ISO 9001

How to define roles and responsibilities for your ISO 9001 QMS

October 19, 2022

How to define roles and responsibilities for your ISO 9001 QMS

Clause 5.3 of ISO 9001:2015 requires top management to ensure that roles and responsibilities and authorities for your Quality Management System (QMS) are assigned, communicated, and understood, but what exactly are these roles and responsibilities? And what’s the most effective way to define these for your organisation?

What are the QMS roles and responsibilities that ISO 9001:2015 requires you to define?

Defining ISO 9001 roles and responsibilities in your organisation has many benefits… from boosting operational efficiency to improving communication and collaboration. 

The success of a quality management system depends on commitment from all levels and 

functions of the organisation. It is not the responsibility of just one person to understand the QMS, but all.  A good starting point is to define the QMS compliance roles first. Whether you’re a sole trader or a corporate CEO we all find ourselves wearing multiple hats. Therefore, creating the role (or hat) of ‘Quality Manager’ will help you assign the key responsibility of improving the QMS to the most appropriate person in your organisation.

Responsibilities of the Quality Manager role

Good communication and collaboration are key competency attributes for the Quality Manager role. They will need to liaise with top management, process owners and staff to ensure that all employees have read and understood the Quality Policy and are aware of the quality objectives of the quality management system. Other responsibilities include ensuring that the QMS conforms to the requirements of ISO 9001; monitoring the performance of the QMS, including obtaining customer feedback (both positive and negative); and reporting opportunities for improvement to top management.

The Quality Manager should have an understanding of statutory & regulatory legislation as this is a requirement of the standard. However, the ISO 9001 is not as strict as other standards such as the ISO 14001, 45001 & 27001. – See How to maintain a QMS Legal Register for ISO 9001

Responsibilities of the Top Management role

​​Top management should take accountability for the effectiveness of the QMS and ensure that the QMS achieves its intended results. They must provide appropriate resources for the QMS and ensure responsibilities and authorities for relevant roles are assigned, communicated and understood. 

Top Management have overall responsibility for the integration of the ISO 9001:2015 requirements into business processes. Also, promoting a customer focus and process approach. This starts with defining a Quality policy that includes a commitment to quality, customer satisfaction, internal training and a commitment to continually improve the QMS. Top management can also leverage opportunities to enhance customer satisfaction and improve efficiency by setting objectives in line with the strategic direction of the organisation. 

Responsibilities of the Process Owner role

Process owners and line managers should be assigned responsibility for promoting the ISO 9001 process approach to their team and ensuring that processes deliver their intended outputs. Process owner should also be responsible for ensuring their staff and external suppliers understand the organisation’s quality requirements for products and services. 

Responsibilities of all Staff

All staff are responsible for maintaining the required quality of service. Employees must also be aware of quality objectives and the implications of not conforming with the QMS requirements Staff should also be aware of Key Performance Indicators (KPIs), that will monitor and measure if the process is working as expected. 

How ISO 9001 Software can help you define and communicate your QMS roles and responsibilities

The ISO 9001 standard requires the above QMS roles, responsibilities and authorities to be communicated and understood in your company, so how do you achieve this?

One of the easiest ways to achieve this is to document the roles and responsibilities using ISO 9001 software such as the ISOvA Toolbox, which has a list of predefined QMS Roles and Responsibilities including Quality Manager, Top Management, Process Owners and All Staff. You can easily tailor these to match your organisation or add new roles. The guidance includes how to describe the responsibilities in terms of education, experience, training, and competence requirements. Internal and External communication columns include authorities on what and how information should be communicated. 

Simply review and edit the ISOvA QMS Roles and Responsibilities template to define responsibilities for each role. Whether that is your Managing Director or your Quality manager, we set out the precise expectations of each individual, so everything is clearly communicated. 

Once set, your QMS roles will appear in other related areas of your QMS software, including assigned responsibilities for Objectives, Corrective Actions, KPIs and Risk owners, to keep everything synchronised.

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