4.4 Quality management system 4 Quality management Process inputs / outputs & KPIs Many QMS already cover this system and its processes 4.1 General requirements 5 Leadership 5 Management responsibility 5.1 Leadership and commitment 5.1 Management Increased Focus, More hands on More frequent management commitment direction reviews, or in management meetings 5.1.1 General 5.1 Management Demonstrate commitment commitment 5.1.2 Customer focus 5.2 Customer focus Determine statutory and Contract Review regulatory requirements New product launch process Risks Risks (Process could be documented see 6.1) – 5.2 Quality policy 5.3 Quality policy Documented 5.2.1 developing the quality policy Available to relevant interested parties as applicable 5.2.2 communicating the quality Training & Postings, covered policy communicated and understood regularly 5.3 Organizational roles, 5.5.1 Responsibility and Mgmt Rep implied, may be authority distributed more open & responsibilities and – 5.5.2 Management updated language authorities representative
4.4 Quality management system and its processes 4 Quality management system 4.1 General requirements Process inputs / outputs & KPIs Many QMS already cover this 5 Leadership 5 Management responsibility 5.1 Leadership and commitment 5.1 Management commitment Increased Focus, More hands on direction More frequent management reviews, or in management meetings 5.1.1 General 5.1 Management commitment Demonstrate commitment 5.1.2 Customer focus 5.2 Customer focus Determine statutory and regulatory requirements Risks Contract Review New product launch process Risks (Process could be documented – see 6.1) 5.2 Quality policy 5.2.1 developing the quality policy 5.2.2 communicating the quality policy 5.3 Quality policy Documented Available to relevant interested parties as applicable communicated and understood Training & Postings, covered regularly 5.3 Organizational roles, responsibilities and authorities 5.5.1 Responsibility and authority 5.5.2 Management representative Mgmt Rep implied, may be distributed – more open & updated language
ISO_9001Correlation_Matrices--Rev5.docx