 “Yeah, this procedure is kind of silly, but we have to do it because of ISO…!”
Why do some people within an organization cringe at the thought of having to endure an ISO 9001 implementation?
It may be fear of the unknown or because of horror stories they’ve heard. Some have survived a previous implementation, but fell victim to less than effective processes that were imposed trying to comply with the “letter of the law,” while failing to follow natural business processes that made sense.
A comment from an employee was overheard during an audit: “Yeah, this procedure is kind of silly, but we have to do it because of ISO.” The fact is that the ISO 9001 Standard does not require you to perform complicated or illogical procedures. The Standard is a well-written document intended to apply generically to any type of organization. It is rarely prescriptive, or in other words; it does not tell you HOW to do specific tasks, but tells you WHAT controls you must devise, document and execute.
So how do less-than-effective procedures get developed? Perhaps the procedure was written by someone from outside of the affected department with good knowledge of the ISO standard, but not of the relevant business process. When you engage the Attivo Group to assist you in this process, we combine our domain experience with the “tribal knowledge” within your organization to create natural, flowing procedures that reflect actual practices that also comply with the standard.
FACT: Most discrepancies found during an audit are for not conforming to the company’s own stated procedure, NOT because they don’t conform to the ISO Standard.
Another common mistake is failing to write for the level of the intended user. For instance, a machine operator on the production floor would probably not be familiar with the relevant contents of eight high-level Standard Operating Procedures, yet this is often expected. Managers may understand those SOP’s, but it may not be realistic to expect that level of understanding at the grass-roots level.
Document Control
Aside from the development of meaningful processes, how you control and disseminate documents can be the most critical aspect of ISO 9001 compliance.
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Consequently, this is often the where many quality managers and even consultants do not manage appropriately. In some implementations, the words “controlled document” have taken on an inappropriate meaning resulting from misinterpretation of the intent of the standard. This is where elaborate (and completely unnecessary) schemes such as the stamping of documents as “controlled” are born.
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Attivo can help you implement an easy-to-use electronic document management system. This not only makes it easier to control documents and minimize paper; it actually makes it easier to stay in compliance.
An electronic or near paperless document management system can be developed starting from the simplest of intranets using only Microsoft Office® tools, up to the implementation of a full-featured document management software system.
Does it seem like your documentation was developed by aliens?
While the low cost of creating ISO documentation using fast-track templates is appealing, some “drop-in” procedures developed purely from templates contribute to a disconnect between what is truly going on in an organization and what the documentation says. A short time after completing the procedures, are your personnel are wondering “who wrote this stuff?’
FACT: Over 38% of companies suffer major audit nonconformances or even suspension of certification within 18 months of initial registration. This is often a result of over-complexity in quality management systems, ill-conceived processes, changes in personnel, or the lack of employee participation in the initial development of the system.
After the consultants are gone…
Our methodology emphasizes key personnel involvement to ensure that procedures reflect actual activities during all of the development stages. We maintain a simple document structure that is easy to access and use on a regular basis, and intuitive to manage long after the consultants are gone.
“Salvage Assistance” from The Attivo Group, Inc.
Are you in over your head? Is your implementation dragging on? Or perhaps your fully implemented system is suffering excessive nonconformance findings. If some of these horror stories sound all too familiar, and your organization is already suffering from any of the pitfalls described, we can help salvage your efforts and get the job finished effectively!
Read on for more information on different ways we can assist you. |
