9001MOST POPULAR
ISO 9001:2026
Quality management system
Rs 2,500 Rs 4,500
Non IAF CertificationFinal price. No GST charged.IAF option: Rs 4,000View certificationQUALITY AND COMPETENCE IN MEDICAL LABORATORIES
ISO 15189:2022 Certification
Quality and competence in medical laboratories. Typically about 7 working days after complete documents, payment and review.
Laboratory accreditation to ISO 15189 in India is granted by NABL. This certificate is not an accreditation and cannot be presented as one.
What is ISO 15189:2022?
ISO 15189 sets requirements for quality and competence in medical laboratories. It covers the whole testing cycle, from sample collection to the report, along with staff competence, equipment and quality assurance of results.
Who needs it?
- Pathology and diagnostic laboratories
- Hospital laboratories
- Sample collection centre networks
- Specialised testing laboratories
Review the ISO 15189:2022 preparation checklist
What it can do for your business
- More reliable test results
- Fewer sample and reporting errors
- Structured staff competence records
- Preparation for laboratory accreditation
FROM APPLICATION TO DECISION
How it works
01
Define scope and buyer needs
Identify activities, sites, the standard and edition, and any buyer or tender accreditation requirement.
02
Confirm the certification route
Check the issuing body, accreditation scope, assessment arrangements and total fees in writing before payment.
03
Prepare documents and evidence
Submit initial business documents and the records needed to demonstrate how your management system operates.
04
Complete review and assessment
The applicable review or audit may require additional evidence and corrective action. Timing depends on scope and readiness.
05
Decision and ongoing review
Issuance depends on successful review, not payment alone. Check the issued scope and arrange applicable surveillance and renewal.
STARTING YOUR APPLICATION
Initial business documents
These establish who is applying and the proposed business scope. They are the starting point; the service-specific review or assessment can require additional operational evidence.
Business registration
Udyam, incorporation certificate or shop licence.
Letterhead or visiting card
Your business name and contact details.
One business invoice
A recent sales or purchase invoice.
Your business scope
What you do, in one or two clear lines.
Prepare for ISO 15189:2022
Use these quality and competence in medical laboratories checks to organise your preparation. For each item, identify the responsible person, the procedure used and a recent record showing what happens in practice.
- Impartiality, confidentiality and patient focus
- Competent and authorised personnel
- Calibrated and maintained equipment and controlled reagents
- Defined pre-examination, examination and post-examination processes
- Quality assurance of results, audits and management review
Make your evidence match your scope
- Describe the actual activities and locations to be reviewed, including outsourced work and responsibilities retained by your business.
- Choose current examples from your own operation. Record the date, responsible person and outcome so the reviewer can connect the evidence to your stated scope.
- Identify missing records or unfinished actions before assessment. A policy or blank template alone does not show how a process operates.
- Ask which records apply to your selected service and scope. This preparation checklist is not an exhaustive assessment or a promise of certification.
Laboratory accreditation to ISO 15189 in India is granted by NABL. This certificate is not an accreditation and cannot be presented as one.
BEFORE YOU COMMIT
Confirm these details in writing before payment
Use the published price alongside the agreed scope and service terms when deciding whether the offering meets your requirement.
- Scope and deliverable: the applicable standard or scheme, edition, activities, sites and exclusions, and exactly what document or support the service provides.
- Issuing or assessment body: its name and role. If accredited certification is required, confirm the accreditation body and that the relevant standard and scope are covered.
- Buyer acceptance: share the actual tender or customer clause and confirm that the proposed route meets it. A certificate title alone does not establish acceptance.
- Assessment arrangements: required documents, audit or review stages, remote or on-site work, travel, readiness requirements and expected timing.
- Fees and exclusions: the selected service price, what is included, and any separate implementation, testing, site visit, travel or statutory registration costs.
- Ongoing obligations: applicable surveillance, renewal or reassessment, their fees, and how changes to your activities or locations should be reported.
Certification and accreditation have different roles. See ISO's guidance on choosing a certification body.
ICS✓
CERTIFICATE OF REGISTRATIONNon IAF Certification
ILLUSTRATIVE LAYOUT
ILLUSTRATIVE LAYOUT
Good systems.
Great possibilities.
Great possibilities.
This is to certify that the management system of
YOUR BUSINESS NAMEhas been assessed against the requirements of
ISO 15189:2022
QUALITY AND COMPETENCE IN MEDICAL LABORATORIESCertificate numberSAMPLE-XXXXXNon IAF Certification
SAMPLE
Authorized
signatory
signatory
SAMPLE · NOT A VALID CERTIFICATE
A credential. Not a question mark.Independently checkable, right here.
A VERIFIABLE RECORD
More than a piece of paper.
The sample shows the layout. Issued records include your company, certified scope, applicable standard, dates and status. Specialist schemes follow their own issuer requirements.
Verify a certificateQuestions about ISO 15189:2022
01Is this the same as NABL accreditation?+
No. In India, laboratory accreditation to ISO 15189 is granted by NABL. This is a Non-IAF certificate and not an accreditation.
02Which edition applies?+
ISO 15189:2022. The 2012 edition has been replaced.
03Can a collection centre apply?+
Yes, for the activities it performs, such as sample collection, handling and transport.
A stronger system, together.
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