CASE STUDIES

Quality management system implementation

HTF Associates are a growing business in the pharmaceutical consultancy sector who provide specialist advice, project management services and supply chain management to the pharmaceutical industry.

Project Description:

HTF Associates are industry experts offering guidance and support in Good Distribution Practice (GDP) as defined by the EU and the MHRA which includes the implementation of quality management systems meeting GDP requirements and the provision of contract resources, including the ‘Responsible Person’ (RP) role.

The founder and Managing Director of HTF Associates was consciously expanding the business and wanted to develop the company by way of a process flow environment.  He felt that as the company continued to grow, he should not have to be personally involved in every client project and he needed to feel reassured that things were happening as they should.

Following our initial discussion, we decided to implement a formal quality management system to underpin the everyday operations of the business and to provide the MD with the governance structures and assurance processes he needed as well as meeting the requirements of ISO 9001:2015.

After completing the initial gap analysis and 6 further days on site between Oct 18 and Feb 19, we successfully passed our external audit with ISOQAR and gained ISO 9001:2015 certification in April 2019.

Helen made the process of gaining ISO9001:2015 certification simple and effective. Her advice and support at each stage of implementation proved invaluable. We now have a QMS that is easy to follow and maintain, standardising and continually improving our company processes. We would highly recommend Helen’s excellent services to any company aiming for ISO certification. She has been a joy to work with and is extremely efficient in every challenge she takes on board. We couldn’t have asked for anyone more pleasant to work with, so on behalf of everyone in the office we would like to thank you for your time here at HTF Associates.

project type
Direct HKW Risk Management Project
discipline
Quality Management
Timeframe
6 days from to Oct 18 to Feb 19, 2 days for certification body audits Mar and Apr 19
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