2013 Quistem, LLC. Update of Proposed Changes to International Quality Management System Model

Transcription

1 Update of Proposed Changes to International Quality Management System Model 1

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3 You want to know what s new in terms of ISO 9001 requirements You wonder why the ISO 9001 standard is being changed again You want a timeline for the proposed ISO 9001 changes You want to know what actions you should be taking now to update your organization s QMS 3

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5 » Cathy Fisher is a dedicated quality professional and founder of Quistem, LLC and Quality Improvement Strategies.» With over 30 years of industry experience, Cathy has worked with thousands of organizations representing industry sectors from manufacturing, chemical processing, information management to professional services providers as well as government agencies and contractors.» She provides customized management systems development, business planning, business systems evaluation/audit, process improvement and technical competency development programs to support organizations in their mission to establish customer-focused processes which provide profitable results.» Cathy recently introduced Quistem, LLC, an online quality/technical mentorship program for quality and technical professionals to increase their knowledge and confidently apply quality improvement tools in order to achieve outstanding results for their employer and excel in their career growth. 5

6 Denise Robitaille is a member to US TAG to ISO/TC 176, the standards developers responsible for ISO 9001 and ISO 9004 revisions. She is an internationally recognized speaker and trainer. She is a Fellow of the American Society for Quality and an RAB-QSA certified lead assessor and an ASQ certified quality auditor. As principal of Robitaille Associates, Denise has helped many companies achieve ISO 9001 registration and to improve their quality management systems. Denise is the author of ten books, including ISO 9001:2008 for Small and Medium-Sized Businesses., The Corrective Action Handbook, The Management Review Handbook, and The Preventive Action Handbook. She is a regular columnist for The Auditor and frequent contributor to other quality periodicals. 6

7 » Management system to direct and control an organization with regard to Quality» Quality - degree to which a set of inherent characteristics fulfills requirements, needs, expectations» QMS is achievement of customer satisfaction through fulfillment of customer requirements Includes:» Establishment of quality policy, objectives, responsibilities» Organizational structure» Processes» Procedures» Resources QMS should:» Be results focused» Identify processes needed to achieve planned results» Provide a framework for continually monitoring risks 7

8 » Remember the 8 Quality Management Principles introduced to support the content of ISO 9001:2000?» Now there are 7 Quality Management Principles, (see Annex A of ISO/CD 9001)» Process approach and System Approach have been combined, (QMP 4 Process Approach)» Some other renaming/rewording but content and intent remains the same» Publication/release of updated QMPs to coincide with next release of ISO

9 QMP 1 = Customer Focus QMP 2 = Leadership QMP 3 = Engagement of People QMP 4 = Process Approach QMP 5 = Improvement QMP 6 = Evidence-based Decision Making QMP 7 = Relationship Management 9

10 » Initial release of ISO 9001 in 1987; quality assurance/control focused standard» First revision of ISO 9001 in 1994; quality assurance/control focused but with separate standards, (ISO 9002, ISO 9003), for different types of organizations» Adoption of ISO 9001 requirements as basis for industry sector-specific quality standards 10

11 » ISO 9001:2000 represented shift towards quality management thinking and adoption of process approach; one QMS standard adaptable to any type of organization» ISO 9001:2008 maintained process approach to quality management thinking; no requirements changes; clarifications only» Industry sector-specific standards continue to utilize ISO 9001 requirements as basis for their QMS requirements model 11

12 CUSTOMER INPUT Determination of Requirements Related to Product ACTING of change IMPROVEMENT: (Management) b) maintain integrity of QMS in case 8.5 Improvement: continual improvement, corrective action, preventive action Strategic Planning/Improvement On-Going Improvement BUSINESS PLANNING: (Management) 4.1, 4.2.1, QMS planning & documentation requirements 5.1, 5.2, 5.3, 5.4 Management Responsibilities 6.1 Resource planning Continual Planning PRODUCT REALIZATION 7.1 Planning of Product Realization 7.2 Customer-related processes 7.3 Design & Development $$$ 7.4 Purchasing 7.5 Production & Service Provision including control, validation of processes, identification & traceability, customer property nad preservation of product RESOURCE PROVISION: (Management) 4.2.3, Document & Record Control 5.5 Responsibility, Authority & DOING Communication 6.2 Human Resources including competency, awareness & training 6.3, 6.4 Infrastructure & Work Environment 7.6 Control of Monitoring & Measurement Devices 5.6 Management Review Measures of Effectiveness 2013 Quistem, LLC EVALUATION: (Management) c) training effectiveness Verification of purchased product CHECKING Validation of processes 8.1 planning of monitoring/measurement, analysis & improvement Internal audit 8.2.3, Monitoring/Measurement of Processes & Product 8.3 Control of Nonconforming Product 8.4 Analysis of data Customer Feedback Customer Communication Customer Satisfaction Measures of Efficiency diagram 2: Managed Activities/Process System 12

13 » Introduction of other management systems standards, (ISO 14001, etc.), has driven the need to align common management systems aspects and requirements» Organizations today are moving towards integration of their various management systems to facilitate maintenance and coordinated improvement of business 13

