Understanding ISO 9001:2015
Clause 4.2 Understanding the needs and expectations of interested parties
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
6. There is no requirement to widen the QMS
scope to include meeting the requirements of interested parties not relevant to the QMS. (Annex
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
process expected by RIP’s must be considered in planning the stages and controls for the DD process
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
as ‘anyone who can affect, be affected by, or
believe that they are affected by a decision or activity’ relevant to your QMS.
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.
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
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 requires from a
What a RIP requires from your
roduct and service specifications
for design, manufacture, delivery, support, documentation; etc.
products and services that meet their specifications. Consistency of quality.
Details of their needs and expectations
for intended use
Get good product
performance/ease of use/ safety/
Financial investment; decisions and support
investment/growth in market value of organization.
Leadership; direction; resources; involvement; motivation; etc
Increased growth, sales & profitability/efficiency & effectiveness of
Produce products and services; follow QMS policies and procedures; etc
Good work environment/job security/health/safety/ training/ promotion, recognition and
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.
In my eCourse, I cover many
other RIP's and show you how to evaluate the risks and opportunities they present and provide specific actions
you should take to address them.
The ISO 9001:2015 eCourse shows you how
to easily and effectively IMPLEMENT the requirements listed at the start of this
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