.5.1.1 of the organization ALL
ALL
ALL
occurrence
ALL
Clause Requirements
DEPT.
Eff. Date : 02.01.2017
4.1.1 General requirements- Ensuring control over outsourced processes shall not absolve the organization of the responsibility of conformity to
4.1.1 supplemental all customer requirements.
QMS 0.1 ADSNI QMS Manual
4.2.1 General. The quality management system documentation shall include QMS
a) documented statements of a quality policy and quality objectives QMS
4.2 Documentation b) a quality manual QMS

4.2 requirements
c) documented procedures required by this International Standard
QMS
d) documents needed by the organization to ensure the effective planning, operation and control of its processes QMS
and
4.2.2 Quality manual. The organization shall establish and maintain a quality manual that includes 0.1 ADSNI QMS Manual
QMS
QMS
4.2.2 4.2.2 Quality Manual b) The documented procedures established for the quality management system, or reference to them, and
QMS
e) a description of the interaction between the processes of the quality management system
QMS
ALL

ALL
control of records
ALL
management review
ALL
Communication
ALL
Kaizen
The organization shall determine SALE / ENG
a) requirements specified by the costumer, including the requirements for delivery and post-delivery activities,
SALE / ENG
7,2,1 Determination of
ADSNI-Procedure for
7.2.1 requirements related to the b) requirements not stated by the costumer but necessary for specified or indented use, where known, SALE / ENG marketing and sales
product,
c) statutory and regulatory requirements related to the product, and SALE / ENG
7,2,1 Determination
ADVICS North Indiaof
Pvt Ltd Format No. : 01-IMS-04 F07 Rev. No. : 00
ADSNI-Procedure for
ISO / TS:16949
7.2.1 requirements related to the RESPONSIBLE marketing and name
salesor number Is Procedure effective? Procedure is If your answer is: "No" , please describe the Eff. Date : 02.01.2017
Clause product, Requirements DEPT.
ADSNI procedure
followed on same area? ( Y/N ) corrective action to close the gap´.
d) any additional requirements determinated by the organization. SALE / ENG

Clause Requirements
DEPT.
Eff. Date : 02.01.2017
The organization shall review the requirements related to the product. SALE & ENG ADSNI- Procedure for new
product design &
This review shall be conducted prior to the organization´s commitment to supply a product to the customer SALE & ENG development.
a) product requirements are defined, SALE & ENG ADSNI-Procedure for

marketing and sales
b) contract order requirements differing from those previously expressed are resolved, and SALE & ENG
7,2,2 Review of requirements
7.2.2 related to the product c) the organization has the ability to meet the defined requirements. SALE & ENG
Records of the results of the review and actions arising from the review shall be maintained (see 4,2,4) SALE & ENG
where the customers provides no documented statement of requirement, the customer requirements shall be
SALE & ENG
confirmed by the organization before acceptance.
Where product requirements are changed, the organization shall ensure that relevant documents are amended and
the relevant personnel are made aware requirements of the changed SALE & ENG
7,2,2,1 Review of requirements Waiving the requirements stated in 7,2,2 for a formal review (See note) shall require customer authorization ADSNI- Procedure for
7.2.2.1 related to the product SALE & ENG deviation approval
-supplemental
7,2,2,2Organization The organization shall investigate, confirm and manufacturing feasibility of the proposed products in the contract
7.2.2.2 manufacturing feasibility SALE & ENG, OM
SALE & QA
relation to
7,2,3 Customer
7.2.3 communication. b) enquiries, contracts or order handling, including amendments, and SALE & QA ADSNI- Procedure for
c) customer feedback, including customers complaints customer complaint
SALE & QA handling process
The organization shall have the ability to communicate necessary information, including data, in a customer
7,2,3,1Customer
7.2.3.1 communication -supplemental specified language and form. SALE & QA
7.5.1.7 Feedback of information from service

SALE
7.5.1.7 Feedback of ADSNI-Procedure for
7.5.1.7 information from service marketing and sales
a) A process for communication of information on service concerns to manufacturing, engineering and design
activities shall be established and maintained. SALE
7.5.1.8 Service agreement with customer

SALE
7.5.1.8 Service agreement with ADSNI-Procedure for
7.5.1.8 customer a) The organization shall verify the effectiveness of: marketing and sales
Any organization service centres.
Any special-purpose tools or measurement equipment. SALE
The training of service personnel.
The organization shall exercise care with customer property while it is under the organization's control or being
used by the organization. SALE
The organization shall identify, verify, protect and safeguard customer property provided for use or incorporation into
SALE
7.5.4 7.5.4 Customer property the product.
If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the
SALE
customer and records maintained (see 4.2.4).
NOTE: Customer property can include intellectual property. SALE
NOTE: Customer-owned returnable packaging is included in this clause. SALE
7.5.4.1 Customer-owned Customer-owned tools, manufacturing, test, inspection tooling and equipment shall be permanently marked so that
7.5.4.1 production tooling the ownership of each item is visible, and can be determined. SALE
As one of the measurements of the performance of the quality management system, the organization shall monitor
information relating to the customer perception as to whether the organization has met customer requirements. SALE
8.2.1 8.2.1 Customer satisfaction
The methods for obtaining and using this information shall be determined. SALE
NOTE: Consideration should be given to both internal and external customers. SALE
Customer satisfaction with the organization shall be monitored through continual evaluation of performance of the
SALE
realization processes.
Performance indicators shall be based on objective data and include, but not be limited to: SALE
- delivered part quality performance, SALE
8.2.1.1 Customer satisfaction - SALE
8.2.1.1 Supplemental
- customer disruptions including field returns,
- delivery schedule performance (including incidents of premium freight), and SALE
- customer notifications related to quality or delivery issues. SALE
The organization shall monitor the performance of manufacturing processes to demonstrate compliance with
SALE
customer requirements for product quality and efficiency of the process.
Clause Requirements
DEPT.
Eff. Date : 02.01.2017
COPQ
d) suppliers ALL
ALL
ALL
planning
management review.
ALL kaizen activity.
ALL
ALL
occurrence
ALL
Clause Requirements
DEPT.
Eff. Date : 02.01.2017
ALL

