ISO 15189 Medical Laboratories
ISO 15189 Medical Laboratories
ISO 15189:2012 is a regulatory standard for medical labs. Its criteria help labs develop quality management systems and assess their own competence. The standard is also used by regulators, accreditation bodies and customers to confirm or recognize a lab’s competence.
The ISO 15189:2012 international standard is based on ISO/IEC 15189 and ISO 9001. It applies to all medical laboratories and is becoming the most widely accepted standard for accrediting the competence of clinical laboratories.
Key benefits of ISO 15189 accreditation can be summarized as below:
- Establish systems that are as failure resistant as possible.
- Reduce errors.
- Catch mistakes before they turn into bigger issues.
- Improve right-first-time metrics.
- Identify continual improvement opportunities.
- Enhance their problem-solving capabilities.
Our Approach to Successful Medical Laboratories - ISO 15189 Implementation
Every business is unique, in terms of products, services and processes.We follow the following phases to help you achieve ISO 15189 certification.
ISO 15189 Compliance can be achieved through Seven Phases:
PHASE 1 – Understanding Business and customer requirements
PHASE 2 – Gap Assessment and Lab Risk Assessment
PHASE 3 – Design and Documentation
PHASE 4 – Implementation and ISO 15189 Training
PHASE 5 –Control Measurement
PHASE 6 – Internal Assessment and Management Review
PHASE 7 – External Audit Support for ISO 15189 Certification
Call or write to us at :
for proposal / roadmap / information
Training
We provide bespoke training for ISO 15189, listed below are our offerings.
Shorter Sessions from 1 hour to 4 hours
Interpretation of the ISO 15189 requirements
- 1 Day Awareness Session
- 2 Days Internal Audit Course
- 3 Days Implementation Course covering 10+ hands on exercises
Upon receiving your request, we will provide you further details.
Documentation
Toolkit
ISO 15189 requires documentation of policies, procedures and records. As a result of several consulting assignments, we have some of the best content available that covers all the requirements.
Our documentation has the following salient features:
- Alignment with all ISO 15189-documentation requirements
- Our experiences turned into documentation templates
- Email support
- Expert review of a document
- Live one-on-one online consultations with an ISO 15189 expert
Upon receiving your request, we will provide you further details.
Internal
Audit
An independent assessment helps to assess the state of compliance with ISO 15189.
Our internal audit methodology includes people, process, technology and measurements to assure and provide management the degree of ISO 15189 compliance.
Typically, 3-5 days is required to perform a comprehensive internal audit.
Upon receiving your request, we will provide you further details.
