ISO 13485 is a routine practice for medical devices. Sometimes confidence in the ISO 13485 standard led to knowledge gaps. However, following the first “how to get ISO 13485 certification” query, there are often questions that need to be answered if a medical device maker hasn’t gone through the certification procedure.
The ISO 13485 Documentation Kit is a comprehensive solution for organizations involved in the design, production, installation, and servicing of medical devices. It provides a quick documentation process and easy certification, ensuring a quality system that meets customer requirements. The kit includes quality manuals, procedures, policies, operating instructions, and formats, designed by experienced consultants.
The 5 Important Facts About ISO 13485 That Surprizing You
ISO 13485 is an international standard that outlines the Quality Management System, especially for medical device design, development, manufacture, installation, and servicing. Medical device producers must adhere to enhance their quality of products that are safe, effective and consistent.
- ISO 13485 Certification is Mandatory: According to popular belief, medical device manufactures are not required to certify with ISO 13485; rather, certification is optional. While ISO 13485 does not have mandatory international weight, OEMs can benefit from it. For manufacturers, it is usually the quickest approach to show their ongoing commitment to quality, device quality, and requirement compliance. For suppliers, it’s frequently a crucial factor in securing contracts.
- The ISO 13485 certification is valid for 3 years at the time of Audit and Surveillance occurs: A successful ISO 13485 certification is valid for up to 3 years. But at that time, regulatory bodies are still in operation. The regular maintenance of compliance is ensured by conducting surveillance audits and recertification audits at different intervals. The entire cycle begins anew with a recertification audit of the whole QMS system, assuming the company is in good standing after the three-year period and elects to recertify.
- The Medical Device Single Audit Program (MDSAP) Satisfies Audit Requirements: The US FDA, Health Canada, Therapeutic Goods Administration (Australia), Egencia Nacional de Vigilance Sanitaria (Brazil), and the Pharmaceuticals and Medical Devices Agency (Japan) are the organizations behind the MDSAP effort. Simplifying QMS audits and assessments for medical device manufacturers is the aim, as is standardizing the process for verifying local laws and choosing which nations are eligible for MDSAP coverage.
- The ISO 13485 Certification is not Required for Supply Chain Retailers.
Although ISO 13485 certification is not a must for vendors in a medical device manufacturer’s supply chain, OEMs are increasingly requesting it. The standard emphasizes that original equipment manufacturers (OEMs) oversee their supply chains to maintain partnerships that enhance overall medical device quality and safety, although a manufacturer’s certification does not directly extend to their vendors. - There is No Compatibility between ISO 9001, ISO 13485, and EN ISO 13485.
Quality management system requirements across all industries are covered by ISO 9001. The objectives of quality management as defined by ISO 9001 are relationship management, data-driven decision making, leadership, employee involvement, procedures, and continuous improvement. Specifically focusing on medical equipment, ISO 13485 was developed from ISO 9001. Except for minor adjustments to ensure compliance with the EU Medical Device Regulation (MDR), EN ISO 13485 is almost identical to the worldwide ISO standard.
Both ISO 13485 and EN ISO 13485 include all of the focus areas of ISO 9001 in addition to procedures and design controls unique to medical devices, such as measurement/analysis requirements, resource management, product realization, complaints, and QMS management responsibilities.