Update on ISO 9000 and OHSAS 18001 By

Update on ISO 9000 and OHSAS 18001 By Charles Corrie Secretary ISO/TC 176/SC 2 Tel Aviv, May 2005

ISO/TC 176 Published standards TC 176 ISO/TS 16949: 2002 Quality management systems -- Particular requirements for the application of ISO 9001: 2000 for automotive production and relevant service part organizations TC 176/SC 1 ISO 9000: 2000 Quality management systems -- Fundamentals and vocabulary Tel Aviv, May 2005

ISO/TC 176 Published standards TC 176/SC 2 ISO 9001: 2000 Quality management systems -- Requirements ISO 9004: 2000 Quality management systems -- Guidelines for performance improvements Tel Aviv, May 2005

ISO/TC 176 Published standards TC 176/SC 2 - continued ISO 10005: 1995 Quality management -- Guidelines for quality plans ISO 10006: 2003 Quality management systems -- Guidelines for quality management in projects ISO 10007: 2003 Quality management systems -- Guidelines for configuration management Tel Aviv, May 2005

ISO/TC 176 Published standards TC 176/SC 3 ISO 10002: 2004 Quality management -- Customer satisfaction -- Guidelines for complaints handling in organizations ISO 10012: 2003 Measurement management systems -- Requirements for measurement processes and measuring equipment ISO/TR 10013: 2001 Guidelines for quality management system documentation ISO/TR 10014: 1998 Guidelines for managing the economics of quality Tel Aviv, May 2005

ISO/TC 176 Published standards TC 176/SC 3 - continued ISO 10015: 1999 Quality management -- Guidelines for training ISO/TR 10017: 2003 Guidance on statistical techniques for ISO 9001: 2000 ISO 10019: 2005 Guidelines for the selection of quality management system consultants and use of their services ISO 19011: 2002 Guidelines for quality and/or environmental management systems auditing Tel Aviv, May 2005

ISO/TC 176 Other guidance § “Selection and Use of ISO 9000” brochure § Quality Management Principles § ISO 9000 Introduction and Support Package: • N 524 - Guidance on ISO 9001: 2000 clause 1. 2 'Application' • N 525 - Guidance on the Documentation Requirements of ISO 9001 • N 526 - Guide to the Terminology used in ISO 9001: 2000 and ISO 9004 • N 544 - Guidance on the Concept and Use of the Process Approach for management systems • N 630 - Guidance on Outsourced Processes § Interpretations § ISO Handbook: ISO 9001 for Small Businesses Tel Aviv, May 2005

ISO 9001 Auditing Practices Group Joint ISO/TC 176, ISO/CASCO and IAF team that produces guidance notes focussed on 3 rd party management system auditors, but useful to 1 st party auditors. More than 20 papers posted on the web, e. g. : · The need for a 2 -stage approach to auditing · Measuring QMS effectiveness and improvements · Identification of processes · Understanding the process approach · Determination of the “where appropriate” processes Now due to produce Accreditation Auditing guidance Tel Aviv, May 2005

Web sites www. iso. org (general guidance) www. tc 176. org (interpretations) www. iso. org/tc 176/sc 2 (ISO 9000 Introduction and Support package) www. iso. org/tc 176/ISO 9001 Auditing. Practices. Group (auditing guidance) Tel Aviv, May 2005

ISO/TC 176 Work in Progress TC 176 Interpretations TC 176/SC 1 ISO/DAM/FDIS 9000 Quality management systems -- Fundamentals and vocabulary TC 176/SC 2 ISO/FDIS 10005 Quality management -- Guidelines for quality plans (Approved for publication) + Amendment to ISO 9001 and Revision of ISO 9004 + Working with TC 207/SC 1 on a Joint Vision for future revisions of ISO 9001 and ISO 14001 Tel Aviv, May 2005

ISO/TC 176 Work in Progress TC 176/SC 3 ISO/CD 10001 Quality management -- Customer satisfaction -- Guidelines for codes of conduct ISO/CD 10003 Quality management -- Customer satisfaction -- Guidelines for external customer disputes resolution ISO/DIS 10014 Quality management systems -- Guidelines for realizing financial and economic benefits NWIP – Guidelines for monitoring customer satisfaction Systematic Review of ISO 10015 due to start in 2005 Tel Aviv, May 2005

Amendment to ISO 9001: 2000 and Revision to ISO 9004: 2000 This follows from: - a formal ISO process, for “Systematic Reviews” - the 2004 ISO/TC 176/SC 2 User Feedback Survey - the ISO/TC 176 Interpretations process - papers from Japan, France and Spain indicating potential new directions for ISO 9004 It also required the presentation of a “Justification Study”, and agreement by ISO/TC 176, which was documented in a “Recommendation Report” (These are also part of ISO’s internal processes for management systems standards). This was only achieved in November 2004, so we are still in the early stages of this work. Tel Aviv, May 2005

