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Q1 (8 ) / ISO 9001:2008 QM REVIEW CHECKLIST

API Spec Q1, 8th Edition


and

th

Client:

QM Edition:

ISO 9001:2008
SECT NO.

Reviewed By: Review Date: Fac. No.

9001:2008 FORMAT - QUALITY MANAGEMENT SYSTEM REQUIREMENTS


Italicized and Shaded Items Represent Requirements Specific to API Spec Q1 and Outside ISO 9001:2008 Requirements

QM SEC NO.

QM PG NO.

General Requirements
1.2 4.1 4.1.1 Organization has identified all exclusions that apply to the QMS (limited to Sections 7.3 & 7.5.4) Organization shall control all processes that are outsourced (7.4) Organization shall maintain responsibility for product conformance when processes are outsourced*

Documentation
4.2.1 Documentation includes: a) statement of quality policy and quality objectives b) quality manual c) documented procedures and records d) those determined necessary to ensure planning, operation and control of its processes 4.2.2 Quality Manual includes: a) scope of QMS and exclusions (with justifications) b) documented procedures or reference to them c) a description of interaction between the processes of the QMS 4.2.3 Documented Procedure established and maintained for control of documents a) Approve documents for adequacy prior to issue b) Review and update as necessary and re-approve documents c) Changes to current revisions are identified d) Relevant revisions of documents available at points of use e) Ensure documents remain legible and readily identifiable f) Ensure documents of external origin are identified and distribution controlled g) Prevent unintended used of obsolete documents Apply suitable identification to obsolete documents if they are retained 4.2.3.1 Master list or equivalent established to identify current revisions 4.2.3.2 Changes to documents reviewed and approved by same function as original Documented Procedure for the identification, storage, protection, retrieval, retention and disposition of records 4.2.4 4.2.4.1 Documented Procedure identifies the function responsible for collection and maintenance of records Records retained for minimum of 5 years or as specified in applicable industry standard

Management Responsibility
5.1 5.2 5.3 Top Management commitment to develop and implement QMS and continually improve effectiveness Focus on the customer - requirements are determined and met with aim of enhancing customer satisfaction Quality Policy: (b) includes commitment to comply and continually improve QMS (c) provides a framework for establishing quality objectives (d) is communicated and understood within the organization (e) is reviewed periodically 5.4.1 5.4.2 5.5.1 5.5.2 5.5.3 5.6.1 Top Management establishes quality objectives that are measurable and consistent with quality policy Planning of QMS carried out to meet requirements of quality objectives Responsibilities and authorities are defined Management representative: is identified and has authority to ensure that quality system is implemented and maintained promotes awareness of customer requirements throughout organization Top Management commits to establishing communication within the organization (internal communications) Management Review of QMS conducted Records of management reviews are maintained 5.6.1.1 Management Reviews are conducted as least annually

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SECT NO. 5.6.2

9001:2008 FORMAT - QUALITY MANAGEMENT SYSTEM REQUIREMENTS


Italicized and Shaded Items Represent Requirements Specific to API Spec Q1 and Outside ISO 9001:2008 Requirements Management review includes: a) results of internal audits b) customer feedback c) process performance (to include product nonconformity) d) status of corrective and preventive actions e) follow-up actions from last management reviews f) changes that could affect the QMS (to include oil/gas industry standards) g) recommendations for improvement

QM SEC NO.

QM PG NO.

5.6.3

Management review output includes: a) improvement of effectiveness of QMS b) improvement of product to meet customer needs c) resource needs

