ISO 9001:2015 Cl. 4.1 Note 1 - External and Internal issues

[yoosuf]

Hi Everyone,

Good day!!!

under clause number 4.1, ISO 9001:2015 standard requires that

The organization shall monitor and review information about these external and internal issues.

NOTE 1 Issues can include positive and negative factors or conditions for consideration.


Could any one help me to understand (with examples) the interpretation of " positive factors or conditions for consideration"?.


Many thanks

 

[AMIT BALLAL]

Have you referred following threads for answers?

What do I have to do for ISO 9001:2015 Clause 4.1 and 4.2

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

"Context of the Organization" in ISO 9001:2015 Clause 4.1

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

ISO 9001 Cl. 4.1 and 4.2 - What does monitoring and review mean?

 

[Johnny 3484]

Hello to all,
I have recently found out that ISO wrote an additional standard but it was never issued to support the new ISO 9001:2015 standard, this will clear up the grey areas within the standard against each clause and will undoubtedly make it easier to understand.

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'Quality management systems — Guidelines for the application of ISO 9001:2015'

 

[AMIT BALLAL]

Thanks for sharing info Johny. To add, name of the standard / guideline is "ISO/TS 9002:2016".

 

[AndyN]

Hello to all,
I have recently found out that ISO wrote an additional standard but it was never issued to support the new ISO 9001:2015 standard, this will clear up the grey areas within the standard against each clause and will undoubtedly make it easier to understand.

​

　
'Quality management systems — Guidelines for the application of ISO 9001:2015'

I saw that 9004 has just been released...

 

[yoosuf]

Many thanks for the comments.

Can anyone give couple of examples for positive factors or conditions for consideration?.

 

[Kronos147]

Positive: Your organization has an engaged individual that knows about Elsmar Cove and takes the time to post and follow up.

 

[AMIT BALLAL]

For internal issues, you can use a SWOT analysis tool / any other tool you find useful. Internal issues are inside your organization that you can control.
E.g. In-house PPM is low, competence level of employees is good, etc.

For external issues, you can use tools such as PESTLE (PEST) analysis.
External issues are the ones that are outside your organization that you cannot control, but affects your organization. Hence you can only anticipate that change and act accordingly.
E.g. Change in technology- such as electric vehicles. If you are a battery manufacturer, it can be a positive issue and can result in an opportunity for your organization.

 

[QMS Tom]

I agree with the last post - a SWOT is a good tool to use to get at this requirement.
Determine external and internal issues that are relevant to the strategic direction. May be a good idea to have the strategic direction defined in some way (business plan, strategy plan etc).