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FAQ:  How do we get certification to the ISO 9001 quality standard?

You must go through a formal application and audit process with an accredited certifier or auditing body (often called 'registrar' in the USA and UK).  But the real process to get ISO 9001 begins much earlier.

Process outline: how to get ISO 9001:2008 certification

1. Make the decision to 'get ISO'.  This needs commitment from 'top management' - the person or people in charge.  Don't overlook or skip the importance of this step - the commitment needs to be there, and it needs to be backed up with action as well as words.
    
2. Appoint someone as project manager.  'Getting ISO' is a project, so someone must have the responsibility - and the authority! - to manage it internally.  Allocate resources.  You'll need to decide whether to use a consultant, or do it yourself. 
    
3. Do a 'gap analysis' to establish where you are now, against where you need to be, and identify the tasks to be done.
   You'll probably have some bits of your quality system in place already, but other requirements of the Standard may be only partially done or not done at all. Use the gap analysis results to plan what to do, who will do it and when. 
    
4. Now start work on the plan.  Improve and develop your system: fill the gaps from the Gap Analysis, revising, adding or improving where you need to. This includes identifying your processes, documenting your system, and making all the improvements necessary to meet the requirements of the Standard.  You'll use the 'PDCA' or continuous improvement cycle to do this.
   
   It's this stage that takes the most time & effort.  Get people involved throughout, so that people help build it, and so they they understand and use the system and have opportunities to participate and contribute.  A system developed by one person and imposed on others is rarely a good one.
    
5. Review and audit your own system internally.  You will find some problems -- if you don't, you aren't auditing properly.  Resolve the issues you find, using your formal correction procedure/s (part of the requirements) to do it.
    
6. Choose a certifier, and schedule the external audit.
    
7. Undergo the external audit. During this, the certifier (external auditor) audits your quality system against all of the specific requirements of ISO 9001. 
    
8. Get the certificate and celebrate!
   Assuming you are successful, of course, you can now get that coveted certificate from your certifier. 

The certificate will arrive a bit later, after the audit. The exact format varies according to your certifier (type of logo, etc).  Your certifier enters you onto the official world-ride register of certified organisations - see Links for more info.

You are now said to be 'registered (or certified) to ISO 9001' or to 'have ISO 9001 certification'.  Note that people often refer to this as 'ISO 9001 accredited', though this term isn't actually correct.

While that's a summary of the process, there is of course a little bit more to it.  There are traps for the inexperienced and yes, some 'inside knowledge' is needed.  Without it, you'll find it hard going and of course you'll make mistakes.

The Most Common Mistakes Made with ISO 9001

Some very common mistakes often happen when companies try for ISO 9001. Usually they:

• Don't really know what they want from their system
• Don't make the system work for them
• Don't keep it simple
• Don't understand the Standard, let alone how to apply it to what they do
• Don't know or use a 'systems approach'
• Don't get the documentation right (the dreaded 'quality manual')
• Don't get their people involved
• Don't actually know what they mean by 'quality’.

Then there's the biggest one of all.

• They don't follow their own system.  Is it any wonder?

Perhaps you've already looked into getting ISO 9001.  If you've read it, you'll probably agree it doesn't make great reading.  But it does talk about a 'quality manual', so presumably you have to write lots of documents.  Don't you?

What about that 'quality manual'?

Many people still believe an ISO 9001 system must have reams of documents.  Or that a 'proper' quality manual must have a policy and procedures for every single clause in the Standard.  Which would mean an absolute minimum of at least 22 written policies and as many procedures, if not more, whatever your size or what you do! 

Fact: you don't need to do that.   Unless you really like huge manuals with lots of pages? And really want procedures with titles like "Design Control" or "Management Review" or "Customer-Supplied Product"?  Full of multi-level numbering, like '5.5.6.14 this' and 'refer to 12.7.3.2.9' and see 'Form #QAP-4AU-002'.  (If you think I'm making this stuff up, see here for an example.)

Another assumption:  "everyone" is a big company, yet there are many smaller ones with limited resources, a business to run and customers to satisfy. So if you aren't a big company, how do you find out what you have to do and how? 

There's the hard way: do a lot of work first, then find what you did wrong and redo it.  That costs you time, money and effort. Then there's the easier way: a friendly expert shows you how to do it and explains with a user-friendly DIY ISO 9001 kit. Wouldn't you agree that's more effective?

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