TS Gap Audit

Clause No. Statement Key pointCompliance

Evidence

Availability /

Adaptation (1/2/3)I.D. / Rev. Date / Rev. No Action Note

4 QMS4.1 General Req' Org establish, document, implement, maintain, and continually Improve a QMS Excusion : None

4.1 a) Determine Procs' needed Process Mapping4.1 b) Determine sequence and interaction of Procs' Bussiness Process4.1 c) Determine criteria and method ensuring the effectiveness of ops&control Control of NC and Abnormality4.1 d) ensure availability of resources&information supporting ops &Mon't'ing Procs' Comm Tree4.1 e) Mon't',measure, and analyze Procs'es SPC, MSA, QO4.1 f) implement actions necessary to achieve planned result and continual improvement

Note 1Procs'es needed for the QMS referred to above include Procs'es for management activities, provision of

resources, product realization, Meas'mt, analysis and improvement.

Note 2 Control of outsorced Procs', type and extent applied shall be defined within QMSSupplier Control, SQA, Supplier

Audit

Note 3Ensuring control over outsourced Procs'es does not absolve the Org' of the responsibility of conformity to

all customer, statutory and regulatory Req's.

The type and extent of control to be applied to the outsourced Procs' can be influenced by factors such

as

Note 3 a)the potential impact of the outsourced Procs' on the Org''s capability to provide product that conforms to

Req's,Note 3 b) the degree to which the control for the Procs' is shared,Note 3 c) the capability of achieving the necessary control through the application of 7.4.

4.1.1General requirements —

Su lemental

Ensuring control over outsourced processes shall not absolve the organization of the responsibility of

conformity to all customer requirements.4.2 Doc. Req -4.2.1 General QMS doc shall include :(differ by size,act type,procs complx and interacs,competence)

4.2.1 a) doc Statement of QP&QO Approved QP & QO4.2.1 b) Quality Manual QMS Manual4.2.1 c) Doc. Procedures and Rec' required Procedures (see below)4.2.1 d) Doc.& Rec' Needed to ensure eff. Planning, ops & control of its Procs' Records(see below)

4.2.2 Quality Manual Shall establish and maintain a QM4.2.2 a) QMS scope inc. details, and exclusions's justification QMS Manual4.2.2 b) Doc. Procedures established for QMS or reference to them Procedures see below4.2.2 c) desc. Of interac between Procs'es of QMS Bussiness Process

4.2.3 Control of Documents Documents required by QMS shall be controlled, Rec's controlled by 4.2.4

A doc. Proc. Shall be established to define controls needed : Document Control Procedure4.2.3 a) approve docs. For adequacy Approval Level4.2.3 b) review and update and re-approve Control of Doc Changes4.2.3 c) ensuring revision and current status of docs. Are identified Doc ID4.2.3 d) ensuring relevant versions are available at point of use Control of doc revision4.2.3 e) ensuring that docs. Remain legible and readily identifiable Control of Storage

4.2.3 f)to ensure that documents of external origin determined by the Org' to be necessary for the planning and

operation of the QMS are identified and their distribution ontrolled, andExternal Document List

4.2.3 g) prevent unintended use of obsolete docs. And identify if retained Obsolete handling4.2.3.1 Engineering specifications

P1-1The organization shall have a process to assure the timely review, distribution and implementation of all

customer engineering standards/specificationsand changes based on customer-required schedule.

Review of Received Customer

Specification MoM

P1-2 Timely review should be as soon as possible, and shall not exceed two working weeks. Record Of Distribution

P2The organization shall maintain a record of the date on which each change is implemented in

production.Implementation shall include updated documents.Record of change

Note

A change in these standards/specifications requires an updated record ofcustomer production part

approval when these specifications are referenced on the design record or if they affectdocuments of

production part approval process, such as control plan, FMEAs, etc.4.2.4 Control of Rec's established and maintained to provide evidence of conformity and eff. Ops of QMS Rec Procedure

Doc. Proc. As 4.2.3

exp a)Rec's established to provide evidence of conformity to Req's and of the effective operation of the QMS

shall be controlled.

exp b)The Org' shall establish a documented procedure to define the controls needed for the identification,

storage, protection, retrieval, retention and disposition of Rec's.exp c) Rec's shall remain legible, readily identifiable and retrievable.Note 1 “Disposition” includes disposal.Note 2 “Records” also include customer-specified records

4.2.4.1 Records retention The control of records shall satisfy statutory, regulatory and customer requirements.List of legal & Cust Req

compliance5 Management Responsibility -

5.1 Management CommitmentTop management shall provide evidence of its commitment to the development and implementation of

the QMS and continually improving its effectiveness by

5.1 a) communicating to the Org' the importance of meeting customer as well as statutory and regulatory Req's

5.1 b) establishing the quality policy5.1 c) ensuring that quality objectives are established5.1 d) conducting management reviews, and5.1 e) Ensure availability of resources

5.1.1 Process efficiencyTop management shall review the product realization processes and the support processes to assure

their effectiveness and efficiency.

Process Audit Result, Process

Capability

5.2 Customer FocusTop management shall ensure that customer Req's are determined and are met with the aim of

enhancing customer satisfaction (see 7.2.1 and 8.2.1)

List Cust Req compliance, Design

verification/validation5.3 Quality Policy Top management shall ensure that the quality policy Qpol


Evidence

Availability /


5.3 a) is appropriate to the purpose of the Org'

5.3 b) includes a commitment to comply with Req's and continually improve the effectiveness of the QMS

5.3 c) provides a framework for establishing and reviewing quality objectives5.3 d) is communicated and understood within the Org', and5.3 e) is reviewed for continuing suitability. MoM Mrev on Qpol


Evidence

Availability /


5.4 Planning -

5.4.1 Quality ObjectivesTop management shall ensure that quality objectives, including those needed to meet Req's for product

[see 7.1 a)], are established at relevant functions and levels within the Org'.QO and Cascaded QO

The quality objectives shall be measurable and consistent with the quality policy

5.4.1.1Quality objectives —

Supplemental

Top management shall define quality objectives and measurements that shall be included in the business

plan and used to deploy the quality policy.Bussiness Plan

Note 1 Quality objectives should address customer expectations and be achievable within a defined time period.

5.4.2 QMS Planning Top management shall ensure that

5.4.2 a)the planning of the QMS is carried out in order to meet the Req's given in 4.1, as well as the quality

objectives, and

5.4.2 b) the integrity of the QMS is maintained when changes to the QMS are planned and implemented.

