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Lalith Senaweera
Vulnerability Assessment in Food Sector company
4
Hello, Can any one share a good guide or book on vulnerability assessment ?. Because it is a requirement y for FSSC ...
Lalith Senaweera 10d
Victoria Carenza
Is there a timeframe for phasing in new and/or revised ...
1 9
Is there any sort of documented timeframe for new or revised standards as far as how long you have to update ...
Victoria Carenza Sep '22
Peter Stamps Peter Stamps Oct '22

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

Guiomar Meaders
x
4 51
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Guiomar Meaders Dec '21
Raul Martinez Raul Martinez 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 ...

Norman Witteborg Norman Witteborg Jan '22

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

Dipali Pattanayak Dipali Pattanayak Mar '22

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 ...

Kimberly Moore Kimberly Moore Sep '22

@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
ISO 9001:2015 Clause 8.3 (Process Design not Product ...
2 13
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
Janet Lentz Janet Lentz 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
ISO 17025 Calibration
1 8
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
ISO 9001:2015 Requirements
1 10
Can anyone recommend a good book or resource that gives low level details on how to obtain ISO 9001:2015 ...
Marcelo Flores Jul '22
Paul Ipolito Paul Ipolito Jul '22

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

Nena Ostrogovic
Quality Cafe - ISO Standards
9
ASQ UAE section recently had monthly Quality Cafe with the topic of ISO Standards. Discussion was lively and ...
Nena Ostrogovic Jun '22
Joshua Rask
ISO9001:2015/AS9100D Audit
3 37
We recently had a surveillance audit, and the auditor wrote a finding for missing gauges. The gauges that were ...
Joshua Rask May '22
Robert Tanner Robert Tanner 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 ...

Joshua Rask Joshua Rask May '22

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

Mark Stevens Mark Stevens May '22

Josh,

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

Brandy Vanbuskirk
Equipment qualification/requalification - ...
1 13
We are a GMP facility that follows 21CFR 210 & 211. At what frequency do you temperature map your critical ...
Brandy Vanbuskirk Mar '22
Mara Jensen Mara Jensen Apr '22

Brandy,

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

James Hendrickx
Water system validation
3
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