ISO Revisions

ISO Revisions

ISO 9001 Whitepaper

The history and future of ISO 9001
Approaching change
Introduction
ISO has recently released the results of their 2012 survey of certificates. This annual study shows that over one
million certificates for ISO 9001 have now been issued globally – proving that the standard remains in high
demand. Certified organizations feel the standard helps them to become a more consistent competitor in the
marketplace and with a strong focus on quality management, allows them to attract and meet the needs of high
value customers better. With a certified system in place, they can save time, money and resources while optimizing
their operational performance with fewer errors and higher profits. The standard also helps them to set up efficient
internal processes that motivate staff.
With a revision for 2015 underway, this whitepaper looks at the history of the standard, how it has developed over
the years and the changes companies can expect to see in ISO 9001:2015.

The history of ISO 9001

The UK’s very first quality management servicing, while the third covered final them to deliver on these. The standard also
standard was known as BS 5750. Driven inspection and testing with no concern for looked at how to continuously improve
by the Ministry of Defence, this standard how the product was made. processes and track customer satisfaction.
specified how the manufacturing process Where previous versions focused on quality
should be managed, instead of looking control, ISO 9001:2000 was built on
at what was manufactured. In 1987, BSI
From 1994 to 2008 quality management.
convinced ISO to adopt BS 5750 as an ISO 9001:1994 placed particular emphasis ISO 9001:2008 only made the existing
international standard. It was named on product assurance using preventive requirements of the 2000 version
ISO 9001 with variants developed to cover actions, instead of just checking the final specification clearer. It also incorporated
different types of business. product. It also required companies to some changes to make it more consistent
comply with documented procedures – with ISO 14001:2004, the environmental
Although ISO 9001:1987 followed
recognizing the trend to manage quality by management system standard.
BS 5750’s structure, it also came with
control rather than assurance.
three models for quality management Later in 2009, ISO 9004 (which
systems. One looked at quality assurance ISO 9001:2000 placed quality and process accompanied ISO 9001:2000 for the first
in design, development, production, management at its core, changing the time) was revised to promote a sustainable
installation and servicing for companies previous versions radically. It aimed to business approach. This version focused
creating new products. The second model first understand the client’s requirements on all stakeholders and not just customers
focused on production, installation and before designing processes that would help and social conditions.

Making ISO 9001 work in every industry

ISO 9001’s requirements are generic and • Automotive: ISO/TS 16949 is an Unlike the standards it replaces,
must be carefully interpreted to make sense interpretation that was developed by the ISO 13485:2003 is a stand-alone
within specific organizations. Manufacturing IATF, a group of motor manufacturers specification. That means compliance
is not like a service industry, for example. So, including GM, Ford and Chrysler. with ISO 13485 doesn’t necessarily mean
over time various industry sectors wanted compliance with ISO 9001:2008 and vice
to standardize their interpretations of the • Telecommunications: TL 9000, the versa.
guidelines specifically for their marketplace. Telecom Quality Management and
These include: Measurement System Standard, was • Oil and gas: ISO/TS 29001 looks at
developed by the telecom consortium, the design, development, production,
• Information technology: TickIT interprets QuEST Forum. Unlike ISO 9001 and other installation and service of products for
ISO 9000 for the software development sector-specific standards, TL 9000 sets the petroleum, petrochemical and natural
industry. out standardized product and process gas industries.
measurements that allow companies
• Aviation: AS 9100 is an Aerospace to benchmark their performance in key
Basic Quality System Standard that
process areas against peer organizations.
was developed by major manufacturers,
including Boeing, Lockheed-Martin, • Medical: ISO 13485:2012 is the medical
McDonnell Douglas and Pratt & Whitney. industry’s equivalent of ISO 9001:2008.
 ISO Revisions

Why ISO 9001 is changing

All ISO standards are reviewed every five national position on the draft and comment International Standard is published and
years to make sure they are still current and on it. This normally takes between two to goes out for public comment. This will
relevant in the marketplace. That is why ISO four months. happen during the second quarter of 2014.
9001 is currently under review Once the new draft has been finalized and
Once the national positions have been
– at Committee Draft stage – and an accepted, it is published with a new date
submitted, experts – all nominated by
updated version is due towards the end of following the standard’s number. In this
the ISO members of the participating
2015. The Committee Draft stage is the first case, the revised ISO 9001 standard will be
countries – meet regularly to discuss issues
consultation in the development of an ISO published next year as ISO 9001:2015.
or answer questions that have been raised.
standard where members who have chosen
These meetings will continue until a Draft
to take part in the revision, will form a

