ISO 9001:2015

Quick Guide to help your transition

ISO 9001 revision

ISO REVISION PROCESS

ISO regularly review standards

approximately every 5-7 years.
How much the standard is
revised is determined by user
input.
There seems to be quite
significant changes in structure
and some additional
concepts/requirements in the
revision

CD Committee Draft
ISO 9001 reached this phase in June 2013
DIS Draft International Standard
ISO 9001 reached this phase in May 2014
FDIS Final Draft International Standard
ISO 9001 reached this phase July 2015
ISO Official Standard published
ISO 9001 is projected to reach this phase in
September 2015; thus the ISO 9001:2015
reference

This guide is based upon the ISO 9001:2015 Final Draft International Standard
(FDIS), the final publication is
due later this year, therefore you should take
into consideration that further changes could take place.

Transition

Period of transition
Organisations have up to 3 years
from release of the new standards in
which to transition their existing
certification.
Transition can be done at any time,
the most efficient way will be to
transition during recertification
Organisations will need to meet the
revised requirements and show
effectiveness of their processes.
TV UK will be communicating and
facilitating these transitions to their
clients.

Audit Time Requirements

Usually additional audit time will be
required.
TV UK are encouraging clients to do early
gap analysis and be able to interpret
standard requirements.
TV UK can do Pre-audits to help clients.
Early reviews of gap analysis are possible,
followed by final review after the
publication of the standard.
TV UK will offer transition
audits after the publication
and
certificates after
successful accreditation
(expected towards the end
of
2015).

Overview of Proposed New Structure

4 Context of
the
organisation
Understanding
Understanding &
&
organisation
organisation

Expectations
Expectations of
of
interested
interested
parties/stakeholde
parties/stakeholde
rs
rs

Scope
Scope

Quality
Quality
Management
Management
System
System

5
Leadership

6 Planning

Management
Management &
&
commitment
commitment

Risks
Risks &
&
opportunities
opportunities

Quality
Quality

policy
policy

Responsibilities,
Responsibilities,
authorities
authorities

7 Support

Resources
Resources

8 Operation

Operational
Operational
planning
planning

Quality
Quality
objectives
objectives

Competence
Competence

Market
Market
requirements,
requirements,
customer
customer
interaction
interaction

Planning
Planning of
of
changes
changes

Awareness
Awareness

Planning
Planning process
process
of
of organisation
organisation

Communication
Communication

Control
Control of
of
externally
externally
provided
products
provided products
&
& services
services

Documented
Documented
information
information

Design
Design &
&
development
development of
of
products
products &
&
services
services

Production
Production of
of
products
products &
&
services
services

Releases
Releases of
of
products
products &
&
services
services

Nonconforming
Nonconforming
products
products &
&
services
services

9
Performanc
e evaluation
Measurement,
Measurement,
analysis,
analysis,
evaluation
evaluation

Internal
Internal

audits
audits

Management
Management
review
review

10
Improvemen
t
Non
Non conformity
conformity &
&
corrective
corrective action
action

Improvement
Improvement

Concept of Risk Based

Thinking

ISO 9001:2015 assumes that a

basic understanding of risk
assessment is increasingly
important for organisations of
all kinds.
No risk assessments are
required, use the term risk
thinking instead.
Different methods can be used,
including risk assessments.
However, no formal risk
management system is
required

Context of the organisation clauses - include determination of

external and internal issues relevant to the organisations purpose
and strategic direction; more akin to a business management
system rather than an isolated quality management system.

Leadership clauses In efect replace top management clauses

with some enhancements on commitments including accountabilities,
compatibility, actions and efectiveness.

7.1
6

Organisational knowledge New concept of determining necessary

knowledge for operation of processes and conformity of products and
services

7.5

Documented information Essentially combines requirements for

documented procured and records into one section with similar
treatment.

8.4

Externally provided products and services Incorporates

requirements of Purchasing and Outsourcing into one; recognising
that todays organisations get services and materials from more than
traditional purchasing arrangements, but in essence the concerns
and controls are the similar regardless of the path these external
products and service comes from

Interpretation of the Additional Requirements

What has been dropped?

Some specific requirements have been dropped from the standards. Examples are:

not specifically required, nor mandated as to its

contents

Quality
Manual

Manageme
nt
Representa
tive

now considered part and parcel of the organisations

leadership and top management (5.1.1; 5.3)

Documen
ted
Procedur
es

left to organisations determination and needs (4.4;

7.5.1)

Preventa
tive
Action

Not a specific clause/record moving forward, but

effectively usurped by the Risk Based Thinking to be
applied throughout the QMS.

It should be noted that these changes do not require organisations to eliminate

existing documents, roles etc.
if they are found to be efective or
necessary for operation of the QMS, but do provide additional flexibility.

Identify organisational gaps which need to be

addressed to meet new requirements.

Develop an implementation plan.

Provide appropriate training and awareness for all

parties that have an impact on the effectiveness of the
organisation.

Update the existing quality management system (QMS)

to meet the revised requirements and provide
verification of effectiveness.

Where applicable, liaise with their Certification Body for

transition arrangements.

Organisations using ISO 9001:2008 are recommended to take the following actions:

Competence and Awareness needs

Dual Compliance

Organisations should plan to remain

compliant to the current standards
while preparing for and implementing
changes for the 2015 standards. Early
disassociation from the existing
requirements may leave
organisations without certification
should their 2015 transition not go as
planned.

Organisations should consider

themselves certified/compliant to the
existing standard until such time as
they have their 2015 certificate in
hand; only then can they consider
disassembling any previously
required framework no longer
mandated by the new standards.

Further information

TV UK has already communicated information on the coming ISO

9001 & ISO 14001 transitions to its clients. This information can be
found at: Factsheet 9001; Factsheet 14001
Additional resources include:
ISO/DIS/FDIS standard

www.iso.org

www.asq.org

www.ansi.org

Contact us
TV UK Limited
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www.tuv-uk.com