ACCREDITATION OF LABORATORY COMPLYING GLOBAL STANDARDS FOR TESTING PRODUCTS OF LIVESTOCK ORIGIN

ACCREDITATION OF LABORATORY COMPLYING GLOBAL STANDARDS FOR TESTING PRODUCTS OF LIVESTOCK ORIGIN

Laboratory accreditation is a formal recognition earned by organizations proving they are qualified, competent, and comply with international standards. Laboratories of all kinds can become accredited. In the accreditation world, each of these organizations is referred to as a conformity assessment body, or a CAB.

Why is Laboratory Accreditation Important?

Laboratory accreditation serves many purposes. First and foremost, it shows that an organization and its personnel are qualified and competent. It also inspires confidence in test results and assures customers of a product or service’s quality, strengthening an organization’s credibility. For example, accredited cannabis testing labs test product for potentially harmful substances like pesticides, heavy metals, and mycotoxins. Because the lab is accredited, the end user will be confident that the product is safe and high quality.

Another reason accreditation is so important is that it allows organizations from all over the world to more easily sell their products and services in other countries. International standards equate to international acceptance of test data. Organizations will not spend time and money on inspections and approvals in each country in which they sell. With global standards, products and services are justly accepted all over the world, regardless of industry or country of origin.

NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES (NABL)

NABL is a member of Asia Pacific Laboratory Accreditation Cooperation (APLAC) and International Laboratory Accreditation Cooperation (ILAC).

A laboratory that wishes to be recognized under the LRS must be accredited to the Laboratory Quality Management System, as per IS/ISO/IEC 17025 in the respective field of testing, such as Mechanical, Electrical, Chemical, and Microbiological, as applicable. The laboratory’s accrediting body must be a full member of the International Laboratory Accreditation Cooperation (ILAC), or Asia Pacific Accreditation Co-operation (APAC), or any other regional accreditation cooperation organization.

All the test parameters of the Indian Standard(s) for which recognition is sought shall be covered under the scope of accreditation as per IS/ISO/IEC 17025.

Only Indian Standards that are covered/proposed to be covered by conformity assessment systems will be considered for recognition. Even if the Indian Standard is not covered under any BIS certification program but is covered by the applicant lab’s NABL scope, recognition can be granted.

BIS LABORATORY RECOGNITION SCHEME

The Bureau of Indian Standards (BIS) is the country’s National Standards Body, responsible for developing, monitoring, and assessing Indian standards. To protect consumers’ interests, BIS runs several Conformity Assessment Schemes for producers and service providers of goods and services.

Under the Product Certification Scheme, the BIS grants a license to manufacturers to use the standard mark, also known as the ISI mark, on their products if they comply with Indian Standards.

Under the compulsory registration scheme, BIS grants a license to a manufacturer to use a standard mark with a unique registration number through registration based on self-declaration of conformity whose products conform to relevant Indian Standards as assessed through testing at BIS recognized laboratories.

Testing of items is essential for quality evaluation against the applicable Standard; therefore, the need for a testing facility arises. BIS has a laboratory network of eight laboratories to evaluate samples generated from its conformity assessment schemes.

OBJECTIVE OF LABORATORY RECOGNITION SCHEME

The development of testing facilities for each product covered under BIS conformity assessment schemes is neither physically possible nor economically viable for BIS laboratories. Laboratory Recognition Scheme (LRS) has been formulated to meet the needs of the BIS Conformity Assessment Scheme, to have a sufficient number of outside laboratories in India and overseas, in addition to BIS labs.

Recognition is granted to such laboratories which meet the criteria for recognition and which are able to demonstrate the availability of infrastructure, test facility, and manpower required for testing of products covered or proposed to be covered under Conformity Assessment Schemes of BIS and payment of fees as prescribed by BIS.

WHAT IS LABORATORY RECOGNITION SCHEME?

Laboratory Recognition Scheme is a scheme under BIS to recognize any laboratory in India or outside India for carrying out testing of samples concerning conformity assessment and such other functions as the Bureau may assign to it.

LRS (Laboratory Recognition Scheme) is operated by BIS, which is controlled by Section 13 (4) of the BIS Act 2016 and Rule 32 of the BIS Rules, 2018.

