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Miriam Boudreaux
Published: Friday, July 27, 2012 - 12:28 Deciding how to control your documents can be difficult. ISO 9001, the quality management system (QMS) standard from the International Organization for Standardization (ISO), requires you maintain accurate and up-to-date procedures, but doesn’t give a lot of guidance on how to get there. Between the requirements and the implementation lie grey areas and confusion. Let’s take a look at the difference between what is required and what is a good idea in the world of document review. A procedure is a way of carrying out an activity; it explains who does what, where, and when; it’s a document that defines a process. ISO requires that your procedures, work instructions, etc. are always accurate and truly represent the steps to completing a process. How you ensure that accuracy is up to you. A procedure could describe the process for obtaining customer feedback (e.g., using scheduled customer surveys, or calling customers and saying specific scripts). Review procedures to ensure workers have the most current, complete, and accurate information to do their job. As per ISO 9001, you do not have to review procedures once a year. How often you review procedures depends on the complexity of your business activities. Some people may decide to review their documents every two years and others every three years. In a company where processes are dynamic and procedures are constantly being revised, there may not even be a need for a formal review, since the procedures are probably being reviewed every time they are updated. If your organization doesn’t update procedures very often or isn’t well-disciplined about updating procedures every time a process changes, then it may benefit from implementing a set review time. I once audited an organization whose procedures were 3 years old. Basically it changed its processes and never went back to update its procedures. That was not good. A lot of the information wasn’t applicable anymore. It decided to implement a set review date every year. On the other hand, I audited a company with procedures that were 7 years old and still accurate because its business was not dynamic. In this case, even though everything was fine, the company decided to implement a review date of every three years; perhaps this would force it to consider better ways to do things, given that technology is always changing. Periodically conduct employee surveys regarding the usability of procedures, and schedule times to monitor and review processes to measure the performance and effectiveness of the processes to identify opportunities for improvement. Hopefully you get the idea that there isn’t a right or wrong way to do document review. Remember that ensuring that your procedures, work instructions, and forms are true to what your company actually does is the ultimate goal; your organization must decide how to accomplish that goal. Quality Digest does not charge readers for its content. We believe that industry news is important for you to do your job, and Quality Digest supports businesses of all types. However, someone has to pay for this content. And that’s where advertising comes in. Most people consider ads a nuisance, but they do serve a useful function besides allowing media companies to stay afloat. They keep you aware of new products and services relevant to your industry. All ads in Quality Digest apply directly to products and services that most of our readers need. You won’t see automobile or health supplement ads. So please consider turning off your ad blocker for our site. Thanks, Miriam Boudreaux is the CEO and founder of Mireaux Management Solutions, a technology and consulting firm headquartered in Houston, Texas. Mireaux’s products and services encompass international standards ISO and API consulting, training, auditing, document control and implementation of Web QMS software platform. Mireaux’s 6,500 square foot headquarters, located in the northwest area of Houston, houses their main offices as well as their state-of-the art training center. Mireaux itself is certified to ISO 9001:2015 and ISO 27001:2013. To get in touch with Miriam Boudreaux, please contact her at info@mireauxms.com.Document Review: Do I Have To?
ISO 9001 requires that your procedures and work instructions are always accurate
When I say procedures, what does that include?
Do you have to review your procedures once a year?
So, do I really need to review procedures periodically?
What is the final word?
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Miriam Boudreaux
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Comments
Need clarification
Dear Ma, your article is very helpfu. Thanks
Please i need a clarification on the below question:
Does a manual/procedure have to be re-authorized once the top management changes? For example, the authorized person who prepared the documents resigned from the company, and a new person employed?
Thank you in advance
Re-authorization of Manual post Management Change
Hi Miriam,
Thanks for the great article and sharing your expertise.
Does a manual have to be re-authorized once the top management changes? For example, a CEO who authorized the manual is succeded, does the new CEO have to re-authorize and sign the same?
Thanks,
Rohit
Updating Quality Manual
Hi Miriam.
If you audit a plant and found out that the Quality Manual was created 4 years ago - would it be a major non-conformance or a minor non-conformance? Several members of the Quality Management team are not connected in the company.
Reynaldo
Procedures
Hello Miriam,
Nice article, thank you. I often use two meanings for "procedure". One is the ISO 9000/quality system context in which procedures are level 2 documents, distinguished from level 3 work instructions. Another meaning for me is "all written processes" or even "all processes whether written or not". Of course some people like to debate this meaning. In your article you seem to use procedures to mean "all written processes". Do you agree with that usage? If not, what term do you use when you want to say, "procedures and work instructions, but not forms"?
Jim Cook
Procedures vs Work Instructions