Mark Hammar The role of quality manager is common at many companies, and this individual has often been designated as the quality management representative that was required in the previous version of ISO 9001. However, now that the ISO 9001:2015 standard has removed the requirements for a quality management representative, is there any requirement from the standard for a quality manager? This article will look at what requirements are in the new Quality Management System (QMS) standard and how they could be implemented.
What is in ISO 9001:2015 as requirements for the quality manager?
While there are no direct requirements for a quality manager in ISO 9001:2015, there are many required activities that fit well with the traditional role of a quality manager. If you are looking at what a quality manager does, which can meet some of the requirements of the ISO 9001:2015 standard, these activities could be included in the job description, or part of the team that works with the quality manager:
- Understanding the needs of interested parties: Clause 4.2 requires that the company determine who the interested parties of the QMS are, such as customers and suppliers, and determine what the requirements of these interested parties are. Performing this task and keeping the information up to date is one task that is often within the job description of the quality manager.
- Establishment and continual improvement of the QMS processes: Once the company processes and their interactions are determined and implemented per clause 4.4, this process flow mapping needs to be maintained in order to track the continual improvement of the QMS. Maintaining an overall process integration flow is one activity that many quality managers perform.
- Customer focus and product conformity: When looking at customer focus in clause 5.1.2, there is a need to determine the risks and opportunities that can affect product conformity. Managing the risks and opportunities for product quality could be one of the tasks of the quality manager, and is further elaborated in clause 6.1 of the ISO 9001:2015 standard.
- Responsibility and authority for the QMS: In Clause 5.3 there is a need for top management to assign responsibility and authority for many activities of the QMS such as ensuring QMS conformance, promoting customer focus, and reporting on QMS performance. A quality manager has been the traditional employee to be given this responsibility.
- Quality objectives: Monitoring the quality objectives (clause 6.2) that have been established and reporting this to top management is another traditional role of the quality manager. Having one person focus on the management of this important activity is a good idea to provide focus and direction.
- Internal and external communication: Communicating with customers (clause 7.4) on quality matters is most easily done if you have one point of contact such as a quality manager. This way your customers know the best person to call to get answers when problems occur, rather than taking time to find the right person. Likewise, it is best if your employees receive QMS information from one source. A quality manager is ideal to fill these roles.
- Release of products and services: In section 8.6 the requirements ask that you determine the planned arrangements to verify the products and services and indicate that the products and services have successfully met the requirements. The people who perform these inspections often report to a quality manager, so the quality manager would direct and control these operations within your company.
- Internal audit planning & management: Of all the requirements in clause 9 for performance evaluation, the requirements for managing the internal audit most easily fit into the traditional role of a quality manager. Having one overall person responsible for this activity can once again focus the resources to perform the auditing role within the company. The quality manager can provide this focus, direction, and control for QMS audits.
- Nonconformity and corrective action: Having a quality manager in charge of the nonconformity and corrective action processes per clause 10.2 is another traditional role of the quality manager. With one owner, these processes that are used throughout the organization can be better controlled so that one process is used everywhere and best practices are incorporated by everyone.
For more information on the changes to the requirements on the quality management representative in ISO 9001:2015, see this article on What will be the destiny of the management representative in the new ISO 9001:2015?
Do you need a quality manager to meet the ISO 9001:2015 requirements?
As has been stated, there are no requirements that say you need to have a quality manager, but the above tasks are necessary within the quality management system and can very easily fall within the traditional roles assigned to a quality manager. It is important to remember that even if you do use the position of quality manager to be responsible for the above tasks, that does not mean that they are the sole person to perform all these tasks.
A QMS needs to have the support of all the members of top management, and it is critical to remember that just having a quality manager is not a replacement for a fully supportive top management team – no matter how good the quality manager is.
For a better understanding of the requirements of ISO 9001:2015 and how they can work for you, see this online ISO 9001:2015 Foundations Course.
