ISO 9001 Requirements-Clause 4.2 Understanding interested parties needs

By | June 17, 2017

ISO 9001 Requirements

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:

RIP

What your QMS requires from a
RIP

What a RIP requires from your
QMS

Customer; distributors,
retailers. 


P
 
roduct and service specifications
 
for design, manufacture, delivery, support, documentation; etc.


Receive
 
quality
 
products and services that meet their specifications. Consistency of quality.

End-user 


Details of their needs and expectations
 
for intended use

Get good product
performance/
ease of use/ safety/
reliability/ maintainability/
disposability,
etc  

Owner/shareholder 


Financial investment; decisions and support

Profitability/return on
investment/growth in market value of organization. 

Management 


Leadership; direction; resources; involvement; motivation; etc


Increased growth, sales & profitability/efficiency & effectiveness of
operations.

Employees 


Produce products and services; follow QMS policies and procedures; etc


Good work environment/job security/health/safety/ 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.

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 article.

Understanding ISO 9001:2015 Requirements eCourse

ISO 900:2015 Requirements eCourse