ALL
engineering standards/specifications and changes based on customer-required schedule. NPD / ENG ADSNI- Procedure for new
product design &
4.2.3.1 Engineering
4.2.3.1 specifications Timely review should be as soon as possible, and shall not exceed two working weeks. NPD / ENG development,
The organization shall maintain a record of the date on which each change is implemented in production, Engineering change
implementation shall include updated documents. NPD / ENG
control of records
ALL
management review
ALL
Top management shall ensure that appropriate communication processes are established within the organization ADSNI Procedure for
Communication
The organization shall ensure that personnel with product design responsibility are competent to achieve design
ENG
6.2.2.1 6.2.2.1 Product design skills requirements and are skilled in applicable tools and techniques
Applicable tools and techniques shall be identified by the organization. ENG
ALL
6.4 6.4 Work environment requirements ALL cntinual improvement
Kaizen Activity
SALE / ENG
ADSNI-Procedure for
7.2.1 requirements related to the b) requirements not stated by the costumer but necessary for specified or indented use, where known, SALE / ENG marketing and sales
product,
7,2,1,1 Customer-designated The organization shall demonstrate conformity to customer requirements for designation, documentation and
7.2.1.1 special characteristics
ENG / PE
control of special characteristics
Clause Requirements
DEPT.
Eff. Date : 02.01.2017
The organization shall review the requirements related to the product. SALE & ENG ADSNI - Procedure for new
product design &
This review shall be conducted prior to the organization´s commitment to supply a product to the customer SALE & ENG development.
a) product requirements are defined, SALE & ENG ADSNI-Procedure for
marketing and sales
SALE & ENG
7,2,2,1 Review of requirements Waiving the requirements stated in 7,2,2 for a formal review (See note) shall require customer authorization ADSNI - Procedure for
7.2.2.1 related to the product SALE & ENG deviation approval
-supplemental
7.2.2.2 manufacturing feasibility SALE & ENG, OM
The organization shall plan and control the design an development of product. ENG
a) the design and developments stages, ENG
b) the review, verification and validation that are appropriate to each design and development stage, and ENG
7,3,1 design and development
7.3.1 planning
c) the responsibilities and authorities for design and development ENG
the organization shall manage the interfaces between different groups involved in design and development to
ensure effective communication and clear assignment of responsibility. ENG
planning output shall be updated, as appropriate, as the design and developments progresses. ENG
Inputs relating to product requirements shall be determinated and records maintained (see 4,2,4). ENG
a) functional and performance requirements ENG
b) applicable statutory and regulatory requirements ENG
7,3,2 Design and development c) where applicable, information derived from previous similar designs, and
7.3.2 inputs
ENG
d) other requirements essential for design and development. ENG
these inputs shall be reviewed for adequacy. ENG
Requirements shall be complete, unambiguous and not in conflict with each other ENG
The organization shall identify, document and review the product design inputs requirement, including the following:
-customer requirements (contract review) such as special characteristics (see 7,3,2,3) identification, traceability and ENG
packaging;
7.3.21 7,3,2,1 Product design input
Use of information. The organization shall have a process to deploy information gained from previous design
competitor analysis, supplier feed back, internal input, file data, and other relevant sources, for current and future ENG
projects of a similar nature
7.3.2.3 7,3,2,3 Special Characteristics control plan, -comply with customers-specified definitions and symbols, and -identify process control documents PE & ENG
PE & ENG
a) Met the input requirements for design and development, PE & ENG
7.3.3 outputs b) provide appropriate information for purchasing, production and for service provision, PE & ENG
c) contain or reference product acceptance criteria, and PE & ENG
ADSNI - Procedure for new
b) specify the characteristics of the product that are essential for its safe and proper use. PE & ENG product design &
the product design output shall be expressed in terms that can be verified and validated against product design development,
PE & ENG ADSNI- Procedure for
input requirements.
7,3,3,1 Product design outputs Implementing product
7.3.3.1 - supplemental The product design output shall include -design FMEA, reliability results, -product special characteristics and verification
specifications, -product error-proofing, as appropriate, -product definition including drawings or mathematically PE & ENG ADSNI - Procedure for
based data, -product design revision initial control
PE & ENG
7.3.3.2 design output the manufacturing process design output shall include - specifications and drawings, -manufacturing process flow
chart/layout, -manufacturing process FMEAs, -control plan (see 7,5,1,1), -work instructions, -process approval PE & ENG
acceptance criteria, -data for
a) to evaluate the ability of the results of design and development to meet requirements, and PE & ENG
b) to identify any problems and propose necessary actions. PE & ENG
7.3.3.4 review Participants in such reviews shall include representatives of functions concerned with the design and development
PE & ENG
records of the results of the review and any necessary actions shall be maintained (see 4,2,4) PE & ENG
Measurements at specified stages of design and development shall be defined, analysed and reported with
7.3.4.1 7,3,4,1 Monitoring PE & ENG
summary results as an input to management review.
7.3.5 Design and development a) Verification shall be performed in accordance with planned arrangements. PE & ENG
7.3.5 verification. b) The results of the verification and any necessary actions shall be maintained. PE & ENG
Clause Requirements
DEPT.
Eff. Date : 02.01.2017
a) Design and development validation shall be performed in accordance with planned arrangements. PE & ENG
7.3.6 validation.
PE & ENG
c) Records of the results of validation and any necessary actions shall be maintained. PE & ENG
7.3.6.1 development validation - program timing. PE & ENG
Supplemental
a) The organization shall have a prototype programme and control plan. PE & ENG
PE & ENG
c) All performance- testing activities shall be monitored for timely completion and conformity to requirements. PE & ENG
7.3.6.2 7.3.6.2 Prototype programme d) The organization shall be responsible for the outsourced services, including technical leadership. PE & ENG
7.3.6.3 Product approval process PE & ENG
PE & ENG
customer.
b) The product and manufacturing process approval procedure shall also be applied to suppliers. PE & ENG
a) Design and development changes shall be identified and records maintained. NPD & ENG
7.3.7 Control of design and ADSNI - Procedure for
7.3.7 development changes b) The changes shall be reviewed, verified and validated and approved before implementation. NPD & ENG Engineering change
NPD & ENG
COPQ
d) suppliers ALL
ALL
ALL
planning
management review.
ALL
ALL
occurrence
ALL
Clause Requirements
DEPT.
Eff. Date : 02.01.2017
ALL

ALL
control of records
ALL
management review
ALL
Communication
The organization shall determine and provide the resources needed
a) to implement and maintain the quality management system and continually improve its effectiveness and HR
6.1 6.1 Provision of resources
b) to enhance customer satisfaction by meeting customer requirements HR

6.2.1 Human resources. Personnel performing work affecting product quality shall be competent on the basis of appropriate education,
6.2.1 General
HR
training, skills and experience.
The organization shall a) determine the necessary competence for personnel performing work affecting product
quality HR
b) provide training or take other actions to satisfy these needs, HR
6.2.2 Competence, awareness Training & Development
6.2.2 and training c) evaluate the effectiveness of the actions taken, HR
d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to
HR
the achievement of the quality objectives and
e) maintain appropriate records of education, training, skills and experience HR
The organization shall establish and maintain documented procedures for identifying training needs and achieving
competence of all personnel performing activities affecting product quality. HR
6.2.2 6.2.2 Training
Personnel performing specific assigned tasks shall be qualified, as required, with particular attention to the
satisfaction of customer requirements. HR
ALL
The organization shall have a process to motivate employees to achieve quality objectives, to make continual
improvements and to create an environment to promote innovation HR
The process shall include the promotion of quality and technological awareness throughout the whole organization ADSNI- Procedure for
6.2.2.4 Employee motivation
6.2.2.4 and empowerment HR employee motivation &
empowerment
The organization shall have a process to measure the extent to which its personnel are aware of the relevance and
the importance of their activities and how they contribute to the achievement of the quality objectives. HR
Clause Requirements
DEPT.
Eff. Date : 02.01.2017
The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product
HR / OM
requirements. Infrastructure includes
6.3 6.3 Infrastructure
b) process equipment (both hardware and software), and HR / MANT.
c) supporting services (such as transport or communication) HR
Kaizen Activity
COPQ
d) suppliers ALL
ALL
ALL
planning
management review.
8.5.1.1 of the organization ALL kaizen activity.
ALL
8.5.2.3 Corrective action The organization shall apply to other similar processes and products the corrective action, and controls ADSNI8 - Procedure for
ALL
occurrence
ALL
Clause Requirements
DEPT.
Eff. Date : 02.01.2017
4.1 General requirements. The organization shall establish, document, implement and maintain a quality
management system and continually improve its effectiveness in accordance with the requirements of this QMS
International Standard. The organization shall: 0.1 ADSNI QMS Manual
a) Identify the processes needed for the quality management system and their application throughout the
QMS
organization
b) determine the sequence and interaction of these processes QMS ADSNI Process Map
c) determine criteria and methods needed to ensure that both the operation and control of these processes are
QMS
effective
d) ensure the availability of resources and information necessary to support the operation and monitoring of these
QMS
4.1 General Requirements processes
e) monitor, measure where applicable, and analyse these process, and QMS
f) implement actions necessary to achieve planned results and continual improvement of these processes. QMS
These processes shall be managed by the organization in accordance with the requirements of this International
standard QMS 0.1 ADSNI QMS Manual
Where an organization chooses to outsource any process that affects product conformity with requirements, the
organization shall ensure control over such processes. QMS
Control of such outsourced processes shall be identified within the quality management system QMS
4.1.1 General requirements- Ensuring control over outsourced processes shall not absolve the organization of the responsibility of conformity to
4.1.1 supplemental all customer requirements. QMS
4.2 requirements c) documented procedures required by this International Standard QMS
d) documents needed by the organization to ensure the effective planning, operation and control of its processes
and QMS
0.1 ADSNI QMS Manual
QMS
4.2.2 4.2.2 Quality Manual
b) The documented procedures established for the quality management system, or reference to them, and
QMS
e) a description of the interaction between the processes of the quality management system QMS
ALL

