- 1. ISO 9001 : 2015 ISO 14001: 2015 Revision Changes Sustainable Certification Pty Ltd ISO 9001 & 14001 : 2015 Changes Presentation 1
- 2. Welcome Recent Changes to the Standards ü Summary review of the changes to 9001 & 14001 ü Auditors requirements for transition ü Client transition process and requirements Sustainable Certification Pty Ltd ISO 9001 & 14001 : 2015 Changes Presentation 2
- 3. Part 1: Changes to the Standards Quality: ISO 9001:2008 to ISO 9001:2015 (released September 2015) Environment : ISO 14001:2004 to ISO 14001:2015 (released September 2015 Coming soon (Late 2016) Safety: OHSAS 18001:2007 to ISO 45001:2016 Sustainable Certification Pty Ltd ISO 9001 & 14001 : 2015 Changes Presentation 3
- 4. High Level Structure Annex SL.9 High level structure, identical core text and common terms and core definitions for use in Management Systems Standards from now on: 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 Sustainable Certification Pty Ltd ISO 9001 & 14001 : 2015 Changes Presentation 4
- 5. Context of the Organisation ü The MS has to be relevant to the organizations purpose and strategic direction (4.1) ü Need to determine issues that affect its ability to achieve intended results (4.1) o External context can include legal, technological, competitive, market, cultural, social, and economic, and can be, international, national , regional or local (4.1 note 1) o Internal context can included values, culture, knowledge and performance (4.1 note 2) Sustainable Certification Pty Ltd ISO 9001 & 14001 : 2015 Changes Presentation 5
- 6. Risk Based Thinking ü Risk-based thinking was implicit in previous standards it is now more explicit in 2015 ü ISO 31000 provides guidelines on formal risk management which may be appropriate – but it is not a requirement of these new standards. o Risk for some customers is a minor inconvenience o Risk for others can be far reaching and fatal ü Risk is not always negative – it also includes opportunities ü Options to address risks and opportunities can include: o Avoiding risk o Taking risk in order to pursue an opportunity o Eliminating the risk source o Changing the likelihood or consequences o Sharing the risk o Retaining the risk by informed decision Sustainable Certification Pty Ltd ISO 9001 & 14001 : 2015 Changes Presentation 6
- 7. No more documented procedures…..sort of ü No need for a Quality Manual ü Documented procedures not mandated – remember the 6 from ISO 9001:2008 ü Records not as clearly specified – no more as in ISO 9001:2008 However you now need… ü “Documented information” determined by the organization as being necessary for the effectiveness of the management system (and this includes any records) Now needs to ensure appropriate…. o identification and description – (e.g. a title, date, author, reference number) o format (e.g. language, software version, graphics) and media (e.g. paper, electronic) Sustainable Certification Pty Ltd ISO 9001 & 14001 : 2015 Changes Presentation 7
- 8. 4.Context of the Organisation ü The system has to be relevant to the organization’s purpose and strategic direction ü Need to determine issues that affect its ability to achieve intended results o External context can include legal, technological, competitive, market, cultural, social, and economic; it can also be international, national, regional, or local o Internal context can include values, culture, knowledge, and performance ü This is standard business planning o Tools such as SWOT analysis and Porter’s five forces can help with this Sustainable Certification Pty Ltd ISO 9001 & 14001 : 2015 Changes Presentation 8
- 9. 4. Context of the Organisation - what to look for ü How has the internal and external context been determined? ü Does the context consider legal and non-regulatory requirements, including community expectations? ü What are the needs and expectations of interested parties? ü What is the scope of the system? Have any requirements been excluded? ü What is the interaction of the organisation’s business practices/ processes? Sustainable Certification Pty Ltd ISO 9001 & 14001 : 2015 Changes Presentation 9
- 10. 5. Leadership ü How does your organization demonstrate its leadership? o Integration of discipline-specific requirements into organizational structure ü Policy o Documented information, available to interested parties o Framework for setting objectives ü Roles, responsibilities, and authorities o Assigned and communicated Sustainable Certification Pty Ltd ISO 9001 & 14001 : 2015 Changes Presentation 10
- 11. 5. Leadership: What your auditor will be looking for ü How have top management demonstrated their commitment to the system? ü Is the policy reflective of the organization’s operations and direction? ü Does the policy contain the necessary discipline-specific requirements? ü When was the policy last reviewed? ü Do staff understand their own roles and responsibilities? Sustainable Certification Pty Ltd ISO 9001 & 14001 : 2015 Changes Presentation 11
- 12. 6. Planning ü Actions to address risks and opportunities o Actions taken to be proportionate to the potential impact o Integrated into the organization’s business processes ü Objectives and planning to achieve them o At relevant functions and levels; to achieve continual improvement ü Risk – the effect of uncertainty on objectives ü Requirements for the establishment, implementation, maintenance, and continual improvement of the system ü Framework can be taken from ISO 31000 Risk management principles and guidelines ü Not all processes will present the same level of risk within a system; the system should prioritise high risk processes above low risk processes Sustainable Certification Pty Ltd ISO 9001 & 14001 : 2015 Changes Presentation 12
- 13. 6. Planning: What your auditor will be looking for ü Have high risk activities and processes been considered in the planning of the system? ü Has the full life cycle of activities, processes, and products been considered? ü How have significant environmental aspects been determined? Does the method used deliver consistent results? ü How do compliance obligations apply to business processes? ü What are the responsibilities, means, and timeframes for achieving objectives? ü Are there processes in place to plan and manage change at various functions and levels? Sustainable Certification Pty Ltd ISO 9001 & 14001 : 2015 Changes Presentation 13
