ISO/TS16949:2002

AWARENESS

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 Introduction

Key Goals:

1) INFORMATIVE - Impart meaningful

information

2) ENLIGHTENING - Improve level of

understanding

3) ENTERTAINING - Accomplish #1 & #2 as

painlessly as possible
 Worldwide Adoption of ISO 9000 Standards
(140 Countries as of Jan. 2002)
 Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan
 Bahrain, Bangladesh, Barbados, Belarus, Belgium, Benin, Bolivia, Bosnia and
Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Burkina Faso
 Cambodia, Cameroon, Canada, Chile, China, Colombia, Comoros, Congo, The
Democratic Republic of Congo, Costa Rica, Croatia, Cuba, Cyprus, Czech
Republic, Côte-d'Ivoire
 Denmark, Dominica, Dominican Republic
 Ecuador, Egypt, El Salvador, Estonia, Ethiopia
 Fiji, Finland, France
 Germany, Ghana, Greece, Grenada, Guatemala, Guyana
 Honduras, Hong Kong (China) , Hungary
 Iceland, India, Indonesia, Iran (Islamic Republic of) , Iraq, Ireland, Israel, Italy
 Jamaica, Japan, Jordan
 Kazakhstan, Kenya, Korea (Democratic People's Republic) , Korea (Republic
of) , Kuwait, Kyrgyzstan
 Latvia, Lebanon, Lesotho, Libyan Arab Jamahiriya, Lithuania, Luxembourg
 Macau (China) , Madagascar, Malawi, Malaysia, Mali, Malta, Mauritius, Mexico,
Moldova (Republic of) , Mongolia, Morocco, Mozambique
 Namibia, Nepal, Netherlands, New Zealand, Nigeria, Norway
 Oman
 Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru,
Philippines, Poland, Portugal
 Qatar
 Romania, Russian Federation, Rwanda
 Saint Lucia, Saudi Arabia, Seychelles, Singapore, Slovakia, Slovenia, South
Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic
 Tanzania (United Republic of) , Thailand, The former Yugoslav Republic of
Macedonia, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan
 USA, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay,
Uzbekistan
 Venezuela, Viet Nam
 Yugoslavia
 Zimbabwe
 Evolution of Quality Assurance Standards
UNITED STATES (US) EUROPEAN COMMUNITY (EC)

1918 - The New State, by Mary Parker Follett

1918 - ANSI established
1919 - IQA established
1918 - 1925
Walter A. Shewhart at Western Electric begins espousing
Statistical Process Control
1926 - Shewhart joins Bell Labs
1931 - Economic Control of Quality of Manufactured Product,
by Walter A. Shewhart
1945 - NATO established AQAPs
1946 - ASQC established 1946 - ISO established
W. Edwards Deming makes first trip to Japan
1959 - DOD releases MIL-Q-9858
1963 - DOD releases MIL-Q-9858A
1968 - NATO releases AQAP-1
1979 - BSI develops BS 5750
1979 - ISO forms TC #176
1982 - Quality, Productivity and Competitive Position,
by W. Edwards Deming (14 Points)
1987 - ISO publishes ISO 9000 Standards
1987 - ANSI/ASQC adopts ISO 9000 Std. 1987 - BSI revises BS 5750 to ISO 9000
1989 - ASQC establishes RAB
1993 - RAB & IQA working on Mutual Recognition Agreement (MRA)
1993 - ISO working on global acceptance of ISO 9000 (Vision 2000)
1994 - ISO TC 176 Releases ISO 9001-1994
1994 - Auto industry (Ford, GM, Chrysler) releases QS-9000
1994 - DOD to transition from MIL-Q-9858A to ISO 9000 by Oct 1996
1995 - Federal agencies (10) working toward single quality system
2000 - ISO TC 176 Releases ISO 9000-2000
2002 - ISO Releases TS16949:2002
 Vision 2000
A long range plan through the year
2000 developed by an Ad Hoc Task
Force of ISO TC #176.

