1. GOV 2015 Slide 1 Topics of Interest for Accredited Laboratories ISO 9001 Changes that may Impact ISO 17025 Rita D’Angelo AFDO San Diego, March, 2015 D’Angelo Advantage Consulting

2. GOV 2015 Slide 2 Topics of Interest for Accredited Laboratories? Description of Course: At this session we will discuss proposed changes to ISO 9001 standard and illustrate how those changes may affect your organizational processes associated with ISO 17025 D'Angelo Advantage LLC

3. GOV 2015 Slide 3 Learning Objectives  History of Standardization  Understand the process of ISO 9001  Understand proposed changes within the new standard  Understand how the changes relate to ISO 17025 D'Angelo Advantage LLC

4. GOV 2015 Slide 4 Standardization How it all began D'Angelo Advantage Consulting LLC

5. GOV 2015 Slide 5 History of Standardization  Early Examples of standardization  King Henry I - In the earliest days of recorded measurement, the “Royal Egyptian Cubit” was decreed to be equal to the length of the forearm from the bent elbow to the tip of the extended middle finger - Ell  Calendar  Motion of the sun, moon and stars to determine the time to plant harvest  Modern times  Railroad- Common railroad gauge in the U.S. at the time which measured 4 feet, 8 ½ inches, a track size that originated in England and mandated for use in the Transcontinental Railroad in 1864 and by 1886 had become the U.S. standard  1904-fire hose couplings to ensure uniform fire safety equipment nationwide  Interchangeability of parts- screw which detected differences in length as small as one millionth of an inch  Mechanical and electrical interchangeability for electric lamps led to electric lines and equipment.  Metric System used worldwide (excluding the US) D'Angelo Advantage LLC http://www.ansi.org/consumer_affairs/history_standards.aspx?menuid=5

6. GOV 2015 Slide 6 ISO 9001: What is it? ISO – International Organization for Standardization Geneva, Switzerland  Based on ISO/IEC 17025 and ISO 9001  Worldwide Federation with 19, 500 standards in 163 countries 1946 ISO's first standard In 1951, the first ISO standard (called Recommendations at this time), ISO/R 1:1951 Standard reference temperature for industrial length measurements developed by A panel of experts, within a technical committee

7. GOV 2015 Slide 7 Benefits of ISO  Cost savings – Optimize operations- improve the bottom line  Enhanced customer satisfaction – Improve quality, enhance customer satisfaction and increase sales  Access to new markets – Prevent trade barriers and open up global markets  Increased market share – Increase productivity and competitive advantage  Environmental benefits – Reduce negative impacts on the environment (iso.org) D'Angelo Advantage LLC

8. GOV 2015 Slide 8 ISO Accreditation in the USA D'Angelo Advantage LLC

9. GOV 2015 Slide 9 ISO 9001 Revision- 6 step Process ISO 9001 is currently at the Final Draft International Stage (FDIS), the fifth stage of a six step process D'Angelo Advantage LLC Are the changes really needed? Working Group of experts prepare the working draft Draft from is shared with the members of the parent committee DIS is circulated to all ISO members who get 3 months to vote and comment The FDIS is is circulated to all ISO member for a two- month vote (if not previously approved) Final Document publication

10. GOV 2015 Slide 10 ISO 9001: DIS 2015 D'Angelo Advantage LLC

11. GOV 2015 Slide 11 1Scope 2Normative references 3Terms and definitions 4Context of the organization (Quality Management System) 4.1Understanding the organization and its context 4.2Understanding the needs and expectations of interested parties 4.3Determining the scope of QMS 4.4Quality management system and its processes 5Leadership (Management Responsibility) 5.1Leadership and commitment 5.2Quality policy 5.3Organizational roles, responsibilities and authorities 6Planning for the QMS (Resource Management) 6.1Actions to address risks and opportunities 6.2Qquality objectives and planning to achieve them 6.3Planning of changes Structure of ISO 9001:2015 http://asq.org/standards-iso-9001-2015.html 1/3 (Prior 2008 Revision)

