Practical support for ISO 15189 readiness.
I work with laboratory and quality teams on the procedures, validation records, QC and traceability needed for routine operation and assessment. I help identify gaps, agree priorities and put the changes into daily use.
My experience includes leading the technical work for ABC Labs’ accredited toxicology scope, alongside its QA function, and eleven years of routine before that inside an accredited hospital department, where the drugs-of-abuse laboratory held College of American Pathologists accreditation beside its Swedac accreditation.
- ISO 15189 · EWDTS
- 22 months to an accredited scope, with QA alongside
- 11 years inside an accredited department
- Remote first · Sweden, Europe and the Asia-Pacific
4 starting points
Where laboratories bring me in
- A new scope
A method, a sample type or a whole service is being added to the accreditation, and the procedures, validation records, QC design and training have to exist and be in use before the assessment.
- Implementation support
The quality manager knows what has to change and needs somebody who has worked on the technical side of a laboratory to make the changes land at the bench: procedures that match the work, QC with limits from the laboratory’s own data, records that answer questions.
- Capacity
A competent team with an assessment coming and more to do than hands to do it. I take defined pieces of the preparation and report to your quality manager.
- Gaps found
A non-conformity, an EQA result out of bounds, or an internal audit has shown where the procedure and the practice differ, and the correction has to be designed into the workflow rather than written over it.
8 areas
What I work on
Documents
- Procedures and document control
Procedures written in your quality management system, through its own review and approval route, in the words the people at the bench use.
- Validation governance
The framework a laboratory validates against: which studies each kind of method has to pass, the plan approved before the first run, named owner, reviewer and approver roles. The validations themselves are method validation.
Controls
- Internal quality control
Controls at the decision points that matter, limits from the laboratory’s own running-in data, and a review that looks across runs rather than at one run at a time.
- External quality assessment
Enrollment at the scope you report, assessment of what comes back against the methods, and CAPA when a result is out of bounds.
- Measurement uncertainty
Estimated from the laboratory’s own precision and bias data, so a result near a cut-off can be defended with a number.
Review
- CAPA and change control
Deviations that produce a change, relocation and hardware changes treated as changes, and a revision history that shows the system working.
- Traceability and identity
Equipment, reagent and substance records that can say what, who, when and against which lot, years later; chain of custody where a result may be contested.
- Readiness review
A review before the assessor’s, by somebody who has sat on the laboratory’s side of the table, with findings written the way an assessor would write them.
6 deliverables
What you get
- Gap and action register
The requirements against the operation: what is missing, what exists but is not in use, what exists only on paper, each with an action, an owner and a date, agreed with your quality manager.
- Quality and workflow map
The sample’s path with its controls, approvals, records and retention drawn in, so the quality system and the workflow are one drawing.
- Procedures
Reviewed or written in your templates, your version scheme and your document system.
- Validation structure and QC design
The framework, the plan and report templates, and which controls at which levels with which rules, reviewed how often and by whom.
- Readiness review
Findings written the assessor’s way, and every requirement mapped to the record that shows it is met.
- Implementation
The changes taken into daily use with the people who do the work, not handed over as a binder.
The register is the working document of the engagement. Three rows in the shape I keep it in:
| Ref | Area | Finding | Action | Owner · due |
|---|---|---|---|---|
| G-03 | Document control | Two revisions of the sample reception procedure in use; the printed copy on the bench is one behind the master. | Withdraw the printed copy, issue the current revision as a controlled copy, add the bench to the distribution list. | Quality manager · week 2 |
| G-08 | Internal QC | Control limits for the confirmation method taken from the manufacturer’s insert, not from the laboratory’s own data. | Recalculate limits from the first twenty runs; write down the rule for reviewing them. | Method owner · week 4 |
| G-11 | Equipment | A pipette calibrated on schedule but recorded at a bench it left in March. | Add location to the equipment record; verify every pipette’s position. | Technical lead · week 1 |
Illustrative example with synthetic content. It shows the shape of the register, not any client’s laboratory.
Swedac 10532
Relevant experience
At ABC Labs in Stockholm, a covid testing operation becoming an accredited drugs-of-abuse laboratory (the build is on the home page), what I ran was the technical side: the validation framework and the plans and reports under it, internal QC with limits from the laboratory’s own running-in data, three external quality-assessment schemes reviewed against the methods, measurement uncertainty from the laboratory’s own precision and bias data, procedures written into its quality management system, audit preparation and CAPA. The scope, medical testing to ISO 15189 and workplace drug testing to EWDTS, was accredited in October 2023 as Swedac 10532. Accreditation is won by the laboratory and QA together.
- 22 monthsFirst day to an accredited toxicology scope, with QA alongside
- 12Kinds of study in the validation framework I wrote
- 3External quality-assessment schemes, reviewed against the methods
Two details say more than the certificate. The chain-of-custody procedure and the validation guideline I would show you are both second versions, each rewritten after a non-conformity found in the laboratory; a revision history is evidence that the system does something. And when a clinical chemistry analyzer was moved, the creatinine assay on it was re-verified, because a relocation is a change like any other. The work did not stop at the certificate: procedures and methods were developed further, the LIMS was built out, new staff were trained.
Before that, eleven years inside clinical pharmacology at Karolinska University Hospital, in routine production across three laboratories in one accredited department: therapeutic drug monitoring, drugs of abuse, which was accredited by the College of American Pathologists as well as by Swedac, and the Swedish doping control laboratory, accredited under WADA. How a result was produced had to stand up as well as the result itself, under the US framework and the international one at the same bench. The quality system as it was built, with the validation framework and the ledgers, is on the selected work page.
4 steps
How the work runs
- ReviewA look at the operation and its records, on site where it has to be, and a written proposal: the gaps I would close first and what each needs. A couple of days.
- RegisterThe gap and action register and the quality–workflow map, agreed with your quality manager, with owners and dates.
- ImplementProcedures, QC design, validation structure and records, in your system, with the people who will use them, long enough to produce their own evidence.
- Readiness reviewFindings written the assessor’s way, and the fixes before the visit.
Most of this runs remotely once the operation has been seen; a longer on-site engagement is open for the right project. Engagements run from a couple of days to several months and are quoted in writing before they start; the commercial answers cover the rest. The regulators and guidelines I have worked under are Swedish and European; for a laboratory under another authority I would read its requirements alongside you before assuming any of this maps across.
Scope
Scope and responsibilities
I support preparation and implementation alongside your quality manager; independent audits and accreditation decisions are outside this service. The quality system belongs to the laboratory, and Swedac, or your national body, decides after its own assessment. Nothing here is a certification. Where a method has to be validated inside that system, method validation is priced on its own; where the quality system is one layer of a laboratory being stood up, that is laboratory commissioning.
Six services
First step
Discuss your quality priorities
Tell me which standard, which scope and which date, and what you already know has to change. If an assessment is booked, say when. I will reply with the questions I need and tell you what I would look at first. The first conversation is free. The terms, travel and the other commercial answers are on the contact page. If you would rather not use a form, write to [email protected].
Contracting
- Consulting delivered through Ebihara Solutions (Sweden), a sole trader approved for F-skatt; organization and VAT numbers on every invoice.
- Your NDA signed and your document control followed; no professional indemnity insurance; laboratories in Sweden, Europe and the Asia-Pacific.