Going Beyond Quality ISO 9001:2015. Session #ISO-053. Agenda

Going Beyond Quality ISO 9001:2015 Session #ISO-053 Risk is on the Front Lines Copyright © 2014 BSI. All rights reserved. Agenda • Understanding the...
1 downloads 0 Views 2MB Size
Going Beyond Quality ISO 9001:2015 Session #ISO-053 Risk is on the Front Lines

Copyright © 2014 BSI. All rights reserved.

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

Copyright © 2014 BSI. All rights reserved.

2

1

Understanding the New Rules of the Game and the Alliances that can be made across several Standards

Copyright © 2014 BSI. All rights reserved.

15/02/2015

3

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.

15/02/2015

4

2

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

Copyright © 2014 BSI. All rights reserved.

5

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.

15/02/2015

6

3

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.

Copyright © 2014 BSI. All rights reserved.

15/02/2015

7

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.

Copyright © 2014 BSI. All rights reserved.

15/02/2015

8

4

Copyright © 2014 BSI. All rights reserved.

9

Key changes that are expected for ISO 9001:2015

Copyright © 2014 BSI. All rights reserved.

15/02/2015

10

5

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

Copyright © 2014 BSI. All rights reserved.

d1

11

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

Copyright © 2014 BSI. All rights reserved.

12

6

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

Copyright © 2014 BSI. All rights reserved.

13

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

14

7

Understanding How the New Changes may Affect your Organization

Copyright © 2014 BSI. All rights reserved.

15/02/2015

15

What are the main changes that may affect you? •

The increased role that leadership must play



Decrease in the amount of documentation needed



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



No Longer a requirement for a Quality Manual



No Longer a requirement for a Management Representative



Change management Copyright © 2014 BSI. All rights reserved.

15/02/2015

16

8

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

17

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

Copyright 2014 BSI. All rights reserved. Copyright © 2014 BSI. All rights©reserved.

18

9

10