Risk Management

Risk Based Thinking – And ISO 9001:2015

Tuesday, 15 September 2015
ASR Editor

ISO/FDIS 9001:2015

With the release of the 2015 revision, it is important to revisit one of the major changes to the standard – developing risk based thinking.

ISO 9001:2015 moves risk based thinking from a "should" or a good idea to enhance a QMS to a "shall" requirement. Both ISO 13485:2003 and AS9100 require users to address risk in Section 7 of their respective standards.

A good way to look at risk and to address risk is by utilizing the PDCA cycle - Plan, Do, Check and Act.

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
.

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.

Risk Based Thinking – New for ISO 9001

Wednesday, 29 July 2015
Rand Winters

ISO/FDIS 9001:2015

A final draft of ISO 9001:2015 has been released for a final vote. Official release of ISO 9001:2015 is expected shortly after the September 9th voting deadline. There may be a slight change in the final wording of the document following this final vote.

In advance of the 2015 release of ISO 9001 it is important to revisit one of the major changes to the standard – developing risk based thinking.

ISO 9001:2015 - Takes Aim at Risk Management

Wednesday, 08 October 2014
ASR Editor
ISO 9001:2015 (draft) revision writers thought organizations might reap greater benefits if preventive action was included as part of a formalized risk management system.

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Automotive

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Medical Devices

  • ISO 13485
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Aerospace

  • AS9100
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