5.5 Respsbly, autorithy, and comm. -

5.5.1 Responsibility and AuthorityTop management shall ensure that responsibilities and authorities are defined and communicated within

the Org'.Job Desc. KPI

5.5.1.1 Responsibility for quality

P1Managers with responsibility and authority for corrective action shall be promptly informed of products or

processes which do not conform to requirements.Information on NC

P2 Personnel responsible for conformity to product requirements shall have the authority to stop production

to correct quality problems.Stop Prod. Authorithies

P3Production operations across all shifts shall be staffed with personnel in charge of, or delegated

responsibility for, ensuring conformity to product requirements.Operator Matrix Skill

5.5.2 Management RepresentativeTop management shall appoint a member of the Org''s management who, irrespective of other

responsibilities, shall have responsibility and authority that includesManagement Representative

5.5.2 a) ensuring that Procs'es needed for the QMS are established, implemented and maintained

5.5.2 b)reporting to top management on the performance of the QMS and any need for

improvement, and5.5.2 c) ensuring the promotion of awareness of customer Req's throughout the Org'.

NoteThe responsibility of a management representative can include liaison with external parties on matters

relating to the QMS

5.5.2.1 Customer representativeTop management shall designate personnel with responsibility and authority to ensure that customer

requirements are addressed.Customer representative

P1-2This includes selection of special characteristics, setting quality objectives and related training, corrective

and preventive actions, product design and development.

5.5.3 Internal CommTop management shall ensure that appropriate communication Procs'es are established within the Org'

and that communication takes place regarding the effectiveness of the QMS5.6 Management review -

5.6.1 GeneralTop management shall review the Org''s QMS, at planned intervals, to ensure its continuing suitability,

adequacy and effectiveness.

This review shall include assessing opportunities for improvement and the need for changes to the QMS,

including the quality policy and quality objectives.

Rec's from management reviews shall be maintained (see 4.2.4)

5.6.1.1Quality management system

performance

These reviews shall include all requirements of the quality management system and its performance

trends as an essential part of the continual improvement process.QO trend and analyis

p2Part of the management review shall be the monitoring of quality objectives, and the regular reporting

and evaluation of the cost of poor quality (see 8.4.1 and 8.5.1).p3 These results shall be recorded to provide, asa minimum, evidence of the achievement of

⎯ the quality objectives specified in the business plan, and

⎯ customer satisfaction with product supplied.5.6.2 Review Input The input to management review shall include information on Mrev MoM Details

5.6.2 a) results of audits5.6.2 b) Customer feed back5.6.2 c) Procs' performance&product conformity5.6.2 d) status of PA&CA5.6.2 e) Follow-up action from previous man. Review5.6.2 f) changes that could affect QMS

5.6.2 g) Recommendation for improvement

5.6.2.1 Review input — SupplementalInput to management review shall include an analysis of actual and potential field-failures and their impact

on quality, safety or the environment.5.6.3 Review Out ut The out ut from the mana ement review shall include an decisions and actions related to

5.6.3 a) improvement of the effectiveness of the QMS and its Procs'es5.6.3 b) Improvement to product related to customer Req'5.6.3 c) resources needs

6 Resources Management -6.1 Provision of Resources The Org' shall determine and provide the resources needed

6.1 a) to implement and maintain the QMS and continually improve its effectiveness,6.1 b) Enhance customer satisfaction by meeting customer Req'

6.2 Human Resources -6.2.1 General Personnel performing work aff. To product quality shall competent on basis of appropriate Skill Matrix

education, training skills, and experience

NoteConformity to product Req's can be affected directly or indirectly by personnel performing any task

within the QMS6.2.2 Comptce, Awrness & Training The Org' shall

6.2.2 a) Determine necessary competence6.2.2 b) Provide training or other action necessary6.2.2 c) Evaluate eff. Of action taken


Evidence

Availability /


6.2.2 d)ensure that pers. Aware of relevance & importance of their work act. & how they contribute to QO

achievement6.2.2 e) maintain appropriate Rec' Of education, triniing skills, and experience

6.2.2.1 Product design skillsThe organization shall ensure that personnel with product design responsibility are competent to achieve

design requirements and are skilled in applicable tools and techniques.

Applicable tools and techniques shall be identified by the organization.

6.2.2.2 TrainingThe organization shall establish and maintain documented procedures for identifying training needs and

achieving competence of all personnel performing activities affecting conformity to product requirements.Training Need Analysis

P1-2Personnel performing specific assigned tasks shall be qualified, as required, with particular attention to

the satisfaction of customer re uirements.Defect Poss. In WI

Note 1 This applies to all employees having an effect on quality at all levels of the organization.

Note 2 An example of the customer-specific requirements is the application of digitized mathematically based

data.

6.2.2.3 Training on the jobThe organization shall provide on-the-job training for personnel in any new or modified job affecting

conformity to product requirements, including contract or agency personnel.OJT

Personnel whose work can affect quality shall be informed about the consequences to the customer of

nonconformity to quality requirements.

6.2.2.4Employee motivation and

empowerment

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.

The process shall include the promotion of quality and technological awareness throughout the whole

organization.

The organization shall have a process to measure the extent to which its personnel are aware of the

relevance and importance of their activities and how they contribute to the achievement of the quality

objectives [see 6.2.2 d)].

6.3 Infrastructure The Org' shall determine, provide and maintain the infrastructure needed

to achieve conformity to product Req'6.3 a) Buildings, workspace, and associated utilities Assest List & Management6.3 b) Procs' equipment (hardware and software)6.3 c) supporting services (such as transport, communication or information systems)

6.3.1Plant, facility and equipment

planning

The organization shall use a multidisciplinary approach (see 7.3.1.1) for developing plant, facility and

equipment plans.

P1-2Plant layouts shall optimize materialtravel, handling and value-added use of floor space, and shall

facilitate synchronous material flow.Plant Layout

P1-3Methods shall be developed and implemented to evaluate and monitor the effectiveness of existing

operations.

NoteThese requirements should focus on lean manufacturing principles and the link to the effectiveness of

the quality management system.Yamazuka Sheet

6.3.2 Contingency plansThe organization shall prepare contingency plans to satisfy customer requirements in the event of an

emergency such as utility interruptions, labour shortages, key equipment failure and field returns.Contingency Plans

6.4 Work environment The Org' shall determine and manage the environment needed to achieve conformity

to product Req'

NoteThe term “work environment” relates to those conditions under which work is performed including

physical, environmental and other factors (such as noise, temperature, humidity, lighting or weather)

6.4.1Personnel safety to achieve

conformity to product

re uirements

Product safety and means to minimize potential risks to employees shall be addressed by the

organization,especially in the design and development process and in manufacturing process activities.PPE in WI

6.4.2 Cleanliness of premisesThe organization shall maintain its premises in a state of order, cleanliness and repair consistent with the

product and manufacturing process needs.Cleanliness System


Evidence

Availability /


7 Product Realization7.1 Planning of product realization The Org' shall plan and develop the Procs'es needed for product realization.

Planning of product realization shall be consistent with the Req's of the other Procs'es of the QMS (see

4.1).Product Planning, Schedule

In planning product realization, the Org' shall determine the following, as appropriate:7.1 a) Quality objectives and Req' for product Prod. QO, Capability7.1 b) The need to establish Procs', doc's,and provide resources specific to product

7.1 c)required verification, validation, Mon't'ing, inspection, and test activities specific to product and criteria for

product acceptanceInspection Plan

7.1 d) Rec's needed to prove realization Procs' and resulting product meet Req's

The output of this planning shall be in a form suitable for the Org''s method of operations.

