Indonesia National Accreditation Committee (KAN) Explained

The Komite Akreditasi Nasional (KAN) is Indonesia's official national accreditation body. Established under Government Regulation No. 102 of 2000 and Presidential Decree No. 78 of 2001, KAN ensures that conformity assessment bodies (CABs) maintain confidentiality, objectivity, and impartiality in their accreditation processes.

For healthcare professionals, particularly pathologists, accreditation by KAN signifies adherence to international quality and safety standards. They are essential for laboratories and medical institutions conducting tests, validations, and certifications.

Accreditation for Certification, Validation, and Verification Bodies

KAN provides accreditation to Conformity Assessment Bodies (CABs) under various frameworks. The certification ensures that these bodies comply with ISO standards and relevant industry-specific regulations.

Accreditation Schemes for Healthcare & Laboratories

• ISO/IEC 17021 – Accreditation of management system certification bodies.
• ISO/IEC 17065 – Accreditation of product certification bodies.
• ISO 17024 – Accreditation for personnel certification bodies.
• ISO 14065 – Accreditation for greenhouse gas validation/verification bodies.
• ISO 22003 – Accreditation of food safety management systems.
• ISO 27006 – Accreditation for information security management systems.
• ISO 50003 – Accreditation for energy management system certification bodies.

For laboratories and healthcare facilities, accreditation through these schemes ensures standardised procedures, regulatory compliance, and operational excellence.

Accreditation Process

The accreditation process for a Conformity Assessment Body (CAB) follows a structured approach:

Step	Description
Application Submission	CABs must apply online or offline through the KAN accreditation portal. Submission requires legal documents, quality system documentation, auditor details, and client lists.
Preliminary Visit (Optional)	A preliminary assessment determines the readiness of the CAB and helps identify potential gaps in compliance before the full assessment.
Adequacy Audit	Review of CAB’s documentation, records, and quality systems. If deficiencies exist, KAN may terminate the process or request improvements before proceeding.
On-Site Assessment	A detailed audit of CAB’s processes, personnel, and quality controls to identify non-conformities and areas for corrective actions.
Surveillance Audits	Annual audits to ensure CABs maintain consistent compliance. Failure to meet standards may lead to suspension or withdrawal of accreditation.
Re-Accreditation	Accreditation is valid for four years. Re-accreditation must be requested 12 months before expiry.

Requirements for Healthcare Laboratories

For pathologists and medical professionals, Komite Akreditasi Nasional (KAN) accreditation of laboratories ensures compliance with international healthcare quality standards. Laboratories seeking accreditation must:

• Implement a documented quality system for at least three months.
• Conduct at least one internal audit and management review.
• Register as a legal entity in Indonesia.
• Have qualified personnel, appropriate facilities, and necessary equipment.
• Issue at least one certificate of conformity (for applicable schemes).
• Maintain a list of certified or potential clients.

These requirements ensure that medical laboratories provide accurate, reliable, and standardised testing services.

Surveillance and Witness Assessments

Once accredited, a CAB undergoes periodic surveillance to ensure continuous compliance. Witness assessments involve KAN experts evaluating real-time audits performed by CABs.

Witness Assessment Considerations

• Quality of previous audits
• Complexity of certified processes
• Regulatory compliance factors
• Customer complaints or feedback
• Auditor competency

Failure to meet standards can result in increased surveillance, scope reduction, suspension, or withdrawal of accreditation.

Rights and Responsibilities of Accredited CABs

Accredited bodies are expected to uphold the highest transparency and ethical operations standards. They have the right to:

• Appeal decisions and file complaints with KAN.
• Request clarifications regarding accreditation requirements.
• Use KAN’s accreditation logo in compliance with guidelines.
• Apply for scope extensions or reductions.

Obligations include:

• Complying with KAN accreditation terms and conditions.
• Cooperating with KAN for assessments, audits, and witness reviews.
• Maintaining up-to-date certification records.
• Reporting changes in legal, operational, or ownership status.

Consequences of Non-Compliance

Failure to meet accreditation requirements can result in sanctions, including:

• Additional surveillance audits (if inconsistencies are found).
• Reduction of accreditation scope (if competency is not maintained).
• Suspension of accreditation (for unresolved nonconformities or policy breaches).
• Complete withdrawal of certification (for serious violations).

For medical laboratories, non-compliance could result in loss of certification, legal repercussions, and reputational damage.

Conclusion

KAN accreditation is imperative to ensure standardisation, compliance, and quality assurance in Indonesia’s healthcare sector. For pathologists and medical laboratories, achieving and maintaining KAN accreditation is essential to ensure reliable diagnostics, improved patient care, and adherence to global healthcare standards.
Decoding KAN’s requirements and processes helps institutions navigate the accreditation journey efficiently and sustain compliance with evolving healthcare regulations.

Also check - College of American Pathologists (CAP) in Lab Accreditation