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The purpose of this handout is to provide LRQA clients with Organisations certificated to ISO 9001:2008 will have three
an insight into the newly revised version of the international years following publication of ISO 9001:2015 to transition to
Quality Management System (QMS) Standard ISO 9001:2015, the revised standard. As a result, LRQA recognises that there
which was published on 15 September 2015. will be ongoing demand for knowledge of ISO 9001:2008 at
least until September 2018.
ISO 9001:2015 Overview
Background
All Management System Standards (MSSs) are subject to regular review.
The last significant revision to ISO 9001 was in 2000. ISO 9001:2008
clarified points and enhanced compatibility with ISO 14001 (EMS). More
recently, ISO 9001 has been subject to a comprehensive rewrite to
ensure that purpose appropriately supports the changing needs of
today’s world and reflects the increasingly complex environments in
which organisations operate.
Many organisations use and are Essentially, Annex SL defines how all The significance of changes usually
certificated to multiple management future new and revised MSS will be diminishes as development progresses.
system standards. This had led to structured. The first standard to adopt Once the FDIS is released the nature of
organisations seeking to combine or this structure was the Business Continuity any further change is normally minor.
integrate their management systems in Management standard (ISO 22301).
an effective and efficient manner. The Similarly, the new version of ISO 9001 In May 2014, the new version of ISO 9001
reality is that the continued proliferation has been prepared using the had reached the DIS stage.
of ISO MSSs has resulted in many “High-Level Structure” (i.e. clause
apparently common requirements that sequence, common text and ISO/DIS 9001:2014 was approved by the
are subtly or substantially different. This terminology provided in Annex SL). technical committee and released for
has caused confusion and inconsistent public review and comment. The FDIS
understanding and implementation. The development and approval of version was published in July 2015.
ISO MSSs follows an established process The FDIS version was then adopted as the
In order to deliver consistent and and sequence; Committee Draft (CD), final published standard ISO 9001:2015 on
compatible management system Draft International Standard (DIS), 15 September 2015.
standards in the future, the ISO Technical Final Draft (FDIS) followed by publication
Management Board has produced a of the Standard. There will be a three year transition
common framework for all MSSs. period for existing ISO 9001:2008
This common framework is referred to accredited certifications, giving a deadline
as “Annex SL1”. of September 2018 for organisations to
migrate their QMS to ISO 9001:2015 for
their certification to remain valid.
1 Specifically:
Annex SL of ISO/IEC Directives, Part 1,
Consolidated ISO Supplement, 2013
Leadership
Section 5 dedicates itself to “Leadership”. This clause calls for the organisation’s Thus, the top management assume
top management to demonstrate their an active role in the QMS by taking
This section is divided into involvement and engagement with the accountability for its success themselves
three sub clauses: quality management system though (and not leaving it to the Management
direct participation in, for example: Representative – which, by the way,
5.1. Leadership and commitment. – Taking accountability for the is no longer explicitly called for in the
effectiveness of the quality new version). The leaders must also
5.2. Policy.
management system. integrate the QMS into the organisation’s
5.3. Organisational roles, responsibilities – Promoting the use of the process processes; so the process approach is
and authorities. approach. more to the fore in the new standard.
– Promoting improvement.
ISO 9001:2015 replaces “Management – Supporting other relevant
responsibility” with “Leadership”, and management roles to demonstrate
repositions a number of ISO 9001:2008 their leadership as it applies to their
requirements as leadership activities. areas of responsibility.
Process approach
Where ISO 9001:2008 promotes the For example, determination of inputs For example, ISO 9001:2015 also states
adoption of a process approach required and outputs expected, that organisations need to determine
ISO 9001:2015 requires the organisation resources needed, and assignment of performance indicators that allow for
to establish a process-based quality responsibilities and authorities. the effective operation and control of
management system. processes, identify risks and opportunities
Much of what is given in clause 4.4 of for processes, and plan to address these.
ISO 9001:2015 Clause 4.4 states explicit ISO 9001:2015 can be found in
requirements that need to be met in the ISO 9001:2008. However what
design, operation and maintenance of a was previously promoted is now a
process-based management system. requirement, with requirements around
processes appearing throughout ISO
9001:2015.
Risk-based thinking
The concept of risk-based thinking is described in the
Introduction of ISO 9001:2015.
Risk is about what could happen and what preventive action has disappeared. – Clause 6 (Planning) the organisation
the effect of this happening might be. Risk is required to determine the risks
also considers how likely it is to happen. ISO 9001:2015 requires the use of risk- and opportunities that need to be
based thinking to achieve conformity addressed and plan actions to address
Risk is commonly understood to be in the products and services provided them.
negative. In risk-based thinking, when by an organisation, and thereby improve – Clause 8 (Operation) the organisation
dealing with uncertainty, opportunity customer satisfaction, in the following is required to implement processes to
can also be found. The opportunity could way: address risks and opportunities.
be related to reducing the likelihood of – Clause 4 (Context) the organisation is – Clause 9 (Performance evaluation) the
something going wrong or improving required to determine the risks which organisation is required to monitor,
conformity and customer satisfaction. may affect this (i.e. conformity in the measure, analyse and evaluate the risks
products and services provided by an and opportunities.
