Deviations - Where in ISO 13485 deviations are covered?
Aug 25, 2021 · From my experience, deviations are more commonly used in production. I would recommend referencing: 7.5.1 Control of production and service provision
Sample Retention Requirements - Quality Records procedure
May 14, 2008 · Hello all, just a quick query.l am writing up a control of Quality Records procedure and under the heading of sample retention, i have hit a block. We are a start up medical …
ISO 13485 Quality Record Retention Period - The Elsmar Cove …
Jun 21, 2019 · I’m currently updating our Control of Records SOP in response to the following feedback from a GAP/pre-certification audit: "The control of records procedure did not define …
Standard or minimum requirement governing Certificates of …
Oct 30, 2008 · Hi I am wondering if there is a standard or minimum requirement governing CoA or CoC? We produce contact lenses working under ISO13485 and accept many of our chemicals …
Supplier Management Requirements - AS9100 vs. ISO13485
Mar 1, 2012 · We are an aerospace company developing a medical product for military use. We are busy adapting and modifiying our management system to meet the requirements of …
ISO13485:2016 - Exemption vs. Not Applicable - The Elsmar Cove …
Aug 14, 2017 · I am currently adopting ISO13485: 2016 for our company. We're a component supplier to the Medical Device sector and also an OEM supplier. We currenly exempt …
Does ISO 13485 have a Periodic Document Review Requirement?
Aug 9, 2013 · The requirement for periodic review originates from: ISO 13485 clause 4.2.3 b "b) to review and update as necessary and re-approve documents,"
ISO 13485 Installation Activities 7.5.1.2.2 - The Elsmar Cove Quality …
Feb 15, 2014 · Also, the guidance document on ISO13485 (TR 14969) has the following "Final testing of installed medical devices is carried out after it is in its location for use and connected …
ISO 13485 & Change of Address/Location - Elsmar Cove Quality …
Apr 30, 2012 · Contact your CB well in advance and with a date plan of probable effective change. The location as in your ISO13485 certificate concerns to the scope and processes …
GMP, FDA and ISO13485 Differences - The Elsmar Cove Quality …
Dec 12, 2005 · The difference between GMP, FDA, and ISO13485 Your help is appreciated! G. Graeme. Dec 12, 2005 #2 Welcome!