ALL
control of records
Top management shall provide evidence of its commitment to the development and implementation of the quality
management system and continually improving its effectiveness by QMS
a) communication to the organization the importance of meeting customer as well as statutory and regulatory
QMS
requirements,
5.1 5.1 Management commitment b) establishing the quality policy, QMS 0.1 ADSNI QMS Manual,
c) ensuring that quality objectives are established QMS Management responsibility,
d) conducting management review, and QMS ADSNI107 - Procedure for
management review
e) ensuring the availability of resources QMS meeting
Top management shall review the product realization processes and the support processes to assure their
5.1.1 5.1.1 Process efficiency QMS
effectiveness and efficiency.
Top management shall ensure that customer requirements are determined and are meth with the aim of enhancing
5.2 5.2 Customer focus QMS
customer satisfaction
Clause Requirements
DEPT.
Eff. Date : 02.01.2017

ALL
management review
ALL
Top management shall ensure that
a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1 as QMS
5.4.2 Quality management well as the quality objectives, and
5.4.2 system planning
b) the integrity of the quality management system is maintained when changes to the quality management system
are planned and implemented. QMS
5.5.1 Responsibility and Top management shall ensure

5.5.1 authority
QMS
Managers with responsibility and authority for corrective action shall be promptly informed of products or processes
QMS
which do not conform to requirements.
5.5.1.1 Responsibility for Personnel responsible for product quality shall have the authority to stop production to correct quality problems
5.5.1.1 quality
QMS
ADSNI -Procedure for
Production operations across all shifts shall be staffed with personnel in charge of, or delegated responsibility for, Management Responsibility,
QMS Process Interaction
ensuring product quality.
mapping
Top management shall appoint a member of management who, irrespective of other responsibilities, shall have
QMS
responsibility and authority that includes.
a) ensuring that processes needed for the quality management system are established, implemented and
maintained, QMS
5.5.2 Management
5.5.2 representative b) reporting to top management on the performance of the quality management system and any need for
improvement and QMS
c) ensuring the promotion of awareness of customer requirements throughout the organization. QMS
Top management shall designate personnel with responsibility and authority to ensure that customer requirements
QMS
5.5.2.1 Customer are addressed.
5.2.2.1 representative
This includes selection of special characteristics, setting quality objectives and related training, corrective and
QMS
preventive actions, product design and development.
Communication
Top management shall review the organization's quality management system, at planned intervals, to ensure its
QMS
continuing suitability, adequacy and effectiveness.
5.6.1 5.6.1 Management review This review shall include assessing opportunities for improvement and the need for changes to the quality
QMS
management system, including the quality policy and quality objectives.
Records from management reviews shall be maintained QMS
These reviews shall include all requirements of the quality management system and its performance trends as an
QMS
essential part of the continual improvement process.
Part of the management review shall be the monitoring of quality objectives, and the regular reporting and
5.6.1.1 Quality management QMS
5.6.1.1 system performance evaluation of the cost of poor quality
These results shall be recorded to provide, as a minimum, evidence of the achievement of the quality objectives
QMS
specified in the business plan and
customer satisfaction with product supplied QMS
The input to management review shall include information on results of audits QMS
b) customer feedback QMS Management Review
Meeting
c) process performance and product conformity QMS
5.6.2 5.6.2 Review input d) status of preventive and corrective actions QMS
e) follow up actions from previous management reviews, QMS
f) changes that could affect the quality management system QMS
g) recommendations for improvement QMS
5.6.2.1 Review input- Input to management review shall include an analysis of actual and potential field-failures and their impact on
5.6.2.1 supplemental
QMS
quality, safety or the environment
The output from the management review shall include any decisions and actions related to improvement of the
QMS
effectiveness of the quality management system and its processes,
5.6.3 5.6.3 Review output b) improvement of product related to customer requirements and QMS
c) resource needs QMS
ALL
6.4 6.4 Work environment requirements ALL Continual improvement
kaizen Activity
Clause Requirements
DEPT.
Eff. Date : 02.01.2017
The organization shall plan and implement the monitoring, measurement, analysis and improvement processes
QMS
needed
a) to demonstrate conformity of the product, QMS ADSNI - Procedure for
8.1 8.1 General b) to ensure conformity of the quality management system, and QMS Internal quality system
c) to continually improve the effectiveness of the quality management system. QMS Audit.
This shall include determination of applicable methods, including statistical techniques, and the extent of their use.
QMS
Clause Requirements
DEPT.
Eff. Date : 02.01.2017
The organization shall conduct internal audits at planned intervals to determine whether the quality management
QMS
system
a) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the
QMS
quality management system requirements established by the organization, and
b) is effectively implemented and maintained. QMS
An audit program shall be planned, taking into consideration the status and importance of the processes and areas
QMS
to be audited, as well as the results of previous audits.
The audit criteria, scope, frequency and methods shall be defined. QMS
8.2.2 8.2.2 Internal audit Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. QMS ADSNI- Procedure for
Auditors shall not audit their own work. QMS Internal Quality system
The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining Audit
QMS
records (see 4.2.4) shall be defined in a documented procedure.
The management responsible for the area being audited shall ensure the actions are taken without undue delay to
QMS
eliminate detected nonconformities and their causes.
Follow-up activities shall include the verification of the actions taken and the reporting of verification results (see
QMS
8.5.2).
NOTE: See ISO 10011-1, ISO 10011-2 and ISO 10011-3 for guidance. QMS
8.2.2.1 Quality management The organization shall audit its quality management system to verify compliance with this Technical Specification
8.2.21 system audit and any additional quality management system requirements. QMS
Internal audits shall cover all quality management related processes, activities and shifts, and shall be scheduled ADSNI - Procedure for
8.2.2.4 8.2.2.4 Internal audit plans according to an annual plan. QMS Internal Quality system
Audit
The organization shall have internal auditors who are qualified to audit the requirements of this Technical ADSNI-Procedure for
8.2.2.5 Internal auditor Specification
8.2.2.5 qualification QMS identified & selection of
Internal Auditors
COPQ
d) suppliers ALL
ALL
ALL
planning
management review.
8.5.1.1 of the organization ALL kaizen activity.
ALL
ALL
occurrence
ALL
Clause Requirements
DEPT.
Eff. Date
Target Date
: 02.01.2017
Comments
ALL

b) to review and update as necessary and re-approve documents ALL
4.2.3 4.2.3 Control of documents ADSNI - Procedure for control of documents
ALL
management system shall be controlled.
4.2.4 4.2.4 Control of records The organization shall establish a documented procedure to define the controls needed for identification, storage, ALL ADSNI- Procedure for control of records
Records shall remain legible, readily identifiable and retrievable. ALL