12. GOV 2015 Slide 12 7 Support (Product Realization) 7.1Resources 7.2Competence 7.3Awareness 7.4Communication 7.5Documented information 8 Operation (Measurement, Analysis and Improvement) 8.1Operational planning and control 8.2Determination of requirements for products and services 8.3Design and development of products and services 8.4Control of externally provided products and services 8.5Production and service provision 8.6Release of products and services 8.7Control of non conforming process outputs, products and services Structure of ISO 9001:2015 http://asq.org/standards-iso-9001-2015.html 2/3

13. GOV 2015 Slide 13 9 Performance evaluation 9.1Monitoring, measurement, analysis and evaluation 9.2Internal audit 9.3Management review 10 Improvement 10.1 General 10.2 Non-conformity and corrective action 10.3 Continual improvement Structure of ISO 9001:2015 http://asq.org/standards-iso-9001-2015.html 3/3

14. GOV 2015 Slide 14 Context of the Organization Context: The interrelated conditions in which something exists or occurs The interrelated conditions within an organization http://www.merriam-webster.com/dictionary/context D'Angelo Advantage LLC

15. GOV 2015 Slide 15 Why the Change? ISO 9001 D'Angelo Advantage Consulting LLC

16. GOV 2015 Slide 16 ISO 9001 Revision Why change to ISO 9001 Standard?  Keep the standard current and relevant for the global marketplace  Supply chain integration  To respond to the latest trends and be compatible with other management systems such as ISO 14001  Ensure the new standard reflects the needs of all interested parties  Identify risks from the global economy  Final revision expected END of 2015 D'Angelo Advantage LLC

17. GOV 2015 Slide 17  Greater focus on the customer  Risk-based thinking  Aligning QMS policy and objectives with the strategy of an organization  Greater flexibility with documentation ASQ, 2015 Major Changes

18. GOV 2015 Slide 18 Changes D'Angelo Advantage Consulting LLC ISO 9001 17025

19. GOV 2015 Slide 19 Adopt a Risk Based Approach   ISO 9001:2015 specifically addresses risk   The word "risk" is being incorporated into the new version of ISO 9001   Methods for identifying, managing and mitigating risk   Incorporating risk by the followings:   Define the organization’s objectives   Specifying the risk categories   Identifying risks to the objectives   Developing methods for managing the risks © 2015 D’Angelo Advantage Consulting

20. GOV 2015 Slide 20 Risk in ISO 9001 at a Glance D'Angelo Advantage LLC  Clause 4: The organization is required to determine the risks which can affect its ability to meet objectives  Clause 5: Top management are required to commit to ensuring Clause 4 is followed  Clause 6: The organization is required to take action to identify risks and opportunities  Clause 8: The organization is required to implement processes to address risk  Clause 9: The organization is required to monitor, measure, analyze and evaluate the risks and opportunities  Clause 10: The organization is required to improve by responding to changes in risk

21. GOV 2015 Slide 21 D'Angelo Advantage LLC  The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect to achieve the intended result of its quality management system:  Issues from the followings:  Legal  Technological  Competitive  Market  Social and economic environments Do you know your business? 4. 1 Understanding the Organization and its Context

22. GOV 2015 Slide 22 Customer Focus © 2015 D’Angelo Advantage Consulting

23. GOV 2015 Slide 23 D'Angelo Advantage LLC  The organization shall determine:  The interested parties that are relevant to the QMS  The requirements of these interested parties that are relevant to the QMS 4. 2 Understanding the Needs and Expectations of Interested Parties Who are the interested parties and what are their requirements relevant to your Quality Management System?

24. GOV 2015 Slide 24 The Organization shall establish, implement, maintain and continually improve a QMS, including the processes needed and their interactions, in accordance with the requirements of this international standard  Inputs, outputs and resources  Sequence and interaction  Effective operation  Responsibilities and opportunities for improvement  Risks and the opportunities and actions needed to address them 4.4 Quality Management System and its Processes © 2015 D’Angelo Advantage Consulting What is the framework for change within your QMS?