Resource Management
6.2.1 6.2.2 Human Resources: Personnel shall be competent on the basis of education, training, skills and experience Human Resources: a) Determine necessary competence (requirements) for personnel performing work affecting conformity b) Provide training c) Evaluate effectiveness of actions taken d) Ensure personnel are aware of importance of their work with respect to QMS e) Maintain records of education, training, skills and experience 6.2.2.1 Control Features for Training 6.3 6.4 Determine the frequency of training Provide and maintain the infrastructure (equipment, buildings, etc) needed to achieve conformity to product requirements Determine and manage work environment needed to achieve conformity to product requirements Customer-related Processes Contract Review 7.1a 7.1c 7.2.2 The organization shall determine the quality objectives and requirements for the product The organization shall determine verification, validation, monitoring, measurement, inspection and test activities Contract review ensure that: a) product requirements are defined b) requirements differing from those previously expressed are resolved c) organization has ability to meet defined requirements Records of the results of reviews shall be maintained Organization shall ensure amendments are made and transferred to proper function 7.2.2.1 Control Features for review of requirements related to product Determine and implement arrangements for communication with customers 7.2.3 Design and Development 7.3.1 Organization shall manage the interfaces between different groups involved in design and development Design output updated as the design and development progresses 7.3.1.1 Control features for the design of the product 7.3.1.2 Design development includes methods, assumptions, formulations and calculations Input includes: a) functional and performance requirements 7.3.2 b) applicable statutory and regulatory requirements 7.3.2.1 Input includes customer specified requirements Output shall: a) meet the input requirements 7.3.3 b) provide information for purchasing, production and service c) contain or reference product acceptance criteria d) specify the characteristics of the product that are essential for the safe and proper use 7.3.3.1 Design and development outputs shall be documented* Review shall occur at suitable stages to evaluate design as it meets requirements 7.3.4 Participants of review shall include representatives of functions concerned with design and development Records of review shall be maintained 7.3.4.1 Final design reviews shall be conducted/documented by individual(s) other than the person(s) who developed the design Verification shall be performed 7.3.5 Verification results shall be recorded 7.3.6 7.3.7 Validation shall be performed Validation results shall be recorded Changes shall be identified, reviewed, verified, validated and records maintained Evaluation of design changes on constituent parts and delivered product 7.3.7.1 Changes require the same control as the original design and design documentation

Product Realization (Must Identify in Quality Manual All Parts of Section 7 that are Not Applicable, See Section 4.2.2a)

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SECT NO.

9001:2008 FORMAT - QUALITY MANAGEMENT SYSTEM REQUIREMENTS


Italicized and Shaded Items Represent Requirements Specific to API Spec Q1 and Outside ISO 9001:2008 Requirements Purchasing Organization establish the criteria for evaluation/selection of a supplier ability to supply product in accord with requirements Quality records of acceptable suppliers maintained

QM SEC NO.

QM PG NO.

7.4.1

7.4.1.1 Control features for the purchasing process 7.4.1.2 Criteria for the selection, evaluation and re-evaluation of suppliers shall include one or more of the following: a) Inspection at supplier facility; b) Inspection upon delivery; c) Surveillance of supplier; d) Conforms to Minimum QMS 7.4.2 Purchasing documents includes: a) products, procedures, processes, equipment, personnel and QMS requirements Organization shall ensure adequacy of specified purchase requirements prior to communication to the supplier 7.4.2.1 Purchasing information to supplier includes type, class, grade, specifications, drawings, process requirements, other data Organization established & implemented controls to ensure purchased product meets specified purchasing requirements 7.4.3 Organization has implemented controls for verification of product at suppliers premises (by itself or its customers) 7.4.3.1 Control features for the verification of purchased products (receiving inspection) Organization shall maintain records of verification activities* 7.5.1 Control of Production and Service Provision Controlled conditions include: a) information that describes the characteristics of the product b) availability of work instructions c) use of suitable equipment f) implementation of product release, delivery and post-delivery activities 7.5.1.1 Control features for production and service activities 7.5.1.2 Process controls include compliance with control features, plans, codes, standards, etc. Process controls are documented and include reference to specified requirements and acceptance criteria Validation of Processes for Production and Service Provision 7.5.2 a) Define criteria for review and approval of processes where resulting output cannot be verified by subsequent m & m b) Approval of equipment and qualification of personnel c) Use of specified methods and procedures d) Requirements for records e) Revalidation 7.5.3 Identification and traceability Organization shall identify product by suitable means throughout product realization Where traceability is requirement, organization shall control and maintain records Organization shall identify the product status with respect to monitoring and measurement requirements 7.5.3.1 Control features for identification of product as required by organization, the customer, and applicable specifications 7.5.3.2 Controls include replacement of identification marks and identification records 7.5.3.3 Control features for identification of product status Customer Property 7.5.4 Control of customer property while under organizations control Preservation of Product 7.5.5 Preservation of product during handling Preservation of product during packaging Preservation of product during storage Preservation of product during delivery 7.5.5.1 Control features for describing methods used to preserve the conformity of product 7.5.5.2 Assessment of product or constituent parts in stock at specified intervals Control of Monitoring and Measuring Devices 7.6 Determine the monitoring and measurements required and obtain the required equipment Equipment shall be: a) calibrated against standards traceable to international or national standards b) adjusted or re-adjusted as necessary c) identified to determine calibration status d) safeguarded from adjustments that would invalidate the measurement results e) protected from damage and deterioration during handling, maintenance and storage Assess and record the validity of previous measuring results when the equipment is found not to conform to requirements Action taken on monitoring and measurement equipment when found to be out of calibration Calibration records of equipment maintained 7.6.1 7.6.2 Control features to control, calibrate and maintain monitoring and measuring devices Environmental conditions suitable for inspection and measurements performed 7.5.4.1 Control features for verification, storage, maintenance and control of customer property

