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Apart from product certification, BIS is responsible for framing Indian Standards, conducting laboratory testing, and ensuring consumer protection.

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Some items must be certified before they get released mysteriously made for select goods like cables, switches, cement, gas cylinders, etc.

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Hallmarking Certification is mandatory in India for gold and silver jewellery.The BIS 916 Hallmark confirms 22K gold purity.Silver Hallmarking is compulsory for certain grades like BIS 925.

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FMCS Mark Certification is a BIS-led approval process that enables foreign manufacturers to sell regulated products in the Indian market.

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It helps manufacturers build trust and create a compliance framework. It also markets to eco-conscious consumers.This guide will detail eligibility, provide information on the application procedure, and outline benefits of certification to ISO 14024.

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It is governed by NABL under the Quality Council of India (QCI).Accreditation enhances trust among regulators, industries, and global partners.

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The World Manufacturer Identity (WMI) is a globally recognized code used to identify vehicle manufacturers. WMI registration ensures traceability, compliance, and global brand recognition for automotive makers.

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Stay ahead of regulatory changes with BIS Scheme X Certification. Now extended to September 1, 2026, under the omnibus technical regulation order 2024. Get complete certification support from Diligence Certification.

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Laboratory Accreditation – Compliance, Standards, and Trust

  • The laboratory-accreditation-scheme ensures technical competence and quality assurance in Indian labs.
  • It is governed by NABL under the Quality Council of India (QCI).
  • Accreditation enhances trust among regulators, industries, and global partners.
  • The scheme is mandatory for several sectors including pharma, food, and electronics.

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Introduction

What is the Laboratory Accreditation Scheme?

overview

Objective of the BIS Laboratory Recognition Scheme

Which Labs Require Accreditation?

Eligibility Criteria for BIS LAB Recognition Scheme

What are the Documents Required for the Laboratory Recognition Scheme

Process For Laboratory Accrediation Scheme

Testing Charges

The Procedure for Foreign Laboratories to Recieve Recognition under the BIS Lab Recognition Scheme

Real World use cases

why choose Diligence Certification for the Laboratory Accrediation Scheme ?

Introduction

In 2021, a pharmaceutical testing laboratory in Hyderabad lost a ₹5 crore international contract. The reason? Lack of proper laboratory accreditation. The client demanded NABL accreditation, but the lab only had basic ISO certification. This story is not uncommon in India’s diagnostics, pathology, or manufacturing support labs.

Today, global clients, Indian regulators, and procurement authorities trust only NABL-accredited labs under the laboratory-accreditation-scheme governed by QCI. Accreditation is no longer a choice—it is a commercial necessity.

What is the Laboratory Accreditation Scheme?

The laboratory-accreditation-scheme is a national-level recognition program governed by the National Accreditation Board for Testing and Calibration Laboratories (NABL) under Quality Council of India (QCI). It evaluates and certifies laboratories for their technical competence, infrastructure, personnel training, equipment quality, and process reliability.

Simply put, it assures that a lab is technically capable of producing accurate and trustworthy results.


“Accreditation transforms a testing facility into a certified centre of competence, aligned with Indian and global quality expectations.”

What is Laboratory Accreditation?

Laboratory accreditation is the most important process to ascertain reliable and competent results from relevant laboratories. Laboratory accreditation means formal recognition that a laboratory is competent to perform specific tests or calibrations and conforms to the international standards and criteria set down by the relevant accreditation bodies. 

Immeasurable would be the importance of laboratory certification in sustaining confidence in a laboratory’s performance.

Laboratory Accreditation (BIS Certification)

Objective of the BIS Laboratory Recognition Scheme

In a world where quality assurance and regulation become more crucial, programs such as the BIS LAB Recognition Scheme are really needed to build confidence in goods and services.

The program, which is run by India’s national standards organization, the Bureau of Indian Standards (BIS), attempts to improve the standards and reliability of testing and calibration labs worldwide.

