Technical update on iso 9001 2015

Technical update on ISO 9001:2015

Colin MacNee Duncan MacNee Limited

23rdbackground June 2013 from www.pptbackgrounds.fsnet.co.uk Š 2012, 2013 Duncan MacNee Limited A Free sample

1

Caveat The views expressed are my own and do not represent

BSI CQI IAF IBM IRCA ISO 23rdbackground June 2013 from www.pptbackgrounds.fsnet.co.uk Š 2012, 2013 Duncan MacNee Limited A Free sample

2

Content 

What is the process for updating ISO standards?  



What is the current situation?   



Background:1994, 2000 and 2008 revisions, User Surveys and QMPs The ISO 9001:2015 Project plan, what we have achieved and what we have still to do Current major revisions of ISO 9001, ISO 14001 and ISO 27001 (Reference to Annex SL)

How IRCA auditors influence the development?  



What are the stages Who is involved

When to contribute How to contribute

What ISO 9001:2015 could look like? 

Annex SL plus possible changes

23rdbackground June 2013 from www.pptbackgrounds.fsnet.co.uk © 2012, 2013 Duncan MacNee Limited A Free sample

3

ISO Development Process

1 of 3

The ISO/IEC Directives Part 1 and Consolidated ISO Supplement1 describes in detail the following stages: 1.

2.

3.

4.

5.

6.

7.

Preliminary - Preliminary work item (PWI) Proposal - New work item proposal (NP or NWIP) Preparatory – working draft(s) (WD) Committee – committee draft(s) (CD) Enquiry – draft international standard (DIS) Approval – final draft international standard (FDIS) Publication – international standard (IS) 1

Third edition, 2012 (based on the ninth edition of the ISO/IEC Directives, Part 1)

23rdbackground June 2013 from www.pptbackgrounds.fsnet.co.uk © 2012, 2013 Duncan MacNee Limited A Free sample

4

ISO Development Process

2 of 3

Who will receive the documents? 

Member bodies. E.g. JISC (Japanese Industrial Standards Committee)  

Participating Countries: 73 Observing Countries: 16



Internal liaison to SC 2 (ISO: 8, IEC: 3) External liaison to SC 2 (21)



ALL of the above are allowed to comment.



ONLY member bodies are allowed to vote.



23rdbackground June 2013 from www.pptbackgrounds.fsnet.co.uk © 2012, 2013 Duncan MacNee Limited A Free sample

5

ISO Development Process

3 of 3

Voting 

CD: 2/3 positive of total of member bodies voting



DIS: 2/3 positive AND not more than ¼ negative of total of member bodies voting FDIS: 2/3 positive AND not more than ¼ negative of total of member bodies voting





Not counted in the total vote:  

Abstentions Negative votes without technical justification

23rdbackground June 2013 from www.pptbackgrounds.fsnet.co.uk © 2012, 2013 Duncan MacNee Limited A Free sample

6

Current Situation 

Background   



The ISO 9001:2015 Project plan  



1994, 2000 and 2008 revisions User Surveys Quality Management Principles (QMPs)

What we have achieved What we have still to do

3 major ISO MSSs in development – all using Annex SL



ISO/IEC 27001 (expected later this year) ISO 14001 (expected early 2015) ISO 9001 (expected late 2015)



ISO 22301:2012 developed using an early draft

 

23rdbackground June 2013 from www.pptbackgrounds.fsnet.co.uk © 2012, 2013 Duncan MacNee Limited A Free sample

7

ISO/CD 9001 2013

CD ballot opens: June 2013 CD ballot closes: August 2013 It is standard practice for the CD to be distributed only to member body mirror committees. However, some member bodies may distribute the CD to the public (free or for sale)

23rdbackground June 2013 from www.pptbackgrounds.fsnet.co.uk Š 2012, 2013 Duncan MacNee Limited A Free sample

8

ISO/DIS 9001 2014

DIS ballot opens: April 2014 DIS ballot closes: August 2014 It is standard practice for the DIS to be distributed to members of the public (free or for sale). Some member bodies provide electronic tools for viewing and commenting on the DIS.

