Based in SW England we specialise in the following:

  • Training quality management system auditors (internal and supplier auditors)
  • Carrying out internal and supplier audits for companies
  • Assisting companies to implement their quality management system and assisting them to obtain ISO 9001 certification by companies such as BSI, LRQA etc.
  • Helping companies to develop their management systems to obtain substantial cost and other business benefits
  • We have specialist skills in the pharmaceutical and medical device sectors.

We are registered by the IRCA to run lead auditor courses for general industry and the pharmaceutical sector and have trained several thousand auditors worldwide. Our clients range from Westland Helicopters to GlaxoSmithKline

We run regular internal auditor courses at a specialist conference centre in Bath and also in-house for clients.

Auditing and Developing the System

We undertake internal audits for companies to ease their workload and provide true independence. We audit UK suppliers for several blue chip American companies, saving them considerable expense.

Documenting and implementing a quality management system from “square one” can be a daunting task. We work with your management team and their staff to understand and document the current practices, determine the gaps with ISO 9001 and develop the system to the point where certification is seamless and painless. 

Developing the System

Obtaining certification is an achievement, but the pay-back is from obtaining real business benefits. We can provide case studies for companies which have saved 10% of their sales turnover and increased their capacity with our help.

Pharmaceutical Supplier Auditor/Lead Auditor Training Course

This unique 5-day course is highly recommended for anyone concerned with the quality management systems operated by suppliers of starting materials to the pharmaceutical industry. It has been developed and run over many years in the UK, Europe and the Far East

The course is based on GMP as it relates to starting materials and specified in the PS 9000 series of standards and ISO 15378. PS 9000 applies to contact and secondary packaging and printed components such as labels and patient information leaflets; PS 9100 specifies graded levels of GMP for inactive materials dependent upon their use

ISO 15378 is International Standard for Primary Packaging Materials. These standards have been developed over more than 15 years and are published in the UK by the Pharmaceutical Quality Group of the Institute of Quality Assurance (IQA) and the International Standards Organisation.

Who Should Attend?

The course is designed for Quality Assurance, Quality Control and Purchasing Professionals from Pharmaceutical Companies and Suppliers.

 It is also very useful for auditors from third party certification bodies. The course is highly recommended to existing and intending Qualified Persons (QPs) as part of their Continuous Professional Development (CPD). It is not essential, but recommended that delegates have some prior knowledge of the ISO 9000:2000 series and PS 9000 & PS 9100 before attending the course.

The course is registered by the International Register of Certificated Auditors (IRCA) and meets their training requirements for registration as Auditor and Lead Auditor. Successful delegates will not only obtain invaluable experience and skills in auditing suppliers against the new standards, they will obtain a qualification which is internationally recognised. This puts them on the same or a higher level of recognition than many customer and certification body auditors.

Pharmaceutical Internal Auditor Course

This two day course is designed to meet the primary requirements of Section 9 of the EU Pharmaceutical GMP Guide and Clause 8.2.2 of ISO 9001: 2008. It is highly practical and when run in the client’s facilities we can include live auditing. With our focus on flexibility we can tailor this course to meet the specific needs of different companies and various groups of employees.

Pharmaceutical Packaging Courses (PS 9000 and PS 9004 based)

PS 9000 is a unique “standard” which develops the basic requirements for quality management system (QMS) in ISO 9001: 2000 into the GMP requirements required by the pharmaceutical industry for the manufacture of primary and secondary packaging, printed leaflets, labels and other components used for its products. PS 9004 is a practical, hands-on guide to implementing PS 9000. Both documents have been produced jointly by the pharmaceutical industry and their suppliers.

We can provide a variety of tailor made in house courses that are designed to familiarise staff and management to whatever level is needed.

Pharmaceutical Excipients Training (PS 9100 based)

PS 9100 is also a unique standard developed by the pharmaceutical industry and major suppliers of non-active ingredients (excipients). Building from the base-line of ISO 9001: 2000, it specifies graded levels of GMP for excipients depending upon what the substance will be used for. For example, high level GMP equivalent to that used in the manufacture of pharmaceutical products is specified for inactive ingredients which are used in eye drops, whereas foundation level GMP applies to greases for certain types of ointment.

We can provide a variety of tailor made in house courses that are designed to familiarise staff and management to whatever level is needed.

IRCA Registered Auditor/Lead Auditor to ISO 9001:2008

This course is designed for quality professionals who are required to audit suppliers’ quality management systems. It is also suitable for auditors carrying out internal audits. Others who will benefit from the course are people who manage quality or procurement within their organisation and who will gain from understanding the quality audit process. The course is based on ISO 19011, the internationally recognised guide for auditing quality and environmental management systems and ISO 9001: 2008.

The main benefits are:

The capability to do effective and credible audits of your supply chain and to make the correct purchasing decisions
The knowledge that your management systems are being effectively audited.  On a personal basis auditors and lead auditors gain international recognition for their auditing competence by joining the 24,000 auditors in over 120 different countries worldwide who are IRCA certificated.

ISO 9001 Internal Auditor Training Course

Internal audits are a routine part of today’s quality management. They should concentrate on determining conformance but in many cases auditors only focus on non-compliance. In this course the delegates are shown how to carry out internal audits which:

  • Are effective and efficient
  • Look for improvement opportunities as well as conformance
  • Are value adding

Many of the techniques taught are equally applicable to supplier audits

Can we help?