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Certification Body Approach to ISO 9001:2015 by NQA

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ISO 9001:2015 and ISO 14001:2015 are one year old this month! Here we discuss our experiences and lessons learnt during the first year of assessments to the 2015 standards.

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Certification Body Approach to ISO 9001:2015 by NQA

  1. 1. CERTIFICATION BODY APPROACH TO ISO 9001: 2015 DR MARGARET ROONEY 28 SEPTEMBER 2016
  2. 2. EXPERIENCE AND LESSONS LEARNT DURING THE FIRST YEAR OF ASSESSMENTS TO THE 2015 STANDARDS.
  3. 3. ISO 9001:2015 – EXPERIENCE ONE YEAR IN ISO 9001:2015 and ISO 14001:2015 are one year old this month!
  4. 4. ISO 9001:2015 – EXPERIENCE ONE YEAR IN The younger sibling, ISO 45001, is not expected until the end of 2017. What makes these standards siblings? Annex SL – the common thread for these and all future management system standards.
  5. 5. THE 2015 STANDARDS – ONE YEAR ON
  6. 6. ISO 9001:2015 – EXPERIENCE ONE YEAR IN The certification body approach: • 2015 is a huge learning process for us all • A step at a time… • Steady as she goes…
  7. 7. ISO 9001:2015 – EXPERIENCE ONE YEAR IN The certification body approach - internal: • Finalised our policy in the summer of 2015 • Developed our processes • Brief/train our assessors – we never stop improving • Continue to brief and train our assessors – we never stop improving • Feedback out experience to assessors
  8. 8. ISO 9001:2015 – EXPERIENCE ONE YEAR IN The certification body approach - external: • Finalised and communicated our policy • Communicated our process • Webinars • Web site • Audit booking process • Helpline and transition@nqa.com
  9. 9. ISO 9001:2015 – EXPERIENCE ONE YEAR IN The certification body approach: Range of briefing sessions for assessors and clients: • Annex SL • Specific changes to ISO9001:2015 • Specific changes to ISO14001:2015 • The importance of the gap analysis tool, TR006
  10. 10. ISO 9001:2015 – EXPERIENCE ONE YEAR IN The certification body approach to the 2015 standards: Key changes/enhancements: • Context • Leadership • Process approach • Risk based thinking
  11. 11. ANNEX SL
  12. 12. ANNEX SL ISO/IEC Directives, Part 1 Consolidated ISO Supplement - Procedures specific to ISO • Annex SL (normative) Proposals for management system standards • Appendix 2 (normative) High level structure, identical core text, common terms and core definitions
  13. 13. ANNEX SL PURPOSE Annex SL prescribes a high level structure with identical text headings • Its purpose is to ensure standards can be easily integrated across an organisations business • There are now many standards that organisations may wish to use or be certified to • Annex SL allows easy integration for organisations that wish to apply more than one standard within its business activities
  14. 14. ANNEX SL PURPOSE Annex SL prescribes a high level structure with identical text headings • It applies to all Management System Standards – full ISO standards, Technical Specifications (TS) and Publicly Available Specifications (PAS)
  15. 15. ANNEX SL HIGH LEVEL STRUCTURE 1. Scope 2. Normative References 3. Terms and Definitions 4. Context of the Organization 5. Leadership 6. Planning 7. Support 8. Operation 9. Performance Evaluation 10. Improvement
  16. 16. ANNEX SL HIGH LEVEL STRUCTURE The ten clause numbers and titles cannot be changed. However, for discipline specific text in ISO 9001, ISO 14001 or ISO 45001, you can have: • Additional sub clauses • New bullets • Discipline specific notes or examples • Additional enhancing text
  17. 17. CHANGES & OBSERVATIONS ONE YEAR IN
  18. 18. ISO 9001:2015 – THE BIG CHANGES • Context • Leadership • Risks and opportunities • Process approach
  19. 19. Summary Changes • Reduced emphasis on documentation • No explicit requirement for a management representative • No explicit reference to preventive action • Some new terminology Significant changes • Elevated focus on the process approach • Risk based thinking – including opportunities • Annex SL
  20. 20. ISO 9001:2015 – EXPERIENCE ONE YEAR IN A number of transition audits have taken place Stage 1 and stage 2 audits for new ISO 9001 clients are often based on the 2015 standard.
