2.1. QMS Processes
Established procedures, policies, and controls that ensure the consistent quality of the medical device throughout its development, manufacturing and post-market.
Process for establishing competence, providing needed training and ensuring personnel awareness to the Quality Management System and work affecting product quality.
Process to provide a means for the controls and related responsibilities and authorities for the identification, documentation, evaluation, disposition and notification of nonconforming product.
Process to verify that the installed system functions according to its design, user requirements, and GAMP (good automated manufacturing practice) requirements.
Process to manage design or process changes which can include corrective actions, changes implemented to solve the original issue, changes to turn features on and off for customers, and changes/updates in design documents.
Process for the creation, control and revision of controlled documents and the associated requirements for review, approval, final release, distribution and archiving.
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Process for how product-related complaints are evaluated, investigated, documented, trended and closed in a consistent and effective manner for commercially released product only.
Note:
Complaint refers to any written, electronic, or oral communication that. alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or. performance of a device after it is released for.
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Process to identify, evaluate, correct and/or remove product from commercial distribution where a potential or verified nonconformance in the product or product processing has occurred.
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Process that describes the responsibilities and requirements for planning and conducting internal audits, documenting and reporting internal audit results.
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Process to allow management, with executive responsibility, to review at defined intervals the continuing suitability, adequacy and effectiveness of the Quality Management System. Management Review is intended to assess any opportunities for improvement and the need for any changes to the Quality Management System, including the Quality Policy and Quality Objectives.
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Process in which product final acceptance is achieved by the completion of: the specified verification and validation activities; product specifications and manufacturing process procedures are finalized and released; all product labeling is finalized and released and meet the appropriate requirements for Unique Device Identification (UDI) or Universal Product Code (UPC); the Device Master Record is released, the record retention requirements for the product have been finalized.