Amendment to ISO 9001: 2000 and Revision to ISO 9004: 2000 Currently developing and balloting “Design Specifications” for the amendment /revision. If these are approved, SC 2 will commence drafting in October, and will then follow the usual ISO development path of CD, DIS, FDIS for the standards Publication expected to be achieved in Tel Aviv, May 2005 2008

Changes in the amendment to ISO 9001 to be extremely limited. All inputs to be assessed using a decision matrix of limited Benefits versus Impacts: Decision matrix: Tel Aviv, May 2005

Key to the Decision Matrix Tel Aviv, May 2005

Examples of Categories of Benefits Increases compatibility with ISO 14001 1. High – Considerable increases compatibility with ISO 14001 2. Medium – Improves the compatibility with ISO 14001 3. Low – has no impact on the compatibility with ISO 14001 Improves translatability 1. High – significant improvement on translatability 2. Medium – slight improvement on translatability 3. Low – no improvement on translatability Tel Aviv, May 2005

Examples of Categories of Impact Increase in the number of specified records 1. Low – no additional records to be specified 2. Medium – few additional records to be specified (e. g. one or two new records required) 3. High – greater than 2 addition records to be specified Changes to existing processes 1. Low – negligible change to processes 2. Medium – requires minimum change to processes 3. High – requires extensive change to processes Tel Aviv, May 2005

For ISO 9004 The Design Specification has proposed a new title: “Managing for sustainable success through Quality” and that the document be structured in 3 sections: - A Top Management section, focussing on strategic issues and describing managerial processes - An Operational management section, giving practical guidance on what to consider for achieving operational improvement - A self assessment section, giving tools for assessing both Top management and Operational management issues Tel Aviv, May 2005

Note on the use of “Sustainability” For the future ISO 9004, “sustainability” is not being used in the context of “sustainable development” as in the field of environmental management. Sustainability is being used in the context of the issues that an organization needs to deal with in order to remain successful in the long term Tel Aviv, May 2005

ISO 9004 will address additional Quality Principles The future ISO 9004 will continue to be based on the 8 Quality management Principles, but will also give attention to the additional principles of: • Ethics / Social issues • Mission and Vision of the organization • Adaptability / agility, flexibility and responsiveness • Management of Knowledge • Alignment with other management system elements • Linking Objectives and Actions to Results Tel Aviv, May 2005

The standard will employ an expanded “Process Approach” model: Tel Aviv, May 2005

Consistent Pair A new approach to maintaining ISO 9001 and ISO 9004 as a “consistent pair” will be developed, which is not dependent on clause numbering and clause titles. New main clauses have been proposed for ISO 9004 of: 1. Organizational environment (external and internal) 2. Organization’s identity – Principles, mission, vision and position 3. Strategic imperatives of an organization for sustainable success Tel Aviv, May 2005

4. Processes 4. 1 Management responsibility 4. 2 Resources management 4. 3 Product realization 4. 4 Measurement, analysis and improvements 5. Results and sustainable organization 6. Feedback and learning 7. Strategic improvement and innovation of a quality management system Tel Aviv, May 2005

For operating environment, identity and position of the organization, ISO 9004 will focus its advice on: • Identification of the operational environment, the needs and the expectations of customers and other interested parties, materially affecting the organization’s viability and definition of its strategic imperatives. • The assessment of risks associated with the activities of the organization to enable sustainable success and the facilitation of preventive actions. • Compliance with laws and statutory regulations. Tel Aviv, May 2005

For operating environment, identity and position of the organization, ISO 9004 will focus its advice on: • The adaptability of the organization to its operational environment related to its culture, learning and innovation. • The organizational profile in relation to its strategic vision and values. • The way in which the organization makes decisions and takes actions to achieve its objectives and goals for sustainable success. Tel Aviv, May 2005

For Results and Sustainability, ISO 9004 will focus its advice on: • How management assures that objectives and actions will result in adding value. • The achievement of organizational objectives that are derived from the strategic plan and which should result in sustainable success of the organization. • The achievement of these objectives is a measure of the maturity of the management system. Tel Aviv, May 2005

For Results and Sustainability, ISO 9004 will focus its advice on: • The degree of improvement of adaptability, flexibility and responsiveness of the organization in relation to its vision and objectives. • Analysis of the results achieved, as perceived by interested parties. • Linking results to objectives and actions, including lessons learned. Tel Aviv, May 2005

In conclusion The future ISO 9004 is set to make a significant leap forward in management systems standardization. Its focuses on : - Top Management and Strategy Deployment - Sustainability, Social responsibility - Innovation, Flexibility, Agility - Knowledge Management, Risk Management - Results This is a radical departure from anything ISO has previously attempted Tel Aviv, May 2005

