Clause 4.1: Organization and its Context (Internal and External Issues)

External and internal issues.
I have seen a lot of comments that people have put down culture, export charts gdp, etc.

Would it be wrong to state for
External issues
-Customer satisfaction

Internal Issues
-Employee performance
- Late
_quality output
-Training

Supplier Performance
Price
Quality
Delivery

These are item that directly affect our quality management system.
And these are items that I can monitor

As for these rest you could add the weather if you sold crops.

 

Just want to share MHO in understanding the "context of the organization".

ISO 9000:2015 defines "context of the organization" as the "combination of internal and external issues that can have an effect on an organization’s approach to developing and achieving its objectives".

ISO 9001:2015 clause 4.1 specifies that "The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system. The organization shall monitor and review information about these external and internal issues".

Further, ISO 9000:2015 defines the following:

Mission - "organization’s purpose for existing as expressed by top management";
Vision - "aspiration of what an organization would like to become as expressed by top management";
Strategy - "plan to achieve a long-term or overall objective"​

Let's say that I belong to a taxi company.

Our purpose would be clearly stated in our Mission statement that is: "We exist to provide transport services to the general riding public".
The strategic directions will stem from our Vision statement that is: "To be the the riding public's first choice by providing safe, comfort and convenient riding experience".
The strategic directions then will include: "Provision of road worthy vehicles"; "Advocate Defensive Driving"; "Healthy Driver is a Safe Driver"; "Full Compliance with Regulations"; "Promote You Got a Friend in me Attitude"; "Collect Our Taxi Conveniently"; etc.

• Information about the external issues that we need to monitor and review will include: financing schemes, prices of vehicle parts, traffic rules and regulation, city ordinances, training providers of defensive driving, traffic volume, riding public feedback, road constructions, re-routing schemes, etc.
• Information about the internal issues that we need to monitor and review will include: working hours of drivers, driving behaviors of drivers, programs for preventive maintenance, fast moving parts and supplies, results of medical and psychological examination, time of responses to requests, drivers feedback, etc.

 

Call me cynical but surely "We exist to make money".

 

OK, I'll bite. Call me old fashioned but I'm a fan of Drucker and his view was that that 'there is only one purpose of a business: to create a customer.'

The principle here is that if you concentrate on the money side you lose sight of the customer and they end up moving away.

 

Looking for feedback. The way I plan to fulfill this area of the standard is to
1- Make a general list of applicable items from notes 1,2,and 3.
2- Eliminate the redundant, unimportant, or nominal listed items.
3- From the items remaining, perform a risk-assessment of each
4- Keep this as information retained as a retrievable document; however
- Keep this list in mind when making the conversion from the 2008 to the 2015 version. If listed items are clearly referenced throughout the rest of the documentation, the standard will be satisfied, and the auditors will be as well.

I saw this broadly defined clause as the sort of bulk idea behind the standard, that all of the other clauses work towards. I could have it completely wrong.

 

Documentation may not always be the preferred approach as specified by Annex A.6 of ISO 9001:2015 which says:

Where this International Standard refers to “information” rather than “documented information” (e.g. in 4.1: “The organization shall monitor and review the information about these external and internal issues”), there is no requirement that this information is to be documented. In such situations, the organization can decide whether or not it is necessary or appropriate to maintain documented information.​

 

This requirement is causing everyone a headache. Here is my take on it:
Context relates to the environment, events, settings, or situations surrounding an organizations business activities and interactions that affects its ability and approach to providing products and services to its customer. This means that you need to understand and address the relevant contextual factors that affect your organization's:

1. Purpose and strategic direction;
   
2. QMS scope, policy and objectives
3. QMS products and services
   
4. QMS Flow of processes and information,
   
5. Customers, etc,
   
6. Recognize the risks and opportunities they present.
7. Take appropriate action to address these risks and opportunities
8. Document the above in your QMS processes using the PDCA cycle

Clause 4.1 is pervasive throughout the organization's QMS. Here are the connections:

• 4.3 a. Determining QMS scope
• 4.4. The QMS scope must be addressed through the QMS and its processes
• 5.1.1b. Leadership and commitment
• 5.2.1a. Quality Policy
• 6.2 Quality Objectives - flows from the quality policy
  
• 6.1 Take actions to address contextual risks and opportunities. Integrate these in your QMS processes and evaluate their effectiveness
  
• 0.3. The process approach and use of PDCA
• 8.0. Every process you include in your QMS must address the contextual and operational risks of each process
  
• and naturally clause 9 and 10 to evaluate your risk control actions and improve.

So what exactly are these contextual factors and what makes some of them relevant and others not? Read the attachment for more details.