ISO 9001:2015 Revision overview

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1 ISO 9001:2015 Revision overview Alex Ezrakhovich Head of Australian Delegation to ISOTC176, Member of ISOTC176 SC2 Coordinating Group October 2014

2 Purpose of presentation To provide an overview of the revision of ISO 9001 which will be published in 2015

3 Key perspectives ISO 9001 needs to: maintain relevance integrate with other management systems provide an integrated approach to organizational management provide a consistent foundation for the next 10 years reflect the increasingly complex environments in which organizations operate ensure the new standard reflects the needs of all potential user groups enhance an organization's ability to satisfy its customers

4 What was considered? the results of an extensive web-based user survey the increasing diversity of ISO 9001 users developments in knowledge and technologies broader user interests changes in industry

5 Main changes an emphasis on risk-based thinking increased emphasis on achieving value for the organization and its customers increase flexibility on the use of documentation more readily applicable by service type organizations customers remain the primary focus

6 High level structure a new common format has been developed for use in all management system standards standardized core text and structure standardized core definitions Organizations implementing multiple management systems (e.g. quality, environmental, information security) can achieve better integration and easier implementation The high level structure and common text is public information and can be found in Annex SL of the

7 Quality management principles QMP 1 Customer Focus Statement The primary focus of quality management is to meet customer requirements and to strive to exceed customer expectations. Rationale Sustained success is achieved when an organization attracts and retains the confidence of customers and other interested parties on whom it depends. Every aspect of customer interaction provides an opportunity to create more value for the customer. Understanding current and future needs of customers and other interested parties contributes to sustained success of an organization.

8 Quality management principles QMP 2 Leadership Statement Leaders at all levels establish unity of purpose and direction and create conditions in which people are engaged in achieving the quality objectives of the organization. Rationale Creation of unity of purpose, direction and engagement enable an organization to align its strategies, policies, processes and resources to achieve its objectives.

9 Quality management principles QMP 3 Engagement of People Statement It is essential for the organization that all people are competent, empowered and engaged in delivering value. Competent, empowered and engaged people throughout the organization enhance its capability to create value. Rationale To manage an organization effectively and efficiently, it is important to involve all people at all levels and to respect them as individuals. Recognition, empowerment and enhancement of skills and knowledge facilitate the engagement of people in achieving the objectives of the organization.

10 Quality management principles QMP 4 - Process Approach Statement Consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function as a coherent system. Rationale The quality management system is composed of interrelated processes. Understanding how results are produced by this system, including all its processes, resources, controls and interactions, allows the organization to optimize its performance.

11 Quality management principles QMP 5 Improvement Statement Successful organizations have an ongoing focus on improvement. Rationale Improvement is essential for an organization to maintain current levels of performance, to react to changes in its internal and external conditions and to create new opportunities.

12 Quality management principles QMP 6 Evidence-based Decision Making Statement Decisions based on the analysis and evaluation of data and information are more likely to produce desired results. Rationale Decision-making can be a complex process, and it always involves some uncertainty. It often involves multiple types and sources of inputs, as well as their interpretation, which can be subjective. It is important to understand cause and effect relationships and potential unintended consequences. Facts, evidence and data analysis lead to greater objectivity and confidence in decisions made.

13 Quality management principles QMP 7 Relationship Management Statement For sustained success, organizations manage their relationships with interested parties, such as suppliers. Rationale Interested parties influence the performance of an organization. Sustained success is more likely to be achieved when an organization manages relationships with its interested parties to optimize their impact on its performance. Relationship management with its supplier and partner network is often of particular importance.

14 Structure 1/3 Foreword Introduction 0.1 General /0.2 The ISO standards for quality management /0.3 Process approach/0.4 Plan-Do-Check-Act cycle /0.5 Risk-based thinking / 0.6 Compatibility with other management system standards 1. Scope 2. Normative references 3. Terms and definitions 4. Context of the organization Understanding the organization and its context Understanding the needs and expectations of interested parties Determining the scope of QMS Quality management system and its processes 5. Leadership Leadership and commitment Quality policy Organizational roles, responsibility and authority

15 Structure 2/3 6. Planning Actions to address risks and opportunities Quality objectives and planning to achieve them Planning of changes 7. Support Resources Competence Awareness Communication Documented information 8. Operation Operational planning and control Determination of requirements for products and services Design and development of products and services Control of external provisions of products and services Production and service provision Release of products and services Control of nonconforming process outputs, products and services

