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ISO 9001: Countdown to 2015 Presented by Ellen Diggs Ellen Diggs Consulting February 11, 2015 It’s Not Just for Manufacturing Anymore!

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Presentation on theme: "ISO 9001: Countdown to 2015 Presented by Ellen Diggs Ellen Diggs Consulting February 11, 2015 It’s Not Just for Manufacturing Anymore!"— Presentation transcript:

1 ISO 9001: Countdown to 2015 Presented by Ellen Diggs Ellen Diggs Consulting February 11, 2015 It’s Not Just for Manufacturing Anymore!

2 ISO 9001 facts International standard for quality management systems Originally published in 1987 Underwent major revision in 2000 Implemented by more than one million organizations in over 170 countries Applies to any organization regardless of size or industry Standards are “enablers for other major business processes” – The Boeing Company

3 Reasons for 2015 revision Maintain relevance for increasing diversity of 9001 users (industry, size, customer) Increase focus on effective process management to achieve desired results Facilitate integration with other management system standards –Standard structure, text, definitions Recognition of supply chain complexity Formalize need for risk-based thinking within the context of the organization

4 Major Changes Structure – 10 clauses Understand organizational context Language – new terminology - Products and services - Risks and opportunities - Context and interested parties - Effective resource management - Systematic control of changes Business strategy and QMS integration - Focus on process approach and effective process management - Emphasis on objectives, risks and opportunities within context

5 Major Changes (continued) Language – new terminology -Products and services -Risks and opportunities (preventive action) -Context and interested parties (customers) -Documented information (documents and records) -Relation with context and interested parties (as suitable) -External providers of goods and services (suppliers) -Effective resource management -Systematic control of changes Deleted -Quality manual -Management representative -Verification and validation -Product realization

6 Quality Management Principles (QMPs) 7 QMPs 1.Customer focus 2.Leadership 3.Engagement of people 4.Process approach 5.Improvement 6.Evidence based decision- making 7.Relationship management 8 QMPs 1.Customer focused organization 2.Leadership 3.Involvement of people 4.Process approach 5.System approach 6.Continual improvement 7.Factual approach to decision-making 8.Mutually benefit supplier relationships

7 High Level Structure Improvement (10) Context (4) Planning (6) Performance evaluation (9) Operations (8) Support (7) Leadership (5)

8 Comparing the two… ISO 9001: 2008ISO/DIS 9001: General management system Control of Documents Control of Records 4. Quality management system (QMS) 7.4 Documented information 4.4. Process Approach 5. Management Responsibility 5.4 Planning Quality objectives QMS planning Management representative 5.6 Management review 5. Leadership 6. Planning for the QMS 9.3 Management review 6. Resource Management 6.2 Human resources 6.4 Work environment 7.1 Resources 7.2 Competence Environment for the operation of processes

9 Comparing the two…(continued) ISO 9001: 2008ISO/DIS 9001: Product realization 7.1 Planning of product realization 7.2 Customer-related processes 7.3 Design and development 7.4 Purchasing Verification of purchased product Validation of processes 7.6 Control of monitoring and measuring equipment 8. Operations 8.1 Operational planning and control 8.2 Determine requirements for products and services 8.3 Design and development of products and services 8.4 Control of externally provided goods and services Release of products and services Control of product and services Monitoring and measurement resources

10 Comparing the two…(continued) ISO 9001: 2008ISO/DIS 9001: Monitoring, analysis and improvement Monitoring of process Monitoring of product 8.3 Control of nonconforming product 8.4 Analysis of data 8.5 Improvement Corrective Action Preventive Action 9.1 Monitoring, measurement, analysis, and evaluation 8.6 Release of products and services 8.7 Control of nonconforming process outputs, products and services Analysis and evaluation 10 Improvement 10.2 Nonconformities and corrective action 6.1 Actions to address risks and opportunities

11 The text… Context of the organization (4) - Relevant to strategic direction - Understand and anticipate customer needs and expectations - The organization shall apply a process approach Leadership (5) - With respect to the QMS and the customer (context) - Shall be accountable for the effectiveness of the QMS - Assign responsibility and authority

12 The text….(continued) Planning (6) - Consider context to identify risks and opportunities that need to be addressed - Identify the need and opportunity for change - Take change in a planned matter Support (7) - Resources (infrastructure, process environment, monitoring and measurement devices, and knowledge) - Competence and awareness - Communication - Documented information

13 The text… (continued) Operations (8) - Determination of market needs and interactions with customers - Operational planning process - Control of external provision of goods and services - Development of goods and services - Production of goods and services - Release of goods and services - Nonconforming goods and services

14 The text…(continued) Performance Evaluation (9) - Monitoring, measurement, analysis and evaluation - Internal audit and Management Review - Analysis of data reinforced and clarified - QMS performance indicators Improvement (10) –Shall improve the QMS, processes, and goods and services, as appropriate, in response to: Results of analysis of data Changes in organizational context Changes in identified risk and new opportunities –Shall evaluate, prioritize and determine the improvement to be implemented

15 Where’s the risk?? Risk-based thinking…the organization is required to: 4 (Context) Determine the risks to product or service conformity and customer satisfaction 5 (Leadership) Commit to Clause 4 6 (Planning) Take action to identify risks and opportunities 8 (Operation) Implement process to address risks and opportunities 9 (Performance) Monitor, measure, analyze and evaluate risks and opportunities 10 (Improvement) Respond to changes in risk

16 ISO 9001:2015 timeline June 2013: Committee Draft (CD) Mid 2014: Expected publication of Draft International Standard (DIS) Mid 2015: Expected publication of Final Draft International Standard (FDIS) End 2015: Publication of International Standard as ISO 9001:2015

17 Currently certified to ISO 9001:2008? Transition period begins when new revision is published Expect to have three years before ISO 9001:2008 becomes out of date Certify to ISO 9001:2015 before transition period ends (expected late 2018)

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