How To Document Roles Under ISO 9001

How To Document Roles Under ISO 9001As you implement your Quality Management System (QMS) under ISO 9001, you will discover that you need to document the roles and responsibilities of the QMS system. Top management must define the organizational structure, hierarchy, and lines of accountability/reporting. Human Resources personnel may assist with defining and communicating the appropriate role, duty, responsibility, and authority of each position and person.

Clause 5.3 of ISO 9001 is very specific on which QMS responsibilities and authorities need to be assigned by top management. Following is a list of key assignments:

  1. Responsibility for QMS conformance – while this may be several people, at minimum one person needs to be identified as the one to ensure that the processes your organization is implementing comply with ISO 9001. An extremely important role as you plan your processes and implement them; this responsibility will also continue as you improve and maintain your QMS. Over time, elements may be removed that are essential to meeting ISO 9001 requirements, so it is a requirement to have at least one individual assigned the responsibility for QMS conformance.
  2. Process conformance – this may seem to be related to the prior point but should be defined as a separate role. Once you’ve identified the process owners of your QMS, you can define Key Performance Indicators (KPI’s) that will provide a quick snapshot on whether the system is functioning as expected. Be sure to provide relevant and punctual feedback to any missed KPI’s.
  3. QMS performance reporting – a requirement of the management review is to look at the performance of your QMS. Identify someone who will gather this information and provide reports on it. Provide reporting to your employees, so they know if their processes are doing well or not.
  4. Promote customer focus – a proper customer focus is a key element of ISO 9001, so you need to have someone responsible for conveying the importance of this to everyone. How well this happens will affect customer satisfaction.
  5. QMS integrity during change – while this point is connected to items 1 and 2, you need to have a separate responsibility identified to ensure any organizational or process changes do not make your QMS non-conformant to ISO 9001. Another key element of this responsibility is ensuring that you do not degrade or lose the intended purpose of a process in your QMS. Understanding the interconnectedness and impact of every QMS process is key.

How should you document QMS roles and responsibilities?

Now that you’ve identified your QMS roles and assigned them, you need to make sure you’ve communicated them in a way that can be understood. Some steps for doing that include the following:

  • Consolidated documentation – to comply with the requirements of your QMS, having a single document that lists the roles, responsibilities, authorities, and individuals responsible is needed. This will ensure that anyone who has a question knows who to contact for the specific piece of information.
  • Cross documentation – with every document you have for a process, include the appropriate role and responsibility. This will ensure that each person knows not only the function of their role but also responsibility and authority.
  • Training materials – it may be impractical to document every process, so you may decide to implement training documentation. This is a good way to share appropriate QMS roles and responsibilities while providing the necessary training for a job function.

The path to success

Now that you’ve identified the roles and responsibilities for your QMS, it is key that people know who to call. Providing this documentation will ensure that the proper questions are directed to the appropriate parties and set your organization on the path to success as planned with your newly implemented Quality Management System.