Digital QMS for CBAHI & ISO 15189 Accreditation
The short answer
Start with the facility scope, standard and edition, then map each requirement to a process, owner, document and record. Use QMS for versions, incidents, CAPA, training and audits and verify effectiveness in practice. Only the assessing body decides accreditation.
Three actions to take
- Do not use an old checklist without confirming edition and scope.
- Connect each requirement to evidence created by normal work.
- Measure action closure and effectiveness, not only file count.
1. Build the requirements map
Separate common requirements from service- or laboratory-specific ones, and identify which process creates the evidence and who reviews it.
- Record the source, edition and scope for every item.
- Define the document, record, owner and review frequency.
2. Control documents and actions
Use a clear draft, review, approval, issue, acknowledgement and update cycle, and connect incidents and findings to traceable actions.
- Prevent obsolete copies at the point of use.
- Connect CAPA to cause, evidence and effectiveness review.
3. Prepare for assessment in practice
Run internal audits, management review and field interviews. Do not stage records only for display; confirm that staff understand and use the process.
- Trace a sample record back to its actual source.
- Give every gap an owner, due date and verification plan.
Need to apply this to your facility?
Share the activity, city and current stage, and we can help define an appropriate work scope.
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