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How Well Do Your Procedures Comply with ISO 9001?

Postedby Steve Flick on 10-02-2009

Here’s a question we’re asked from time to time: “Are your products ISO 9001 (or other standard/guideline/regulation) compliant?”

The short answer to that is “Not exactly.”  ”Well, why not?!”, you might ask.  Well, the long answer is:

First, the ISO standard does not specify what a document must look like but, instead, specifies what must be contained in the document (as in the “results and action” of a review).  Documents themselves do not comply with ISO 9001, though they can conform to the standard.  Bizmanualz documents do conform in that they include the required procedures, records, etc.; however, compliance comes from how you use your documents.

Quality management systems are what must comply to the standard.  To be certified ISO 9001-compliant, your quality management system, or QMS, has to be audited by an independent external body (certification auditor) who verifies that the QMS conforms to the requirements specified in the standard.

Documents and records are evidence of a system’s conformance to requirements.  Your quality policy, quality manual, and other quality documents and records are all forms of evidence — part of the proof the certifying auditor needs to see in order to verify, or confirm, that your company has a quality management system in place.

Furthermore, it’s not just a matter of whether you have documented processes (procedures) or whether you’re keeping records.  The effectiveness of your quality management system is ultimately determined by how — and whether — your organization uses the information it gathers to continually drive improvement in the system.

Having an effective quality management system means your organization is gathering information from (and about) its processes and is using that information to continually improve:

  • The quality of its products and services;
  • Business process effectiveness;
  • Its quality management system; and
  • Its customers’ overall experience.

Second, the content Bizmanualz provides in its policies and procedures (PnP) manuals hasn’t been developed with a specific organization or category in mind.  Our policies and procedures are written in a general tone so that any organization may adapt them to its unique circumstances, issues, and needs, as well as shape them to the requirements that all organizations have in common.

This is exactly what ISO has done — and continues to do — with all of its standards, designing them in a general fashion to assist any organization — not just manufacturers, not just service organizations, not just large or small companies, but all of them.  How much benefit you derive from ISO standards or Bizmanualz PnP products is entirely up to you.

Of course, we want to hear from you on your experiences — good and bad — with our products.  Just like you, we’re always looking for ways to improve our products and services and we need your help.  Like the TV pitchmen say, “Call NOW!”

ISO 9001 Manual Updated to 2008 Standard

Postedby Steve Flick on 06-15-2009

We’ll be releasing our updated ISO 9001 QMS Policies, Procedures, and Forms manual this week.  The ISO 9001 standard, “Quality Management Systems – Requirements”, was updated for the first time in eight years and released last November.  The changes to our manual go quite a bit further than merely substituting every occurrence of “2000” with “2008”, of course.

We now offer you a leaner manual in more than one sense.  There are fewer pages and fewer procedures in our soon-to-be-released product than in the previous version, reflecting our “lean” philosophy.

The Quality Manual reflects lean thinking most of all.  Rather than borrow the text of the standard verbatim, we stripped the Quality Manual to the bare essentials.  It’s not going to be for everyone – some will, no doubt, still insist that their Quality Manuals parrot the text of the ISO 9001 standard, so that they’re sure their Quality Management System documentation covers every aspect of ISO 9001.  Putting in a lot of verbiage that’s not required by the standard, however, can make your Quality Manual less user-friendly, less useful, and less likely to be improved.

There are fewer procedures in the new and improved ISO 9001 QMS manual.  Procedures retained are ones that many organizations consider important or critical (e.g., Internal Auditing, Corrective Action).  Those procedures are modeled on the Deming Cycle — they have a Plan, Do, Check, and Act phase.  Some procedures that aren’t typically high priority and/or that didn’t amount to much more than simple work instructions (e.g., Serial Number Designation) have been omitted.

Throughout the updated manual, we refer to ISO 9001 requirements.  The six required procedures are highlighted in the Quality Manual; they’re also the first six of the twenty-three procedures we provide.

We’ve done something new with the “Forms and Records” section at the end of each procedure.  We’re still providing sample forms for you to use, but now they’re categorized as “required” or “other” and we tell you which ISO 9001 clause requires the record.  For example, in the Internal Audits procedure, there’s a form for audit reports; the Forms/Records table tells you the report requirement is in clause 8.2.2.

We think this is a much improved product, one that will smooth the bumps in your organization’s road to ISO 9001 compliance and certification.

As always, we eagerly await your comments.

ISO 9001 update

Postedby Steve Flick on 03-05-2009

The long awaited update to ISO 9001:2000 arrived last November.  While ISO 9001:2008 isn’t a huge change from its predecessor, it’s still a great time for us to update our ISO 9001 QMS Policies, Procedures, and Forms manual.

So, I’d like to hear from you.  Whether you purchased our product some time ago, purchased a competitor’s product, designed and implemented a quality management system on your own, or have yet to consider a quality management system for your business, we value your input.

How can we help you?  What are the pitfalls in designing and implementing a quality management system and how can we help you avoid them?  What information do you need?  What features would you like to see?  What would you change in our current product, and what would you keep?  In short, how can we improve our product to serve you better?

We also offer a number of courses dealing with quality and process improvement.  Maybe you’ve taken one of our courses – perhaps you weren’t aware of our offerings.  Either way, take a look at our course listings and let me know what you think.

I look forward to hearing from all of you.

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