The International Standards Organization (ISO) creates documents that provide guidelines to ensure that products, processes or services are fit for their manufactured use. Standards ensure the quality we’ve come to expect in goods and services we purchase.
Standards such as ISO 13485 are created by technical committees whose members are experts in their fields. These committees are comprised of ISO members from around the world.
Standards may take years to develop and approve and once approved, they may supplant other well-known standards. For example, FDA is working with the ISO Technical Committee to combine certain parts of 21CFR Part 820 with ISO 13485. Professionals working in quality administration need to stay current on these types of international developments.
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Meeting the requirements for ISO 13485 involves completing a great deal of paperwork. ISO registration using automation ensures an orderly compilation of the information in a format that is quick and easy to retrieve and simple to update.
Transforming manual processes into automated processes in areas such a document control and process management can provide dramatic results in terms of assuring ISO 13485 compliance and maintaining ISO 13485 certification.
Businesses desiring to be competitive in today’s international markets find implementing and maintain a quality management system imperative for product differentiation. Conforming to ISO 13485 can deliver a number of benefits:
MasterControl’s Quality Excellence solutions are aimed at helping medical device companies ensure that there are compliant with ISO 13485-2016. Quality Excellence solutions automate and accelerate documents and change control, training, CAPA, audits, risk and mitigation and validation throughout the product life cycle from a single centralized system. Learn more about how the MasterControl Quality Excellence system can help you achieve compliance with ISO 13485-2016 guidelines.
MasterControl and its partner, i4DM, have served as the quality management system (QMS) providers for the FDA’s Office of Regulatory Affairs since 2009. They also serve as QMS providers for the Division of Pharmaceutical Analysis, part of the FDA’s Center for Drug Evaluation and Research (CDER).