SECTION 4: Doc. No.

:PRK-PKD MJG-PAT-QM
DAERAH MANJUNG Management
Requirements Version No.:01 Amendment No:00

UNIT PATOLOGI Date of issue: 16th August 2016

4.14 Evaluation and Audits Page 1 of 4

GENERAL POLICY

The laboratory will conduct internal audits once a year to ensure that the laboratories
comply with both the managerial and technical requirement of the quality management
system. Special emphasis is given to areas of critical importants to patient care.This will
provide assurance to management that the quality system is being implemented exactly as
intended;assist in identifying the causes of quality problems and breakdowns in the quality
system and determining the corrective action needed to elimate them.

DASAR AM

- audit dalaman setahun sekali

1. siapa yg terlibat
2. bagaimana audit dilakukan
3. checklist utk audit

PROCEDURAL POLICIES

4.14.1 Periodic review of requests, and suitability of procedure and sample requirement
a. All the examination provided by the laboratory are being reviewed
(yearly or when appropriate) by a trained and competent staff to
ensure that they are clinically appropriate for the request received
b. The review includes (not limited to) :
i. Sample volume
ii. Collection devices
iii. Preservatives used for blood, urine and other samples
c. This review is to ensure that the volume of the sample is adequate,
properly collected and preserve the measurand

DASAR PROSEDUR

Kajian berkala terhadap permintaan dan kesesuaian sampel dan

prosedur
1. User manual
- container, volume, LTAT, Pengawet yang digunakan untuk darah,
air kencing dan sampel lain
2. Kajian penolakan spesimen
 SECTION 4: Doc. No.:PRK-PKD MJG-PAT-QM
DAERAH MANJUNG Management
Requirements Version No.:01 Amendment No:00

UNIT PATOLOGI Date of issue: 16th August 2016

4.14 Evaluation and Audits Page 2 of 4

Penilaian maklum balas pengguna

1. aduan dan faktor-faktor lain yang berkaitan, daripada doktor , pesakit dan pihak-pihak lain
2. kajian kepuasan pelanggan , aduan , cadangan , perbincangan dengan pelanggan
dalaman dan luaran , sesi
3. cadangan maklumbalas dari staf
Semua kakitangan digalakkan untuk menawarkan cadangan untuk pembaikan mana-mana
aspek makmal. Semua cadangan ini direkodkan, dinilai dan dilaksanakan jika berguna.
mekanisma
i. mesyuarat unit
ii. peti cadangan
iii. Sesi perbincangan antara pengurusan dan teknikal

c. The audit criteria, scope and frequency are defined in the audit plan.
The internal auditors are selected to ensure that auditors do not
audit their own work.
d. The written report is prepared as soon as possible after completion
of the audit and non-conformance and opportunities for
improvement are identified. The appropriate and agreed upon time
frame for corrective/preventive actions required for non
conformance and opportunities for improvement is documented in
the relevant NCR form.

Audit dalaman
1. Senarai Semak
i. Pemilihan prosedur Analisis, kawalan dan pengesahan –
ii. Kalibrasi peralatan dan penyelenggaraan rekod
iii. Ujian Kemahiran
iv. Rekod latihan
v. Laporan bertulis disediakan secepat mungkin selepas selesai audit dan
ketidakpatuhan dan peluang untuk penambahbaikan dikenalpasti.
audit susulan dijalankan jika perlu untuk pengesahan tindakan yang diambil.
Keputusan audit dalaman dikemukakan untuk perbincangan semasa kajian semula
 SECTION 4: Doc. No.:PRK-PKD MJG-PAT-QM
DAERAH MANJUNG Management
Requirements Version No.:01 Amendment No:00

UNIT PATOLOGI Date of issue: 16th August 2016

4.14 Evaluation and Audits Page 3 of 4

pengurusan mesyuarat.
Pengurusan Risiko

a. penilaian risiko dilaksanakan ke atas semua aktiviti dan prosedur yang

dilakukan di jabatan.
b. penilaian risiko dijalankan dan tindakan yang perlu diambil untuk
mewujudkan amalan kerja yang selamat dan betul
c. Penilaian risiko dikemas kini apabila peralatan atau metodologi ditukar
4.14.6 Petunjuk Kualiti
Makmal ini telah melaksanakan petunjuk prestasi utama untuk memantau
Bidang Keberhasilan Utama dalam penyediaan perkhidmatan patologi
berkesan dan pematuhan kepada dasar kualiti ( "untuk memberikan
keputusan yang boleh dipercayai dan tepat pada masanya kepada
pelanggan kami melalui penambahbaikan berterusan perkhidmatan") dan
menyumbang secara berkesan kepada pesakit peduli.
Petunjuk ini dipantau 6 bulan bagi memastikan standard dikekalkan.
4.14.7 Ulasan Organisasi Luar

a. Setiap Disiplin dalam Patologi menyertai skim penilaian kualiti luaran

yang diluluskan yang sesuai untuk peperiksaan dan tafsiran disediakan.
b. Makmal ini telah mengambil bahagian dalam program-program
akreditasi seperti MS ISO9001: 2008 dan MS ISO15189: 2014

c. Rekod-rekod prestasi dalam skim ini adalah terpakai, disemak dan

disampaikan kepada kakitangan dengan disiplin individu. Di mana
keputusan yang diambil oleh disiplin berhubung dengan prestasi mereka,
ini direkodkan, dipantau dan diambil tindakan.
d. Dalam keadaan di mana luar skim penilaian kualiti yang sesuai tidak
wujud dan tiada lain program perbandingan antara makmal rasmi boleh
didapati, disiplin membangunkan satu mekanisme untuk menentukan
penerimaan prosedur ini yang tidak dinilai sebaliknya luaran.

4.14.5 Risk Management

a. Risk assessments are performed on all activities and procedures

performed in the department.
b. Risk assessments are undertaken and necessary actions are taken
to establish safe and proper working practice
c. The risk assessments are updated when instrumentation or methodology is
changed
 SECTION 4: Doc. No.:PRK-PKD MJG-PAT-QM
DAERAH MANJUNG Management
Requirements Version No.:01 Amendment No:00

UNIT PATOLOGI Date of issue: 16th August 2016

4.14 Evaluation and Audits Page 4 of 4

4.14.6 Quality Indicators

The laboratory has implemented key performance indicators to monitor
the key results areas in the provision of effective pathology service and
compliance to the quality policy (“to provide reliable and timely results to
our customers through continual improvement of the services”) and
contribute effectively to patient care.
These indicators are monitored 6 monthly to ensure the standard is maintained.
4.14.7 Reviews by External Organisations

a. Each Discipline within Pathology participate in approved external quality

assessment schemes appropriate to the examinations and interpretations
provided.
b. The laboratory participated in accreditation programmes such as MS
ISO9001:2008 and MS ISO15189:2014

c. Records of performance in these schemes are maintained, reviewed and

communicated to staff by the individual disciplines. Where decisions are
taken by disciplines in relation to their performance, these are recorded,
monitored and acted upon.
d. In instances where an appropriate external quality assessment scheme
does not exist and no other formal inter-laboratory comparison
programme is available, disciplines develop a mechanism for determining
the acceptability of these procedures which are not otherwise externally
evaluated.

ASSOCIATED DOCUMENT:

Audit Kualiti Dalaman MKA Ipoh