ISO 9001:2015 vs. ISO 9001:2008 (A side by side comparison) Many people are understandably curious about how the new ISO 9001:2015 stacks up against the existing 1S 9001:2008 standard. Perry Johnson Registrars has prepared this report to offer you greater insight into the comparison, and to illustrate that much of the new ISO 9001:2015 standard has already been present in the existing ISO 9001:2008 standard. ‘The most obvious change is that the 2015 standard is presented in 10 sections, required per Annex SL. ISO 9001:2015 Clause Number nt ISO 9001:2008 Clause Num 1 Scope 1 Scope 2 Normative Reference 2 Normative Reference 3 Terms and Definitions 3 Terms and Definitions 4 Context of the Organization (Section title) N/A ‘None (although in spirit this requirement was 4.1 Understanding the organization andits context | find under 11) 4.2 Understanding the needs and expectations of |_| None (although in spirit this requirement was interested parties found under 1.1) 4.3 Determining the scope of the quality ‘None (although this content was previously management system specified under 4.2.2) 4.4 Quality management system and its processes | 4.1 5 Leadership (Section title) NA 5.1 Leadership and commitment 5.152 5.2 Policy 53 5.3 Organizational roles, responsibilities and 55.1 authorities 6 Planning (Section title) N/A ‘None (although this new requirement borrows ideas previously found in 8.5.3, 5.4.2 and 7.1) 6.2 Quality objectives and planning to achieve them | 5.4.1 6.1 Actions to address risks and opportunities 6.3 Planning of changes 542 ‘7 Support (Section title) N/A 7.1 Resources 61 7.1.1 General 61 7.1.2 People 62 7.1.3 Infrastructure 63 7.1.4 Environment for the operation of processes | 6.4 7.1.5 Monitoring and measuring resources 16 7.1.6 Organizational knowledge None BZ very sohnson Resistars. ne. wow.pircom 1-800-800-79107.2. Competence 62 7.3 Awareness 62 7.4 Communication 55.3 7.5 Documented Information 423,424 7.5.1 General 7.5.2 Creating and Updating services 75.3 Control of Documented Information 423,424 8 Operation (Section title) N/A 8.1 Operational planning and control TL 8.2 Requirements for products and services 72 8.2.1 Customer communication 72.3 8.2.2 Determination of requirements related to 721 products and services 8.2.3 Review of requirements related to products | 7 4 5 and services 8.2.4 Changes to requirements for products and 722 services é 8.3 Design and development of products and 13 8.3.1 General ‘None (although the ideas behind this requirement are rooted in clause 7.3 at large) 8.3.2 Design and development planning 73.1 8.3.3 Design and development inputs 732 8.3.4 Design and development controls 734,735,736 8.3.5 Design and development outputs 733 8.3.6 Design and development changes 73.7 8.4 Control of externally provided processes, products and services 741 8.4.1 General TAL 8.4.2 Type and extent of control 741,743 8.4.3 Information for extemal providers 742 8.5 Production and service provision 751,752 8.5.1 Control of production and service provision | 7.5.1, 7.5.2 8.5.2 Identification and traceability 753 8.5.3 Property belonging to customers or external providers 154 8.5.4 Preservation 755 8.5.5 Postdelivery activities 751,721 8.5.6 Control of changes 423,542,737 BEE Pers stnzon Reiss www.pjr.com 1-800-800-79108.6 Release of products and services 8.2.4 8.7 Control of nonconforming outputs 83 9 Performance evaluation (Section title) NIA 9.1 Monitoring, measurement, analysis and evaluation 51,82 9.1.1 General 8.1, 82 9.1.2 Customer satisfaction 82.1 9.1.3 Analysis and evaluation 84 9.2 Tntemal audit 82.2 9.3 Management review 5.6 10 Improvement (Section title) NIA 10.1 General 83,85 10.2 Nonconformity and Corrective Action 83,852 10.3 Continual Improvement 85.1 woew.pjr-com 1-800-800-7910Now let’s examine the comparison the other way ting ISO 9001:2008 Clause Number 4 Quality Management System (Section title) Proposed ISO 9001:2015 Clause Number NA 4.1 General Requirements 4.4 Quality management system and its processes 4.2.2 Quality Manual None (a Quality Manual is no longer specifically required, however the content previously found in a quality manual is now specified under clauses 4.3 Determining the Scope of the Quality ‘Management System, 7.5.1 General, and 