How to Audit - Quality Management Systems
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Improving Your Auditing Skills, The How To Audit Series, new for 2012
Tuesday 02 October 2025
York Marriott Hotel, York, UK
£495.00 excl VAT – £594.00 inc VAT
Type: Pharmaceutical
About this course
A good Quality Management System (QMS) is essential to any business. It is effectively a business management system that ensures that products delivered to the customers are of the correct quality. For pharmaceutical companies that must comply with Good Manufacturing Practice (GMP), it is a legal requirement to have an effective QMS. Suppliers and contractors to the pharmaceutical industry are also expected to have a defined QMS.
Every audit conducted by pharmaceutical auditors includes a review of some, if not all, of the elements of a QMS. An auditor cannot make a good assessment of any department or company without evaluating the QMS and the documented approach to quality.
Many auditors have struggled to understand exactly what makes up a QMS and how to audit the overall QMS in the all too limited time available. Auditors faced with performing their own internal audits or audits of suppliers and contractors have many questions:
- What exactly is a QMS? What does it include?
- What QMS standard do I apply? Is GMP enough?
- Should I apply ISO 9001 as a standard or ICH Q10?
- How do I know what is the correct approach to auditing a QMS?
- How can I judge the QMS in such little time available?
- Is there an easy way to approach a QMS audit?
- How do I assess the significance of any findings?
Course outline
This one-day course will attempt to answer all of these questions in a practical way so that you have materials you can use in your QMS auditing work.
Also at the end of the day you will have had practice in:
- Deciding what should be the QMS standard applied
- Developing an audit plan for a QMS audit
- Developing aide-mémoires for some of the QMS elements that ensure you don’t forget the important things
- Classifying audit observations and assessing the level of risks associated with these QMS audit observations
Venue
York Marriott Hotel, York, UK
The York Marriott Hotel is within walking distance of York city centre
and its many attractions including the National Railway Museum and
York Minster. Castle Howard, the Yorkshire Dales and the North
Yorkshire Moors are within a 1 hour drive of the hotel. With 151
stylish guest bedrooms the hotel is ideal for the business or social traveller.
The hotel offers a range of banqueting rooms holding up to 190 delegates theatre style, secure WIFI internet access is available in public areas and our recently refurbished Leisure Club features a heated pool, sauna, steam room, Jacuzzi, gymnasium & private tennis court.
The all new Chase Bar & Grill serves a varied menu and offers a wide
choice of refreshments whilst offering unrivalled views of York
Racecourse from its sun terrace. The York Marriott’s recent accolades
include retaining the BDRC Best Conference Venue in Yorkshire
Award for 2008 (for the 3rd year in succession), as well as winning
the highly coveted York Tourism Bureau Award for Hotel of the
Year 2009.
Hotel Accommodation
- We have a block booking of bedrooms at the York Marriott Hotel, at a specially negotiated bed and breakfast rate per delegate per night.
- As part of our improvements to the booking process, we have arranged for an online booking service with the hotel and details of how to make your accommodation booking will be included in your course joining instructions (issued to you at the time of booking). Alternatively you will be able to make a telephone booking directly with the hotel. If you need any help or guidance with the accommodation booking process, please contact our course administration team.
- Your account with the hotel should be settled at check out.
- Any charges made by the hotel as a result of you not taking up your reservation for any reason will remain your responsibility, therefore please ensure you are aware of the hotel’s cancellation policy.
Tutors
We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.
Our experts for this course are:
What you've said
What delegates have said of our ‘How to Audit’ courses
“Good practical advice from an experienced tutor”
Nicholas Medcalf, Smith & Nephew Group Research Centre, UK,
“Very informative and friendly course. I found it very beneficial and a great start to a new compliance job.”
Tamara Alani, GlaxoSmithKline, UK
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