The IMB is committed to the implementation and maintenance of a documented quality management system which is continually improved. The system is based on the requirements of the legislation, the regulatory system and ISO 9000:2000; it also takes into account guidelines, standards and best practices from Irish and international organisations. The IMB has adopted a quality policy:

To help us to achieve the goals set out in our mission statement, we will ensure that quality is central to all aspects of our work by:

• Establishing, implementing and maintaining a documented, effective quality management system in line with best international practice
• Incorporating IMB corporate quality objectives, essential to the implementation of strategy and based upon our customers’ needs and expectations, into functional targets and work plans
• Monitoring our performance against these quality objectives, and reviewing and revising them as necessary to ensure that we achieve our aims for continuous improvement
• Ensuring that a trained and experienced team of IMB personnel, committed to achieving our quality objectives, is available and that these staff members are provided with appropriate resources, in terms of infrastructure, to achieve these objectives
• Complying with the requirements of all relevant financial reporting standards, legislation, and Board and government policies
• Aiming to maximise the reuse and recycling of materials and minimise the production of waste material

The quality system is implemented and operated by all IMB staff, with a cross-departmental team to ensure consistency and commitment, and a dedicated section within the Chief Executive’s Office to oversee and co-ordinate the work. Internal audits help to provide quality assurance to management that the system is operating effectively, and contribute to the improvement of systems and processes.


Benchmarking

The Heads of European Medicines Agencies have established a benchmarking exercise ‘to contribute to the development of a world-class pharmaceutical regulatory system, based on a network of agencies, operating to best practice standards.’  The benchmarking of European Medicines Agencies (BEMA) is based on a self-assessment by each agency against a set of questions in four areas: organisation and management; assessment of marketing authorisation applications; pharmacovigilance (drug safety) and inspections. Following the self-assessment, peer reviewers from other Member States conduct an independent assessment of the agency and compile a report on the strengths/best practices of the agency and areas for further improvement. Reports from all the visited agencies are entered into a database which forms a valuable resource for best practice across the entire EU/EEA network of medicines agencies.