  21. 21. CONTEXT – CERTIFICATION BODY APPROACH
  22. 22. ISO 9001:2015 – EXPERIENCE ONE YEAR IN CONTEXT Combination of internal and external factors and conditions that can have an effect on an organization's approach to its products, services and investments and interested parties In April 2016, guidance was published in InTouch, to explain context and suggest possible ways of identifying context and the associated interested parties
  23. 23. ISO 9001:2015 – EXPERIENCE ONE YEAR IN A number of organisations have used PESTEL or SWOT tools to assist them brainstorm: • Internal and external issues • Risks and opportunities associated with those issues • Interested parties
  24. 24. ISO 9001:2015 - STRATEGIC CONTEXT • You will be expected to demonstrate a broader understanding of the context in which you operate. • QMS must be able to meet its intended outcome – • Understanding of the organisation’s direction, culture, resources and external influences
  25. 25. LEADERSHIP- CERTIFICATION BODY APPROACH
  26. 26. ISO 9001:2015 – EXPERIENCE ONE YEAR IN LEADERSHIP Auditors now meet with top management and discuss: • Strategic issues • High level risks, e.g. the risk register, if there is one • Longer term business plans and expectations • How the QMS should deliver these
  27. 27. ISO 9001:2015 – EXPERIENCE ONE YEAR IN LEADERSHIP • Strategic issues – high level documents and messages • High level risks, e.g. the risk register, if there is one • Longer term business plans and expectations – internal communications • How the QMS should deliver these
  28. 28. ISO 9001:2015 - STRATEGIC LEADERSHIP • Senior managers will need to promote & be accountable for the QMS. • QMS should be integrated with other business processes • Decisions are made with consideration for the QMS at all levels
  29. 29. INTERVIEWING TOP MANAGEMENT Risks to the business and how these are managed Business Legal Technological Social Economical Business Political Environmental
  30. 30. INTERVIEWING TOP MANAGEMENT What about……. • Values • Culture • Knowledge • Performance
  31. 31. INTERVIEWING TOP MANAGEMENT • Commitment to effective implementation • Internal communication processes • Performance review process • Understanding the customer requirements
  32. 32. INTERVIEWING TOP MANAGEMENT The assessor may be a customer and ask about things like; • Delivery • Returns • Rework • Complaints • Efficiency
  33. 33. RISK AND PROCESS- CERTIFICATION BODY APPROACH
  34. 34. RISK REFERENCES PREVADE ISO 9001:2015
  35. 35. RISK, CONTROL AND OBJECTIVES • ensure all equipment is correctly calibrated – • risk - workmanship • controlled by internal audit • ensure rule books, work instructions on site are at correct issue – • risk - workmanship and personal safety • Controlled by internal audit and site safety tours • all staff to be correctly trained and certified: no staff to be unavailable because of late certification • risk - workmanship, safety and business risk • controlled by daily monitoring of the database
  36. 36. RISK BASED THINKING - EXAMPLE John Smith demonstrated the cutting of 32 m of AMC-50FY. The cable was delivered as a 500 m drum. John and two other colleagues have received specialist training, in Holland, in the use of the cutting machine. A previous contractor damaged a significant amount of cable, so the company took the decision to have proper training to reduce damage risk. There has been no cable damage as a consequence.
  37. 37. ISO 9001:2015 – EXPERIENCE ONE YEAR IN THE PROCESS BASED APPROACH Auditors now discuss processes and process effectiveness • How do you know your process is effective? • What measures do you need to judge efficiency and effectiveness? • What are the potential weak points in your process, (risk), and how do you address these?
  38. 38. ISO 9001:2015 – EXPERIENCE ONE YEAR IN THE PROCESS BASED APPROACH • What are the challenges you face in delivering an effective solution? • What might go wrong and how does your approach, (or procedure) address this?
