How do you write an ISO 9001 procedure?

A Quality Management System (QMS) consists of processes with procedures to specify how activities or operations are performed. Having a well-written and documented procedure is vital because it provides a consistent approach to ensure that products or services meet quality requirements and customer needs.

But what is a procedure? And how do you write a procedure that is consistent with ISO 9001 standards?

What is a procedure?

A procedure is a set of detailed instructions that outlines how a particular process should be performed to meet a specific standard’s requirements. Procedures must be followed to ensure the organisation consistently produces quality products and services.

Examples of procedures include steps to document processes, perform internal audits, or handle customer complaints.

How to write an ISO 9001 procedure

1. Determine the purpose and scope of the procedure

The first step is to identify the area of your business that the procedure will cover and its purpose. You can do this by reviewing the applicable ISO 9001 requirements and the long-term objectives.

This review should consider the scope of the QMS and the applicable laws and regulations. It is also important to assess any potential risks associated with those activities. Additionally, considerations should be made for the resources available and other activities necessary to complete the procedure successfully.

2. Align to business process

Once you establish the purpose and scope of your procedure, it is time to align it to the business process. Take the time to understand the internal and external issues (business context) that will potentially affect the procedure as well as the needs of the stakeholders.

That way, you’ll be able to determine the risks and hazards associated with the process and find ways to mitigate them.

3. Gather process information

Your procedure will need a comprehensive document structure detailing all the process requirements. Collect all the necessary information, including resources, activities, input, output, and the individuals responsible for each activity. Methods that can be used to gather information may include flowcharts and the five Ws, which include five questions:

• Why is the procedure important?
• What are the materials?
• Who is involved?
• When do activities happen?
• Where do activities take place?

4. Develop a document structure for procedures

The fourth step is to create a standard document structure that will also act as a procedure template. A document structure should incorporate all ISO 9001 requirements, such as ISO 9001:2015 clauses and other related standards. The document should include the following:

• Definitions.
• Scope and purpose.
• Responsibilities.
• References.
• Procedure.
• Version history.

5. Document the procedure

Once you identify the purpose of the procedure, align it to the business process, gather information, and create a document structure, the next step is to write the procedure. We recommend hiring an expert, like Citation Certification, to help document each process.

Your written procedure shouldn’t be voluminous but detailed enough to incorporate all the necessary steps.

6. Monitor, review, and update the procedure

The last step is to monitor and review the procedure occasionally to ensure it’s recent and relevant. Make the necessary adjustments or updates to the procedure and communicate them to stakeholders and other relevant parties.

Best practices for writing ISO procedures

When developing ISO procedures, organisations should focus on clarity, consistency, and alignment with ISO 9001 requirements. Consider the following best practices:

• Use clear and concise language to ensure every employee can understand and follow the procedure without ambiguity.
• Align procedures with business objectives and ISO clauses to maintain consistency across your Quality Management System.
• Define roles and responsibilities to clarify accountability for each activity or process step.
• Incorporate version control and document history to track updates, approvals, and revisions over time.
• Ensure accessibility by making procedures readily available to all relevant personnel across the organisation.
• Include measurable criteria where possible to support monitoring and evaluation of performance.
• Maintain consistency in formatting and structure to promote uniformity across all QMS documentation.
• Regularly review and update procedures to keep them relevant to current business operations and regulatory requirements.
• Encourage employee involvement in drafting or reviewing procedures to improve understanding and engagement.
• Link supporting documents and records (such as forms, checklists, or templates) to streamline implementation and recordkeeping.

Clear, well-documented procedures are essential to maintaining an effective Quality Management System. By defining clear steps, assigning responsibilities, and maintaining regular reviews, organisations can ensure their processes remain consistent, compliant, and aligned with quality objectives.