ISO9001:2015 Cl. 4.4.1 - What Processes Do I Need Documented

#1
I'm new to being the QA Manager, and am trying to get my company upgraded to 9001:2015. I've had to revamp our whole ISO system, because it was neglected for many years. I think I'm getting close, but am curious about 4.4.1 "The organization shall establish, implement, maintain and continually improve a QMS including the processes needed & their interactions, in accordance with the requirements of this international standard"
We have work instructions (that need updating) but no "Processes" that are documented. What exactly do I need to have here?
Just processes pertaining to the Quality Department, or processes showing the main functions of the company? We're a distributor, so we don't manufacture anything.
Any examples you could give would be very helpful! Thanks!
 
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#2
Re: ISO9001:2015 - What Processes Do I Need Documented

I would say processes showing the main functions of the company. Should show what you need for your company to run its business.

Just out of curiosity, you say you are revamping your old ISO (9001) system. What revision of the standard was it developed against? The ISO process system came about with the ISO 9001:2000 release. If your system was against this version or the 2008 you "should" already have processes defined.
 
#3
Re: ISO9001:2015 - What Processes Do I Need Documented

It was updated to the 9001:2008 version, but nothing had been updated since 2012 maybe? The main issue what that when our old QA manager left, no one replaced her until me, and in that time, we've changed our computer system, so we lost most of what we had. So a lot of things had to be updated, and a lot was missing, so I'm trying to fill in the blanks. Thanks for helping me out!
 

Pancho

wikineer
Super Moderator
#4
ISO 9000 defines a process as a set of related activities that transform inputs into outputs. An industrial distributor may likely have the following key processes: Sales, Purchasing, Warehousing, Service, Billing, etc.

Each of these processes has a set of inputs, some procedures and work instructions that describe how the various tasks in the process get done, some records that evidence that the tasks were done right, and some output. For example, the sales process may have, as input, a phone or email inquiry, then have some procedures for quoting and follow up, files (records), and an order received as "output".

One common pitfall is to think that "quality" is a department that can "handle ISO" and "maintain certification". This is not so. Quality is achieved by building it into your processes, not by inspection. A successful implementation requires everyone in the company, especially top management, participating in it.
 

Randy

Super Moderator
#5
The ones you deem appropriate and necessary regardless of what others say, unless ISO 9001:2015 specifies otherwise.

If you can maintain effective control without documentation go for it. As a 3rd party I couldn't care less as long as the requirements of the standard are met, your requirements and obligations are met, and everything is effective.
 
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