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Lalith Senaweera
Hello, Can any one share a good guide or book on vulnerability assessment ?. Because it is a requirement y for FSSC ...
Victoria Carenza
Is there any sort of documented timeframe for new or revised standards as far as how long you have to update ...

@Victoria Carenza There is no single requirement that covers the effective date of all standards. Some are as long ...

Guiomar Meaders
4 51
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Guiomar Meaders Dec '21

I am no expert on eQMS but have created a couple of electronic QMS in SharePoint, so assuming you are starting with a ...

We have had QT9 for a couple of years. Anything I can help you with let me know

Hi there, Were you able to find a template for it? I need to do the same for another eQMS and can use your help, if ...

@Guiomar Meaders Hi Guiomar, did you find a template? I too am in need of a template as we are migrating from one QMS to ...

Jerri Alexander
We exclude Clause 8.3 in our QM and Scope however we do have a Quality Procedure titled: 830 Process Design and ...
Jerri Alexander May '22

Not that exact one, but know that your registrar’s opinion on what you should name procedures is just that - an ...

Duke Okes Duke Okes Sep '22

@Jerri Alexander

  1. Auditors are not supposed to make recommendations.
  2. Ask him/her how it would improve the QMS, ...
Jason Weaver
We are a medical device company, certified to ISO 13485, and use multiple pieces of measurement equipment. We are ...
Jason Weaver Aug '22
Duke Okes Duke Okes Sep '22

@Jason Weaver

ISO 17025 certification applies to the organization, not to a specific device. Traceability to ...

Marcelo Flores
Can anyone recommend a good book or resource that gives low level details on how to obtain ISO 9001:2015 ...
Marcelo Flores Jul '22

@Marcelo Flores - “ISO 9001-2015 In Plain English” Craig Cochran. Paton Press.

Nena Ostrogovic
ASQ UAE section recently had monthly Quality Cafe with the topic of ISO Standards. Discussion was lively and ...
Nena Ostrogovic Jun '22
Joshua Rask
We recently had a surveillance audit, and the auditor wrote a finding for missing gauges. The gauges that were ...
Joshua Rask May '22

I am only speculating, but are the extra set of thread anvils of the same type used as a control and ensuring the ...

Robert, thanks for your reply. No, there is a set master that is used to “zero” the mic. The anvils are for different ...

Josh,

I'm flabbergasted by the finding! I assume there is a gage control system that would be available to ...

Brandy Vanbuskirk
We are a GMP facility that follows 21CFR 210 & 211. At what frequency do you temperature map your critical ...

Brandy,

Annual calibration and performance verification seems to be a logical and adequate cycle time for ...

James Hendrickx
Hello all, I am looking for the best method for CIP cleaning validation. I work in a non cGMP facility and we are ...
James Hendrickx Feb '22