ISO 13485 is a quality management system for a medical device manufacturing organization, which is used to control the various processes within an organization so that manufactured products meet the established quality standards.
Getting ISO 13485 certification includes documentation of quality policy, objectives, procedures and formats. Once the documents are prepared and implemented, the application is made to the Certification body who after a thorough Stage 1 and Stage 2 audit of the performance of an organization against the latest version of the ISO 13485 requirements decides if the certificate can be issued or not. This certificate is used for a period of 3 years and must be re-certified to maintain its ISO 13485-certification status. However, a surveillance audit is performed annually.
ISO 13485 has several advantages that cannot be emphasised. Companies of all sizes have realised considerable cost and time savings, as well as other benefits from an effective Quality Management System. The following are six of the most compelling reasons to get ISO 13485 Certification for your organisation:
Maven helps you prepare the required documentation, help you implement systems accordingly, help conduct your first IQA and MRM and assist you during both stages of audit. Any non-conformities raised by the auditor are resolved by our assistance until it is assured that a manufacturer is being awarded with the certification. We customize your quality management best suited to your needs, processes, and available resources. It does not matter if your organization has only a few employees or a multinational or if your processes are outsourced, there is always a best-suited quality management system and we help you unlock the same.
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