The regulations impose increasingly stringent requirements at every stage of the product life cycle, including handling and delivery. As a result, organizations must demonstrate the effectiveness of their quality management processes and implement best practices in all their activities. ISO 13485, an internationally recognized standard, specifies a quality management system specific to the medical device sector. This article provides a quick but comprehensive overview of this standard and why it is essential to manufacture medical devices.
If you work in the medical devices industry, you realize the importance of ISO 13485. Even in countries where compliance with the law doesn’t require this standard, the ISO 13485 is becoming wanted by investors, partners, and customers. Certification guarantees potential customers, suppliers, and other entities in international trade that your product is safe and the processes are efficient. In addition, this warranty can provide colossal marketing and sales benefits. So let’s take a closer look at ISO 13485.
ISO 13485 standard for medical devices
ISO 13485 is an international quality management standard addressed to all organizations related to medical devices: manufacturers, suppliers, subcontractors, and distributors. That also applies to repair or maintenance companies. As a result, we can classify products such as an instrument, machine, implant, and even an in vitro reagent into a broad group of medical devices, which can diagnose, prevent, and treat diseases.
ISO 13485 standard is fully autonomous but very often harmonized with ISO 9001. However, if you intend to start producing medical devices or subcontract a certified external company, you should be aware of the differences between the two standards.
How is ISO 13485 different from ISO 9001?
The ISO 13485 norm is an extension of the provisions of ISO 9001 about the medical devices sector. The principal difference between the two norms is that ISO 13845 applies mainly to companies in the medical device industry. On the other hand, the ISO 9001 applies to companies of all sizes and sectors. In addition, the ISO 9001 standard requires a certified company or organization to demonstrate that it continuously improves its processes. In contrast, ISO 13485 only requires proof of compliance with its quality system.
Another difference is that ISO 13485 excludes ISO 9001 requirements for customer satisfaction and focuses instead on managerial responsibilities. Finally, unlike ISO 9001, standard 13485 emphasizes the importance of risk. It requires medical device manufacturers and their intermediate suppliers and subcontractors to apply risk management and analysis from product design to production.
Device manufacturers who plan to sell their products in the European Union must ensure that their products comply with the Medical Device Directive (MDD) requirements and the “CE” marking process. ISO 13485 plays a crucial role in ensuring compliance with the MDD directive. That is one of the primary causes why ISO 13485 certification is so important.
Most organizations that implement the quality management system according to ISO 13485 simultaneously implement the ISO 9001. As a result, after completing the certification process, the organization receives two quality management certificates, i.e., ISO 13485 and ISO 9001.
What exactly does ISO 13485 cover?
Implementing the ISO 13485 standard requires an analysis of possible risks for users of medical devices and the development of repair methods to prevent this risk and adapt the offered products to the applicable legal standards. In addition to the requirements typical for quality management systems (known, e.g., from ISO 9001), this standard regulates many legal issues, including:
- Technical Documentation
- Reference to legal requirements
- Product risk management
- Detailed requirements for product realization, environment, and personnel qualifications
- Specific requirements for products with a limited use period or special storage conditions
- Feedback system
- Incident reporting
- Storage of documents for the life of the product
The ISO 13485 standard states that medical devices are subject to detailed classification. They are assigned a risk class related to medical use, described with numbers: 1, 2a, 2b, 3. The higher the course, the greater the risk level. That is closely related to the need to obtain appropriate certificates confirming, among other things, the application and use of a quality management system.
Why is ISO 13485 so significant?
There are many reasons why ISO 13485 certification may be necessary to a medical device company.
Increased customer confidence
The certification confirms the company’s commitment to quality, which often leads to increased clients confidence. If you are involved in the production, having a certificate will increase your company’s credibility in the eyes of clients, customers, employees, and other stakeholders. But suppose you are looking for a reliable subcontractor to whom you can entrust the installation of medical electronics. In that case, you can be sure that the subcontractor with the ISO 13485 certificate will carry out its scope of work based on the highest possible standards of performance.
Promote better communication with reduced discrepancies
ISO 13485 promotes international harmonization of legal requirements to enable device manufacturers and quality experts to communicate using a familiar, standardized vocabulary. That helps fill gaps and clear up misunderstandings that often result in discrepancies, inconsistencies, and other quality issues that can harm patients, leading to regulatory sanctions and significant loss of income.
Improving efficiency and relationships with suppliers
The application of a widely recognized uniform process control system leads to improved products and processes. That, in turn, leads to enhanced end-recipients satisfaction and better relationships with suppliers and partners.
Better brand positioning
With product and process improvements, device manufacturers can more easily ensure high-quality products and reduce or avoid embarrassing outcome recalls and costly regulatory penalties. In this way, brand positioning is improved, which is a significant competitive advantage.
Reduced time to market
ISO 13485 certification helps organizations meet the quality system requirements of the European Medical Device Directive (93/42 / EEC), the In Vitro Diagnostic Medical Device Directive (98/79 / EEC), and the Implantable Medical Device Directive (90/385 / EEC). That clearly shows that the manufacturer’s implementation of a standard dedicated to medical devices significantly accelerates introducing a new product to the market.
ISO 13485: The highest production quality of medical devices
Certified organizations confirm a devotion to building the quality of all stakeholders, be it end-users, customers and regulators. Certification, although of the size of your company, allows you to improve overall performance, eliminate uncertainty and introduce risk management. Consequently, production carried out by a certified manufacturer may turn out to be much less expensive.
The implementation and certification of a quality management system is also a highly effective way to optimize resources and manage clinical risk and crises. Furthermore, the certificate of compliance with the EN ISO 13485 standard is recognizable not only on the European market, so introducing medical devices simultaneously on several foreign markets may turn out to be much easier.
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