What is laboratory accreditation?

Laboratory accreditation is a third-party assessment of a calibration or testing laboratory by the Laboratory Accreditation Body, to evaluate the laboratory’s compliance to the requirements of ISO/IEC 17025 and any additional, applicable accreditation policies.

A.2 Why a testing laboratory should be accredited?

Testing laboratory involves multistep processes that are susceptible to multiple sources of error. These errors can lead to significant result variability and decreased accuracy, which in turn can potentially lead to incorrect diagnosis and inappropriate treatment. Production of quality data on which decisions are based on good laboratory practice (GLP), guidelines and other international conventions. High quality laboratory results are also required to protect consumers’ health and safety.

Laboratory accreditation is a widely accepted process of evaluation of a laboratory’s quality, performance, reliability and efficiency. It is a means to promote and enforce better quality in testing laboratory and to ultimately reduce testing errors. Accreditation also increases the credibility of results and services delivered by a laboratory through providing recognition that it is compliant with quality and competence standards considered necessary for accurate, reliable and safe testing. The value of accreditation lies in promoting the delivery of reliable results to the customers.

A.3 How does laboratory accreditation facilitate trade?

1. As governments increase technical barriers to trade in an effort to regulate their markets, accreditation provides assurance to trading partners that an exporting country is competent to test, inspect or certify to the trading partners’ requirements, thus overcoming trade barriers by assuring compliance with the WTO/TBT Agreement.

2. Accreditation of laboratories ensures that test results can be reproduced to a sufficient degree in any accredited laboratory. It is an independent method of monitoring laboratory competence and performance. It assures the validity of results to users. An accredited laboratory can establish Mutual Recognition Agreements (MRAs) with counterpart bodies. These agreements ensure equivalency of systems in different countries. There is automatic acceptance of test results from accredited laboratories, which are parties to a given MRA. Costs are reduced because there is no need for duplicate testing by both exporters and importers and this serves to eliminate technical trade barriers and facilitate trade.

3. Using accredited laboratories also facilitates economic growth. The accrediting process relies on a uniform approach to determining laboratory competence – an approach that has been accepted and implemented across many borders. Because of internationally accepted testing and measurement practices, data generated by an accredited laboratory may lead to the more ready acceptance of exported goods in overseas markets.

A.4 What is RSB doing so far in accreditation

The National Quality Testing Laboratories Division (NQTLD) was first accredited based on ISO 17025 in 2018 with 6 parameters in Microbiology and 6 parameters in chemical testing; and is house to a gradually increasing accredited scope to meet customer expectations.

In February 2020, NQTLD increased its accredited scope to 20 parameters, 9 parameters in Microbiology and 11parameters in chemical testing. Specific accredited parameters are accessible at www.rsb.gov.rw
 

A.5 Laboratory designation

Based on the East Africa Community Standardization, Quality Assurance, Metrology and Testing (SQMT) act 2006, Article 12, which requires Partner States to establish or designate an organization to function as Testing Laboratories to provide scientific and technical services to perform conformity assessment services for technical regulation or compulsory standards. The designation is conducted based on the EAC procedure for designation of Testing laboratories based on ISO/IEC 17025 General requirements for competence of testing and calibration laboratories.

The National Quality Testing Laboratories Division (NQTLD) is in charge of the designation practice in Rwanda. The facilitation include:

1. Identification of testing laboratories in different disciplines;

2. Awareness training on the ISO/IEC 17025 as the standard under which the designation is based on;

3. Initial drafting of all Quality management systems required documents;

4. Review of the designation application and developed documents from different laboratories;

5. Assessments and recommendation to the Minister responsible to designated;

6. Follow up and surveillance audit for designated laboratories;

7. Awareness training on review and changes in current version of ISO/IEC17027:2017;

A.6 Why should a laboratory seek designation?

1. Regional recognition,

2. Improved service performance (e.g. Tracking of testing /calibration records),

3. Improved productivity and cost reduction,

4. Improved confidence between customer and service provider,

5. Provides protection against liability claims,

6. Customer satisfaction,

7. Improved national and regional reputation and image of the laboratory,

8. Prepares the laboratory accreditation readiness.

A.7 Benefits of Laboratory designation to the laboratory owner and customers

1. A system to continuously improve both the management and technical aspects of the business Improved customer service and higher customer satisfaction with laboratory testing;

2. Laboratory designation gives assurance to the client that the data they rely on was generated in a competent laboratory;

3. A competitive support over competitors who are not designated in a regional accepted quality system;

4. Clearly the general public benefits from laboratory designation as well.  Consumers want assurances that the products and services they purchase meet their expectations and conform to specific requirements. Reliable test data means consumer goods of consistent quality that conform to applicable standards.

5. Laboratory designation process is cheaper than accreditation process but prepares the laboratory for accreditation when deemed necessary.

A.8 Designated laboratories in Rwanda

The designation scheme was initiated in 2015, and the first 11 laboratories were designated in 2018. Since 2018, the number of laboratories seeking designation services has been increasing and those are from different parts of the country.

Laboratory designation may cover the entire scope of laboratory or a part of the testing scope that is why the designation scope is defined at the time of designation.

List of designated laboratories in different fields is accessible at RSB website www.rsb.gov.rw.

A.6 Inter-laboratory comparison and proficiency testing (PT)