16 Structure 3/3 9. Performance evaluation Monitoring, measurement, analysis and evaluation Internal audit Management review 10. Improvement General Non-conformity and corrective action Continual improvement Annex A (informative) Clarification of new structure, terminology and concepts Annex B (informative) Quality management principles Annex C (informative) The ISO portfolio of quality management standards Bibliography

17 ISO New Clause Structure 1.Scope 2.Normative references 3.Terms and definitions PLAN 4.Context of the organization Understanding the organization and its context Needs and requirements Scope Management System and its processes 5.Leadership General Management commitment Policy Roles, responsibility and authority 6. Planning Actions to address risks & opportunities Objectives and plans to achieve them 7. Support Resources Competence Awareness Communication Documented information DO 8. Operation Operational planning and control Determination of requirements for products and services Control of external provision of products and services Design and Development of products and services Production of products and provision of services Release of products and services Nonconforming products and services CHECK 9. Performance evaluation Monitoring, measurement, analysis & evaluation Internal audit Management review ACT 10. Improvement Non conformity and corrective action Continual Improvement

18 QMS Structure PLAN DO CHECK ACT 4 Context of the organization 5 Leadership 6 Planning 7 Support 8 Operation 9 Performance and evaluation 10 Improvement Understanding of the organization and its context Leadership and commitment Actions to address risk and opportunity Resources Operations of planning and control Monitoring, measurement, analysis and evaluation Nonconformity and corrective action Expectations of interested parties Quality policy Quality objectives Competence Determination of market needs and interactions with customers Internal audit Continual improvement Scope of management system Roles, responsibilities and authorities Planning of changes Awareness Operational planning process Management review QMS and its processes Communication Control of external provision of products and services Documented information Development of products and services Knowledge Production of products and provision of services Release of products and services Nonconformi ng products and services

19 Quality management system and its processes The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard. The organization shall retain documented information to the extent necessary to have confidence that the processes are being carried out as planned.

20 Quality management system and its processes The organization shall determine the processes needed for the quality management system and their application throughout the organization and shall determine: The required inputs and expected outputs The sequence and interaction of these processes The criteria, methods, measurements and related performance indicators to ensure the effective operation and control of these processes The resources needed and ensure their availability Responsibilities and authorities for these processes Risks and opportunities with an appropriate action plan to address them Methods for monitoring, measuring and evaluation of processes and, if needed, change processes to ensure intended results are achieved Opportunities for improvement of the processes and quality management system

21 4.1, 4.2, 4.3 Establish context, define relevant interested parties & scope of QMS 10 Continual improvement * 5 Leadership Customers & other relevant interested parties 6 Planning 4.4 QMS - General & Process Approach * 9 Performance evaluation Customer Satisfaction Requirements Inputs Outputs 8 Operations Products & services 7 Support processes

22 Interaction with other processes Act incorporate improvements as necessary INPUTS Plan the process - (Extent of planning depends on RISK) Do Carry out the process OUTPUTS Check - monitor / measure process performance Interaction with other processes

23 Supporting documents certification transition plan and timeframe guidance documents on specific topics, e.g. the process approach comparison of ISO 9001:2008 and 9001:2015 frequently asked questions ISO website updates

24 Clarification of terms Elimination of take account and address The replacement of establish with: establish, implement and maintain Outcomes replaced with RESULTS Outsourcing is replaced by operation of a function or process of the organization by an external provider. Production replaced with Realization More attention to consistency: defined/identified as appropriate/as practical ensured/assured etc.

25 Structure and Terminology The structure of clauses is intended to provide a coherent presentation of requirements rather than a model for documenting an organization s policies, objectives and processes; There is no requirement for the structure of the quality management documentation or a quality manual to mirror that of the standard. There is no requirement for the terms used by an organization to be replaced by the terms used in the standard to specify quality management system requirements (for example organizations can use records, procedures, protocols, etc. rather than documented information ).