Measurement, Analysis and Improvement


Monitoring and Measurement 8.2.1 Customer Satisfaction - monitor info relating to customer perception whether organization met customer requirements
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SECT NO. 8.2.2

9001:2008 FORMAT - QUALITY MANAGEMENT SYSTEM REQUIREMENTS


Italicized and Shaded Items Represent Requirements Specific to API Spec Q1 and Outside ISO 9001:2008 Requirements Procedure includes responsibilities for planning and conducting audits, establishing records and reporting results Internal audits: consider the results of previous audits auditors shall not audit their own work audit criteria, scope, frequency and methods shall be defined management responsible shall ensure that any actions are taken to eliminate nonconformities follow up includes verification of action taken and reporting results

QM SEC NO.

QM PG NO.

8.2.2.1 Internal audits scheduled and conducted at least annually 8.2.2.2 The organization shall identify response times for addressing nonconformities* 8.2.3 8.2.4 Apply suitable methods of monitoring and measurement of QMS conformity Monitor characteristics of product to verify it meets requirements Monitoring carried out at appropriate stages of product realization process Evidence of product conformity maintained Records indicate the person(s) authorizing release of product for delivery Product release and delivery to customer shall not proceed until planned arrangements have been completed 8.2.4.1 Control features for required inspection and testing 8.2.4.2 Final acceptance inspection/testing is controlled by independent personnel Control of Nonconforming Product 8.3 Documented procedure established for dealing with nonconforming product Nonconforming product controlled by taking action to eliminate nonconformity; acceptance under concession; or by taking action to preclude its intended use or application Organization shall take appropriate action when nonconformity is detected after delivery or use Responsibility for review and disposition defined Records of nonconformities and any subsequent actions maintained When nonconformity is corrected, it shall be re-verified to demonstrate conformity to requirements 8.3.1 8.3.2 8.3.3 a) Controls for evaluation/disposition of accepting nonconforming product that does not meet manufacturing acceptance criteria b) Controls for evaluation/disposition of accepting nonconforming product that does not meet original design acceptance criteria Documented procedure shall include identifying, documenting, reporting, and analysis of field nonconformities Organization shall notify customers in the event that product not conforming to design acceptance criteria has been delivered* Organization shall maintain records of customer notifications* Analysis of Data 8.4 8.4.1 8.5.1 8.5.2 Determine, collect & analyze data to demonstrate the suitability & effectiveness of QMS & evaluate continual improvement Data provided relating to customer satisfaction, product conformity, process/product trends, supplier information Control features for the identification and use of the techniques for analysis of data Improvement Continually improve the effectiveness of the QMS Corrective Action Documented procedure required to take action to eliminate the causes of nonconformities to prevent recurrence Corrective action established and include: a) reviewing nonconformities (including customer complaints) b) determining the cause of nonconformities c) evaluating the need for action to ensure that nonconformities do not recur d) determining and implementing action to eliminate nonconformity e) records of results taken f) reviewing the effectiveness of corrective action taken 8.5.2.2 Organization shall identify response times for addressing corrective action* Preventive Action 8.5.3 Documented procedure required to take action to eliminate the cause of potential nonconformities to prevent occurrence Preventive action established: a) to determine potential nonconformities and their causes b) evaluating the need for action to prevent nonconformities c) determining and implementing action needed d) records of results taken e) reviewing the effectiveness of preventive action taken

API Spec Q1, Annex A (API Monogram Program Requirements)


API Monogram Program: Licensee Responsibilities A3.3 a) Controls implemented to apply the Monogram, including license number and date of manufacture b) Subsequent removal of Monogram and license number controlled on nonconforming product e) Authority responsible for applying and removing the Monogram identified in Quality Management System

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