ISO 9001:2008 specifies requirements for a quality management system where an organization
- needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
- aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
All requirements of ISO 9001:2008 are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
Where any requirement(s) of ISO 9001:2008 cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.
Where exclusions are made, claims of conformity to ISO 9001:2008 are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.-------From www.iso.org/
ISO 13485 is now considered to be inline standard and requirement for medical devices even with "
Global Harmonization Task Force 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 Regulatory Forum (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.
-----From https://en.wikipedia.org
