Update of Proposed Changes to International of Proposed Changes to International ... • ISO 9001...

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Knowledge + Action = Results www.Quistem.com

Update of Proposed Changes to International

Quality Management System Model

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•  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


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»  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.


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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.


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»  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


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»  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 9001


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•  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


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»  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


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»  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


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$$$

DOING

PLANNING

CUSTOMER INPUT7.2.1 Determination

of RequirementsRelated to Product

BUSINESS PLANNING: (Management)4.1, 4.2.1, 4.2.2 QMS planning &

documentation requirements5.1, 5.2, 5.3, 5.4 Management

Responsibilities6.1 Resource planning

RESOURCE PROVISION: (Management)4.2.3, 4.2.4 Document & Record Control

5.5 Responsibility, Authority &Communication

6.2 Human Resources includingcompetency, awareness & training

6.3, 6.4 Infrastructure & WorkEnvironment

7.6 Control of Monitoring & MeasurementDevices

CHECKINGEVALUATION: (Management)6.2.2 c) training effectiveness

7.4.3 Verification of purchased product7.5.2 Validation of processes

8.1 planning of monitoring/measurement,analysis & improvement

8.2.2 Internal audit8.2.3, 8.2.4 Monitoring/Measurement of

Processes & Product 8.3 Control of Nonconforming Product

8.4 Analysis of data

ACTINGIMPROVEMENT: (Management)

5.4.2 b) maintain integrity of QMS in caseof change

8.5 Improvement: continual improvement,corrective action, preventive action

PRODUCT REALIZATION7.1 Planning of Product Realization

7.2 Customer-related processes7.3 Design & Development

7.4 Purchasing7.5 Production & Service Provision including control,validation of processes, identification & traceability,

customer property nad preservation of product

Strategic

Planning/Improvement

Continual Planning

Measures of Efficiency

On-GoingImprovement

diagram 2: Managed Activities/Process System

5.6 ManagementReview

Customer Feedback7.2.3 Customer Communication

8.2.1 Customer Satisfaction

Measures of Effectiveness

Measures of Efficiency


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»  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


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Quality Management System - customer

Environmental Management System – neighbors, etc.

Safety & Health Management System –

employees

Financial Management System - shareholders

Technology Management Systems – competitors, industry

Information Management System – internal, etc.

Resource Management System – suppliers, etc.

Other management systems

Top Management


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•  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 well-implemented QMS

•  Organizations are better able to improve their performance with a robust QMS

•  Why??? 15

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»  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


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»  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 9001:2015


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» 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


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»  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


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»  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


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»  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)


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»  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


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»  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


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»  4 - Context of the Organization »  5 – Leadership »  6 – Planning »  7.1.5 – 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 »  8.6.6 – Control of Changes »  (NOTE: lots of rewording of specific requirements)


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»  Would you like a cross-reference table mapping the CD/ISO 9001:2015 to the current ISO 9001:2008?

Visit: www.Quistem.com and click the QMS MAP button

to download your FREE copy


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»  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


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»  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


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ISO 14001 Environmental Management Systems ISO 50001 Energy Management ISO 27001 Information Security ISO 22000 Food Safety ISO 13485 Medical Device ISO/TS 16949 Automotive AS9100 Aerospace TL9000 Telecommunications OHSAS 18001 Occupational Health & Safety Etc.

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•  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?


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»  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


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»  Start considering how to make changes to your organization’s QMS

»  Visit www.iso.org for updates and resources

»  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 Knowledge + Action = Results www.Quistem.com

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» Visit www.Quistem.com to download your FREE QMS Map along with a copy of this presentation.

» Visit the Knowledge Center at www.Quistem.com to access a FREE recording of Risk-based Thinking webinar Denise and Cathy presented in December, 2013.


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Update of Proposed Changes to International of Proposed Changes to International ... • ISO 9001...

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