Irish Quality Centre Ltd

Since its foundation in 1997, Irish Quality Centre (IQC) has become one of Ireland’s leading providers of training, consultancy and auditing. The Dublin-based company has specialist expertise in the HealthCare, Pharma, Biopharma, Chemicals and Medical Device sectors and serves life sciences companies across Europe and North America.

IQC offers a range of professional services including auditor training, consultancy, supplier audits, simulated inspections and both bespoke and standard training courses in key areas that include Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Laboratory Practice (GLP) Good Clinical Practice (GCP), Pharmacovigilance (GVP) and regulatory affairs.

Products & Services

IQC offers four main product and service streams:

• Training: a wide range of student-based and highly interactive training courses delivered by expert tutors in subjects that include ISO standards 90001 (Quality Management), 13485 (Medical Device Quality Management), 14001 (Environmental Management Systems), 17025 (Laboratory Management Systems MS), and 45001 (Health & Safety), along with Medical Device Training, Risk Management, Technical Writing, OSH, etc.
• E-Learning: A range of web-based distance learning courses covering the main topics delivered by the core IQC training syllabus but self-directed and self-paced for remote learning.
• Consultancy: IQC is one of Ireland’s leading providers of consultancy on Quality Management Systems and Environmental Health and Safety Systems, with consultants available to support QMS development or improvement, GxP compliance, or achieving ISO certification across sectors that include Pharma, Biopharma and MedTech.
• Auditing: IQC auditing services include auditor training, support in conducting internal or supplier audits and helping organisations and employees to become Audit or Inspection Ready.

Company History and Structure

Founded in 1997, the Irish Quality Centre has been under new management since early 2018 and is now led by Managing Director Philip Byrne. Mr. Byrne is a Lead Auditor in the Pharma, Biopharma and Medical Device industries, with more than 25 years’ experience in auditing and management of Quality, Environmental and Health and Safety Management Systems. He is also a lecturer at Technological University Dublin and Griffith College specializing in Regulatory Affairs and GxP compliance, Technology Transfer, Validation and GxP Auditing.

Other key figures in IQC’s leadership include:

• Fergal King (Director of Technical Services), leading the MedTech side of the business including consultancy, auditing, and training. Mr. King is a highly expert auditor with many years’ experience in the medical device and other industry sectors in assessing conformance of established Quality Management Systems (QMS) against regulations and standards across various regulatory jurisdictions.
• Paul O Shea (Consultant Lead Auditor and Trainer): Mr. O’Shea is an IRCA-certified Lead Auditor covering Site, Divisional and Corporate Audits to the requirements of ISO 13485, MDSAP and EU MDR with more than 20 years’ experience that includes geography specific audits including on-site audits within Brazil, Turkey, and India, supplier lead auditing of component and packaging suppliers to the Medical Device sector, Medical Device manufacturer site start-up and establishment of QMS, and manufacturing site preparation for audits.
• Martin Duffy (Consultant Lead Auditor and Trainer): A Quality Assurance and Regulatory Affairs expert with more than 30 years’ experience in the regulated Pharmaceutical, Medical Device, and In-Vitro Diagnostic sectors, Mr. Duffy focuses on Auditing, Quality Management, Compliance, Supply Chain Quality, Validation, Product Development, Quality Management System establishment, and FDA / IVDR / MDR inspection readiness etc. He lectures on Level 9 Medical Device Technology and Digital Quality Transformation MSc programs at Griffith College, Dublin.

Quality, Regulatory and Standards

IQC is an ISO 9001 certified organization that complies with all EU and International Pharma Supplier Regulations/Guidelines as specified by its clients.

It is a member of the Chartered Quality Institute (CQI) and its International Register of Certificated Auditors (IRCA) and was the first body to be approved as a provider of IRCA MDR Training in Ireland.

IQC is further accredited by Exemplar Global as an Approved Training Provider.