ISO 15189 – Medical laboratories

Similar to ISO 9001, ISO 15189 Medical laboratories is a Quality Management System. The salient difference is that the latter gives requirements that are specific to medical laboratories.

Another standard that is also relevant to medical laboratories is ISO 17025. The main difference between the 2 standards is that:

  • ISO 15189 sets out the guidelines for a quality management system specific to the requirements of patient care
  • ISO 17025 defines the requirements for the competence of testing and calibration laboratories

Like any other ISO Standard, the guidelines explain what needs to be done – but not “how” to it. Each laboratory has to evaluate their current situation, and together with its ISO Consultant, define the best strategy to adopt for the implementation of the standard.

Process Requirements

The ISO 15189 standard, given that it is specific to Medical laboratories, includes more details on specifics of how the service is given to the customer. Specifically, when defining the processes for the organisation, we must also consider:

  • Pre-examination – processes that start, in chronological order, from the clinician’s request and include the examination request, preparation and identification of the patient, collection of the primary sample(s), and transportation to and within the laboratory, and end when the analytical examination begins
  • Examination – set of operations having the object of determining the value or characteristics of a property
  • Post-examination – processes following the examination including review of results, retention and storage of clinical material, sample (and waste) disposal, and formatting, releasing, reporting and retention of examination results
  • Reported results (including automated selection) – the process by which patient examination results are sent to the laboratory information system and compared with laboratory-defined acceptance criteria, and in which results that fall within the defined criteria are automatically included inpatient report formats without any additional intervention

Source for the above definitions given in the link.

Guidelines within the standard

Given that the standard is specific, ISO could delve deeper into what is required of the organizations. The following are a list of items that need to be considered:

  • Key processes
    • Receipt, handling, storage and disposal of samples
    • Evaluation of customer requirements and handling customer agreements
    • Safe handling, transport, storage and use of equipment to prevent its contamination or deterioration
    • Reception, storage, acceptance testing
    • Collection and handling of primary samples
    • Transporation of samples
    • Sample receipt
  • Supporting activities
    • Control of documents and records
    • Selecting and evaluation of external providers
    • Purchasing
    • Management of complaint and other feedback from clinicians, patients, laboratory staff and other parties
    • Corrective and preventive actions
    • Internal Audits Criteria
    • Management Reviews
    • Personnel training
    • Facility and work environment maintenance and upkeep

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