ISO 9001:2008 small changes but big opportunities

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ISO9001:2008 with small changes provides big opportunity

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ISO 9001:2008 small changes but big opportunities

  1. 1. ISO 9001:2008 Small Changes, BIG OPPORTUNITIES Nigel H Croft Founding Co-chairman, ISO 9000 Advisory Group Co-Convenor TC176 Conformity Assessment Liaison Group ISO/TC176 liaison representative to ISO/CASCO Member, IAF/ILAC/ISO Joint Working Group Member, ISO/IAF Auditing Practices GroupApril 2009 (c) Nigel H Croft 1
  2. 2. Small Aim of the book: To provide a common platform for organizations, understand: Intent of each clause of ISO 9001 Interpretation of the clause Typical evidence that might be expected in order to demonstrate conformity To highlight the changes and opportunities introduced in the ISO 9001:2008 version To explain some common misunderstandingsApril 2009 (c) Nigel H Croft 2
  3. 3. Management System set of interrelated or interacting elements Hardware Software (equipment) (methods)to Interact within processes establish policy and objectivesand to Humanware (people) achieve those objectivesApril 2009 (c) Nigel H Croft 3
  4. 4. ISO 9001 Scope Clause 1.1 - requirements for organization to: demonstrate ability to consistently provide product that meets customer and applicable regulatory requirements ISO 14001 and OHSAS 18001 have similar performance-based objectives DID WE ALL FORGET THIS???April 2009 (c) Nigel H Croft 4
  5. 5. What is the objective ofa management system audit? Personal opinion (Nigel Croft) and/or OHSAS 18001 requirements, and thereby provide objective evidence of an Objectives:May 2005 (c) Nigel H Croft 2005 5
  6. 6. What are we looking for? (Case of ISO 9001) Evidence that the way things are being planned meets the requirements of Customers Applicable legislation ISO 9001:2000 Evidence that things are being done the way they were plannedMay 2005 (c) Nigel H Croft 2005 6
  7. 7. Basic Principlesof good auditing Concentrate on the processes, not the documents Look at the results System effectiveness PDCA approachMay 2005 (c) Nigel H Croft 2005 7
  8. 8. Cause and Effect PROCESS UNDESIRABLE OUTPUTS Environmental Impacts Health & Safety risksMay 2005 (c) Nigel H Croft 2005 8
  9. 9. Act Plan How to improve What to do? next time? How to do it? Check Do Did things happen Do what was according to plan? plannedMay 2005 (c) Nigel H Croft 2005 9
  10. 10. HOW TO PROVIDE CONFIDENCE? (ISO 9001 example) -promoting activitiesConfidence IAF Recognition (ISO/CASCO) Confidence ISO 17011 ISO 17021-1 Accreditation Body ISO 17021-2 Confidence ISO 17024 Certification Body ISO/TC176 Confidence ISO 9001:2008 Organization Confidence Confidence National Body Customers (Translation) Jan 2009 (C) Nigel H Croft 2009 - All rights reserved 10
  11. 11. ISO TC176 Standardization Confederation of National Standards Bodies Based in Geneva Quality management and Quality AssuranceApril 2009 (c) Nigel H Croft 11
  12. 12. Secretariat: Canada (SCC)Chair: Dr Gary CortVice-Chair Mr Li Tienan ISO/TC 176 CALG CSAG Interpretations WG Spanish Trans TG Automotive TG Arabic Trans TG SC 1 SC 2 SC 3 WG1 WG2 WG3 WG18 WG1 WG6 JWGApril 2009 TGx(c) NigelTGy H Croft TGz 12
  13. 13. Chairman Strategic Advisory Group ISO ISO/TC 176 CALG CSAG Interpretations WG Spanish Trans TG Automotive TG Arabic Trans TG SC 1 SC 2 SC 3 WG1 WG2 WG3 WG18 WG1 WG6 JWGApril 2009 TGx(c) NigelTGy H Croft TGz 13
  14. 14. Conformity Assessment Liaison ISO/TC 176 Group CALG CSAG Interpretations WG Spanish Trans TG Automotive TG Arabic Trans TG SC 1 SC 2 SC 3 WG1 WG2 WG3 WG18 WG1 WG6 JWGApril 2009 TGx(c) NigelTGy H Croft TGz 14
  15. 15. ISO/TC 176ISO 9000 CALG CSAG Interpretations WG Spanish Trans TG Automotive TG Arabic Trans TG SC 1 SC 2 SC 3 WG1 WG2 WG3 WG18 WG1 WG6 JWGApril 2009 TGx(c) NigelTGy H Croft TGz 15
  16. 16. ISO 9001 ISO/TC 176ISO 9004 CALG CSAG Interp Interpretations WG Spanish Trans TG Automotive TG omotive Arabic Trans TG SC 1 SC 2 SC 3 WG1 WG2 WG3 WG18 WG1 WG6 JWGApril 2009 TGx(c) NigelTGy H Croft TGz 16
  17. 17. ISO 19011 ISO/TC 176 &ISO 10000 C CALG CSAG series Interpretations WG pretations Spanish Trans TG Automotive TG Arabic Trans T abic TG SC 1 SC 2 SC 3 WG1 WG2 WG3 WG18 WG1 WG6 JWGApril 2009 TGx(c) NigelTGy H Croft TGz 17
