PARTICIPATION of NATIONAL HEALTH LABORATORY IN A PROFICIENCY TESTING SCHEME ACCREDITED TO ISO/IEC 17043

6^th April 2015

1. Introduction

National Health Laboratory (NHL) is a division of Maldives Food and Drug Authority (MFDA) with the main mandate of safety, quality control and hygiene verification of food and pharmaceuticals. NHL is divided into two main sections namely, Chemistry and Microbiology laboratories. The matrices tested   include water, food and swabs and brought from food establishments, factories and resorts etc. and pharmaceuticals.

NHL has been accredited to the international standard ISO/IEC 17025 since December 2008. For the maintenance of its accreditation status it is compulsory to assure quality of tests. To fulfill this obligation of ISO/IEC 17025, NHL intends to participate in a Proficiency Testing (PT) scheme.

Thus this “Terms of Reference” (TOR) has been developed to find a suitable PT provider/ program.

2. Scope and Objectives

The objective of this TOR is to find a competent PT provider/program accredited to the international standard ISO/IEC 17043 for NHL to participate for the assurance of the quality of tests.

The chosen party should provide PT services including but not limited to the following:

1. Send PT samples to NHL
2. Evaluate the test results by comparing the test results with assigned or nominal value or harmonized value obtained with all participating laboratories in the program
3. Provide a report for the score of NHL’s test result

The details of the parameters for which PT are required are included in the list 1 attached. Testing of the PT samples will be carried out at NHL.

3. Requirements / Qualifications

1. The PT providers intending to offer PT services to NHL shall have the following qualifications and requirements.

a)   The PT provider offering the PT services must be accredited to the standard ISO/IEC 17043.

b)   The program shall cover all the tests in the list 1 attached and in the given ranges.

c)   Submission of test results should be available via electronic method or electronic correspondence.

d)   Time for the submission of results should allow sufficient time for transport of the sample/ material, processing and testing. The time taken for processing and testing for different parameters are included in the list 1.

e)   A schedule of the PT program for a year should be available prior to the start of the year’s program.

f)    Provision of transport/courier services for the sample materials to NHL.

g)   Reports of evaluation of the test results shall be available via electronic media.

h)   Statistical method used for the evaluation of each test result must be sent along with the reports of evaluation of test results.

i)    The PT provider must have at least 3 years’ experience of providing to PT and must be currently engaged in the service.

j)    The PT program must have at least 5 laboratories participating in its program.  

k)   Full charges for one year program should be stated in advance.

1. 10. Submission of applications

                  i.  Interested qualified parties should submit a quotation for charges of PT services inclusive of :

a.  Prices of the PT pack for the tests in US Dollars

b.  Charges for courier/delivering the PT materials (for each test or pack of test ) for each round of the test parameter to the following address:

National Health Laboratory,

Maldives Food and Drug Authority

Ministry of Health

Roashanee Building, Sosun Magu,

Male’ 20184

Republic of Maldives

c. Time allowed for postage and testing.

d. Any other charges that might incur

                 ii.  In addition to the quotation interested parties should submit:

a)  A copy of the accreditation certificate to ISO 17043.

b)  Schedule of the PT program

c)  Criteria used to evaluate and decide acceptable test results

d)  Brief profile

e)  List of clients/ laboratories which had participated in the past 3 years.

f)  Details of ways to submit test results and sending reports of evaluation of test results

g)  Payment conditions

h)  Any other terms and conditions subject to the process

i)   Contact details

2. Duration: All required test rounds to be covered within a year of start date.
3. Contact:  Thooma Adam/ Maldives Food and Drug Authority
4. Deadline for submission:

Interested parties are to submit signed quotations and other required documents on or before the 14^th May 2015 to

Maldives Food and Drug Authority, Ministry of Health,

Roashanee Building,

Sosun Magu,

Male’ 20184

Republic of Maldives.

Electronic versions of the quotations and documents can be emailed to [email protected] before the above due date. Late submissions cannot be considered under any circumstances.