The 9000 Resource

ISO is Consistency: Say what you do, do what you say, etc.

Please keep in mind that ISO 9000 doesn’t really care about HOW it is documented, just that it is clearly documented and all parties “sing form the same songbook”.  If you want to call your department Procedures a Quality Manual, then you may do so – it really doesn’t matter. ISO 9000 just wants a few simple things:

1. Say what you do. (document your processes = procedures)
2. Do what you say. (follow procedures)
3. Be consistent – if your processes are designed to meet certain goals/objectives, then if followed they should meet them every time.  Like a recipe for cookies.
4. Ensure that everyone knows their role and what is expected of them. (people are trained on processes and have been tested to ensure the training was effective)

And all of the above must be customer driven…you must be meeting or exceeding customer expectations. You could follow #1-4 above, but if you are designing CONCRETE life jackets your customer will be disappointed, even though you are making them consistently to the specification.

I should be able to walk into your facility and ask anyone WHY they are doing a particular task, and HOW they know to do it this way.  An employee should be able to say:

• I was trained on this procedure/task/work instruction (and there should be a record of it) on 4/11/06 (for example)
• I have a document (that the employee can quickly reference) that outlines the procedure/task/work instruction next to me/in my filing cabinet/on my PC
• The procedure is the current revision

Remember, this isn't rocket science - it's just good business practice.

What is the ISO 9001 Process Model?

The process model is based on the idea that an organization is a system of interlinked processes. The ISO 9001:2000 Standard is designed to manage and improve those processes.

1. Identify your key processes.
2. Define quality standards for those processes.
3. Decide how process quality will be measured.
4. Document your approach to achieving the desired quality, as determined by your measurements.
5. Evaluate your quality and continuously improve.

What is the Process Model?

The process model is based on the idea that an organization is a system of interlinked processes. The ISO 9001:2000 Standard is designed to manage and improve those processes.

First, you identify your key processes.

Second, you define quality standards for those processes.

Third, you decide how process quality will be measured.

Fourth, you document your approach to achieving the desired quality, as determined by your measurements.

Fifth, you evaluate your quality and continuously improve.

Incoming inspection: do we have to inspect everything?

This is a common question from organizations starting ISO 9001 programs, so here is the good news: there is no requirement that you have to inspect everything. The requirement is that you determine how you will know that you have good parts, raw materials and services that go into making your product.

This ties in very closely with purchasing. The purchasing process is where you put controls in place to make sure that your suppliers provide you with quality products and services. When you establish these criteria, you will also establish compatible inspection and test criteria.

Many companies have a program to designate "certified suppliers". They receive products from these suppliers directly into stock. If you qualify suppliers by auditing their quality system, by inspecting trial orders or by other means you can determine what kind of sampling plan you need to monitor the quality of their product.

Some products come with certain certifications or standards already met for the product. These come with a Certificate of Analysis or other evidence that control is exercised at the supplier's location. If this is the case, your inspection may be checking for a Certificate. Incoming inspection can be as simple as reviewing the packing slips and verifying that the correct item and quantity are received. It is up to your organization to determine how the quality of the supplies affects your product quality and how you will measure and monitor.