Accreditation looks like a single event, an assessment. In practice it is a sequence, and the order matters because several steps produce records that the next step asks for.
CALA, the Canadian Association for Laboratory Accreditation, publishes its process in a set of free documents. This is that process in order, with the rules from those documents that I think catch labs out. It is written for a testing lab, chemistry or microbiology. The Standards Council of Canada also accredits testing labs to ISO/IEC 17025; this piece covers CALA only.
The nine steps
1. Buy the standard. CALA requires evidence that the lab has purchased ISO/IEC 17025:2017 before it will schedule an assessment. With proof of purchase, CALA supplies its A02 assessment rating guide (CALA P04-03, section 5).
2. Build the management system, and map it. The quality manual, procedures and records, plus CALA’s A18 form, which cross-references your system to each clause.
3. Decide the scope. Each method you want accredited becomes an “appendix”: matrix, analyte, method and reference. Choose with the six-month rule in mind (below).
4. Validate every method and estimate its uncertainty. Validation or verification records for every analyte on the proposed scope, including detection limit, precision, bias and measurement uncertainty where applicable (CALA A06, sections 4.3.5 and 4.4.2). CALA’s uncertainty policy covers every quantitative method, using data from more than one day or run (CALA P19-01).
5. Run the system and keep the records. At least one internal audit and one management review, with records, because CALA asks for both before the visit.
6. Plan and start proficiency testing. Submit a PT plan to CALA. At least one proficiency test or interlaboratory activity must be completed to CALA’s satisfaction before accreditation is granted (CALA P02-03, sections 3.1 and 3.4).
7. Apply through CAMS. Accounts, laboratory details, appendices, terms and conditions, payment. A pre-assessment is optional: a document review and site visit that tells you how ready you are, without advice on how to fix gaps (A06, section 4.2).
8. Submit documents, then the visit. New labs send methods, validation, audit and management review records, the A02 and A18, and deviations from reference methods eight weeks before the assessment. The proposed scope is fixed two months before (A06, sections 4.3.3 and 4.3.5). On the day, assessors interview staff, examine records and may ask to watch a test (A06, section 4.4.3).
9. Close the findings. Findings are graded A (needs evidence), B (needs an action or plan) or C (comment). An applicant lab has 90 calendar days from the closing meeting to give objective evidence for every A (A06, sections 4.4.6 and 4.5.1).
After accreditation: a surveillance visit at one year, a full reassessment at two years, then every two years (A06, section 4.4.1).
The rules that catch labs out
A statement is not evidence. CALA’s wording: “Written affirmation, without supporting documentation, cannot be accepted as a satisfactory response to a requirement. This includes requirements relating to management reviews and internal audits” (A06, section 4.5.1). Evidence means SOPs, training records, calibration certificates, run data, invoices, photographs.
Every accredited method must run every six months. To keep a method on the scope, the lab must run it at least once every six months on a sample reflecting typical matrices. Proficiency testing samples and standards alone do not count; the sample does not have to be a customer’s (A06, section 4.3.3). If a method only runs twice a year by chance, decide on purpose whether it belongs on the scope.
Someone proficient must be there. For a method to be assessed, an analyst proficient in it must be available (A06, section 4.4.2). In a small lab with turnover, competence leaves with people. CALA’s application of the standard also asks for competence requirements per position, for all training to be documented, including in-house training, and for the effectiveness of training to be evaluated (CALA P07, clause 6.2.5).
Proficiency testing runs on a calendar. For common analytes, two studies a year with four samples per round; the second study of the year at least four months after the first, between July and December; results to CALA within 30 days of the PT report; a cause analysis and corrective action for every unacceptable result (P02-03, sections 3.2.1 and 3.4).
Impartiality is a written risk list. The lab must identify and document risks to impartiality and act on them (P07, clauses 4.1.4 and 4.1.5). In an owner-run lab that also advises the same clients, that list is worth writing carefully.
Safety counts. CALA “will not participate in the accreditation of a laboratory that presents known safety hazards” (A06, section 3).
What accreditation is, and is not
CALA’s own disclaimer is a useful line for anyone selling accredited work: accreditation “is a demonstration of confidence in the laboratory’s technical competence. It is not a guarantee” (A06, section 2). It covers the methods on the scope, as performed by that lab.
For what it costs, see what ISO 17025 accreditation costs a small Canadian lab.
Sources
All CALA documents are free on cala.ca; revision numbers as downloaded on 2 October 2026.
- CALA A06, Accreditation program, policies and procedures, revision 1.16, March 2023.
- CALA P04-03, Application for new accreditation, revision 2.2, June 2024.
- CALA P02-03, Proficiency testing policy for accreditation, revision 2.2.
- CALA P19-01, Measurement uncertainty policy, revision 2.1, June 2024.
- CALA P07:2017, Application of requirements in ISO/IEC 17025:2017, revision 1.5.
If your lab is starting this and you want to know where the method validation and uncertainty work will take the longest, tell me your scope on LinkedIn. The validation-readiness checklist is a good first pass on the method side.
Common questions
- How do I get ISO 17025 accreditation in Canada?
- Through an accreditation body that is a signatory to the ILAC mutual recognition arrangement, such as CALA or the Standards Council of Canada. With CALA, a lab applies through the CAMS portal, submits its management system and method validation documents, takes part in proficiency testing, and passes an on-site assessment against ISO/IEC 17025 and CALA's policies.
- What documents does CALA need before an assessment?
- Proof of purchase of ISO/IEC 17025:2017, the completed A02 rating guide, management system documents, the A18 cross-reference, test methods and supporting procedures, method validation or verification data, internal audit records, management review records, a list of deviations from reference methods, and proficiency testing results where available.
- How long do I have to fix findings after a CALA assessment?
- Applicant labs have 90 calendar days from the closing meeting and accredited labs 45 days. Every A-graded nonconformity needs objective evidence; written affirmation without supporting documents is not accepted. B-graded items need a documented action or plan.
- How often does CALA reassess an accredited lab?
- A surveillance visit one year after the initial assessment, a full reassessment one year after that, and then reassessments every two years.
- How often must I run an accredited method?
- CALA requires each method on the scope to be run at least once every six months on a sample reflecting typical matrices. Proficiency testing samples or standards alone do not count; the sample need not be a customer sample.
- Is proficiency testing required before CALA accreditation?
- Yes. CALA's proficiency testing policy requires at least one proficiency testing or interlaboratory activity, completed to CALA's satisfaction, before accreditation, and a PT plan agreed with CALA.