The plan includes providing

additional guidance on how to apply
the ISO 9000 series standards to
four generic product categories
(hardware, software, processed
goods, and services), as well as
providing guidance on related
issues, such as quality system
auditing.

The long range goal is to have a

single Total Quality Management
(TQM) Standard by the year 2000.
 ISO 9000:1994 Series of
Standards
ISO 9000
Guidelines For Selection And Use
ISO 9001 Quality Systems
Model for quality assurance in design,
development, production, installation and
servicing
ISO 9002 Quality Systems
Model for quality assurance in production,
installation and servicing
ISO 9003 Quality Systems
Model for quality assurance in final inspection
and test
ISO 9004
Quality Management and Quality System
Elements
ISO10011 Calibration
ISO 10012 Auditing Guidelines
ISO 9000-3 Implementation for Software
The ISO 9000:2000 Standard rolled all three
systems into one and requires companies
to take exception to items that do not
apply.

The ISO 9000 series of standards are

equally applicable to both small and large
organizations since they deal with:
- planning for quality
- identifying your customers’ requirements
- taking all measures necessary to ensure
you meet those requirements.
This quality planning process applies across
all the operations of a business.
(Except Finance/Accounting controlled by
Generally Accepted Accounting
Procedures)
 Quality System Requirements
ISO 9000:1994
MANAGEMENT RESPONSIBILITY 9003 9002 9001
QUALITY SYSTEM 9003 9002 9001
CONTRACT REVIEW 9003 9002 9001
DESIGN CONTROL 9001
DOCUMENT AND DATA CONTROL * 9003 9002 9001
PURCHASING 9002 9001
CONTROL OF CUSTOMER- SUPPLIED PRODUCT 9003 9002 9001
PRODUCT IDENTIFICATION AND TRACEABILITY 9003 9002 9001
PROCESS CONTROL * 9002 9001
INSPECTION AND TESTING * 9003 9002 9001
CONTROL OF INSPECTION, MEASURING, AND 9003 9002 9001
TEST EQUIPMENT *
INSPECTION AND TEST STATUS 9003 9002 9001
CONTROL OF NONCONFORMING PRODUCT * 9003 9002 9001
CORRECTIVE AND PREVENTIVE ACTION * 9003 9002 9001
HANDLING, STORAGE, PACKAGING, 9003 9002 9001
PRESERVATION AND DELIVERY
CONTROL OF QUALITY RECORDS 9003 9002 9001
INTERNAL QUALITY AUDITS * 9003 9002 9001
TRAINING 9003 9002 9001
SERVICING 9002 9001
STATISTICAL TECHNIQUES 9003 9002 9001

(*) = Areas in which misunderstanding and misinterpretation often occurs

 Quality System Requirements
ISO 9000:2000
QUALITY MANAGEMENT SYSTEM
General requirements
General documentation requirements
MANAGEMENT RESPONSIBILITY
Management commitment
Customer focus
Quality policy
Planning
Quality objectives
Quality planning
Administration
General
Responsibility and authority
Management representative
Internal communication
Quality manual
Control of documents
Control of quality records
Management review
General
Review input
Review output
RESOURCE MANAGEMENT
Provision of resources
Human resources
Assignment of personnel
Training, awareness and competency
Facilities
Work Environment
 Quality System Requirements
ISO 9000:2000
PRODUCT REALIZATION
Planning of realization processes
Customer related processes
Identification of customer requirements
Review of product requirements
Customer communication
Design and or development
Design and/or development planning
Design and/or development inputs
Design and/or development outputs
Design and/or development review
Design and/or development verification
Design and/or development validation
Control of design and/or development changes
Purchasing
Purchasing control
Purchasing information
Verification of purchased product
Production and service operations
Operations control
Identification and traceability
Customer property
Preservation of product
Validation of processes
Control of measuring and monitoring devices
MEASUREMENT, ANALYSIS AND IMPROVEMENT
Planning
Measurement and monitoring
Customer satisfaction
Internal audit
Measurement and monitoring of processes
Measurement and monitoring of product
Control of nonconformity
Analysis of data
Improvement
Planning for continual improvement
Corrective action
Preventive action
 TS16949:2002
Explained
ISO9001:1994