Enhancing the legality and competence of testing and calibration labs operating in India is the fundamental goal of the BIS LAB Recognition Scheme.

This is accomplished by giving these labs a legal structure to show that they follow globally accepted standards, especially ISO/IEC 17025, “General Requirements for the Competence of Testing and Calibration Laboratories.”

Which Labs Require Accreditation?

The following types of laboratories must or should obtain accreditation under the scheme:

  • Testing Laboratories (Food, Pharma, Chemicals, Electronics)

  • Calibration Laboratories (Weighing, Electrical, Mechanical)

  • Medical Laboratories (Pathology, Diagnostics, RT-PCR)

  • Proficiency Testing Providers

  • Reference Material Producers

Even government labs like those under BIS or FSSAI need NABL accreditation to prove independence and technical accuracy.

Eligibility criteria for BIS LAB Recognition Scheme.

A laboratory needs to show its architectural accessibility, testing abilities, and workforce—all of which must be sufficient in accordance with the product testing that must be done under Conformity Assessment Schemes—as well as pay the necessary fee set by the BIS in order to be recognized under the BIS LRS.

The following conditions must be satisfied by the laboratory applying for BIS Lab recognition:

  1. Accreditation: Accreditation must be obtained for the lab by a body that is a full member of ILAC or APAC and adheres to ISO/IEC 17025.
  2. To be recognized per the Indian standards: Indian laboratories must go through a difficult process to be recognized by the Bureau of Indian Standards (BIS) to perform tests under Set Indian Standards. This certification is essential for proving expertise and ensuring the accuracy of the test results. Although the BIS Conformity Assessment Schemes describe the accreditation process, a successful application depends on knowing the details of test exemptions and the key impartiality criteria.
  3. Recognition of Approved Test Exemptions: When certain tests are impossible or challenging for a laboratory to conduct, BIS allows limited exemptions on an individual basis. BIS examines each case on its benefits, taking into account elements including the test’s nature, the availability of suitable alternatives, and its potential effect on the product’s overall evaluation.

What are the Documents Required for the Laboratory Recognition Scheme?

The list may be complex, so it will be easier to navigate if you know why every document is there.

Below is a breakdown of the main categories:

  • Certificate of Incorporation (for companies)
  • Partnership Deed (for partnership firms)
  • Registration Certificate (for sole proprietorships)
  • Memorandum of Association (MOA) and Articles of Association (AOA) (for companies): These documents outline the company’s objectives, rules, and regulations.
  • PAN Card: Both the organization’s and the key personnel’s PAN cards are essential.
  • GST Registration Certificate: Demonstrates compliance with Goods and Services Tax regulations.
  • Legal Identity Proof of Authorized Signatory: Aadhar Card, Passport, or other government-issued ID.
  • Legal Identity of the Laboratory
  • Authentication of laboratory premises
  • Certificates of accreditation for IS/ISO/IEC 17025
  • List of Indian Standards
  • Organization chart of the laboratory
  • Detailed list of technical and managerial personnel
  • Layout plan of the laboratory

Process for Laboratory Accreditation Scheme

  1. Meeting Recognition Criteria: Recognition criteria must be reviewed and satisfied in detail by laboratories before proceeding with the application process since it sets the foundation for any successful application. These criteria usually touch upon many aspects of the laboratory’s functioning, namely: 
  • Quality Management System: A strong and documented system in line with applicable international standards such as ISO/IEC 17025. 
  • Technical Competence: Acrobat expertise in testing or calibration for which recognition is concerned. 
  • Infrastructure and Resources: Sufficient facilities, equipment, and competent personnel to conduct necessary tests or calibrations. 
  • Traceability and Measurement Uncertainty: Validated methods are used to ensure traceability of measurements and quantify measurement uncertainty. 
  1. Submission of Application – Gathering the Required Documents

Once a laboratory is convinced that compliance with the recognition criteria has been met, the next step is the preparation and submission of a complete application package. The package usually involves:

