Sections of the Standard. Evidence / Comments. (Y) / Nonconforming (NC)

Transcription

1 Date: Sections of the Standard 4 Context of the Organization 4.1 Understanding the organization and its context 4.2 Understanding the needs and expectations of interested parties 4.3 Determining the scope of the QMS Determining the scope of the QMS Customer-specific requirements 4.4 QMS and its processes Establish, implement, maintain and continually improve the QMS Conformance of products and processes Product Safety Maintain and retain documented information 5 Leadership 5.1 Leadership and commitment General Corporate responsibility Process effectiveness and efficiency Process owners Customer Focus Communicating the quality policy 5.3 Organizational roles, responsibilities and authorities Organizational roles, responsibilities, and authorities Responsibility and authority for product requirements and corrective action 6 Planning 6.1 Actions to address risks and opportunities Conforming (Y) / Nonconforming (NC) Auditor: Evidence / Comments

2 Risk Analysis Preventive Action Contingency Planning 6.2 Quality objectives and planning to achieve them Quality objectives and planning to achieve them 6.3 Planning of changes 7 Support 7.1 Resources General People Infrastructure Plant, facility, and equipment planning Environment for the operation of processes Environment for the operation of processes Monitoring and measuring resources Measurement systems analysis Calibration / verification records Laboratory requirements Internal laboratory External laboratory Organizational knowledge 7.2 Competence 7.3 Awareness Competence Competence on-the-job training Internal auditing competency Second-party auditor competency Awareness Employee motivation and empowerment 7.4 Communication 7.5 Documented Information

3 7.5.1 General Quality management system documentation Creating and updating Control of documented information 8 Operation Record retention Engineering specification 8.1 Operational planning and control Operational planning and control Confidentiality 8.2 Requirements for products and services Customer communication Customer communication Determining the requirements for products and services Determining the requirements for products and services Review of the requirements for products and services Review of the requirement for products and services Customer-designated special characteristics Organization manufacturing feasibility Changes to requirements for products and services 8.3 Design and development of products and services General Design and development of products and services Design and development planning Design and development planning Product design skills Development of products with embedded software

4 8.3.3 Design and development inputs Product design input Manufacturing process design input Special characteristics Design and development controls Monitoring Design and development validation Prototype program Product approval process Design and development outputs Design and development outputs Manufacturing process design output Design and development changes Design and development changes 8.4 Control of externally provided processes, products and services General General Supplier selection process Customer-directed sources (directed-buy) Type and extent of control Type and extent of control Statutory & regulatory requirements Supplier QMS development Automotive product-related software or automotive products with embedded software Supplier monitoring Second-party audits Supplier development Information for external providers Information for external providers 8.5 Production and service provision

5 8.5.1 Control of production and service provision Control plan Standardized work operator instructions and visual standards Verification of job set-ups Verification after shutdown Total productive maintenance Management of production tooling and manufacturing test, inspection tooling and equipment Production scheduling Identification and traceability Identification and traceability Property belonging to customers or external providers Preservation Preservation Post-delivery activities Feedback of information from service Service agreement with customer Control of changes Control of changes Temporary change of process controls 8.6 Release of products and services Release of products and services Layout inspection and functional testing Appearance items Verification and acceptance of conformity of external provided products and services Statutory and regulatory requirements Acceptance criteria 8.7 Control of non-conforming outputs

6 Customer authorization for concession Control of nonconforming product customer-specified process Control suspect product Control of reworked product Control of repaired product Customer notification Nonconforming product disposition 9 Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation General Monitoring and measurement of manufacturing processes Identification of statistical tools Application of statistical concepts Customer satisfaction Customer satisfaction Analysis and evaluation 9.2 Internal audit Prioritization Internal audit program Quality management system audit Manufacturing process audit Product audit 9.3 Management review 10 Improvement 10.1 General Management review Management review inputs Management review outputs 10.2 Non-conformity and corrective action Problem Solving Error-proofing

7 Warranty management systems Customer complaints and field failure test analysis 10.3 Continual improvement Continual improvement Annex A: Control Plan A.1 Phases of the control plan A.2 Elements of the control plan