4.2.4.1 4.2.4.1 Records retention ADSNI- Procedure for record retention
ALL
c) provides a framework for establishing and reviewing quality objectives, ALL ADSNI - Procedure for management review
ALL
Top management shall ensure that appropriate communication processes are established within the organization
ADSNI- Procedure for Internal & External
5.5.3 5.5.3 Internal communication and that communication takes place regarding the effectiveness of the quality management system. ALL
Communication
ALL
including contract or agency personnel.
6.2.2.3 6.2.2.3 Training on the job Personnel whose work can affect quality shall be informed about the consequences to the customer of
ADSNI - Procedure for Training & Development
The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product
HR / OM
6.3 6.3 Infrastructure requirements. Infrastructure includes
The organization shall use a multidisciplinary approach for developing plant, facility and equipment plans. ADSNI- Procedure for New Tooling
development & Maintenance
6.3.1 Plant, facility and
6.3.1 equipment planning
PE / OM
The organization shall determine and manage the work environment needed to achieve conformity to product ADSNI- Procedure for continual improvement
requirements
ALL
Kaizen
Clause Requirements
DEPT.
Eff. Date
Target Date
: 02.01.2017
Comments
7.2.2.2 SALE & ENG, OM
manufacturing feasibility
ALL
8.4 8.4 Analysis of data ADSNI - Procedure for COPQ
d) suppliers ALL
ALL
8.4.1 8.4.1 Analysis and use of data b) determination of key customer-related trends and correlation for status review, decision-making and longer term ADSNI - Procedure for COPQ
ALL
planning
management review.
The organization shall define a process for continual improvement ADSNI- Procedure for continual improvement
8.5.1.1 Continual improvement kaizen
ALL ADSNI - Procedure for corrective & preventive
8.5.2.1 8.5.2.1 Problem solving elimination
8.5.2.3 Corrective action The organization shall apply to other similar processes and products the corrective action, and controls ADSNI- Procedure for warranty analysis
8.5.2.3 impact implemented, to eliminate the cause of a non conformity ALL
ALL
occurrence
ALL
Format No. : 01-IMS-04 F07 Rev.
Eff. Date : 02.01.2017
No. : 00
Eff. Date : 02.01.2017
Clause Requirements
DEPT.
Is Procedure effective?
Procedure is followed on same area? ( Y/N )
4.1 General requirements. The organization shall establish, document, implement and maintain a quality
management system and continually improve its effectiveness in accordance with the requirements of this QMS
International Standard. The organization shall: 0.1 ADSNI QMS Manual
a) Identify the processes needed for the quality management system and their application throughout the
QMS
organization
b) determine the sequence and interaction of these processes QMS ADSNI Process Map
c) determine criteria and methods needed to ensure that both the operation and control of these processes are
QMS
effective
d) ensure the availability of resources and information necessary to support the operation and monitoring of these
QMS
4.1 General Requirements processes
e) monitor, measure where applicable, and analyse these process, and QMS
f) implement actions necessary to achieve planned results and continual improvement of these processes. QMS
These processes shall be managed by the organization in accordance with the requirements of this International
standard QMS 0.1 ADSNI QMS Manual
Where an organization chooses to outsource any process that affects product conformity with requirements, the
organization shall ensure control over such processes. QMS
Control of such outsourced processes shall be identified within the quality management system QMS
4.1.1 General requirements- Ensuring control over outsourced processes shall not absolve the organization of the responsibility of conformity to all
4.1.1 supplemental customer requirements. QMS
4.2 requirements c) documented procedures required by this International Standard QMS
d) documents needed by the organization to ensure the effective planning, operation and control of its processes and
QMS
0.1 ADSNI QMS Manual
QMS
4.2.2 4.2.2 Quality Manual
b) The documented procedures established for the quality management system, or reference to them, and
QMS
e) a description of the interaction between the processes of the quality management system QMS
engineering standards/specifications and changes based on customer-required schedule. NPD / ENG
4.2.3.1 Engineering
4.2.3.1 specifications Timely review should be as soon as possible, and shall not exceed two working weeks. NPD / ENG
The organization shall maintain a record of the date on which each change is implemented in production,
implementation shall include updated documents. NPD / ENG
Top management shall provide evidence of its commitment to the development and implementation of the quality
management system and continually improving its effectiveness by
a) communication to the organization the importance of meeting customer as well as statutory and regulatory
requirements,
5.1 5.1 Management commitment b) establishing the quality policy,
c) ensuring that quality objectives are established
d) conducting management review, and
e) ensuring the availability of resources
Top management shall review the product realization processes and the support processes to assure their
5.1.1 5.1.1 Process efficiency
effectiveness and efficiency.
Top management shall ensure that customer requirements are determined and are meth with the aim of enhancing
5.2 5.2 Customer focus
customer satisfaction
Top management shall ensure that
a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1 as well
5.4.2 Quality management as the quality objectives, and
5.4.2 system planning
b) the integrity of the quality management system is maintained when changes to the quality management system are
planned and implemented.
5.5.1 Responsibility and Top management shall ensure

5.5.1 authority
Managers with responsibility and authority for corrective action shall be promptly informed of products or processes
which do not conform to requirements.
5.5.1.1 Responsibility for Personnel responsible for product quality shall have the authority to stop production to correct quality problems
5.5.1.1 quality
Production operations across all shifts shall be staffed with personnel in charge of, or delegated responsibility for,
ensuring product quality.
Top management shall appoint a member of management who, irrespective of other responsibilities, shall have
responsibility and authority that includes.
5.5.2 Management
ADVICS North India Pvt Ltd a) ensuring that processes needed for the quality management system are established, implemented and maintained, Format No. : 01-IMS-04 F07 Rev. No. : 00
5.5.2 Management Eff. Date : 02.01.2017
5.5.2 representative b) reporting to top management on the performance of the quality management system and any need for
improvement and
c) ensuring the promotion of awareness of customer requirements throughout the organization.
Top management shall designate personnel with responsibility and authority to ensure that customer requirements
5.5.2.1 Customer are addressed.
5.2.2.1 representative This includes selection of special characteristics, setting quality objectives and related training, corrective and
preventive actions, product design and development.
Top management shall review the organization's quality management system, at planned intervals, to ensure its
continuing suitability, adequacy and effectiveness.
5.6.1 5.6.1 Management review This review shall include assessing opportunities for improvement and the need for changes to the quality
management system, including the quality policy and quality objectives.
Records from management reviews shall be maintained
These reviews shall include all requirements of the quality management system and its performance trends as an
essential part of the continual improvement process.
Part of the management review shall be the monitoring of quality objectives, and the regular reporting and evaluation
5.6.1.1 Quality management of the cost of poor quality
5.6.1.1 system performance
These results shall be recorded to provide, as a minimum, evidence of the achievement of the quality objectives
specified in the business plan and
customer satisfaction with product supplied
The input to management review shall include information on results of audits
b) customer feedback
c) process performance and product conformity
5.6.2 5.6.2 Review input d) status of preventive and corrective actions
e) follow up actions from previous management reviews,
f) changes that could affect the quality management system
g) recommendations for improvement
5.6.2.1 Review input- Input to management review shall include an analysis of actual and potential field-failures and their impact on quality,
5.6.2.1 supplemental safety or the environment
The output from the management review shall include any decisions and actions related to improvement of the
effectiveness of the quality management system and its processes,
5.6.3 5.6.3 Review output b) improvement of product related to customer requirements and
c) resource needs
The organization shall determine and provide the resources needed
a) to implement and maintain the quality management system and continually improve its effectiveness and
6.1 6.1 Provision of resources
b) to enhance customer satisfaction by meeting customer requirements