  18. 18. Overall Scenario of TC176 Generic QMS standards have broad application: all market sectors both private and public organizations +/- 1,000,000 worldwide certifications to ISO 9001 Other guidelines produced by ISO/TC 176 assist organizations in improving their quality management processes. ISO 9000 ISO 9004 Others (ISO 10001/2/3; ISO 19011 etc)April 2009 (c) Nigel H Croft 18
  19. 19. 1979 - BS 5750 1987 ISO 9000 series 1990 1994 Revision to ISO 9000 series 1996 ISO 14000 series published 2000 Major ISO 9000 revision 2002 2002 ISO 19011 published 2004 Revision to ISO 14001 2005 Small revision to ISO 9000 (not ISO 9001)April 2009 (c) Nigel H Croft 19
  20. 20. ISO Review process: Requires continual review (every 5 years) to keep standards up to date. User inputs: User questionnaire Suggestions arising from the interpretation process. Opportunities for increased compatibility with ISO 14001 Current trends: Keeping up with recent developments in management system practices.April 2009 (c) Nigel H Croft 20
  21. 21. Key inputs for ISO 9001:2008 Web based User Feedback Survey conducted by ISO/TC 176/SC2 ISO/TC 176 approved interpretations See www.tc176.org/ for details Some interpretation requests indicate need for clarification of ISO 9001 text The ISO 9001:2008 Introduction & Support Package set of documents (www.iso.org) ISO 14001:2004April 2009 (c) Nigel H Croft 21
  22. 22. Results of User Survey (2003) Responses from 941 users in 63 countries. 1477 individual comments All four product categories (Hardware, Software, Processed Materials and Services) well represented. Approx 80% of respondents were satisfied with the ISO 9001:2000 standard.April 2009 (c) Nigel H Croft 22
  23. 23. Survey responses 229 UNITED STATES CHINA 337 GERMANY UNITED KINGDOM 20 MEXICO 25 JAPAN 28 CANADA COLOMBIA 32 39 AUSTRALIA 70 45 ITALY 58 OtherApril 2009 58 (c) Nigel H Croft 23
  24. 24. Size of organization 3 271 290 small medium large Blank 377April 2009 (c) Nigel H Croft 24
  25. 25. How long certified? 450 424 400 350 300 264 250 250 200 150 100 50 3 0 0-3 4-10 YEARS 10+ BlankApril 2009 (c) Nigel H Croft 25
  26. 26. How well does ISO 9001:2000meet your needs? 16 42 137 Excellent 167 Good No comment (or NOT APPLICABLE) Needs to be improved 14 Not adequate Blank 565April 2009 (c) Nigel H Croft 26
  27. 27. Are you happy with theprocess approach? 22 70 Yes No Blank 849April 2009 (c) Nigel H Croft 27
  28. 28. Most commented clauses /813 (55%) of total 1477 comments related to: 4.1 General requirements 4.2 Documentation 6.2 Human resources 7.3 Design and development 7.5 Production and Service Provision 8.2 Monitoring and Measurement 8.5 ImprovementApril 2009 (c) Nigel H Croft 28
  29. 29. Objectives for ISO 9001 Initial objectives of ISO 9001:2008: to improve the existing standard; to provide greater clarity and ease of use, to improve compatibility with ISO 14001:2004April 2009 (c) Nigel H Croft 29
  30. 30. Impacts and benefits Changes to ISO 9001 focus on high benefit / low impact cases Some high benefit / high impact improvements that were identified are being saved for the next revision cycle Criteria are shown in the following slidesApril 2009 (c) Nigel H Croft 30
  31. 31. Impact of changes to ISO 9001Impact CriteriaCategoryHigh Additional or reduced requirements significantly affecting many users Change in intent of requirement Need for urgent revision of related QMS standards Decreased compatibility with ISO 14001 Inconsistency within the ISO 9000 family Need for recertification or significant transition period Need for extensive user education or trainingMedium Minor additional or reduced requirements for some users Possible impact on understanding by many users Need for limited changes of an organizations QMS documentation Need for eventual revision of other QMS standards No significant need for additional education or training for users Creates a minimal requirement for recertification or transition periodLow No increased or reduced requirement No change in intent of requirement No impact on most users No need for additional education or training for users April 2009 (c) Nigel H Croft 31
