We were involved in the development of the current ISO 9001 series through participartion in the drafting committee for BS 5750. We have been training lead auditors and auditors since the IRCA scheme (then ARB) started in 1984, initially for nationalised industries and then for general industry. Many current auditors for the certification bodies and the accreditation authrorities have gained their certification from our courses.
Our course LEADER is a hands-on certification lead auditor who works for two global certification bodies. The course is highly practical and is equally applicable to supplier audits and major internal audits (e.g. cross-divisional).
The course fulfils all the training requirements for registration as an IRCA Lead Auditor or Auditor.
Our highly practical pharmaceutical and medical device internal auditor courses can be tailored exactly to your requirements. Run
over two days the programme includes on site process based auditing. The standards can be EU GMP, Q10, PS 9000, ISO 15378, ISO 13485
or varied to suit your requirements.
It focuses on performing process based audits that look for improvement opportunities as well as conformance. The standard is ISO 9001:2015 but the techniques can be applied to any of the PDCA based standards.
ebook for auditing Free Download
We have been providing assistance to companies for over twenty five years. In this time our clients have achieved certification to
various ISO standards, have implemented improvements and achieved substantial cost savings. read more.....
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As a member of the teams that created the new PS 9000: 2011 standard
and the PQG Supply Chain Risk Management Guide
, our 5-day CQI
and IRCA certified Pharmaceutical lead auditor course is right up to date.
Other standards covered on the course are EU GMP,
ICH Q7, Q8, Q9, Q10, PS 9100 (excipients), ISO 15378 (primary packaging), and ISO 19011.
Reliable, Practicle, Flexible, Cost Effective
Auditor Training, Assessment & Consultancy
The New ISO 9001:2015 Standard
ISO publised ISO 9001: 2015 in Sep 2015. The changes are significant. The core material appears in all the ISO management standards
known as “Annex SL” or high level system [HLS]. If you want to get ahead of the curve and start appraising what needs to be done,
we have produced the following tools and course: