What’s it all About? www.sustainingedge.com Delivering Manufacturing and Service Organizations Solutions for Improved Business Performance Background and Satisfied Clients Walter Tighe President/Owner of Sustaining Edge Solutions, Inc. Management Consulting & Training Firm Founded 2002 in Arizona 28 years quality assurance management experience MBA, CQM, SSBB, RAB/QSA QMS Auditor Dennis Stambaugh Senior Management Consultant 30 years organizational effectiveness experience National Baldrige Examiner and Regional Judge MHA, FACHE Donavan Hardenbrook President/Owner of Leap Innovation, LLC. 30 years’ experience in engineering, manufacturing, quality, marketing and product development Tucson (520) 572-9642 Phoenix (602) 222-9000 Email: [email protected] Website: www.sustainingedge.com What We Deliver - Our Services Business Performance Improvement Systems ISO 9001: 2015 Management System AS 9100/10/20 Aviation, Space and Defense Management System ISO 13485 Medical Devices Management System ISO 14001 Environmental Management System ISO 27001 Information Security Management System ISO/TS 16949 Automotive Management System National Aerospace and Defense Accreditation – NADCAP Lean Manufacturing, Kaizen Events and Six Sigma Value Stream Mapping, 5S and Performance Measurement Systems & Processes Lead to Success Training: Onsite, E-Learning and Classroom Baldrige Performance Excellence Assessments Market Research Business Development Project Management and Social Media Agenda • Why the Change? • ISO 9001:2015 Standard Changes • Annex SL • Terms and Definitions • Context of the Organization • Documented Information • Risk-Based Thinking and Requirements • Auditing Risk • Leadership • Business and Quality Importance ISO 9001 Journey • International standard for a Quality Management System (QMS) • Originally published in 1987 – Inspection Based • Underwent major revision in Year 2000. 2008 revision included no new requirements - Process Based • ISO 9001:2015 – Risk Based Approach • Applies to any organization regardless of size or industry • Implemented by more than 1.3 million organizations in over 170 countries ISO 9001:2015 Timeline ISO TC/176: Technical Committee oversight leading revision June 2013: Committee Draft (CD) May 2014: Publication of Draft International Standard (DIS) July 2015: Expected publication of Final Draft International Standard (FDIS) Sept 23, 2015: Publication of Standard as ISO 9001:2015 Sept 2018: All 2008 standard certifications will be under the new standard. All initial certifications from March 2017 will be under the new standard. Why the Change? • Increased organizational complexity • Technical advances in business • Growth of global business and services • Multiple standards held in many organizations • Fifteen years since the ISO 9001 standard has changed! Impact of Change: over 1 million globally certified companies, OEMs, customers, supply chain, certification bodies, third party auditors, end users, consultants and regulatory agencies. ISO 9001:2015 Main Changes • The adoption of the high level structure • Risk-based thinking to improve process approach application • Fewer prescribed requirements • Less emphasis on documents • Improved applicability for services • Requirement to define the QMS boundaries • Increased leadership requirements Annex SL - The New ISO 9001Structure There is now 10 Sections (instead of 8 ) in the Standard. The requirements Clause Description themselves are set out in Clauses 4 - 10 1 Scope 2 Normative references 3 Terms and Definitions 4 Context of the organization – New Clause 5 Leadership 6 Planning for the quality management system 7 Support 8 Operation 9 Performance evaluation 10 Improvement High Level Structure – Annex SL • The new standard adopts the high-level structure and terminology of Annex SL (used for the development of all new ISO standards) • High level structure, identical core text and common terms, including core definitions for use in all Management System Standards • Enhance the consistency and alignment of different management system standards • Organizations that implement a single system addressing multiple standards (e.g. QMS, EMS, ISMS) will see the most potential benefit There is no requirement for the structure of an organization's quality management system documentation to mirror the Standard