Under this provision, the BIS has the authority to recognize any laboratory in India or abroad to conduct sample testing concerning product conformity assessment and other functions that the BIS may assign to it.

SCOPE OF BIS LRS

The Rules also provide guidelines for suspension, withdrawal, renewal, and revocation of accredited laboratories. The Bureau of Indian Standards keeps a record of all recognized laboratories that test samples of items or processes against applicable Indian Standards.

Laboratory Recognition Scheme lays down the criteria, terms, and conditions of grant and operation of recognition, revocation or renewal of recognition, suspension or withdrawal of recognition, instructions for testing and issuing test reports, appeals, complaint handling mechanism, administrative and charges relating to the recognition of outside labs.

WHAT IS THE CRITERIA FOR RECOGNITION OF LABORATORY?

The laboratory that wishes to be recognized under LRS must meet the following requirements:

1. Accreditation – The laboratory seeking recognition must be accredited to Laboratory Quality Management System AS PER IS/ISO/IEC 17025. The accreditation body must be a full member of ILAC and/or Asia Pacific Accreditation Co-operation.
2. Indian Standards for recognition – Recognition shall be considered only for Indian Standards, which are covered under the conformity assessment schemes of BIS or related standards, for all the requirements/ parameters/ tests in the standard.
3. Subcontracting – Subcontracting of tests is strictly prohibited. Subcontracting may be agreed upon if existing test equipment fails and only for samples that are already being tested.
4. Testing facility – All testing-related activities must take place in the same premises as the laboratory.
5. Impartiality – Laboratory operations must be organized and regulated to maintain neutrality.

RECOGNITION OF FOREIGN LABORATORIES

Criteria for recognition of Foreign Laboratories shall be the same as that for Indian Laboratories with the additional requirement as given below:

1. The auditee laboratory shall bear the auditors’ travel and lodging expenses as per the auditors’ entitlement.
2. For BIS recognition, international laboratories must establish a liaison/branch office in India with the necessary licenses, which must meet all requirements under the BIS act, rules, and regulations.
3. The adoption of all other terms and conditions of this scheme, as well as the decision of the BIS in this regard, will be required for foreign laboratories to be recognized.

WHAT ARE THE DOCUMENTS REQUIRED FOR LRS?

Following documents are required for LRS-

1. Legal Identity of the laboratory
2. Authenticating premises of the laboratory
3. Certificates of accreditation for IS/ISO/IEC 17025
4. List of Indian Standards
5. Organization chart of the laboratory
6. List of Technical & Managerial personnel of the laboratory in details
7. Layout Plan of the Laboratory

Any other document considered relevant by the laboratory

WHAT IS THE PROCESS FOR LABORATORY RECOGNITION?

The following process is involved in laboratory recognition:

1. Documentation and meeting recognition criteria – Applicant needs to ensure that laboratory must fulfill recognition criteria. Any laboratory fulfilling the laboratory recognition criteria may apply for recognition.
2. Submission of Application – Any laboratory fulfilling the laboratory recognition criteria may apply for recognition along with the requisite documents and fees.
3. Receipt of Application – BIS will check the completeness of the application provided by the laboratory.
4. Recording of Application – If the application is found complete in terms of documentation and fee submission, and accepted for further processing. The application would be recorded and an ‘Application Number’ also called a unique serial number assigned to each application.
5. Evaluation of Documents – After the recording of the application, BIS will evaluate the document submitted by the laboratory.
6. Initial audit – On the satisfactory evaluation of documents after the recording of the application, an initial audit of the laboratory shall be conducted for on-site assessment of the laboratory’s compliance.
7. Decisions for Recognition – The application for recognition will be completed based on the audit findings, the closure of all non-conformities discovered if any, and confirmation on record that the criteria for recognition are met and the laboratory has agreed to follow the scheme’s terms & conditions.
8. Grant of recognition – Based on the audit, the application shall be processed for grant of recognition.

TESTING CHARGES:

1. The testing charges for recognized laboratories shall be declared and fixed at the time of their recognition/renewal for three years.
2. The laboratory must adhere to BIS policies on testing charges, as revised from time to time.
3. There shall be no upward revision in the testing charges during three years.

Compiled  & Shared by- Team, LITD (Livestock Institute of Training & Development)

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