Medical Devices

ISO 13485 - Revised Medical Device Standard Soon To Be Released

Monday, 25 January 2016
ASR Editor
Medical device 4Sometime in the first quarter of 2016 we will see the release of ISO 13485 for medical device manufacturers. The final voting on the ISO 13485 was concluded December 29, 2015 and now we will wait for the official release in 2016. 

Minor clerical changes are permitted but no significant technical changes should occur.  

Changes In the New ISO 13485 Standard (DIS)

Thursday, 18 June 2015
ASR Editor
The draft standard to ISO 13485 (ISO TC 210 WG1) has added new requirements and clarifications in a number of areas.

This article covers a few areas

  • QMS
  • Management Responsibility
  • Human Resources
.

Marketing Your Management System Certificate

Friday, 07 March 2014
ASR Editor

Heads Up..

As a reminder, website, printed promotional and sales material must conform to your Management System's certification scope.

Some organizations have opted to exclude certain functions from the scope of their Management System and those exclusions are listed on their certificate.

What Does Your Website Say About Your Quality System?

Wednesday, 24 February 2016
ASR Editor
Your organization's web site has information that is important to your QMS. It might be advertising (communications media) your firm's capabilities and should reflect the current operating status and scope statement found on your registration certificate.

The American National Accreditation Board (ANAB) governs USA registration bodies and they have mandated certain requirements for client communications material. ANAB's objective is to ensure certificate holders don't promote a service such as design when the organization's certificate scope does not reflect that activity.

Medical Device Makers and Component Suppliers Software Validation Reminder

Thursday, 15 November 2012
Rand E. Winters - ASR Senior Auditor
Medical device manufacturers will want to review their QMS documents to ensure they are addressing software  validation requirements.

ISO 9001:2008 -7.5.2.1 and the FDA requirements in 21 CFR 820.30 and 21 CFR 820.70i spell out validation requirements for software design as well software in the production environment.

Timely Corrective Action Responses

Thursday, 06 February 2014
Karl Dorr - ASR Quality Manager
ASR's operating procedures require that upon the closing of an audit, an organization has 30 days to address and implement a response, and return the response to the auditor for review.

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Automotive

  • IATF 16949
  • Intl. Automotive Task Force
  • BS 25999
  • OHSAS 18001

Medical Devices

  • ISO 13485
  • Product Safety
  • Device Recalls
  • Emergency Situations

Aerospace

  • AS9100
  • AS9110
  • AS9120
  • SAE Technical Standards

Environmental

  • ISO 14001
  • EPA Regulations
  • EMS Tools
  • Emergency Preparedness