Fertility Quality Management
National and international quality and safety standards within the fertility sector such as the HFEA, EU Tissue and Cells Directive and ISO, require all establishments collecting and processing human tissues and cells to implement a Quality Management System (QMS).
Find out how Q-Pulse can provide you with a user-friendly QMS today – reducing the time, effort and cost spent on achieving and maintaining regulatory compliance.
Manchester Fertility Services implement Q-Pulse to comply with ISO standards.
Manchester Fertility Services (MFS) provides assisted conception services in the North West of England and is one of the UK’s most successful centres. Based at Bridgewater Hospital in Manchester, MFS’ purpose-built laboratories and theatre are amongst the most modern in the world.
In order to improve service quality and achieve certification to both national and international standards including ISO 9001, MFS required an electronic QMS and chose Q-Pulse.
Compliance, Efficiency, Safety and Productivity
The College of American Pathologists (CAP), Clinical Pathology Accreditation (CPA), Medicines and Healthcare Products Regulatory Agency (MHRA) and the Food and Drug Administration (FDA) are committed to ensuring quality and best practice is maintained to a high level. Compliance with ISO 15189 demands commitment tooperational excellence and this places a burden of work on thelaboratory.
The historic management approach of fragmented systems, paperand manual processes, electronic documents, spreadsheets andemail is inadequate and creates a crippling bureaucratic burden.
Q-Pulse, from Ideagen, is a fully integrated Electronic QualityManagement Solution (eQMS) that helps laboratories transformtheir operational processes and substantially decrease the timespent on compliance activities.
- Audits must be carried out to ensure these procedures
- followed, staff can easily report problems.
- Assets must calibrated and maintained with an audit trail.
- Suppliers must be audited to ensure their products and
- are of the necessary standard.
- Risks must be identified and treated.
- Staff must be shown to be competent.
ISO 15189 Compliance
Q-Pulse helps medical laboratories worldwide achieve and maintain ISO 15189 accreditation.
- Ensuring effective diagnosis through accurate analytical work
- Improving patient care with streamlined and robust quality processes
- Releasing resources to help improve service quality and reliability