25. GOV 2015 Slide 25 D'Angelo Advantage LLC 5.1 Leadership and Commitment  Top Management must demonstrate leadership and commitment with respect to the QMS by:  Ensuring the quality policy and objectives are are established for the QMS and are competitive with the strategic direction and context of the organization  Ensure the integration of the QMS into the organizations business practices 5.1 Leadership

26. GOV 2015 Slide 26 D'Angelo Advantage LLC Ensure integration if the QMS requirements into the organization business process  Ensure the resources needed for the QMS are available  Communicate the importance of the QMS  Ensure the QMS achieves the intended results  Engage, direct and support persons to contribute to the effectiveness of the QMS  Promote continuous improvement  Support management 5.1 Leadership Leadership is responsible to guide the organization and ensure intended outcomes

27. GOV 2015 Slide 27 D'Angelo Advantage LLC  5.2.1 “Top management” shall establish, review an maintain a quality policy that:  Is appropriate to the purpose and context of the organization  Provides a framework for setting and reviewing quality objectives  Communicated to staff  Includes a commitment to satisfy applicable requirements  Commitment to continuous improvement  MORE Detail 5.2 Quality Policy 17025 What does your organizational framework look like? How does it allow for changes in objectives?

28. GOV 2015 Slide 28 D'Angelo Advantage LLC  6.1 Actions, Risks and Opportunities  6.1.1 When planning for the QMS the organization shall consider the issues referred in 4.1/4.2 and determine the risks and opportunities that need to be addressed  Give assurance that the QMS can achieve its intended results  Prevent of reduce undesirable events (risk)  Evaluate the effectiveness of these actions  Achieve continuous improvement 6. Planning for the QMS What are the organizational risks?

29. GOV 2015 Slide 29 D'Angelo Advantage LLC  The organization shall establish quality objectives at relevant functions, levels and processes and include:  Consistency with the quality policy  Measurable  Applicable requirements  Monitored  Communicated  Updated as appropriate  Retain documented information on the objectives  MORE Detail What are the processes that make up the Quality Management System? 6.2 Quality Objectives and Planning to Achieve Them 17025

30. GOV 2015 Slide 30 The Objectives D'Angelo Advantage Consulting LLC Leadership Defines Internal and external Factors Internal and external Customers

31. GOV 2015 Slide 31 6.2.2 When Planning How to Achieve Objectives D'Angelo Advantage LLC Establish what, how, who, when to achieve objectives 6.3 Changes in a planned and systematic manner  Purpose of the changes  Responsibility and authority to make change  Availability of resources 17025 Are the details to achieve objectives planned and documented ?

32. GOV 2015 Slide 32 D'Angelo Advantage LLC  7.1 The organization shall determine and provide the resources needed for the establishment implementation, maintenance, and continual improvement of the QMS 7.0 Support How is the continuous improvement program implemented? Who is responsible? 17025

33. GOV 2015 Slide 33 D'Angelo Advantage LLC 7.2 The Organization shall:  Determine the necessary competence of persons doing the work under it control that affects its quality performance  Ensure that persons are competent on the basis of appropriate education, training and or experience  Take actions to acquire the necessary competence and evaluate the effectiveness of actions taken  Retain appropriate documented information as evidenced of competence 7.2 Competence Is there a process in place to take action for employees who require retraining or reassignment to ensure competency? 17025

34. GOV 2015 Slide 34 D'Angelo Advantage LLC Persons doing the work under the organization's control shall be aware of the following:  Quality policy  Their contribution to the effectiveness of the QMS, including the benefits if improved quality performance  Implications if not conforming with the QMS requirements  The organization shall determine the internal and external communications relevant to the QMS including:  What will be communicated  When to communicate  Whom to communicate  How to communicate How is the continuous improvement program implemented? 7.3 Awareness 7.4 Communication

35. GOV 2015 Slide 35 D'Angelo Advantage LLC  The organizations QMS shall include:  Documented information required by this standard  Documented information determined by the organization as being necessary for the effectiveness of the QMS May differ from one organization to another due to:  The size of the organization  The complexity of the processes and their interactions  The competence of employees 7.5 Documented Information 17025 Are all processes are documented?