  32. 32. Benefits of changes to ISO9001Benefit CriteriaCategoryHigh Addresses a widely expressed specific user need by improving clarity and eliminating confusion Corrects an error in the existing standard Eliminates inconsistencies within ISO 9001 Eliminates inconsistencies within the ISO 9000 family Eliminates major problems of translationMedium Improves clarity in regard to a widely expressed user need but may not eliminate confusion and/or translation difficulty Improves clarity in response to needs identified by some users Increases compatibility with ISO 14001 Demonstrates willingness to respond to the wish to see improvement in compatibility between ISO 9001 and ISO 14001 even though alignment is not a priority for this amendment Reduces problems of translationLow Improves clarity only in response to low number of requests for improvement Marginal improvement in clarity where benefit may be offset by risk of unintended consequences, e.g. with respect to translation, interpretation Changes not addressing a clear user needApril 2009 (c) Nigel H Croft 32
  33. 33. Impact analysis Impact Benefits 1 2 3 High Medium Low 1 Low 1 2 3 2 Medium 2 4 6 3 High *3 6 9 1-2 Incorporate the change. 3-4 Additional analysis should be conducted prior to making the decision. 6-9 Do not incorporate the change. - - No change allowed, but we need to record details of proposed change, to provide input into future revisions .April 2009 (c) Nigel H Croft 33
  34. 34. Main changes in ISO 9001:2008 - Changes to the wording of some clauses - Organizations need to revisit their QMS to check if better understanding leads to a need for change. The changes are small, but they provide BIG OPPORTUNITIES for organizations to take a step back & look at the overall effectiveness of their QMSApril 2009 (c) Nigel H Croft 34
  35. 35. WRONG!April 2009 (c) Nigel H Croft 35
  36. 36. SMALL CHANGE, BIGOPPORTUNITY #1 (Clause 0.1) Clause 0.1 confirms that the intent of the standard is not to impose uniformity of documentation Consider your documentation: Are you in the driving seat, or are you a slave to your documentation? Did it make sense to structure your quality documentation in the way that you have? Does it really help you to manage your processes more effectively? Do the people in your organization understand it? Is it user-friendly? Is it consistent with other documentation in your company? Is there any value to making a change now? Why not take this opportunity to streamline your documentation, and eliminate those documents that are not adding value?April 2009 (c) Nigel H Croft 36
  37. 37. SMALL CHANGE, BIGOPPORTUNITY #2 (Clause 0.1) Clause 0.1 now refers to the organizational environment, changes in that environment and associated risks. BIG OPPORTUNITY - check to ensure that your QMS continues to be relevant to the changing business environment in which you are operating. As you grow, your situation may change new technologies, market opportunities, consumer demands, threats etc. Is the level of detail of your QMS and associated processes still appropriate to the risks involved in your activities? In the current financial climate, you should be looking to your QMS to guide you through troubled times Ensure that despite cutbacks etc, your product or service quality (and with them your reputation) does not suffer.April 2009 (c) Nigel H Croft 37
  38. 38. SMALL CHANGE, BIGOPPORTUNITY #3 (Clause 0.1) ISO 9001:2008 clarifies that only statutory and regulatory requirements applicable to the product must be addressed (not, for example, those related to environmental, social, financial or other topics). You might find it beneficial to use your QMS to ensure regulatory compliance in these other areas, but ISO 9001 does not require it. Of course, all statutory and regulatory requirements are important, and a prudent organization will ensure they are meeting all of these. BIG OPPORTUNITY - determine which statutory and regulatory requirements should and could be addressed within your quality management system, and whether they are being managed to maximum benefit. Why not make use of the structure and discipline of your QMS to allow you to monitor your conformity to other statutory and regulatory requirements?April 2009 (c) Nigel H Croft 38
  39. 39. SMALL CHANGE, BIGOPPORTUNITY #4 (Clause 0.2) Text added to clause 0.2 to emphasize the importance of processes being capable of achieving desired outcomes. Probably one of the most subtle but important changes introduced in the new standard. Emphasizes that the QMS should be achieving its primary objective - Did we all forget this?? Too much focus on documents and records, rather than on managing processes to achieve desired results. Take a long, hard look is your system really producing the desired outcomes for you, your customers, and your employees? If not, then why not? What needs to be changed?April 2009 (c) Nigel H Croft 39
