Venue details provided were not correct. Explanation provided by trainer via email; "I have checked with the office and it transpires that they did inform them of the revised arrangements for the two courses (cancelling tomorrows and booking today’s instead) but an error occurred in the venue not updating their spreadsheets to this effect. We have instigated corrective action to address this (more ‘on-the-eve’ checking and confirmation will be put into place)." I feel this is unfair and is not the case as I had booked onto this course weeks in advance so it was not a last minute course to cover a cancellation. Course was extremely basic, did not appear to be an in depth look at transition, rather, a very basic overview of the "new" standard. Slightly worrying that the only Post Market Surveillance which was discussed was customer feedback questionnaires, this is not the full extent of PMS. I feel the trainer should have made this clear, I doubt an auditor would accept customer feedback questionnaires as appropriate PMS. Felt that the knowledge of (most of ) other course delegates was not to the same level as my own therefore felt uncomfortable stating that my objectives had not been met. Venue was nice, once the correct room was found and the food provided was enjoyable. The trainer was personable, however, I do not believe the level of the course was as it should have been. The course felt more like an introduction to ISO 13485. It did not appear that a certain level of knowledge of ISO 13485 was required prior to the course, therefore those of us with a thorough understanding of the current ISO 13485 were left disappointed by the very basic approach to the 2016 standard.
I appreciate that the course had been condensed into a two-hour slot but I feel that too much was crammed into the time period allotted. It was often confusing at times and some areas seemed to be repeated and delivered simply in a different format. The course notes are also very difficult to read in places as the print is too small. I think the course would benefit from including training on how the new standard is applied in practise.
I was very disappointed with this course. I'm not sure I learnt anything. I have got more familiar with the ISO standard but I do not feel competent to lead an audit or judge when an issue is actually a non conformance. The evening work did not re-inforce any learning as it was all about stuff that had not yet been taught. I feel as though we were just being taught how to pass an exam and I'm not entirely sure I managed that!
Course was a real struggle. the combination of ISO9001 with Mars QMP didn't help but overall the pace was very slow and hard to follow. As a trainer I found Paul to struggle flexing to the styles of the trainee's. it felt at times it was as much about what we thought then what he thought which didn't inspire confidence in the material we were learning. luckily the training materials are excellent which does help. overall I believe the course really needs a revamp to fit the objective of it. my main take out is that quality auditing is about the PDCA style and pracitscing it, the role play exercises were excellent and we could of done with doing 3-4 of these over 2 days rather than the one. we also only got the pre-read that day which made it feel like a very rushed agenda.
Inadequate provision of training material - difficult to share documentation in a group of 4/5 Unclear instructions on case studies / course work Was expecting to relate some case study examples to specific clauses within the ISO standard to help assign to real life audit findings Not a full 2 day training course Trainer friendly and polite