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Laboratory Certification
Criteria For Assessment
Effective date of implementation: January 01, 2005
The Laboratory Certification
Programme of the Guyana National Bureau of Standards (GNBS) is recognising
laboratories as either Level I, Level II or Level III based on
the minimum criteria established. Level III will be recognised as Class A,
Level II as Class B and Level I as Class C. The requirements of the GYS
170: 2003 standard, General requirements for the operation of a
laboratory, will determine which level of certification will be granted
to the laboratory.
1. Level I
The laboratory granted a Level I Certification
provides evidence that the laboratory confirms to the basic requirements for
operation.
The laboratory must have policies and procedures for
the following sections in the GYS 170:2003 standard.
| 1.1 |
3 |
Management requirements |
| |
|
|
| |
3.1 |
Quality System |
| |
3.2 |
Organisation |
| |
3.5 |
Purchasing of laboratory services and supplies |
| |
3.12 |
Quality Assurance reviews |
| |
|
|
| 1.2 |
4 |
Basic Safety policies and procedures that are adequate
for the laboratory's operations. (Universal precautions) |
| |
|
|
| 1.3 |
5 |
Technical requirements |
| |
|
|
| |
5.1 |
Personnel |
| |
5.2 |
Accommodation and environmental conditions |
| |
5.3 |
Test methods |
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5.5 |
Equipment |
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5.9 |
Assuring the quality of test results. |
2. Level II
The laboratory granted Level II Certification
provides evidence that the laboratory has a basic laboratory management
system meeting the following requirements of the GYS 170:2003 standard in
addition to the requirements for the Level I Certification.
| 2.1 |
3 |
Management requirements |
| |
|
|
| |
3.1 |
Quality system |
| |
3.2 |
Organisation |
| |
3.3 |
Document Control |
| |
3.5 |
Purchasing of services and supplies |
| |
3.6 |
Review of requests, tenders and contracts |
| |
3.8 |
Control of nonconforming testing |
| |
3.9 |
Corrective action |
| |
3.12 |
Quality assurance reviews |
| |
|
|
| 2.2 |
4 |
Basic Safety policies and procedures that are adequate
for the laboratory's operations. (Universal precautions) |
| |
|
|
| 2.3 |
5 |
Technical requirements |
| |
|
|
| |
5.1 |
Personnel |
| |
5.2 |
Accommodation and environmental conditions |
| |
5.3 |
Test method and method validation |
| |
5.5 |
Equipment |
| |
5.6 |
Measurement traceability |
| |
5.7 |
Sampling |
| |
5.8 |
Handling of test items |
| |
5.9 |
Assuring the quality of test results |
| |
5.10 |
Reporting the result |
Note: The new requirements for Level II
certification are highlighted in bold.
3. Level III Certification
The laboratory granted Level III Certification,
provides evidence that the laboratory has a quality system meeting all the
requirements of the GYS 170:2003 standard, “General requirements
for the operation of a laboratory.
3.1 The Laboratory must have:
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Quality manual and quality system procedures.
-
Technical manuals for tests within the scope of certification.
-
Sample
collection manual.
-
Laboratory
user manual.
-
Test
Information bulletin.
-
A safety
manual with basic safety policy and procedures for the
laboratory
operations.
| 3.2 |
3 |
Management requirements |
| |
|
|
| |
3.1 |
Quality system |
| |
3.2 |
Organisation |
| |
3.3 |
Document Control |
| |
3.4 |
Subcontracting of tests |
| |
3.5 |
Purchasing of services and supplies |
| |
3.6 |
Review of requests, tenders and contracts |
| |
3.7 |
Complaint |
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3.8 |
Control of nonconforming testing |
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3.9 |
Corrective action |
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3.10 |
Preventive action |
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3.11 |
Control of records |
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3.12 |
Quality assurance reviews |
| |
3.13 |
Management reviews |
| |
|
|
| 3.3 |
4 |
Safety |
| |
|
|
| |
|
Basic Safety policies and procedures that are adequate
for the laboratory's operations. (Universal precautions) |
| |
|
|
| 3.4 |
5 |
Technical requirements |
| |
|
|
| |
5.1 |
Personnel |
| |
5.2 |
Accommodation and environmental conditions |
| |
5.3 |
Test method and method validation |
| |
5.4 |
Control of data |
| |
5.5 |
Equipment |
| |
5.6 |
Measurement traceability |
| |
5.7 |
Sampling |
| |
5.8 |
Handling of test items |
| |
5.9 |
Assuring the quality of test results |
| |
5.10 |
Reporting the result |
Note: The new requirements for Level III
certification are highlighted in bold.
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