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© NQA, USA 2015
2015 STANDARDS
REVISION OVERVIEW
PRESENTER:
TIMOTHY WOODCOME
DIRECTOR
© NQA, USA 2015
Agenda
Here we go again… The ISO Revision Process
New “High Level Structure”: Annex SL
The Big Picture: Initial Take-Away’s
Wait for it… Next Steps
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THE ISO REVISION
PROCESS
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1980 1987 1994 2000 2008 2015
TC176
formed1st
Edition
1st Minor
Revision
1st Major
Revision
2nd Minor
Revision
2nd Major
Revision
ISO 9001 & 14001 History
2015
2nd Major
Revision
1st Major
Revision
1996 2004
1st
Edition
TC207
formed
1993
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AS 9100
Upcoming Revisions** Projections as of February 2015 – SUBJECT TO CHANGE
2014 2015 2016
ISO 9001
ISO 14001
2017 2018
OHSAS 18001 / ISO 45001
2013
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Standards Revision Timelines*
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Revision Stage ISO 9001 ISO 14001 AS 9100
CD June 2013 March 2013
DIS May 2014 June 2014 2014**
FDIS ~Jun 2015 ~Jun 2015 2015**
Publication Q3/Q4 2015 Q3/Q4 2015 ~Mid 2016
Transition Begins Q3/Q4 2015 Q3/Q4 2015 ~Mid 2016
Transition Ends Q3/Q4 2018 Q3/Q4 2018 ~Mid 2018
• *Projections as of February 2015 – SUBJECT TO CHANGE
• ** AS 9100 does not go through ISO DIS/FDIS stages per se
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User Surveys
ISO 9001
•11,722 responses; 122 countries
•75% small/medium organizations
ISO 14001
•5000 responses; 110 countries
DIS content
was derived in
part from these
surveys
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ISO 9001: 2015 must…
Remain RELEVANT
INTEGRATE with other management systems
Provide ORGANIZATIONAL management
FOUNDATION for next 10+ years
Reflect increasingly COMPLEX ORGANIZATIONAL
ENVIRONMENTS
Reflect needs of ALL POTENTIAL USERS
Enhance an organization’s ability to SATISFY CUSTOMERS
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ISO14001: 2015…
Maintain & Improve basic principles including:
Meeting REGULATORY REQUIREMENTS
Improving ENVIRONMENTAL PEFORMANCE
Consider “Future Challenges”:
• POLLUTION PREVENTION
• EFFICIENCY
• LIFE-CYCLE THINKING
Clarifications, Annex A, ISO 14004
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ANNEX SL
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Why Annex SL?
ISO/IEC Directive
High level structure (HLS)
Identical core text
Common terms and definitions
Increased compatibility
ISO 9001, ISO 14001, ISO 27001, ISO 22301, ISO 45001, etc.
Also: AS 9100, TL 9000, TS 16949
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Implications of Annex SL
• Alignment and integration with business strategy
• Organizational context & interested parties
• Risk-based approach
• Outsourced process controls
• Some revised terminology
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Annex SL - High Level Structure
1 - Scope
2 - Normative References
3 - Terms and definitions
4 - Context of the Organization
5 – Leadership
6 – Planning
7 – Support
8 – Operation
9 – Performance Evaluation
10 – Improvement
“AUDITABLE
SECTIONS”
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Annex SL - High Level Structure
4 – Context
of the
Organization
5 - Leadership 6 – Planning 7 - Support
8 - Operation 9 – Performance
Evaluation
10 - Improvement
Plan
Do Check Act
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Annex SL – Identical Core Text
4 - Context of the Organization
5 – Leadership
6 – Planning
7 – Support
9 – Performance Evaluation
10 – Improvement
Section 8 will vary from
scheme to scheme
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Annex SL – NEW Terms/Concepts
Context of the Organization – business environment; combination of
internal and external factors and conditions that can have an effect on
an organization’s approach to its products, services…and interested
parties
“4 Context of the organization”
“4.1 Understanding the organization and its context”
“The organization shall determine external and internal issues that are
relevant to its purpose and its strategic direction that affect its ability to
achieve the intended results of its QMS/EMS.”
