What is ISO 15189?
ISO 15189 specifies requirements for quality and competence in medical laboratories, covering the pre-examination, examination and post-examination processes to ensure reliable patient results.
Benefits of Certification
- ✔Assure reliable patient test results
- ✔Meet healthcare regulatory expectations
- ✔Improve patient safety and clinical confidence
- ✔Standardise laboratory processes
- ✔Support accreditation and reimbursement
Scope
For medical and clinical laboratories developing quality management systems and assessing their own competence.
Who it applies to
- ●Testing & calibration laboratories
- ●Construction & materials testing
- ●Environmental & water testing
- ●Petroleum & chemical labs
- ●Clinical & medical labs
- ●Food & agriculture labs
What the scope covers
- ▸Method validation and measurement uncertainty
- ▸Traceability of measurements
- ▸Competence of personnel and equipment
- ▸Sampling and handling of test items
- ▸Quality assurance of results
- ▸Impartiality and confidentiality
Key Requirements
- ▸Pre-examination processes and sample handling
- ▸Examination processes and validation
- ▸Post-examination and result reporting
- ▸Competence of laboratory personnel
- ▸Equipment, reagents and consumables control
- ▸Risk management and continual improvement
Certification Process
- 1
Application & Quotation
Submit your details and receive a tailored, fixed-price quotation based on scope, sites and headcount.
- 2
Gap Analysis (Optional)
An optional pre-audit review identifies gaps between your current practices and the standard.
- 3
Stage 1 Audit
Documentation review to confirm your management system is designed and ready for assessment.
- 4
Stage 2 Audit
On-site (or remote) assessment of the implementation and effectiveness of your system.
- 5
Certification Decision
An independent technical review leads to the certification decision and issue of your certificate.
- 6
Surveillance & Renewal
Annual surveillance audits maintain your certification over the three-year cycle before recertification.
Documents Required
- 📄Company registration / incorporation details
- 📄Organisation chart and list of sites
- 📄Scope statement of activities
- 📄Management system manual / documented information
- 📄Key policies and procedures relevant to the standard
- 📄Records demonstrating implementation (audits, reviews, training)
Frequently Asked Questions
How long does ISO 15189 certification take?
Typical timelines range from 4 to 12 weeks depending on the size of your organisation, the number of sites and how mature your existing management system is.
How long is a ISO 15189 certificate valid?
Certificates are issued for a three-year cycle, subject to successful annual surveillance audits, after which recertification renews the cycle.
Can the audit be conducted remotely?
Yes. Where appropriate, UKCTL can conduct Stage 1 and parts of Stage 2 remotely, combined with on-site verification as required.
Is ISO 15189 certification accredited?
UKCTL issues accredited certificates recognised internationally, giving your customers and stakeholders confidence in the assessment.
Get ISO 15189 certified with UKCTL
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