14 Quality Management System - customer Information Management System internal, etc. Environmental Management System neighbors, etc. Resource Management System suppliers, etc. Top Management Safety & Health Management System employees 2013 Quistem, LLC Other management systems Technology Management Systems competitors, industry Financial Management System - shareholders 14

15 To date, there are over 1 million ISO 9001 certificates worldwide Majority of ISO 9001 certifications are in Europe and Asia ISO is not a certification body ISO 9001 certification is not mandatory Certification is the result of a wellimplemented QMS Organizations are better able to improve their performance with a robust QMS Why??? 15

16 » Systematic review October 2011» Result of ballot: revise» Ongoing work in and around SC2 White papers User surveys Panel discussions» Design specification balloted October 2012» Result of ballot: approval 16

17 » Committee draft, (CD), was proposed for comment in June, 2013» CD/ISO 9001:2015 was approved in September, (80% acceptance)» Over 2800 comments received, (compared with over 6000 comments at same stage of ISO 9001:2000 revision)» ISO/TC 176 SC2 met in Portugal, November, 2013 Strategic review of comments submitted based on CD Disposition of these comments relative to additional changes to proposed ISO 9001:2015 content Define pathway forward for ISO 9001:

18 » The proposed revision information we are sharing with you today is subject to change in the future, up until the final release of the ISO 9001:2015 standard.» Please proceed with caution in implementing any changes to your organization s QMS solely for the purpose of conforming to this draft standard 18

19 » High level structure: referred to as Annex SL Developed by JTCG (Joint Technical Coordination Group) at the request of the TMB (Technical Management Board) Adopted and inserted into ISO directives» Requires use of Annex SL for all ISO MSS allows for deviations justification for deviations must be documented and sent to TMB» Rationale for high level structure and common text Easier for organizations to implement multiple standards Greater alignment Same sub-clauses across all ISO MSS Core vocabulary Approximately 30% common text with other standards 19

20 » Based on Annex SL structure» Still process-oriented layout» Relocation of certain requirements to different sections, (e.g. Control of Monitoring & Measurement Devices was 7.6, now included in Support which was formerly section 6, Resources)» 4 Context of the organization» 5 Leadership» 6 Planning» 7 Support» 8 Operation» 9 Performance evaluation» 10 - Improvement 20

21 » Generic requirements for ease of application to non-manufacturing entities» Context of the Organization determine issues and requirements that can impact on planning of QMS; use as input to QMS development» Process approach now as specified requirement, (4.4.2) 21

22 » Risk and Preventive Action risks identified and acted upon; risk referred to throughout standard; proactive risk consideration is preventive action; no requirement for formal risk management» Change management planning of changes, (6.3), control of changes, (8.6.6), emphasize importance of managing change and considering associated risks while maintaining integrity of QMS as well as goods and services 22

23 » Documented Information documented procedures, quality manual, etc. no longer specified; combines consideration of documents vs. records» Control of External Provision of Goods and Services Outsourced processes are now addressed alongside Purchasing; includes consideration of associate company and other relationships 23

24 » 4 - Context of the Organization» 5 Leadership» 6 Planning» Knowledge» 7.5 Documented Information» 8.1 Operational Planning & Control» 8.2 Determination of market needs and interactions with customers» 8.4 Control of External Provision of Goods & Services» 8.5 Development of Goods & Services» Control of Changes» (NOTE: lots of rewording of specific requirements) 24

25 » Would you like a cross-reference table mapping the CD/ISO 9001:2015 to the current ISO 9001:2008? Visit: 2013 Quistem, LLC and click the QMS MAP button to download your FREE copy 25

26 » Goods & Services to replace Product; intended output resulting from operational processes; deliverables for customer» Improvement to replace Continual Improvement» Documented Information to replace documents and records; information required to be controlled and maintained by organization and medium on which it is contained 26

27 » Risk effect of uncertainty; consequences and likelihood of potential events» Performance measurable result» Interested party person or organization that can affect, be affected by, or perceive themselves to be affected by a decision or activity 2013 Quistem, LLC 27

28 ISO Environmental Management Systems ISO Energy Management ISO Information Security ISO Food Safety ISO Medical Device ISO/TS Automotive AS9100 Aerospace 2013 Quistem, LLC TL9000 Telecommunications OHSAS Occupational Health & Safety Etc. 28

29 High level structure, (based on Annex SL) Clause structure loses process-approach Requirements watered down Ambiguous/inconsistent terminology Elimination of certain terms/requirements preventive action, quality manual, management representative Relevant Interested Parties Auditability What are your concerns? 29

30 » Develop DIS, (draft international standard): November, 2013 March, 2014» DIS release for ballot expected in April, 2014» DIS balloting to close November, 2014» FDIS release expected April, 2015» Publication expected in September, 2015» 3 year transition period has been approved * All dates contingent on need for additional drafts and results of ballots 30

31 » Start considering how to make changes to your organization s QMS» Visit for updates and resources 2013 Quistem, LLC» Consider utilizing the self-assessment in ISO 9004:2009 to recognize areas for enhancement of your organization s current QMS» Begin studying concept of Risk-based Thinking 31

32 » Visit to download your FREE QMS Map along with a copy of this presentation.» Visit the Knowledge Center at to access a FREE recording of Risk-based Thinking webinar Denise and Cathy presented in December,