Pedestrians crossing a street at a crosswalk. Whether you run a business, work for a company or government, or want to know how standards contribute to products and services that you use, you’ll find it here. A set of processes that show your product, service iso 13485 requirements pdf system meets the requirements of a standard.
Back view of people in a meeting, looking at a presentation on a screen. ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization. The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system by monitoring, maintaining, and controlling the processes. If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system.
These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to ISO 13485:2016 reflect any exclusion of design and development controls. If any requirement in Clauses 6, 7 or 8 of ISO 13485:2016 is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system. For any clause that is determined to be not applicable, the organization records the justification as described in 4.
Intended to guide organizations in the development, implementation and maintenance of their quality management system in accordance with ISO 13485. Organizations active in the medical device sector can benefit from this publication. Uncover how ISO Standards help doctors treat patients and keep people safe at work, at home, wherever. Manage quality throughout the life cycle of a medical device. Electronic syringe with an automatic loading.
The medical devices industry is one of the most highly regulated sectors in the world. Significant quality systems and product requirements must be satisfied to ensure the medical devices produced are fit for their intended purpose. It won’t be long before robots become a normal part of our everyday lives. Soon, our mobile companions will provide everything from coaching to communication to companionship, keeping us independent as we grow older. With medical devices ranging from simple needles to life-saving high-tech implants, ensuring the highest possible level of safety is one of the industryʼs greatest priorities. Here, as the Chair of the ISO technical committee for quality management and related general aspects for medical devices, Dr.
Quality and safety are non-negotiable in the medical devices industry. Requirements for regulatory purposes, intends to help keep that level of quality up to scratch. A standard for quality management systems specific to the medical devices industry is under review and has just moved a step closer to completion. We are committed to ensuring that our website is accessible to everyone. All ISO publications and materials are protected by copyright and are subject to the user’s acceptance of ISO’s conditions of copyright.
Any use, including reproduction requires our written permission. The current ISO 13485 effective edition was published on 1 March 2016. ISO 13485 requires only that the certified organization demonstrate the quality system is effectively implemented and maintained. Examples of market-specific regulatory requirements include 21 CFR 820, the Quality System Regulation for medical devices sold in the United States, enforced by the U. Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements. EEC must be assessed before sale is permitted.
ISO 13485 the preferred method to prove compliance to such standards is to seek its official certification which is issued by certifying organizations known as “Registrars”. The GHTF guidelines are slowly becoming universal standards for design, manufacture,export and sales of various medical devices. GHTF as only the regulators, that are primary members of the group, get to make many of the decisions. NOM-241-SSA1-2012, Buenas Practicas de Fabricación para Establecimientos dedicados a la Fabricación de Dispositivos Médicos. The scope of application is mandatory in the national territory, for all establishments dedicated to the process of medical devices marketed in the country.
The cofepris is the body assigned to its control, verification and to grant the records of compliance to the companies that implement this Standard of Good Manufacturing Practices. This standard is partially in line with ISO 13485: 2003 and ISO 9001: 2008. NOM-241 Standard, putting special attention on manage of risks during manufacture and regulating by manufacturing lines some of the most important medical devices manufacturing processes. This standard will be pusblished in August, 2018 and 180 days after publication will come mandatory for the industry. Medical devices include products of the following categories: medical equipment, prostheses, orthotics, functional aids, diagnostic agents, supplies for dental use, surgical, healing and hygiene products.