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ISO9001 and The Resource Requirements

ISO9001:2015 Section 7, Support, has had a few changes, Clause 7.1 – Resources especially, it goes from only 31 words in the 2008 version of the standard to 2 pages! Resources required around your Quality Management System have always been a bit subjective and varied wildly, now, however, the ISO9001:2015 version of the standard puts some much-needed structure around it and while it will need more thought it really will help your organisation.

In this post, we will cover sections 7.1.1 (general) to 7.1.4 (Environment for the Operation of processes) the remaining sections 7.1.5 & 7.1.6 we'll cover in our next post.

Clause 7.1.1 General

This is largely what the clause was before, the organisation needs to figure out what resources are required to not only implement the Quality Management System but also have time to carry out improvements are available. There are two options for this resource, of course, it can be internal, or it can be a suitably qualified external person, both are ok to use. In both cases however you need to ensure that they have the required capabilities, training, funding and capacity to get the work done.

Clause 7.1.2 People

This little clause is all about specifically ensuring that you have the people available to implement the ISO9001:2015 Quality Management System, run it, control it and improve it. They need to be trained and deemed competent for the part that they play. That means you need to be able to prove that in some way either through your paper training records or if you have a system like Mango QMS you can just look it up in the HR module which links the training directly to the documentation.

Clause 7.1.3 Infrastructure

What has this got to do with ISO9001:2015? Well think about it if you don't have adequate equipment, software, buildings – are they falling down a rabbit warren that stifles great communication? (and their associated utilities e.g. water!) you will have a problem delivering a quality product. Similarly, if you physically can't transport the product around either internally or externally you can't deliver a quality product and of course, information and communication systems are now so integrated into a business that you really must control these, how stable are your servers? How is your Disaster recovery side of things if your server fails? Are your documents backed up? The organisation needs to determine which elements of its infrastructure needs and will vary wildly based on the size & type of organisation & it's products and services

Clause 7.1.4 Environment For Operation Of Processes

This clause of the standard requires organisations to determine & control the environment for the operation of it's processes to ensure good quality. So, what does that mean? Let's take an electronics company for instance, the environment there should ideally be temperature controlled and if you are in a high or very low humidity environment then the humidity levels must also be controlled as these things can impact the quality of the product. More overt they can impact the physical well being of your staff as well.
This section requires you to look at your organisation from 3 angles and determine if they impact your Quality Management System
  • Social – do you operate a non-discrimination, non-confrontational environment? How do you do that? Are you socially responsible?
  • Psychological – do you have things in place which will reduce stress, prevent burnout of your people and support them emotionally as needed
  • Physical – Are you controlling the temperature / humidity the light levels the hygiene or the noise?

Each of these items will impact organisations in different ways and each should be assessed with your organisation in mind. They should consider both the people in your organisation who, after all, are responsible for executing your Quality management System but also your products and your processes. Again, for example high temperature swings in an organisation who is measuring small high tolerance metal parts may be an issue due to thermal expansion, it may not be an issue if you are a foundry.

Summary

ISO9001:2015 Clause 7.1 - resources is all about ensuring that the organisation has thought about and put in place the resources required to do what they say they are going to do. So really when you stop and think about it for a moment, the 3 sections discussed so far – People, Infrastructure and Environment for operation really do help prompt the organisation to understand if they have the resources they need at a capability level that is required to really deliver the quality product that they want to, if not then they get to understand that and put steps in place on how to create it.



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Saturday, 17 August 2019

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