Note 1 A document specifying the Procs'es of the QMS (including the product realization Procs'es) and the

resources to be applied to a specific product, project or contract can be referred to as a quality plan

Note 2 The Org' may also apply the Req's given in 7.3 to the development of product realization Procs'es

NoteSome customers refer to project management or advanced product quality planning as a means to

achieveproduct realization. APQP

Advanced product quality planning embodies the concepts of error prevention and continual

improvement as contrasted with error detection, and is based on a multidisciplinary approach.

7.1.1Planning of product realization —

Su lemen tal

Customer requirements and references to its technical specifications shall be included in the planning

of product realization as a component of the quality plan.Control Plan - PreProduction

7.1.2 Acc eptance cri ter ia Acceptance criteria shall be defined by the organization and, where required, approved by the

customer. AQL

For attribute data sampling, the acceptance level shall be zero defects (see 8.2.3.1).

7.1.3 Confident ial i ty The organization shall ensure the confidentiality of customer-contracted products and projects under

development, and related product information.Confidentiality Agreement

7.1.4 Change control The organization shall have a process to control and react to changes that impact product realization. Process Change Control

p1-2 The effects of any change, including those changes caused by any supplier, shall be assessed, and

verification and validation activities shall be defined, to ensure compliance with customer

requirements. p1-3 Changes shall be validated before implementation.

p2 For proprietary designs, impact on form, fit and function (including performance and/or durability) shall

be reviewed with the customer so that all effects can be properly evaluated.

p3When required by the customer, additional verification/identification requirements, such as those

required for new product introduction, shall be met.

Note 1 Any product realization change affecting customer requirements requires notification to, and

a reement from the customer.Note 2 The above requirement applies toproduct and manufacturing process changes.

7.2 Customer Related Procs' -7.2.1 Det. of Req's related to prod. The Org's shall determine Contract/Supply Agreement

7.2.1 a) Req's Specified by Cust. (inc. delivery & post delv. Activities7.2.1 b) Req's not stated but necessary for specified or intended use7.2.1 c) Statutory & regulatory Req's related to product7.2.1 d) any additional Req's determined by the Org's

NotePost-delivery activities include, for example, actions under warranty provisions, contractual obligations

such as maintenance services, and supplementary services such as recycling or final disposal

Note 1Post-delivery activities include any after-sales product service provided as part of the customer contract

or purchase order.

Note 2 This requirement includes recycling, environmental impact and characteristics identified as a result of

the organization's knowledge of the product and manufacturing processes (see 7.3.2.3).

Note 3Compliance to item c) includes all applicable government, safety and environmental regulations,

applied to acquisition, storage, handling, recycling, elimination or disposal of materials.

7.2.1.1Customer-designated special

character ist ics

The organization shall demonstrate conformity to customer requirements for designation, documentation

and control of special characteristics.Special characteristic in SQA

7.2.2 Review of Req's related to prod. The Org' shall review the Req's related to the product. Product Req

This review shall be conducted prior to the Org''s commitment to supply a product to the customer Product Release MoM, PPAP

(e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or

orders) and shall ensure that7.2.2 a ) Prod. Req's are defined7.2.2 b ) contract or order Req's differing from those previously expressed are resolved, and MoM w/ Cust7.2.2 c ) The Org's has ability to meet the defined Req's

Rec's of the results of the review and actions arising from the review shall be maintained

when there's no doc's for Req's , cust req shall be confirmed before acceptance

Where product Req's are changed, the Org' shall ensure that relevant documents are amended and that

relevant personnel are made aware of the changed Req's

NoteIn some situations, such as internet sales, a formal review is impractical for each order. Instead the

review can cover relevant product information such as catalogues or advertising material


Evidence

Availability /


7.2.2.1Review of requirements related to

the product — Supplemental

Waiving the requirement stated in 7.2.2 for a formal review (see note) shall require customer

authorization.

7.2.2.2 Organizat ion manufactur ing

feasibil i t

The organization shall investigate, confirm and document the manufacturing feasibility of the proposed

roducts in the contract review rocess includin risk anal sis.

7.2.3 Customer communicationThe Org' shall determine and implement effective arrangements for communicating with customers in

relation to7.2.3 a) product information7.2.3 b) enquiries, contract, or order handling, including amendments7.2.3 c) customer feedback incl. cust. com laints

7.2.3.1Organization manufacturing

feasibility

The organization shall have the ability to communicate necessary information, including data, in a

Customerspecified language and format (e.g. computer-aided design data, electronic data exchange).


Evidence

Availability /


7.3 Design & DevelopmentNOTE The requirements of 7.3 include product and manufacturing process design and development,

and focus on error prevention rather than detection.7.3.1 D&D planning The Org' shall plan and control the D & D of product

During the D & D planning, the Org' shall determine7.3.1 a) D&D stages7.3.1 b) review, verification, & validation appropriate to each D&D stages7.3.1c) responsibilities & authorities for D&D

The Org' shall manage the interfaces between different groups involved in D & D to ensure effective

communication and clear assignment of responsibility

Planning output shall be updated, as appropriate, as the D & D progresses

NoteD & D review, verification and validation have distinct purposes. They can be conducted andRec'ed

separately or in any combination, as suitable for the product and the Org'

7.3.1.1 Mult idiscipl inary approach The organization shall use a multidisciplinary approach to prepare for product realization, including Cross Functional Team, QCC

⎯ development/finalization and monitoring of special characteristics,

⎯ development and review of FMEAs, including actions to reduce potential risks, and FMEA, 4M Analysis

⎯ development and review of control plans.

Note A multidisciplinary approach typically includes the organization's design, manufacturing, engineering,

quality, production and other appropriate personnel.

7.3.2 D&D inputInputs relating to product Req's shall be determined and Rec's maintained (see 4.2.4). These inputs shall

include7.3.2 a) Functional & performance Req'7.3.2 b) applicable statutory & regulatory Req's7.3.2 c) where applicable, information derived from similar designs7.3.2 d) other Req's essential for D&D

The inputs shall be reviewed for adequacy. Req's shall be complete, unambiguous and not in conflict

with each other MoM D&D Input

Note Special characteristics (see 7.2.1.1) are included in this requirement. DFMEA

7.3.2.1 Product design inputThe organization shall identify, document and review the product design input requirements, including

the following:

⎯ customer requirements (contract review) such as special characteristics (see 7.3.2.3), identification,

traceability and packaging;

⎯ use of information: the organization shall have a process to deploy information gained from previous

design projects, competitor analysis, supplier feedback, internal input, field data, and other relevant

sources, for current and future projects of a similar nature;

⎯ targets for conformity to product requirements, life, reliability, durability, maintainability, timing and cost.

7.3.2.2 Manufacturing process design

input

The organization shall identify, document and review the manufacturing process design input

requirements, includingPre-Production Trial

7.3.2.3 ⎯ product design output data,

⎯ targets for productivity, process capability and cost,

⎯ customers requirements, if any, and

⎯ experience from previous developments.

