Contents 1 Background 2 Reason for use 3 See also 4 References 5 External links


Background[edit] Though it is tailored to the industry's quality system expectations and regulatory requirements, an organization does not need to be actively manufacturing medical devices or their components to seek certification to this standard, in contrast to the automotive sector's ISO/TS 16949, where only firms with an active request for quotation, or on the bid list, of an International Automotive Task Force supply chain manufacturer can seek registration.[2]


Reason for use[edit] While it remains a stand-alone document, ISO 13485 is generally harmonized with ISO 9001. A principal difference, however, is that ISO 9001 requires the organization to demonstrate continual improvement, whereas ISO 13485 requires only that the certified organization demonstrate the quality system is effectively implemented and maintained. Additionally, the ISO 9001 requirements regarding customer satisfaction are absent from the medical device standard.[3] Other specific differences include: the promotion and awareness of regulatory requirements as a management responsibility. 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.S. Food and Drug Administration (FDA), or the Medical Devices Directive 93/42/EEC, required for doing business in the European Union controls in the work environment to ensure product safety focus on risk management activities and design control activities during product development specific requirements for inspection and traceability for implantable devices specific requirements for documentation and validation of processes for sterile medical devices specific requirements for verification of 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 conformity of Medical Devices and In-vitro Diagnostic Medical Device according to European Union Directives 93/42/EEC, 90/385/EEC and 98/79/EEC must be assessed before sale is permitted. One of the major requirements to prove conformity is the implementation of the Quality Management System according ISO 9001 and/or ISO 13485 and ISO 14971.[4] Although the European Union Directives do not mandate certification to ISO 9001 and/or 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". Several registrars also act as Notified Body. For those medical devices requiring the pre-market involvement of a Notified Body, the result of a positive assessment from the Notified Body is the certificate of conformity allowing the CE mark and the permission to sell the medical device in the European Union. A very careful assessment of the company Quality Management System by the Notified Body, together with the review of the required Technical Documentation, is a major element which the Notified Body takes into account to issue the certificate of conformity to the company product(s). This standard adopted by CEN as EN ISO 13485:2003/AC:2007 is harmonized with respect to the European medical device directives 93/42/EEC, 90/385/EEC and 98/79/EC.[5] ISO 13485 is now considered to be inline standard and requirement for medical devices even with "Global Harmonization Task Force Guidelines" (GHTF).[6] The GHTF guidelines are slowly becoming universal standards for design, manufacture,export and sales of various medical devices. The GHTF has been replaced in the last few years by the International Medical Device Regulatory Forum (IMDRF)[7] and is structured differently from the GHTF as only the regulators, that are primary members of the group, get to make many of the decisions. The IMDRF main membership (the regulators) do want to have non-regulators involved without voting rights and in this way they are hoping to get the process and documents completed quicker than under the GHTF system (regulators & non-regulators were equal in voting rights) that worked reasonably well, but somewhat slow. This standard adopted by CEN as EN ISO 13485:2012 is harmonized with respect to the European Medical Devices Directive 93/42/EEC.[8] Mexico has published in October 11, 2012 a national standard as a Norma Oficial Mexicana (NOM) to control manufacture of medical devices inside the country. NOM-241-SSA1-2012, Buenas Practicas de Fabricación para Establecimientos dedicados a la Fabricación de Dispositivos Médicos.[9] 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. In 2017, The Farmacopea de los Estados Unidos Mexicanos (United Mexican States Pharmacopoeia), medical industrial sectors and cofepris are working together for updating 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. In Spain medical devices are named in ISO-13485 as "Sanitary Products" as castellano-language translation of ISO-13485 but in Mexico they are known as "Medical Devices" and correspond to those used in medical practice and that meet the definition established by NOM-241 as: Medical device, to the substance, mixture of substances, material, apparatus or instrument (including the computer program necessary for its proper use or application), used alone or in combination in the diagnosis, monitoring or prevention of human or auxiliary diseases in the treatment of the same and of the disability, as well as the employees in the replacement, correction, restoration or modification of the anatomy or human physiological processes. 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.