26 Major differences in terminology between ISO 9001:2008 and ISO 9001:2015 ISO 9001:2008 ISO 9001:2015 Products Exclusions Documented procedure, records Work environment Purchased product Supplier Outsourced Monitoring and measuring equipment Products and services Not used (may be applicability) Documented information Environment for the operation of processes Externally provided products and services External provider Externally provided Monitoring and measuring resources

27 Products and services ISO 9001:2008 used the term product to include all output categories. This International Standard uses products and services. The term products and services includes all output categories (hardware, services, software and processed materials).

28 Concepts related to results and related concepts outputs, products, services objective (3.7.1) result to be achieved quality objective ( ) objective related to quality success (3.7.2) achieving an objective output (3.7.3) result of a process risk (3.7.4) effect of uncertainty on an expected result sustainable success ( ) success over a period of time performance (3.7.5) measurable result product ( ) output that is a result of activities where none of them necessarily is performed at the interface between the provider and the customer service ( ) intangible output that is the result of at least one activity necessarily performed at the interface between the provider and the customer efficiency (3.7.6) relationship between the result achieved and the resources used effectiveness (3.7.7) extent to which planned activities are realized and planned results achieved

29 Products and services The specific inclusion of services is intended to highlight the differences between products and services in the application of some requirements. The characteristic of services is that at least part of the output is realised at the interface with the customer. This means, for example, that conformity to requirements cannot necessarily be confirmed before service delivery.

30 Products and services In most cases, the terms products and services are used together. Most outputs that organizations provide to customers, or are supplied to them by external providers, include both products and services. The organization needs to take into account where, for example, a tangible product has some associated intangible service or an intangible service has some associated tangible product

31 OUTPUT RESULT OF A PROCESS There are four generic output categories, as follows: services (e.g. transport); software (e.g. computer program, dictionary); hardware (e.g. engine mechanical part); processed materials (e.g. lubricant).

32 OUTPUT Many outputs comprise elements belonging to different generic output categories. Whether the output is then called: service, product, software, hardware or processed material depends on the dominant element. For example, a car consists of: hardware (e.g. tires), processed materials (e.g. fuel, cooling liquid), software (e.g. engine control software, driver's manual), and service (e.g. operating explanations given by the salesman). The ownership of a product can usually be transferred. This is not necessarily the case for a service.

33 SERVICE INTANGIBLE OUTPUT THAT IS THE RESULT OF AT LEAST ONE ACTIVITY NECESSARILY PERFORMED AT THE INTERFACE BETWEEN THE PROVIDER AND THE CUSTOMER Provision of a service can involve, for example, the following: an activity performed on a customer-supplied tangible product (e.g. a car to be repaired); an activity performed on a customer-supplied intangible product (e.g. the income statement needed to prepare a tax return); the delivery of an intangible product (e.g. the delivery of information in the context of knowledge transmission); the creation of ambience for the customer (e.g. in hotels and restaurants); A service is usually experienced by the customer.

34 PRODUCT OUTPUT THAT IS A RESULT OF ACTIVITIES WHERE NONE OF THEM NECESSARILY IS PERFORMED AT THE INTERFACE BETWEEN THE PROVIDER AND THE CUSTOMER Hardware is generally tangible and its amount is a countable characteristic. Processed materials are generally tangible and their amount is a continuous characteristic. Hardware and processed materials often are referred to as goods. Software consists of information and is generally intangible and can be in the form of approaches, transactions or documented information.

35 Context of the organization There is no requirement in the standard for the organization to consider interested parties which are not be relevant. There is no requirement to address a particular needs and expectations of relevant interested parties if the organization considers that need and expectation not to be relevant. The organization may decide to accept some additional requirements to satisfy interested parties going beyond what is strictly required by the standard.

36 Risk-based thinking One of the key purposes of a formal management system is to act as a preventive tool Consequently, there is no separate clause or sub-clause titled Preventive action in the standard because the requirements are now formulated to encourage risk-based thinking throughout the planning, implementation, performance evaluation and improvement of the quality management system. The risk-driven approach has also facilitated some reduction in prescriptive requirements and their replacement by performance-based requirements. Although risks have to be determined and addressed, there is no requirement for formal risk management or a risk management system.

37 Application The standard no longer makes specific reference to exclusions when determining the applicability of the requirements of the standard to the organizations quality management system. However, it is recognised that some adaptability of application of requirements may be justified due to the size of an organization, the management model it adopts, the type of the organizations activities, and the nature of the risks and opportunities it encounters. However, this adaptability should not result in an increased probability of failure to consistently provide conforming products and services or a reduction in the organizations potential ability to enhance customer satisfaction.