OHSAS 18001 and OHSAS 18002 OHSAS 18001 was published in 1999; now 6 years old Currently undertaking: - Survey of OH&S standards and Certificates to end of 2004 (a similar survey was done for 2003). Results currently being processed. - A Systematic Review, to see if the standards need changing Submissions due by 1 June. Tel Aviv, May 2005

Scope of 18001 a) establish an OH&S management system to eliminate or minimize risk to employees and other interested parties who may be exposed to OH&S risks associated with its activities; b) implement, maintain and continually improve an OH&S management system; c) assure itself of its conformance with its stated OH&S policy; d) demonstrate such conformance to others; e) seek certification/registration of its OH&S management system by an external organization; or f) make a self-determination and declaration of conformance with this OHSAS specification. OHSAS 18002 gives application guidance on OHSAS 18001 Tel Aviv, May 2005

Facts and figures OHSAS Standards and Certificates survey (to October 2003) • • • 31 guidance documents 23 requirement standards Certification in 70 countries 8399 certificates in total 3898 to 18001 or direct equivalent Tel Aviv, May 2005

2003 - OHSAS (or equivalent) survey results: By Country: No discernable pattern between: - Large versus Small countries - Developed versus developing countries By Industrial sector: Highest uptake has been in the chemical, construction, engineering, and distribution sectors. Food sector also prominent. Tel Aviv, May 2005

The Future • Increasing adoption of 18001 as a national standard in different countries • Development of OHS standards by ANSI in the USA , and by CSA in Canada • Development of a CEN Guidance document • ISO ? ? ? June 2005 ISO/TMB meeting will be critical to this issue Tel Aviv, May 2005

Systematic Review This will lead to a decision to either: - Confirm (unchanged) - Withdraw - Amend - Revise the standards. Expected outcome is for an Amendment. Tel Aviv, May 2005

Drivers for change - Ongoing revision to ISO 14001 for EMS, and the need for the standards to remain “compatible” (Note with ISO 9001: 2000 revision, this merely led to revised “Correspondence tables” being included in Annex A) - The need to reduce identified risks to a situation of being “As low as reasonably practicable” or ALARP. (Note, this is the only technical comment received against 18001 in 5 years) Tel Aviv, May 2005

ISO 14001 compatibility OHSAS 18001 was developed very closely against ISO 14001. The publication of ISO 14001: 2004 has not introduced any significant new requirements, but has re-sequenced some of the sub-clauses and introduced new sub-clauses. The market may require OHSAS 18001 to maintain its explicit level of compatibility with 14001, and for similar resequencing to be introduced. Alternately, the market may require stability and no change to OHSAS 18001, with the relationship to ISO 14001 being defined through revised correspondence tables. Tel Aviv, May 2005

ALARP – As Low As Reasonably Practicable ALARP could change the fundamental basis of the OHSAS standards At the moment risks are reduced to what the organization considers to be “tolerable”, and makes a cost versus benefits judgement as to where to set the level. ALARP may require the organization to implement measures beyond what it considers economically beneficial, but which external observers may consider practicable. This leads to questions concerning the subjective evaluation of what is “practicable”. ALARP is already frequently required by regulations. Tel Aviv, May 2005

Other OHSAS Project Group considerations • 2004 Standards and certificates survey • An auditing standard (or a supplement to ISO 19011) • Auditor qualification criteria • ISO ? ? ? • Why do so few small businesses understand or comply with OHS regulations ? (UK survey showed that 90% do not comply) Tel Aviv, May 2005

Compatibility / Alignment / Integration ISO 14001: 2004 recently published Already, a number of commentators have expressed the view that the changes have not enhanced the “alignment” of ISO 14001 to ISO 9001, and are calling for ISO to improve this situation. They do not accept the original objective of the revision, which was to enhance the existing “compatibility” between the two standards. Tel Aviv, May 2005

Compatibility / Alignment / Integration “Compatibility” means that common elements of the two series of standards can be implemented in a shared manner, in whole or in part, by organizations without unnecessary duplication or the imposition of conflicting requirements. (Based around ISO/IEC Guide 2: 1996, term 2. 2) Note: “Compatibility” does not mean that the text of common elements of the standards needs to be identical, although they should be whenever practicable. Tel Aviv, May 2005

Compatibility / Alignment / Integration Alignment/ Compatibility is directed at: - Basic principles - Terminology - General management system requirements (but not the Technology specific requirements) - Structures Tel Aviv, May 2005

Compatibility / Alignment / Integration Basic principles The principles are very similar Tel Aviv, May 2005

Compatibility / Alignment / Integration Terminology Many similar terms are used in the differing standards, however, their definitions appear to vary considerably. Is this a problem ? Answer = No Why not ? Because the underlying intent, or concept, of the definitions are generally very similar Tel Aviv, May 2005

