ISO 15189 is the international standard that defines the competence and quality requirements for a medical laboratory, and in Canada it is adopted voluntarily rather than handed down as a federal licence. It asks a laboratory to be clear about who is accountable, to control the staff, equipment, reagents and consumables it uses, to run every examination step under a written procedure, and to prove all of it with records an assessor can follow. The edition in force is ISO 15189:2022, and it is organised into clause groups 4 through 8.
What does ISO 15189 actually cover?
The standard covers the whole journey of a specimen, from the moment a request is received to the moment a result is released and stored. It is written for the laboratory as an organisation, which is why it spends as much space on governance, document control and personnel competence as it does on analytical method. A laboratory cannot satisfy it by buying good instruments alone; it has to show that the system around those instruments is planned and repeatable.
Two ideas run through every clause. The first is risk-based thinking, where the laboratory decides what could go wrong and controls it in proportion to that risk. The second is traceability, so that every result can be linked back to the people, equipment, reagents and consumable lots behind it.
Which clause groups does ISO 15189:2022 use?
The 2022 edition replaced the older two-part structure with five groups that run from general obligations through to improvement. Each group names the evidence an assessor expects to see.
| Clause group | What it requires | Evidence and consumables typically involved |
|---|---|---|
| 4 General requirements | Impartiality, confidentiality, documented quality policy | Quality manual, confidentiality agreements |
| 5 Structural and governance | Legal identity, defined roles, documented responsibility | Org chart, job descriptions, competency records |
| 6 Resource requirements | Personnel, facilities, equipment, reagents and consumables | Acceptance records, lot traceability, storage temperature logs |
| 7 Process requirements | Pre-examination, examination, post-examination, reporting | Specimen labelling, collection devices, transport packaging, result release rules |
| 8 Management system | Risk, documents, records, nonconformity, audit, improvement | Internal audit reports, corrective-action log, management review minutes |
Groups 6 and 7 are where most consumables live. Reagents, collection devices, containers and transport packaging are not background items; they are part of the resource and process requirements, and their acceptance and lot records form part of the evidence.
Is ISO 15189 mandatory for a Canadian lab?
No, it is not a federal licence. Laboratories are licensed and funded through provincial and institutional channels, and ISO 15189 accreditation is granted by accreditation bodies working within the Standards Council of Canada framework. It becomes mandatory in practice through contracts, hospital policy and provincial reference-laboratory requirements rather than through a single statute.
That distinction matters when you check a supplier. The useful question is which body assessed the laboratory, against which edition, and for which scope of testing.
How is point-of-care testing covered?
Point-of-care testing now sits inside ISO 15189 itself. The separate standard that used to govern it, ISO 22870, has been withdrawn, and its content was folded into the 2022 edition. A laboratory running glucose meters, blood gas analysers or rapid tests therefore documents that testing inside its own quality system instead of maintaining a second, parallel system.
In practice the same controls apply at the bedside as at the bench: defined operators, training and competency records, equipment checks, quality control results, and a way to trace the consumable lot that was used.
What records and consumables do auditors ask for?
Assessors work from records, so the question is always to show them. The items that come up most often are the ones that connect a result to a physical object.
- Acceptance records for collection devices, containers and transport packaging.
- Lot numbers recorded against the results they produced.
- Storage temperature logs for reagents and controls.
- Competency records for everyone who performs the examination.
A sterile screw-cap specimen container and a case of 15 mL sterile centrifuge tubes are ordinary items, but their acceptance and lot records are what let a laboratory answer an assessor without reconstructing history afterwards.
How do you buy lab consumables that support an accredited quality system?
Buy the specification, not just the item. Put acceptance criteria into the purchase order, ask for a named lot and a shelf life with every delivery, and keep the receiving record next to the goods. That way the consumable evidence an assessor wants is produced by routine work instead of assembled in the week before an assessment.
Related Reading
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- Diagnostic laboratory supply checklist
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Related Reading
- Diagnostic laboratory supply checklist
- QC laboratory supplies and sterility testing consumables
- Laboratory and clinical learning hub
- Wholesale and multi-site ordering
- diagnostic & research lab supplies
Frequently Asked Questions
Is ISO 15189 mandatory for a laboratory in Canada?
No. It is not a federal licence. Laboratories are licensed and funded through provincial and institutional channels, and ISO 15189 accreditation is granted by accreditation bodies that operate under the Standards Council of Canada framework. In practice it becomes mandatory through contracts, hospital policy or provincial reference-lab requirements.
What changed in ISO 15189:2022?
The 2022 edition restructured the requirements around risk-based thinking and folded point-of-care testing into the main standard. The separate POCT standard, ISO 22870, has been withdrawn, so a laboratory running POCT now documents it inside its own ISO 15189 quality system.
How long must a laboratory keep records?
ISO 15189 requires each laboratory to define its own retention periods and follow them; there is no single number in the standard. Provincial licensing requirements and payer contracts often set the longer clock, so the retention schedule has to satisfy the strictest applicable source.
Which consumables should be qualified before use?
Anything whose failure changes a result: collection devices, specimen containers, transport packaging, reagents and media. The practical control is documented acceptance at receipt plus lot traceability, so an audit can answer which lot produced which result.
CliniEco Medical is a licensed medical device establishment (MDEL #35334).
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