Technical update on
ISO 9001:2015
Colin MacNee
Duncan MacNee Limited
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Caveat
The views expressed are my own and do not represent
BSI
CQI
IAF
IBM
IRCA
ISO
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Content
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What is the process for updating ISO standards?
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What is the current situation?
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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?
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What are the stages
Who is involved
When to contribute
How to contribute
What ISO 9001:2015 could look like?
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Annex SL plus possible changes
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ISO Development Process
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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)
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ISO Development Process
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Who will receive the documents?
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Member bodies. E.g. JISC (Japanese Industrial Standards Committee)
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Participating Countries: 73
Observing Countries: 16
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Internal liaison to SC 2 (ISO: 8, IEC: 3)
External liaison to SC 2 (21)
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ALL of the above are allowed to comment.
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ONLY member bodies are allowed to vote.
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ISO Development Process
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Voting
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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:
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Abstentions
Negative votes without technical justification
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Current Situation
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Background
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The ISO 9001:2015 Project plan
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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
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ISO/IEC 27001 (expected later this year)
ISO 14001 (expected early 2015)
ISO 9001 (expected late 2015)
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ISO 22301:2012 developed using an early draft
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ISO/CD 9001
2013
Jan
Mar
Feb
May
Apr
Jul
Jun
Sep
Aug
Nov
Oct
Dec
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)
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ISO/DIS 9001
Jan
Mar
Feb
May
Apr
2014
Jul
Jun
Sep
Aug
Nov
Oct
Dec
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.
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ISO/FDIS 9001
2015
Jan
Mar
Feb
May
Apr
Jul
Jun
Sep
Aug
FDIS ballot opens: July 2015
FDIS ballot closes: August 2015
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Nov
Oct
Dec
ISO 9001 published:
September 2015
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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
10. Improvement
Appendix
Bibliography
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MSS – High Level Structure
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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
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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
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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
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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
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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
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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
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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
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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
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Thank You
Any Questions?
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