2013/04/11 – Audit Pengawasan (Standard Malaysia)

Pengenalan

Untuk memastikan bahawa makmal yang diiktiraf terus mematuhi MS ISO 15189 dan keperluan SAMM selain memantau dan menilai sumbangan makmal kepada penjagaan pesakit. Audit juga adalah untuk mengesahkan pelaksanaan tindakan pembetulan ke atas ketidakpatuhan yang dibangkitkan dalam penilaian terakhir.

Audit Ketua Juru Audit: Mdm. Ng Pui Wan Government Retiree (JKM)

Juru Audit Teknikal: Datin Tunku Marinah Ashraf Tunku Abdullah (Government Retiree & Dr. Alawiyah Bt. Awang Abd. Rahman (Hospital Sultanah Nur Zahirah)

Pemerhati: Ms. Aini-Ardena Mustapha Binti Mohd Mustapha PPUKM

Wakil STANDARDS MALAYSIA: Mr. Mohamad Hafanizam Hassan

Pada 11-12 April 2013, butiran adalah seperti berikut: (dalam Bahasa Inggeris)

Type of Assessment:

Surveillance

Aim & Purpose of Assessment:

1 To ensure that the accredited laboratory continues to comply with MS ISO 15189 and SAMM requirements.

2 To monitor and evaluate laboratory’s contribution to patient care

3 To verify effective implementation of corrective action on non-conformities raised in the last assessment.

4 Others (e.g.: extension of scope)

Scope of Medical Testing: Chemical Pathology and Haematology

SAMM’s Accreditation Standard/Criteria and Policy:

1 MS ISO 15189

2 SAMM Policy Requirements (where applicable)

3 Specific Criteria

4 Specific Technical Requirements

Assessment of Laboratory Documentations:

1. Laboratory’s Quality Manual & Procedures,

2. Test Methods in use,

3. Other relevant documentations.

Confidentiality:

The above team members have provided written undertaking to STANDARDS MALAYSIA to protect the confidentiality of all information acquired during the course of the assessment.

Language of Assessment: English and Bahasa Malaysia

Auditee Personnel to be Interviewed:

1. Technical Manager;

2. Quality Manager;

3. Nominated/Approved Personnel;

4. Lab staff carrying out the tests.