Documents of external origin. How to manage the legislative updating process
For a Medical Device and In Vitro Diagnostics manufacturer, keeping up with continuous legislation changes that characterize this sector at national, European and international level is an incessant challenge, that can be very demanding and, at times, also rather frustrating.
For this reason, the management of documents of external origin inside the Quality Management System plays a crucial role.
This requirement is also stressed by the technical standard ISO 13485 (sect. 4.2.4):
“The Organization should set up a documented procedure to define the controls needed to ensure that documents of external origin, determined by the organization to be necessary for the planning and operation of the quality management system, are identified and their distribution controlled.”
Consequently, for Medical Device and In Vitro Diagnostics manufacturers it becomes mandatory to keep a list of documents of external origin that is always updated, to be submitted to the controls of Notified Bodies, Certifying Agencies and Regulatory Authorities, to demonstrate that the organization has implemented product and system regulatory changes according to the state of the art.
Which are the documents of external origin?
The documents considered of external origin are the binding and/or applicable norms, laws, regulations, technical standards and any other public or private deed that is required for the development and implementation of the Quality Management System as well as manufacturing/service providing.
Examples of these documents include the ISO 13485 or other standards used in the frame of the medical device design and development (ISO 14791, ISO 10993, etc.), certificates issued by Notified Bodies and Regulatory Authorities or any document containing regulatory requirements (e.g. common specifications) as well as documents containing the modes of operation for the implementation of the regulations (e.g. the MDCG guideline).
How should documents of external origin be managed?
Documents of external origin should be identified based on what they are (title and short description) and their intended use. There are many ways to do this. A simple way to manage these documents is to keep an up-to-date list.
The list of documents of external origin contains the list of laws, norms, regulations and guidelines demonstrating that the organization has implemented the product and system regulatory requirements according to the state of the art. This document can be subject to controls by Notified Bodies, Certifying Agencies, and Regulatory Authorities.
With their 40-year long experience, Di Renzo Regulatory Affairs can assist you in the implementation of the Quality System for Medical Devices and In Vitro Diagnostics, in compliance with the requirements established by the regulations, providing full assistance.
Di Renzo Regulatory Affairs has a highly qualified staff dedicated to quality management services and can assist companies in the following activities:
- advice for the implementation and maintenance of the Quality Management System (QMS) according to the standard ISO 13485
- gap-analysis for the verification of the Quality Management System
- drafting of the Quality Manual
- drafting of Standard Operating Procedures (SOP)
- setup of the data recording system
- taking on the role of Quality Assurance for the ISO 13485 systems
- audits on the manufacturers’ and/or distributors’ Quality Management System
- audits at manufacturers and manufacturing sites of medical devices before and after inspections by Notified Bodies and Competent Authorities
- audits at suppliers of manufacturers/manufacturers of medical devices to evaluate the level of compliance with ISO 13485
- assistance in the management of non conformities and of corrective and preventive actions (CAPA)
- taking part to meetings for the review of the executive management and/or support in the minutes drafting (Management Review)
- in-house training on the QMS and on the general principles of specific ISO standards
- advice for the implementation and maintenance of the post-marketing surveillance system
Written on 05/04/2024 by Felisiano Cipressi