One of the key changes in ISO 9001:2015 organisation). – Clause 10 (Improvement) the
is to establish a systematic approach to – Clause 5 (Leadership) top management organisation is required to improve by
risk, rather than treating it as a single is required to commit to ensuring the responding to changes in risk.
component of a QMS; as is the case with risks and opportunities that can affect
ISO 9001:2008 where preventive action is a conformity of products and services
standalone clause. and the ability to enhance customer
Now risk is considered and included satisfaction are determined and
throughout the standard and the term addressed.
ISO 9001:2015 Overview
Other changes
Most of the requirements of ISO 9001:2008 are carried forward to
ISO 9001:2015. To improve consistency of interpretation and
understanding, and aid translation, many requirements remain
unchanged. Also the restructuring of the standard
often means existing requirements have new clause numbers.
– The term ‘product’ is replaced by This is information that the This ensures that there is commonality
‘products and services’. organisation is required to keep, with other management system
– ‘Quality objectives’ is expanded to control and maintain. standards and so you will be able to see
‘Quality objectives and planning to the same headings in ISO 14001:2015
achieve them’ with more emphasis – There is no longer a requirement and ISO 45001 (the replacement for
on planning how objectives will be to appoint a ‘Management OHSAS 18001 when it is published) and
achieved and making these planning representative’. group what you do for them together in
requirements explicit rather than your management system.
implicit. There are other changes where aspects
– The phrase ‘externally provided of a management system are more clearly Lastly, there is clause 10 about
processes, products and services’ described because the Annex SL format Improvement. ISO 9001:2015 recognises
replaces ‘Purchasing’. has a clause to address it. that incremental (continuous)
– References to a documented quality improvement is not the only
manual, documented procedures and Such as: improvement profile. Improvement
to quality records are removed. – Competence can also arise as a result of periodic
Instead, throughout ISO/FDIS 9001:2015 – Awareness breakthroughs, reactive change or as
there are specific references to – Scope a result of reorganisation.
“Documented Information”. – Communication
Changes to the model of a
process–based quality management system
The new version of the standard brings with it an updated
version of the model, including the relevant clause numbers.
Quality Management System (4)
Organisation
and its
content (4)
Support
and
Operation
(7, 8)
Plan Do Customer
satisfaction
Products
Act Check and services
Conclusion
The most significant changes that ISO 9001:2015 will introduce
come from adopting Annex SL.
Organisations will need to review fully In preparation for the changes, LRQA These will be:
their current QMS to ensure all the new can perform a Gap Analysis on your – ISO 9001:2015 for internal auditors
and enhanced requirements of current system to determine how much A one day course for internal
ISO 9001:2015 are met. For any work you need to do to bring it into auditors.
organisation the degree of change line with the new standard. – ISO 9001:2015 Lead Auditor transition
necessary will be dependent upon the training
maturity and effectiveness of the current We will also be offering a number A two day course for those who
management system, organisational of highly useful training courses to have successfully completed QMS
structure and practices. bring you, your management and Auditor/Lead Auditor training based
your auditors up to speed on the on ISO 9001:2008 or ISO 9001:2000,
It will be September 2018 before new standard in readiness for a and want to upgrade to the new
certificated organisations must complete smooth transition to being certified standard; including those auditors
transition to the new standard, however to ISO 9001:2015. seeking re-registration with IRCA or
accredited certification bodies are advising another auditor certification body.
that their clients start to make appropriate We are offering:
preparations as soon as practical and not – ISO 9001:2015 – Update Workshop In the meantime we will continue to
delay until the last moment. A one day appreciation course. keep clients and delegates informed
– Preparing for ISO 9001:2015 and ensure our courses remain current
ISO 9001:2015 will build upon the A two day implementation course for and relevant.
current standard; it will not take quality management system managers.
management in a new and completely
different direction. The course you are We will also offer transition courses
attending now will give you essential which will bring your auditors up to
knowledge and skills and help lay the speed with the new requirements and
foundation for your further development the types of evidence that you will be
and transition to ISO 9001:2015. looking for to verify conformance.
ISO 9001:2008
ISO 9001:2015 to ISO 9001:2015
Overview
Correlation Matrix
lrqa.co.uk/iso-revisions
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for inaccuracies in, or changes to, information. Lloyd’s Register and variants of it are trading names of Lloyd’s Register Group
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© Lloyd’s Register Quality Assurance Limited 2016. A member of the Lloyd’s Register group. Pub. April 2016