ISO 13485:2016 (Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes) is the international standard that defines Quality Management Systems (QMS) requirements for organizations that design, develop, manufacture, install and service medical devices and design, develop, and provide related services, including manufacturers of materials or component parts that are used in medical devices. The latest version of the standard was published in March 2016. It shares the same QMS principles and also follows the general increased emphasis on risk management shown within the range of QMS standards. ISO 13485 was originally derived from ISO 9001 and shared the same basic principles, but required greater documentation and placed additional emphasis on areas such as the work environment, risk management, design control and regulatory requirements. ISO 13485:2016 is beneficial for many organizations, and can be used by suppliers and external parties that are involved with providing medical device products. Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, they apply equally to associated services as supplied by the organization. The requirements may vary based upon the class of medical device – from a wheelchair to a pacemaker. The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization are the responsibility of the organization and are accounted for in the organization’s quality management system by monitoring, maintaining, and controlling the processes. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to ISO 13485:2016 reflect any exclusion of design and development controls. In general, a company would use customer specifications, process charts, product plans, checklists, bills of materials, supplier agreements, and a whole host of other documents to control ISO 13485. With test instructions and test protocols, companies will know what’s required to ensure the products or services are safe for the public. Technical specifications and manufacturing specifications provide the necessary instruction to build a product in the manner it was intended. Diagrams, process charts, and drawings provide the visuals necessary to achieve quality. Any document that will ensure proper control of the process will be necessary. Reports of nonconformity and internal audit plans are often necessary to achieve the quality required of medical suppliers. Each and every document can be used to control ISO 13485. Even material specifications and approved lists of suppliers will make a difference in how the products are produced. When considering the documents necessary to control ISO 13485, ensure that all possibilities are reviewed. This will allow your company more opportunity to build a quality product without any problems. If any problems emerge, they’ll be minimal compared to the number of problems, inefficiencies or defects that may arise without consideration of these important documents.
Conclusion
As per the ISO 13485 a relevant procedure that outlines the process of control of internal and external origin documents needs to be put in place covering all aspects of adequacy, approval, re-approval, issue, availability, revision and legibility in accordance to the international standards and regulatory bodies in your Quality Management system for Medical Devices. The objective of the documentation in the QMS is to ascertain that crucial processes are well controlled. The ISO 13485 Standard gives such regulatory requirements the same scale as any standard requirement for documents when it relates to the realization of the product. So this type of Documents is used to Control ISO 13485.
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