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1. Does your quality policy include the framework for setting quality objectives?

(Clause 5.2.1)

This question was in the earlier 2008 version of 9001, however it is so often missed, by both
the people writing the policy and the auditors checking it. So what do they mean by a
framework? Well it’s like a mini procedure or process. A framework should give you, the
reader, an understanding at a high level of what is to happen. Some example answers might
be.

“We set annual quality objectives and our performance is measured against them”.

“We have a five-year rolling business plan that includes quality objectives which are
measured and reported on as part of our annual report”.

2. What are the external and internal issues that are relevant to your organisation, its
purpose and its strategic direction, and how do you keep this information up to date?
(Clause 4.1)

This question is about the alignment of the quality management system with the
organisation’s strategic business plan. The purpose of this clause is to ensure that the
business’s strategic direction (or where the business wants to go) and its QMS are working
together. The QMS needs to be part of, and not separate from, the business.

3. Who are the interested parties that are relevant to your organisation, and what are
their requirements that are relevant to your quality management system? (Clause 4.2)

This is essentially new and it requires the organisation to now determine the requirements of
interested parties as well as the requirements of their customers.

But a word of advice… the only interested parties that the organisation needs to consider are
those that it decides are relevant to the QMS. This is explained in Annex A3 of ISO
9001:2015.

4. Is your QMS documented around the processes of your organisation and have you
determined the sequence and interaction of these processes? (Clause 4.4.1).

This is not a new requirement; in fact it has been in ISO 9001 since the 2000 version but it
seems to be one of the requirements that organisations really struggle with. Essentially what
it means is that the QMS should be written and aligned around the organisation’s business
processes and not written and aligned with the numbers of ISO 9001.

Note: If your management system aligns with the numbers of ISO 9001 or any other standard
or set of requirements, it is not correct.

5. Have you determined the inputs and the expected outputs from these processes?
(Clause 4.4.1).

This is new and it re-enforces the previous question. When done correctly, an organisation
will find that the outputs from one process will be the inputs to the next process; and for a
process to operate effectively it needs to have the correct outputs from the previous process.
This is a positive additional requirement to ISO 9001.

Leadership

The following questions about leadership apply directly to the boss and, to a slightly lesser
extent, the senior management (leadership) team. These questions are about how leadership
and commitment are demonstrated, and they all come from ISO 9001 clause 5.

Note: Whilst top management was responsible for certain things in the previous 2008 version
and therefore leadership was expected, the actual term “leadership” was not specifically
used.

6. How are you accountable for the effectiveness of the QMS? (Clause 5.1.1 a)

Top management used to have to demonstrate commitment, now they have to really step up
and be accountable for the QMS. Being accountable means they have ultimate responsibility
– they are expected to make decisions and justify actions. The buck stops with them.

7. How do you promote the use of the process approach and risk-based thinking?
(Clause 5.1.1 d)

There are two things here that the boss needs to know: 1. the process approach and 2. risk-
based thinking; but the question should actually not be about their knowledge, but about how
they “promote” both things. Do they ‘walk the talk’? Do they chair awareness sessions? Do
they say and do the right things?

8. How do you engage with, direct, and support persons to contribute to the
effectiveness of the QMS? (Clause 5.1.1 h)

This is not about abdicating the responsibility to someone else (in the old days this may have
been the “quality manager”). This is about persons (plural), so it means everyone involved in
the QMS. How actively involved is the boss with the people on the ground or those on the
front line?

9. How do you promote improvement? (Clause 5.1.1 i)

Improvement means that the organisation is becoming better – and this improvement should
be aligned with the quality objectives (Clause 6.2) and the strategy direction. But similar to
question 7, this is not about the boss knowing these things, it’s about how he/she promotes
them.

10. How do you support the other management so they can demonstrate their
leadership? (Clause 5.1.1 j)

What does the boss do to ensure that the other managers (at all levels) are able to show to
their staff the importance of the QMS and how its applies to them? How do the other
managers from the senior management team down to the front line promote the requirements
and benefits of the QMS?
Hopefully you will have noticed similarities between the key areas in the 2008 and 2015
versions; and for the most part, there are some strong continuations. However, the
requirements for 2015 focus more on aligning with the organisation’s strategy and making
the QMS more relevant to the business.