Risk for Quality Assurance Department in a Hospital - Hospital Incident Reporting

#1
Hi All,

I am a QA officer in a hospital. I would like to know do I have to create a risk register for my department. For your info, we have created all the department's risks, however, mine not.

Do I need to create a risk for the Hospital Incident Reporting? Please advise.

thank you!
 
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John C. Abnet

Teacher, sensei, kennari
Staff member
#2
Good day @farah ;
Specific to the limited scope (the standards) you are referencing, the short answer is "no". There is no requirement in the ISO 9001 standard for a "register" . It is up to your organization to determine "...risks that need to be addressed..." as they relate to what your organization determined as per clauses 4.1 and 4.2.

Hope this helps.

Be well.
 
#3
Good day to you too John!.

Thank you for your explanation. I'm a bit clear now. So, it's not wrong to use the JCI Risk Register as guidelines for the ISO right?


Thanks. Be safe!
 

John C. Abnet

Teacher, sensei, kennari
Staff member
#4
Good day to you too John!.

Thank you for your explanation. I'm a bit clear now. So, it's not wrong to use the JCI Risk Register as guidelines for the ISO right?


Thanks. Be safe!
Good day @farah ;
You are correct, ...it is not wrong to use a JCI risk register.

Please be reminded, however, that risks and opportunities can be very dynamic and should be considered, and/or have the opportunity to bring to top management, frequently. Be careful not to get "locked in" to a static document.

Hope this helps.
Be well.
 

Richard Regalado

Trusted Information Resource
#6
Good day @farah ;
You are correct, ...it is not wrong to use a JCI risk register.

Please be reminded, however, that risks and opportunities can be very dynamic and should be considered, and/or have the opportunity to bring to top management, frequently. Be careful not to get "locked in" to a static document.

Hope this helps.
Be well.
Aside from having that "risk document", it is equally important (or maybe more important!) to have a risk management framework that looks at the entire risk cycle from identification, treatment, monitoring, and reporting. This is where ISO 31000 compliments ISO 9001 greatly when it comes to risks and opportunities.
 
#7
Aside from having that "risk document", it is equally important (or maybe more important!) to have a risk management framework that looks at the entire risk cycle from identification, treatment, monitoring, and reporting. This is where ISO 31000 compliments ISO 9001 greatly when it comes to risks and opportunities.
Good day @Richard Regalado!

Thanks for your reply. Actually we do have the framework. But like you said, risk cycle from identification to reporting, some of the clinical and non-clinical here document the activities of their works. Will be acceptable or not?

Thanks and be safe!
 

Richard Regalado

Trusted Information Resource
#8
Good day @Richard Regalado!

Thanks for your reply. Actually we do have the framework. But like you said, risk cycle from identification to reporting, some of the clinical and non-clinical here document the activities of their works. Will be acceptable or not?

Thanks and be safe!
Hello farah.

The risk requirements for ISO 9001 is not so stringent as compared to other management system standards. For example, in ISO 9001 6.1.2, the requirement is to plan actions to address risks and opportunities. In other standards such as ISO/IEC 27001, the requirement will go as far to formulate and implement a risk treatment plan.

In your question whether what you are doing is acceptable or not, I would like to refer you to the requirements of ISO 9001, 6.1. If you are meeting the "shall" requirements, then you are doing good.

Richard
 
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