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It's finally time, you have done all the hard yards and now it's time to actually get your new ISO9001:2015 system officially certified, so what exactly does that mean and how do you do it, there are a few steps to move through to get to that all important ISO9001:2015 certificate. In this post we will cover the 1st two steps.
Firstly, what is a certifying body? That's just the name given to the group of organisations who have been accredited by the International Standards Organisation (ISO) to audit organisations and decide if they are meeting the requirements of the assorted standards, if they aren't nationally accredited then obviously, they are of zero use to you here! Within New Zealand they should be accredited by JASANZ, in the United Kingdom it's UKAS and US it's ANAB. You should be selective when picking a company to act as your certifying body, they have the potential to add a lot of value to your organisation, so you want to pick a good one, here are a few hints.
The stage 1 audit is basically a preaudit that is generally conducted at your site, it doesn't have to be, however. If you have an online system like Mango or say in Google docs that you could give someone access to remotely it can be done off site, of course how much experience the auditor has on your industry is also a factor here.
The purpose of the stage 1 audit is to make sure you have all of the required processes and procedures in place and of course that your resources are ready (and available).
As part of the ISO9001:2015 stage 1 audit they will look at the scope of the management system, this sets the boundaries of what they will audit, so for example if you don't do any design work you would exclude design from the audit, this removes most of clause 8 and dramatically cuts down the auditing time. Be warned however, excluding things from your audit obviously means that any ISO9001:2015 certification will not cover that area and of course you should have a very good reason for the exclusion.
As part of the process the auditor is looking to understand your operation, it's processes and the equipment that is being used. As part of these discussions they are interested in understanding the level of controls you have in place, how you manage those controls and who is responsible for what. They need to understand the impact of any external requirements either form customers or from industry requirements, in electronics for example, frequently IPC requirements are a factor in your quality system.
Essentially then it's a brief (1-2 days) look under the hood of the quality management system to make sure everything is there and there are no glaring issues that would stop a full audit. As part of the stage 1 process the auditor will review these things and create a report for you, if there are issues that would result in a failed audit they will list them in the report as areas of concern that you need to fix prior to the stage 2 audit. This is where the auditor really earns their money, remember at stage 1 you want them to find things, it's where some of the improvement in your Quality management System comes in.
As already mentioned you should expect feedback on area's that need to be improved in order to pass a stage 2 ISO9001 audit, these will also be accompanied by a number of nice to do things that should be looked at as basically tune-ups for your system to help it run better, again give these serious thoughts, they are there to help.
As well as this the auditor will try to figure out if they need more people for e a stage 2 audit to get it done in a reasonable timeframe.
The findings of the audit will generally be presented at the end in a sit-down discussion so the auditor can explain their findings and make sure you understand. This is a great opportunity for you to as questions… ask lots and lots of questions, it's your money.
Selecting the right auditor is a bit part of having a worth while audit, you don't want someone who will give things a cursory glance and say yes or no, you want someone who is really going to look to understand and give helpful advice. The Stage 1 audit is about understanding your organisation and it's readiness for the full audit, out of this you should expect a level of feedback which will include things you need to fix to pass the full audit, these are what you want, it's a good thing so take it as such. It may be that the Audit actually says you are not yet ready for a stage 2 audit, again this is OK, they will give you the list of the gaps and you can re-engage when you have these gaps closed.
If you need any support in developing or improving your ISO or Quality Systems we'd love to hear from you, just click here to make an appointment and find out how we can help you Make Things, Better
You can also call John on 0211649739 to set up a meeting