  40. 40. SMALL CHANGE, BIGOPPORTUNITY #5 (Clause 0.3) Reflect on the changes you may need to introduce as a result of the new ISO 9001:2008 standard, and think about using ISO 9004 BIG OPPORTUNITY is to read through ISO 9004 and get a sense of how it might apply to your business Make a self-assessment - identify your own strengths and weaknesses and opportunities for improvement.April 2009 (c) Nigel H Croft 40
  41. 41. SMALL CHANGE, BIGOPPORTUNITY #6 (Clause 0.3) ISO 9001:2008 mentions that ISO 9004 is currently being revised Once the new ISO 9004 standard is published, your BIG OPPORTUNITY will be to use its guidance to determine whether your QMS is structured in a way that will contribute to your sustained, long-term success.April 2009 (c) Nigel H Croft 41
  42. 42. SMALL CHANGE, BIGOPPORTUNITY #7 (Clause 0.4) Some small editorial changes have been introduced for better alignment with ISO 14001:2004 No impact on the requirements of ISO 9001, but intent is to facilitate understanding for organizations that have chosen to develop an integrated management system For organizations that presently maintain separate systems, your BIG OPPORTUNITY is to determine whether it makes sense from a resource standpoint to consider moving toward an integrated approach.April 2009 (c) Nigel H Croft 42
  43. 43. SMALL CHANGE, BIGOPPORTUNITY #8 (Clause 1.1) Re-emphasizes that the aim of the QMS should be to provide confidence in the As you go through your QMS to check for changes that might be needed, the BIG OPPORTUNITY is always to keep in mind the objectives mentioned in Clause 1.1 as you do this. Is your system helping you to achieve these objectives?April 2009 (c) Nigel H Croft 43
  44. 44. SMALL CHANGE, BIGOPPORTUNITY #9 (Clause 1.1) Throughout ISO 9001:2008, the text has been modified (for consistency) to address statutory and regulatory requirements. regulatory requirements may sometimes be expressed as legal requirements. erminology used in ISO 9001 and (see www.iso.org) provides good dictionary definitions for these terms. BIG OPPORTUNITY is to make sure that you understand what is might affect your product and your liabilities in the markets you service. How do you identify these requirements and any changes to them? Are you currently addressing and meeting them? Have you considered the risks involved to your image and reputation if you do not?April 2009 (c) Nigel H Croft 44
  45. 45. SMALL CHANGE, BIGOPPORTUNITY #10 (Clause 1.1) 9001:2008 it refers to any intended output resulting from the product realization processes. It is not limited to final product. Emphasizes that requirements related to the product are applicable throughout the whole product realization process, from purchasing through final delivery (including post-delivery activities). BIG OPPORTUNITY is for you to ensure that your system address the requirements of purchased product and intermediate product as well as final product being delivered to your customer. This will help eliminate non-conforming product at an earlier stage, and reduce your overall costs of qualityApril 2009 (c) Nigel H Croft 45
  46. 46. SMALL CHANGE, BIGOPPORTUNITY #11 (Clause 1.2) When reviewing the requirements of ISO 9001:2008, think about the scope of When you first implemented your QMS, did it include all the products and services you provide, or only a small part of these? BIG OPPORTUNITY is to look at the advantages of extending your system to include other parts of your business that could benefit from better organization and discipline, even though certification might not be needed.April 2009 (c) Nigel H Croft 46
  47. 47. SMALL CHANGE, BIGOPPORTUNITY #12 (Clause 1.2) Think about the application of the ISO 9001:2008 requirements in your organization As you review your QMS in the light of ISO 9001:2008, there is a BIG OPPORTUNITY to check and make sure it is properly applied throughout your organization. Have you excluded any ISO 9001 requirements that maybe you Have a long, hard look at the concept of product design and Can you really justify excluding all the requirements of clause 7.3, or What is the impact on your ability to provide confidence in your products and services?April 2009 (c) Nigel H Croft 47
  48. 48. SMALL CHANGE, BIGOPPORTUNITY #13 (Clause 2) ISO 9001:2008 now refers to the ISO 9000:2005 version understand? The BIG OPPORTUNITY is for you to consult the principles and terminology given in ISO 9000:2005 and the many guidance documents produced by ISO/TC176 then either you have misunderstood the requirement or you are probably doing it wrong!April 2009 (c) Nigel H Croft 48
