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Human Capital: How to Meet Requirements of 7.6 (Monitoring/Measuring Equipment)?

GStough

Staff member
Super Moderator
#1
Working in the service contract industry now for the last 6 months, I'm still trying to get my head wrapped around how to apply the requirements of ISO 9001 to the human capital services that we provide. How does one calibrate human capital objectively?

Also, in regards to 7.5.3 Identification and Traceability, how does one identify and trace human capital? Would employee ID badges suffice, and is this enough when the services required by our human capital mandate a transfer to remote regions of the globe?

I'm interested in hearing how other companies in similar industries address these requirements....

:thanx:
 
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BradM

Staff member
Admin
#2
Re: Human Capital: How to Meet Requirements of 7.6 (Monitoring/Measuring Equipment)?

Hmmm... interesting. :agree1:

Working in the service contract industry now for the last 6 months, I'm still trying to get my head wrapped around how to apply the requirements of ISO 9001 to the human capital services that we provide. How does one calibrate human capital objectively?
Why would you think you would need to "calibrate" human capital? Calibration is mandated when required to assure valid results. If you have documented training, R&R studies, observations and such as to human performance, would that not be sufficient evidence of their abilities?
 

GStough

Staff member
Super Moderator
#3
Re: Human Capital: How to Meet Requirements of 7.6 (Monitoring/Measuring Equipment)?

Hmmm... interesting. :agree1:



Why would you think you would need to "calibrate" human capital? Calibration is mandated when required to assure valid results. If you have documented training, R&R studies, observations and such as to human performance, would that not be sufficient evidence of their abilities?
Thanks, Brad.....

Documented training, yes. Observations, yes. Specific testing results, yes. These things together are evidence that our human capital is qualified and competent. Testing is done on a regular, specified basis to ensure continued compliance to contract requirements. I'm just trying to make sure that we haven't missed anything. "Calibration" of human capital is a completely new and foreign concept to this medical device chick, but I think I'm catching on, finally. ;)

Now, do you have any comments regarding the ID and Traceability requirement? :cool: Any input you have would be helpful. :yes:
 
S

sathishthantri

#5
If you are providing only human capital or carrying out specific contracted work, please look into the possibilities of going for exemptions on the requirements of ISO 9001 in Section 7, giving proper justifications.
Calibration is for measuring / monitoring equipment and Identification & Traceability is for materials (including products).
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#7
Ah. Do you train your own people or test them using products, either commercially available or internally developed?
 

GStough

Staff member
Super Moderator
#8
We try to recruit linguists who are already fluent in the language(s) we need. If screening/testing reveals rusty skills, and 'training' or skills improvement is needed, we provide it internally, followed by additional testing to ensure contract requirements are met before deployment.
 

somashekar

Staff member
Super Moderator
#10
We try to recruit linguists who are already fluent in the language(s) we need. If screening/testing reveals rusty skills, and 'training' or skills improvement is needed, we provide it internally, followed by additional testing to ensure contract requirements are met before deployment.
One of the things a customer will look to see in such contracts is the resume of the human and such other credentials, testimonials, past work records and letters of recognition from other clients for similar services (technical translations)
Calibration concerns to equipment and Human = equipment is wrong. So no calibration.
Identification and traceability = Signature or an allotted code for a human for internal Identification / Traceability.
 
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