Pharmaceutical

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.

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