6.2.1 Human resources. Personnel performing work affecting product quality shall be competent on the basis of appropriate education,
6.2.1 General training, skills and experience.
The organization shall a) determine the necessary competence for personnel performing work affecting product
quality
b) provide training or take other actions to satisfy these needs,
6.2.2 Competence, awareness
6.2.2 and training c) evaluate the effectiveness of the actions taken,
d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to
the achievement of the quality objectives and
e) maintain appropriate records of education, training, skills and experience
The organization shall ensure that personnel with product design responsibility are competent to achieve design
6.2.2.1 6.2.2.1 Product design skills requirements and are skilled in applicable tools and techniques
Applicable tools and techniques shall be identified by the organization.
The organization shall establish and maintain documented procedures for identifying training needs and achieving
competence of all personnel performing activities affecting product quality.
6.2.2 6.2.2 Training
Personnel performing specific assigned tasks shall be qualified, as required, with particular attention to the
satisfaction of customer requirements.
The organization shall have a process to motivate employees to achieve quality objectives, to make continual
improvements and to create an environment to promote innovation
6.2.2.4 Employee motivation The process shall include the promotion of quality and technological awareness throughout the whole organization
6.2.2.4 and empowerment
The organization shall have a process to measure the extent to which its personnel are aware of the relevance and
the importance of their activities and how they contribute to the achievement of the quality objectives.
b) process equipment (both hardware and software), and

c) supporting services (such as transport or communication)
Plant layouts shall optimize material travel, handling and value-added use of floor space, and shall facilitate
synchronous material flow. Methods shall be developed and implemented to evaluate and monitor the effectiveness
of existing operations
The organization shall prepare contingency plans to satisfy customer requirements in the event of an emergency
6.3.2 6.3.2 Contingency plans
such as utility interruptions, labour shortages, key equipment failure and field returns.
Product safety and means to minimize potential risks to employees shall be addressed by the organization, especially
6.4.1 Personnel safety to
6.4.1 achieve product quality
in the design and development process and in manufacturing process activities.
ADVICS North India Pvt Ltd The organization shall plan and develop the processes needed for product realization. NPD Format No. : 01-IMS-04 F07 Rev. No. : 00
Eff. Date : 02.01.2017
Planning of product realization shall be consistent with the requirements of the other processes of the quality
NPD
management system (see 4.1)
In planning product realization, the organization shall determine the following, as appropriate: a) quality objectives
NPD
and requirements for the product
7.1 Planning of product b) the need to establish processes, documents and provide resources specific to the product, NPD
7.1 realization
c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for
NPD
product acceptance
d) record needed to provide evidence that the realization processes and resulting product meet requirements (see
NPD
4.2.4)
The output of this planning shall be in a form suitable for the organization's method of operations NPD
7,1,1 Planning of product Customer requirements and references to its technical specifications shall be included in the planning of product
7.1.1 NPD
realization- supplemental realization as a component of the quality plan.
Acceptance criteria shall be defined by the organization and, where required by the costumer.
7.1.2 7,1,2 Acceptance criteria
For attribute data sampling, the acceptance levels shall be zero defects (see 8,2,3,1).
The organization shall have a process to control and react to changes that impact product realization. NPD
The effects of any change, including those changes caused by any supplier, shall be assessed, NPD
and verification and validation activities shall be defined, to ensure compliance with the customer requirements. NPD
7.1.4 7,1,4 Change control Changes shall be validated before implementation NPD
For proprietary designs, impact on form, fit and function (including performance and/or durability) shall be reviewed
NPD
with the costumer so that all effects can be properly evaluated.
When required by the costumer, additional verification/identification requirements, such as those required for new
NPD
product introduction, shall be met.
SALE / ENG
7.2.1 requirements related to the b) requirements not stated by the costumer but necessary for specified or indented use, where known, SALE / ENG
product,
7,2,1,1 Customer-designated The organization shall demonstrate conformity to customer requirements for designation, documentation and control
7.2.1.1 special characteristics
SALE & ENG
of special characteristics
The organization shall review the requirements related to the product. SALE & ENG
This review shall be conducted prior to the organization´s commitment to supply a product to the customer SALE & ENG
a) product requirements are defined, SALE & ENG
SALE & ENG
7,2,2,1 Review of requirements Waiving the requirements stated in 7,2,2 for a formal review (See note) shall require customer authorization
7.2.2.1 related to the product SALE & ENG, OM
-supplemental
SALE & QA
relation to
7,2,3 Customer
7.2.3 communication. b) enquiries, contracts or order handling, including amendments, and SALE & QA
c) customer feedback, including customers complaints
SALE & QA
The organization shall have the ability to communicate necessary information, including data, in a customer specified
7,2,3,1Customer
7.2.3.1 communication -supplemental language and form. SALE & QA
The organization shall plan and control the design an development of product.
a) the design and developments stages,
b) the review, verification and validation that are appropriate to each design and development stage, and
7,3,1 design and development
7.3.1 planning
c) the responsibilities and authorities for design and development
the organization shall manage the interfaces between different groups involved in design and development to ensure
effective communication and clear assignment of responsibility.
planning output shall be updated, as appropriate, as the design and developments progresses.
The organization shall use a multidisciplinary approach to prepare for product realization, including
7,3,1,1 Multidisciplinary
7.3.1.1 approach -development/finalization and monitoring of special characteristics, - development and review of FMEAs, including
actions to reduce potential risks, and
Inputs relating to product requirements shall be determinated and records maintained (see 4,2,4).
a) functional and performance requirements
b) applicable statutory and regulatory requirements
7,3,2 Design and development c) where applicable, information derived from previous similar designs, and
7.3.2 inputs
d) other requirements essential for design and development.
7.3.2 inputs
ADVICS North India Pvt Ltd these inputs shall be reviewed for adequacy. Format No. : 01-IMS-04 F07 Rev. No. : 00
Eff. Date : 02.01.2017
Requirements shall be complete, unambiguous and not in conflict with each other
The organization shall identify, document and review the product design inputs requirement, including the following:
-customer requirements (contract review) such as special characteristics (see 7,3,2,3) identification, traceability and
packaging;
7.3.21 7,3,2,1 Product design input
Use of information. The organization shall have a process to deploy information gained from previous design
competitor analysis, supplier feed back, internal input, file data, and other relevant sources, for current and future
projects of a similar nature
the organization shall identify, document and review the manufacturing process design input requirements, including
7,3,2,2 Manufacturing process -product design output data - targets for productivity, process capability and cost, -customer requirements, if any and
7.3.2.2 design input
-experience from previous developments,
7.3.2.3 7,3,2,3 Special Characteristics control plan, -comply with customers-specified definitions and symbols, and -identify process control documents
a) Met the input requirements for design and development,
7.3.3 outputs b) provide appropriate information for purchasing, production and for service provision,
c) contain or reference product acceptance criteria, and
b) specify the characteristics of the product that are essential for its safe and proper use.
the product design output shall be expressed in terms that can be verified and validated against product design input
requirements.
7,3,3,1 Product design outputs
7.3.3.1 - supplemental The product design output shall include -design FMEA, reliability results, -product special characteristics and
specifications, -product error-proofing, as appropriate, -product definition including drawings or mathematically based
data, -product design revision
7.3.3.2 design output the manufacturing process design output shall include - specifications and drawings, -manufacturing process flow
chart/layout, -manufacturing process FMEAs, -control plan (see 7,5,1,1), -work instructions, -process approval
acceptance criteria, -data for
a) to evaluate the ability of the results of design and development to meet requirements, and
b) to identify any problems and propose necessary actions.
7.3.3.4 review Participants in such reviews shall include representatives of functions concerned with the design and development
records of the results of the review and any necessary actions shall be maintained (see 4,2,4)
Measurements at specified stages of design and development shall be defined, analysed and reported with summary
7.3.4.1 7,3,4,1 Monitoring
results as an input to management review.
7.3.5 Design and development a) Verification shall be performed in accordance with planned arrangements.
7.3.5 verification. b) The results of the verification and any necessary actions shall be maintained.
a) Design and development validation shall be performed in accordance with planned arrangements.
7.3.6 validation.
c) Records of the results of validation and any necessary actions shall be maintained.
7.3.6.1 development validation - program timing.
Supplemental
a) The organization shall have a prototype programme and control plan.
c) All performance- testing activities shall be monitored for timely completion and conformity to requirements.
7.3.6.2 7.3.6.2 Prototype programme d) The organization shall be responsible for the outsourced services, including technical leadership.
7.3.6.3 Product approval process
customer.
b) The product and manufacturing process approval procedure shall also be applied to suppliers.
a) Design and development changes shall be identified and records maintained. NPD & ENG
7.3.7 Control of design and
7.3.7 development changes b) The changes shall be reviewed, verified and validated and approved before implementation. NPD & ENG
NPD & ENG
7.4 Purchasing process
PURCHASING / SQA
a) The organization shall be ensure that purchased product conforms to specified purchase requirements.} PURCHASING / SQA
b) The type and extent of control applied to the supplier and the purchased product shall be dependent upon the
PURCHASING / SQA
effect of the purchased product on subsequent product realization or the final product.
c) The organization shall evaluate and select supplier based on their ability to supply products in accordance with the
organization´s requirements. PURCHASING / SQA
7.4.1.1 Regulatory conformity