  39. 39. WHAT IS THE PROCESS APPROACH? – ISO 9001:2015 0.3 Process Approach When used within a quality management system, the process approach ensures: a) understanding and consistently meeting requirements b) consideration of processes in terms of added value c) the achievement of effective process performance d) improvement of processes based on evaluation of data and information e) consideration of risk
  40. 40. PROCESS AUDIT “TURTLE” TOOL Outputs Conforming product delivered to customer schedule (8.6) Inputs Customer schedule (8.2.1) Raw materials (8.4.1) How? Control plans (8.5.1) Work instructions (8.5.1) Preventive maintenance (7.1.3) SPC (9.1.3) Nonconforming product procedure (8.7) Dispatch process (8.6) Contingency plan (8.5.6/6.1) Document control/ records (7.5.3) Change control (8.5.6) What Results? Analysis of data (9.1.3) Customer satisfaction (9.1.2) Other Organisational objectives (6.2) Maintenance objectives (8.5) Cost of poor quality (9.1.3) Process capability (9.1) Management review (9.3) Continual improvement results (10.3) Audit records (9.2) With Who Induction/ training records (7.2) Agency/ Contract labour (7.3/8.4) Job responsibilities/ authorities (5.3) Training effectiveness (7.2) SPC awareness (7.2) Personnel safety (7.1.4) Awareness of policy/ objectives (5.2.2) With What? Plant and machinery (7.1.3) Measuring equipment (7.1.5) Tooling (7.1.3) Maintenance (7.1.3) Packaging/labelling (8.5.4) Cleanliness of premises (7.1.4) Customer property (8.5.3) Transportation (7.1.3) Process Manufacturing Process (8.5) (Support Processes) IT (7.1.3) Human resource (7.1.2) Logistics (7.1.3) Sales (7.4) Preventive maintenance (7.1.3) Identify risks (6.1)
  41. 41. PROCESS AUDIT “TURTLE” TOOL Outputs Conforming product delivered to customer schedule (8.6) Inputs Customer schedule (8.2.1) Raw materials (8.4.1) How? Control plans (8.5.1) Work instructions (8.5.1) Preventive maintenance (7.1.3) SPC (9.1.3) Nonconforming product procedure (8.7) Dispatch process (8.6) Contingency plan (8.5.6/6.1) Document control/ records (7.5.3) Change control (8.5.6) What Results? Analysis of data (9.1.3) Customer satisfaction (9.1.2) Other Organisational objectives (6.2) Maintenance objectives (8.5) Cost of poor quality (9.1.3) Process capability (9.1) Management review (9.3) Continual improvement results (10.3) Audit records (9.2) With Who Induction/ training records (7.2) Agency/ Contract labour (7.3/8.4) Job responsibilities/ authorities (5.3) Training effectiveness (7.2) SPC awareness (7.2) Personnel safety (7.1.4) Awareness of policy/ objectives (5.2.2) With What? Plant and machinery (7.1.3) Measuring equipment (7.1.5) Tooling (7.1.3) Maintenance (7.1.3) Packaging/labelling (8.5.4) Cleanliness of premises (7.1.4) Customer property (8.5.3) Transportation (7.1.3) Process Manufacturing Process (8.5) (Support Processes) IT (7.1.3) Human resource (7.1.2) Logistics (7.1.3) Sales (7.4) Preventive maintenance (7.1.3) Identify risks (6.1)
  42. 42. PROCESS AUDIT “TURTLE” TOOL Outputs Conforming product delivered to customer schedule (8.6) Inputs Customer schedule (8.2.1) Raw materials (8.4.1) How? Control plans (8.5.1) Work instructions (8.5.1) Preventive maintenance (7.1.3) SPC (9.1.3) Nonconforming product procedure (8.7) Dispatch process (8.6) Contingency plan (8.5.6/6.1) Document control/ records (7.5.3) Change control (8.5.6) What Results? Analysis of data (9.1.3) Customer satisfaction (9.1.2) Other Organisational objectives (6.2) Maintenance objectives (8.5) Cost of poor quality (9.1.3) Process capability (9.1) Management review (9.3) Continual improvement results (10.3) Audit records (9.2) With Who Induction/ training records (7.2) Agency/ Contract labour (7.3/8.4) Job responsibilities/ authorities (5.3) Training effectiveness (7.2) SPC awareness (7.2) Personnel safety (7.1.4) Awareness of policy/ objectives (5.2.2) With What? Plant and machinery (7.1.3) Measuring equipment (7.1.5) Tooling (7.1.3) Maintenance (7.1.3) Packaging/labelling (8.5.4) Cleanliness of premises (7.1.4) Customer property (8.5.3) Transportation (7.1.3) Process Manufacturing Process (8.5) (Support Processes) IT (7.1.3) Human resource (7.1.2) Logistics (7.1.3) Sales (7.4) Preventive maintenance (7.1.3) Identify risks (6.1)
