Writing a quality procedure seems simple until you realize that no one in your company follows it. This is one of the most common problems in Quality Management Systems: well-intentioned documents that end up shelved, ignored or outdated. The cause is almost always the same – the procedure was written with the auditor in mind, not the person who has to execute it.
In this article we explain how to write a quality procedure that is clear, practical and that your team will actually use in their day-to-day work.
Table of Contents
What is a quality procedure and what is it for?
A quality procedure is a document that describes in a structured way how an activity or process is performed within a Quality Management System. Its function is to guarantee that all the people who execute that process do it in the same way, with the same criteria and obtaining consistent results.
ISO 9001:2015 does not require procedures to have a specific format or a specific number of pages. What it does require is that the documented information is sufficient to ensure that the processes are carried out in a planned and controlled manner.
A good quality procedure answers three basic questions: what is done, who does it and how it is done. Anything beyond that must be justified by a real need for the process.
Why many quality procedures are not used
Before discussing how to write a good procedure, it is useful to understand why so many procedures fail:
The first and most frequent is too much content. Twenty-page procedures with elaborate flow charts, cross-referenced responsibility tables and references to dozens of other documents. No one reads them because reading them takes longer than doing the work.
The second problem is unnecessary technical language. Using ISO terminology directly in the procedure when the personnel who will execute it are not familiar with that terminology generates confusion and mistrust.
The third is not involving those executing the process. A procedure written by the quality manager alone, without consulting the people who perform the activity on a daily basis, usually describes how the process is thought to be done, not how it is actually done.
The fourth is not updating it. A procedure that was valid two years ago but no longer reflects how the process works today is a hindrance, not a help.
Recommended structure for a quality procedure
An effective quality procedure does not need to be long. It needs to be clear. The following structure covers all the elements that ISO 9001 requires without adding unnecessary complexity:
1. Header and control data
It includes the name of the procedure, the identification code, the version, the effective date and who approved it. This information is essential for document traceability and version control.
2. Objective
One or two sentences explaining why this procedure exists. It should be specific. For example, “To ensure that all customer complaints are recorded, analyzed and responded to within 48 hours.”
3. Outreach
Defines to which processes, areas, products or services the procedure applies and, if relevant, what is outside its scope.
4. Responsibilities
Indicate which persons or roles have responsibility for the execution of the procedure. Use role names, not specific people, so that the procedure remains valid when personnel changes occur.
5. Step-by-step process description
This is the core of the procedure. It describes the activities in chronological order, using clear and straightforward language. Each step should indicate what is done, who does it and, where relevant, when it is done and with what tools or resources.
Use short sentences in the active voice. Instead of writing “the documentation should be reviewed by the appropriate manager,” write “the quality manager reviews the documentation before sending it to the customer.”
6. Associated records
Indicates which records are generated when executing this procedure, how they are named and where they are stored. This section is key to the documentary traceability of the QMS.
7. Related documents
References to other procedures, work instructions or external documents that the user may need to consult.
8. Change history
A table that records what version was changed, what changed, who authorized it, and on what date. This history is one of the first items an auditor reviews.
Practical tips for drafting procedures to be used
Write it for the person who will be executing it
Before you start writing, ask yourself who is going to use this procedure. Is it someone with technical expertise or someone who has just joined? Do they have access to the document on paper or on screen? Are they going to consult it in an office or in the field? The answers to these questions should influence the level of detail, language and format.
Involve the team in the writing
The people who run the process on a daily basis are the best source of information for drafting a realistic procedure. Interview them, observe how they work and check the draft with them before approving it. A procedure that is validated by those who will use it is much more likely to be adopted.
Use the minimum number of words necessary
A procedure is not an academic manual. Eliminate any paragraph that does not provide information necessary to execute the process. If a sentence can be deleted without losing clarity, delete it.
Use visuals when they help.
A flow chart can be more useful than three paragraphs of text in explaining a process with multiple decisions. A table of responsibilities can replace a long paragraph. Use these elements when they simplify, not when they add complexity.
Define clear acceptance criteria
A procedure that describes how something is done but does not indicate when the result is correct creates ambiguity. Whenever possible, include measurable criteria: maximum times, percentages, quantities, approval status.
Establish a review cycle
Every procedure should have a periodic review date, even if there have been no changes to the process. An annual review is sufficient for most procedures. This ensures that the documentation is kept up to date and reflects the reality of the organization.
How many procedures does a QMS really need
A frequent question asked by SMEs implementing ISO 9001 is how many procedures they should have. The answer is: enough to control the processes that have an impact on quality, not one more.
ISO 9001:2015 eliminated the obligation to have a minimum number of documented procedures. What matters is that the organization can demonstrate that its processes are under control and that the results are consistent.
A service SME can manage its Quality Management System with ten or twelve well-written and actually implemented procedures. A hundred poorly written procedures that no one follows do not meet the requirements of the standard or provide any value.
Example of a summarized structure of a quality procedure
To illustrate the above, here is the summary structure of a procedure for handling customer complaints:
Code: PRO-AC-001 – Version: 2 – Effective since: 01/03/2026 Objective: Manage customer complaints in an orderly manner, ensuring response in less than 48 hours and root cause analysis. Scope: Applies to all complaints received through any channel (email, telephone, face-to-face). Responsible: Quality coordinator. Steps: 1. Register the complaint in the system within a maximum period of 2 hours. 2. Classify the complaint by type and seriousness. 3. Notify the responsible area. 4. Manage the solution and communicate it to the customer. 5. Record the closure and analyze the root cause. 6. Open corrective action if applicable. Records: Complaint form (REG-AC-001), corrective action log (REG-AC-002).
Conclusion
A quality procedure that no one uses is useless, neither for the auditor nor for the company. The difference between a filed procedure and one that becomes part of the daily work is in how it is written, with whom it is written and for whom it is written.
Applying the principles described in this article does not require advanced ISO 9001 experience. It requires clarity, practicality and a willingness to put the user of the procedure at the center of the writing.
At QualityWeb 360 we help you document your Quality Management System processes clearly, effectively and ready to pass any audit.
Frequently asked questions about quality procedures
Frequently asked questions about quality proceduresWhat is the difference between a procedure and a work instruction?
A procedure describes what is done and who does it at the process level. A work instruction goes into the operational detail of how a specific task is executed, usually directed at a specific person in a specific job. Procedures are broader in scope; instructions are more specific and detailed.
Are procedures required to be signed by management in ISO 9001?
ISO 9001:2015 does not require physical signatures on procedures. What it does require is that the documented information is approved by persons with the authority to do so. That approval can be recorded in different ways: digital signature, record in the document management system or formal approval email.
How often should quality procedures be reviewed?
There is no mandatory timeframe established by ISO 9001. The most common practice is to review them annually or when there is a significant change in the process, when a non-conformity related to that procedure appears or when the results of an internal audit indicate that the document does not reflect reality.
