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 organizations 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 CBs (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

DQS-UL Management Systems Solutions

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