Dec 4, 2008 · Simplest key difference is you can now easily read and apply ISO 13485:2003 as a stand alone document - without the constant refering to 9001(as with 46001 and previous 13485); annex B showing the the correspondence to ISO 9001:2000 (obviously some changes now due to the 2008 version).

May 1, 2000 · EN ISO 46001/2 have been replaced by EN ISO 13485/8:2000 by 2004-03-01. (Generally the date of cessation of presumption of 46001/2 conformity was this date). Since 2004-04-02 EN ISO 13485:2003 is a harmonized standard (Official Journal under Directives C 83 of 2004-04-02) EN ISO...

Iso 13485 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

Nov 21, 1999 · This year there was talk at the global harmonization task force meeting in Bethesda, Maryland of Europe phasing out EN 46001 and start using ISO !3485. But since ISO 13485 is based on ISO 9001 which is being changed to include continuous improvement and customer satisfaction, the regulators have indicated that they have second thoughts on how ...

Aug 29, 2016 · FDA’s involvement with the ISO TC 210 made it clear that ‘‘risk analysis’’ is the comprehensive and appropriate term. When conducting a risk analysis, manufacturers are expected to identify possible hazards associated with …

Feb 5, 2025 · Going from "ISO/TR 14969:2004 - Medical Devices - Quality Management Systems - Guidance on the application of ISO 13485:2003", to "ISO 13485:2016 - Medical devices - A practical guide" to "ISO 23485 - Medical Devices - Quality Management Systems - Guidance on the application of ISO 13485:2016" just adds another item I need to explain to people ...

Oct 7, 2024 · The answer is right here at the very beginning in (a)... 7.1.5.1 When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be: a) calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to ...

Oct 4, 2011 · ISO doesn't say. It's up to you and your system. If you find value in keeping markups then make sure your procedures tell people what to do with them as they are quality records. If you find no value, then just keep the signed approval sheet. Just make sure your document control and control of records procedures reflect what actually happens.

Jan 26, 2025 · According to ISO 9001:2015, clause 8.5.2, “The organization shall identify outputs when it is necessary to ensure conformity of products and services.” Stock was found without GRN numbers, failing to meet the organization's traceability

Apr 19, 2018 · under clause number 4.1, ISO 9001:2015 standard requires that The organization shall monitor and review information about these external and internal issues. NOTE 1 Issues can include positive and negative factors or conditions for consideration.