QS9000
QS9000 Released by GM, Ford, and Chrysler
Complete text of ISO9001:1994 plus specific
Automotive Requirements

ISO9000:2000

TS16949:2002
TS16949 Released by International Standards
Organization (ISO)
Complete text of ISO9000:2000 plus specific
International Automotive Requirements
So What Are All These Automotive
Specific Requirements?
“THE 7 PACK” of Manuals
QS9000 (AND NOW TS16949)
QSA
APQP
PPAP
FMEA
MSA
SPC

QUALITY SYSTEMS ASSESSMENT

How do you know you are doing what the standard requires?

ADVANCED PRODUCT QUALITY PLANNING

A guide to how to invent a product from customer request to delivery on their dock.

PRODUCTION PROTOTYPE APPROVAL PROCESS

Can you really produce 300 units a day and deliver them to our line side?

FAILURE MODE EFFECTS ANALYSIS

Think of all the ways your product can break and then make sure they don’t.

MEASUREMENT SYSTEMS ANALYSIS

When you says it’s 120VAC output, will we get the same answer?

STATISTICAL PROCESS CONTROL

In theory everyone knows the math, in practice the answers are not always the same.
 Quality Management System
The ISO 9000:2000 standard is the result
of over 80 years of progressive quality
systems experience and improvement.

“The focus of this International Standard

is for improving the processes of an
organization in order to enhance
performance.”
-ISO 9004:2000 - Quality management
systems - Guidelines for performance
improvements
CONTINUAL IMPROVEMENT OF THE
QUALITY MANAGEMENT SYSTEM

CUSTOMER
CUSTOMER (ISO9001) AND
(ISO9001) AND Management OTHER
OTHER responsibility INTERESTED
INTERESTED PARTIES
PARTIES (ISO9004)
(ISO9004)
Measurement,
Resource
management
analysis, Satisfaction
improvement

Input Product Output

Requirements realization
Product

Model of the process approach to quality management systems

Quality Management System
Section 4
General Requirements (4.1)
• Establish, document, implement,
maintain, and continually improve a
QMS
• Identify the processes needed for
QMS
• Determine sequence and interaction
of processes
• Determine criteria and methods to
ensure operation and control of
processes
• Ensure availability of information to
support operation and monitoring of
processes
• Measure, monitor, analyze and
implement action to achieve results
and continual improvement
 Quality Management System
Section 4
General Documentation Requirements (4.2)
• QMS shall include
• Documented Procedures* required by
the standard
• Documents required by us to ensure
the effective operation and control of
processes

*Requires the procedure to be established,

documented, implemented and
maintained
 Management Responsibility
Section 5
Management Commitment (5.1)
• Top management shall provide evidence
of its commitment to the development
and improvement of the QMS by:
• Communicating importance of
meeting customer, regulatory and
legal requirements
• Establishing quality policy and quality
objectives
• Conducting management reviews
• Ensuring availability of resources

Customer Focus (5.2)