See also[edit] List of ISO standards ISO 14971 Good manufacturing practice


References[edit] ^ "ISO 13485:2016 - Medical devices -- Quality management systems -- Requirements for regulatory purposes". www.iso.org. Retrieved 2016-03-24.  ^ "IATF 16949:2016 Automotive Quality Management System - BSI America - BSI America". www.bsiamerica.com.  ^ "Understanding ISO 13485".  ^ "ISO 9001".  ^ "Summary list of titles and references of harmonised standards related to medical devices - DG Enterprise & Industry. European Commission". Archived from the original on 2009-02-01.  ^ "GHTF is no longer in operation". www.ghtf.org.  ^ "International Medical Device Regulators Forum". www.imdrf.org.  ^ "CENELEC - Standards Development - List of Technical Bodies -". www.cenelec.eu.  ^ "NORMA Oficial Mexicana NOM-241-SSA1-2012, Buenas prácticas de fabricación para establecimientos dedicados a la fabricación de dispositivos médicos". http://www.dof.gob.mx/nota_detalle.php?codigo=5272051&fecha=11/10/2012. Retrieved 19 October 2017.  External link in |website= (help)


External links[edit] Guide to ISO 13485 ISO Organisation 13485 page Guidance MEDDEVs - Guidance for regulatory compliance for EU medical device manufacturers CFR - Code of Federal Regulations Title 21, Food and Drug Administration's Quality System Regulation v t e ISO standards by standard number List of ISO standards / ISO romanizations / IEC standards 1–9999 1 2 3 4 5 6 7 9 16 31 -0 -1 -2 -3 -4 -5 -6 -7 -8 -9 -10 -11 -12 -13 128 216 217 226 228 233 259 269 302 306 428 518 519 639 -1 -2 -3 -5 -6 646 690 732 764 843 898 965 1000 1004 1007 1073-1 1413 1538 1745 1989 2014 2015 2022 2047 2108 2145 2146 2240 2281 2709 2711 2788 2848 2852 3029 3103 3166 -1 -2 -3 3297 3307 3602 3864 3901 3977 4031 4157 4217 4909 5218 5428 5775 5776 5800 5964 6166 6344 6346 6385 6425 6429 6438 6523 6709 7001 7002 7098 7185 7200 7498 7736 7810 7811 7812 7813 7816 8000 8178 8217 8571 8583 8601 8632 8652 8691 8807 8820-5 8859 -1 -2 -3 -4 -5 -6 -7 -8 -8-I -9 -10 -11 -12 -13 -14 -15 -16 8879 9000/9001 9075 9126 9293 9241 9362 9407 9506 9529 9564 9594 9660 9897 9899 9945 9984 9985 9995 10000–19999 10005 10006 10007 10116 10118-3 10160 10161 10165 10179 10206 10218 10303 -11 -21 -22 -28 -238 10383 10487 10585 10589 10646 10664 10746 10861 10957 10962 10967 11073 11170 11179 11404 11544 11783 11784 11785 11801 11898 11940 (-2) 11941 11941 (TR) 11992 12006 12182 12207 12234-2 13211 -1 -2 13216 13250 13399 13406-2 13450 13485 13490 13567 13568 13584 13616 14000 14031 14224 14289 14396 14443 14496 -2 -3 -6 -10 -11 -12 -14 -17 -20 14644 14649 14651 14698 14750 14764 14882 14971 15022 15189 15288 15291 15292 15398 15408 15444 -3 15445 15438 15504 15511 15686 15693 15706 -2 15707 15897 15919 15924 15926 15926 WIP 15930 16023 16262 16612-2 16750 16949 (TS) 17024 17025 17100 17203 17369 17442 17799 18000 18004 18014 18245 18629 18916 19005 19011 19092 (-1 -2) 19114 19115 19125 19136 19439 19500 19501 19502 19503 19505 19506 19507 19508 19509 19510 19600:2014 19752 19757 19770 19775-1 19794-5 19831 20000+ 20000 20022 20121 20400 21000 21047 21500 21827:2002 22000 23270 23271 23360 24517 24613 24617 24707 25178 25964 26000 26300 26324 27000 series 27000 27001 27002 27006 27729 28000 29110 29148 29199-2 29500 30170 31000 32000 38500 40500 42010 55000 80000 -1 -2 -3 Category ″ Retrieved from "https://en.wikipedia.org/w/index.php?title=ISO_13485&oldid=811677100" Categories: ISO standardsRegulation of medical devicesMedical technologyMedical equipmentHidden categories: CS1 errors: external links


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