WHAT IS ISO 13485 CERTIFICATION?
ISO 13485:2016 is a quality management standard specifically designed for the medical device manufacturing industry. ISO 13485 certification is assessed and issued by independent third-party certification bodies.
WHY DOES AN ORGANIZATION NEED ISO 13485 CERTIFICATION?
With ISO 13485 certification, an organization demonstrates its commitment to providing more consistent quality in its products and services, making its products more reliable and better able to meet customer requirements.
OVERVIEW OF ISO 13485:2016 CERTIFICATION SERVICES
WHAT IS ISO 13485:2016?
ISO 13485 is a quality management standard specifically designed for medical device manufacturing. The standard is based on ISO 9001 but includes additional requirements specifically related to the production, installation, and servicing of medical devices.
ISO 13485 also helps companies involved in the production, installation, and servicing of medical devices improve processes, operational efficiency, and product quality.
BENEFITS OF OBTAINING ISO 13485:2016 CERTIFICATION
- Enhanced risk management: ISO 13485 certification helps you manage risk by increasing traceability and consistency of your products and services.
- Improved customer satisfaction: A medical device QMS enables you to deliver more consistent quality in your products and services, making your products more reliable and better able to meet customer requirements. This improved quality increases customer satisfaction.
- Legal compliance: ISO 13485 certification requires compliance with all applicable legal and regulatory requirements. It also helps you improve your understanding of how these requirements impact your organization and customers.
- Reduced operating costs: ISO 13485 certification helps you continually improve your processes and make them more efficient over time, saving costs for your organization.
- Better access to information: The documentation required by ISO 13485 can support your organization in building a consolidated knowledge base, helping identify issues and improve products and processes. Documentation also ensures that team members have access to accurate information whenever needed.
- Support for ISO 9001 certification: Achieving ISO 13485 certification can make it easier to obtain ISO 9001 certification, as the two standards share many common requirements. However, some differences must still be considered.
- Greater business opportunities: Many companies prefer to work with medical device organizations that hold ISO 13485 certification, and some require it as a condition of partnership.
- Enhanced business credibility: ISO 13485 certification is internationally recognized as a mark of a reputable business and high-quality products, improving your credibility among existing and potential customers, investors, partners, suppliers, and other stakeholders.
- International expansion opportunities: ISO 13485 is internationally recognized as a sign of product quality and is often a first step toward regulatory approval in many major markets.
TO BE CERTIFIED ISO 13485, AN ORGANIZATION MUST MEET THE REQUIREMENTS OF THE ISO 13485 STANDARD
WHY CHOOSE KMR CERTIFICATION BODY?
1. By choosing ISO certification body KMR, your ISO certificate will be internationally recognized (IAF, KAB). KMR certificates are recognized worldwide through the mutual recognition agreement, the International Accreditation Forum Multilateral Recognition Arrangement (MLA). To ensure that your certification is appropriately recognized both internationally and nationally, the certification activities of ISO certification body KMR Vietnam have been licensed by the Directorate for Standards, Metrology and Quality under the Ministry of Science and Technology in accordance with Decree No. 107/2016/ND-CP, with Certificate No.: 3535/TĐC-HCHQ.
2. The certification auditors of KMR are leading experts with extensive experience and in-depth understanding of your industry. Their constructive working approach and conformity-based audit perspective in accordance with standards help give you peace of mind.
3. Our office staff and coordinators always provide the most dedicated support to ensure that registration and certification audit activities are carried out conveniently and according to plan.
4. Our ISO certification costs are competitive, clear, and transparent.
5. Our experience, technical knowledge, and service standards have enabled us to provide certification services to many client organizations/enterprises across various sectors in numerous countries worldwide. Our certification experts are always ready to support your organization — this is also the mission of ISO certification body KMR. KMR is committed to accompanying enterprises not only during the certification process but also after certification.
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