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Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1/4.2
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Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1/4.2
Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1/4.2
Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1/4.2
Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1/4.2
Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1/4.2
Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1/4.2
Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1/4.2
Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1/4.2
Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1/4.2
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Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1/4.2 - Page 8


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context of the organization, evidence, interested parties, iso 9001:2015, records (evidence) and records control, scope (general term)
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  Post Number #57  
Old 7th April 2018, 02:11 AM
AMIT BALLAL's Avatar
AMIT BALLAL

 
 
Total Posts: 175
Re: Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1

qualprod, you can choose any option. Its upto you.

When you take action on an issue, measure effectiveness of that action and after finding the action effective, you can revise the list to remove the issue from list. Or you can just update the status of issue as "Closed" in the list- keeping the issue on the list.

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  Post Number #58  
Old 7th April 2018, 01:18 PM
qualprod

 
 
Total Posts: 92
Re: Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1

Thanks Amit for your patience.
I appreciate too much your support
Have a good time
  Post Number #59  
Old 15th May 2018, 05:24 AM
maria12

 
 
Total Posts: 1
Please Help! Re: Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1

URGENT HELP!!!
I´m in the middle of the IATF audit for transition, and the auditor is putting a non conformity bacause I haven´t a range/score table of severity x occurance for interested parts requirements.
I have identified interested parties and risks associated with their requirements and actions to manage those risks. Is it mandatory to score in terms of priority?
  Post Number #60  
Old 15th May 2018, 05:29 AM
dsanabria

 
 
Total Posts: 1,332
Re: Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1

Quote:
In Reply to Parent Post by maria12 View Post

URGENT HELP!!!
I´m in the middle of the IATF audit for transition, and the auditor is putting a non conformity bacause I haven´t a range/score table of severity x occurance for interested parts requirements.
I have identified interested parties and risks associated with their requirements and actions to manage those risks. Is it mandatory to score in terms of priority?
Ask the auditor to show you in the standard that requirements - also let him know that you will appeal that NCR.

I have not seeing that requirement.


4.2 Understanding the Needs and Expectations of Interested Parties

Due to their effect or potential effect on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine:

a. the interested parties that are relevant to the quality management system;

b. the requirements of these interested parties that are relevant to the quality management system.

The organization shall monitor and review information about these interested parties and their relevant requirements.
Thanks to dsanabria for your informative Post and/or Attachment!
  Post Number #61  
Old 15th May 2018, 05:50 AM
AMIT BALLAL's Avatar
AMIT BALLAL

 
 
Total Posts: 175
Look! Re: Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1

Risk based thinking is addressed in 6.1.1 and 6.1.2:

6.1.1 asks:
Refer requirements referred to in 4.2 and determine the risks
and opportunities that need to be addressed to:
b) enhance desirable effects;
c) prevent, or reduce, undesired effects;
d) achieve improvement.

Intent is to determine the risks and opportunities against needs and expectations of interested parties.
Unless you determine the risk and opportunity rating:
how you'll be able to prioritize for enhancing desirable effects (Opportunities), prevent or reduce undesired effects (risks) / achieve improvement?

The intent is to quantify risk and you need to have some criteria for risk rating and weight-age. If you don't have any rating criteria, it will be subjective and will depend on interpretation of individual to decide whether the risk is significant or not.
  Post Number #62  
Old 15th May 2018, 06:06 AM
dsanabria

 
 
Total Posts: 1,332
Re: Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1

Quote:
In Reply to Parent Post by AMIT BALLAL View Post

Risk based thinking is addressed in 6.1.1 and 6.1.2:

6.1.1 asks:
Refer requirements referred to in 4.2 and determine the risks
and opportunities that need to be addressed to:
b) enhance desirable effects;
c) prevent, or reduce, undesired effects;
d) achieve improvement.

Intent is to determine the risks and opportunities against needs and expectations of interested parties.
Unless you determine the risk and opportunity rating:
how you'll be able to prioritize for enhancing desirable effects (Opportunities), prevent or reduce undesired effects (risks) / achieve improvement?

The intent is to quantify risk and you need to have some criteria for risk rating and weight-age. If you don't have any rating criteria, it will be subjective and will depend on interpretation of individual to decide whether the risk is significant or not.
In addition:

6.1.2 The organization shall plan:

a. actions to address these risks and opportunities;

b. how to:

1. integrate and implement the actions into its quality management system processes (see 4.4);

2. evaluate the effectiveness of these actions.

Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services.

NOTE 1: Options to address risks can include avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision.

NOTE 2: Opportunities can lead to the adoption of new practices, launching new products, opening new markets, addressing new customers, building partnerships, using new technology and other desirable and viable possibilities to address the organization’s or its customers’ needs.


As lang as you have address the risk (any written form to include management review) and made a decision I don't understand the thinking of the auditor.
Thanks to dsanabria for your informative Post and/or Attachment!
  Post Number #63  
Old 15th May 2018, 06:15 AM
AndyN's Avatar
AndyN

 
 
Total Posts: 8,855
Let Me Help You Re: Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1

Quote:
In Reply to Parent Post by maria12 View Post

URGENT HELP!!!
I´m in the middle of the IATF audit for transition, and the auditor is putting a non conformity bacause I haven´t a range/score table of severity x occurance for interested parts requirements.
I have identified interested parties and risks associated with their requirements and actions to manage those risks. Is it mandatory to score in terms of priority?
It's non-sense! You are not required to do anything of the sort. Tell the auditor you will be appealing the finding and that you'll also be making a formal complaint. This is way beyond what's required.
Thank You to AndyN for your informative Post and/or Attachment!
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