• Top management shall ensure that
customer needs and expectations are
determined, converted into requirements
and fulfilled with the aim of achieving
customer satisfaction.
 Management Responsibility
Section 5
Quality Policy (5.3)
• Top management ensures that the quality
policy:
• is appropriate to the organization’s
purpose
• includes a commitment to meeting
requirements and continual
improvement
• provides a framework for establishing
and reviewing quality objectives
• is communicated and understood in
the organization
• is reviewed for continuing suitability
• The quality policy shall be controlled
 Management Responsibility
Section 5
Planning (5.4)
• Quality Objectives (5.4.1)
• Top management ensures quality
objectives are established at relevant
functions and levels within the
organization.
• Quality objectives shall be measurable
and consistent with the quality policy
including the commitment to continual
improvement.
• Quality objectives shall include those
need to meet requirements for product
• Quality Planning (5.4.2)
• Top management ensures that
resources needed to achieve quality
objectives are identified and planned
• Out put of the planning shall be
documented)
 Management Responsibility
Section 5
Planning (5.4)
• Quality Planning (5.4.2)
• Top management ensures that
resources needed to achieve quality
objectives are identified and planned
• Out put of the planning shall be
documented
• Quality planning includes:
• Processes of the QMS, considering
permissible exclusions
• The resources needed
• Continual improvement of the QMS
• Planning ensures that change is
conducted in a controlled manner and
the integrity of the QMS is maintained
during change.
 Management Responsibility
Section 5
Administration (5.5)
• Responsibility and authority (5.5.2)
• Functions and interrelations within the
organization, including responsibilities
and authorities, shall be defined and
communicated to facilitate effective
quality managment
• Management representative (5.5.3)
• Top management appoints member(s)
of the management who have
responsibility and authority that
includes:
• Ensuring that processes of the QMS
are established and maintained
• Reporting to top management on the
performance of the QMS, including
needs for improvement
• Promoting awareness of customer
requirements throughout the
organization
 Management Responsibility
Section 5
Administration (5.5)
• Management representative (5.5.3)
• Top management appoints member(s)
of the management who have
responsibility and authority that
includes:
• Ensuring that processes of the
QMS are established and
maintained
• Reporting to top management on
the performance of the QMS,
including needs for improvement
• Promoting awareness of customer
requirements throughout the
organization
• May include liaison with external
parties on matters relating to the
QMS
 Management Responsibility
Section 5
Administration (5.5)
• Internal communication (5.5.4)
• The organization ensures
communication between its various
levels and functions regarding the
processes of the QMS and their
effectiveness.
 Management Responsibility
Section 5
Administration (5.5)
• Quality Manual (5.5.5)
• A quality manual must be established
and maintained that includes:
• scope of the QMS
• documented procedures or
reference to them
• description of the sequence and
interaction of the processes in the
QMS
• The quality manual must be controlled
 Management Responsibility
Section 5
Administration (5.5)
• Control of documents (5.5.6)
• Documents required for the QMS must
be controlled. A documented
procedure must be established to:
• approve documents for adequacy prior to
issue
• review, update and re-approve documents
• identify current revision of documents
• ensure relevant versions of documents are
available at points of use
• ensure documents remain legible,
identifiable and retrievable
• ensure externally originated documents are
identified and controlled
• prevent unintended use of obsolete
documents and apply identification if they
are retained for any purpose
• Documents defined as quality records
must be controlled
 Management Responsibility
Section 5
Administration (5.5)
• Control of quality records (5.5.7)
• Required records for the QMS must be
controlled
• Records must be maintained to
provide evidence of conformance to
requirements and of effective
operation of the QMS
• Documented procedure must be
established for the identification,
storage, retrieval, protection, retention
time and disposition of quality records
 Management Responsibility
Section 5
Management review (5.6)
• General (5.6.1)
• Top management must review the
QMS at planned intervals to ensure
continuing suitability, adequacy, and
effectiveness
• Review must evaluate need for
changes to the QMS, including quality
policy and quality objectives
 Management Responsibility
Section 5
Management review (5.6)
• Review input (5.6.2)
• Inputs to management review must
include current performance and
improvement opportunities related to:
• Results of audits
• Customer feedback
• Process performance and product
conformance
• Status of preventive and corrective
actions
• Follow-up actions from earlier
management reviews
• Changes that could affect the QMS
 Management Responsibility
Section 5
Management review (5.6)
• Review Output (5.6.3)
• Output from the management review
must include actions related to:
• Improvement of the QMS and its
processes
• Improvement of product related to
customer requirements
• Resource needs
 Resource Management
Section 6
Provision of resources (6.1)
• The organization must determine and
provide, in a timely manner, the resources
needed to:
• Implement and improve the processes
of the QMS
• Address customer satisfaction
 Resource Management
Section 6
Human resources (6.2)
• Assignment of personnel (6.2.1)
• Personnel assigned responsibilities
defined in the QMS must be
competent on the basis of applicable
education, training, skills and
experience
 Resource Management
Section 6
Human resources (6.2)
• Training, awareness and competency
(6.2.2)
• The organization must:
• Identify competency needs for
personnel performing activities
affecting quality
• Provide training to satisfy these
needs
• Evaluate the effectiveness of the
training provided
• Ensure employees are aware of
relevance and importance of their
activities and how they contribute
to achievement of quality objectives
• Maintain records of education,
experience, training and
qualifications
 Resource Management
Section 6
Facilities (6.3)
• The organization must identify, provide
and maintain the facilities needed to
achieve product conformity including:
• Workspace and associated facilities
• Equipment, hardware and software
• Supporting services

