ISO 9001:2015

Overview
October 29, 2014
Cindy Soltis
UL DQS Inc.

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Revision Process
Overview
 Why are revisions needed?

All ISO standards

are considered • Web-based ISO 9001 user survey
for revision in 2011 - 122 countries input
periodically to • International ballot decision to
assure relevance revise in 2012
and adequacy.

• Increasing diversity of ISO 9001

users

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Revision • Developments in knowledge and
Considerations technologies
• Broader user interests
• Changes in industry
 Development of ISO 9001

 1987: Quality assurance

 20 elements
 1994: Small revision

 2000: Quality management

 process approach 

 2008: Minor revision

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 2015: Planned publication of the revised standard
 New structure, including risk based thinking

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 ISO 9001:2015 Timeline

2013 2014 2015

June 2013: CD
(Committee
Draft)
Transition period
for certification
May 2014: DIS
(Draft International
Standard)

July 2015: FDIS

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(Final Draft
International Standard)

September 2015: IS
International
Standard
 ISO 9001:2015 Certification Transition

2015 2016 2017 2018

September 2015:
Published
International Standard

September 2015:

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Start of 3 years transition period to September 2018

Transition Timeline for ISO 14001 not yet determined

but likely three years
 Main objectives for ISO 9001:2015

Maintain current focus on effective process

management to produce desired outcomes

Apply the new High Level Structure of ISO

Directives to enhance compatibility and alignment
with other management system standards

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Simplified language and writing styles to aid
understanding and consistent interpretations of
requirements

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Source: Design specification for the revised ISO 9001
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Summary of
Changes
 General Changes to ISO 9001

High level structure and core text from „annex SL“

Increased requirements for top management commitment and

involvement.
Emphasis on risk-based thinking

Increased emphasis on achieving value for the organization

and its customers (“output matters”)
Need to understand the context of the organization and the
needs and expectations of interested parties

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Increased flexibility on the use of documentation

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 Consistent structure for MS

ISO/IEC Directives, Part 1, Consolidated ISO supplement,

2013, Annex SL, Appendix 2 sets out the high level
structure, identical core text and common terms and
core definitions that are to form, when possible, the
nucleus of future and revised management system
standards such as ISO 9001 and ISO 14001.

Organizations implementing multiple management

systems (e.g. quality, environmental, information

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security) can achieve better integration and easier
implementation

High level structure and common text is public information and can be
found in Annex SL of the www.iso.org/directives 10
 High Level Structure
1. Scope

2. Normative reference

3. Terms and definitions

4. Context of the organization

5. Leadership

6. Planning

7. Support

8. Operation

9. Performance evaluation

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10. Improvement

ISO 9001: Annex A-C – Clarifications, Quality Management Principles, QMS family of stds

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 New structure - Details (9001)
1 Scope

2 Normative references

3 Terms and definitions

4 Context of the organization

• Understanding the organization and its context
• Understanding the needs and expectations of interested parties
• Determining the scope of QMS
• Quality management system and its processes
ISO/TC 176/SC 2/WG23 N063

5 Leadership
• Leadership and commitment
• Quality policy

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• Organizational roles, responsibilities and authorities
6 Planning
• Actions to address risks and opportunities
• Quality objectives and planning to achieve them
• Planning of changes
 New structure - Details (9001)
7 Support
• Resources
• Competence
• Awareness
• Communication
• Documented information
8 Operation
ISO/TC 176/SC 2/WG23 N063

• Operational planning and control

• Determination of requirements for products and services

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• Design and development of products and services
• Control of externally provided products and services
• Production and service provision
• Release of products and services
• Control of nonconforming process outputs, products &
services
 New structure - Details (9001)

9 Performance evaluation
• Monitoring, measurement, analysis and evaluation
• Internal audit
• Management review
10 Improvement
• General
ISO/TC 176/SC 2/WG23 N063

• Nonconformity and corrective action

• Continual Improvement

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 High Level Structure Question

Will certified organizations be

required to revise their
management system
manuals to align with the
high level structure and

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terms?

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 Other ISO 9001 Changes

Explicit requirement for process approach

Preventive action disappears as explicit

requirement – included in risk-based approach
More readily applicable by “service” type
organizations
Enhance requirements for competence of

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personnel
Revised Quality Management Principles

Customers remain the primary focus

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Details of Selected
Changes
 Context of the Organization (New)

• The organization shall

• determine external & internal
4.1 issues that are relevant to its
Understanding purpose & its strategic
direction and that affect its
the ability to achieve the intended
organization results of its QMS
and its context • shall monitor and review the

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information about these
external and internal issues

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ISO/ DIS 9001:2014
 Interested Parties (New)

• Due to their impact or potential impact on

the organization’s ability to consistently
provide products & services that meet
4.2 customer & applicable statutory &
Understanding regulatory requirements, the organization
shall determine
the needs and • The interested parties that are relevant
expectations of to the QMS
interested • The requirements of these interested
parties that are relevant to the QMS
parties • The organization shall monitor & review

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the information about these interested
parties and their relevant requirements

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ISO/ DIS 9001:2014
 Risk based thinking

ISO 9001:2015 will require a risk based

approach in organizational processes
• identify what the risks and opportunities are in the
organization – it depends on context
• ISO 9001:2015 will not require a full, formal risk
assessment nor a “risk register”
• Risk based approach addressed in all Sections 4
to 10 with primary requirement in 6.1

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• ISO 31000 (“Risk management — Principles and
guidelines”) will be useful but not mandated.

