汽車行業生產件和相關服務件的組織實施ISO90012000的特殊要求(doc 46)中英文

Foreword前言

Remarks for certification有關認證的說明

Introduction引言

0.1 General總則

0.2 Process approach過程方法

0.3 Relationship with ISO 9004與ISO 9004的關係

0.3.1 IATF Guidance to ISO/TS 16949:2002IATF關於ISO/TS 16949:2002的指南

0.4 Compatibility with other management systems與其他管理體係的相容性

0.5 Goal of this Technical Specification本技術規範的目的

1 Scope範圍

1.1 General總則

1.2 Application應用

2 Normative reference引用標準

3 Terms and definitions術語和定義

3.1Terms and definitions for the automotive industry汽車行業的術語和定義

4 Quality management system

4.1 General requirements

4.1.1 General requirements - Supplemental

4.2 Documentation requirements

4.2.1 General

4.2.2 Quality manual

4.2.3 Control of documents

4.2.3.1 Engineering specifications

4.2.4 Control of records

4.2.4.1 Records retention

5 Management responsibility

5.1 Management commitment

5.1.1 Process efficiency

5.2 Customer focus

5.3 Quality policy

5.4 Planning

5.4.1 Quality objectives

5.4.1.1 Quality objectives ? Supplemental

5.4.2 Quality management system planning

5.5 Responsibility, authority and communication

5.5.1 Responsibility and authority

5.5.1.1 Responsibility for quality

5.5.2 Management representative

5.5.2 1 Customer representative

5.5.3 Internal communication

5.6 Management review

5.6.1 General

5.6.1.1 Quality management system performance

5.6.2 Review input

5.6.2.1 Review input ? Supplemental

5.6.3 Review output

6 Resource management

6.1 Provision of resources

6.2 Human resources

6.2.1 General

6.2.2 Competence, awareness and training

6.2.2.1 Product design skills

6.2.2.2 Training

6.2.2.3 Training on the job

6.2.2.4 Employee motivation and empowerment

6.3 Infrastructure

6.3.1 Plant, facility andequipmentplanning

6.3.2 Contingency plans

6.4 Work environment

6.4.1 Personnel safety to achieve product quality

6.4.2 Cleanliness of premises

7 Product realization

7.1 Planning of product realization

7.1.1 Planning of product realization ? Supplemental

7.1.2 Acceptance criteria

7.1.3 Confidentiality

7.1.4 Change control

7.2 Customer?related processes

7.2.1 Determination of requirements related to the product

7.2.1.1 Customer?designated special characteristics

7.2.2 Review of requirements related to the product

7.2.2.1 Review of requirements related to the product ? Supplemental

7.2.2.2 Organization manufacturing feasibility

7.2.3 Customer communication

7.2.3.1 Customer communication ? Supplemental

7.3 Design and development

7.3.1 Design and development planning

7.3.1.1 Multidisciplinary approach

7.3.2 Design and development inputs

7.3.2.1 Product design input

7.3.2.2 Manufacturing process design input

7.3.2.3 Special characteristics

7.3 3 Design and development outputs

7.3.3.1 Product design outputs ? Supplemental

7.3.3.2 Manufacturing process design output

7.3.4 Design and development review

7.3.4.1 Monitoring

7.3.5Design and development verification

7.3.6 Design and development validation

7.3.6.1 Design and development validation ?Supplemental

7.3.6.2 Prototype programme

7.3.6.3 Product approval process

7.3.7 Control of design and development changes

7.4 Purchasing

7.4.1 Purchasing process

7.4.1.1 Regulatory conformity

7.4.1.2 Supplier quality management system development

7.4.1.3 Customer?approved sources

7.4.2 Purchasing information

7.4.3 Verification of purchased product

7.4.3.1 Incoming product quality

7.4.3.2 Supplier monitoring

7.5 Production and service provision

7.5.1 Control of production and service provision

7.5.1.1 Control plan

7.5.1.2 Work instructions

7.5.1.3 Verification of job set?ups

7.5.1.4 Preventive and Predictive maintenance

7.5.1.5 Management of production tooling

7.5.1.6 Production scheduling

7.5.1.7 Feedback of information from service

7.5.1.8 Servicing agreement with customer

7.5.2 Validation of processes for production and service provision

7.5.2.1 Validation of processes for production and service provision ? Supplemental

7.5.3 Identification and traceability

7.5.3.1 Identification and traceability ? Supplemental

7.5.4 Customer property

7.5.4.1 Customer?owned production tooling

7.5.5 Preservation of product

7.5.5.1 Storage and inventory

7.6 Control of monitoring and measuringdevices

7.6.1 Measurement system analysis

7.6.2 Calibration/Verification records

7.6.3 Laboratory requirements

7.6.3.1 Internal laboratory

7.6.3.2 External laboratory

8 Measurement, analysis and improvement

8.1 General

8.1.1 Identification of statistical tools

8.1.2 Knowledge of basic statistical concepts

8.2 Monitoring and measurement

8.2.1 Customer satisfaction

8.2.1.1 Customer satisfaction ? Supplemental

8.2.2 Internal audit

8.2.2.1 Quality management system audit

8.2.2.2 Manufacturing process audit

8.2.2.3 Product audit

8.2.2.4 Internal audit plans

8.2.2.5 Internal auditor qualification

8.2.3 Monitoring and measurement of processes

8.2.3.1 Monitoring and measurement of manufacturing processes

8.2.4 Monitoring and measurement of product

8.2.4.1 Layout inspection and functional testing

8.2.4.2 Appearance items

8.3 Control of nonconforming product

8.3.1 Control of nonconforming product? Supplemental

8.3.2 Control of reworked product

8.3.3 Customer information

8.3.4 Customer waiver

8.4 Analysis of data

8.4.1 Analysis and use of data

8.5 Improvement

8.5.1 Continual improvement

8.5.1.1 Continual improvement of the organization

8.5.1.2 Manufacturing process improvement

8.5.2 Corrective action

8.5.2.1 Problem solving

8.5.2.2 Error?proofing

8.5.2.3 Corrective action impact

8.5.2.4 Rejected product test/analysis

8.5.3 Preventive action

Annex A (normative) Control Plan附錄A (標準的)控製計劃

A.1 Phases of the control plan/控製計劃的階段

A.2 Elements of the control plan/控製計劃的要素

Bibliography/引用文獻

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