  43. 43. PROCESS AUDIT “TURTLE” TOOL Outputs Conforming product delivered to customer schedule (8.6) Inputs Customer schedule (8.2.1) Raw materials (8.4.1) How? Control plans (8.5.1) Work instructions (8.5.1) Preventive maintenance (7.1.3) SPC (9.1.3) Nonconforming product procedure (8.7) Dispatch process (8.6) Contingency plan (8.5.6/6.1) Document control/ records (7.5.3) Change control (8.5.6) What Results? Analysis of data (9.1.3) Customer satisfaction (9.1.2) Other Organisational objectives (6.2) Maintenance objectives (8.5) Cost of poor quality (9.1.3) Process capability (9.1) Management review (9.3) Continual improvement results (10.3) Audit records (9.2) With Who Induction/ training records (7.2) Agency/ Contract labour (7.3/8.4) Job responsibilities/ authorities (5.3) Training effectiveness (7.2) SPC awareness (7.2) Personnel safety (7.1.4) Awareness of policy/ objectives (5.2.2) With What? Plant and machinery (7.1.3) Measuring equipment (7.1.5) Tooling (7.1.3) Maintenance (7.1.3) Packaging/labelling (8.5.4) Cleanliness of premises (7.1.4) Customer property (8.5.3) Transportation (7.1.3) Process Manufacturing Process (8.5) (Support Processes) IT (7.1.3) Human resource (7.1.2) Logistics (7.1.3) Sales (7.4) Preventive maintenance (7.1.3) Identify risks (6.1)
  44. 44. PROCESS AUDIT “TURTLE” TOOL Outputs Conforming product delivered to customer schedule (8.6) Inputs Customer schedule (8.2.1) Raw materials (8.4.1) How? Control plans (8.5.1) Work instructions (8.5.1) Preventive maintenance (7.1.3) SPC (9.1.3) Nonconforming product procedure (8.7) Dispatch process (8.6) Contingency plan (8.5.6/6.1) Document control/ records (7.5.3) Change control (8.5.6) What Results? Analysis of data (9.1.3) Customer satisfaction (9.1.2) Other Organisational objectives (6.2) Maintenance objectives (8.5) Cost of poor quality (9.1.3) Process capability (9.1) Management review (9.3) Continual improvement results (10.3) Audit records (9.2) With Who Induction/ training records (7.2) Agency/ Contract labour (7.3/8.4) Job responsibilities/ authorities (5.3) Training effectiveness (7.2) SPC awareness (7.2) Personnel safety (7.1.4) Awareness of policy/ objectives (5.2.2) With What? Plant and machinery (7.1.3) Measuring equipment (7.1.5) Tooling (7.1.3) Maintenance (7.1.3) Packaging/labelling (8.5.4) Cleanliness of premises (7.1.4) Customer property (8.5.3) Transportation (7.1.3) Process Manufacturing Process (8.5) (Support Processes) IT (7.1.3) Human resource (7.1.2) Logistics (7.1.3) Sales (7.4) Preventive maintenance (7.1.3) Identify risks (6.1)
  45. 45. PROCESS AUDIT “TURTLE” TOOL Outputs Conforming product delivered to customer schedule (8.6) Inputs Customer schedule (8.2.1) Raw materials (8.4.1) How? Control plans (8.5.1) Work instructions (8.5.1) Preventive maintenance (7.1.3) SPC (9.1.3) Nonconforming product procedure (8.7) Dispatch process (8.6) Contingency plan (8.5.6/6.1) Document control/ records (7.5.3) Change control (8.5.6) What Results? Analysis of data (9.1.3) Customer satisfaction (9.1.2) Other Organisational objectives (6.2) Maintenance objectives (8.5) Cost of poor quality (9.1.3) Process capability (9.1) Management review (9.3) Continual improvement results (10.3) Audit records (9.2) With Who Induction/ training records (7.2) Agency/ Contract labour (7.3/8.4) Job responsibilities/ authorities (5.3) Training effectiveness (7.2) SPC awareness (7.2) Personnel safety (7.1.4) Awareness of policy/ objectives (5.2.2) With What? Plant and machinery (7.1.3) Measuring equipment (7.1.5) Tooling (7.1.3) Maintenance (7.1.3) Packaging/labelling (8.5.4) Cleanliness of premises (7.1.4) Customer property (8.5.3) Transportation (7.1.3) Process Manufacturing Process (8.5) (Support Processes) IT (7.1.3) Human resource (7.1.2) Logistics (7.1.3) Sales (7.4) Preventive maintenance (7.1.3) Identify risks (6.1)
  46. 46. PROCESS Questioning a process • Who is the process owner • Who is the customer of the process and what are their expectations • What are the KPI’s / objectives / targets • Are these appropriate to the risks • Ask about the risks that were identified earlier • What are the measurements / performance indicators • What are the results • What are they doing to improve • What are the inputs • What are the required outputs • How do they know it is working well • Record inputs to various process categories • Is information correct and up to date • Effectiveness and Efficiency
  47. 47. ISO14001:2015 – ONE YEAR ON