  49. 49. SMALL CHANGE, BIGOPPORTUNITY #14 (Clause 3) As you review the changes in ISO 9001:2008, think about the various components of the product you provide Are you applying your system to all of your intended products? Many organizations only think about the tangible products they provide (particularly when it comes to design and development) and forget about the service component of their product. The BIG OPPORTUNITY is to consider very carefully whether you have included all the different product categories (hardware, software, service and processed materials) that apply to your organization, and theirApril 2009 (c) Nigel H Croft 49
  50. 50. SMALL CHANGE, BIGOPPORTUNITY #15 (Clause 4.1) Note 1 to Clause 4.1 clarifies that the processes needed for the QMS include not only processes for management activities, provision of resources and product realization, but also those needed for measurement, analysis and improvement. The BIG OPPORTUNITY is for you to check and make sure you are managing your measurement, analysis and improvement processes in terms of this clause 4.1. Have you identified the intended outputs? Have you allocated adequate resources? Are you monitoring these processes to ensure they are effective?April 2009 (c) Nigel H Croft 50
  51. 51. SMALL CHANGE, BIGOPPORTUNITY #16 (Clause 4.1) Clause 4.1 (e) now clarifies that process measurement may not be applicable in all cases (though all processes must be monitored). Do you know the difference between monitoring and measuring? In some cases, you may have been induced by consultants and/or auditors to come up with process measurements that are not practical, meaningful or useful, simply because ISO 9001 was understood to require them. Your BIG OPPORTUNITY through ISO 9001:2008 is to re-evaluate the need for such measurements, and to ensure that any measurements that are necessary really do add value to your organizationApril 2009 (c) Nigel H Croft 51
  52. 52. SMALL CHANGE, BIGOPPORTUNITY #17 (Clause 4.1) Notes have been added to explain more about outsourcing what is meant by The BIG OPPORTUNITY is for you to review the way you manage your outsourced processes. Are they being carried out in line with the requirements of ISO 9001:2008? Can you introduce greater efficiencies by considering alternate sourcing or imposing more meaningful monitoring initiatives? Are there any indications of customer dissatisfaction with these processes? Could you benefit from outsourcing other processes? Might it be appropriate to bring some outsourced processes back in-house?April 2009 (c) Nigel H Croft 52
  53. 53. SMALL CHANGE, BIGOPPORTUNITY #18 (Clause 4.2.1) ISO 9001:2008 now clarifies that a single document may address the requirements for one or more procedures. Equally, an ISO 9001 requirement for a documented procedure may be covered by more than one document You may choose, for example, to address corrective and preventive action in a single procedure (provided that the procedure covers all the requirements of clauses 8.5.2 and 8.5.3). For some processes like internal audit, it might be convenient to develop two or three separate procedures (e.g. planning, execution and reporting) that cover all the requirements of clause 8.2.2. BIG OPPORTUNITY is to re-evaluate all your documentation. Is it used? Is it useful? - Can it be pruned down to be more readable? Maybe use some figures, drawings or photographs to substitute words?April 2009 (c) Nigel H Croft 53
  54. 54. SMALL CHANGE, BIGOPPORTUNITY #19 (Clause 4.2.1) Clause 4.2.1 (c) and (d) mention that records are a type of documentation that are required for the quality management system. Although this change should have no impact, here is another BIG OPPORTUNITY. Have you considered developing check-lists to control your processes instead of heavy procedures - when complete, the check-list can be used as a record? You might want to try to eliminate duplicate information on different records (time-consuming, costly, and may introduce inconsistencies).April 2009 (c) Nigel H Croft 54
  55. 55. SMALL CHANGE, BIGOPPORTUNITY #20 (Clause 4.2.3) Explains that the only external documents that need to be identified and have controlled distribution are those that are deemed necessary by the organization for the planning and operation of the QMS. Does not apply to all external documents that might be used by your organization. BIG OPPORTUNITY is to allow you more flexibility in the way you control documents of external origin, based on their impact on your QMS. You might also want to consider bringing (or leaving) all externally-generated documents under your document control process, if you find this to be beneficial.April 2009 (c) Nigel H Croft 55
