Forum Discussion: Clause 7.5.3 and Required Work Instructions in ISO 9001

This forum discussion from late November 2023 focused on the requirement of work instructions in Clause 7.5.3 Required Work Instructions in ISO 9001, particularly under controlled conditions as per clause 8.5.1. One user pointed out a potential misinterpretation of the clause, suggesting that the necessity for documented information should be determined based on its applicability to a particular situation. Another user emphasized that the clause’s phrase “as applicable” indicates that organizations should assess and decide the relevance of specific controls, including work instructions.

The conversation also highlighted practical applications and interpretations of this clause. One participant shared their method of using a simple Sort/Rework form, which becomes obsolete at the end of a project, as a means of recording instructions. This approach was contrasted with others’ experiences, where detailed work instructions were deemed non-value-added or unnecessary. One user described witnessing entire cars being assembled without written work instructions, emphasizing that assemblers, due to their frequent repetition of tasks, often don’t need written instructions but rely on their training and muscle memory.

The discussion further delved into the variability in the requirement of work instructions based on the complexity of tasks and the skills of the personnel involved. It was pointed out that the instructions could be high-level for highly skilled tasks, like those requiring a Ph.D. in material science. In contrast, more detailed step-by-step directions might be necessary for less-trained individuals.

The conversation concluded with a consensus that while work instructions are not always needed, their requirement and level of detail should be assessed based on risks, process complexity, and the operators’ skills. In some industries, such as automotive manufacturing, detailed work instructions might be less crucial due to the training and expertise of the workers. At the same time, in other scenarios, like shipboard steam plant piping inspections, not following documented procedures could have serious consequences. Therefore, the necessity and depth of work instructions should be determined by the specific context and requirements of the task at hand.

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