I did make an introductory mention to the ISO 9001:2015 standard expected to be released in September 2015.
The principled changes are mentioned there. Some QMII
students and alumni have asked me to write a few introductory comments on the
expected structure. I have already written on the HLS (High Level Structure).
In this second blog entry on 9001:2015, I want to introduce our readers and followers
of my blog to the expected changes to ISO
9001:2008 when it is revised and available as ISO 9001: 2015.
In the terms and definitions
itself, some changes are expected. Stakeholder remains a term but the preferred term “interested party” has been
introduced. Audit, conformity, continual
improvement, correction, corrective action, documented information, effectiveness,
management system, measurement, monitoring, non-conformity, objective, organization,
performance, policy, process, requirement, risk, competence, and top management , have now been defined.
ISO 9001:2008 has stood the test
of time, and there are statistics to clearly show that there is satisfaction
with the current version. However, with the change in environment and to ensure
the standard will continue to deliver in the future, changes are required. The
standard must meet not only customer expectations but must consistently provide
goods and services that meet the statutory and regulatory requirements. In the
revised standard, the term “product” is being replaced by “goods and services.”
Some of the standards had different definitions and or implications for the
same term. Now these terms have been standardized for all the standards. The
terms “outsourced” and “purchasing” have been removed and replaced with
"external provision of goods and services". Another major conceptual change is
that “design and development” has been replaced by “development.”
In ISO 9001:2008, clauses under
7.3 took us from design and development planning (7.3.1) to inputs (7.3.2) to
outputs (7.3.3) to review (7.3.4) to verification and validation to control of
design and development changes (7.3.4 thru 7.3.7). However, the standard
allowed exclusions under 7.3 since not all organizations go through each of
these stages. This has now been done away with.
The principles in clauses grouped
under 4 have not changed in concept, except that clause 4.3 has left the
determination of the scope of the organization to the organization. The clauses
under 5 are for leadership and these in principle have not changed. Clauses
grouped under 6 provide the requirements for planning. Clause 6.3 is a change
in that it requires an organization to plan the changes. It replaces the
concept of integrity of the system covered under clause 5.4.2 of ISO 9001:2008.
As we study what to expect under
clauses 7, we see overall the concept is the same. Except in 7.1 resources, there
are changes. Presently in ISO 9001: 2008, clause 6.3 & 6.4 provide the
requirements for infrastructure and work environment. This has been elaborated
and process environment defined together with infrastructure, monitoring and
measuring and in 7.1.5 Knowledge. This new requirement on how organizations
manage knowledge, understand it and deal with it is a new concept. It is still
not clear if this concept will remain and be approved by the committee. Clause 7.5.3
control of documented information replaces the ISO 9001:2008 clauses 4.2.3 and
4.2.4.
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ReplyDeleteFrom Lonney Vogt (Quality Assurance) an Alumni
ReplyDeleteThe new risk focus will be a welcome addition, it has been ignored far too long. We are actively creating a risk-procedure, policy, training, and online tools in preparation. In a previous position, we had launched a very rigorous capability to a US Space Command contract, and it paid great dividends in customer confidence as well as their active participation in a Risk Review Board. We’re basing our implementations on this model currently.