KAN-TN-LP 02 Issue Number : 3
April 2016
Dokumen ini tidak dikendalikan jika diunduh Uncontrolled when downloaded
1
SPECIFIC REQUIREMENT FOR ACCREDITATION OF MICROBIOLOGY TESTING
1. INTRODUCTION
a. This Specific requirements are an interpretation of the general requirements of ISOIEC 17025-2005.
b. This accreditation requirements are applicable to field of testing microbiology, testing technical, type of test, and or specific test in microbiology area, as extra
information to the already generally stated requirements in each of the clauses ISOIEC 17025-2005.
c. Microbiological testing is taken to include sterility testing, detection, isolation, enumeration and identification of micro-organisms including viruses, bacteria,
fungi and protozoa and their metabolites in different materials and products, or any kind of assay using micro-organisms as part of a detection system as well as the
use of micro-organisms for ecological testing. d. This document can also provide guidance to laboratories using techniques in
areas related to microbiology, such as biochemistry, molecular biology and cell culture laboratories.
2. PERSONNEL
a. The Laboratory analyst has been working in relevant test areas of a microbiology laboratory for at least two years.
b. Technical Manager, Laboratory Supervisors and Laboratory analysis shall possess a basic education in biological analysis vocation or a related science.
c. The laboratory shall be directed by persons having executive responsibility
competence to assume responsibility for the services of microbiology testing.
KAN-TN-LP 02 Issue Number : 3
April 2016
Dokumen ini tidak dikendalikan jika diunduh Uncontrolled when downloaded
2 d.
Laboratory management shall ensure that : i.
Appropriate numbers of laboratory personnel, with the required education training, to meet the demands of the service to customers.
ii. Laboratory personnel have the knowledge, skills, and abilities based on
education, experience, demonstrated skills, and training. To perform their duties.
iii. Laboratory personnel had trained in handling pathogenic agents. iv. Full educational and professional records of all technical staffs available to
confirm their competence in microbiology testing. e.
Laboratory shall establish and define an internal training program and ensure the competency of laboratory personnel.
f. Laboratory shall have training procedure that used to ensure that training has
taken place with each employee for procedures and methods that the employee performs. The procedure applies to on-the-job training, in-house training and new-
hire training. g.
The training procedure is applicable to new employees, for the introduction of new procedures and methods, for retraining of employees, and for re-verification of
employee performance. h.
The laboratory shall maintain an up-to-date record of the training that each member of staff has received.
3. ACCOMMODATION AND ENVIRONMENTAL CONDITIONS