  • a completed application form, accurately filled and signed, providing all the necessary information of the laboratory. 
  • documented quality manual – an exhaustive document outlining the quality management system of the laboratory. 
  • supporting documents – evidence demonstrating compliance with the recognition criteria (e.g., calibration certificates, proficiency testing results, personnel qualifications). 
  • required fees: payment of application fees as specified by BIS.
  1. Verification of Application

BIS will first check whether the application is complete upon receipt. Once all documents and information are found to be in order, the application will be presented to the BIS for formal entry into the system. At this point, a unique application number is allotted to the file, which will serve as a reference for all future communication and follow-ups.

  1. Evaluation of Documents 

The expert panel will evaluate the documents at BIS to certify the laboratory’s compliance with the recognition criteria. Evaluation includes examination of the quality manual, supporting documents, and other relevant materials. The laboratory will be informed of any discrepancies or issues needing clarification for further explanation or corrective action.

  1. BIS Audit 

If the evaluation of documents is found satisfactory, an initial audit will be arranged by BIS on the facilities of the laboratory. The on-site assessment permits auditors to check with regard to the actual implementation of the quality management system, observe testing or calibration procedures as well as to meet laboratory personnel. It seeks to verify that the operations of the laboratory are by the submitted documents and recognition criteria.

   6. Grant of Recognition 

Once the laboratory meets all the criteria for recognition and addresses any nonconformities, the application will proceed for recognition. The laboratory receives official certification of its accredited status, which specifies the scope of recognition about some specific tests or calibrations.

Testing charges

  • The BIS policies on testing fees, as revised periodically, must be implemented by the laboratory.
  • Over three years, the testing fees cannot be raised. 
  • Whenever a laboratory is recognized or renewed for three years, the testing fees will be announced and set.

The procedure for foreign laboratories to receive recognition under the Lab Recognition Scheme.

Certain additional terms and conditions must be finalized for foreign laboratories participating in the Indian Lab Recognition Process.

  • A liaison office must be established in compliance with applicable Indian laws. 
  • The laboratory will be responsible for covering travel and accommodation expenses as well as per diem for incurred travel costs. 
  • The test certification issued must be accredited in line with the most recent updated version of ISO/IEC 17025.
  •  Recognition will be granted only after a legal agreement has been signed and all terms and conditions have been agreed upon by both the Foreign Laboratory and BIS.
  •  Any complaints received by any means will be promptly investigated. In instances where the BIS Schemes, Acts, Rules, or Regulations do not address a specific issue, BIS holds ultimate authority over the matter.

Why choose Diligence certification for Laboratory Accreditation Scheme ?

Diligence Certification is a trusted provider of Laboratory Accreditation scheme, a brand in India that promotes environmentally friendly products.

There are several advantages to choosing Diligence Certification for your Eco Mark certification, such as:

  1. Expertise and Experience: Diligence Certification has an expert team with years of experience that are experienced in the Laboratory Accreditation scheme process. 
  2. Simplified Procedure: By simplifying the Laboratory Accreditation scheme process, Diligence Certification reduces both costs and time.
  3. Reliability: Being a recognized certifying management, Diligence Certification’s certification procedure is transparent, impartial, and compliant with worldwide regulations.
  4. Continuous Support: To guide companies in maintaining their certification and continuously improving their Goodwill they offer ongoing guidance and support.

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Frequently Asked Questions

Laboratory accreditation is a third-party independent recognition of a laboratory's capability to carry out specific tests or calibrations. It shows that the laboratory operates a quality management system, validated testing methods, and provisions for accurate, precise, and general results, hence people are usually inclined to trust laboratory services.

Laboratory accreditation had various benefits. 