Work environment (6.4)

• The organization must identify and
manage the human and physical factors
of the work environment needed to
achieve product conformity
 Product Realization
Section 7
Planning of realization processes (7.1)
• Sequence of processes required to
achieve product
• Consistent with other requirements of
QMS
• Documented
• Planning must determine, as appropriate:
• Quality objectives for the product,
project or contract
• Need to establish processes and
documentation, provide resources,
facilities specific to the product
• Verification and validation and criteria
for acceptability
• Records necessary to provide
confidence of conformity of the
processes and resulting product
 Product Realization
Section 7
Customer-related processes (7.2)
• Identification of customer requirements
(7.2.1)
• The organization must determine
customer requirements including
• Customer specified product
requirements including availability,
delivery and support
• Requirements not specified but
necessary for intended or specified
use
• Product obligations including
regulatory and legal requirements
 Product Realization
Section 7
Customer-related processes (7.2)
• Review of product requirements (7.2.2)
• Organization must review customer
and other determined requirements
• The review must be prior to
commitment to supply a product to the
customer and ensure that:
• Product requirements are defined
• In the absence of customer
provided requirements, customer
requirements are confirmed
• Differences from requirements
previously expressed are resolved
• Organization has the ability to meet
requirements
• Results must be recorded
• Changes must be documented and
communicated
 Product Realization
Section 7
Customer-related processes (7.2)
• Customer communication (7.2.3)
• Organization must identify and
implement arrangements for
communication with customers
relating to:
• Product information
• Enquiries, contracts or order
handling including amendments
• Customer feedback, including
customer complaints
 Product Realization
Section 7
Design and/or development (7.3)
• Design and/or development planning
(7.3.1)
• Plan and control design/development
of product
• Planning must determine:
• Stages of design/development
processes
• Review, verification, and validation
activities appropriate to each stage
• Responsibilities and authorities for
design/development activities
• Interfaces between involved groups
must be managed to ensure effective
communication and clarity of
responsibilities
• Planning output must be updated as
design/development progresses
 Product Realization
Section 7
Design and/or development (7.3)
• Design and/or development inputs (7.3.2)
• Inputs relating to product requirements
must be defined and documented,
including:
• Functional and performance
requirements
• Regulatory and legal requirements
• Information derived from previous
similar designs
• Other requirements essential for
design/development
• Inputs must be reviewed for adequacy
• Incomplete, ambiguous or conflicting
requirements must be resolved
 Product Realization
Section 7
Design and/or development (7.3)
• Design and/or development outputs
(7.3.3)
• Outputs must be documented in a
manner that enables verification
against the inputs
• Output must:
• Meet the input requirements
• Provide information for production
and service operations
• Contain or reference acceptance
criteria
• Define the characteristics of the
product essential to its safe and
proper use
• Output documents must be approved
prior to release
 Product Realization
Section 7
Design and/or development (7.3)
• Design and/or development review
(7.3.4)
• At suitable stages, systematic reviews
must be conducted to:
• Evaluate the ability to fulfill
requirements
• Identify problems and propose
follow-up actions
• Participants in reviews must include
representatives of functions concerned
with design/development stages
reviewed
• Results of reviews and subsequent
follow-up actions must be recorded
 Product Realization
Section 7
Design and/or development (7.3)
• Design and/or development verification
(7.3.5)
• Must be performed to ensure output
meets inputs
• Results of verification and follow-up
actions must be recorded (see 5.5.7)

