Understand the context
Define the medical laboratory’s services, scope and applicable requirements.
MEDICAL LABORATORY QUALITY & COMPETENCE
ISO 15189 accreditation consultancy for practical implementation.
ISO 15189 specifies requirements for quality and competence in medical laboratories. It is intended for use by medical laboratories in developing their management systems and assessing competence.
01 / Understanding the framework
Start with the right context.
ISO 15189 specifies requirements for quality and competence in medical laboratories. It is intended for use by medical laboratories in developing their management systems and assessing competence.
The requirements and practical arrangements should be interpreted in relation to the organisation’s activities, scope, interested parties, applicable obligations and intended outcomes. The appropriate standard edition and any sector-specific requirements should be confirmed before implementation planning.
02 / Key considerations
Build a system that works in context.
The following areas commonly require attention. Their relevance and depth depend on the selected framework and the organisation’s scope.
Address relevant requirements
Address patient-centred processes, impartiality, confidentiality and personnel competence.
Build practical controls
Establish pre-examination, examination and post-examination process controls.
Evaluate and improve
Monitor quality, evaluate risks and manage nonconforming work and improvement.
03 / A considered journey
From review to readiness.
A proportionate plan should be agreed after understanding the organisation’s scope, current practices and intended outcomes. These stages are indicative, not a guaranteed timeline or outcome.
Define the scope
Understand activities, boundaries, interested parties and applicable requirements.
Review current practices
Identify existing controls, strengths, gaps and priorities relevant to the intended framework.
Plan and implement
Agree responsibilities and develop or improve processes and documented information where needed.
Evaluate effectiveness
Use appropriate monitoring, internal evaluation and management review to identify improvement needs.
Prepare for independent assessment
Address findings and understand the independent assessment or accreditation route where applicable.
04 / Scope and responsibilities
Understand the boundaries.
What this service does — and does not — mean.
Medical laboratory accreditation readiness is separate from accreditation, clinical licensing, statutory permissions and clinical decision-making.
Any engagement scope, delivery arrangements, consultant qualifications and applicable credentials must be confirmed before they are represented as part of a service offer.
05 / Frequently asked questions
ISO 15189, explained.
ISO 15189 is an international standard specifying requirements for quality and competence in medical laboratories.
They are distinct standards with different scopes and intended contexts. ISO 15189 is specific to medical laboratories; ISO/IEC 17025 covers testing and calibration laboratory competence.
Accreditation applies to a defined scope. Users should review the laboratory’s current accreditation certificate and scope for the relevant examinations and locations.
No. Consultancy can support readiness, while the relevant accreditation body makes the independent accreditation decision.
Continue the conversation
Begin with your organisation’s requirements.
Review the wider service catalogue or return to the main page to explore the approach.