Medical devices and related service quality management systems are governed by ISO 13485 standards. The International Organization for Standardization is the publisher. ISO 13485 addresses:
- Quality assurance
- Risk Control
- Adherence to the law
- Efficiency in operations
- Capacity to track and retrieve goods and equipment
- Improvement of procedures and goods
Pharmaceutical and medical device companies can obtain ISO 13485, a quality management system certification, which is evolved from ISO 9001. It covers specific requirements that make applying certain of the ISO 9001 requirements challenging. Organizations that manufacture medical products and associated services can benefit greatly from ISO 13485 since it guarantees quality commitment, boosts productivity, and expands clientele. Additionally, certification can lessen production lag, product liability, and impediments to international markets. The most recent revision was released in February 2016.
The Advantages of ISO 13485
Companies that have adopted ISO 13485 report various advantages. Due to the certification’s potential financial benefits, many businesses pursue it. Their dedication to producing high-calibre medical equipment is demonstrated by the certification. As a result, companies can draw in more customers than before.
Among the most desired advantages are the following:
- Agreement with Bigger Businesses: Large medical device companies often have a preference for working with ISO 13485-certified vendors. The 2016 upgrade has increased demand for certification. The changes state that large corporations are now responsible for ensuring that all subcontractors adhere to ISO 13485 standards; subcontractors that currently possess this certification are likely to be given preference.
- Show Your Commitment to Excellence: ISO 9001 and ISO 13485 are regarded as markers of an organization’s dedication to quality. Getting a quality management accreditation shows customers and authorities that your company values quality.
- Increase Possible Market: International medical device standards like ISO 13485 and ISO 9001. The ISO 13485 standard is created to ensure that medical devices in different places demonstrate reality and quality. If you are taking into account the exporting the products the ISO 13485 can give the advantage.
- Win More in Business: Many corporations seek to collaborate with medical device organizations that hold ISO 13485 certification, and some demand that their partners hold this certification as well. This is partly because, as of the most recent version of ISO 13485, corporations have to guarantee that any subcontractors they engage with meet the requirements of ISO 13485. Gaining more business is made possible by ISO 13485 certification due to these preferences and criteria.
- Make It Easier to Obtain ISO 9001 Certification: Numerous companies are certified to both ISO 9001 and ISO 13485 standards. If your business is currently accredited under ISO 13485, the process of becoming certified to ISO 9001 is considerably easier. The requirements of these two standards are largely compatible. While several standards pertaining to business terms are not covered by ISO 13485, you will have previously finished most of the work with ISO 9001.
- Assist Staff in Obtaining Relevant Data: The ISO 13485 documentation kit requirements are made to make sure that every member of a development team always has access to the data they require, which can cut down on the time and costs involved in developing new products.
- Increase and Strengthen Your Business Knowledge: Additionally, we hear from clients that by recording the procedures related to their medical devices, the company may create a centralised knowledge base. This information can be used to pinpoint issues, enhance the final product, and expedite the production process. It also facilitates the onboarding process for new hires.
Difference Between ISO 9001 and ISO 13485
ISO 13485 and ISO 9001 are both quality management systems for the general industry, with ISO 9001 focusing on customer satisfaction through high standards. However, they differ in their focus on the safety and efficacy of medical devices. ISO 9001 is more focused on customer satisfaction and aligns with regulatory standards, while ISO 13485 is more closely linked to safety and efficacy, requiring more extensive documentation. Companies that manufacture both medical devices and other products may want to maintain both certifications.
Specific requirements and elements of ISO 13485 are as follows:
- Extra precautions to avoid contamination
- Monitoring centred on achieving customer needs as opposed to arbitrary metrics of customer satisfaction
- The Necessity for several documents at every stage of the product development process instead of concentrating on continual improvement as mandated by ISO 9001,
- Concentrate on preserving the effectiveness of the quality management system.
- Managing risks during the design and production phases
- Extra requirements for recalls, advisory notices, and regulatory reporting
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