ISO/DIS 9001:2000
This International Standard
specifies requirements for a quality management system where an organization needs to demonstrate its ability to consistently provide product that meets customer and applicable 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 regulatory requirements.
ISO 13485:2003
This International Standard specifies requirements for a
quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
The primary objective of this International Standard is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes
some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems
conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001 (see Annex B)
U.S. Quality System Regulation
(21 CFR 820)
(1) Current
good manufacturing practice (CGMP) requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging,labeling, storage, installation, and servicing of all finished devices intended for human use. The requirements in this part are intended to ensure that finished devices will be
safe and effective
and otherwise in
compliance with the Federal Food, Drug, and Cosmetic Act (the act). This part establishes basic requirements applicable to
manufacturers of finished
medical devices.
Tidak ada komentar:
Posting Komentar