NoteThe manufacturing process design includes the use of error-proofing methods to a degree appropriate to

the magnitude of the problems and commensurate with the risks encountered.

7.3.2.3 Special characteristics The organization shall identify special characteristics [see 7.3.3 d)] andProduct Special characteristic in

SQA

⎯ include all special characteristics in the control plan,

⎯ comply with customer-specified definitions and symbols, and

⎯ identify process control documents including drawings, FMEAs, control plans, and operator

instructions

with the customer's special characteristic symbol or the organization’s equivalentsymbol or notation to

include those process steps that affect special characteristics.Note Special characteristics can include product characteristics and process parameters

7.3.3 D&D outputThe outputs of D & D shall be in a form suitable for verification against the D & D input and shall be

approved prior to release

MoM D&D output, prototype,

sample

D & D outputs shall7.3.3 a) meet input Req's for D&D7.3.3 b) provide appropriate information for purchasing, production, & service provision7.3.3 c) contain / reference product acceptance criteria7.3.3 d) specify the characteristic of prod. That are essential for it's safe and proper use

Note Information for production and service provision can include details for the preservation of product

7.3.3.1Product design outputs —

Supplemental

The product design output shall be expressed in terms that can be verified and validated against

product design input requirements. The product design output shall includeDFMEA, APQP, PPAP.

⎯ design FMEA, reliability results,

⎯ roduct s ecial characteristics and s ecifications

⎯ product error-proofing, as appropriate,

⎯ product definition including drawings or mathematically based data,

⎯ roduct desi n reviews results and

⎯ diagnostic guidelines, where applicable.

7.3.3.2 Manufactur ing process design

output

The manufacturing process design output shall be expressed in terms that can be verified against

manufacturing process design input requirements and validated.

Process Standard, Control Plan,

PFMEA, WI, Master Sample

The manufacturing process design output shall include

⎯ specifications and drawings,

⎯ manufacturing process flow chart/layout,


Evidence

Availability /


⎯ manufacturing process FMEAs,

⎯ control lan see 7.5.1.1

⎯ work instructions,

⎯ process approval acceptance criteria,

⎯ data for quality, reliability, maintainability and measurability,

⎯ results of error-proofing activities, as appropriate, and

⎯ methods of rapid detection and feedback of product/manufacturing process nonconformities.

7.3.4 D&D review At suitable stages, systematic reviews of D & D shall be performed in accordance with planned

arrangements (see 7.3.1)7.3.4 a) evaluate ability of result of D&D to meet Req's7.3.4 b) identify any problem and propose necessary actions

Participants in such reviews shall include representatives of functions concerned with the D & D stage(s)

being reviewed

Rec's of the results of the reviews and any necessary actions shall be maintained (see 4.2.4).

NoteThese reviews are normally coordinated with the design phases and include manufacturing process

design and development.

7.3.4.1 MonitoringMeasurements at specified stages of design and development shall be defined, analysed and reported

with summary results as an input to management review.n time Production

Note These measurements include quality risks, costs, lead-times, critical paths and others, as appropriate.

7.3.5 D&D VerificationVerification shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the

D & D outputs have met the D & D input Req'sMoM Pre-production

Rec's of the results of the verification and any necessary actions shall be maintained (see 4.2.4).

7.3.6 D&D Validation

D & D validation shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that

the resulting product is capable of meeting the Req's for the specified application or intended use, where

known

MoM before Mass Production

Wherever practicable, validation shall be completed prior to the delivery or implementation of the product.

Rec's of the results of validation and any necessary actions shall be maintained (see 4.2.4).Note 1 The validation process normally includes an analysis of field reportsfor similar products.Note 2 The requirements of 7.3.5 and 7.3.6 above apply to both product and manufacturing processes.

7.3.6.1Design and development

validation — Supplemental

Design and development validation shall be performed in accordance with customer requirements,

including programme timing.

7.3.6.2 Prototype programme When required by the customer, the organization shall have a prototype programme and control plan.

The organization shall use, wherever possible, the same suppliers, tooling and manufacturing processes

as will be used in production.

All performance-testing activities shall be monitored for timely completion and conformity to requirements.

While services may be outsourced, the organization shall be responsible for the outsourced services,

including technical leadership.

Product approval processThe organization shall conform to a product and manufacturing process approval procedure recognized

b the customer.Note Product approval should be subsequent to the verification of the manufacturing process.

This product and manufacturing process approval procedure shall also be applied to suppliers.7.3.7 Control of D&D changes D & D changes shall be identified and Rec's maintained. Process Changes

The changes shall be reviewed,verified and validated, as appropriate, and approved before

implementation.

The review of D & D changes shall include evaluation of the effect of the changes on constituent parts

and product already delivered

Rec's of the results of the review of changes and any necessary actions shall be maintained (see 4.2.4)

Note Design and development changes include all changes during the product programme life (see 7.1.4).


Evidence

Availability /


7.4 Purchasing -7.4.1 Purchasing Procs' The Org' shall ensure that purchased product conforms to specified purchase Req's

The type and extent of control applied to the supplier and the purchased product shall be dependent

upon the effect of the purchased product on subsequent product realization or the final productControl of Supplier

The Org' shall evaluate and select suppliers based on their ability to supply product in accordance with

the Org''s Req's.

Criteria for selection, evaluation and re-evaluation shall be established.

Rec's of the results of evaluations and any necessary actions arising from the evaluation shall be

maintained (see 4.2.4).Suppier evaluation

Note 1Purchased products above include all products and services that affect customer requirements such as

subassembly, sequencing, sorting, rework and calibration services.

Note 2 When there are mergers, acquisitions or affiliations associated with suppliers, the organization should

verify the continuity of the supplier's quality management system and its effectiveness.

7.4.1.1Statutory and regulatory

conformity

All purchased products or materials used in product shall conform to applicable statutory and regulatory

requirements.List of legal & Req compliance

7.4.1.2 Supplier quality management

system development

The organization shall perform supplier quality management system development with the goal of

supplier conformity with this Technical Specification.

Supplier Control, SQA, Supplier

Audit

Conformity with ISO 9001:2008 is the first step in achieving this goal.

NoteThe prioritization of suppliers for development dependsupon, for example, the supplier's quality

performance and the importance of the product supplied.

Unless otherwise specified by the customer, suppliers to the organization shall be third party, registered

to ISO 9001:2008 by an accredited third-party certification body.

7.4.1.3 Customer-approved sourcesWhere specified by the contract (e.g. customer engineering drawing, specification), the organization shall

purchase products, materials or services from approved sources.

The use of customer-designated sources, including tool/gauge suppliers, does not relieve the

organization of the responsibility for ensuring the quality of purchased products.