  56. 56. SMALL CHANGE, BIGOPPORTUNITY #21 (Clause 4.2.4) The sequence of this clause has been changed for greater clarity and better alignment with ISO 14001. No real implications, but the BIG OPPORTUNITY would be for you to look at how you might achieve better integration of the records generated by your quality, environmental and other management systems in order to achieve greater efficiency.April 2009 (c) Nigel H Croft 56
  57. 57. SMALL CHANGE, BIGOPPORTUNITY #22 (Clause 5.5.2) The new version of the standard clarifies that the management representative If you are currently using a part-time consultant as your management representative the BIG OPPORTUNITY yourselves and integrate the QMS into your day-to-day work routine. The consultant can still have an important role in helping your MR to carry out his/her functions, but the subtle and obliges you to take charge of your own destiny.April 2009 (c) Nigel H Croft 57
  58. 58. SMALL CHANGE, BIGOPPORTUNITY #23 (Clause 6.2) ISO 9001:2008 makes an important clarification that competence requirements relate not only to personnel whose work directly affects product quality, but also where it indirectly affects product quality via the operation of the QMS (e.g. purchasing, supplier evaluations, internal audits etc). If you have previously limited your attention to competence requirements for personnel directly involved in production or service delivery processes, the BIG OPPORTUNITY is to assess where you may need to include other activities such as those mentioned above, among others. This might mean an extra work-load in the short-term, but it is likely to bring long-term benefits.April 2009 (c) Nigel H Croft 58
  59. 59. SMALL CHANGE, BIGOPPORTUNITY #24 (Clause 6.2) The change in sequence of the title of this clause to bring it in line with the equivalent clause of ISO 14001 may have gone un-noticed. Although the change is trivial, it does provide a BIG OPPORTUNITY for you to think about the ways in which you address the requirements of your quality and environmental management system (if you have one). Do you use a common, integrated approach? If not, then why not?April 2009 (c) Nigel H Croft 59
  60. 60. SMALL CHANGE, BIGOPPORTUNITY #25 (Clause 6.3) This clause now recognizes the importance of information technology (IT) in modern organizations and the effect that information systems can have on product conformity. Not a new requirement, but the specific inclusion of IT as an example of infrastructure provides you with a BIG OPPORTUNITY to review your dependence on IT Risk analysis of potential problems should a failure occur (system crash, computer virus, loss of confidential data, file corruption etc). No requirement to use IT in your QMS (many organizations can operate quite effectively without it), but where it is used, the risks must be understood and mitigation measures put in place as appropriate.April 2009 (c) Nigel H Croft 60
  61. 61. SMALL CHANGE, BIGOPPORTUNITY #26 (Clause 6.4) This does not change any requirement (the note is simply a partial repetition of the ISO 9000:2005 definition BIG OPPORTUNITY is for you to consider the implications of the work environment on your ability to provide conforming products Although not mentioned in the note, the ISO 9000:2005 definition also includes psychological and ergonomic factors that can be particularly relevant in a service provision situation. You should look at the ISO 9000:2005 definition, for a better understanding.April 2009 (c) Nigel H Croft 61
  62. 62. SMALL CHANGE, BIGOPPORTUNITY #27 (Clause 7.1) ISO 9001:2008 now strengthens the requirement for product realization planning to include measurement (as appropriate). BIG OPPORTUNITY during product realization planning is to think about and define what measurements you need to make in order to ensure control over your processes and conformity of the resulting product. All processes have to be monitored, but it is not always feasible, meaningful or cost-effective to establish measurements for everything. Think about the reasons measurements might be needed (eg for evidence of conformity to requirements, or to provide process control data for subsequent action) and the potential consequences of not making measurements for every process.April 2009 (c) Nigel H Croft 62