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Annex SL – NEW Terms/Definitions
Risk– effect of uncertainty
“When planning for the QMS/EMS, the organization shall consider the
issues referred to in 4.1 [Org & Context] and the requirements referred to in
4.2 [Interested parties] and determine the risks and opportunities that need
to be addressed…”
“The organization shall plan actions to address these risks …”
• i.e. avoiding, taking, eliminating, changing likelihood or consequence, sharing, retaining
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Annex SL – NEW Terms/Concepts
Documented Information – information required to be controlled and
maintained by an organization and the medium on which it is
contained.
• [replaces both ‘documented procedure’ and ‘records’; must use in context to
determine which intent…]
“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”
• “maintain” infers procedure
• “retain” infers record
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ISO/DIS Common/Related Clauses
4 Context of the Organization4.1 - Understanding the organization and its context
4.2 - Understanding the needs and expectation of interested parties
4.3 - Determining the scope of the QMS/EMS
4.4 – Quality/Environmental management system and its processes
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ISO/DIS Common/Related Clauses
5 Leadership5.1 - Leadership and commitment
5.2 – Quality/Environmental policy
5.3 - Organizational roles, responsibilities and authorities
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ISO/DIS Common/Related Clauses
6 Planning for the QMS6.1 - Actions to address risk…
6.2 – Quality/Environmental objectives and planning to achieve 6.3 -
Planning of changes (9001 only)
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ISO/DIS Common/Related Clauses
7 Support7.1 – Resources
7.2 - Competence
7.3 - Awareness
7.4 – Communication
7.5 - Documented information
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ISO/DIS Common/Related Clauses
8 Operation
[this is where most variation will occur]
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ISO/DIS Common/Related Clauses
9 Performance Evaluation9.1 - Monitoring, measurement, analysis and evaluation
9.2 - Internal audit
9.3 - Management review
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ISO/DIS Common/Related Clauses
10 Improvement10.1 – General
10.2 - Nonconformity and corrective action
10.3 - Continual improvement
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INITIAL
TAKE AWAY’S
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Risk-Driven Approach
Pervades ISO/DIS 9001 & ISO/DIS 14001
Explicit and Implicit inclusions
• “complexity”, “potential impact”, “controls”
Process Approach model with integrated risk
ISO ‘white paper’ on Risk-Based Thinking
Preventive Action is dead:
• LONG LIVE Preventive Action
…in the
form of
Risk
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Some Additional Mindset Shifts
Context of the Organization
Internal & External
Strategic Direction & Intended Outcomes
Interested Parties
External Provision
Purchasing & Outsourcing
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Other Key Intents
Increased emphasis on intended outcomes and customer focus
De-emphasis on prescriptive requirements and documented
procedures
Improved applicability for service organizations
Increased leadership requirements
Increased organizational alignment
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The “Small Stuff”
• High Level Structure
• “Documented Information”
• No Management Representative
• No Quality Manual
• Zero Documented Procedures• Except those required by 4.4 & 7.5.1…
Don’t
“sweat” it…
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NEXT STEPS
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Likely Certification Transition
Per International Accreditation Forum (IAF):
3 Year Transition from ISO publication**
ISO 9001: ~September 2015 – September 2018
ISO 14001: ~July 2015 – July 2018
** current official ISO target dates - - subject to change
Encouraging early start
NQA Customer Service will actively facilitate and manage process
Audit Time
May require additional time… NQA plans to offer no-cost options (i.e. over time)
Awaiting ANAB guidance
Worst Case Scenario… Additive time (not full initial assessment)
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To-Do List
STAY CALM and IMPROVE ON…
Get/Provide training and awareness as appropriate
ISO/DIS Standards available from iso.org
Understand Key Concepts & Intents
Identify gaps in system & update
Practice risk analysis/assessment methodologies
Begin Planning for Transition
How to address Annex SL (High Level Structure)
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To-Do List
Stay-Tuned
NQA Content
www.nqa-usa.com
LinkedIn, Twitter, Facebook
Future NQA Events
FDIS Release
2008 to 2015 Cross-Reference
Official IAF/ANAB Transition Requirements