38 Documented Information or Documents & Records While this is a change in terminology from ISO 9001:2008, the term documented information does not need to be adopted within an organization s quality management system. Organizations can choose to use terms which suit their operations and the changes introduced by the use of new technology. Where ISO 9001:2008 would have referred to documented procedures (e.g. to define, control or support a process) this is now expressed as a requirement to maintain documented information. Where ISO 9001:2008 would have referred to records this is now expressed as a requirement to retain documented information.

39 Organisational knowledge Clause Organisational knowledge addresses the need for organization to determine and maintain the knowledge obtained by the organization, including by its personnel, to ensure that the organization can achieve conformity of products and services. The process for considering and controlling past, existing and additional knowledge needs to take account of the organization s context, including its size and complexity, the risks and opportunities it needs to address, and the need for accessibility of knowledge. The balance between knowledge held by competent people and knowledge made available by other means is at the discretion of the organization, provided that conformity of products and services can be achieved.

40 Control of external provision of products and services Clause 8.6 Control of external provision of products and services addresses all forms of external provision, whether it is by purchasing from a supplier, through an arrangement with an associate company, through the outsourcing of processes and functions of the organization or by any other means. The organization is required to take a risk-based approach to determine the type and extent of controls appropriate to particular external providers and externally provided products and services. There is no requirement for the organization to adopt the use of the terms external provider or external provision within their quality management system. Organizations can choose to use terms which suit their operations.

41 The ISO portfolio of quality management standards The International Standards (and other ISO deliverables) have been produced as part of the ISO portfolio of quality management standards by ISO's Technical Committee ISO/TC 176. These International Standards can provide assistance to organizations when they are establishing or seeking to improve their quality management systems, their processes or their activities. Table shows the relationship between these standards and the pertinent clauses of ISO9001.

42 The relationship of other ISO quality management and quality management system standards (and other deliverables) to the clauses of ISO 9001 ISO 9001 Clause No ISO 9000 All All All All All All All ISO 9004 All All All All All All All ISO , ISO ISO ISO ISO , All All ISO All All All All All All All ISO ISO All All All All All All All ISO ISO/TR ISO All All All All All All All ISO ISO/TR ISO All All All All All All All ISO ISO

43 Other important Information The revision of ISO 9001 will impact on other related standards and documents. Expect changes to: industry-specific standards supporting documents

44 ISO 9001:2015 Timeline June 2013 CD (Committee Draft) May 2014 DIS (Draft International Standard) July 2015 FDIS (Final Draft International Standard) September 2015 Published International Standard

45 ISO 9001:2015 Certification Transition Timeline Deadline for the accepting application for certification to the ISO9001:2008 is 18 month September 2015 Published International Standard September 2015 start of 3 years transition period to September 2018 Certifications to ISO 9001:2008 will no longer be valid after September 2018

46 I need to ensure my organization... knows about the key changes understands the key concepts plans to implement the new requirements stays informed as the revision proceeds takes full advantage of the revision of ISO 9001

47 ISO Connect May ISO/DIS 9001 and ISO/DIS 9000 Quality Management System Published ISO 9001 and ISO 9000 Quality Management Systems has been published as a Draft International Standard (DIS) and is now available. Main changes include the same high-level structure used by other management system standards which will help companies implementing more than one standard, the identification of risk and risk control as requirements in the standard, the requirement of top management to take a more active role in aligning quality policies with business needs, and a number of changes in terminology

48 Latest news DIS ballot for ISO 9001 was approved on the 10 th of October by a VERY comprehensive margin: 90% positive vote!

49 What is next? Updates will be made available as the revision proceeds Thank you!

50 Results of DIS Ballot

51 Results of Ballot and comments 3115 comments on 428 pages Result of voting :428 pages 3115 comments P-Members voting: 64 in favour out of 72 = 89 % (requirement >= 66.66%) (P-Members having abstained are not counted in this vote.) Member bodies voting: 8 negative votes out of 79 = 10 % (requirement <= 25%) Approved

52 Negative ballot: Canada Finland Germany Ireland Israel Japan South Africa USA

53 PROCESS APPROCH

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