5Ħ Quality Management System What is a quality management system (QMS)? A system to establish policy and objectives and to achieve those objectives (ISO) Your organization 6ħ About ISO Designed in particular for medical device manufacturers Released in 2003 updated in Is a stand-alone Standard, meaning that a company can apply it without the support of any other quality system standard (i.e. 3Ĥ ISO Background & Overview The ISO standard ISO certification 4ĥ What is ISO 13485? ISO is an International Organization for Standardization (ISO) standard that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. Through these services Purdue MEP clients report new sales, product and market growth, cost reductions, and job growth. We offer public workshops, on-site training, and consulting services. What we do: We work exclusively with Indiana businesses, primarily manufacturers, to maximize performance through streamlined processes, increased profitability, and increased competitiveness. Our staff consists of subject matter experts (SMEs) from a wide variety of business and manufacturing sectors. For medical device companies that are FDA registered and ISO 13485:2016 certified, it is possible to create a single DMR/MDF file which encompasses both sets of requirements – as mentioned, for ease of use and maintenance, it is recommended to use a table of contents format.5:2016 QUALITY MANAGEMENT SYSTEMS STANDARD Overview Purdue Manufacturing Extension Partnership (800)Ģ About the Instructor Aaron Ramsey Lead Service Manager of Quality, Purdue MEP Experience: Quality, operations, project management, and machining Manufacturing, Pharmaceutical, and Medical Device industries Skills & expertise: Lead Auditor Certified ISO 9001:2015 / ISO 13485:2003 NSF HACCP training 2ģ About Purdue MEP Who we are: Purdue Manufacturing Extension Partnership (MEP) Division of Purdue Technical Assistance Program. To avoid duplication and to ensure that the contents of the file are up to date, an option is to manage each medical device file as a table of contents with links or references to the location of the source documents in the QMS.įDA 21 CFR 820.181 Device Master Record (DMR) v ISO 13485:2016 Medical Device File (MDF)īoth the DMR and MDF are very similar in so far as they both require documented procedures and records outlining the process for building the medical device. The medical device file includes documents and records from many different sources.
Requirements for installation, if applicable: Instructional information on how to install the medical device, Installation checklists, Verification specifications, Training/competence requirements, Acceptance criteria and release procedures.Measuring and monitoring procedures: Validation and verification, Quality assurance, Test instructions, Instructions for operating monitoring and measuring equipment.Process specifications or procedures including but not limited to: Instructions for preservation, storage, identification and traceability, Production methods/work instructions, Assembly plans, Cleanliness and sterilization processes, Resources requirements – equipment, machinery and tool specifications, Training plans and competency criteria, Environmental specifications, Packaging requirements and instructions, Release activities and associated acceptance criteria, Risk controls.
ISO 13485:2016 requires the organization to establish and maintain a medical device file for each medical device type or family.