  63. 63. SMALL CHANGE, BIGOPPORTUNITY #28 (Clause 7.2.1) The standard now clarifies that post-delivery activities may include actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal. BIG OPPORTUNITY is to think about the whole range of characteristics of your product that can affect customer satisfaction. As global environmental awareness increases, considerations such as unnecessary packaging or end-of-life product disposal (particularly for electronic and electrical items) become a concern Take a positive and proactive approach to these issues, and you will not only be meeting the intent of ISO 9001:2008 you may be able to use them as a strategic marketing tool to gain an advantage over your competitors.April 2009 (c) Nigel H Croft 63
  64. 64. SMALL CHANGE, BIGOPPORTUNITY #29 (Clause 7.3.1) A note has been added to explain that design and development review, verification and validation have distinct purposes. As such, they may be conducted and recorded separately or in any combination as suitable for the product and the organization. BIG OPPORTUNITY is the greater flexibility in the way you address design review, verification and validation. If you have large, complex design and development projects for high-risk equipment or services, you are likely to need formal and distinct processes for these activities, which might be carried out in various phases over a range of time. For simple design and development process and low-risk projects, it might be acceptable to carry out all activities at the same time.April 2009 (c) Nigel H Croft 64
  65. 65. SMALL CHANGE, BIGOPPORTUNITY #30 (Clause 7.3.3) In addition to minor editorial changes in the body of Clause 7.3.3, a new note has been added to explain that design and development outputs can also include details for the preservation of product. BIG OPPORTUNITY do the design outputs provide sufficient confidence that your product will not be damaged prior to delivery to its intended point of use? Should you be addressing product packaging or handling information as an important output of your design and development process?April 2009 (c) Nigel H Croft 65
  66. 66. SMALL CHANGE, BIGOPPORTUNITY #31 (Clause 7.5.3) The wording of this clause has been changed to clarify that identification may be needed throughout the product realization process not only for the final product BIG OPPORTUNITY is to think about the ways in which you identify your products (and services) during the product realization process. Are there benefits to be obtained by improving identification? You might want to consider making temporary changes during periods where non-conformities are occurring with a greater frequency (to facilitate identification of nonconforming product, or for enhanced problem-solving).April 2009 (c) Nigel H Croft 66
  67. 67. SMALL CHANGE, BIGOPPORTUNITY #32 (Clause 7.5.4) The note to this clause now explains that both intellectual property and personal data should be considered customer property There is a BIG OPPORTUNITY here, particularly if you are working in the service sector. Your customers are no doubt worried about fraud and identity theft, so if you can demonstrate that you are controlling this in an effective way, that should give you a competitive advantage. Such data might include credit card information (internet purchases), address or passport details (hotel check-in) or confidential medical information (health service).April 2009 (c) Nigel H Croft 67
  68. 68. SMALL CHANGE, BIGOPPORTUNITY #33 (Clause 7.6) has been added regarding the use of computer software. The note describes verification and configuration management as typical methods of satisfying the intended application and maintaining suitability for use. The editorial changes should have no impact. BIG OPPORTUNITY is to consider the extent to which computer software is used in the course of your monitoring and measuring activities. Do you know the impact of this software on the accuracy of your results? Are you confident that the software is up-to-date and suitably protected against virus, memory loss, system crashes etc? If not, then you might well be vulnerable!April 2009 (c) Nigel H Croft 68
