ISO 13485:1996 - EN 46001 - Medical devices - Particular requirements - ISO 9001

[Marc]

Is anyone familiar with this?

ISO 13485:1996
Quality systems -- Medical devices -- Particular requirements for the application of ISO 9001

Edition: 1 (Monolingual)
Number of pages: 10
Technical committee / subcommittee: TC 210
ICS: 03.120.10, 11.040.01
Stage: 60.60
Stage date: 1996-12-26

This document is ISO-900X series with a few additions particular to the medical device industry. The major additions are in section 4.9, and address housekeeping, cleanliness, and PM.

Christian's got it. Also keep in mind that how much of it applies to your situation depends on the classification of the devices you make. Some of it only applies if your product is active (powered) and/or implantable. The definitions at the front help a lot.

ISO 13485 is based on, and very similar to, EN 46001, which seems to be slowly fading.

[Marc]

Does anyone know if this is the 'Latest & Greatest' with respect to ISO 13485?

[Wes Bucey]

Originally Posted by Marc

Does anyone know if this is the 'Latest & Greatest' with respect to ISO 13485?

It appears there is an update in 2003. This is the catalog from ISO quoting prices in Swiss Francs for 13485 and its companion, 14969:1999.
Found at:
http://www.iso.org/iso/en/CombinedQu...ryString=13485

ISO 13485:2003
Medical devices -- Quality management systems -- Requirements for regulatory purposes
Edition: 2 (Monolingual)
Number of pages: 57
Technical committee / subcommittee: TC 210
ICS: 11.040.01; 03.120.10
Stage: 60.60
Stage date: 2003-07-03

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ISO 13485:2003 PDF version (en) CHF 150,00 587 KB
ISO 13485:2003 PDF version (fr) CHF 150,00 810 KB
ISO 13485:2003 paper version (en) CHF 150,00
ISO 13485:2003 paper version (fr) CHF 150,00
Abstract
ISO 13485:2003 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 ISO 13485:2003 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 ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.
If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with ISO 13485:2003 reflect exclusion of design and development controls.
If any requirement(s) in Clause 7 of ISO 13485:2003 is(are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system.
The processes required by ISO 13485:2003, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system.
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ISO 14969:1999
Quality systems -- Medical devices -- Guidance on the application of ISO 13485 and ISO 13488
(available in English only)

Edition: 1 (Monolingual)
Number of pages: 30
Technical committee / subcommittee: TC 210
ICS: 03.120.10; 11.040.01
Stage: 90.92
Stage date: 2000-01-19

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ISO 14969:1999 PDF version (en) CHF 116,00 115 KB
ISO 14969:1999 paper version (en) CHF 116,00
Abstract
No abstract available

[DannyK]

Marc,

ISO 13485:2003 was released last summer and it is the latest and greatest.

For Health Canada, companies have till March 15, 2006 to switch over from ISO 13485 or 13488,1996 version.

The new standard is based on the ISO 9001:2000 structure.

Danny

[Vincnet]

I think I'v' red somewhere they are in the process of rewriting ISO 14969:1999
but I couldn't find any infos on the ISO site.

[Aaron Lupo]

EN 46001/2 is now obsolete (as of 03/31/04) it was replaced by ISO 13485:2003. In the Last I knew the Notified Bodies/Registrars are not yet issuing accredited Certificates as there is no accreditation scheme available yet. (don't quote me on this as it may have changed). ISO/TR 14969 Guidance on the application of ISO 13485:2003 as of 02/13/04 was approved as a DIS.

If you order a copy of ISO 13485:2003 it does include a very informative break down of teh differences between ISO 9001:2000 and ISO 13485:2003.