ISO 9001 clause 7.5.1 work instructions

Q: Within my organization there has been much debate on what a work instruction is. The term work instruction is not defined in the ISO 9001-2008 Quality management systems—Requirements standard (appears in clause 7.5.1).

Our question is that if the organization is providing services such as maintenance and repair of the customer’s equipment, and the customer provides maintenance and repair manuals and publications for this equipment to the organization, would this literature satisfy the requirements of ISO 9001:2008 as work instructions? Any assistance provided would be greatly appreciated.

A: You are correct when you state that “work instructions” is not defined in ISO 9001:2008, nor is it in ISO 9000:2005 Quality management systems–Fundamentals and vocabulary.

Terms are not defined by the Technical Advisory Group (the standard developers)  when it is felt that the general accepted usage is clear and unambiguous. Such is the case with this term. A work instruction is simply what the name implies, instructions to do work. Written instructions might not be necessary and so the phrase “as necessary” is in the text of the standard. It depends on your specific situation.

The challenge to comply with the requirements of clause 7.5.1 is not in the definition (or lack of definition) of work instructions. It is planning and carrying out production and service work under controlled conditions.

Are your work processes controlled? This clause identifies six elements that need to be considered. Work instructions are one of the six elements. Do your operators know what to do? Are they trained? Do they need written instructions? In general, you must make this call, not an auditor. If you are challenged by an auditor, you need to be able to defend you position. But there is no hard and fast rule here.

Let me note that telltale signs of lack of control are frequent errors, defects and rejects. This indicates to an auditor that you don’t have a controlled process. You need to tighten things down including addressing those of the six elements that are at the root cause of your process failures. You might need work instructions or improved work instructions based on process performance.

You mention that your organization maintains customer equipment and that the customer provides manuals. These manuals might be adequate. They might not. Let’s say that part of your maintenance is changing the oil on a gasoline engine. The manual, hopefully, states when this needs to occur. It might not. You probably need to establish a maintenance schedule for changing the oil and lubricating the machine, recording when this is done. Do you need a detailed work instruction on how to change the oil? Probably not. However, the machine might be complicated and have many lubrication points, a number of them not at all obvious. In such a case, a simple work instruction might be useful.

The key is to control your process and use whatever is needed to do so.

Joe Tsiakals
Voting member of the U.S. TAG to ISO/TC 176 (ASQ)
Voting member of the U.S. TAG to ISO/TC 210 (AAMI)

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