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: wtighe@sustainingedge.com 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
Terms and Definitions ISO 9001:2008 - was ISO 9001:2015 – now is Exclusions As applicable… Products Products and Services Quality Manual / Procedures [Maintain] Documented Information Records [Retain] Documented Information Work Environment Environment for the Operations of Processes Purchased Products Externally Provided Products and Services Supplier External Provider There is no requirement for the terms used by an organization to be replaced by the terms used in this International Standard to specify quality management system requirements. Organizations can choose to use terms which suit their operations (e.g. using “records”, “documentation” or “protocols” rather than “documented information”; or “supplier”, “partner” or “vendor” rather than “external provider”).
NEW Clause 4: Context of the Organization 4.1 Understanding the Organization and its Context “The organization will determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system (QMS) . The organization will monitor and review the information about these external and internal issues.” 5.5.1 Quality policy & objectives are compatible with the company strategic direction and context “Leadership QMS Strategic External and Know Thyself” Internal Issues: Planning Process = • Values Monitor and QMS Tactical Purpose and • Culture Review Strategic Direction • Knowledge Information • Performance • Legal • Competition Partnerships • Market External – Performance of competitive analysis, assessment of existing and emerging technology, impact on environment. Internal – Values, culture, knowledge and performance of the organization
External and Internal “Determine external and internal issues” What to consider and how far to go? Purpose & Strategic Direction Examples of Internal Issues Examples of External Issues • Self-assessment results • Economic environment & trends • Organizational performance • Competitive products and services • Internal audit results • Technology trends • Competitive analysis • Opportunities for outsourcing • Customer reviews/complaints • Material availability and pricing • Employee satisfaction data • International trade Internal & External Issues • Best practices and industry • Benchmarking best-in-class Monitor and Review benchmark comparisons performers in and outside your Information current market
NEW Clause 4: Context of the Organization 4.2 Understand the Needs and Expectations of Interested Parties “Due to their effect or potential effect on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements , the organization will determine: • the interested parties that are relevant to the QMS; • the requirements of the interested parties that are relevant to the QMS. The organization will monitor and review information about these interested parties and their relevant requirements. Internal Interested External Interested Interested Parties Parties Parties Requirements Relevant to QMS? • Owners • Customers QMS • Employees • Suppliers/Vendors • Company Divisions • End users of your • External Departments products/services outside of QMS? • Public • Regulators Monitor and Review • Competitors Information and Relevant Requirements
NEW Clause 4: Context of the Organization 4.3 Determining the Scope of the Quality Management System “ The organization will determine the boundaries and applicability of the QMS to establish its scope.” When determining this scope, the organization will consider: • the internal and external issues referred to in 4.1; • the requirements of relevant interested parties referred to in 4.2; and • the products and services of the organization. The organization will apply all the requirements of this International Standard if they are applicable within the determined scope. The scope of the QMS will be available and be maintained as documented information. The scope will state the types of products and services covered, and provide justification for any requirement determined not to be applicable to the scope of the QMS. Conformity to this standard can only be claimed if the requirements determined as not being applicable do not affect the organizations ability or responsibility to ensure conformity of its products and services and the enhancement of customer satisfaction.
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