Introducing ISO 13485 QMS for Medical Device Industry

Summary:

This article aims to explain the foundation of the ISO 13485 quality management system that is needed for the medical device manufacturing industry.

ISO 13485 is a specified standard meant for the medical device industry and it lays down the requirements for establishing their quality management system (QMS). Every manufacturer of medical equipment needs to comply with its requirements, which will prove that their QMS is competent and eligible for ISO 13485 certification. Successfully certified manufacturers have been able to demonstrate the effectiveness of their quality management processes, resulting in more alliances or contracts with healthcare centers, professionals, laboratories, and medical research institutes. In short, the certification raises the credibility of the medical device manufacturers and opens up potential business opportunities.

ISO 13485 is the foundation for laying an appropriate QMS that complies with all essential regulatory and customer requirements. However, to establish it, you need to ensure two things:

• A quality policy with feasible goals and for your particular medical device manufacturing,
• A process approach for quality management with the integration of QMS according to ISO 13485 standard.

The processes you should be considering in this approach are:

1. Product design and development
2. Documentation management
3. Supplier evaluation and management
4. Risk management
5. Internal auditing
6. Management reviewing
7. Implementation of corrective/preventive actions
8. Evaluating resources (HR, infrastructure, materials for packaging, systems for delivery)
9. Handling customer feedback and inquires

Following these processes in the given sequence will help a medical device manufacturer have complete control over their production and ensure the delivery of high-quality and risk-free products (such as devices or equipment).

Step-by-Step Procedure for Establishing a QMS as per ISO 13485 Requirements

These are the steps that a medical device manufacturer needs to abide by to establish a QMS that conforms with ISO 13485 requirements.

Define the Scope of QMS

Depending on the type of medical products, production processes, or services used, the manufacturer needs to decide the scope of their QMS. Even the expectations of customers (end-users of the products) must be considered to determine the scope.

Getting an Experienced Quality Certification Agency

It is essential to pick a notified and credible certification agency that will guide you through the compliance process. Manufacturers do not often know everything about the ISO 13485 standard and its mandatory requirements. Therefore, they need to consult with a quality certification agency that will help them understand every requirement and train them on how to achieve them.

Documenting and Establishing the QMS

Once a manufacturer has evaluated its scope of the QMS and the quality goals to achieve, it needs to start documenting the QMS. This is a customary procedure to manually define the manufacturing procedures, work instructions, quality control processes, templates, and review checklists. To prepare a documented QMS, everything should be considered from the start to the end of the manufacturing process. This includes the stages involved, the sequence or flow of the stages, inputs and outputs at each stage, and the interdependence between stages. Finally, how to include each instruction of QMS into the manufacturing process will also be established in documents.

Work According to QMS

The medical device manufacturer now needs to work according to the processes and instructions of the QMS, as laid down in the documentation stage. Each member should be trained regarding the new work processes with the QMS to ensure quality devices are delivered on time.

Performing an Audit

Auditing is necessary to make sure that your operational QMS is competent, improves the quality of your products, and is ready to be certified with ISO 13485. Auditing will be done by a certification body that will eventually be responsible for granting the certification to your manufacturing unit. To pass the final audit, make sure you have conducted an internal audit with a qualified quality management experts from a quality certification agency. This will help you identify any minor and major contradictions in your QMS against ISO 13485 requirements which you can correct before the final audit occurs.

Get ISO Certified

Once the team of certification body auditors is assured about the compliance of your QMS with regulatory requirements of the standard, they will give you ISO 13485 certification. This certification is valid for 3 years, and you will need to conduct surveillance audits and periodically review and update your QMS to ensure it complies with the certification.

Conclusion

Well, ISO 13485 is a crucial certification for medical device manufacturers, as it helps them demonstrate the quality and reliability of their products to end-users. However, manufacturing any medical equipment, tools, or infrastructure is a complex task due to their use in treatment services. So, a QMS regulating their features, utility, and quality aspects is indeed a complex matter. Implementing this QMS according to ISO 13485 requirements requires proper planning and discretion.