ISO 13485 Certification

ISO 13485 is an International Organization for Standardization (ISO) standard, published in

2003, that represents the requirements for a comprehensivequality management system for the

design and manufacture of medical devices.[1] This standard supersedes earlier documents

such as EN 46001 and EN 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488

(also 1996).
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]
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 theMedical 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. The preferred method to prove conformity is the

certification of the Quality Management System according ISO 9001 and/or ISO 13485 and ISO

14971 by a Notified Body. The result of a positive assessment is the certificate of

conformity allowing the CE mark and the permission to sell the medical device in the

European Union.
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.[4]
ISO 13485 is now considered to be inline standard and requirement for medical devices even

with "Global Harmonization Task Force Guidelines" (GHTF).[5] 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)[6] 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.