Quality Professionals are invited to attend an open forum on expected changes to the ISO 9001:2015 International Standard. This forum is part of a series of updates from Charleston area subject-matter experts aimed at assisting organizations in their preparation of the upgrade to the new standard. The panel of experts will include veterans from various sectors such as automotive, aerospace, environmental and information security to discuss the potential impacts on various industry-specific standards (ISO/TS 16949, AS9100, ISO 27001 and ISO 14001).
Quality Professionals are invited to attend an open forum on expected changes to the ISO 9001:2015 International Standard. This forum is part of a series of updates from Charleston area subject-matter experts aimed at assisting organizations in their preparation of the upgrade to the new standard. The panel of experts will include veterans from various sectors such as automotive, aerospace, environmental and information security to discuss the potential impacts on various industry specific (ISO/TS 16949, AS9100, ISO 27001 and ISO 14001).
Its projected that starting late 2015 many organizations (thru the quality professional) face the prospect of installing a risk management process into their ISO 9001:2015 quality management system. There are several questions to be answered: [bulletlist]
- What is risk-based thinking?
- How extensive does it have to be?
- How much more work will this be?
- Could I do this quick enough?
- How do I get started?
How extensive does it have to be?
Risk-based thinking will be new for ISO 9001:2015. In the aerospace industry, risk-based thinking has been required as a part of the AS-series of standards for years. The federal government and NASA also have standards addressing risk management. The AS9100 standard does not specify how to implement a risk management process.
How much more work will this be?
Actually, risk-based thinking could prove to be a very valuable process for your company. Risk entails a probability and impact of a loss or gain. Some useful risk publications include:
- ISO 31000:2009, Risk management – Principles and guidelines, provides principles, framework and a process for managing risk.
- (Sept, 2012). NIST Special Publication 800-30 revision 1: Guide for conducting risk assessments.
- Project Management Institute. (2013). A guide to the project management body of knowledge (PMBOK Guide
- Prichard, C., & Tate, K. (2013). The risk management memory jogger.
- ISO Guide 73:2009, Risk management - Vocabulary complements ISO 31000 by providing a collection of terms and definitions relating to the management of risk.
- ISO/IEC 31010:2009, Risk management – Risk assessment techniques focuses on risk assessment.
Can I do this quick enough?
Get started now! There have been some articles on risk-based thinking in Quality Progress (ASQ magazine). See Palmes, P. (Sept 2014). “A new look: 15 things you must know about the upcoming ISO 9001 revision”. Also, there are opportunities to network with experts through ASQ section meetings and through webinars.
How do I get started?
Seek advice from your Registrar about how they are directing their auditors to assess risk. You may want to write a new risk management procedure containing the concepts and body for a risk-based thinking process. It should follow the steps of the standard you want to use, such as NIST SP80-31. (The NIST standard and NASA procedures/ standards are free to the public.)
There will be more blogs on details of risk-based thinking to follow. Of course, Concentric is in place to be the external resource for you to succeed in implementing a good risk-based thinking process. For Glenn's full article register for our upcoming ISO 9001:2015 Forum - January Webinar. You can get update on all the changes including risk-based thinking. Register online here.
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