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ISO 9001 Blog

Mark Hammar

Deciding Which Procedures to Document in QMS

If you are implementing a Quality Management System, you may struggle with the decision of what needs to be written down, and this is common. While only six documented procedures are required (see List of mandatory documents for ISO 9001), any remaining procedure documentation is at the discretion of the company (under certain guidelines). So, you may ask: “What should I document?” Answering this question wisely can avoid complexity in your Quality Management System, saving time and money.

What are the guidelines for other documented procedures?

In addition to the six required procedures, there is a requirement to create documented procedures when non-conformances would occur if the procedure was not written down. Simply put, if you need to have a written procedure to make sure that mistakes are not made, you need to have a written procedure. I have found that there are a few simple things to think about when deciding if a documented procedure is needed, and those below are a good start.

Does the order of operations matter? If there are several ways to get the same outcome, and the important thing is the outcome, then there is not a need to write down what process to use. An example would be certain design analyses. There are several ways to analyze the mechanical design of a product, and many different computer design tools to use, but all give very similar results. If the result of any of the available processes is acceptable, then why prescribe which to use?

Can any simple requirements be covered by training or forms? As a corollary to the first question, there are other ways to ensure things are done properly. If you have a standard form (paper or electronic) for purchasing that highlights all the required information to be sent to a supplier for the purchase of product, do you really need a written procedure to tell someone how to fill out the form to place the order? If the important thing is for the required information to be there, the form can stand for itself. Any additional information, such as how to find a part number in your system to fill in the form, may be able to be acquired through training without needing to write a document.

Does the process need the same level of change control that is afforded Quality Management System documents? Some companies like to document all of their Human Resource Policies as part of the Quality Management System, but you need to understand that there are costs to having a procedure as part of that system. Does the procedure need to have change control that is as strict as other documents, or could having controlled change access on a computer drive be just as effective? Does every detail of the procedure need to be audited, or is it there mostly for the information of employees when they need it (such as a travel policy)? Remember that just because some information is important, it doesn’t mean that it needs to be controlled in the Quality Management System documentation; other avenues are also available.

This is also a good question to ask when deciding if something needs to be a controlled form or not. Often, a company’s Documentation Procedure will specify the change control on forms, whereas some checklists can be more effective if their content is controlled more easily by the few people who use it rather than through a more complicated change control system. If the shippers have a checklist of what they need to ensure is in place to ship product, and they all agree to add an additional check after a problem occurs, ensuring this change happens quickly can help avoid the same problem from recurring.

How many people are doing the job? Using purchasing as an example again, if you only have a few people doing the job, then they can very likely ensure that between them the process outputs are consistent, meaning that the information going to the suppliers is always similar enough to make sure that good product is received. This also allows the few people to share process improvements to help the process flow better.

Does competence of the workers make a written procedure unnecessary? I have always liked the addition to the ISO9001 standard that separates Competence from Training. If your hiring practices for a machine shop comprise only hiring licensed machinists or their apprentices, then you don’t really need written instructions on how to use a lathe. This is part of the competence of a machinist. The old ISO9001 adage of  “write what you do, do what you write” need not apply.

Why written documentation for every process may be bad

When you document a specific order of operations for a process, you can limit the participants in the process to use any flexibility in how they do their job, potentially lowering job satisfaction and employee engagement, while hindering any efforts to find process improvements. In the worst case, the effort to try to change the process for the better can be seen as greater than just continuing to use the flawed or imperfect process. Sharing of best practices should be encouraged, and by writing a prescriptive process, employees’ desire to improve what they do can be hindered.

Click here to download a free white paper  Mandatory Documentation Required by ISO 9001:2008.

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