- 14. 7. Support ü Resources o Including people, infrastructure, work environment, knowledge; o Consider the capabilities and constraints of internal resources and what’s needed from external providers ü Competence o What level of competence is required? ü Awareness o Policy; objectives; their contribution; implication of not conforming with requirements; benefits of improved performance ü Communication o Internal and external ü Documented Information o In a suitable medium; creation, updating, and control o Can differ from one organization to another due to: § Size and type of the organization § Complexity of operations § Competence of personnel Sustainable Certification Pty Ltd ISO 9001 & 14001 : 2015 Changes Presentation 14
- 15. 7. Support: What your auditor will be looking for ü Are the resources adequate? ü What are the necessary competence requirements for personnel? ü Are employees aware of their own responsibilities? ü Have effective communication strategies been implemented to ensure the exchange of relevant information in a timely manner? ü Has control been lost due to a lack of documentation? ü What has been decided to communicate about externally? How will it be communicated? Sustainable Certification Pty Ltd ISO 9001 & 14001 : 2015 Changes Presentation 15
- 16. 8. Operation ü Discipline specific: o Quality – Are you customers happy? o Environmental – Are you controlling your significant environmental aspects? o Occupational health and safety – Are you keeping people safe, now and into the future? ü Control of outsourced processes, including procurement Sustainable Certification Pty Ltd ISO 9001 & 14001 : 2015 Changes Presentation 16
- 17. 8. Operation: What your auditor will be looking for ü What are the requirements for products and services? What happens when these requirements change? ü Is the hierarchy of control considered when controlling significant environmental aspects? ü Are controls of high risk aspects, activities, and processes prioritised? ü Are external providers controlled according to their level of risk? ü What processes are in place to control production and provision? ü Who is authorized to release products and services? Is the authority traceable? ü What is a nonconforming product? How about a nonconforming service? Sustainable Certification Pty Ltd ISO 9001 & 14001 : 2015 Changes Presentation 17
- 18. 9. Performance Evaluation ü Monitoring, measurement, analysis, and evaluation o What do you need to monitor; how are you performing; how will you monitor your performance; are you improving; how do you know? ü Internal audit o Do you conform to your system’s requirements? o Does you system conform to your business processes? ü Management review o Top management to review the system and its performance at planned intervals Sustainable Certification Pty Ltd ISO 9001 & 14001 : 2015 Changes Presentation 18
- 19. 9. Performance Evaluation: What your auditor will be looking for ü What documented information is necessary to demonstrate monitoring and measurement? ü What do various interested parties (including customers) think about the organization’s performance? ü What is done with the information that is collected? ü Has the organization developed a risk-based audit programme? How often does it review the effectiveness of the programme? ü Have management reviews resulted in improvements to the system, including opportunities for enhanced customer satisfaction? Sustainable Certification Pty Ltd ISO 9001 & 14001 : 2015 Changes Presentation 19
- 20. 10. Improvement ü Non Conformity o What is a non conformity ? o What will you do to stop the issue from happening again? ü Continual improvement o Including identification of under performance and opportunities Sustainable Certification Pty Ltd ISO 9001 & 14001 : 2015 Changes Presentation 20
- 21. 10. Improvement: What your auditor will be looking for ü What is a non conformity? ü What are the details of previous non conformity ? ü Has the organization undertaken effective corrective actions that have prevented the recurrence of the non conformity? ü Has the organization transferred knowledge gained from corrective actions across departments and projects? Sustainable Certification Pty Ltd ISO 9001 & 14001 : 2015 Changes Presentation 21
- 22. Requirements to transition ü Identify organizational gaps which need to be addressed ü Develop an implementation plan ü Provide appropriate training to applicable personnel ü Update the MS to meet revised requirements Sustainable Certification Pty Ltd ISO 9001 & 14001 : 2015 Changes Presentation 22
- 23. SC Audit Approach ü Next audit ensure a transition plan is developed & in place ü Summary will be included in audit report on the progress towards the transition. ü When your organisation confirms readiness to transition to 2015 standard a Triennial/Re- Certification must be conducted. ü ISO 9001: 2008 and ISO 14001: 2004 Certification & Triennial audits conducted from this point will have a certificate expiry of 31st of August 2018 ü All clients expected to be transitioned by this date 31st of August 2018 ü Between now and 31st August 2017 observations only will be made against the gaps to the revised standards. ü From 31st of August 2017 any identified gaps will be raised as minor NC’s to ensure adequate time to address and comply with 2015 requirements. ü SC will be ready to take applications to the 2015 standards from 1st of December 2015 Sustainable Certification Pty Ltd ISO 9001 & 14001 : 2015 Changes Presentation 23
- 24. ISO 9001:2015 & ISO 9001: 2008 Comparison Table Sustainable Certification Pty Ltd ISO 9001 & 14001 : 2015 Changes Presentation 24
- 25. ISO 9001:2015 & ISO 9001: 2008 Comparison Table Cont.. Sustainable Certification Pty Ltd ISO 9001 & 14001 : 2015 Changes Presentation 25
- 26. ISO 9001:2015 & ISO 9001: 2008 Comparison Table Cont…. Sustainable Certification Pty Ltd ISO 9001 & 14001 : 2015 Changes Presentation 26
- 27. Sustainable Certification Pty Ltd ISO 9001 & 14001 : 2015 Changes Presentation 27 ISO 14001:2015 & ISO 14001:2004 Comparison Table
- 28. Sustainable Certification Pty Ltd ISO 9001 & 14001 : 2015 Changes Presentation 28 ISO 14001: 2015 & ISO 14001: 2004 Comparison Table Cont…..
- 29. Documentation Requirements Sustainable Certification Pty Ltd ISO 9001 & 14001 : 2015 Changes Presentation 29
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