PURCHASING / SQA
a) All purchased product or materials used in product shall conform to applicable regulatory requirements.
7.4 7.4 Purchasing process PURCHASING / SQA
7.4.1.2 Supplier quality management system development

PURCHASING / SQA
a) The organization shall perform supplier quality management system development with a goal of supplier conformity
with technical specification. PURCHASING / SQA
ADVICS North India Pvt Ltd 7.4.1.3 Customer - approved sources Format No. : 01-IMS-04 F07 Rev. No. : 00
PURCHASING / SQA Eff. Date : 02.01.2017
a) The organization shall be purchase products, materials or service from approved sources.
PURCHASING / SQA
7.4.2 Purchasing Information PURCHASING / SQA

Requirements for approval of product, procedures, processes and equipment.
Requirements for qualification of personnel. PURCHASING / SQA
7.4.2 7.4.2 Purchasing Information
b) The organization shall be ensure the adequacy of specified requirements prior to their communication to the
PURCHASING / SQA
supplier.
7.4.3 Verification of purchased product.
7.4.3 Verification of purchased a) The organization shall establish and implemented the inspection or other activities necessary for ensuring that
7.4.3 product. purchased product meets specified purchase requirements.
b) The organization shall state the intended verification arrangements and method of product release in the
purchasing information.
7.4.3.1 Incoming Product quality
a) The organization shall have a process to assure the quality of purchased product utilizing one or more of the
7.4.3.1 Incoming Product
7.4.3.1 quality
following methods:
Receipt of, and evaluation of, statistical data by the organization.
Receiving inspection and/or testing
7.4.3.2 Supplier Monitoring PURCHASING
a) Supplier performance shall be monitored through the following indicators:
Delivered product quality.
7.4.3.2 7.4.3.2 Supplier Monitoring Customer disruptions including field returns. PURCHASING
Delivery schedule performance.
Special status customer notifications
b) The organization shall promote supplier monitoring of the performance of their manufacturing processes. PURCHASING
7.5 Production and service 7.5.1 Control of production and service provision
7.5 provision
a) The organization shall plan and carry out production and service provision under controlled condition. PRODUCTION / QA
7.5.1 Control of production and b) The availability of work instructions.
7.5.1 service provision c) The use of suitable equipment.
PRODUCTION / QA
d) The availability and use of monitoring and measuring devices
7.5.1.1 Control Plan

a) The organization shall:
Develop control plans at the system, subsystem, component and/or material level for the product supplied, including
those for processes producing bulk materials as well as parts, and
Have a control plan for pre-launch and production that takes into account the des
b) The Control Plan shall:
List the controls used for the manufacturing process control.
7.5.1.1 7.5.1.1 Control Plan Include methods for monitoring of control exercised over special characteristics (see 7.3.2.3) defined by both the
customer and the organization.
Include the customer-required information. If any, and
Initiate the specified reaction plan (see 8.2.3.1) when the process becomes unable or not statistically capable.
c) Control Plans shall be reviewed and updated when any changes occurs affecting product, manufacturing process,
measurement, logistics, supply sources or FMEA (see 7.1.4).
7.5.1.2 Work Instructions PRODUCTION
a) The organization shall prepare documented work instruction for all employees having responsibilities for the
PRODUCTION
7.5.1.2 7.5.1.2 Work Instructions operation of processes that impact product quality.
b) The instruction shall be derived from sources such as the quality plan, the control plan and the product realization
PRODUCTION
process.
7.5.1.3 Verification of job set-ups
a). Job set-ups shall be verified whenever performed , such as an initial run of a job, material changeover or job
7.5.1.3 Verification of job set-
7.5.1.3 ups change.
b) Work instructions shall be available for set-up personnel.
c) The organization shall use statistical methods of verification where applicable.
7.5.1.4 Preventive and predictive maintenance
a) The organization shall identify key process equipment and provide resources for machine/equipment maintenance
and develop an affective planned total preventive system.
b) The system shall include:
7.5.1.4 Preventive and Planned maintenance activities.
7.5.1.4 predictive maintenance
Packaging and preservation of equipment, tooling and gauging.
Availability of replacement parts for key manufacturing equipment.
Documenting, evaluating and improving maintenance
c) The organization shall utilize predictive maintenance methods to continually improve the effectiveness and the
efficiency of production equipment.
7.5.1.5 Management of production tooling
a) The organization shall provide resources for tool and gauge design, fabrication and verification activities.
7.5.1.5 Management of Maintenance and repair facilities and personnel.
7.5.1.5 production tooling Set-up.
c) The organization shall implement a system to monitor these activities if any work is outsourced.
7.5.1.6 7.5.1.6 Production scheduling

ADVICS North India Pvt Ltd a) Production shall be scheduled in order to Meet customer requirements, such as just in time supported by an Format No. : 01-IMS-04 F07 Rev. No. : 00
7.5.1.6 7.5.1.6 Production scheduling information system that permits access to production information at key stages of the process. Eff. Date : 02.01.2017
PPC & PROD.
7.5.1.7 Feedback of information from service

7.5.1.7 Feedback of
7.5.1.7 information from service
a) A process for communication of information on service concerns to manufacturing, engineering and design
activities shall be established and maintained.
7.5.1.8 Service agreement with customer
7.5.1.8 Service agreement with

7.5.1.8 customer a) The organization shall verify the effectiveness of:
Any organization service centres.
Any special-purpose tools or measurement equipment.
The training of service personnel.
7.5.2 The organization shall validate any processes for production and service provision where the resulting output
cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies
become apparent only after the product is in use or the service has been delivered.
7.5.2 Validation of processes

