ASQ 1216 LaCrosse Winona Using your ISO 9001:2008 QMS to Plan the Upgrade to 2015 Andy Nichols East Coast Sales Mgr
Session Agenda ISO 9001:2015 outline/timeline Basic Requirements Change It s a Process Inputs, Processes, Outputs Plan, Do, Check, Act Key Components of Your QMS Next steps Information Sources
ISO 9001:2015 HIGH LEVEL REVIEW
High level structure A new common format has been developed for use in all management system standards: standardized core text and structure for multiple ISO management systems for integration ISO/TC 176/SC 2/ N1219 standardized core definitions Organizations implementing multiple management systems (e.g. quality, environmental, information security) can achieve better integration and easier implementation The high level structure and common text is public information and can be found in Annex SL of the www.iso.org/directives 4 Date:
Structure of ISO 9001:2015 1/3 ISO/TC 176/SC 2/ N1219 1 2 3 4 5 6 Scope Normative references Terms and definitions 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 QMS 4.4 Quality management system and its processes Leadership 5.1 Leadership and commitment 5.2 Quality policy 5.3 Organizational roles, responsibilities and authorities Planning for the QMS 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes 5 Date:
ISO/TC 176/SC 2/ N1219 Structure of ISO 9001:2015 2/3 7 Support 7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information 8 Operation 8.1 Operational planning and control 8.2 Determination of requirements for products and services 8.3 Design and development of products and services 8.4 Control of externally provided products and services 8.5 Production and service provision 8.6 Release of products and services 8.7 Control of non conforming process outputs, products and services 6 Date:
Structure of ISO 9001:2015 3/3 9 Performance evaluation ISO/TC 176/SC 2/ N1219 9.1 Monitoring, measurement, analysis and evaluation 9.2 Internal audit 9.3 Management review 10 Improvement 10.1 10.2 10.3 General Non-conformity and corrective action Continual improvement 7 Date:
ISO 9001:2015 Timeline 2013 2014 2015 June 2013 CD (Committee Draft) May 2014 FDIS ISO/TC 176/SC 2/ N1219 (Draft International Standard) July 2015 FFDIS (Final Draft International Standard) September 2015 Published International Standard 8 Date:
ISO 9001:2015 Certification Transition Timeline 2015 2016 2017 2018 ISO/TC 176/SC 2/ N1219 September 2015 Published International Standard September 2015 start of 3 years transition period to September 2018 Certifications to ISO 9001:2008 will no longer be valid after September 2018 9 Date:
History Lesson 1 P A MI L- Q98 58 A 0 9 ISO 7 8 19 : 1 0 Q A O T A N BS 5 750 01 1 q d For
ISO 9001:2015 MANAGING THE CHANGES Whatever they may be for your organization
How to Avoid the Cliff Effect ISO 9001:2008 ISO 9001:2015
How to Avoid the Cliff Effect ISO 9001:2008 ISO 9001:2015
Basic Steps
Basics of your QMS Quality management system 4 The organization shall establish, document, implement and maintain a quality management system in accordance with the requirements of this International Standard
Basics of your QMS Quality management system 4 These processes shall be managed by the organization in accordance with the requirements of this International Standard
Change is a Process INPUTS ACTIVITIES OUTPUTS
Inputs to the Planning Process Document Control 4.2.3 Control of documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system
The Planning Process Quality management system planning 5.4.2 Top management shall ensure that The planning of the quality management system is carried out in order to meet the requirements given in 4.1 and,
The Planning Process The integrity of the quality management system is maintained when changes to the quality management system are planned and implemented
The Planning Process Management Representative 5.5.2 a) ensuring that processes needed for the quality management system are established, implemented and maintained
Planning Process Management review 5.6.1 General This review shall include assessing the need for changes to the quality management system
Inputs? Review input 5.6.2 The input to management review shall include information on f) changes that could affect the quality management system
The Output & Actions Review output 5.6.3 The output of from the management review shall include any decisions and actions relating to a) Improvement of the effectiveness of the quality management system and its processes c) Resource needs
Actions? Competency, awareness and training 6.2.2 a) determine the necessary competence of personnel performing work affecting quality
Checks? Internal audit 8.2.2 The organization shall conduct internal audits at planned intervals to determine whether the quality management system a) conforms to the planned arrangements (see 7.1) to the requirements of this International Standard and to the quality management requirements established by the organization
Checks? Internal audit 8.2.2 cont d An audit programme shall be planned, taking into consideration the status and importance of the processes
Checks? Internal audit 2015 wording The organization shall: a) plan, establish, implement and maintain an audit programme(s) which shall take into consideration the importance of the processes concerned, changes affecting the organization, and the results of previous audits
Actions? What (likely) key changes in ISO 9001:2015 are going to require decisions and actions from your Organization s management review of the QMS?
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Questions