Ten steps for implementing ISO 13485

 

ISO 13485 is the quality management requirements for medical devices standard. Companies looking to manufacture medical devices for sales in the US and Europe among other places need to have a system in place that conforms to this standard. This includes ISO 13485 training for all personnel from the top management to all personnel on the shop floor.

ISO 13485 uses the Plan-Do-Check-Act approach to implement a quality management system. In implementing the management system, the following ten steps needs to be considered:

•        Top management commitment needs to be evident at all levels and the system needs management buy-in for its success. It is advisable to provides ISO13485 training in an overview format so that management understand their role in the system and what is needed from them for system effectiveness.

•        Documentation must capture all the relevant key processes to deliver confidence that the system can meet customer and regulatory requirements. There should also be a robust document and record control process in place. Do not over document the system as this too can lead to the failure of the system.

•        Conduct awareness training for all personnel. This ISO 13485 training will educate personnel on the policy, relevant objectives, their contribution to the system and the impact of their not conforming.

•        Develop a policy that clearly outlines the management commitment to meeting requirements and continual improvement. The policy must be easy to understand and communicated to all relevant stakeholders.

•        Identify the requirements that the organization need to comply with and make sure to incorporate these into the management system.

•        Conduct ISO 13485 training for the internal audit team and implement an internal audit program to assess the effectiveness of the system. Preferably two audit cycles should be completed before pursuing certification.

•        Once the system is implemented conduct at least one management review of the system per the requirements of the standard. Keep a record of this management review should an auditor want to evidence it.

•        Implement a process to control your suppliers to ensure an adequate level of control on the suppliers selected. The type and extent of control on each supplier will be based on the risk they pose to meeting the requirements.

•        Is the company is involved in design if the product then a robust design process must be developed that accommodates planning, testing, verification, validation and accommodation in the planning phase of potential causes of failure.

•        Implement a risk management program to control risks to the product. This is important phase and guidance exists for the development of risk management programs.

The above ten steps should be kept in mind when implementing an ISO 113485 QMS including the needed ISO 13485 training.