Surgical Material Testing Laboratory (SMTL) is an NHS laboratory staffed by pharmacists, lead auditors, Trainee Qualified Person (QP) and scientists who have many years of experience of working in the medical device and pharmaceutical quality assurance field of both NHS and in Industry.
SMTL's commitment and aim is to deliver the best in contract testing and Quality technical services to the medical device and Pharmaceutical industry.
Our laboratories are UKAS accredited against the requirements of the internationally recognised standard ISO/IEC 17025; providing customers with the assurance of SMTL’s ability to produce precise, accurate tests and data.
Quality Assurance Services:
Auditing: ISO 17025, GMP, PS9000
SMTL's auditing services adds value to our client’s businesses by assisting them to achieve or maintain regulatory compliance for equipment, facilities, utilities, processes and suppliers. Our experienced lead auditors are available to conduct audits and assessments supporting all parts of the manufacturing supply chain for both medical device and pharmaceutical.
SMTL can provide pre-inspection auditing services to pick potential deficiencies in your QMS and can offer advice as to how these can be remedied to ensure a smooth inspection visit.
Quality Management Systems (QMS)
The fundamental importance of an effective QMS has been re-emphasised by the major regulatory authorities. The management of deviations, changes, and CAPA is being subjected to ever closer regulatory scrutiny as are your processes to ensure that resources are matched appropriately to patient and business risk. SMTL can help start-ups / smaller-scale organisations design and implement a compliant QMS that meets your current requirements (ISO 17025 & GMP) and will grow with your business.
SMTL can provide documentation services for compliance with ISO 17025, GMP (Eudralex Volume 4) and PS900.
Pharmaceutical and Healthcare Consulting Services
SMTL offer Quality support and advice to the pharmaceutical, healthcare and medical device industry. Please contact the Quality Assurance department at SMTL for further information.