We have almost everything completed in our ISO folder for our upcoming audit next month. My questions is do we need to make a new OFI for each document/form we update in our ISO folder? Ex: we updated our recruiting and on-boarding checklist, do we need to make an OFI for this or...
I received OFI from auditor
~ (The Change Control Procedure could be est to outline control with regards to sudden changes with regards to internal/external aspect, such people, amendment in customer requirements, legal/regulatory requirements, technology, environment and QMS...
Our CB Auditor issued a Minor Nonconformance stating "Risks identified show enhancement of desirable effects, and no opportunities were addressed." This was a recert audit. He is recommending us for recert, but the NC has to be addressed.
Regarding opportunities, we just need to do a better...
Our continual improvement processes cover our Corrective Action processes/records, but we have no processes in regards to Corrections or OFI (Opportunities For Improvement). We're a small company with limited resources and are relatively new to ISO so are trying to walk before we run...
When talking about improvement, for example,
In 6.1 opportunities for improvement, in
9.3, again opportunities for improvement,
In 10 again improvement and there are other mentions thru the standard.
Does the standard refer to the same when ask ing improvements? Or is there...
Just wondering what would be the main difference between process quality objectives and opportunities of improvement?
I mean if i say "Increase on time delivery to 95%" isn't that an opportunity for improvement of the Delivery process?
Long time lurker, first time poster.
How far down into the organization must Interested Parties and Risks and Opportunities be addressed? Of course Senior Management must do so. Does each process area have to do this? Is this required for individual procedures? Is tracking this on a COTO...
ISO 17021-2015 188.8.131.52 allows auditors to identify and record opportunities for improvement.
If an auditor records an opportunity for improvement, does ISO 17021 allow the CB to raise this to a nonconformance?
If so, is there any time limit for this, or can this still be done months after...
Does anybody know methods to use in order to decide if is worth to pursue an opportunity? (6.1 Actions to address risks and opportunities).
I think that similar to the way we evaluate a risk, maybe would also exist something for opportunities.
Something like PxB...
Anybody has an example for implementing 6.1.1 (and 6.1.3 NOTE) ....."determine risks and opportunities associated with compliance obligations"?
What this means? How to approach?
Do I have to identify risk and opp for every compliance obligations?? - this would man hundreds of risks etc.
Trying to find some ideas on how I can demonstrate compliance with this clause. Have heard lots of opinions, but not very much specific guidance. Anyone have any ideas? A risk register? A risk assessment spreadsheet? FMEA's. Is there a simple way to comply?? Thank you.
I recently had an ISO 13485 Audit and the auditor gave me a Cat 3 finding (opportunity for improvement) that "The firm does not keep a traditional CAPA Log, but there is evidence of active tracking of CAPA performance both at management reviews and in Quarterly Data Analysis...
In detecting risk and opportunities in ISO 9001 2015.
I stumbled upon the next:
If I detect a risk in a process, should the opportunity be looked always coming from the risk?, or may come apart?
If I detect a risk, e.g. lacking of key personnel in some area.
well I have...
Per 6.1.1 - Actions for Risks and Opportunities
Can anyone give me a definition of an Opportunity. It is not defined in ISO9001 or 9000.
The ISO White Paper - Risk-Based Thinning in ISO 9001:2015 gives the following:
Risk is commonly understood to have only negative consequences; however the...
Hi forum folks!
Our 3rd party auditor Wants a corrective action for our internal audits which he says fulfill the requirements, but could be enhanced with a heavier focus on the EMS requirements. The problem is, we're a small metal stamper that just doesn't have that much that threatens the...
We are in the middle of an external audit for 14001 and 9001 both done by one auditor 2.5 days for the 14001 and 3.5 for the 9001 he is onsite auditing for 14 to 15 hours each day....
So here is my problem/question... As always every auditor comes and and tells us we are doing something...
Have you conducted product audit (service provided-operation) with previously prepared checklist, that kind of checklist is a template with constant points to be checked wherever you audit the same area you will check the same points.
Some call this Product Audit while others call it QC Audit...