  • Greater Credibility: Customers, regulatory bodies, and other stakeholders see accredited laboratories as credible.
  • Improved Quality: The qualification makes sure testing and calibration results are relevant and reliable through enforceable quality systems.
  • Reduced Errors: A quality system reduces the number of errors and increases the efficiency of lab operations. 
  • Client Trust: Clients know that the laboratory is competent and can be trusted to generate results that are credible. 
  • Competitive advantage: The edge over the competition can act as an attractive market determinant that brings customers to your lab.

A vast number of industries, among them, include: 

  • Healthcare (medical laboratories)
  • Environmental Analysis
  • Food Safety
  • Pharmaceuticals
  • Testing of Construction Materials
  • Calibration Services 
  • Manufacturing 
  • Forensic Science

Accreditation is meaningfully scope dependent. Accordingly, it applies to a given test, calibration, or type of analysis. Some well-known types of accreditation schemes are as follows: 

  • ISO/IEC 17025 Accreditation: for Testing and Calibration Laboratories - It's known worldwide as the primary standard concerning laboratory competency. 
  • ISO 15189: for Medical Laboratories - Quality and competence concern only medical laboratories. 
  • Certain Industry-recognized Accreditations: This follows a number of industries' schemes of their respective accreditation like environmental monitoring and food testing.

An international standard ISO/IEC 17025 provides the competence for testing laboratories and calibration laboratories. General requirements for the competence of such laboratories as applies to testing or calibration, including sampling, are splendid be. Requirements are as follows: 

  • Management System: Establish a common quality management system. 
  • Technical Requirements: Skills of personnel, efficiency in the use of equipment; validation of methods; handling of samples; and results reporting. 
  • Independence: The laboratory is to be objective and impartial. 
  • Confidentiality: Protection of the confidence that private information provides. 
  • Resources Requirements: Adequate resources; human resource management, physical facilities, equipments, consumables. 
  • Process Requirements: Ranges from receipt of work to the issuing of reports. 
  • Management System Requirements: Alternatives to installing and sustaining a management system against ISO 9001. 

These are both standards with regard to the management of quality, though with differing perspectives. 

  • ISO 9001: Most of the time is more concerned with the management of an organization in terms of quality so as to ensure that products/services are consistently meeting requirements of customer and thereby achieve customer satisfaction. 
  • ISO/IEC 17025: This deals with the technical competence and quality management system needs of laboratories performing tests and/or calibrations. In this case, compliance with ISO/IEC 17025 also includes addressing the technical requirements for lab operations.

The general process for the accreditation includes these basic steps: 

  • Choosing the Right Accreditation Body: An appropriate body should be added as an accredit institution, that is by the scope of testing/calibration. Understanding of Accreditation Standards: It is very important to know the requirements of the respective standard (ISO/IEC 17025). 
  • Gap Analysis: This intends to see what the lab does against the standard requirements and find gaps that need some improvement. 
  • Formation of Quality Management System: Document and implement a quality management system that is compliant with the requirements of the standard-such as written policies, procedures and work instructions. 
  • Internal Audit: Internal audits are required to demonstrate that the QMS is functioning effectively. 
  • Management Review: The management meets regularly to review the QMS and identify any potential improvements. 
  • The Application: An official application is sent to the authority granting accreditation. 
  • Assessment: On-site assessment of the laboratory is done by visiting assessors from the accreditation body. 
  • Corrective Action: Any non-conformities identified by the assessment need to be resolved. 
  • The Accreditation Award: If the accreditation body is satisfied with the laboratory's ability to comply with the requirements, accreditation will be granted.
  • Different timelines apply to different factors: 
  • The complexity of your testing/calibration activities. 
  • Current status of the quality management system in place. 
  • Responsiveness of your team. 
  • Workload of the accreditation body. It requires anything around 6 months up to 18 months for granting generally. 
  • The fees charged by the accreditation body.
  • The breadth of scope of accreditation, i.e. number of tests/calibrations that would be covered.
  • Dimensionality and complexity of your laboratory.
  • Need for consulting or training services. In addition to this, application assessment and continuous upkeep fees have to be put into consideration.