Previously, we published an article introducing the basic concepts, definitions and requirements for Quality Management Systems (QMS) within the medical device industry. Here, we have created additional guidance to support manufacturers in developing and implementing a QMS according to ISO 13485:2016.
Where to start? Development of the QMS
When thinking about developing a QMS, the organisation’s top management, together with the quality team (if applicable), should start by asking themselves some key questions that might help to establish the QMS:
- What defines us as an organisation?
- The answer will be used to define the quality policy.
- What do we want to do?
- The answer will provide insights into creating the organisation’s quality objectives.
- How will we do it?
- The answer will support the organisation, ensuring that the quality objectives are measurable.
- Which methods will we use?
- The answer will support the determination of the applicable processes under ISO 13485, which should then be included in the quality manual. The potential exclusions and non-applicable clauses may also be identified as an output of this question.
- Who will be responsible for these processes, and who will develop these procedures?
- To answer this question, the organisation should define the human resources needed, including the appointment of the management representative, a figure required by the standard.
- How will the processes interact with each other?
- The organisation needs to define the inputs and outputs of each of the processes and define the interactions between processes.
- When should the QMS be implemented?
- The implementation should be done following the development of the QMS documentation. A method to review the implementation status is to conduct an internal audit. For external and certification audits, it is advisable to gather evidence at least three months prior to the audit.
- Where should we compile all this information?
- Your quality manual should be a comprehensive document accessible and known to all the employees that contain a summary of the organisation’s QMS.
How to follow? Development of QMS documentation
Once the organisation has identified the applicable requirements and processes, the QMS documentation needs to be developed. The QMS documentation may include the quality manual, documented procedures, work instructions, and forms. The documented procedures should cover all the applicable ISO 13485 clauses, including general QMS requirements, management responsibilities, resource management, product realisation and measurement, analysis and improvement.
When it comes to creating the documented procedures, manufacturers should consider that some ISO 13485 requirements are clearly defined in the standard, whereas others are more open to interpretation. Importantly, when developing the documented procedures, the organisation should always determine the scope of the procedure, references used, responsibilities as well as the tasks to be conducted. Regarding procedure development, these can be developed internally or outsourced to a quality assurance specialist.
Everything is settled, and we follow the procedures, are we done now? Implementation is crucial
The QMS is not only a bunch of documents to be followed. Once you have planned and approved the QMS documentation, the organisation can start the “Do” phase. While doing the activities, the organisation should record the output from the activities in approved forms. These records are mandatory for some requirements and provide evidence that the organisation can use to demonstrate that the QMS is implemented and effective. Keeping alive and continuously improving the organisation’s QMS is essential to obtaining and maintaining the ISO 13485 certification and building a system that can add value to your organisation and the manufacturing product.
How can AKRN help you?
Our Regulatory Affairs and Quality Assurance team can support you with a wide range of activities related to QMS 13485 development and implementation:
- Starting with a GAP Assessment QMS under ISO 13485, we will determine the potential non-conformities and areas of improvement in your QMS and propose potential measurements you might implement.
- Our QMS development and implementation services can support manufacturers in developing the QMS.
- Our qualified lead auditors can perform ISO 13485 internal audits of the organisation’s QMS.
- In addition, we also provide tailored ISO 13485 training sessions (introduction, development, implementation and auditing).
Contact us and let us guide you through this path to achieve all your goals!
Subject Matter Experts
José Velazquez, M.Sc.
Quality Assurance Manager LinkedIn
Arancha López-Pérez, Ph.D.
Regulatory Affairs Scientist LinkedIn