  48. 48. ISO 14001:2015 - EXPERIENCE ONE YEAR IN • As with ISO 9001:2015 published on 15th September 2015 • Follows the Annex SL Model • Will continue to be used until 2025 and possibly beyond. • 5 Main Changes: • Strategic Leadership • Strategic Context • Interested Party Analysis and Communication • Risks and Opportunities • Lifecycle Perspective
  49. 49. ISO 14001:2015 - RISKS AND OPPORTUNITIES • There are three principle sources of risk and opportunity: • Environmental aspects • Compliance obligations • Other issues and requirements • Requirement to assess these sources for risks and opportunities that need to be addressed. • Maximise the opportunities & minimise/mitigate the risks • This will ensure the success of the EMS and benefit the organisation as a whole
  50. 50. ISO 14001:2015 - LIFECYCLE PERSPECTIVE • Determine environmental aspects at each stage of the lifecycle of product or service: • Acquisition of raw materials • Design • Production • Transportation/delivery • Use and end of life/disposal • Not just those relating to onsite activities • Information about potential significant environmental impacts can be provided
  51. 51. ISO 14001:2015 – OBJECTIVES EXAMPLE Activity Aspect Impact Interested parties Risk/opp - ortunity Control Objective Production of the final product Use of energy Global warming Employees Shareholders Customers Energy heavy Use of renewables. Invest in green energy Energy efficiency measures 5% carbon reduction per year Sourcing of raw materials Consumpti on of materials Resource depletion/ ground pollution Customers Pressure groups Modify design to use recycled materials Demonstrate CSR Increase sales Design control and verification measures. Monitor suppliers 50% increase in recycled content in 3 years 10% growth in sales in 3 years Use of the product Disposal of product Ground and water pollution Employees Shareholders Customers Pressure groups Take back for re- use/re-working. Sales promotion Programme to offer take back of product to re- use materials Increase sales and take back by 10% per year
  52. 52. LESSONS LEARNT
  53. 53. ISO 9001:2015 & ISO 14001:2015 – LESSONS LEARNT • So what have we learned in the last 12 months? • The most successful transitions have been undertaken by those companies with an advanced, mature EMS and QMS • Planning this change for some time – use of ‘FDIS’ • Dialogue with their assessor • Use of gap analysis tool • Although new standard allows for radical changes to style of documented system – most have adapted existing system • ‘Buy in’ and demonstrable leadership at a senior level (Managing Director or equivalent)
  54. 54. ISO 9001:2015 & ISO 14001:2015 - PITFALLS • So what are the pitfalls? • Assuming the new standard only requires a minor ‘tweak’ to the existing EMS / QMS • Failure to go ‘back to basics’ and properly understand the context of the organisation • Still thinking that the EMS is JUST about their own environmental impact and failure to look at how the environment affects them • Top management not being involved – “we pay you to do that!” • Not allowing sufficient time.
  55. 55. ISO 9001:2015 – EXPERIENCE ONE YEAR IN To ensure a smooth transition, clients must complete a transition gap analysis checklist • Ensures all changes have been considered and addressed • Ensures a smoother transition audit on the day • Fulfils internal audit requirements Many transition clients have benefitted from this
  56. 56. FORM TR006 – PART 2
  57. 57. ISO 9001:2015 – EXPERIENCE ONE YEAR IN
  58. 58. ISO 9001:2015 – TOP TAKE AWAYS • We are all still learning – Assessors too! • It may take several years for the full benefits of the Annex SL, context and risk to enable your QMS to fully integrate with and support the business. • Don’t delay with your implementation
  59. 59. ISO45001:2017(?) – STATUS OF THE YOUNGER SIBLING
  60. 60. ISO 45001 - DELAYED
  61. 61. NQA’S ADVICE STARTING FROM SCRATCH • Implement OHSAS 18001 as a stepping stone • Read the standard • Identify sources of legal compliance info • Review hazard and risk assessment • Gap analysis – to identify improvement points MIGRATING FROM OHSAS 18001 • Maintain OHSAS 18001 until FDIS of ISO 45001 • Read the standard (from ISO) • Gap analysis – to identify improvement points • Mapping exercise for management system migration NB: Be prepared, but remember, migration of certification is not possible until the ISO is published in 2017.
  62. 62. Thank you for listening Keep In Touch • www.nqa.com • 0800 052 2424 • nqaukwebinar@nqa.com • NQA Certification Ltd

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