Validation shall demonstrate the ability of these processes to achieve planned results.
7.5.2 for production and service
provision. The organization shall establish arrangements for these processes including, as applicable
a) defined criteria for review and approval of these processes,
b) approval of equipment and qualification of personnel,
c) use of specific methods and procedures,
d) requirements for records (see 4.2.4), and
e) revalidation.
The requirements of 7.5.2 shall apply to all processes for production and service provision.
7.5.2.1 Validation of processes
7.5.2.1 for production and service
provision - Supplemental
Where appropriate, the organization shall identify the product by suitable means throughout product realization.
The organization shall identify the product status with respect to monitoring and measurement requirements.
7.5.3 Identification and
7.5.3 traceability Where traceability is a requirement, the organization shall control and record the unique identification of the product
(see 4.2.4).
NOTE: Inspection and test status is not indicated by the location of product in the production flow unless inherently
obvious, such as material in an automated production transfer process. Alternatives are permitted, if the status is
clearly identified, documented and achieves the designated purpose.
7.5.3.1 Identification and The words "Where appropriate" in 7.5.3 shall not apply.
7.5.3.1 traceability - Supplemental
The organization shall exercise care with customer property while it is under the organization's control or being used
by the organization.
The organization shall identify, verify, protect and safeguard customer property provided for use or incorporation into
7.5.4 7.5.4 Customer property the product.
If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the
customer and records maintained (see 4.2.4).
NOTE: Customer property can include intellectual property.
NOTE: Customer-owned returnable packaging is included in this clause.
7.5.4.1 Customer-owned Customer-owned tools, manufacturing, test, inspection tooling and equipment shall be permanently marked so that
7.5.4.1 production tooling the ownership of each item is visible, and can be determined.
The organization shall preserve the conformity of product during internal processing and delivery to the intended
PPC
destination.
7.5.5 7.5.5 Preservation of product
The preservation shall include identification, handling, packaging, storage and protection. PPC
Preservation shall also apply to the constituent parts of a product. PPC
In order to detect deterioration, the condition of product in stock shall be assessed at appropriate planned intervals.
PPC
7.5.5.1 7.5.5.1 Storage and inventory The organization shall use an inventory management system to optimize inventory turns over time and assure stock
PPC
rotation, such as "first-in-first-out" (FIFO).
Obsolete product shall be controlled in a similar manner to nonconforming product. PPC
The organization shall determine the monitoring and measurement to be undertaken and the monitoring and
measurement devices needed to provide evidence of conformity of product to determined requirements (see 7.2.1).
The organization shall establish processes to ensure that monitoring and measurement can be carried out and are
carried out in a manner that is consistent with the monitoring and measurement requirements.
Where necessary to ensure valid results, measuring equipment shall:

a) be calibrated or verified at specific intervals, or prior to use, against measurement standards traceable to
international or national measurement standards; where no such standards exist, the basis used for calibration or
verification shall be recorded
b) be adjusted or re-adjusted as necessary;
7.6 Control of monitoring and
7.6 measurement devices c) be identified to enable the calibration status to be determined;
d) be safeguarded from adjustments that would invalidate the measurement result;
e) be protected from damage and deterioration during handling, maintenance and storage.
In addition, the organization shall assess and record the validity of the previous measuring results when the
equipment is found not to conform to requirements.
The organization shall take appropriate action on the equipment and any product affected.
Records of the results of calibration and verification shall be maintained (see 4.2.4).
ADVICS North India Pvt Ltd When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy Format No. : 01-IMS-04 F07 Rev. No. : 00
the intended application shall be confirmed. Eff. Date : 02.01.2017
This shall be undertaken prior to initial use and reconfirmed as necessary.
NOTE: Confirmation of the ability of computer software to satisfy the intended application would typically include tis
verification and configuration management to maintain its suitable for use.
Statistical studies shall be conducted to analyze the variation present in the results of each type of measuring and
test equipment system.
7.6.1 Measurement system This requirement shall apply to measurement systems referenced in the control plan.
7.6.1 analysis The analytical methods and acceptance criteria used shall conform to those in customer reference manuals on
measurement system analysis. Other analytical methods and acceptance criteria may be used if approved by the
customer.
Records of the calibration/verification activity for all gauges, measuring and test equipment, needed to provide
evidence of conformity of product to determined requirements, including employee- and customer-owned equipment,
shall include
- equipment identification, including the measurement standard against which the equipment is calibrated,
7.6.2 Calibration/verification
7.6.2 records - revisions following engineering changes,
- any out-of-specification readings as received for calibration/verification,
- an assessment of the impact of out-of-specification condition,
- statements of conformity to specification after calibration/verification, and
- notification to the customer if suspect product or material has been shipped.
7.6.3 7.6.3 Laboratory requirements
An organization's internal laboratory facility shall have a defined scope that includes its capability to perform the
required inspection, test or calibration services.
This laboratory scope shall be included in the quality management system documentation.
The laboratory shall specify and implement, as a minimum, technical requirements for
- adequacy of the laboratory procedures,
- competency of the laboratory personnel,
7.6.3.1 7.6.3.1 Internal laboratory
- testing of the product,
- capability to perform these services correctly, traceable to the relevant process standard (such as ASTM, EN, etc.),
and
- review of the related records.
NOTE: Accreditation to ISO/IEC 17025 may be used to demonstrate the organization's in-house laboratory conformity
to this requirement but it is not mandatory.
External/commercial/independent laboratory facilities used for inspection, test or calibration services by the
organization shall have a defined laboratory scope that includes the capability to perform the required inspection, test
or calibration, and either
- there shall be evidence that the external laboratory is acceptable to the customer, or
- the laboratory shall be accredited to ISO/IEC 17025 or national equivalent.
7.6.3.2 7.6.3.2 External laboratory NOTE1: Such evidence may be demonstrated by customer assessment, for example, or by customer-approved
second-party assessment that the laboratory meets the intent of ISO/IEC 17025 or national equivalent.
NOTE2: When a qualified laboratory is not available for a given piece of equipment, calibration services may be
performed by the equipment manufacturer. In such cases, the organization should ensure that the requirements listed
in 7.6.3.1 have been met.
8 Measurement, analysis and

8 improvement
The organization shall plan and implement the monitoring, measurement, analysis and improvement processes
needed
a) to demonstrate conformity of the product,
8.1 8.1 General b) to ensure conformity of the quality management system, and
c) to continually improve the effectiveness of the quality management system.
This shall include determination of applicable methods, including statistical techniques, and the extent of their use.
8.1.1 Identification of statistical Appropriate statistical tools for each process shall be determined during advance quality planning and included in the
8.1.1 tools
PE
control plan.
Basic statistical concepts, such as variation, control (Stability), process capability and over-adjustment shall be
understood and utilized throughout the organization. PE
8.2 Monitoring and

