ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes are the standards of the International Organization for Standardization (ISO) published for the first time in 1996; it is a requirement for a comprehensive quality management system for the design and manufacture of medical devices. This standard replaces previous documents such as EN 46001 and EN 46002 (both 1997), ISO 13485 previously published (1996 and 2003), and ISO 13488 (also 1996).
The current effective edition of ISO 13485 was published on March 1, 2016.
Video ISO 13485
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Although adapted to the expectations of the industry quality system and regulatory requirements, an organization does not need to actively make medical equipment or their components to seek certification for this standard, in contrast to ISO/TS 16949 in the automotive sector, where only firms with active demand for quotations, or on the supply list, from the supply chain manufacturers the International Automobile Work Force may request registration.
Maps ISO 13485
Reasons for use
While it remains a stand-alone document, ISO 13485 is generally aligned with ISO 9001. However, the main difference is that ISO 9001 requires organizations to demonstrate continuous improvement, while ISO 13485 only requires that certified organizations demonstrate that the quality system is effectively implemented and maintained. In addition, the requirements of ISO 9001 regarding customer satisfaction do not exist from standard medical devices.
Other specific differences include:
- promotion and awareness of regulatory requirements as management responsibility. Examples of market-specific regulatory requirements include 21 CFR 820, Quality System Regulations for medical devices sold in the United States, enforced by the US Food and Drug Administration (FDA), or 93/42/EEC Guidelines for Medical Devices, necessary to conduct business in the European Union
- control in the work environment to ensure product safety
- focus on risk management activities and design control activities during product development
- special requirements for inspection and search for devices that can be implanted
- special requirements for process documentation and validation for sterile medical devices
- special requirements for verifying the effectiveness of corrective and preventive actions
Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements. The suitability of Medical Devices and Medical Equipment of In-vitro Diagnostics in accordance with the EU Directive 93/42/EEC, 90/385/EEC and 98/79/EEC shall be assessed before the sale is permitted. One of the main requirements to prove conformity is the application of a Quality Management System pursuant to ISO 9001 and/or ISO 13485 and ISO 14971. Although the EU Directive does not mandate ISO 9001 and/or ISO 13485 certification the preferred method of proving compliance with those standards is to seek its official certification issued by a certification body known as "Registrant". Some registrars also act as Notified Body. For medical devices requiring pre-market involvement of the Announced Body, the results of a positive appraisal of the Announced Body are certificates of conformity allowing the CE mark and permission to sell medical devices in the EU. Careful assessment of the Company's Quality Management System by the Recognized Body, together with the necessary Technical Document review, is a key element that the Reminded Body considers to issue a certificate of conformity to the company's products.
This standard was adopted by CEN as EN ISO 13485: 2003/AC: 2007 synchronized with reference to European medical device 93/42/EEC, 90/385/EEC and 98/79/EC directives.
ISO 13485 is now considered as the standard and inline requirements for medical devices even with the "Global Harmonization Task Force" (GHTF). The GHTF guidelines are slowly becoming a universal standard for the design, manufacture, export and sale of various medical devices. GHTF has been replaced in recent years by the International Medical Device Settings Forum (IMDRF) and is structured differently from GHTF because only regulators, who are the main members of the group, can make many decisions. The main membership of IMDRF (regulator) wants to have non-regulators involved without voting rights and in this way they hope to get the process and documents completed faster than under the GHTF system (the same regulator & non-regulator in voting rights) which works pretty well, but it's a bit slow.
This standard was adopted by CEN as EN ISO 13485: 2012 synced in conjunction with the European Medical Devices Directive 93/42/EEC.
Mexico has been published on October 11, 2012 as the national standard Norma Oficial Mexicana (NOM) to control the manufacture of medical equipment in the country. NOM-241-SSA1-2012, Buenas Practicas de FabricaciÃÆ'³n para Establecimientos dedicados a la Fabricación de Dispositivos MÃÆ'Ã… © dicos. The scope of the application is mandatory in the national territory, for all companies dedicated to the process of medical equipment marketed in the country. Cofepris is the body assigned to control, verify and to provide compliance records to companies that implement this Good Practice Standards. This standard is partially in line with ISO 13485: 2003 and ISO 9001: 2008.
In 2017, The Farmacopea de los Estados Unidos Mexicanos (United Mexican States Pharmacopoeia), the medical industry sector and Cofepris work together to update the NOM-241 Standard, place particular attention on risk management during manufacture and set up by several manufacturing lines of the most process manufacturing devices medical importance. This standard will be published in August 2018, and 180 days after publication it will become mandatory for the industry.
In Spain, medical devices are named ISO-13485 as "Sanitary Products" as Castellano ISO-13485, but in Mexico they are known as "Medical Devices" and are in accordance with those used in medical practice and that meet the established definition by NOM-241 as: Medical devices, for substance, mixtures of substances, materials, devices or instruments (including computer programs required for their use or application), used alone or in combination in diagnosis, monitoring or prevention of human or additional diseases in the same treatment and disability, as well as employees in the replacement, correction, recovery or modification of anatomy or human physiological processes. Medical equipment includes products of the following categories: medical equipment, prosthesis, orthotics, functional aids, diagnostic agents, supplies for dental use, surgery, healing and hygiene products.
See also
- ISO 14971
- Good manufacturing practices
- List of ISO standards
References
External links
- Guide to ISO 13485
- ISO Organization 13485 pages
- MEDDEVs Guides - Regulatory compliance guidelines for EU medical device manufacturers
- CFR - Federal Regulatory Code Title 21, Quality System Regulations Food and Drug Administration
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