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