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 Risk based approach

Risk: Effect of uncertainty

on an expected result
Note 2: Uncertainty
is the state, even Note 4: Risk is often
Note 3: Risk is often
partial, of efficiency of expressed in terms of
Note 1: An effect is a characterized by
information related to, a combination of the
deviation from the reference to potential
understanding or consequences of an
expected — positive events and
knowledge of, an event and the

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or negative. consequences or
event, its associated likelihood
combination of these
consequence, or of occurence.
likelihood.

Source: ISO/DIS
9001, 3.09

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 What does 6.1 require an organization do?

Identify what YOUR risks and opportunities are – it depends on context

Analyse and prioritize your risks and opportunities

Plan actions to address the risks

Implement the plan – take action

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Check the effectiveness of the actions – does it work?

Learn from experience – continual improvement

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 7 Quality Management Principles

Annex B
Customer
focus

Relationship
Leadership
management

Evidence-
Engagement of
based decision
people
making

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Process
Improvement
approach

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 No Management Representative?

While no explicit requirement for a

“Management Representative”, 5.3
requires that:
• Top management shall assign the responsibility
and authority for:
• Ensuring that the QMS conforms to the
requirements of the standard
• Reporting on the performance of the QMS, on

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opportunities for improvement and on the
need for change or innovation, and especially
for reporting to top management

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 Scope / Exclusions

ISO/DIS 9001:2014 continues

to allow for exclusions (2008
version: 1.2 Application)
• Not restricted to specific section
(2008 “Clause 7”)
ISO/TC 176/SC 2/WG23 N063

• Only allowed if requirement cannot be

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applied
• Documented Justification required
 Documented Information

From Annex SL Appendix 2 core text replaces the terms

‘document’ and ‘record’ throughout the standard by
‘documented information’.

Documented information can be in any format and

media and from any source.
ISO/TC 176/SC 2/WG23 N063

Documented information can refer to the management

system/ processes, information created in order for the
organization to operate (documentation) or evidence of

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results achieved (records).
 ISO 14001 Changes

6.1.2 Environmental Aspects: Now includes consideration of a life cycle perspective

when evaluating environmental aspects

6.1.3 Legal Requirements & other requirements: now ‘Compliance obligations’

6.2 Environmental objectives: Performance indicators are to be defined for each

environmental objective

8.1 Supply chain planning & control: New requirement to ensure outsourced processes,
design process/ life cycle related environmental requirements are controlled or influenced

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9.1.2 Evaluation of compliance: New requirement for the evaluation process with
including a requirement for the organization to maintain knowledge and understanding of
its compliance status.

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Transition
Process
 Transition Planning Guidance

 IAF issued Draft Transition Planning Guidance for

ISO 9001:2015 available here:
 http://isotc.iso.org/livelink/livelink/open/tc176SC2public
 Guidance intended for:
 Organizations certified to ISO 9001:2008
 Accreditation Bodies
 Certification Bodies
 Training Bodies & Consultants
 Draft will not be finalized until ISO 9001:2015 is

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published, but it gives all parties the opportunity to
prepare

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 Transition Planning

We will
18 months Transition
encourage
after Existing audits during A staged
customers to
publication certificates a scheduled approach to
transition
(March 2017), must upgrade surveillance transition is
during their
initial by September or allowed.
recertification
certifications 2018 through recertification Audit records
audit to
shall be to a transition audits will must show
minimize the
ISO audit more audit progress.
additional
9001:2015 time
costs

Transition period from

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September 2015 to
September 2018
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 Certification Body Activities

Auditors Accreditation Body Certified

Customers

• Comprehensive • Apply for • Start briefing

training of Accreditation customers at
auditors at DIS after Auditor DIS stage
Stage training • Preliminary
• Additional • Complete CB Evaluations
training on Transition Audit allowed
differences at focused on • Perform
FDIS and ISO changes and Transition audit
stages the CB’s (Surveillance,
• Verify Auditor transition plan Recertification
Competence (May include or Special)
Witness audit) • Verify closure of
any

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nonconformities
• Issue certificate
to ISO
9001:2015

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 Sector Standard Impact

Revision of Sector standards will follow after

the ISO standards are published.

Sector Representatives are actively engaged

and have influenced the ISO 9001 revisions
• Aerospace – AS9100 (likely release early 2016)
• Telecom – TL9000

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• Automotive – ISO/TS16949
• Exception – Medical Device – ISO 13485:2015
revision aligns with ISO 9001:2008 structure

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 Questions?

Contact me:

Cindy Soltis
Business Manager
Cindy.Soltis@us.dqs-ul.com

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