ISO 13485

Online Training with a 50% discount for ISO and IATF courses.

Thursday, 20 July 2017
ASR Editor
OnlineStandardsTraining.com and ASR have agreed to offer steep discounts for ASR clients.

Because of the costs, organizations only train a few people; not everyone that needs it.  To  train the entire staff or work group, training can cost thousands of dollars. Whether you're an employee, an employer or going it alone. The money saved from travel alone can be substantial

ISO Re-Certification Count Down

Tuesday, 25 April 2017
ASR Editor
Keep These Transition Dates Handy!

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.  

Risk Management - Advanced Product Planning for Industry

Friday, 07 March 2014
ASR Editor
Risk Management is part of ISO 13485:2003 and AS9100 Rev C.

These two standards need to be fully understood before an effectively implemented system can be developed. Some  type of risk management plan might be valuable for all manufacturing and service industries.

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
.

New ANAB Logo Effective January 1, 2016

Thursday, 30 July 2015
ASR Editor
Accredited organizations using ASR's logo and the ANAB logo on their respective stationery, marketing materials, and electronic media/websites will need to replace the ANAB logo by December 31, 2017. Use of the ANAB logo and the ASR logo is optional.

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.

Quality/Business Management Standards

Monday, 16 February 2015
ASR Editor
It is anticipated that in the next two years many of the quality management system standards will be revised.

As part of that process, users should keep in mind that in most cases there will be a three year implementation phase negating a grand rush to implement new or revised documents.
When revised standards are released, organizations will want to review the standard with all appropriate personnel, fully understand the scope of the changes, develop an action plan, and gradually implement.

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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