ISO 9001: 2015 ISO 9001:2008 New Requirements Potential QMS Locations Where the & change notes (1) requirements are addressed in your Note: Bold items are where the main Quality content could be addressed. Management System 1 Scope 1 Scope 1.1 General 4 Context of the 4 Quality management organization system 4.1 Understanding the 4 Quality management New Requirements Policy Manual – organization and its context system Understanding (Defining) Context Mgmt Responsibility of organization - & reviewed Mgmt Review Internal & External Issues Contract Review & new product launch process - Inputs 4.2 Understanding the needs 4 Quality management New Requirements Mgmt Responsibility – and expectations of system Interested party needs & review Contract Review, New Product interested parties (Need to know what they are, but launch process, customer only need to meet customer surveys and feedback (Inputs) requirements) Mgmt Review Regulatory & Statutory Interested Party Matrix (e.g. Requirements (Monitor & Review) Policy Manual and Management Review) 4.3 Determining the scope of 1.2 Application New Requirements Policy manual & – 4.2.2 Quality manual Scope & Justification for the quality management Justification for exclusions – exclusion system Many QMS already this
ISO 9001: 2015 ISO 9001:2008 New Requirements Potential QMS Locations & change notes (1) Note: Bold items are where the main content could be addressed. Where the requirements are addressed in your Quality Management System 1 Scope 1 Scope 1.1 General 4 Context of the organization 4 Quality management system 4.1 Understanding the organization and its context 4 Quality management system New Requirements – Understanding (Defining) Context of organization - & reviewed Internal & External Issues Policy Manual Mgmt Responsibility Mgmt Review Contract Review & new product launch process - Inputs 4.2 Understanding the needs and expectations of interested parties 4 Quality management system New Requirements – Interested party needs & review (Need to know what they are, but only need to meet customer requirements) Regulatory & Statutory Requirements (Monitor & Review) Mgmt Responsibility Contract Review, New Product launch process, customer surveys and feedback (Inputs) Mgmt Review Interested Party Matrix (e.g. Policy Manual and Management Review) 4.3 Determining the scope of the quality management system 1.2 Application 4.2.2 Quality manual New Requirements Scope & Justification for exclusion Policy manual – & Justification for exclusions – Many QMS already this