The changes to ISO 9001:2015 are fundamental and are stretching a lot of companies. Companies making the transition will need to go through a ‘transition’ audit where the updates will get specific attention. Having been through the process a number of times now with our clients, here is the list of top 5 things that auditors have asked for.
Demonstrate ‘Risk Based Thinking'
Management of Risk is a loaded term. Often, people will jump straight to Health and Safety, because they associate risk with H&S. But, what you need to demonstrate is that you have considered the things that could go wrong in your business from a ‘quality’ point of view. Issues like non-delivery, warranty claims or complaints, and reject levels.
Consider these comprehensively, and show that you have prioritised the issues most likely to cause a problem.
Do you know your Organisational Context?
The context of the organisation can be described simply as ‘How we want to do it here’. The context can be a quick guide to how you operate with your customers, your suppliers and with your staff.
The point of knowing the context is that it frames how you manage your processes – for example, if you don’t have a complex supply chain, you don’t then need to build a complex purchasing strategy and process.
Are Leaders committed to the integration of the QMS into the company Strategy?
Quality has often been the domain of the white coated inspection blokes who wander round the factory. No longer – Quality seeps through every part of the business from sales to final delivery, and quite often into after-sales service. To make the ISO 9001 work effectively, it needs to work with the company strategy.
Consider this; what is your company aiming to do? The ISO 9001 standard provides a framework that will support and drive your goals.
This is simple. If you have a document that doesn’t add value, don’t have it.
If your team is online, move your system online.
A system that drives consistency and improvement
All the points above are driving consistency and improvement. If your company has clear goals, these should be reflected in the ‘quality’ objectives. The processes and projects that fall out of those should help you deliver your products and services. If things go wrong, the ISO 9001 framework sets out actions that help you correct things, and prevent them going wrong. After a while, your management team can review and if necessary, redirect things.