7.4.2 Purchasing Information Purchasing information shall describe the product to be purchased, including, where appropriate Supplier's Contract Agreements

7.4.2 a) req's for approval of product, procedures, Procs'es, & equipment7.4.2 b) req's for personnel qualification7.4.2 c) QMS Req's

The Org' shall ensure the adequacy of specified purchase Req's prior to their communication to the

supplier

7.4.3 Verification of purchased productThe Org' shall establish and implement the inspection or other activities necessary for ensuring that

purchased product meets specified purchase Req's.Incoming Inspection

Where the Org' or its customer intends to perform verification at the supplier's premises, the

Org' shall state the intended verification arrangements and method of product release in the purchasing

information.

7.4.3.1Incoming product conformity to

re uirements

The organization shall have a process to assure the quality of purchased product (see 7.4.3) utilizing one

or more of the following methods:

⎯ receipt of, and evaluation of, statistical data by the organization;

⎯ receiving inspection and/or testing, such as sampling based on performance;

⎯ second- or third-party assessments or audits of supplier sites, when coupled with records of acceptable

delivered product conformity to requirements;

⎯ part evaluation by a designated laboratory;

⎯ another method agreed with the customer.

7.4.3.2 Supplier monitoring Supplier performance shall be monitored through the following indicators: Supplier Performance Monitoring

⎯ delivered roduct conformit to re uirements

⎯ customer disruptions, including field returns;

⎯ delivery schedule performance (including incidents of premium freight);

⎯ special status customer notifications related to quality or delivery issues.

The organization shall promote supplier monitoring of the performance of their manufacturing processes

7.5 Production and Service Provision -

7.5.1 Control of P&S provisionThe Org' shall plan and carry out production and service provision under controlled conditions.

Controlled conditions shall include, as applicable

Process Standard, Control Plan,

PFMEA, WI, Master Sample

7.5.1 a) the availability of information that describes the characteristics of the product7.5.1 b) availability of work instruction as necessary7.5.1 c) use of suitable e ui ment7.5.1 d) availability & use of mon't&meas equipments7.5.1 e) implementation of mon't&mes'nt7.5.1 f) implementation of release, delv, & post delv. Activities

7.5.1.1 Control plan The organization shall

⎯ develop control plans (see Annex A) 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 design FMEA and

manufacturing process FMEA outputs.

The control plan shall

⎯ list the controls used for the manufacturing process control,

⎯ 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


Evidence

Availability /


⎯ initiate the specified reaction plan (see 8.2.3.1) when the process becomes unstable or not statistically

capable.

Control plans shall be reviewed and updated when any change occurs affecting product, manufacturing

process, measurement, logistics, supply sources or FMEA (see 7.1.4).Note Customer approval may be required after review or update of the control plan.

7.5.1.2 Work instructionsThe organization shall prepare documented work instructions for all employees having responsibilities for

the operation of processes that impact conformity to product requirements.

These instructions shall be accessible for use at the work station.

These instructions shall be derived from sources such as the quality plan, the control plan and the

roduct realization rocess.

7.5.1.3 Verification of job set-upsJob set-ups shall be verified whenever performed, such as an initial run of a job, material changeover or

job change.

Jobs Set-up, Process & Personnel

Capability, Cycle Time

Work instructions shall be available for set-up personnel. The organization shall use statistical methods of

verification, where applicable.Note Last-off-part comparisons are recommended.

7.5.1.4Preventive and predictive

maintenance

The organization shall identify key process equipment and provide resources for machine/equipment

maintenance and develop an effective planned total preventive maintenance system. As a minimum, this

system shall include the following:

Preventive and predictive

maintenance

⎯ planned maintenance activities;

⎯ packaging and preservation of equipment, tooling and gauging;

⎯ availability of replacement parts for key manufacturing equipment;

⎯ documenting, evaluating and improving maintenance objectives.

The organization shall utilize predictive maintenance methods to continually improve the effectiveness

and the efficienc of roduction e ui ment.

7.5.1.5 Management of production tooling The organization shall provide resources for tool and gauge design, fabrication and verification activities. Tooling Management Procedure

The organization shall establish and implement a system for production tooling management including:

⎯ maintenance and repair facilities and personnel;

⎯ storage and recovery;

⎯set-up;

⎯ tool-change programmes for perishable tools;

⎯ tool design modification documentation, including engineering change level;

⎯ tool modification and revision to documentation;

⎯ tool identification, defining the status, such as production, repair or disposal.

The organization shall implement a system to monitor these activities if any work is outsourced.

Note This requirement also applies to the availability of tools for vehicle service parts.

7.5.1.6 Production scheduling

Production shall be scheduled in order to meet customer requirements, such as just-in-time supported

by an information system that permits access to production information at key stages of the process and

is order driven.

Production Schedule

7.5.1.7 Feedback of information from

service

A process for communication of information on service concerns to manufacturing, engineering and

design activities shall be established and maintained.

NoteThe intent of the addition of “service concerns” to this subclause is to ensure that the organization is

aware of nonconformities that occur outside of its organization.

7.5.1.8 Service agreement with customer When there is a service agreement with the customer, the organization shall verify the effectiveness of

⎯ any organization service centres,

⎯ any special-purpose tools or measurement equipment, and

⎯ the training of service personnel.

7.5.2 Val of Procs' for P&S provision

The Org' shall validate any Procs'es for production and service provision where the resulting output

cannot be verified by subsequent Mon't'ing or Meas'mt and, as a consequence, deficiencies become

apparent only after the product is in use or the service has been delivered

Inspection Plan, Product

Capability, Control Plan

Validation shall demonstrate the ability of these Procs'es to achieve planned results

The Org' shall establish arrangements for these Procs'es including, as applicable,7.5.2 a) defined criteria for review & approval of the Procs'7.5.2 b) approval of equipment & qualification of personnel7.5.2 c) use of specific methods & procedures7.5.2 d) Re ' for Rec's7.5.2 e) revalidation

7.5.2.1

Validation of processes for

production and service provision

— Su lemental

The requirements of 7.5.2 shall apply to all processes for production and service provision.

7.5.3 Identification & trace ability Where appropriate, the Org' shall identify the product by suitable means throughout product realization.Identification & trace ability

methods

The Org' shall identify the product status with respect to Mon't'ing and Meas'mt Req's throughout

product realization.

Where traceability is a Req', the Org' shall control the unique identification of the product and maintain

Rec's (see 4.2.4).

NoteIn some industry sectors, configuration management is a means by which identification and traceability

are maintained.

NoteInspection 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

ur ose.


Evidence

Availability /


7.5.3.1Identification and traceability —

Su lemen tal The words “W here appropriate” in 7.5.3 shall not apply.

7.5.4 Customer propertyThe Org' shall exercise care with customer property while it is under the Org''s control or being used by

the Org'.List of cust property

The Org' shall identify, verify, protect and safeguard customer property provided for use or incorporation

into the product.

If any customer property is lost, damaged or otherwise found to be unsuitable for use, the Org' shall

report this to the customer and maintain Rec's (see 4.2.4).Note Customer property can include intellectual property and personal data

Customer-owned returnable packaging is included in this subclause.

