ISO 9001:2015 - Identifying interested parties, or stakeholders

[Marc]

A good read from ASQ's Quality Progress: Expert Answers: February 2018

Under ISO 9001:2015, how specific must you be when stating your interested parties? Can you simply put "customers, stakeholders, employees and suppliers," for example? Or is it better to list the names of organizations and individuals? What is the most effective way of obtaining this information? How should it be diagrammed?

 

[qualprod]

I think it doesnt matter how, while you identify their needs and expectations, as well the way you do the monitoring and revision.

 

[John Broomfield]

I think it doesnt matter how, while you identify their needs and expectations, as well the way you do the monitoring and revision.

qualprod,

On hearing this you, as a trained auditor, can imagine that you may then ask. For example:

1. How does your organization respond to upcoming changes that may be imposed by your government regarding x?

2. How much notice do you receive of any planned changes in taxation that would affect your sales process and who provides this notice?

Other questions usually flow from the auditor as he or she listens intently to the auditee’s answers to these questions.

Find out from top management what actually happens when no one is surprised by such changes.

You should then be well on the way to understanding how your organization works as a system to successfully fulfill its purpose with the help of its stakeholders.

John

 

[Jim Green]

THANKS!
Question: You list a great Table of Interested parties including monitoring and review. Can someone in layman's terms describe the link to 6.1

"When planning for the QMS we shall consider the issues refered to in 4.1 and requirements is 4.2 and determine the risks and opportunities that need to be addressed to:
A) give assurance that the QMS can achieve intended results
b) enhance desirable effects;
etc:

I don't know exactly what to do in relationship to 4.1 and 4.2 regarding Risk based thinking in 6.1... IT is just not clicking with me...

We are not a big company and I just want to keep it simple... Thank you

 

[Sidney Vianna]

I don't know exactly what to do in relationship to 4.1 and 4.2 regarding Risk based thinking in 6.1... IT is just not clicking with me...

Let's imagine a small machine shop that is involved with non-critical, commercial products...they have their stakeholders and context.

Owner gets greedy ambitious and, after hearing that there is a tremendous amount of profit to be made in the medical device and aerospace supply chains, he decides to market the machine shop in these new fields.

Well the risks associated with products in those markets are much higher. Stakeholders such as the FDA and the FAA are now part of the new context. The expectations for system robustness and governance are much higher. Falsify a material certification in the aerospace supply chain and you might end up in jail, after having your business raided by the FBI.

So, risks are obviously connected with your context; present and future.

 

[Paul Simpson]

Hi, Jim. I wrote a short blog a while back that is available on Elsmar somewhere but the original content is here.
Text reproduced below:

ISO 9001:2015 Context is King

In the second instalment of our guest blog series in collaboration with PMI, Paul Simpson uses the example of a corner shop to set the challenge to larger organisations aiming to understand the importance of ‘context’ in ISO 9001:2015

The 5th edition of ISO 9001 contains significant requirements for organisations to assess and take actions on information in their working environment.

In a small number of words the standard creates huge responsibilities for the organisation’s leaders and the only effective way to demonstrate those requirements are met is to look at the organisation as a system and understand the processes that interact with others in the operating environment.

So, what does that mean in practice?

Thinking of my local corner shop to test out a concept

I live in a village where my local shop owner has a very good idea as to who her customers are and their buying patterns. She knows her regulars and those who pop in once a month for a pint of milk late on Sunday. Each time a customer purchases something it is scanned and goes through the till and she gets sales reports as often as she wants. Her staff make a note when someone asks for something not in stock and, periodically, she sits down and decides whether the current stock holding needs to change.

She has supplier reps and multiple mail shots from suppliers to give options and alternative products to stock. Her stock deliveries take place twice a week and an emergency delivery can be called up if needed. She knows her regular sales team, their strengths and weaknesses and sickness patterns and meets each of them daily and talks about what is happening currently and what she plans to do.

In the village the Parish Council is fairly active and occasionally she meets one of the councillors and they talk about village traffic, problems with parking and litter. All in all the relationship is amicable. In surrounding villages there are similar shops and recently one of the majors opened an Express outlet.

In all of the above there are risks and opportunities that can affect the sustainability of her business so she has a plan that attempts to deal with the risks and maximise the opportunities. The plan is in her head and is occasionally discussed with her husband and some ideas are tested with selected customers. The plan adapts in the light of changes to the operating environment of the store.

In the spirit of ISO 9001:2015

So, in my example, we have a system (corner shop) operating in a range of wider systems (village, local area, grocery supply network). The shop is part of a range of processes that take food from farm to fork and news from event to the reader. Each process is operating in real time and competes for time from members of staff and space in the owner’s head in terms of developing plans and strategies.

I’ll put my neck on the line here and state that not only is my local shop owner doing a good job of running her business but her practices are in line with the Deming Cycle and meet the spirit and letter of the requirements in ISO 9001:2015.

For larger organisations context assessment is a much more complicated process, part of strategic management but, if done well, requires no further effort to comply with ISO 9001:2015.

If, however, you haven’t done this piece of work effectively, not only are you in serious danger of failing to meet your system objectives of being a sustainable, profitable business but you cannot hang your 2015 certificate on the wall in reception with a clear conscience.