Clause 4 of ISO 9001:2008 requires you to “establish, document, implement and maintain a quality management system and continually improve its effectiveness”.

Good news: your business already has a system.! You have processes. Guaranteed.. You would not be in business without them. Your current system may or may not exactly meet the standard. It may or may not be exactly what you want. But it is a starting place.

Now, back to the standard.

General requirements:

First, determine your key processes and their interactions. (A process is a series of action taken to achieve a particular end.) Do a bit of brainstorming here. Individuals will have different viewpoints. You, as senior management will have the best overall view. Be careful not to get caught up in the fine details. Product design may be a key process, the test procedures are not.

Don’t just use words. Draw a picture. Use lots of arrows to show connections. Create a process flow.

Here are some possible key processes:

Now you put the blocks in the order that reflects your business

OK, you have your key processes. Now what? How do you manage them? How you know they are effective? How do you know that you are successful? A key element of this is to define what the output of the process.

Now, determine the inputs needed. Determine the resources needed. Determine how you will measure and monitor these systems to ensure success.

Anything reading as if it is from outer space? I didn’t think so. You know your business. Now you are simply breaking it down into manageable, controllable steps.

By the way, any process that you outsource (an integral part of your process performed by an outside entity) must be controlled. Manufacturers may send something out to be heat treated. A service organization may outsource their call center.

Documentation Requirements:

You must document everything you do in excruciating detail. You should anticipate at least 20 volumes.

I am kidding.

Here, however, is what you do need:

ü A quality policy

ü Quality objectives

ü A quality manual

ü The six required procedures

o Control of documents

o Control of records

o Control of nonconforming product

o Corrective action

o Preventive action

o Internal quality audits

ü Documents, including records, determined by you to be necessary for the effective planning, operation and control of your processes

That’s if for today. We’ll take a more in depth look at the documentation requirements in future blogs.

Remember: The requirements of ISO 9001:2008 are simple and logical. You get to decide how to best apply them for your business.

As always, please contact us for help with any of your Quality Management needs. We are ready to assist!

Regards,

DonnaLynn

Clause 4 ISO 9001:2008 Quality Management System