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Update on ISO 9000 and OHSAS 18001 By Charles Corrie Secretary ISO/TC 176/SC 2

Update on ISO 9000 and OHSAS 18001 By Charles Corrie Secretary ISO/TC 176/SC 2. ISO/TC 176 Published standards TC 176 ISO/TS 16949:2002

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Update on ISO 9000 and OHSAS 18001 By Charles Corrie Secretary ISO/TC 176/SC 2

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  1. Update onISO 9000 and OHSAS 18001 By Charles CorrieSecretary ISO/TC 176/SC 2 Tel Aviv, May 2005

  2. 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

  3. 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

  4. 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

  5. ISO/TC 176 Published standards TC 176/SC 3 ISO 10002:2004Quality 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

  6. 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 9001:2000ISO 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

  7. ISO/TC 176 Other guidance • “Selection and Use of ISO 9000” brochure • Quality Management Principles • ISO 9000 Introduction and Support Package: • N524 - Guidance on ISO 9001:2000 clause 1.2 'Application' • N525 - Guidance on the Documentation Requirements of ISO 9001 • N526 - Guide to the Terminology used in ISO 9001:2000 and ISO 9004 • N544 - Guidance on the Concept and Use of the Process Approach for management systems • N630 - Guidance on Outsourced Processes • Interpretations • ISO Handbook: ISO 9001 for Small Businesses Tel Aviv, May 2005

  8. ISO 9001 Auditing Practices Group Joint ISO/TC 176, ISO/CASCO and IAF team that produces guidance notes focussed on 3rd party management system auditors, but useful to 1st 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

  9. Web sites www.iso.org(general guidance) www.tc176.org(interpretations) www.iso.org/tc176/sc2(ISO 9000 Introduction and Support package) www.iso.org/tc176/ISO9001AuditingPracticesGroup(auditing guidance) Tel Aviv, May 2005

  10. ISO/TC 176 Work in Progress TC 176Interpretations 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

  11. ISO/TC 176 Work in Progress TC176/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

  12. 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 9004It 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

  13. 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, SC2 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 2008 Tel Aviv, May 2005

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

  15. Key to the Decision Matrix Tel Aviv, May 2005

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

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

  18. 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

  19. 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

  20. 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

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

  22. 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

  23. 4. Processes • 4. 1Management 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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; implement, maintain and continually improve an OH&S management system; assure itself of its conformance with its stated OH&S policy; demonstrate such conformance to others; seek certification/registration of its OH&S management system by an external organization; or make a self-determination and declaration of conformance with this OHSAS specification. OHSAS 18002 gives application guidance on OHSAS 18001 Scope of 18001 Tel Aviv, May 2005

  31. 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 Facts and figures Tel Aviv, May 2005

  32. 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

  33. 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 The Future Tel Aviv, May 2005

  34. 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

  35. 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

  36. 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 re-sequencing 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

  37. 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

  38. 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

  39. 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

  40. 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

  41. 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

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

  43. 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

  44. 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

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

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

  47. 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

  48. Compatibility / Alignment / Integration 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 how the standards may be integrated into an organization’s management system Tel Aviv, May 2005

  49. Compatibility / Alignment / Integration • 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

  50. 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

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