ISO Revisions

The changes
All ISO management systems share common better understanding for those tasked with Clause 1: Scope
elements. But despite this, these systems implementing them.
come in many different shapes and structures Clause 2: Normative references
This new high-level structure is sometimes
which can lead to confusion and difficulties Clause 3: Terms and definitions
referred to as Annex SL and all ISO technical
when they are implemented.
committees who develop management Clause 4: Context of the organization
ISO has already completed some initial system standards in future will use this as Clause 5: Leadership
work to provide an identical structure, text their blueprint. The high level structure is
and common terms and definitions for designed to align format, text, terms and Clause 6: Planning
all management system standards of the definitions, while still giving standards Clause 7: Support
future. This means that both future and developers all the flexibility they need
revised management system standards Clause 8: Operation
to integrate their technical topics and
will be consistent and simpler to integrate. requirements. ISO 9001:2015 will adopt the Clause 9: Performance evaluation
The revised structure will also make the new high level structure and will have the Clause 10: Improvement
standards easier to read – leading to a following outline:
ISO Revisions

Key changes in detail

Clause 4 refers to the context of Clause 5 is about leadership. As mentioned customer needs and improve their overall
the organization. This is a brand-new before, this requirement has been set in satisfaction. The third change to Clause 7
requirement and highlights the need place to ensure quality policies are aligned refers to the competence requirements that
for senior managers to understand the with strategic direction. This will help relate to every process or set of processes
expectations of all relevant parties. They’ll organizations to identify, assess and manage within organizations.
also need to know how internal and external all risks that could stand in the way of Clause 8 has two new requirements. The
challenges could affect their ability to meeting product requirements. Clause 5 also first is contingency planning to improve
meet these. This clause is closely linked highlights the need to allocate responsibility customer communication, while the second
to leadership which means management for process management. looks at ways to assess the suitability of a
systems can no longer be held at arm’s design before it reaches operations. Clause 8
There are significant changes in Clause 6.
length, but should form part of the strategic also specifies the importance of controlling
This section will now replace the need
direction of the business. This will help to all outsourced activities through efficient risk
for preventive action and focus on risk
raise the standards in the boardroom and management.
and opportunities that relate to product
align management systems with the needs
conformity and customer satisfaction. Clause 9 includes stronger monitoring
of the business.
Clause 6 also sets out better requirements and measurement requirements and also
to help organizations manage change in a introduces how this works in relation to risk
Clause 4 also looks at process management.
systematic manner. and the effectiveness of an organization’s
From now on organizations need to
determine process risk and have measures Clause 7 looks at how to manage changes quality management system.
in place to ensure effective operation. They’ll to resources more effectively. It also includes Finally, Clause 10 sets out a more structured
also need to allocate responsibilities for a new requirement to determine, present and approach for Continual Improvement
particular processes or sets of processes. maintain knowledge to continuously meet Internal Audits.
 ISO Revisions

ISO 9001: 2015

In summary
According to the draft design specification, process management, the standard will also ISO 9001:2015 will also improve
the revised standard will provide a stable, reflect the changes in quality management implementation and conformity
core set of requirements for the next ten system practices and technology since the assessments for first, second and third
years or more. These will stay generic, but last major revision in 2000. By applying parties. Using simplified language and
be relevant to organizations of all types Annex SL, the revised standard will improve writing styles, the new updated standard
and sizes operating in any sector. While compatibility and alignment with other ISO will help all stakeholders to understand and
maintaining its current focus on effective management system standards. interpret key areas better.

More about PAS 99:2012

PAS 99 is a Publicly Available Specification this specification, much of the thinking in reflects Annex SL and uses its text where
designed to integrate common PAS 99 had an impact on the development, it is appropriate – providing a future-proof
management systems. With many BSI structure and content of Annex SL. approach for integrating new management
clients choosing to have their integrated PAS 99 was introduced in 2006 and revised systems.
management systems (IMS) certified against in 2012. This revised version therefore
ISO Revisions

Certification Support from BSI

When ISO 9001:2000 was first introduced, BSI will carry on monitoring the proposed changes and keep all clients
there was a three-year transition period updated throughout the development process. This information will be
for certified organizations to make the available on bsigroup.com and webinars, as well as regular newsletters,
necessary changes and retain their workshops, publications and training courses. BSI will also make sure that
certification. It has been confirmed by the
all their client managers are fully briefed on the changes, so they can advise
International Accreditation Forum that
their clients in advance about the impact these revisions will have on their
ISO 9001: 2015 will have the same transition
period of three years. organization.
ISO Revisions

Getting ready for change

Certified organizations should talk to their making senior management aware of the benefits are significant. It takes between

BSI/UK/394/SC/0314/en/BLD
client managers to keep up-to-date on the coming changes and ensure a transition plan six to 12 months from starting a project to
proposed changes. It’s worth considering is in place. When the draft becomes available getting certified, so there is still enough time
purchasing PAS 99 to understand the for public comment in 2014, organizations to achieve this and then take advantage
implications and opportunities of Annex can buy it to become familiar with the of the transition period. BSI and other
SL – especially since BSI will continue to changes before the official publication in certification bodies will continue to issue
issue certificates against PAS 99. Anyone 2015. existing certificates up until September
adopting PAS 99 will find the transition to 2015. Once certified, these companies have
© BSI Group

Organizations that are still considering

the revised ISO 9001:2015 much smoother until September 2018 to make the necessary
getting ISO 9001:2008 certified, should
due to its similarities found within Annex SL. changes and get ISO 9001:2015 certified.
not delay implementation – the business
All certified organizations must also start

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