8.2 measurement
As one of the measurements of the performance of the quality management system, the organization shall monitor
information relating to the customer perception as to whether the organization has met customer requirements. MKT
8.2.1 8.2.1 Customer satisfaction
The methods for obtaining and using this information shall be determined. MKT
NOTE: Consideration should be given to both internal and external customers. MKT
Customer satisfaction with the organization shall be monitored through continual evaluation of performance of the
MKT
realization processes.
Performance indicators shall be based on objective data and include, but not be limited to: MKT
- delivered part quality performance, MKT
8.2.1.1 Customer satisfaction - MKT
8.2.1.1 Supplemental
- customer disruptions including field returns,
- delivery schedule performance (including incidents of premium freight), and MKT
- customer notifications related to quality or delivery issues. MKT
The organization shall monitor the performance of manufacturing processes to demonstrate compliance with
MKT
customer requirements for product quality and efficiency of the process.
The organization shall conduct internal audits at planned intervals to determine whether the quality management
system
ADVICS North India Pvt Ltd a) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the Format No. : 01-IMS-04 F07 Rev. No. : 00
quality management system requirements established by the organization, and Eff. Date : 02.01.2017
b) is effectively implemented and maintained.
An audit program shall be planned, taking into consideration the status and importance of the processes and areas to
be audited, as well as the results of previous audits.
The audit criteria, scope, frequency and methods shall be defined.
8.2.2 8.2.2 Internal audit Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process.
Auditors shall not audit their own work.
The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining
records (see 4.2.4) shall be defined in a documented procedure.
The management responsible for the area being audited shall ensure the actions are taken without undue delay to
eliminate detected nonconformities and their causes.
Follow-up activities shall include the verification of the actions taken and the reporting of verification results (see
8.5.2).
NOTE: See ISO 10011-1, ISO 10011-2 and ISO 10011-3 for guidance.
8.2.2.1 Quality management The organization shall audit its quality management system to verify compliance with this Technical Specification and
8.2.21 system audit any additional quality management system requirements.
8.2.2.2 Manufacturing process The organization shall audit each manufacturing process to determine its effectiveness.
8.2.2.2 audit
The organization shall audit products as appropriate stages of production and delivery to verify conformity to all
8.2.2.3 8.2.2.3 Product audit specified requirements, such as product dimensions, functionality, packaging and labeling, at a defined frequency.
Internal audits shall cover all quality management related processes, activities and shifts, and shall be scheduled
8.2.2.4 8.2.2.4 Internal audit plans according to an annual plan.
The organization shall have internal auditors who are qualified to audit the requirements of this Technical
8.2.2.5 Internal auditor Specification
8.2.2.5 qualification
The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality
management system processes.
8.2.3 Monitoring and
8.2.3 measurement of processes These methods shall demonstrate the ability of the processes to achieve planned results.
When planned results are not achieved, correction and corrective action shall be taken, as appropriate, to ensure
conformity of the product.
The organization shall perform process studies on all new manufacturing (including assembly or sequencing)
processes to verify process capability and to provide additional input for process control
The results of process studies shall be documented with specifications, where applicable, for means of production,
measurement and test, and maintenance instructions.
These documents shall include objectives for manufacturing process capability, reliability, maintainability and
availability, as well as acceptance criteria
The organization shall maintain manufacturing process capability or performance as specified by the customer part
approval process requirements.
The organization shall ensure that the control plan and process flow diagram are implemented, including adherence
to the specified:
a) measurement techniques,
8.2.3.1 8.2.3.1 Monitoring
b) sampling plans,
c) acceptance criteria,
d) reaction plans when acceptance criteria are not met.
Significant process events, such as tool change or machine repair, shall be recorded
The organization shall initiate a reaction plan from the control plan for characteristics that are either not statistically
capable or are unstable.
These reaction plans shall include containment of product and 100% inspection as appropriate.
A corrective action plan shall then be completed by the organization, indicating specific timing and assigned
responsibilities to assure that the process becomes stable and capable.
The plans shall be reviewed with and approved by the customer when so required
The organization shall maintain records of effective dates of process changes.
The organization shall monitor and measure the characteristics of the product to verify that product requirements
have been met.
This shall be carried out at appropriate stages of the product realization process in accordance with the planned
8.2.4 Monitoring and arrangements
8.2.4 measurement of product Evidence of conformity with the acceptance criteria shall me maintained
Records shall indicate the persons authorizing release of product
Product release and service delivery shall not proceed until all the planned arrangements have been satisfactorily
completed, unless otherwise approved by a relevant authority, and where applicable by the customer.
A layout inspection and a functional verification to applicable customer engineering material and performance
8.2.4.1 Layout inspection and standards shall be performed for each product as specified in the control plans.
8.2.4.1 functional testing
Results shall be available for customer review.
For organizations manufacturing parts designated by the customer as "appearance items", the organization shall
provide:
a) appropriate resources including lighting for evaluation,
8.2.4.2 8.2.4.2 Appearance items
b) masters for colour, grain, gloss, metallic brilliance, texture, distinctness of image (DOI), as appropriate,
c) maintenance and control of appearance masters and evaluation equipment, and
d) verification that personnel making appearance evaluations are competent and qualified to do so.
The organization shall ensure that product which does not conform to product requirements is identified and
controlled to prevent its unintended use or delivery.
The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a
documented procedure.
The organization shall deal with nonconforming product by one or more of the following ways: a) by taking action to
eliminate the detected nonconformity,
b) by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by
8.3 Control of nonconforming the customer,
8.3 product
8.3 Control of nonconforming
8.3 product
ADVICS North India Pvt Ltd c) by taking action to preclude its original intended use or application Format No. : 01-IMS-04 F07 Rev. No. : 00
Eff. Date : 02.01.2017
Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be
maintained
When nonconformity product is corrected it shall be subject to re-verification to demonstrate conformity to the
requirements
When nonconforming product is detected after delivery or use has started, the organization shall take action
appropriate to the effects, or potential effects, of the nonconformity
8.3.1 Control of Product with unidentified or suspect status shall be classified as nonconforming product
8.3.1 nonconforming product-
supplemental
8.3.2 Control of reworked Instructions for rework, including re-inspection requirements, shall be accessible to and utilized by the appropriate
8.3.2 PROD./ QA
product personnel
Customers shall be informed promptly in the event that nonconforming product has been shipped.
8.3.3 8.3.3 Customer information
The organization shall obtain a customer concession or deviation permit prior to further processing whenever the
QUA
product or manufacturing process is different from that which is currently approved.
The organization shall maintain a record of the expiration date or quantity authorized
QUA
8.3.4 8.3.4 Customer waiver The organization shall also ensure compliance with the original or superseding specifications and requirements when
QUA
the authorization expires.
Material shipped on an authorization shall be properly identified on each shipping container. QUA
This applies equally to purchased product. The organization shall approve any requests from suppliers before
submission to the customer QUA
The organization shall use error-proofing methods in their corrective action process.
8.5.2.2 8.5.2.2 Error-proofing
The organization shall analysis parts rejected by the customers manufacturing plants, engineering facilities and
dealerships.
8.5.2.4 Rejected product The organization shall minimize the cycle time of this process.
8.5.2.4 test/analysis
Records of these analysis shall be kept and made available upon request
The organization shall perform analysis and initiate corrective action to prevent recurrence

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ADVICS North India Pvt Ltd Format No. : 01-IMS-04 F07 Rev. No.

A documented procedure shall be established to define the controls needed ALL

7.5.1.2 Work Instructions PRODUCTION

A documented procedure shall be established to define the controls needed ALL

a) buildings, workspace and associated utilities, HR / MANT. / OM

7.5.1.4 Preventive and predictive maintenance MAINTENANCE

A documented procedure shall be established to define the controls needed ALL

7.4 Purchasing process PURCHASING /

7.5.1.3 Verification of job set-ups QA ADSNI- Procedure for pre-

7.5.2 Validation of processes QA

Where necessary to ensure valid results, measuring equipment shall: QA

This shall be undertaken prior to initial use and reconfirmed as necessary. QA

- review of the related records. QA

4.2.1 General. The quality management system documentation shall include

a) documented statements of a quality policy and quality objectives

c) documented procedures required by this International Standard

A documented procedure shall be established to define the controls needed ALL

ADSNI - Procedure for

A documented procedure shall be established to define the controls needed ALL

7.5.1.5 Management of production tooling PE & MAINT.

A documented procedure shall be established to define the controls needed ALL

7.4 Purchasing process PURCHASING /

7.4.1.3 Customer - approved sources PURCHASING /

4.2 Documentation b) a quality manual QMS

A documented procedure shall be established to define the controls needed ALL

d) any additional requirements determinated by the organization. SALE / ENG

a) product requirements are defined, SALE & ENG ADSNI-Procedure for

7.5.1.7 Feedback of information from service

7.5.1.8 Service agreement with customer

A documented procedure shall be established to define the controls needed ALL

A documented procedure shall be established to define the controls needed ALL

b) to enhance customer satisfaction by meeting customer requirements HR

A documented procedure shall be established to define the controls needed ALL

Top management shall ensure that the quality policy ALL

5.5.1 Responsibility and Top management shall ensure

A documented procedure shall be established to define the controls needed ALL

Records shall remain legible, readily identifiable and retrievable. ALL

5.5.1 Responsibility and Top management shall ensure

b) to enhance customer satisfaction by meeting customer requirements

b) process equipment (both hardware and software), and

7.4.1.1 Regulatory conformity

7.4.1.2 Supplier quality management system development

7.4.2 Purchasing Information PURCHASING / SQA

7.5.1.1 Control Plan

7.5.1.6 7.5.1.6 Production scheduling

7.5.1.7 Feedback of information from service

7.5.1.8 Service agreement with

7.5.2 Validation of processes

Where necessary to ensure valid results, measuring equipment shall:

7.6.3 7.6.3 Laboratory requirements

8 Measurement, analysis and

8.2 Monitoring and

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