4.4 Quality Management System and it’s processes) 4.2.3 Control of Documents 7.5 Documented Information, 7.5.1 General, 7.5.3 Control of Documented Information, 8.5.6 Control of changes 4.2.4 Control of Records 7.5 Documented Information, 7.5.1 General, 7.5.3 Control of Documented Information, 8.5.6 Control of changes 5 Management Responsibility (Section title) NA 5.1 Management Commitment 5.1 Leadership and commitment 5.2 Customer Focus 5.1 Leadership and commitment 5.3 Quality Policy 5.2 Policy 1 Quality Objectives 62 Quality objectives and planning to achieve 5.4.2 Quality Management System Planning 62 Quality objectives and planning to achieve them, 6.3 Planning of changes 5.5.1 Responsibility and Authority 5.3 Organizational roles, responsibilities and authorities 2 Management Representative None (this position has been eliminated) 5.5.3 Internal Communication 7.4 Communication 5.6 Management Review 9.3 Management review ‘6 Resource Management (Section title) NA 6.1 Provision of Resources 7.1 Resources, 7.1.1 General 6.2 Human Resources 7.1.2 People, 7.2 Competence, 7.3 Awareness 6.3 Infrastructure 7.13 Infrastructure 64 Work Environment 7:14 Environment for the operation of processes 7 Product Realization (Section title) NA 7.1 Planning of Product Realization 8.1 Operational planning and control 7.2 Customer Related Processes 8.2 Requirements for products and services BZ very sohnson Resistars. ne. woew.pjr-com 1-800-800-79107.2.1 Determination of Requirements Related to the Product 8.2.2 Determination of requirements related to products and services, 8.5.5 Post-delivery activities 7.2.2 Review of Requirements Related to the Product 8.2.3 Review of requirements related to products and services 7.2.3 Customer Communication 8.2.1 Customer communication 7.3 Design and Development 8.3 Design and development of products and services 3 Design and Development 8.3.1 General Design and Development Planning 8.3.2 Design and development planning 73.2 Design and Development Inputs 8.3.3 Design and development Inputs 7.3.3 Design and Development Outputs 8.3.5 Design and development outputs 7.3.4 Design and Development Review 8.3.4 Design and development controls 7.3.5 Design and Development Verification 8.3.4 Design and development controls 7.3.6 Design and Development Validation 8.3.4 Design and development controls 7.3.7 Design and Development Changes 8.3.6 Design and development changes 7.4.1 Purchasing Process 8.4 Control of externally provided products and services, 8.4.1 General, 8.4.2 Type and extent of control 7.4.2 Purchasing Information 8.4.3 Information for external providers 7.4.3 Verification of Purchased Product 8.4.2 Type and extent of control 7.5.1 Control of Production and Service Provision 8.5 Production and service provision, 8.5.1 Control of production and service provision 75.2 Validation of Processes for Production and Service Provision 8.5 Production and service provision, 8.5.1 Control of production and service provision 7.5.3 Mentification and Traceability 8.5.2 Identification and traceability 7.5.4 Customer Property 8.5.3 Property belonging to customers or external providers 7.5.5 Preservation of Product 8.5.4 Preservation 7.6 Control of Monitoring and Measurement Equipment 7.5 Monitoring and measuring resources 8 Measurement, Analysis, and Improvement (Section title) NA 8.1 General 9.1.1 General 8.2 Monitoring and Measurement 9.1 Monitoring, measurement, analysis and evaluation 8.2.1 Customer Satisfaction 9.1.2 Customer satisfaction 8.2.2 Internal Audit 9.2 Internal audit 8.2.3 Monitoring and Measurement of Processes 9.1 Monitoring, measurement, analysis and evaluation z erry Johnson Registrars, Ine, www.pjr.com 1-800-800-79108.2.4 Monitoring and Measurement of Product 8.6 Release of products and services 8.3 Control of Nonconforming Product 8.7 Control of nonconforming outputs, 10.1 General, 10.2 Nonconformity and Corrective Action 8.4 Analysis of Data 9.1.3 Analysis and evaluation 8.5.1 Continual Improvement 10.1 General, 10.3 Continual Improvement 8.5.2 Corrective Action 10.2 Nonconformity and Corrective Action 8.5.3 Preventive Action ‘None (although in spirit this requirement is found in clause 6.2.1 and 6.2.2) erry Johnson Registrars, Ine, www.pjr.com 1-800-800-7910