  69. 69. SMALL CHANGE, BIGOPPORTUNITY #34 (Clause 8.2.1) A note has been added to explain that monitoring of customer perception can include input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, warranty claims and dealer reports. No new requirement, but you have a BIG OPPORTUNITY to review the way in which you go about obtaining this information. Are you obtaining valid, actionable information that will help give you the meet the requirements of ISO 9001? You might find it useful to consult the guidance given in ISO/TS 10004 Monitoring and measuring customer satisfaction. refer exclusively to the contractual customer. It may include both internal and external customers as well as consumers, clients, end users, retailers, beneficiaries and purchasers.April 2009 (c) Nigel H Croft 69
  70. 70. SMALL CHANGE, BIGOPPORTUNITY #35 (Clause 8.2.2) This clause now expects management responsible for the area being audited to ensure that both correction and corrective actions are addressed as appropriate with respect to detected nonconformities. The BIG OPPORTUNITY is that you can now consider the need for correction of detected nonconformities and recognize that it might not be necessary or appropriate to take corrective action for all nonconformities found during internal audits. After a root cause analysis of the situation and based on a number of factors, including the risk and probability of a recurrence correct the problem, without the need for corrective action.April 2009 (c) Nigel H Croft 70
  71. 71. SMALL CHANGE, BIGOPPORTUNITY #36 (Clause 8.2.3) A note has been added here to clarify that when deciding on appropriate monitoring and/or measurement methods, you should consider both the impact on product conformity and on the effectiveness of your quality management system. When QMS processes do not achieve planned results, you must now evaluate the need to make corrections and/or take corrective action, regardless of the direct impact on product conformity. BIG OPPORTUNITY is for you to emphasize to all in your organization that it is not only product realization processes that are important. If system processes such as document control, management review, internal audits and others are not achieving planned results, corrections and/or corrective actions will also be needed.April 2009 (c) Nigel H Croft 71
  72. 72. SMALL CHANGE, BIGOPPORTUNITY #37 (Clause 8.5.2) The standard now makes it clear that it is the effectiveness of the corrective action that must be reviewed, not just the corrective action itself. This provides a BIG OPPORTUNITY for you to look carefully at the corrective actions you have initiated, and to make sure they are achieving the intended results. If the corrective actions are to address specific nonconformities (in product, process or the quality management system), have they successfully eliminated (or significantly reduced) the problem?April 2009 (c) Nigel H Croft 72
  73. 73. SMALL CHANGE, BIGOPPORTUNITY #38 (Clause 8.5.3) The standard now makes it clear that it is the effectiveness of the preventive action that must be reviewed, not just the preventive action itself. This provides you with a BIG OPPORTUNITY to look carefully at the preventive actions you have initiated, and to make sure they are achieving the intended results. If the preventive actions are to address unfavourable trends or specific potential nonconformities (in product, process or the QMS), have they successfully prevented the nonconformity from occurring? Were they successful in terms of cost/benefit?April 2009 (c) Nigel H Croft 73
  74. 74. ISO 9001:2008 ImplementationPolicy(Joint communiqué published by ISO and IAF) November 15th 2008 Publication of ISO 9001:2008 Before publication of ISO 9001:2008 no accredited certificates to new standard were allowed New certificates only after a routine surveillance or recertification audit against ISO 9001:2008.April 2009 (c) Nigel H Croft 74
  75. 75. ISO 9001:2008 ImplementationPolicy (continued) Up to Nov 15th 2009 certification / renewal to ISO 9001:2000 still permitted Beginning Nov 15th 2009, no new certificates to ISO 9001:2000 allowed all audits to be conducted to ISO 9001:2008 From Nov 15th 2010 ISO 9001:2000 certificates will no longer be validApril 2009 (c) Nigel H Croft 75
  76. 76. Implications No additional audits should be required Auditors need to be aware of changes Use ISO 9001:2008 Annex B Organizations should take advantage of the changes to re-assess the value of their QMS and make the most of this BIG OPPORTUNITYApril 2009 (c) Nigel H Croft 76
  77. 77. Summary The details of the quality management OUTPUT MATTERS! 9001 Clauses 4.1 8.5.3!!April 2009 (c) Nigel H Croft 77
  78. 78. THANK YOU nigelhcroft@sapo.ptApril 2009 (c) Nigel H Croft 78

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