ISO 13485 ''Medical devices -- Quality management systems -- Requirements for regulatory purposes'' is a voluntary standard, published by
International Organization for Standardization
The International Organization for Standardization (ISO ) is an international standard development organization composed of representatives from the national standards organizations of member countries. Membership requirements are given in Ar ...
(ISO) for the first time in 1996, and contains a comprehensive
quality management system for the design and manufacture of
medical device
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...
s. The latest version of this standard supersedes earlier documents such as EN 46001 (1993 and 1996) and EN 46002 (1996), the previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996).
The current ISO 13485 edition was published on 1 March 2016.
Background
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
IATF 16949:2016 is a technical specification aimed at the development of a quality management system which provides for continual improvement, emphasizing wikt:defect, defect prevention and the reduction of variation and waste in the automotive ind ...
, where only firms with an active
request for quotation
A request for quotation (RfQ) is a business process in which a company or public entity requests a quote from a supplier for the purchase of specific products or services. RfQ generally means the same thing as Call for bids (CfB) and Invitatio ...
, or on the bid list, of an
International Automotive Task Force supply chain manufacturer can seek registration.
Reason for use
While it remains a stand-alone document, ISO 13485 is generally harmonized with
ISO 9001
The ISO 9000 family is a set of five quality management systems (QMS) standards that help organizations ensure they meet customer and other stakeholder needs within statutory and regulatory requirements related to a product or service. ISO 90 ...
. A principal difference, however, is that ISO 9001 requires the organization to demonstrate
continual improvement
A continual improvement process, also often called a continuous improvement process (abbreviated as CIP or CI), is an ongoing effort to improve products, services, or processes. These efforts can seek "incremental" improvement over time or "breakth ...
, 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
Customer satisfaction (often abbreviated as CSAT) is a term frequently used in marketing. It is a measure of how products and services supplied by a company meet or surpass customer expectation. Customer satisfaction is defined as "the number of c ...
are absent from the medical device standard.
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
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
(FDA), or the
Medical Devices Directive
The Medical Device Directive (Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ No L 169/1 of 1993-07-12) is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a ' ...
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 action
Corrective and preventive action (CAPA or simply corrective action) consists of improvements to an organization's processes taken to eliminate causes of non-conformities or other undesirable situations. It is usually a set of actions, laws or regu ...
s
*specific requirements for cleanliness of products
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
European, or Europeans, or Europeneans, may refer to:
In general
* ''European'', an adjective referring to something of, from, or related to Europe
** Ethnic groups in Europe
** Demographics of Europe
** European cuisine, the cuisines of Europe a ...
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
ISO 14971 ''Medical devices — Application of risk management to medical devices'' is a voluntary standard for the application of risk management to medical devices. "Voluntary standards do not replace national laws, with which standards' users a ...
. 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
A notified body, in the European Union, is an organisation that has been designated by a member state to assess the conformity of certain products, before being placed on the EU market, with the applicable essential technical requirements. These e ...
.
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
On commercial products, the letters CE (as the logo ) mean that the manufacturer or importer affirms the good's conformity with European health, safety, and environmental protection standards. It is not a quality indicator or a certificat ...
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.
ISO 13485 is now considered to be inline standard and requirement for medical devices even with "
Global Harmonization Task Force The Global Harmonization Task Force (GHTF) was “a voluntary group of representatives from national medical device regulatory authorities (such as the U.S. Food and Drug Administration (FDA)) and the members of the medical device industry” Guidelines" (GHTF). 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 Regulators Forum
International is an adjective (also used as a noun) meaning "between nations".
International may also refer to:
Music Albums
* ''International'' (Kevin Michael album), 2011
* ''International'' (New Order album), 2002
* ''International'' (The T ...
(IMDRF) 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.
Mexico published on October 11, 2012, a national standard as a
Norma Oficial Mexicana
The Norma Oficial Mexicana (Official Mexican Standard), abbreviated NOM, is the name of each of a series of official, compulsory standards and regulations for diverse activities in Mexico. They are more commonly referred to as ''NOMs'' or ''norma ...
(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.
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
The Federal Commission for Protection against Health Risks (in Spanish, Comisión Federal para la Protección contra Riesgos Sanitarios, Cofepris) is a regulatory body of the Mexican government. It is a decentralized organ of (and supervised by) t ...
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 managing risks during manufacture and regulating by manufacturing lines some of the most important medical devices manufacturing processes. 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 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.
ISO 13485:2016 Certificates meets the requirement of IEC 60601-2-25 : 1993 + A1: 1999 safety of Electrocardiograms.
Chronology
See also
*
ISO 14971
ISO 14971 ''Medical devices — Application of risk management to medical devices'' is a voluntary standard for the application of risk management to medical devices. "Voluntary standards do not replace national laws, with which standards' users a ...
*
Good manufacturing practice
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutica ...
*
References
External links
Guide to ISO 13485Overview, guidance and regulatory compliance for EU medical device manufacturersCFR_-_Code_of_Federal_Regulations_Title_21,_Part_821,_Food_and_Drug_Administration's_Quality_System_Regulation.html" ;"title="Food and Drug Administration">CFR - Code of Federal Regulations Title 21, Part 821,
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Regulation of medical devices
Medical technology
Medical equipment