Data-describing-quality-management.md

QMS1: Sample management

Availability of Process Descriptions (PD) and/or Standard Operating Procedures (SOPs) for sample management, covering…

Attribute Code	Attribute Name	Allowed Values	Description
QMS1.1	Participant registration management	Y/N/u/ns*	Availability of Process Descriptions (PD) and/or Standard Operating Procedures (SOPs) addressing applicable registration requirements , e.g. Informed Consent Management, medical records, etc.
QMS1.2	Sample processing	Y/N/u/ns*	Availability of Process Descriptions (PD) and/or Standard Operating Procedures (SOPs) addressing the sample collection and processing
QMS1.3	Sample transport	Y/N/u/ns*	Availability of Process Descriptions (PD) and/or Standard Operating Procedures (SOPs) addressing the sample transport process
QMS1.4	Sample quality assessment	Y/N/u/ns*	Availability of Process Descriptions (PD) and/or Standard Operating Procedures (SOPs) addressing sample quality assessment e.g. verification, validation, sample stability
QMS1.5	Sample storage	Y/N/u/ns*	Availability of Process Descriptions (PD) and/or Standard Operating Procedures (SOPs) addressing sample storage conditions
QMS1.6	Molecular tests	Y/N/u/ns*	Availability of Process Descriptions (PD) and/or Standard Operating Procedures (SOPs) for applicable molecular tests or other analytical methods performed to ensure sample integrity, QC

QMS2: Data management

Availability of Process Descriptions (PD) and/or Standard Operating Procedures (SOPs) for data management, covering…

Attribute Code	Attribute Name	Allowed Values	Description
QMS2.1	Data structure description	Y/N/u/ns*	Availability of a data model, e.g. as Entity Relationship Diagram, and a data dictionary
QMS2.2	Data entry	Y/N/u/ns*	Availability of Process Descriptions (PD) and/or Standard Operating Procedures (SOPs) for data entry covering control of mistake and recording of source information
QMS2.3	Data quality	Y/N/u/ns*	Availability of Process Descriptions (PD) and/or Standard Operating Procedures (SOPs) for data quality tests and improvements, e.g. data cleaning, control of missing information and definition of NULL values.
QMS2.4	Data storage	Y/N/u/ns*	Availability of Process Descriptions (PD) and/or Standard Operating Procedures (SOPs) for long term data storage and backup.
QMS2.5	Data security	Y/N/u/ns*	Availability of Process Descriptions (PD) and/or Standard Operating Procedures (SOPs) for data security
QMS2.6	Data protection	Y/N/u/ns*	Availability of Process Descriptions (PD) and/or Standard Operating Procedures (SOPs) for data protection

QMS3: Organisational requirements

Availability of Process Descriptions (PD) and/or Standard Operating Procedures (SOPs) for organisational requirements, covering…

Attribute Code	Attribute Name	Allowed Values	Description
QMS3.1	ELSI	Y/N/u/ns*	Availability of Process Descriptions (PD) and/or Standard Operating Procedures (SOPs) for compliance with applicable national law & ethics
QMS3.2	Staff qualification and training	Y/N/u/ns*	Availability of Process Descriptions (PD) and/or Standard Operating Procedures (SOPs) for staff qualification and training
QMS3.3	Equipment management	Y/N/u/ns*	Availability of Process Descriptions (PD) and/or Standard Operating Procedures (SOPs) for equipment management
QMS3.4	Documentation management	Y/N/u/ns*	Availability of Process Descriptions (PD) and/or Standard Operating Procedures (SOPs) for documentation management
QMS3.5	Reception management	Y/N/u/ns*	Availability of Process Descriptions (PD) and/or Standard Operating Procedures (SOPs) for the receipt and handling of biological material for deposit e.g. Material Transfer agreement (MTA), safety aspects etc.
QMS3.6	Quality check on biological material for deposit	Y/N/u/ns*	Availability of Process Descriptions (PD) and/or Standard Operating Procedures (SOPs) for quality check on samples for deposit e.g. performing authentication tests, stability test etc. (QC)
QMS3.7	Supply chain management	Y/N/u/ns*	Availability of Process Descriptions (PD) and Standard Operating Procedures (SOPs) for supply chain management, e.g. audit of suppliers
QMS3.8	Identification and control of non-conformities	Y/N/u/ns*	Availability of Process Descriptions (PD) and Standard Operating Procedures (SOPs) to identify and manage non-conformities of the QMS including sample management

QMS4: Quality Management System

Is the biobank operation done according to internal, national or international standards and/or guidelines?

Attribute Code	Attribute Name	Allowed Values	Description
QMS4.1	Applied Standards	String List	Which guidelines national and/or international standards applied? E.g. OECD Guidelines, ISO 9001, ISO 15189, ISO15190, ISO17025, NFS96-900. ISO and/or CEN/TS family can be specified.
QMS4.2	Quality Monitoring	Y/N/u/ns*	Is a monitoring process of the biobank operation in place
QMS4.3	Quality Audits	Y/N/u/ns*	Is a frequent audit of the biobank operation in place
QMS4.4	Documentation and record Archive	Y/N/u/ns*	Does the biobank QM system include a maintenance for documentation and records archiving process
QMS4.5	Integrated QMS	Y/N/u/ns*	Is the biobank part of a QM System of a hospital, university etc.)
QMS4.6	Integrated QMS certified	Y/N/u/ns*	Is the biobank part of a certified QM System (e.g. hospital is certified – Biobank affiliated)
QMS4.7	Certification	Y/N/u/ns*	Is the biobank QM system stand alone certified

Allowed values

Y	Yes
N	No
u	Unknown
ns	Not specified