ISO 9001: Countdown to 2015 Presented by Ellen Diggs Ellen Diggs Consulting ekdiggs@verizon.net February 11, 2015 It’s Not Just for Manufacturing Anymore! This is presentation is part of a member meeting kit offered with assistance from the ASQ Knowledge Center. Find more information and resources here: http://asq.org/knowledge-center/member-meeting-kits.html. The purpose is to involve local Sections and other ASQ member groups in discussions occurring across the Society on key topics in quality. The presentation will also point you to some of the content benefits you have access to with your membership through the Knowledge Center. The Knowledge Center is designed to be your front door to ASQ publications and other content resources. It contains editors picks that focus on new content, links to topics and types of publications, and a search function that allows you to search all ASQ publications by keyword. If you have questions or would like assistance before delivering this presentation, contact the ASQ Knowledge Center team at knowledgecenter@asq.org. Thank you for helping to deliver the key messages in this presentation!

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 ISO 9001 is one standard in the ISO 9000 series on quality management and quality assurance. The standards were developed to help companies effectively document the elements they need to maintain an efficient quality system. They are not specific to any one industry. The series includes ISO 9000:2005 (definitions), ISO 9001:2008 (requirements) and ISO 9004:2009 (continuous improvement). ISO 9001:2008 is the only standard in the ISO 9000 series to which organizations can certify. For more introductory information, visit http://asq.org/learn-about-quality/iso-9000/overview/overview.html.

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 All ISO standards are periodically updated to maintain relevance. Regarding ISO 9001:2015, in particular, the revision will … - Respond to the increasing diversity of users, ensuring that needs of all user groups and industry sectors are met. - Allow for easier integration with other management system standards. The revision will use a common structure defined for management system standards such as environmental, health and safety, energy, and emergency preparedness. For a short video discussion, play an except (0:22 to 1:49) from this ASQ TV episode on standards and auditing: http://videos.asq.org/standards-and-auditing

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 Risk and prevention in relation to context and interested parties.

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

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

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

Comparing the two… ISO 9001: 2008 ISO/DIS 9001:2015 4. General management system 4.2.3 Control of Documents 4.2.4 Control of Records 4. Quality management system (QMS) 7.4 Documented information 4.4. Process Approach 5. Management Responsibility 5.4 Planning 5.4.1 Quality objectives 5.4.2 QMS planning 5.5.2 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 7.1.4 Environment for the operation of processes Planning for QMS includes identifying actions to address Risks and Opps and Change Management Planning 4.1 relevant to strategic direction Things to consider :Changes and trends, Relations and Perceptions of relevant IP Governance, strategic priorities, Resources 4.2 Understanding the needs - Understand and anticipate needs of and expectations of interested parties expectations affecting customer Requirements and customer satisfaction. Identifies relevant IP to be considered Note on Innovation Opportunities

Comparing the two…(continued) ISO 9001: 2008 ISO/DIS 9001:2015 7. Product realization 7.1 Planning of product realization 7.2 Customer-related processes 7.3 Design and development 7.4 Purchasing 7.4.3 Verification of purchased product 7.5.2 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 8.4.3 Release of products and services 8.5.1 Control of product and services 7.1.5 Monitoring and measurement resources Purchasing - Addresses all forms of external provision • Risk based approach to determine type and extent of control

Comparing the two…(continued) ISO 9001: 2008 ISO/DIS 9001:2015 Monitoring, analysis and improvement 8.2.3 Monitoring of process 8.2.4 Monitoring of product 8.3 Control of nonconforming product 8.4 Analysis of data 8.5 Improvement 8.5.2 Corrective Action 8.5.3 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 8.1.3 Analysis and evaluation 10 Improvement 10.2 Nonconformities and corrective action 6.1 Actions to address risks and opportunities Monitoring of process and product removed and covered by section 9.1 , Control of n/c product is now Control of nonconforming process outputs, products and services.

The text… Context of the organization (4) Leadership (5) 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

The text….(continued) Planning (6) Support (7) 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

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

The text…(continued) Performance Evaluation (9) Improvement (10) 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

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 Definition of risk – the effect of uncertainty on an expected result (in this case, product or service conformity and customer satisfaction)

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  Currently, ISO 9001:2015 is in the committee draft stage. Countries participating in the development process are forming their national positions on the committee draft, which will result in the Draft International Standard (DIS). The DIS is expected to be released in mid 2014 and will be made available for public comment.

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)

And members can always find more information about standards and ISO 9001 by visiting the Knowledge Center. From any page on the ASQ site, use the main menu bar to navigate to the Knowledge Center, and you’ll find a topic menu. For assistance finding ASQ content, contact the Knowledge Center team at knowledgecenter@asq.org.