BS ISO 17822:2020 In vitro diagnostic test systems — Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens — Laboratory quality practice guide.
confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled
Note Ito entry: The term “validated” is used to designate the corresponding status.
Note 2 to entry: Adapted from ISO 9000:2015(31l.
Note 3 to entry: See Annex B for additional information.
[SOURCE: ISO 15189:2012, 3.26]
confirmation, through provision of objective evidence, that specified requirements have been fulfilled
Note ito entry: The term ‘verified” is used to designate the corresponding status.
Note 2 to entry: Confirmation can comprise activities such as performing alternative calculations, comparing a new design specification with a similar proven design specification, undertaking tests and demonstrations, and reviewing documents prior to issue.
Note 3 to entry: See AnnxB for additional information.
[SOURCE: ISO 9000:2015]
4 General laboratory requirement for microbial pathogens NAAT
4.1 General laboratory risk management and biosafety requirements
The medical laboratory management shall ensure the safety and protection of laboratory staff and service personnel. The requirements of ISO 15190 apply. As many microbes are pathogenic appropriate biosafety standards shall he applied.
The nucleic acid-based examination process shall be assessed by the medical laboratory to identify risks such as failure modes, operation errors, hazards and hazardous situations. The risks to patients and laboratory workers shall be identified prior to, and mitigated during examination development. Risks shall also be reviewed, monitored and mitigated prior to and during implementation, and regularly during the life cycle of operation.
NOTE I The medical laboratory can also refer to ISO 35001(91.
NOTE 2 The WHO hiosafety manual can be applied, WHO/CDS/EPR/2006.61U1.
NOTE 3 The general principles and risk management practices described in W] can also he applied to medical laboratories.
NOTE 4 For general guidance br reduction of laboratory error, see also ISO 22367l4-l.
NOTE S For information about quality control planning based upon risk management principles, see also
CLSI EP23lll.
4.2 General laboratory set ups for pathogen detection
General requirements for best practice in NAAT laboratory set up shall be followed and typically include separation of pre- and post-amplification rooms and potentially further modularization of laboratory steps. Specific considerations around pathogen containment shall also be adhered to along with the appropriate risk assessment.BS ISO 17822 pdf download.