ISO/IEC 17025:2017
The ISO/IEC Quality Management System (QMS) applies only in the qPCR laboratory of the Institute of Medical Science (IMS) and covers rapid detection of COVID-19 from human saliva samples by Multiplex qRT-PCR kit.
The Quality Management System includes the following:
Quality Statement - Demonstrating University of Aberdeen's intent to comply and maintain quality assurance procedures.
Quality Manual - Details the outline structure of the QMS
Standard Operating Procedures (SOPs) -
Standard Operating Procedures (SOPs) are detailed, written instructions which must be followed when performing certain tasks. They are an essential source for communicating to operators the agreed, defined methodology which must be followed to ensure consistency between all operators and compliance with the QMS.
On this page you will find a range of SOPs for those involved in the above testing, which are written to ensure that analysis is conducted and reported in compliance with the international standard ISO/IEC 17025:2017 (General requirements for the competence of testing and calibration laboratories). University of Aberdeen is currently working towards achieving accreditation to ISO/IEC 17025:2017 with the United Kingdom Accreditation Service (UKAS).
User Guides provide specific instruction or further information on a particular task.
Templates may also be associated with some SOPs and these can be downloaded as Word documents if required.
For further information regarding the ISO/IEC Quality Management System, or accreditation, please contact:
Richard Cowie Quality Assurance Manager richard.cowie@nhs.scot
or
Nimesh Mody Technical Manager n.mody@abdn.ac.uk
Please check this page regularly as new SOPs may become available or updated versions may be added.
Quality Statement and Quality Manual
Reference | Version | Title | Associated Document(s) |
ST-2 | 1 | ISO/IEC 17025:2017 Quality Statement | - |
QM-2 | 1 | ISO/IEC 17025:2017 Quality Manual | - |
Standard Operating Procedures
Reference | Version | Title | Associated Document(s) |
SOP-IMS-28 | 1 | Management of SOPs |
TMP-QA-29 TMP-QA-30 TMP-QA-40 TMP-QA-83 TMP-QA-85 |
SOP-IMS-29 | 1 | Good Documentation Practice | - |
SOP-IMS-30 | 2 | Training and Competence |
TMP-QA-1 TMP-QA-22 TMP-QA-40 |
SOP-IMS-31 | 1 | Control of Records | - |
SOP-IMS-32 | 1 | Accomodation and Environment | TMP-QA-28 |
SOP-IMS-33 | 1 | Critical Equipment | - |
SOP-IMS-34 | 1 | Internal Audit | TMP-QA-80 |
SOP-IMS-35 | 1 | External Audit/Inspection | - |
SOP-IMS-36 | 2 | Deviations | TMP-QA-86 |
SOP-IMS-37 | 1 | Complaints | TMP-QA-91 |
SOP-IMS-39 | 1 | Management Review | TMP-QA-63 |
SOP-IMS-40 | 1 | Use of Accreditation Mark | - |
SOP-IMS-41 | 1 | Measurement Uncertainty | - |
SOP-IMS-42 | 1 | Reporting of Results | - |
SOP-IMS-43 | 1 | Sample reception and preparation (saliva) | TMP-QA-88 |
SOP-IMS-44 | 1 | RNA Extraction from saliva or swab samples | TMP-QA-87 |
SOP-IMS-47 | 1 | Sample reception and preparation (swabs) | TMP-QA-89 |
SOP-IMS-45 | 2 | qRT-PCR of RNA extracted from saliva or swab samples | TMP-QA-90 |
SOP-IMS-46 | 1 | Reporting qRT-PCR results | - |
User Guides
Reference | Version | Title | Associated Document(s) |
UG-QA-5 | 1 | Operation of safety cabinets in qPCR facility | |
UG-QA-6 | 1 | Operation of plate centrifuge/vortex in qPCR facility | |
UG-QA-7 | 1 | Operation of Roche LightCycler in qPCR facility | |
UG-QA-8 | 1 | Operation of multi-tube vortexer in qPCR facility | |
UG-QA-9 | 1 | Naming convention for COVID-19 testing traceability | |
UG-QA-10 | 1 | Use of COVID-19 sample database |