ABSTRACT

Scope (title only) 1 1 Scope General 1.1 Application 1.2 Normative references 2 2 Normative references Terms and defi nitions 3 3 Terms and defi nitions Quality management system (title only) 4 4 Environmental management

system requirements (title only)

General requirements 4.1 4.1 General requirements Documentation requirements (title only) 4.2 General 4.2.1 4.4.4 Documentation Quality manual 4.2.2 Control of documents 4.2.3 4.4.5 Control of documents Control of records 4.2.4 4.5.4 Control of records Management responsibility (title only) 5 Management commitment 5.1 4.2 Environmental policy

4.4.1 Resources, roles, responsibility, and authority

Management representative 5.5.2 4.4.1 Resources, roles, responsibility, and authority

Customer focus 5.2 4.3.1 Environmental aspects 4.3.2 Legal and other requirements 4.6 Management review

Quality policy 5.3 4.2 Environmental policy Planning (title only) 5.4 4.3 Planning (title only)

continued

Quality objectives 5.4.1 4.3.3 Objectives, targets, and program(s)

QMS planning 5.4.2 4.3.3 Objectives, targets, and program(s)

Responsibility, authority, and communication (title only)

5.5

Responsibility and authority 5.5.1 4.1 General requirements

4.4.1 Resources, roles, responsibility, and authority

Management representative 5.5.2 4.4.1 Resources, roles, responsibility, and authority resources, role

Internal communication 5.5.3 4.4.3 Communication

Management review (title only) 5.6 4.6 Management review

General 5.6.1 4.6 Management review

Review input 5.6.2 4.6 Management review

Review output 5.6.3 4.6 Management review

Resource management (title only) 6

Provision of resources 6.1 4.4.1 Resources, roles, responsibility, and authority

Human resources (title only) 6.2

General 6.2.1 4.4.2 Competence, training, and awareness

Competence, training, and awareness 6.2.2 4.4.2 Competence, training, and awareness

Infrastructure 6.3 4.4.1 Resources, roles, responsibility, and authority

Work environment 6.4

Product realization (title only) 7 4.4 Implementation and operation (title only)

Planning of product realization 7.1 4.4.6 Operational control

Customer-related processes (title only) 7.2

Determination of requirements related to the product

7.2.1 4.3.1 4.3.2 4.4.6

Environmental aspects Legal and other requirements Operational control

Review of requirements related to the product

7.2.2 4.3.1 4.4.6

Environmental aspects Operational control

Customer communication 7.2.3 4.4.3 Communication

Design and development (title only) 7.3

Design and development planning 7.3.1 4.4.6 Operational control

Design and development inputs 7.3.2 4.4.6 Operational control

Design and development outputs 7.3.3 4.4.6 Operational control

Design and development review 7.3.4 4.4.6 Operational control

Design and development verifi cation 7.3.5 4.4.6 Operational control

Design and development validation 7.3.6 4.4.6 Operational control

Control of design and development changes

7.3.7 4.4.6 Operational control

Purchasing (title only) 7.4

Purchasing process 7.4.1 4.4.6 Operational control

Purchasing information 7.4.2 4.4.6 Operational control

Verifi cation of purchased product 7.4.3 4.4.6 Operational control

Production and service provision (title only)

7.5

Control of production and service provision

7.5.1 4.4.6 Operational control

Validation of processes for production and service provision

7.5.2 4.4.6 Operational control

Identifi cation and traceability 7.5.3

Customer property 7.5.4

Preservation of product 7.5.5 4.4.6 Operational control

Control of monitoring and measuring equipment

7.6 4.5.1 Monitoring and measurement

Measurement, analysis, and improvement (title only)

8 4.5 Checking (title only)

General 8.1 4.5.1 Monitoring and measurement

Monitoring and measurement (title only) 8.2

Customer satisfaction 8.2.1

Internal audit 8.2.2 4.5.5 Internal audit

Monitoring and measurement of processes

8.2.3 4.5.1 Monitoring and measurement

4.5.2 Evaluation of compliance

Monitoring and measurement of product 8.2.4 4.5.1 Monitoring and measurement

4.5.2 Evaluation of compliance

Control of nonconforming product 8.3 4.4.7 Emergency preparedness and response

4.5.3 Nonconformity, corrective action, and preventive action

Analysis of data 8.4 4.5.1 Monitoring and measurement

Improvement (title only) 8.5

continued

Continual improvement 8.5.1 4.2 Environmental policy

4.3.3 Objectives, targets, and program(s)

4.6 Management review

Corrective action 8.5.2 4.5.3 Nonconformity, corrective action, and preventive action

Preventive action 8.5.3 4.5.3 Nonconformity, corrective action, and preventive action