4.2 Understanding Interested Parties Needs

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ISO 9001 Requirements-Clause 4.

2 Understanding interested parties needs


Let’s start with paraphrasing what the standard (not just this clause) says and
requires regarding RIP’s:
1. An RIP may affect your ability to consistently provide conforming products and
services to customers.
2. We need to identify each RIP and ascertain exactly in what way, shape or form
they affect this ability (4.2).
3. We need to determine their specific requirements that impact this ability (4.2).
4. We need to track, collect and review information about RIP’s and their
requirements (4.2).
5. When determining the scope of the QMS, the organization must consider the
requirements of RIP’s that are relevant to the QMS (4.3).
6. There is no requirement to widen the QMS scope to include meeting the
requirements of interested parties not relevant to the QMS. (Annex A.3)
7. The quality policy must be available to RIP’s as appropriate (5.2.2.c).
8. The level of control for the design and development (DD) process expected by
RIP’s must be considered in planning the stages and controls for the DD process
(8.3.2.i).
9. The management review of QMS performance and effectiveness must also
consider feedback from RIP’s (9.3.2.c1).
In clause 4.1 we discussed in detail, how an organization must recognize and take
into consideration the various contextual factors impacting it in developing its QMS.
Another big contextual factor that must also be considered are the needs and
expectations of interested parties.
ISO 9000:2015 defines an interested party as ‘anyone who can affect, be affected
by, or believe that they are affected by a decision or activity’ relevant to your QMS.
An interested party is a person, group, or organization that has an interest or a
stake in a decision or activity. Examples include consumer, client, end-user,
retailer, receiver of product or service from an internal process, beneficiary and
purchaser, regulatory body, shareholder, financial institution, insurance company,
etc.
An interested party becomes relevant to your QMS when you have a requirement
that they can meet (i.e. they can affect your organization). For example you have
a requirement for specific materials for your product you manufacture, and they
can provide you with those materials.
The requirement of an interested party becomes relevant to your QMS when they
have requirements that you can meet (i.e. you can affect their organization). Using
the same example as above, in order to provide reliable on-time delivery, they have
a requirement for receiving accurate materials forecasts from you, which you can
provide them.
Now that we understand the definition of a RIP, let’s look at some examples of
these relevant relationships:
What your QMS What a RIP requires from
requires from a your
RIP RIP QMS

P
roduct and service Receive
specifications quality
for design, products and services that
Customer; manufacture, meet their
distributors, delivery, support, specifications. Consistency of
retailers. documentation; etc. quality.
Get good product
performance/ease of use/
Details of their safety/
needs and reliability/
expectations maintainability/disposability,
End-user for intended use etc

Financial
investment; Profitability/return on
decisions and investment/growth in market
Owner/shareholder support value of organization.

Leadership;
direction; Increased growth, sales &
resources; profitability/efficiency &
involvement; effectiveness of
Management motivation; etc operations.

Produce products
and services; follow Good work environment/job
QMS policies and security/health/safety/
Employees procedures; etc training/ promotion,
recognition and
reward
This gives some examples of RIP’s whose needs may directly or indirectly impact
your organization and the ability of your QMS to consistently provide products and
services that meet customer and statutory and regulatory requirements. There are
many other RIP’s that may affect your organization and QMS.
Your organization must carefully evaluate each RIP and their specific requirements
to determine relevance. For example, if your organization has no need of financing,
then financial institutions are not a RIP. If your business is not unionized, the trade
union is not a RIP. Apply the same rationale for other RIP’s listed above.

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