7.5.4.1Customer-owned produ ct ion

tool ing

Customer-owned tools, manufacturing, test, inspection tooling and equipment shall be permanently

marked so that the ownership of each item is visible, and can be determined.List of cust property

7.5.5 Preservation of productThe Org' shall preserve the product during internal Procs'ing and delivery to the intended destination in

order to maintain conformity to Req's.

Storage & Inventory of material &

Product incl Packaging

As applicable, preservation shall include identification, handling, packaging, storage and

rotection.

Preservation shall also apply to the constituent parts of a product.

7.5.5.1 Storage and inventoryIn order to detect deterioration, the condition of product in stock shall be assessed at appropriate

planned intervals.

The organization shall use an inventory management system to optimize inventory turns over time and

assure stock rotation, such as “first-in-first-out” (FIFO).

Obsolete product shall be controlled in a similar manner to nonconforming product. Obsolete Prod. Treatment


Evidence

Availability /


7.6 Cont'l of mont & meas devicesThe Org' shall determine the Mon't'ing and Meas'mt to be undertaken and the Mon't'ing and measuring

equipment needed to provide evidence of conformity of product to determined Req's.

Calibration mark, List, schedule,

certificate, Calibration/verification

standard & Procedures

The Org' shall establish Procs'es to ensure that Mon't'ing and Meas'mt can be carried out and are carried

out in a manner that is consistent with the Mon't'in and Meas'mt Re 's.

Where necessary to ensure valid results, measuring equipment shall

7.6 a)be calibrated or verified, or both, at specified intervals, or prior to use, against Meas'mt standards

traceable to international or national Meas'mt standards;

where no such standards exist, the basis used for calibration or verification shall be Rec'ed (see 4.2.4);

7.6 b) be adjusted or re-adjusted as necessary7.6 c) have identification in order to determine its calibration status7.6 d) be safeguard from adjustment that would invalidate the Meas'mt result7.6 e) be protected from damage and deterioration during handling maintenance and storage

In addition, the Org' shall assess and Rec' the validity of the previous measuring results when the

equipment is found not to conform to Req's

The Org' shall take appropriate action on the equipment and any product affected.

Rec's of the results of calibration and verification shall be maintained (see 4.2.4).

When used in the Mon't'ing and Meas'mt of specified Req's, the ability of computer software to satisfy the

intended application shall be confirmed.

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

NoteConfirmation of the ability of computer software to satisfy the intended application would typically

include its verification and configuration management to maintain its suitability for use

Note A number or other identifier traceable to the device calibration record meets the intent of requirement

c) above.

7.6.1 Measurement system analysisStatistical studies shall be conducted to analyse the variation present in the results of each type of

measuring and test equipment system.MSA

This requirement shall apply to measurement systems referenced in the control plan.

The analytical methods and acceptance criteria used shall conform to those in customer reference

manuals on measurement s stems anal sis.

Other analytical methods and acceptance criteria may be used if approved by the customer.

7.6.2 Calibrat ion/veri f icat ion records

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

Calibration List

⎯ equipment identification, including the measurement standard against which the equipment is

calibrated,

⎯ 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 Laboratory requirements Lab Policy, Scope, WI, KPI,

Capability

7.6.3.1 Internal laboratory 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,

⎯ 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.

NoteNOTE Accreditation to ISO/IEC 17025 may be used to demonstrate the organization's in-house

laboratory conformity to this requirement but is not mandatory.

7.6.3.2 External laboratory

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

Cert. oF ISO 17025

⎯ 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.

Note1Such 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 Meas'mt, Analysis, & Imprv'mt

8.1 General the or shall lan & im lmt the mont meas. Anals & im rv rocs needed8.1 a) to demonstrate conformity of prod.8.1 b) to ensure conformity of QMS8.1 c) continually improve the eff of QMS

This shall include determination of applicable methods, including statistical techniques, and the extent of

their use.

8.1.1 Identification of statistical tools Appropriate statistical tools for each process shall be determined during advance quality planning and

included in the control plan.Control Plan


Evidence

Availability /


8.1.2 Knowledge of basic statistical

concepts

Basic statistical concepts, such as variation, control (stability), process capability and over-adjustment

shall be understood and utilized throughout the organization.SPC

8.2 Mon't'ing & Meas'mt -

8.2.1 customer satisfaction As one of the Meas'mts of the performance of the QMS, the Org' shall Mon't' information relating to

customer perception as to whether the Org' has met customer Req's.customer satisfaction data

The methods for obtaining and using this information shall be determined.

Note

Mon't'ing customer perception can include obtaining input from sources such as customer satisfaction

surveys, customer data on delivered product quality, user opinion surveys, lost business analysis,

compliments, warranty claims and dealer reports.Note NOTE Consideration should be given to both internal and external customers.

8.2.1Customer satisfaction —

Supplemental

Customer satisfaction with the organization shall be monitored through continual evaluation of

performance of the realization processes.

Performance indicators shall be based on objective data and include, but not be limited to:

⎯ delivered part quality performance,

⎯ customer disruptions, including field returns,

⎯ delivery schedule performance (including incidents of premium freight), and

⎯ customer notifications related to quality or delivery issues.The organization shall monitor the performance of manufacturing processes to demonstrate

compliance with customer requirements for product quality and efficiency of the process

8.2.2 internal auditThe Org' shall conduct internal audits at planned intervals to determine whether the quality

management systemInternal Audit Records, CA/PA

8.2.2 a)conforms to the planned arrangements (see 7.1), to the Req's of this International Standard and to the

QMS Req's established by the Org', and8.2.2 b) is effectivel im lemented and maintained.

P2-1 An audit programme shall be planned, taking into consideration the status and importance of the

Procs'es and areas to be audited, as well as the results of previous audits.P2-2 The audit criteria, scope, frequency and methodsshall be defined.

P2-3The selection of auditors and conduct of audits shall ensure objectivity and impartiality of the

audit Procs'.P2-4 Auditors shall not audit their own work.

P3-1 A documented procedure shall be established to define the responsibilities and Req's for planning and

conducting audits, establishing Rec's and reporting results.P4-1 Rec's of the audits and their results shall be maintained (see 4.2.4).

P5-1The management responsible for the area being audited shall ensure that any necessary corrections and

corrective 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 19011 for guidance

8.2.2.1 Quali ty management system audit The organization shall audit its quality management system to verify compliance with this Technical

Specification and any additional quality management system requirements.QMS Audit

8.2.2.2 Manufactur ing process audit The organization shall audit each manufacturing process to determine its effectiveness. Mfg Audit

8.2.2.3 Product audit

The organization shall audit products at appropriate stages of production and delivery to verify

conformity to all specified requirements, such as product dimensions, functionality, packaging and

labelling, at a defined frequency.

Prod Audit

8.2.2.4 Internal audit plans Internal audits shall cover all quality management related processes, activities and shifts, and shall be

scheduled according to an annual plan. Audit schedule

When internal/external nonconformities or customer complaints occur, the audit frequency shall be

appropriately increased.Note S ecific checklists should be used for each audit. Audit Check List

8.2.2.5 Internal aud itor qu al i f icat ion The organization shall have internal auditors who are qualified to audit the requirements of this

Technical Specification( see 6.2.2.2). Auditors Competence


Evidence

Availability /


8.2.3 mon't & meas'mt of Procs'es The Org' shall apply suitable methods for Mon't'ing and, where applicable, Meas'mt of the QMS Procs'es.

