Applicable framework
The assessment hierarchy begins with the primary standard and includes applicable normative, regulatory, scheme-owner and ISCB documents. When requirements conflict, ISCB will identify the controlling criterion before assessment.
- ISO 15189:2022 is the primary quality and competence standard.
- ISO/IEC 17011:2017 governs ISCB's accreditation process and decisions.
- Applicable legal, ethical, patient-safety, confidentiality and professional requirements remain binding in each jurisdiction.
Core organisational requirements
Legal status and responsibility
The applicant must be a legally identifiable entity, or a defined part of one, that can be held responsible for its conformity-assessment activities, contractual obligations and decisions.
Impartiality and independence
Identify, analyse, evaluate, treat, monitor and record risks to impartiality. Commercial, financial, ownership, relationship, consultancy and self-review threats must be controlled continuously.
Confidentiality and information security
Protect confidential information, personal data, intellectual property, examination or scheme security and electronic records. Disclosures must be legally authorised and appropriately communicated.
Organisation and governance
Define authority, responsibilities, reporting lines, committees and safeguards. Technical work, review and decisions must be assigned to competent and appropriately independent functions.
Competence and resources
Set competence criteria for every role affecting accredited activities; evaluate, authorise, monitor and periodically re-evaluate personnel. Control facilities, equipment, software and externally provided resources.
Controlled operations
Accept work only after confirming capability and scope. Use controlled methods and records, handle deviations, review outputs and ensure decisions are traceable to adequate objective evidence.
Management system
Maintain document and record control, risk and opportunity processes, complaints, appeals, nonconforming work, corrective action, internal audit, management review and continual improvement.
Accreditation claims
Claims, certificates, symbols and references to accreditation must be accurate, limited to the granted scope and changed immediately when accreditation is suspended, reduced, withdrawn or expires.
Service-specific technical requirements
- Define the requested scope by discipline, examination, specimen, method or platform and location.
- Control pre-examination, examination and post-examination processes, including patient preparation, collection, transport, acceptance, critical results and report authorization.
- Verify or validate examination procedures and demonstrate measurement uncertainty or other appropriate evaluation of result quality where applicable.
- Maintain internal quality control and suitable external quality assessment or interlaboratory comparison coverage.
- Manage biological reference intervals, clinical decision limits, metrological traceability, reagents, equipment, information systems and data integrity.
- Apply risk management, continuity planning and patient-impact evaluation to nonconforming work and significant changes.
Minimum application and readiness evidence
Submit current, approved documents and representative implementation records. Templates without operational evidence are not sufficient.
Assessment, decision and continued accreditation
Application and scope review
ISCB reviews legal identity, requested scope, locations, resources, readiness and applicable criteria before quotation and assessment planning. Acceptance of an application is not a promise of accreditation.
Assessment
Assessment may include document review, office or remote assessment, on-site technical assessment, witnessing, interviews, vertical and horizontal record tracing, and evaluation of representative activities. The mix depends on scope and risk.
Nonconformities and decision
The applicant must determine causes, correct the specific issue, implement proportionate corrective action and provide evidence of effectiveness within the notified period. Accreditation decisions are made independently from assessment and only for demonstrated competence.
Maintenance
Accredited bodies must remain competent, comply with surveillance and reassessment, notify significant changes without delay, cooperate with witnessing and record access, address complaints and nonconformities, and control all accreditation claims.
Principal references
- ISO 15189:2022
- ISO/IEC 17011:2017
- ILAC P9 and P10, where applicable
- Applicable national medical laboratory and patient-data requirements
Document editions and external publications can change. The edition stated in the accreditation agreement, transition notice or other formal ISCB communication controls the assessment. Applicants should verify current editions before use.