Needs and expectations for the ISO9001 2015 renewal Juhani Anttila, Academician International Academy for Quality (IAQ) Helsinki, Finland juhani.anttila@telecon.fi , ww.QualityIntegration.biz                                      These pages are licensed under the Creative Commons 3.0 License http://creativecommons.org/licenses/by/3.0 (Mention the origin) September, 2014

35 years ISO 9000 standardization, Five generations ISO 9000 standards Technical committee ISO/TC 176 formed in 1979. Five generation of the ISO 9000 series standards: ISO 8402:1986, and ISO 9000/9001/9002/9003/9004:1987 ISO 9000/9001/9002/9003/9004:1994 ISO 9000/9001/9004:2000 ISO 9000:2005, ISO 9001:2008, and ISO 9004:2009 ISO 9001:2015 and ISO 9004:20?? In addition to prepare standards for quality management, the work in committee ISO/TC 176 has an important role in the worldwide quality discipline and social collaboration of the professionals. 2012 4315/14.9.2014/jan

Requirements for the ISO 9001 revision 2015 Strategic objectives of the ISO 9000 responsible committee ISO/TC 176/SC2 Systematic review on ISO 9001:2008 Worldwide user survey of the ISO 9001 and 9004 standards Analysis of the quality management concepts for considering the future ISO 9000 work Design specification: Challenging targets to meet the needs and expectations of modern organizations Renewed quality management principles (QMPs) ISO Directives Annex SL: High level structure, identical core text, common terms and core definitions in the management system standards Emphasized a harmonized risk management approach with the ISO 31000 4316/14.9.2014/jan

Design specification for the ISO 9001 revision 2015 The revision will: a) Take account of changes in quality management systems practices and technology since the last major revision to ISO 9001 (in the year 2000) and to provide a stable core set of requirements for the next 10 years or more. b) Ensure that requirements in this standard reflect the changes in the increasingly complex, demanding, and dynamic environments in which organizations operate. c) Ensure that requirements are stated to facilitate effective implementation by organizations and effective conformity assessment by 1st, 2nd and 3rd parties. d) Ensure that the standard is adequate to provide confidence in those organizations meeting the standard’s requirements How well have these requirements been realized in the standard? xxxx/14.9.2014/jan

Performance improvement and organizational excellence Revision of the ISO 9000 QMPs (Quality management principles) The existing ISO 9000 QMPs: Customer focus Leadership Involvement of people Process approach System approach to management Continual improvement Factual approach to decision making Mutually beneficial supplier relationships Revised QMPs in 2013: Customer focus Leadership Engagement of people Process approach Improvement Evidence-based decision making Relationship management Improved performance Quality management, Performance improvement and organizational excellence QMPs are fundamental truths or propositions that serve as the foundation for a system of belief or behavior, or for a chain of reasoning for the ISO 9000 standardization. How well have these QMPs taken into account in the standard? 4317/14.9.2014/jan

The common structure for all management system requirements standards supports business integration Required contents for the discipline XXX management in an organization: E.g. quality is a XXX discipline. 4. Context of the organization 4.1 Understanding of the organization and its context 4.2 Understanding the needs and expectations of interested parties 4.3 Determining the scope of the XXX management system 4.4 XXX management system 5. Leadership 5.1 Leadership and commitment 5.2 Policy 5.3 Organizational roles, responsibilities and authorities 6 Planning 6.1 Actions to address risks and opportunities 6.2 XXX objectives and planning to achieve them 7. Support 7.1Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information 7.5.1 General 7.5.2 Creating and updating 7.5.3 Control of documented Information 8. Operation 8.1 Operational planning and control 9. Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.2 Internal Audit 9.3 Management review 10. Improvement 10.1 Nonconformity and corrective action 10.2 Continual improvement Factually this a general structure for any business management. All XXX aspects are standardized and implemented to organization’s business processes according to this structure. How well have this structure realized in the standard text? 4318/14.9.2014/jan (Ref.: ISO Directives Annex SL )

Risk management in the ISO 9001:2015 The new ISO 9001 standard makes risk-based thinking more explicit than the previous ones and this covers the whole standard including requirements for the establishment, implementation, maintenance and continual improvement of the quality management system. Organizations must decide how the necessary risk management is to be applied to the entire organization, at its different areas and levels, at any time, as well as to specific functions, projects and activities. Standard ISO 31000 provides guidelines on formal risk management and recommends how the organization can develop, implement and continuously improve a framework whose purpose is to integrate the process for managing risk into the organization's overall governance, strategy and planning, management, reporting processes, policies, values and culture. How well have risk management items realized and allocated in the standard text? 4319/14.9.2014/jan

Pros and cons of the general international standardization All standardization has positive and proactive aims: Improved business performance and confidence, and quality of products Decreased operational costs Improved communication between people and organizations Pros of general standardization: Broad acceptance and distribution of the texts Extensive expertise in preparing and commenting the standards Wide commitment and recognition No restrictions for innovative implementation Cons of general standardization: There is uneven and unbalanced groups of voluntary people participating the standardization work. Management of the standardization is weak. Only communally interesting issues are accepted to the final standard texts mainly due to the consensus principle. Influence of the strong and active individuals and lobbying. Only trivial means to implement the standard clauses may be considered in the standards. Handling of the issues in the standard text is superficial. Standardization process is very slow. Participating in standardization is expensive. All general international standards have serious inadequacies, inconsistencies and other problems mainly due to the normal standardization processes and particularly the consensus practices. Organizations applying the standards should highlight their own responsibility of business leaders and experts and clarify, correct, and complete general standards and find creative solutions in their implementations in order to achieve business benefits. 4320/14.9.2014/jan

Standardization, a linking factor between science and practice An activity giving solutions for repetitive application, to problems essentially in the spheres of science, technology and economics, aimed at the achievement of the optimum degree of order in a given context. Generally, the activity consists of the processes of formulating, issuing and implementing standards. (ISO Guide 2) Standard A technical specification or other document available to the public, drawn up with the cooperation and consensus or general approval of all interests affected by it, based on the consolidated results of science, technology and experience, aimed at the promotion of optimum community benefits and approved by a standardization body (ISO Guide 2) 1 4073/2.8.2013/jan

Implementing the ISO 9000 series of standards The ISO 9000 standards series for quality management systems (QMS) is it is an ensemble of: ISO 9000: Fundamentals and vocabulary ISO 9001: Requirements ISO 9004: Managing for the sustained success of an organization Different parts of the series form a complementary whole. Starting point for implementing ISO 9001 is the organization itself, its business needs, and its QMS: ISO 9001 presents requirements for organizations’ QMS QMSs should be created by organizations themselves. QMSs have not been specified in any standards. 4321/14.9.2014/jan