Mapping between the requirements of ISO …

1 Mapping between the requirements of ISO 9001:2008 and ISO FDIS 9001:2015 Mapping GuideIntroductionThis document gives a comparison between ISO 9001:2008 and the Final Draft International Standard (FDIS) of ISO 9001 and vice versa. This guide provides the following:1. An overview of the changes, deletions, new or enhanced ISO 9001 requirements2. A Mapping between Quality Management System (QMS) requirements in ISO 9001:2008 and ISO FDIS 9001:2015 where the requirement is essentially the same3. The reverse Mapping Table 1 will help if you are considering a transition project from ISO 9001:2008 to the new 2 is for checking backwards compatibility , between new and old systems; if you are designing your Quality Management System from new, but need to understand how the system might be compatible with other earlier versions of the system ( on other sites, elsewhere in a corporate group or supply chain etc.)

2 Some of the specific changes are: Greater integration with strategic direction and business processes Risk based thinking Context of the organization must be understood Outsourcing and purchasing is combined A quality manual is no longer a requirement The focus is on leadership rather than management and generally includes a strengthening of the requirements to achieve strategic alignment behind the organizational objectives, as well as support of the adoption of the process approach. The need for 6 mandatory procedures has been withdrawn and the standard acknowledges the various forms that documentation can take. But as part of the alignment with other management system standards a common clause on Documented Information has been adopted. Consequently, the terms documented procedure and record have both been replaced throughout the requirements by documented information.

3 Where ISO 9001:2008 would have referred to documented procedures ( to define, control or support a process) this is now expressed as a requirement to maintain documented information to demonstrate the processes have been carried out as planned and conformity of the product and services to requirements . Where ISO 9001:2008 would have referred to records this is now expressed as a requirement to retain documented information. A management representative is no longer a specific requirement although certification bodies will require a nominated contact. The focus on performance rather than procedures of the organization. ISO RevisionsLatest updateNew and Revised3 ISO 9001 - Quality Management System - Mapping Guide1. Overview of the changes by clause number2 Clause 4 The introduction of a requirement to understand the Context of the Organization as well as the expectations of interested parties, as it impacts on the objective of the system which is to achieve customer 5 Leadership includes most of the existing management responsibility requirements .

4 Clause 6 Greater emphasis on Planning , which focuses on the identification of risks and opportunities as they impact on the scope of the system. This removes the need for preventive action as defined in the 2008 version, but includes strengthened requirements for the management of change and risk 7 Support includes most of the requirements of the previous clause 6 resource management but includes a new requirement to manage organizational knowledge .Clause 8 Operations replaces the previous Product realisation clause 7 but contains most of the previous requirements . The intention is to make it more relevant to the service 9 Performance evaluation replaces the previous clause 8 and withdraws the need for preventive action which has now been subsumed into clause 6 10 Increases the focus on Improvement and includes non-conformities and corrective action previously in clause 8.

5 Clause Requirement 2. ISO 9001:2008 to ISO FDIS 9001:2015 Correlation Matrix 4 Quality management system 4 Context of the General requirements Quality management system and its Documentation requirements Documented General Quality manual Determining the scope of the quality

6 Management system General Quality management system and its Control of documents Creating and updating Control of documented Control of records Creating and updating Control of documented information5 Management responsibility 5 Management commitment Leadership and commitment Customer focus Customer Quality policy Policy Developing the quality policy Communicating the quality Planning 6 Planning for the quality management Quality objectives Quality objectives and planning to achieve them Quality management system planning 6 Planning Actions to address risks and opportunities Planning of Responsibility, authority and communication 5 Responsibility and authority Organizational roles, responsibilities and Management representative Title removed Organizational roles.

7 Responsibilities and Internal communication Management review Management General General Review input Management review inputs Review output Management review outputs6 Resource management Provision of resources General PeopleContinued >>ISO 9001:2008 ISO FDIS 9001:2015 ISO RevisionsLatest updateISO RevisionsLatest Human resources Title removed Competence General Competence Competence, training and awareness Competence Awareness Infrastructure Work environment Environment for the operation of processes7 Product realization 8 Planning of product realization Operational planning and Customer-related processes requirements for products and Determination of requirements related to the product Determination of requirements related to products and Review of requirements related to the product Review of requirements related to products and Customer communication Customer Design and development Changes to requirements for products and services Production and service Design and development planning Design and development of products and services

8 General Design and development Design and development inputs Design and development Design and development outputs Design and development Design and development review Design and development Design and development verification Design and development Design and development validation Design and development Control of design and development changes Design and development Purchasing Control of externally provided processes, products and services Purchasing process General Type and extent of Purchasing information Information for external Verification of purchased product Release of products and Production and service provision Production and service Control of production and service provision Control of production and service provision Post-delivery Validation of processes for production and service Control of production and service provision provision5 ISO 9001 - Quality Management System - Mapping Identification and traceability Identification and traceability Customer property Property belonging to customers or external Preservation of product Preservation Control of monitoring and measuring equipment Monitoring and

9 Measuring Measurement, analysis and improvement Monitoring, measurement, analysis and General Monitoring and measurement Monitoring, measurement, analysis and evaluation Customer satisfaction Customer satisfaction Internal audit Internal audit Monitoring and measurement of processes Monitoring and measurement of product Release of products and Control of nonconforming product Control of nonconforming Analysis of data Analysis and Improvement 10 Continual improvement General Continual Corrective action Nonconformity and corrective Preventive action Clause removed Actions to address risks and opportunities (see , )ISO 9001:2008 ISO FDIS 9001:2015 ISO 9001:2008 ISO FDIS 9001:2015 ISO RevisionsLatest updateISO RevisionsLatest update2.

10 Mapping table continued2. Mapping table continuedContinued >>67 ISO 9001 - Quality Management System - Mapping guide3. ISO FDIS 9001:2015 to ISO 9001:2008 Correlation Matrix 4 Context of the organization Understanding the organization and its context Understanding the needs and expectations of interested General Determining the scope of the quality management system Application Quality Quality management system and its processes 4 Quality management system General requirements5 Leadership 5 Management Leadership and commitment Management General Management Customer focus Customer Policy Quality Developing the quality Communicating the quality Organizational roles.