4.1 General Requirements of an ISO9001:2000 Quality Management System

Continuing this blog, we know that some of the general requirements of an ISO9001:2000 quality management system include:

  • identifying and documenting the processes and procedeures used in your quality management system
  • determining and documenting the sequence of your processes, and how they interact with one another.
  • determining and documenting your criteria needed to show your processes are effective and what methods you use to accomplish this.

If you choose to outsource any process that affects your product’s (or service’s) quality,
then you must also take steps to make sure that outsourced process is under your control.

For example, let’s say you produce an NAS- standard aluminum washer to be used on a military aircraft. In your shop you’ve got the machines needed to stamp out bolts and put threads on them. But the military specification calls for a hard anodizing, and you don’t have capability to perform plating in your shop. No problem, just find an anodizing shop, right?

It’s not quite that simple. Who are your customers for that washer? What are their requirements? If you want to sell the washer to Boeing, you probably have to use a plating shop that is also approved by Boeing. In addition to customer requirements, you have to go thru the process (there’s that word again…) of finding and approving the plating shop you’ll use. Are they also ISO9001:2000 certified? How about AS9100? Have you inspected their facility? Can you be reasonably certain they are not farming the work out to another vendor that isn’t approved?

Once you’ve followed your process and approved the plating shop as your vendor, there’s more work to do to ensure your product meets YOUR requirements. The military specification calls for a total thickness of .085 inches, and your company specifications and drawings do the same. It is not ultimately your vendor’s responsibility to ensure your product is in conformance with your specifications. This is YOUR responsibility. Every shipment of washers should be inspected upon receipt from your vendor. I’m not saying that every washer should be inspected, but a reasonable sampling should be measured before any parts can be used or sold.

Remember that you want to make sure your product conforms to your specifications, and also your customer requirements. Many industries and products require documentation to prove that the various processes used are also in conformance and were done by approved sources.

Not only does the product have to conform to satisfy your customer, but you’ve also got to satisfy your ISO auditor. Have you taken reasonable steps to ensure your product is always in conformance? Is it possible that, even tho your products so far are in conformance, that maybe you’ve just been lucky? How likely is it that something could go wrong? Will your process stand up to the scrutiny of an outside auditor?

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