The Cove Business Standards Discussion Forums More Free Files Forum Discussion Thread Post Attachments Listing Cove Discussion Forums Main Page
UL - Underwriters Laboratories - Health Sciences
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > National and International Business System Standards > ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

Risk Management (and Risk Based Thinking) in ISO 9001:2015 - Page 3


Elsmar XML RSS Feed
Elsmar Cove Forum RSS Feed

Monitor the Elsmar Forum
Sponsor Links




Courtesy Quick Links


Links that Cove visitors will find useful in your quest for knowledge:

International Standards Bodies - World Wide Standards Bodies

ASQ - American Society for Quality

International Standards Organization - ISO Standards and Information

Howard's
International Quality Services


Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum


Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining


Ajit Basrur
Claritas Consulting, LLC


NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


Some Related Topic Tags (Not all threads are Tagged)
iso 9001:2015, organizational knowledge, risk based thinking (rbt), risk management and analysis
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #17  
Old 21st January 2015, 09:55 AM
LUV-d-4UM

 
 
Total Posts: 744
Re: Risk Management in ISO 9001:2015

Thank you Marc.

I think I can also include the phrase "Risk-based thinking" into the uality policy. I'll post it when I come up with something.
Thanks to LUV-d-4UM for your informative Post and/or Attachment!

Sponsored Links
  Post Number #18  
Old 21st October 2016, 10:27 AM
Lise Quality

 
 
Total Posts: 2
Re: Risk Management in ISO 9001:2015

does anyone made risk identification and assessment to share with us?

i like to see some samples

Because we have decided to continue with the written process and we are going to transition to IATF 16949, here is what I use for each of my processes (blank copy) When you click on the risk analysis format at the end of the document, it brings you to excel.
Attached Files: 1. Scan for viruses before using, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: doc Process Map template.doc (64.0 KB, 554 views)
Thank You to Lise Quality for your informative Post and/or Attachment!
Sponsored Links

  Post Number #19  
Old 21st October 2016, 10:54 AM
Lise Quality

 
 
Total Posts: 2
Re: Risk Management in ISO 9001:2015

Quote:
In Reply to Parent Post by aburaggi View Post

hello everyone

does anyone made risk identification and assessment to share with us?

i like to see some samples
Hello,
I answered you and shared what we used on the post above this one.
Thanks to Lise Quality for your informative Post and/or Attachment!
  Post Number #20  
Old 26th October 2016, 11:31 PM
Marc's Avatar
Marc

 
 
Total Posts: 25,731
Re: Risk Management in ISO 9001:2015

Thank you for sharing, Lise Quality.

Does anyone else have anything to share with us? Other examples perhaps?
  Post Number #21  
Old 27th October 2016, 08:10 AM
Mike S.

 
 
Total Posts: 2,132
Re: Risk Management in ISO 9001:2015

Quote:
In Reply to Parent Post by Lise Quality View Post

does anyone made risk identification and assessment to share with us?

i like to see some samples
Search here or on the internet for FMEA, PFMEA, and/or risk register. Those are a few ways to do it and you will see lots of examples.

Or you can do it much more informally, simply listing a risk and how you intend to deal with it.

You use risk-based thinking quite often in your everyday life with no documentation: Do I need an umbrella or not; do I need a jacket or not, is it safe to pull into traffic now, if I speed on this road will I get a ticket, how much life insurance do I need, what deductible do I get on my car insurance, do I buy the extended warranty, will these tires get me through winter, do I trade in my old car now or wait until next year, do I need to get that mole looked at, should I get a cancer screening, do I get a flu shot, should I try for that other job, should I ask that person out on a date, etc. etc. etc.
  Post Number #22  
Old 4th January 2017, 01:04 AM
dhakadmilind

 
 
Total Posts: 11
Re: Risk Management in ISO 9001:2015

Dear ,
I need help to under stand risk base approach for ISO9001. As 14001 is very clear to have Risk base approach on aspects,compliance obligation and interested party issue.But ISO 9001 is not specific about Risk base apporach application.DO we have to consider all process with Risk base approach in ISO like calibration,maintainacne etc.
Regards
  Post Number #23  
Old 4th January 2017, 11:32 AM
Jen Kirley's Avatar
Jen Kirley

 
 
Total Posts: 5,992
Re: Risk Management in ISO 9001:2015

Quote:
In Reply to Parent Post by dhakadmilind View Post

Dear ,
I need help to under stand risk base approach for ISO9001. As 14001 is very clear to have Risk base approach on aspects,compliance obligation and interested party issue.But ISO 9001 is not specific about Risk base apporach application.DO we have to consider all process with Risk base approach in ISO like calibration,maintainacne etc.
Regards
It is important to not make the subject of risk-based thinking (RBT) too complex. The ISO 9001:2015 standard does not cite specific requirements because organizations need flexibility, and they need to both understand and operate to the concept.

Organizations have been already doing RBT in many cases; now they need to recognize that and be ready to "speak to it" (demonstrate it) for certification purposes. Examples include:
  • Calibration frequency set based on instrument's amount of use, the environment in which it is being used, its sensitivity and the degree to which it is important to ensure conforming output reaches the customer.
  • Planned maintenance is scheduled based on machine criticality for producing conforming outputs, its age, its extent of usage, its physical environment, etc. OEM Manuals often suggest frequencies, which provides a good starting point but these frequencies may need to be adjusted based on the above factors.
  • A checklist at Shipping helps personnel ensure outgoing parcels are complete and correct.
  • A SWOT Analysis in Management Review facilitates a strategic-level overview of internal and external issues, opportunities, and how internal and external changes might affect the organization

There are similar discussion threads referenced at the bottom of this page. Two threads have my Risk-Based Planner attachment for those organizations that really want a tool. The Planner's Instructions page also has links to four other RBT information sources, including checklists and SWOT.

I hope this helps!
Thank You to Jen Kirley for your informative Post and/or Attachment!
  Post Number #24  
Old 5th January 2017, 12:20 AM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,228
Re: Risk Management in ISO 9001:2015

The Risk based thinking has got to do a lot about people in the organization knowing their business well. It stems from the properly applied people (see 7.1.2) as well as from the Organizational knowledge (see 7.1.6)
Decisions and actions taken based on Analysis and evaluation (see 9.1.3) as said in the Actions to address risks and opportunities (see 6.1) ... and in this process if you are able to keep ready a plan B., then this is all the risk based thinking approach is.
Therefore if you are doing something knowing well what you are doing, and if you are not doing something because you have been said to do so., you are on proper risk based thinking. You will certainly be able to walk the talk about it.
Experience, Statistical knowledge, market research information, state of the art techniques, and many other as guided in clause 7.1.6 of the standard has to make you stronger in your risk based thinking and decision.
If you are looking to make or copy a documented procedure for this., then I guess you have not understood the standard OR more so your business.....
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > National and International Business System Standards > ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards

Bookmarks



Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Emoticons are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
Risk Management Implementation for ISO 9001:2015 SystemsQualityGuy ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 47 15th April 2017 05:38 PM
Is it worth the effort to implement ISO 31000 Risk based on ISO 9001:2015? QAMTY ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5 2nd March 2017 10:10 AM
Risk Management - Additional Process in ISO 9001:2015? QAMTY ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3 7th February 2017 08:58 PM
Risk Impact - Risk Assessment Sample/Method per ISO 9001:2015 QAMTY ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1 19th January 2017 07:45 AM
Are the TC 176 Documents on Risk Based Thinking useful to you? Sidney Vianna ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11 23rd January 2015 05:06 PM



The time now is 11:39 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


 
 


NOTE: This forum uses "Cookies"