P1-2 These methods shall demonstrate the ability of the Procs'es to achieve planned results.

P1-3 When planned results are not achieved, correction and corrective action shall be taken, as appropriate.

Note

When determining suitable methods, it is advisable that the Org' consider the type and extent of

Mon't'ing or Meas'mt appropriate to each of its Procs'es in relation to their impact on the conformity to

product Req's and on the effectiveness of the QMS

8.2.3.1Monitor ing and measurement of

manufactur ing processes

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.⎯ measurement techniques,

These documents shall include objectives for manufacturing process capability, reliability,

maintainability and availability, as well as acceptance criteria.⎯ sampling plans,

The organization shall maintain manufacturing process capability or performance as specified by the

customer part approval process requirements.⎯ acceptance criteria, and

The organization shall ensure that the control plan and process flow diagram are implemented,

including adherence to the specified

⎯ reaction plans when acceptance

criteria are not met.

⎯ measurement techniques,

⎯ sampling plans,

⎯ acceptance criteria, and

⎯ 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.

8.2.4 mon't & meas'mt of productThe Org' shall Mon't' and measure the characteristics of the product to verify that product

Req's have been met.Product inspection layout

P1-2 This shall be carried out at appropriate stages of the product realization Procs' in accordance with the

planned arrangements (see 7.1)P1-3 Evidence of conformity with the acceptance criteria shall be maintained.

P2-1 Rec's shall indicate the person(s) authorizing release of product for delivery to the customer (see 4.2.4).

P3-1The release of product and delivery of service to the customer shall not proceed until the planned

arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant

authority and, where applicable, by the customer

NoteWhen selecting product parameters to monitor compliance to specified internal and external

requirements, the organization determines the types of product characteristics, leading to

⎯ the types of measurement,

⎯ suitable measurement means, and

⎯ the capability and skills required.

8.2.4.1Layout inspect ion and funct ional

test ing

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.

Results shall be available for customer review.

NoteLayout inspection is the complete measurement ofall product dimensions shown on the design

records.

8.2.4.2 App earance items For organizations manufacturing parts designated by the customer as “appearance items”, the

organization shall provide Appereance Master Sample

⎯ appropriate resources, including lighting, for evaluation,

⎯ masters for colour, grain, gloss, metallic brilliance, texture, distinctness of image (DOI), as

appropriate,

⎯ maintenance and control of appearance masters and evaluation equipment, and

⎯ verification that personnel making appearance evaluations are competent and qualified to do so.

8.3 Control of NC productThe Org' shall ensure that product which does not conform to product Req's is identified and controlled

to prevent its unintended use or delivery.NC Procedures

P1-2 A documented procedure shall be established to define the controls and related responsibilities and

authorities for dealing with nonconforming product.

P2-1 Where applicable, the Org' shall deal with nonconforming product by one or more of the following ways

8.3 a) by taking action to eliminate the detected nonconformity;

8.3 b)by authorizing its use, release or acceptance under concession by a relevant authority and, where

applicable, by the customer;

8.3 c) by taking action to preclude its original intended use or application;

8.3 d)by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming

product is detected after delivery or use has started.

P2-1When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity

to the Req's.

P3-1Rec's of the nature of nonconformities and any subsequent actions taken, including concessions

obtained, shall be maintained (see 4.2.4).


Evidence

Availability /


8.3.1Control of nonconforming product

— Su lementalProduct with unidentified or suspect status shall be classified as nonconforming product (see 7.5.3).

8.3.2 Control of reworked productInstructions for rework, including re-inspection requirements, shall be accessible to and utilized by the

appropriate personnel.

8.3.3 Customer information Customers shall be informed promptly in the event that nonconforming product has been shipped.

8.3.4 Customer waiver The organization shall obtain a customer concession or deviation permit prior to further processing

whenever the 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.

The organization shall also ensure compliance with the original or superseding specifications and

requirements when the authorization expires.

Material shipped on an authorization shall be properly identified on each shipping container.

This applies equally to purchased product.

The organization shall approve any requests from suppliers before submission to the customer.

8.4 Analysis of data

The Org' shall determine, collect and analyse appropriate data to demonstrate the suitability and

effectiveness of the QMS and to evaluate where continual improvement of the effectiveness of the QMS

can be made.

Data Analysis Recs

P1-2 This shall include data generated as a result of Mon't'ing and Meas'mt and from other relevant sources.

P2-1 The anal sis of data shall rovide information relatin to8.4 a) cust satisfaction8.4 b) conformity to prod. Req's

8.4 c)characteristics and trends of Procs'es and products, including opportunities for preventive action

(see 8.2.3 and 8.2.4), and

8.4 d) suppliers (see 7.4)

8.4.1 Analysis and use of dataTrends in quality and operational performance shall be compared with progress toward objectives and

lead to action to support the following:

⎯ development of priorities for prompt solutions to customer-related problems;

⎯ determination of key customer-related trends and correlation for status review, decision-making and

longer term planning;

⎯ an information system for the timely reporting of product information arising from usage.Note Data should be compared with those ofcompetitors and/or appropriate benchmarks.

8.5 Improvement -

8.5.1 Continual improvement

The Org' shall continually improve the effectiveness of the QMS through the use of the quality policy,

quality objectives, audit results, analysis of data, corrective and preventive actions and management

review.

Continual Improvements System

8.5.1.1Continual improvement of the

or anizationThe organization shall define a process for continual improvement.

8.5.1.2 Manufacturing process

improvement

Manufacturing process improvement shall continually focus upon control and reduction of variation in

product characteristics and manufacturing process parameters.Note1 NOTE 1 Controlled characteristics are documented in the control lan.

Note2 NOTE 2 Continual improvement is implemented once manufacturing processes are capable and stable,

or product characteristics are predictable and meet customer requirements.

8.5.2 Corrective action The Org' shall take action to eliminate the causes of nonconformities in order to prevent recurrence.CAR including analysis recs, and

error proofings

Corrective actions shall be appropriate to the effects of the nonconformities encountered.

A documented procedure shall be established to define Req's for 8.5.2 a) reviewing NC (incl. cust complaints)8.5.2 b) determining the causes of NC8.5.2 c) evluating the need for action to ensure that NC do not occur 8.5.2 d) determining & implementing action needed8.5.2 e) Rec's of the result of action taken8.5.2 f) reviewing eff. of C/A taken

8.5.2.1 Problem solvingThe organization shall have a defined process for problemsolving leading to root cause identification and

elimination.

If a customer-prescribed problem-solving format exists, the organization shall use the prescribed format.

