INFO QUALITY - KONSULTAN ISO 13485 - MDD - STANDARD MUTU ALAT KEDOKTERAN RUMAH SAKIT

Info Konsultan ISO 13485 - MDD Consultant

noreply@blogger.com (webmaster) — Mon, 23 Feb 2009 17:53:00 +0000

Why ISO 13485 or MDD ?

noreply@blogger.com (webmaster) — Mon, 23 Feb 2009 17:44:00 +0000

There is probably no other industry where the importance of product conformity is as crucial as that in the design and manufacture of medical devices. Standards in any industry are an important way both to safeguard product conformity while simultaneously harmonizing requirements, not only nationally, but internationally as well.
An important step in safeguarding product conformity and ensuring that a manufacturing or design process can consistently produce product of the required standard, is a structured management system.
ISO 13485 is a standard that provides specific requirements for the application of ISO 9000 to the medical devices industry for regulatory purposes.
This standard help to ensure the consistent application of quality requirements in this industry, they are being applied as part of the regulatory regime for medical devices in a number of countries.

Konsultan ISO 13485

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Tentang ISO 13485:2003

noreply@blogger.com (webmaster) — Wed, 15 Oct 2008 10:07:00 +0000

ISO 13485:2003 International Standard specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services.
It can also be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer and regulatory requirements.

It is emphasized that the quality management system requirements specified in this International Standard are complementary to technical requirements for products. The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization's quality management system is influenced by varying needs, particular objectives, the products provided, the processes employed and the size and structure of the organization. It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.
There is a wide variety of medical devices and some of the particular requirements of this International Standard only apply to named groups of medical devices.

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.

All requirements of this International Standard are specific to organizations providing medical devices, regardless of the type or size of the organization.