Going Beyond Quality ISO 9001:2015 Session #ISO-053 Risk is on the Front Lines
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Agenda • Understanding the New Rules of the Game – Annex SL/Directive 1 • Latest Timelines • Key Changes to ISO 9001:2015 • Best Practice Transition Journey • Understanding How the New Changes may Affect your Organization
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Understanding the New Rules of the Game and the Alliances that can be made across several Standards
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Ten clauses of the new Annex SL - Directive 1 for ISO Management Systems • Annex SL describes the framework for a generic management system. However, it requires the addition of discipline-specific requirements to make a fully functional quality, environmental, service management, food safety, business continuity, information security and energy management system standard • ISO/IEC Directives, Part 1, Consolidated ISO Supplement, 2014 • High level structure, identical core text, common terms and core definitions – 10 Main Clauses Copyright © 2014 BSI. All rights reserved.
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Reasons For The Changes • Easier integration of multiple standards using a common foundation and common language • Increase involvement of Top Management • Decrease the emphasis on Documentation • Increase the emphasis on Achieving Value for the Organization and its customers • Increase emphasis on Risk Management to achieve objectives
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Directive 1 – 10 Clauses 1. Scope
6. Planning
2. Normative references
7. Support
3. Terms and definitions
8. Operation
4. Context of the organization
9. Performance evaluation
5. Leadership
10. Improvement
Implement Once, Comply Many Copyright © 2014 BSI. All rights reserved.
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What is “risk-based thinking”? • Risk-based thinking is something we all do automatically and often sub-consciously. • The concept of risk has always been implicit in ISO 9001 – this revision makes it more explicit and builds it into the whole of the management process • Risk-based thinking should already part of the process approach. • Risk-based thinking makes preventive action routine.
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15/02/2015
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Aligning Risk with Corrective Action • One of the key purposes of a formal management system is to act as a preventive tool. • Consequently, the standard requires an assessment of the organization’s “external and internal issues that are relevant to its purpose and that affect its ability to achieve the intended outcome(s)‟ in clause 4.1, and to “determine the risks and opportunities that need to be addressed to: assure the quality management system can achieve its intended outcome(s); prevent, or reduce, undesired effects; achieve improvement” in in clause 6.1.
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15/02/2015
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Key changes that are expected for ISO 9001:2015
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QMS Structure PLAN 4 Context of organization
5 Leadership
Understanding of the organization and its context Expectations of interested parties Scope of management system
DO 6 Planning
Leadership and commitment
Quality policy Roles, responsibilities and authorities
7 Support Actions to address risk and opportunity
CHECK
8 Operation
9 Performance and Evaluation
Resources
Operations of planning and control
Quality objectives
Competence
Determination of requirements for products and services
Planning of changes
Awareness
Communication
QMS
Documented information
ACT
Design and development of products and services Control of external provided products and services
10 Improvement
Monitoring, measurement, analysis and evaluation
Nonconformity and corrective action Continual improvement
Internal audit
Management review
Production and service provision Release of products and services Control of nonconforming process outputs, products and services
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ISO 9001 Key differences ISO 9001:2008
ISO DIS 9001:2015
0 Introduction
0 Introduction
1 Scope
1 Scope
2 Normative references
2 Normative references
3 Terms and definitions
3 Terms and definitions
4 Quality system
4 Context of the organization
5 Management responsibility
5 Leadership
New requirement Enhanced requirements
6 Resource management
6 Planning
Significant change Enhanced requirements
7 Product realization
7 Support
Enhanced requirement New requirement
8 Operation
New requirement Enhanced requirement Simplified requirement Enhanced requirement
9 Performance evaluation
New requirement
10 Improvement
More structured approach
8 Measurement, analysis and improvement
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Slide 12 d1
Suggest we key in on the Annex SL Directive 1 which describes the main areas of change as in 4 - 10 of this slide and slide 12. Then cover the unique changes to each standard. Less confusion for the audiance when done this way. The message of cohesiveness and business improvement hits home much clearer that way. My audiances have always liked this approach. dimariaj, 1/19/2015
ISO 9001 – Key changes
Leadership
• There is a greater emphasis for senior managers to be involved in the strategic alignment of the management system
Risk
• An effective risk management process will be critical for successful certification to the new version. Replaces Preventive Action
Context of Organization Planning
• Relevant needs of interested parties are a new focus
• Change Management - Changes to the QMS must now be carried out in a planned and systematic manner
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Client Transition Plan – ISO 9001 2014 Q4
2015 Q1
Standards Transition Training
Available End Feb
Updated Standard Courses
Available End Feb
Transition Client Pack
Q2 July FDIS
2016 Q3 Sept ISO
Q4
Q1
Q2
Q3
2017
2018
Stop issue
Expire 09/18
Q4
Available End Dec
GAP Assessments Unaccredited Certification against FDIS
Available April Available July
Certificates to ISO 9001:2008 Transition Assessments
Available Oct
Copyright © 2014 BSI. All rights reserved. Certificates to ISO 9001:2015
Available Oct
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Understanding How the New Changes may Affect your Organization
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15/02/2015
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What are the main changes that may affect you? •
The increased role that leadership must play
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Decrease in the amount of documentation needed
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Risk management processes may need to be developed to determine the level and extent of control for internal and external (supply-chain) processes and services, if not already in place.
•
Auditors and stakeholders will need to become familiar with the revised standards and so training may need to be considered
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No Longer a requirement for a Quality Manual
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No Longer a requirement for a Management Representative
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Change management Copyright © 2014 BSI. All rights reserved.
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Documentation “The organization shall maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confidence that the processes are being carried out as planned”. 7.5 Documented Information. – 7.5.1 (b. documented information determined by the organization as being necessary for the effectiveness of the quality management system. Copyright © 2014 BSI. All rights reserved.
15/02/2015
Source: ISO 9001:2015 DIS
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Thank You! Address:
BSI Group America Inc. 12950 Worldgate Drive, Suite 800
Herndon, VA 20170 Email John DiMaria –
[email protected] Main Office Telephone:
888-429-6178
Fax:
703 437 9001
Email:
[email protected]
Links:
http://www.bsiamerica.com
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