36. GOV 2015 Slide 36 D'Angelo Advantage LLC Operation Planning and Control The organization shall plan, implement and control the processes as outlined in 4.4, needed to meet requirements and to implement actions determined in 6.1 by:  Establishing criteria for the processes  Implement control of the processes in accordance with the criteria  Retaining documented information to the extent necessary to have confidence that the process have been carried out as planned  The organization shall control planned changes and review the consequences of unintended changes  Endure outsource processes are controlled How is the continuous improvement program implemented? 8.1 Operation

37. GOV 2015 Slide 37 D'Angelo Advantage LLC 9.1 Monitoring, measurement, analysis and evaluation  The organization shall determine:  What needs to be monitored and measured  The methods for monitoring measurement, analysis and evaluation, to ensure valid results  When monitoring and measuring shall be performed  When the results from monitoring and measurement shall be analyzed and evaluated  Maintain documented information  Evaluated the quality performance and effectiveness of the QMS 9.0 Performance Evaluation What are your methods for monitoring effectiveness?

38. GOV 2015 Slide 38 D'Angelo Advantage LLC Organization shall conduct internal audits at planned intervals to provide information on whether the QMS conforms to: 1. Its own requirements 2. ISO Standard 9.2.2 Plan, establish, implement, and maintain an audit program including "frequency, methods, responsibilities, planning requirements and reporting."  Importance of the process related risks  Results of previous audits  MORE detail 9.2 Internal Audit 17025 ISO Audits Scheduled Audits Are the quality objectives being met?

39. GOV 2015 Slide 39 D'Angelo Advantage LLC  9.3.1 Top management shall review the organizations QMS at planned intervals to ensure its continuing suitability, adequacy and effectiveness  The management review shall be planned and carried out taking into consideration:  Status of actions from previous management reviews  Changes in external and internal issues that are relevant to the QMS  Non-conformities/corrective actions  Monitor and measurement results  Audit results How is the continuous improvement program implemented? 9.3 Management Review 1702 5

40. GOV 2015 Slide 40 D'Angelo Advantage LLC When a conformity occurs the organization shall react to the non-conformity:  Take action, control and correct it  Deal with the consequences  Evaluate the need for action and eliminate the non- conformance so it does not occur again  Review and determine the cause  Determine if similar NC exists  Implement any action needed  Review the effectiveness of any corrective action  Make changes to the QMS  Corrective actions shall be appropriate to the effects of the NC How is the continuous improvement program implemented? 10.2 Conformity and Corrective Action 1702 5

41. GOV 2015 Slide 41 D'Angelo Advantage LLC  The organization shall continually improve the suitability, adequacy and effectiveness of the QMS:  Results of data collection  Changes in the context of the organization  Changes in identified risk  New opportunities 10.3 Continual Improvement 1702 5 What is the process for continuous improvement of the QMS?

42. GOV 2015 Slide 42 D'Angelo Advantage LLC Next Steps 1.Document applicable changes of ISO 9001 that have the potential to effect your organization 2. Review the organizational QMS for necessary updates 3. Stay informed on the upcoming changes to the standard 4. 3 year grace period to comply with changes

43. GOV 2015 Slide 43 QUESTIONS?? dangeloadvantage@gmail.com Dangeloadvantage.com D'Angelo Advantage Consulting LLC

44. GOV 2015 Slide 44 D'Angelo Advantage LLC 1.Sandford Liebesman, ISO 9001:2015 specifically addresses risk. Is your organization ready? 2.http://www.qualitydigest.com/inside/quality-insider-article/iso-90012015- preparing-change.htmlhttp://www.qualitydigest.com/inside/quality-insider-article/iso-90012015- preparing-change.html 3.http://asq.org/standards-iso-9001-2015.htmlhttp://asq.org/standards-iso-9001-2015.html 4.http://www.ansi.org/consumer_affairs/history_standards.aspx?menuid=5 References