Changes to ISO 9001:2015 Presented by Jim Thompson 266 Meeting Street - Suite B Charleston, SC 29401 843.469.8279 acommoncenter.com January 26 th, 2016 ASQ Charleston con cen tric (ken-sĕn trĭk) adjective - Having a common center. con cen tric (ken-sĕn trĭk) adjective - Having a common center. acommoncenter.com
YOUR QUALITY RESOURCE HUB Where we are: HQ in downtown Charleston, SC New location in Sao Paulo, Brazil Staff throughout NA, SA & Europe What we do: Management system products Software implementation Training & consultation SME placement con cen tric (ken-sĕn trĭk) adjective - Having a common center. con cen tric (ken-sĕn trĭk) adjective - Having a common center. acommoncenter.com
Stages of Standard Development Final Draft (FDIS) Published 9/23/15 Source: http://www.iso.org/iso/home/standards/management-standards/iso_9000/iso9001_revision.htm con cen tric (ken-sĕn trĭk) adjective - Having a common center. acommoncenter.com
Focus Key Changes of presentation: System integration through Annex SL structure More relevant to various organizations Reinforced focus on achieving desired results Connection with strategic planning of organization From preventive to risk-based thinking Risks and opportunities associated with change Improvement & control of organizational knowledge con cen tric (ken-sĕn trĭk) adjective - Having a common center. acommoncenter.com
con cen tric (ken-sĕn trĭk) adjective - Having a common center. acommoncenter.com
New Structure in ISO 9001:2015 Setting the Stage Contents (Table of Contents) Forward Introduction 1 Scope 2 Normative reference 3 Terms & definitions 4 Context of the organization Plan Do Check Act 5 Leadership 6 Planning 7 Support 8 Operation 9 Performance evaluation 10 Improvement 4.1 Understanding the organization & its context 5.1 Leadership & commitment 6.1 Actions to address risks & opportunities 7.1 Resources 8.1 Operational planning & control 9.1 Monitoring, measurement, analysis & evaluation 10.1 General 4.2 Understanding the needs & expectations of interested parties 5.2 Policy 6.2 Quality objectives & planning to achieve them 7.2 Competence 8.2 Requirements for products & services 9.2 Internal audit 10.2 Nonconformity & corrective action 4.3 Determining the scope of the QMS 5.3 Organizational roles, responsibilities & authorities 6.3 Planning of changes 7.3 Awareness 8.3 Design & development of products & services 9.3 Management review 10.3 Continual improvement 4.4 QMS & its processes 7.4 Communication 8.4 Control of externally provided processes, products & services 7.5 Documented information 8.5 Production & service provision 8.6 Release of products & services 8.7 Control of nonconforming outputs Annex A (informative) Clarification of new structure, terminology & concepts Informative Annex B (informative) Other international standards on quality management & quality management systems developed by ISO/TC 176 Bibliography Citations [1] [28] 2015 Concentric Management Systems, Inc. Strengthen the Core of Your Business con cen tric (ken-sĕn trĭk) adjective - Having a common center.
Clause 8 Operation Plan Do Check Act 4 Context of the organization 5 Leadership 6 Planning 7 Support 8 Operation 9 Performance evaluation 10 Improvement 8.1 Operational planning & control 8.2 Requirements for products & services 8.3 Design & development of products & services 8.4 Control of externally provided processes, products & services 8.5 Production & service provision 8.6 Release of products & services 8.2.1 Customer communication 8.3.1 General 8.4.1 General 8.5.1 Control of production & service provision 8.7 Control of nonconforming process outputs 8.2.2 Determination of requirements related to products & services 8.3.2 Design & development planning 8.4.2 Type & extent of control 8.5.2 Identification & traceability 8.2.3 Review of requirements related to products & services 8.3.3 Design & development Inputs 8.4.3 Information for external providers 8.5.3 Property belonging to customers or external providers 8.2.4 Changes to requirements for products & services 8.3.4 Design & development controls 8.5.4 Preservation 8.3.5 Design & development outputs 8.5.5 Post-delivery activities 8.3.6 Design & development changes 8.5.6 Control of changes 2015 Concentric Management Systems, Inc. Strengthen the Core of Your Business con cen tric (ken-sĕn trĭk) adjective - Having a common center. 7
How to Purchase Source: http://asq.org/quality-press con cen tric (ken-sĕn trĭk) adjective - Having a common center. acommoncenter.com
Pro s ISO 9001:2015 Flexibility Inclusion of service organizations Focus on risk Integration of various systems Connected to strategy Integration Quality Business Improvement
Con s ISO 9001:2015 Generic = Confusion Context of the huh? Where are the records? Who will be the leader? Auditor interpretation No
Context of organization Who are you? Components (processes) of your system? Internal vs. external processes? Needs & expectations of interested parties? Who is an interested party? Suppliers Recruiters Installation Techs Warehouse Employees Service Dept Logistics Dept Customers End Users
To record or not to record Information Documented information Maintaining documented information Retaining documented information that is the question
Follow the leader Management representative not a single person Who will be driver? Will driver know requirements?
Variance in interpretation Q: Will auditors need to be retrained on the new requirements? A: Yes. Additional training in the new requirements is strongly recommended.
Transition planning Q: What is the expectation regarding transitioning? A: Get started now with a plan with a transition/implementation plan. 2016 Gap Assessment Implementation Plan 2017 Transition Audit Initial Audit for newly registered companies limited to 2015 version after March 2018 Monitor transition of key suppliers Continue to improve
Training recommendations Audit Program Managers Lead Auditors Internal Auditors Process Owners Leadership Awareness All employee awareness
Implementation Resources Globally - ASQ ASQ.org ASQ TV Regionally SC Technical Colleges SC Department of Commerce SCMEP Locally Asqcharleston.org Concentric
Concentric Resources Articles Key Links Videos Webinar Registration Transition Tools con cen tric (ken-sĕn trĭk) adjective - Having a common center. acommoncenter.com
Upcoming Training February 23 rd 25 th, 2016 8am-5pm Charleston, SC Presented by: Concentric + Trident Technical College Only $999 for 24hr Class 2 students/company max ISO 9001:2015 Lead Auditor Training +ADD a 4th day to make this a Lead Internal Auditor Class per ISO/TS 16949:2009 requirements. 4 th Day is Friday, February 26 th, 2016 Registration Link: http://www.acommoncenter.com/iso90012015 con cen tric (ken-sĕn trĭk) adjective - Having a common center. acommoncenter.com
Contact Us Jim Megan Ronii Sidney Monica Concentric 266 Meeting St, Charleston, SC 843.469.8279 acommoncenter.com info@cmsicharleston.com facebook.com/cmsicharleston twitter.com/acommoncenter concentric-management-systems-inc. con cen tric (ken-sĕn trĭk) adjective - Having a common center. acommoncenter.com