ISO/IEC 17025 accreditation in India

ISO 17025 accreditation in India at a glance

Laboratory accreditation in India rests with NABL, the National Accreditation Board for Testing and Calibration Laboratories, which accredits testing and calibration laboratories to ISO/IEC 17025 and is a signatory to the ILAC and APAC mutual recognition arrangements, so its accredited results travel. It is accreditation, not certification: NABL's assessors examine technical competence test by test, including method validation, measurement uncertainty, traceability and proficiency testing, as well as the management system. Regulators lean on it in different ways; CDSCO's medical device FAQ, for example, expects testing laboratories to conform to a laboratory quality management system. For a manufacturer's in-house laboratory or an independent testing house, the work is defining a scope NABL can assess and building the technical records behind every test in it. Sterling's Navi Mumbai office prepares the laboratory for NABL assessment and supports corrective actions afterwards, with Effivity and Sterling Academy included; NABL alone grants accreditation. The questions laboratories ask follow.

Who needs ISO 17025 in India, and what happens without it

In India the question rarely comes from a law. It comes from the buyer, the regulator or the partner that wants proof before it signs. These are the organisations that get asked.

• Testing and calibration laboratoriesNABL accredits testing and calibration laboratories to ISO/IEC 17025.
• Medical device testing laboratoriesCDSCO's FAQ requires testing labs to conform to a laboratory quality management system.
• Manufacturers' in-house laboratoriesCustomers and regulators accept results more readily from accredited labs.

ISO 17025 requirements in India

Strip away the vocabulary and ISO/IEC 17025 requires a laboratory to prove six things about its competence and the results it reports.

In India these six sit alongside the local laws and regulations listed under drivers below; one system can evidence both. The detail is on the global hub: ISO/IEC 17025 explained →

• ISO 17025 requirements, clause by clause in plain language
• The documents ISO 17025 expects
• ISO 17025 checklist

How to get ISO 17025 accreditation in India

One team from the Mumbai office carries the work from scoping to accreditation. Across India from the Navi Mumbai office: on-site in Mumbai and the Mumbai Metropolitan Region, on-site or remote for other states; remote delivery for distributed teams.

1. Discovery call and scopeEntities, locations, regulators and target date, agreed before any proposal.
2. Gap assessment against ISO/IEC 17025 and the Indian requirements that apply to youControls you already run for your regulators and customers are reused, not rebuilt.
3. Your system built with your team in EffivityRisks, controls, evidence, incidents and reviews in one live system the auditor can see.
4. Internal audit, management review and corrective actionsYour internal auditors trained by Sterling; the evidence proven before any external review.
5. The accreditation body assessmentThe accreditation body assesses and decides. Sterling supports the assessment.

The Sterling Promise: 100% on-time completion, 100% success, 8,100+ client engagements.Sterling does not certify. Certification decisions stay with independent bodies.

• ISO 17025 gap analysis
• ISO 17025 implementation plan
• ISO 17025 internal audit

How long does ISO 17025 accreditation take in India?

There is no standard duration: it depends on your scope and on how much of the system already runs. In India these are the factors that set the timeline.

• Scope of tests or calibrations to be accredited
• Method validation and measurement uncertainty evidence
• Proficiency testing results available
• NABL assessment scheduling

Sterling agrees a dated plan with you on the discovery call, once the scope is known.

• What drives the ISO 17025 timeline
• Scope and timeline estimator

How much does ISO 17025 accreditation cost in India?

The cost has two parts: the consulting work to build and prove the system, and the accreditation body’s fees, which are quoted separately. In India these factors move both.

• Number of tests, disciplines and sites in scope
• NABL fees quoted separately from consulting
• Equipment calibration and reference standards
• Proficiency testing participation

Sterling gives one customised, all-inclusive proposal after the discovery call, never before the scope is agreed.

• What makes up the cost of ISO 17025

ISO 17025 consultants and assessors in India

Two different organisations are involved. A consultant helps you build the system and prove it works; the accreditation body then audits or assesses it and decides. Keeping the two separate is what makes the result credible to buyers and regulators.

• Check that the body’s accreditation or approval covers ISO 17025 and your sector, and that its certificates can be verified online.
• Ask the consultant how the local requirements in India are mapped into the same system, so nothing runs twice.
• Ask for client references in your sector; Sterling’s client letters are available on request.
• Agree who owns the evidence and the tool after the engagement; with Sterling the system stays yours, in Effivity.

ISO 17025 in India: questions clients ask

More on ISO 17025 for Indian organisations

• ISO/IEC 17025: the complete guide
• Watch: How to implement ISO/IEC 17025
• Calibration laboratories: ISO/IEC 17025 for the sector
• Chemical and microbiological testing: ISO/IEC 17025 for the sector
• Construction materials testing: ISO/IEC 17025 for the sector
• Environmental laboratories: ISO/IEC 17025 for the sector
• Food and agriculture: ISO/IEC 17025 for the sector
• Government and forensic laboratories: ISO/IEC 17025 for the sector
• In-house manufacturing laboratories: ISO/IEC 17025 for the sector
• Sterling in Mumbai
• ISO 17025 accreditation in India and every other standard Sterling delivers there

Other standards Indian businesses ask Sterling for

Organisations in India often combine ISO/IEC 17025 with one of these, under one management system where the scopes allow.

All 23 standards Sterling delivers in India →