ISO 9001 Clause 7.5.3. What are the Required Work Instructions?

• Work instructions (WI) are not always mandatory if the organization deems them unnecessary based on competence.
• Clause 7.5.1 can override 7.5.3, allowing organizations to forego documented WIs if not needed for effectiveness.
• Auditors can only enforce documentation requirements if there is a lack of control or effectiveness.

The forum discussion revolves around the necessity and interpretation of Clause 7.5.3 regarding required work instructions (WIs) in quality management systems. A key point raised is that while Clause 7.5.3 discusses the need for documented information, Clause 7.5.1 provides flexibility. This clause states that the organization’s quality management system should include only the documented information necessary for effectiveness, which can vary based on personnel competence.

The participants argue that if an organization has determined that a documented WI is unnecessary because employees are competent, then Clause 7.5.1 allows for this exception. They emphasize that competence can justify the absence of documented WIs, making Clause 7.5.1 a potential override of Clause 7.5.3. The discussion suggests challenging any nonconformance issued by auditors on the grounds of missing WIs if competence and control are maintained.

The conversation highlights that auditors should only enforce documentation requirements if they can link the absence of WIs to a lack of control or effectiveness. The participants recommend appealing any nonconformance that lacks a solid basis, pointing out that auditors themselves might not have comprehensive documented procedures, which could be used to counter their arguments.

Overall, the forum emphasizes the importance of context and competence in determining the need for documented work instructions, encouraging organizations to assess their specific requirements and be prepared to defend their decisions during audits.

Read the full forum discussion