ts16949 2002 awareness

8/14/2019 Ts16949 2002 Awareness

1/50

ISO/TS16949:2002ISO/TS16949:2002AWARENESSAWARENESS

8/14/2019 Ts16949 2002 Awareness

2/50

Quality Management SystemQuality Management SystemSection 4Section 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 ofprocesses

Ensure availability of information to

support operation and monitoring of

processes

Measure, monitor, analyze and

implement action to achieve results

and continual improvement

8/14/2019 Ts16949 2002 Awareness

3/50

Quality Management SystemQuality Management SystemSection 4Section 4

General Documentation Requirements (4.2) QMS shall include

Documented Procedures* required by

the standard

Documents required by us to ensurethe effective operation and control of

processes

*Requires the procedure to be established,

documented, implemented andmaintained

8/14/2019 Ts16949 2002 Awareness

4/50

Management ResponsibilityManagement ResponsibilitySection 5Section 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 thatcustomer needs and expectations are

determined, converted into requirements

and fulfilled with the aim of achieving

customer satisfaction.

8/14/2019 Ts16949 2002 Awareness

5/50


Quality Policy (5.3) Top management ensures that the quality

policy:

is appropriate to the organizations

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

8/14/2019 Ts16949 2002 Awareness

6/50


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)

8/14/2019 Ts16949 2002 Awareness

7/50


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 andthe integrity of the QMS is maintained

during change.

8/14/2019 Ts16949 2002 Awareness

8/50


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 haveresponsibility 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 theorganization

8/14/2019 Ts16949 2002 Awareness

9/50


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 onthe 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

8/14/2019 Ts16949 2002 Awareness

10/50


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.

8/14/2019 Ts16949 2002 Awareness

11/50


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

8/14/2019 Ts16949 2002 Awareness

12/50


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 obsoletedocuments and apply identification if they

are retained for any purpose

Documents defined as quality records

must be controlled

8/14/2019 Ts16949 2002 Awareness

13/50


Administration (5.5) Control of quality records (5.5.7)

Required records for the QMS must be

controlled

Records must be maintained toprovide 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

8/14/2019 Ts16949 2002 Awareness

14/50


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

8/14/2019 Ts16949 2002 Awareness

15/50


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

8/14/2019 Ts16949 2002 Awareness

16/50


Management review (5.6) Review Output (5.6.3)

Output from the management review

must include actions related to:

Improvement of the QMS and itsprocesses

Improvement of product related to

customer requirements

Resource needs

8/14/2019 Ts16949 2002 Awareness

17/50

Resource ManagementResource ManagementSection 6Section 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

8/14/2019 Ts16949 2002 Awareness

18/50


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

8/14/2019 Ts16949 2002 Awareness

19/50


Human resources (6.2) Training, awareness and competency

(6.2.2)

The organization must:

Identify competency needs forpersonnel performing activities

affecting quality

Provide training to satisfy these

needs

Evaluate the effectiveness of thetraining 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

8/14/2019 Ts16949 2002 Awareness

20/50


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

8/14/2019 Ts16949 2002 Awareness

21/50

Product RealizationProduct RealizationSection 7Section 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

8/14/2019 Ts16949 2002 Awareness

22/50


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 specifieduse

Product obligations including

regulatory and legal requirements

8/14/2019 Ts16949 2002 Awareness

23/50


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 tocommitment to supply a product to the

customer and ensure that:

Product requirements are defined

In the absence of customer

provided requirements, customerrequirements are confirmed

Differences from requirements

previously expressed are resolved

Organization has the ability to meetrequirements

Results must be recorded

Changes must be documented and

communicated

8/14/2019 Ts16949 2002 Awareness

24/50

8/14/2019 Ts16949 2002 Awareness

25/50


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 effectivecommunication and clarity of

responsibilities

Planning output must be updated as

design/development progresses

8/14/2019 Ts16949 2002 Awareness

26/50


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 conflictingrequirements must be resolved

8/14/2019 Ts16949 2002 Awareness

27/50


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 andproper use

Output documents must be approved

prior to release

8/14/2019 Ts16949 2002 Awareness

28/50


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 includerepresentatives of functions concerned

with design/development stages

reviewed

Results of reviews and subsequent

follow-up actions must be recorded

8/14/2019 Ts16949 2002 Awareness

29/50


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

8/14/2019 Ts16949 2002 Awareness

30/50


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 theextent applicable

Results of the validation and follow-up

actions must be recorded (see 5.5.7)


8/14/2019 Ts16949 2002 Awareness

31/50


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)


8/14/2019 Ts16949 2002 Awareness

32/50


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

8/14/2019 Ts16949 2002 Awareness

33/50


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

8/14/2019 Ts16949 2002 Awareness

34/50


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 purchasinginformation

8/14/2019 Ts16949 2002 Awareness

35/50


Production and service operations (7.5) Operations Control (7.5.1)

Must control production and service

operations through:

Availability of information specifyingcharacteristics of product

Availability of work instructions

(where necessary)

Use and maintenance of suitable

equipment for production andservice operations

Availability and use of measuring

and monitoring devices

Implementation of monitoringdevices

Implementation of defined

processes for release, delivery, and

applicable post-delivery activities

8/14/2019 Ts16949 2002 Awareness

36/50


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, wheretraceability is a requirement (see

5.5.7)

Customer property (7.5.3)

Preservation of product (7.5.4)

8/14/2019 Ts16949 2002 Awareness

37/50


Production and service operations (7.5) Customer property (7.5.3)

Must exercise care with customer

property while under organizations

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 recordedand reported to customer

Preservation of product (7.5.4)

8/14/2019 Ts16949 2002 Awareness

38/50


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

8/14/2019 Ts16949 2002 Awareness

39/50

8/14/2019 Ts16949 2002 Awareness

40/50


Control of measurement and monitoringdevices (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

8/14/2019 Ts16949 2002 Awareness

41/50

Measurement, Analysis andMeasurement, Analysis and

ImprovementImprovementSection 8Section 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

8/14/2019 Ts16949 2002 Awareness

42/50



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

8/14/2019 Ts16949 2002 Awareness

43/50



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

8/14/2019 Ts16949 2002 Awareness

44/50




Measurement and monitoring of

processes (8.2.3)

Must apply methods of M&M of

processes necessary to meetcustomer requirements

Must confirm continuing ability of

process to satisfy its intended purpose

8/14/2019 Ts16949 2002 Awareness

45/50




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 activitieshave been completed, unless

approved by customer

8/14/2019 Ts16949 2002 Awareness

46/50



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 documentedprocedure

When nonconforming product is detected

after delivery or use, must take action

regarding consequences

8/14/2019 Ts16949 2002 Awareness

47/50



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

8/14/2019 Ts16949 2002 Awareness

48/50



Improvement (8.5)

Planning for continual improvement

(8.5.1)

Must plan and manage processes

necessary for the continualimprovement 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

8/14/2019 Ts16949 2002 Awareness

49/50



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 correctiveaction

Recording results of actions taken

Reviewing corrective action taken

8/14/2019 Ts16949 2002 Awareness

50/50



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