23rdbackground June 2013 from www.pptbackgrounds.fsnet.co.uk Š 2012, 2013 Duncan MacNee Limited A Free sample

9

ISO/FDIS 9001 2015

FDIS ballot opens: July 2015 FDIS ballot closes: August 2015 23rdbackground June 2013 from www.pptbackgrounds.fsnet.co.uk Š 2012, 2013 Duncan MacNee Limited A Free sample

ISO 9001 published: September 2015 10

MSS – High Level Structure Introduction

4. Context of the organization

1. Scope

5. Leadership

2. Normative references

6. Planning

3. Terms and definition

7. Support

1 of 3

8. Operation 9. Performance evaluation

Appendix

10. Improvement

Bibliography 23rdbackground June 2013 from www.pptbackgrounds.fsnet.co.uk Š 2012, 2013 Duncan MacNee Limited A Free sample

11

MSS – High Level Structure

2 of 3

4. Context of the organization 4.1 Understanding the organization and its context 4.2 Understanding the needs and expectations of interested parties 4.3 Determining the scope of the XXX management system 4.4 XXX management system 5. Leadership 5.1 Leadership and commitment 5.2 Policy 5.3 Organization roles, responsibilities and authorities 6. Planning 6.1 Actions to address risks and opportunities 6.2 XXX objectives and planning to achieve them

23rdbackground June 2013 from www.pptbackgrounds.fsnet.co.uk Š 2012, 2013 Duncan MacNee Limited A Free sample

12

MSS – High Level Structure 7. Support 7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information 7.5.1 General 7.5.2 Creating and updating 7.5.3 Control of documented information

3 of 3

8. Operation 8.1 Operational planning and control 9. Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.2 Internal audit 9.3 Management review 10. Improvement 10.1 Nonconformity and corrective action 10.2 Continual improvement

23rdbackground June 2013 from www.pptbackgrounds.fsnet.co.uk Š 2012, 2013 Duncan MacNee Limited A Free sample

13

MSS – Common Terms and Definitions Organization Interested party (preferred term) Stakeholder (admitted term) Requirement Management system Top management Effectiveness Policy Objective Risk Competence Documented information

Process Performance Outsource (verb) Monitoring Measurement Audit Conformity Nonconformity Correction Corrective action Continual improvement

23rdbackground June 2013 from www.pptbackgrounds.fsnet.co.uk Š 2012, 2013 Duncan MacNee Limited A Free sample

14

Possible ISO 9001:2015 *

1 of 3

4. Context of the organization 4.1 Understanding the organization and its context 4.2 Understanding the needs and expectations of interested parties 4.3 Determining the scope of the quality management system 4.4 Quality management system 5. Leadership 5.1 Leadership and commitment 5.2 Policy 5.3 Organization roles, responsibilities and authorities 6. Planning 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes *Note: This structure is based on a early draft of ISO CD 9001:2015 23rdbackground June 2013 from www.pptbackgrounds.fsnet.co.uk Š 2012, 2013 Duncan MacNee Limited A Free sample

15

Possible ISO 9001:2015 *

7. Support 7.1 Resources 7.1.1 General 7.1.2 Infrastructure 7.1.3 Process environment 7.1.4 Monitoring and measuring devices 7.1.5 Knowledge

7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information 7.5.1 General 7.5.2 Creating and updating 7.5.3 Control of documented information

2 of 3

8. Operation 8.1 Operational planning and control 9. Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.1.1 General 9.1.2 Customer satisfaction 9.1.3 Analysis and evaluation of data

9.2 Internal audit 9.3 Management review 10. Improvement 10.1 Nonconformity and corrective action 10.2 Continual improvement

*Note: This structure is based on a early draft of ISO CD 9001:2015 23rdbackground June 2013 from www.pptbackgrounds.fsnet.co.uk Š 2012, 2013 Duncan MacNee Limited A Free sample

16

Possible ISO 9001:2015 *

8. Operation 8.1 Operational planning and control 8.2 Determination of market needs and interactions with customers 8.2.1 General 8.2.2 Determination of requirements related to the goods and services 8.2.3 Review of requirements related to the goods and services 8.2.4 Customer communication

8.3 Operational planning 8.4 Control of external provision of goods and services 8.4.1 General 8.4.2 Type and extent of control of external provision 8.4.3 Documented information for external providers

3 of 3

8.5 Development of goods and services 8.5.1 Development processes 8.5.2 Development controls 8.5.3 Development transfer

8.6 Realization of goods and services 8.6.1 Control of production of goods and provision of services 8.6.2 Identification and traceability 8.6.3 Property belonging to customers or external providers 8.6.4 Preservation of goods or services 8.6.5 Post delivery activities 8.6.6 Control of changes

8.7 Release of goods or services 8.8 Nonconforming goods and services

*Note: This structure is based on a early draft of ISO CD 9001:2015 23rdbackground June 2013 from www.pptbackgrounds.fsnet.co.uk Š 2012, 2013 Duncan MacNee Limited A Free sample

17

Thank You Any Questions?

A Free sample 23rdbackground June 2013 from www.pptbackgrounds.fsnet.co.uk Š 2012, 2013 Duncan MacNee Limited

18