ISO 9001:2008 Do you comply?
You may well now have been audited to the new ISO 9001:2008 standard by your Certification Body but what exactly are Certification Bodies looking for and what tangible changes can and should you make to your Quality System?
Okay, the first thing to remember is this… There are no new requirements to ISO 9001:2008… but the standard has introduced a few specific areas that Certification Bodies are asking questions about during their routine visits.
QCS has compiled this insider’s report based on our contacts within Certification Bodies and also from our vast network of customers who have been assessed since the standard was issued in November 2008.
Here are the 8 most common questions…
- Do you outsource any part of your processes that affect your product or service? How do you control the outsourced supplier?
- Is the management representative a member of your management team?
- Has necessary competence been defined for people performing work that affects your product or service?
- Have you identified product (or service) status with respect to monitoring and measurement requirements throughout product/service delivery (not just at the end)?
- Does your corrective action procedure ensure that you review each corrective action to ensure it is implemented and is effective (i.e. has fixed the root cause of the issue)?
- Are you reviewing the effectiveness of each corrective action?
- Does your preventive action procedure ensure that you review each preventive action to ensure it is implemented and is effective (i.e. will fix the root cause of any potential issue)?
- Are you reviewing the effectiveness of each preventive action?
So what do you need to do? Well review the list of common questions by all means but if you have been running your system as a genuine business improvement tool then the answer is probably very little.
Other tips to show you have embraced the new standard and made all necessary changes may include:
- Buy a copy of the standard! Yes I know there are few changes but how can you claim compliance to a standard you don’t actually own.
- Review the 2008 standard as part of an internal audit and document the audit to show that you have evaluated any changes.
- Document the transitional review in your Management Review – it’s a great way to show the management team are keeping up to speed with the changes – however small the changes are.