ISO 10007 for guidance

 Product Realization
Section 7
Design and/or development (7.3)
• Design and/or development validation
(7.3.6)
• Must be performed to confirm that
product is capable of meeting
requirements for intended use.
• Must be completed prior to delivery or
implementation of product
• If full validation is impractical, partial
validation must be performed to the
extent applicable
• Results of the validation and follow-up
actions must be recorded (see 5.5.7)

ISO 10007 for guidance

 Product Realization
Section 7
Design and/or development (7.3)
• Design and/or development changes
(7.3.7)
• Must be identified, documented and
controlled.
• Includes evaluation of effect of
changes on constituent parts and
delivered products
• Must be verified and validated, as
appropriate
• Approved before implementation
• Results of review of changes and
follow-up actions must be documented
(see 5.5.7)

ISO 10007 for guidance

 Product Realization
Section 7
Purchasing (7.4)
• Purchasing Control (7.4.1)
• Must control purchasing processes to
ensure purchased product conforms to
requirements
• Type and extent dependent on
realization processes and their output
 Product Realization
Section 7
Purchasing (7.4)
• Purchasing Information (7.4.2)
• Purchasing documents must contain
information describing the product to
be purchased including, where
appropriate:
• Requirements for approval or
qualification of
• Product
• Procedures
• Processes
• Equipment
• Personnel
• QMS requirements
• Must ensure adequacy of specified
requirements contained in purchasing
documents prior to release
 Product Realization
Section 7
Purchasing (7.4)
• Verification of purchased product (7.4.3)
• Must identify and implement activities
necessary for verification of purchased
product
• If organization or customer proposes
to perform verification at supplier,
organization must specify intended
verification arrangements and method
of product release in purchasing
information
 Product Realization
Section 7
Production and service operations (7.5)
• Operations Control (7.5.1)
• Must control production and service
operations through:
• Availability of information specifying
characteristics of product
• Availability of work instructions
(where necessary)
• Use and maintenance of suitable
equipment for production and
service operations
• Availability and use of measuring
and monitoring devices
• Implementation of monitoring
devices
• Implementation of defined
processes for release, delivery, and
applicable post-delivery activities
 Product Realization
Section 7
Production and service operations (7.5)
• Identification and traceability (7.5.2)
• Must identify, where appropriate,
product by suitable means throughout
production and service operations
• Must identify status of product with
respect to measurement and
monitoring activities
• Must control and record unique
identification of product, where
traceability is a requirement (see
5.5.7)
• Customer property (7.5.3)

• Preservation of product (7.5.4)

 Product Realization
Section 7
Production and service operations (7.5)
• Customer property (7.5.3)
• Must exercise care with customer
property while under organization’s
control or being used by organization
• Must identify, verify, protect and
maintain customer property provided
for use or incorporation into product
• Customer property lost, damaged, or
otherwise unsuitable must be recorded
and reported to customer

• Preservation of product (7.5.4)