Compatibility / Alignment / Integration General management systems requirements (See ISO Guide 72) Policy Planning Implementation and operation Improvement Management review Both ISO 9001 and ISO 14001 cover these elements Tel Aviv, May 2005

Compatibility / Alignment / Integration Structures: - ISO 9000 Process Approach Continual improvement of the quality management system Management responsibility Customer s Requirement s Resource management Input Measurement, analysis and improvement Product realization Tel Aviv, May 2005 Product Satisfaction Output

Compatibility / Alignment / Integration Structures: - ISO 14001 Modified PDCA Tel Aviv, May 2005

Compatibility / Alignment / Integration Structures: Structures themselves are a conceptual way of showing how the various management system elements fit together to form a “system”. They also attempt to show that individual elements of the “system” cannot be treated in isolation, but have to be taken together. The “system” will fail, if any one of those elements is ignored. The structures themselves are not a requirement to which compliance has to be achieved. Each representation has its own merits. Tel Aviv, May 2005

Compatibility / Alignment / Integration Many voices are now saying to ISO that it should develop integrated standards. ISO/TMB has established a group to look at many different aspects of management system standardization, including the need for common elements and structure, and how such work should be organized. ISO/TMB has established a task group to develop an ISO Handbook, to show the standards may be integrated into an organization’s management system Tel Aviv, May 2005

Compatibility / Alignment / Integration Where is the pressure coming from for ISO to take further action ? - Developing countries - Micro / Small businesses - Large Global businesses Tel Aviv, May 2005

Conflicting views between developing countries and developed countries. Developing countries view ISO 9001 and ISO 14001 certification as a barrier to trade. They also suffer from a lack of management systems infrastructure within their countries (consultants, training courses, certification bodies), which means the costs of obtaining certification are relatively higher. They are pushing for IMS standards as a cheaper alternative. Developed countries have a lot more availability and choice for their management systems infrastructures. Organizations in developed countries therefore pick and choose management systems programmes to differentiate themselves, for competitive advantage. Tel Aviv, May 2005

Micro / Small businesses Micro/small businesses are considered vital to the growth of all economies Most have little or no management systems knowledge. In the critical start-up phase, many are also faced with (financial) resource shortages, and little time for executives to be available to assist in the implementation of a formal system. They are looking for standards that are simple to follow, can be implemented quickly, and at low cost. Tel Aviv, May 2005

Large Global Organizations There associations of large global organizations that wish ISO to stop producing MSS. This is also impacting many national standardization projects. They are particularly critical of 3 rd party certification systems, which they would wish to see disappear. They want ISO to have extremely difficult criteria that have to be met, before it starts work on MSS Tel Aviv, May 2005

What strategies can ISO follow ? - a very rigid one - a very flexible one - somewhere in-between (a pragmatic one) Tel Aviv, May 2005

Integration - Conclusion An organization’s management system will be unique, and will need to take account of many management system programmes, both from within ISO and external to it. Understanding the intention behind management standards will enable the organization to integrate the requirements of the standards into it’s own management system in a planned and consistent manner. Organizations need to learn to have the confidence to deal with new MS initiatives. ISO can assist them with such learning. Business efficiencies can be achieved through the use of a fully integrated system. Tel Aviv, May 2005

Integration – Conclusion Integration is usually applied to ISO 9001, ISO 14001 and OHSAS 18001. Even when taken together, these do not cover the wider scope needed by an organization for its management system (e. g. they do not cover financial controls, personnel management, IT/technology investment strategies, mergers and acquisitions, etc. ) To develop a standard for an integrated MSS at this time, from the currently available components, would still not meet the needs of all interested parties. Tel Aviv, May 2005

TC 176/SC 2 & TC 207/SC 1 JTG proposed “Joint Vision” for ISO 9001 and ISO 14001 (being considered during 2005) The future revisions of ISO 9001 and ISO 14001 will be aligned and will seek to enhance further the current levels of compatibility between the two standards, through the promotion of identical: identical • titles, • sequence of titles, • text and definitions that are permitted to diverge only where necessitated by specific differences in managing environment or quality. Tel Aviv, May 2005

TC 176/SC 2 & TC 207/SC 1 JTG proposed generic “systems” structure (being considered during 2005) • Context of the organization Consideration of the needs and expectations of interested parties (including customers and stakeholders) • Leadership - Commitment and actions by management • Support Resources and other needs that enable the organization to function • Operations Activities/processes that make the organization achieve its purpose • Performance evaluation Measurement and data gathering, analysis and use • Improvement - Action to enhance the organization's performance Tel Aviv, May 2005

Thank you for your attention Charles Corrie Secretary ISO/TC 176/SC 2 Tel Aviv, May 2005