ISO 15189
Medical Laboratory Quality Management System
ISO 15189 is the global standard for medical laboratory quality and competence. Achieving accreditation demonstrates your commitment to quality, patient safety, and continual improvement in laboratory operations.
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ISO 15189 is an international standard designed for the accreditation of medical laboratories. This standard includes an assessment of the laboratories quality management system and technical practices. It aligns with good medical laboratory practices such as the importance of: appropriate technical qualifications, ethical practices, safe environmental conditions, rigorous traceable reporting requirements, the use of validated methods, sample storage, retention and disposal requirements and traceable equipment and reference standards.
ISO 15189 can be utilized by regulators or by end users as it gives them confidence laboratories are competent to perform medical tests/examination results, have staff committed to the quality of their lab, that their service has up to date technologies and its procedures and techniques reflect current best practice.
Why Become Accredited to ISO 15189
- Increase your ability to produce reliable results within client timeframes
- Reduce Potential Costs and Risks
- Promote your laboratory has appropriate procedures for ethics, confidentiality and the safety of the patient
- Promote Compliance to International Standards
PJLA offers accreditation in various fields such as:
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Laboratories are required to be assessed ever year to ensure they are meeting the requirements of ISO 15189 and PJLA policies/criteria. Click Here to download locate PJLA’s medical program documents.
Apply for ISO 15189 Accreditation
ISO 15189 Accreditation may be applied for online through our easy application form.
To receive additional information about our accreditation programs, please contact our office at
1-877-369-5227 or (248) 519-2603 or email us at pjlabs@pjlabs.com.
The Pathway
Your Journey to Accreditation
We’ve transformed the accreditation process into a clear, structured, and guided pathway. Our team supports your progress at every step — from application to certificate issuance.
Application & Optional Pre-Assessment
Submit your application, identify your scope, and begin working with a dedicated project manager. A pending letter of accreditation is issued once the service agreement is executed.
Preliminary Assessment Preparation
Your documents and proposed scope undergo a detailed internal review. Assessment dates are confirmed and your assessor receives your system documentation 30 days prior.
On-Site Assessment
A formal opening meeting starts the assessment. Your management system, technical activities, staff competence, records, and demonstrations of capability are reviewed.
Corrective Actions & Final Review
A closing meeting outlines any non-conformities. You submit corrective actions within 60 days, after which assessors conduct a full review and finalize the assessment package.
Accreditation Decision & Certificate Issuance
PJLA’s Executive Committee performs the final decision. Once approved, you receive your accreditation certificate and logo files for official marketing use.
Why Choose PJLA
We deliver responsive, transparent, and reliable accreditation services backed by knowledgeable assessors and real-person support.
- Knowledgeable assessors – Experienced experts across multiple laboratory disciplines.
- No hidden costs – Transparent pricing with no surprises.
- Superior customer service – Dedicated, responsive support every step of the way.
- No application fees – Apply without upfront charges.
- No travel markup – Fair, standardized assessor travel costs.
- No assessor transit day billing – You only pay for meaningful assessment time.
- Clients have a voice in assessor selection – Choose assessors who best fit your needs.
- Complimentary marketing services – Promote your accreditation with free support.
- Responsive to client needs – Fast turnaround and flexible scheduling.
- Dedicated assessment scheduling team – Ensuring smooth and timely coordination.
- Live, real-person support – No automated systems; talk to a real human every time.
Accreditation Expertise for Every Laboratory Discipline
At Perry Johnson Laboratory Accreditation, Inc. (PJLA), we provide internationally recognized accreditation services across a wide range of conformity assessment bodies.
Select a program below to learn more, or browse all accreditation programs.
ISO/IEC 17025
ISO/IEC 17020
ISO/IEC 17043
ISO/IEC 17065
ISO 17034
ISO 15189
ISO/IEC 17024
ASTM E2659
What Our Clients Say
Accreditation provides the marketplace confidence that your organization has a well-established quality management system producing reliable and accurate results. Accreditation is utilized globally by various industries to confirm traceability in results. Becoming accredited symbolizes integrity and competency within your organization which provides you a market advantage over competition. Accreditation is strongly utilized by regulatory agencies as a qualifying factor to accept organizations for specific programs or schemes.
Just as our customers, Perry Johnson Laboratory Accreditation, Inc. (PJLA) is evaluated every 4 years by our recognition body the Asia Pacific Accreditation Cooperation (APAC). This evaluation includes our adherence to ISO/IEC 17011:2017 Conforming Assessment – General Requirements for Accreditation Bodies Accrediting Conformity Assessment Bodies as well as ILAC and APAC criteria. During this same visit, PJLA may also be observed by industry regulators for any national programs we offer accreditation services for. Please visit the ILAC website at www.ilac.org or APAC website at www.apac-accreditation.org to view our credentials as a signatory to both MRAs.
Initially organizations should purchase a copy of the standard wishing to be accredited for. This can be purchased under from the International Organization for Standardization (ISO) website at www.iso.org. A full system internal audit and a full management review shall be conducted prior to our arrival. This allows organizations to have a sufficient understanding of where any gaps are between their system and the requirements of the standard. Appropriate training shall be conducted of all pertinent personnel and records shall be available to demonstrate adherence to the standard. Organizations should ensure that the following PJLA documents are downloaded from the PJLA website and are implemented:
- PL-1 Proficiency Testing Requirements
- PL-2 Traceability Requirements
- PL-3 Measurement Uncertainty Requirements
- PL-4 Calibration Scopes of Accreditation Requirements
- SOP-1 Accreditation Procedure
- SOP-3 Use of Accreditation Claims and Symbols
- WI-8 Testing Scopes of Accreditation Requirements
- WI-9 Inspection Scopes of Accreditation
To view these documents, please go to our Documents webpage.
All organizations should to sign up to our receive notifications on our home page that will provide you weekly updates on any news, changes to our policies and criteria and Free Training Events. Organizations not meeting these additional requirements, will be issued a nonconformity. Additionally, PJLA offers various guidance tools and free training to assist organizations implement the requirements of the standard.
Frequently Asked Questions
Have questions about ISO 9001 or our certification process? We’ve got answers.