8.5.2.2 Error-proofing The organization shall use error-proofing methods in their corrective action process.

8.5.2.3 Corrective action impactThe organization shall apply to other similar processes and products the corrective action, and controls

implemented, in order to eliminate the cause of a nonconformity.Horizontal Deployment

8.5.2.4 Rejected product test/analysisThe organization shall analyse parts rejected by the customer's manufacturing plants, engineering

facilities and dealerships.

The organization shall minimize the cycle time of this process.

Records of these analyses shall be kept and made available upon request.

The organization shall perform analysis and initiate corrective action to prevent recurrence.

NoteNOTE Cycle time related to rejected product analysis should be consistent with the determination of root

cause, corrective action and monitoring the effectiveness of implementation.


Evidence

Availability /


8.5.3 Preventive actionsThe Org' shall determine action to eliminate the causes of potential nonconformities in order to prevent

their occurrence.PAR

Preventive actions shall be appropriate to the effects of the potential problems

A documented rocedure shall be established to define Re 's for 8.5.3 a) determining the potential NC and their causes8.5.3 b) evluating the need for action to prevent occurance of NC8.5.3c) determining & implementing action needed

8.5.3 d) Rec's of the result of action taken8.5.2 e) reviewing eff. Of P/A taken

No. Clause Title1 4.2.3 Control of Documennts2 4.2.4 Control of Rec'3 8.2.2 Internal audit4 8.3 Control of Nonconforming product5 8.5.2 Corrective action6 8.5.3 Preventive action

5.6.1 Management Review -General- Rec's from management reviews shall be maintained (see 4.2.4)6.2.2 e) Comptce, Awrness & Training maintain appropriate Rec' Of education, triniing skills, and experience

7.1 d) Planning of Product Realization Recs needed to prove realization Procs' and resulting product meet Req's

7.2.2 Review of Req's related to prod. Rec's of the results of the review and actions arising from the review shall be maintained

7.3.2 D&D input Inputs relating to product Req's shall be determined and Rec's maintained (see 4.2.4).7.3.4 D&D Review Rec's of the results of the reviews and any necessary actions shall be maintained (see 4.2.4).

7.3.5 D&D VerificationRec's of the results of

the verification and any necessary actions shall be maintained (see 4.2.4).7.3.6 D&D Validation Rec's of the results of validation and any necessary actions shall be maintained (see 4.2.4).7.3.7 Control of D&D changes D & D changes shall be identified and Rec's maintained.

7.4.1 Purchasing Procs'Rec's of the results of evaluations and any necessary actions arising from the evaluation shall be

maintained (see 4.2.4).7.5.2 d) Val of Procs' for P&S provision Req' for Rec's

7.5.3 Identification & trace abilityWhere traceability is a Req', the Org' shall control the unique identification of the product and maintain

Rec's (see 4.2.4).

7.5.4 Customer propertyIf any customer property is lost, damaged or otherwise found to be unsuitable for use, the Org' shall

report this to the customer and maintain Rec's (see 4.2.4).

7.6 Cont'l of mont & meas devices where no such standards exist, the basis used for calibration or verification shall be Rec'ed (see 4.2.4);

8.2.2 P4-1 internal audit Rec's of the audits and their results shall be maintained (see 4.2.4).8.2.4 P1-3 mon't & meas'mt of product Evidence of conformity with the acceptance criteria shall be maintained.

8.2.4 P2-1 mon't & meas'mt of product Rec's shall indicate the person(s) authorizing release of product for delivery to the customer (see 4.2.4).

8.3 P3-1 Control of NC productRec's of the nature of nonconformities and any subsequent actions taken, including concessions

obtained shall be maintained see 4.2.4 .8.5.2 e) Corrective action Rec's of the result of action taken8.5.3 d) Preventive actions Rec's of the result of action taken

The 6 Mandatory Documentation

The 20 Mandatory Rec'


Evidence

Availability /


(a) Customer focusOrg's depend on their customers and therefore should understand current and future customer needs,

should meet customer Req's and strive to exceed customer expectations.

(b) LeadershipLeaders establish unity of purpose and direction of the Org'. They should create and maintain the

internal environment in which people can become fully involved in achieving the Org'’s objectives.

(c) Involvement of peoplePeople at all levels are the essence of an Org' and their full involvement enables their abilities to be used

for the Or '’s benefit.

(d) Procs' approach A desired result is achieved more efficiently when activities and related resources are managed as a

Procs'.

(e) System approach to managementIdentifying, understanding and managing interrelated Procs'es as a system contributes to the Org'’s

effectiveness and efficiency in achieving its objectives.

(f) Continual improvement Continual improvement of the Org'’s overall performance should be a permanent objective of the Org'.

(g)Factual approach to decision

makinEffective decisions are based on the analysis of data and information.

(h)Mutually beneficial supplier

relationships

An Org' and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of

both to create value.

1 Purpose establish the Org'’s purpose and the needs and expectations of stakeholders relative to this purpose.

2 Policydefine, document, maintain and communicate the overall intentions, prin-

ciples and values related to quality.

3 Planningestablish objectives, measures and targets for fulfilling the organiza-

tion’s purpose and its policies, assessing risks and develop plans and Procs'es

for achieving the objectives that take due account of these risks.

4 Implementationresource, operate and manage the plans and Procs'es to deliver

outputs that achieve the planned results.

5 Meas'mtMon't', measure and audit Procs'es, the fulfilment of objectives

and policies and satisfaction of stakeholders.

6 Review

analyse and evaluate the results of Meas'mt, determine performance

against objectives and determine changes needed in policies, objectives, measures,

targets and Procs'es for the continuing suitability, adequacy and effectiveness of

the system

7 Improvementundertake action(s) to bring about improvement by better control,

better utilization of resources and better understanding of stakeholder needs. This

might include innovation and learning.

1

2

3

4

5 The Org' shall demonstrate that it is achieving these objectives as measured, that they are being achieved in the best way and that they remain

Attainment Levels of QualityI. Freedom from deficiencies which require better controls and result in lower costs but does not necessarily retain satisfied customers.

II. Conformity with customer Req's which requires capable Procs'es and results in lower costs but does not necessarily retain satisfied customers.

III. Satisfying customer’s needs and expectations which requires innovation as well as capable Procs'es and results in lower operating costs and higher development

costs but in return creates and retains satisfies customers and leads to sustained success.

The Org' shall demonstrate that it has an effective system of interacting Procs'es for enabling the Org' to meet these objectives in the most

8 Quality Management Principles

A principle is a fundamental law, truth or assumption that is verifiable.

A principle may not be useful under all conditions and a violation of a principle under certain conditions may not invalidate the principle for all conditions.

A violation of a principle results in consequences usually by making operations more inefficient or less effective, but that may be a price worth paying under certain

circumstances.In order to make this judgement, managers need a full understanding of the consequence of ignoring the principles.

The Basic Management Req's

The 5 Basic Assurance Req's

The Org' shall demonstrate its commitment to the achievement of quality.

The Org' shall demonstrate that it has effective policies for creating an environment that will motivate its personnel into satisfying the needs and

The Org' shall demonstrate that it has effectively translated the needs and expectations of its customers and applicable statutory and regulatory