 Product Realization
Section 7
Production and service operations (7.5)
• Preservation of product (7.5.4)
• Must preserve conformity of product
with customer requirements during
internal processing and delivery to
intended destination
• Must include identification, handling,
packaging, storage, and protection
• Also applies to constituent parts of a
product
 Product Realization
Section 7
Production and service operations (7.5)
• Validation of processes (7.5.5)
• Must validate any production and
service processes where the resulting
output cannot be verified by
measurement or monitoring
• Includes processes where deficiencies
may become apparent only after product
is in use or service delivered
• Must define arrangements for validation
that must include, as applicable:
• Qualification of processes
• Qualification of equipment or
personnel
• Use of defined methodologies and
procedures
• Requirements for records
• Re-validation
 Product Realization
Section 7
Control of measurement and monitoring
devices (7.6) (See ISO 10012)
• Must identify measurements to be made
and measuring and monitoring devices
required to assure conformity of product
to requirements
• Devices must be used and controlled to
ensure measurement capability is
consistent with measurement
requirements
• Devices must (where applicable)
• Be calibrated
• Be safeguarded from adjustments
• Be protected from damage
• Have calibration results recorded (see
5.5.7)
• Have validity of previous results
assessed if found out of calibration
 Measurement, Analysis and
Improvement
Section 8
Planning (8.1)
• Must define, plan and implement
measurement and monitoring activities to
assure conformity and achieve
improvement
• Includes determination of need for, and
use of, statistical techniques
 Measurement, Analysis and
Improvement
Section 8
Measurement and monitoring (8.2)
• Customer satisfaction (8.2.1)
• Must monitor information on customer
satisfaction as measurement of
performance of QMS
• Must determine methods for obtaining
an using this information
 Measurement, Analysis and
Improvement
Section 8
Measurement and monitoring (8.2)
• Internal audit (8.2.2)
• Must conduct internal audits to determine
whether QMS:
• conforms to ISO
• has been effectively implemented and
maintained
• Must plan audit program considering
• Status and importance of activities and areas
• Results of previous audits
• Must define scope, frequency and methodologies
• Documented procedure must include
responsibilities and requirements for conducting
audits, ensuring independence, recording results,
and reporting to management
• Management must take corrective action on
deficiencies
• Follow up actions must include verification of
implementation of corrective action, and reporting
of verification results
See ISO 10011
 Measurement, Analysis and
Improvement
Section 8
Measurement and monitoring (8.2)
• Measurement and monitoring of
processes (8.2.3)
• Must apply methods of M&M of
processes necessary to meet
customer requirements
• Must confirm continuing ability of
process to satisfy its intended purpose
 Measurement, Analysis and
Improvement
Section 8
Measurement and monitoring (8.2)
• Measurement and monitoring of product
(8.2.4)
• Must M & M characteristics of product
to verify that requirements are met
• Must be carried out at appropriate
stages of realization process
• Evidence of conformity must be
documented.
• Records must indicate authority
responsible for release of product (see
5.5.7)
• Product release and service delivery
must not proceed until all activities
have been completed, unless
approved by customer
 Measurement, Analysis and
Improvement
Section 8
Control of nonconformity (8.3)
• Must ensure that nonconforming product
is identified and controlled to prevent
unintended use or delivery
• Activities must be defined in documented
procedure
• When nonconforming product is detected
after delivery or use, must take action
regarding consequences
 Measurement, Analysis and
Improvement
Section 8
Analysis of data (8.4)
• Must collect and analyze data to
determine the suitability and effectiveness
of QMS and to identify improvement
opportunities
• Includes data generated by measuring
and monitoring activities and other
relevant sources
• Must analyze data to provide information
on:
• Customer satisfaction and/or
dissatisfaction
• Conformance to customer
requirements
• Characteristics or processes, product,
and trends
• Suppliers
 Measurement, Analysis and
Improvement
Section 8
Improvement (8.5)
• Planning for continual improvement
(8.5.1)
• Must plan and manage processes
necessary for the continual
improvement of QMS
• Must facilitate the continual
improvement of QMS through quality
policy, objectives, audit results,
analysis of data, corrective and
preventive action and management
review
 Measurement, Analysis and
Improvement
Section 8
Improvement (8.5)
• Corrective action (8.5.2)
• Must take corrective action to eliminate the
cause of nonconformities to prevent
recurrence.
• Must be appropriate to impact of problems
encountered
• Documented procedure must define
requirements for:
• Identifying nonconformities
• Identifying customer complaints
• Determining causes of nonconformity
• Evaluating need for action to prevent
recurrence of nonconformity
• Determining and implementing corrective
action
• Recording results of actions taken
• Reviewing corrective action taken
 Measurement, Analysis and
Improvement
Section 8
Improvement (8.5)
• Preventive action (8.5.3)
• Must identify preventive action to
eliminate causes of potential
nonconformities to prevent occurrence
• Must be appropriate to impact of
potential problems
• Documented procedure must define
requirements for:
• Identifying potential
nonconformities and their causes
• Determining and ensuring
implementation of preventive action
• Recording results of action taken
• Reviewing preventive action taken