[Home](/)/[Resources](/resources)/BIS ISI Documentation IndiaFactory Audit Guide # BIS ISI Mark Documentation and Factory Audit Preparation The BIS factory audit is the critical gate between application and license grant. Proper documentation and preparation can mean the difference between a smooth 90-day process and months of delays with re-audits. Copy Link[Share on WhatsApp](https://wa.me/?text=https%3A%2F%2Fkrono-labs.com%2Fguides%2Fbis-isi-documentation) At a glance Pre-audit documents 13 Audit day items 6 Common NCs 7 ## Documents to prepare before the audit 01Application Forms I and II with complete factory details 02Factory layout plan showing production flow and storage areas 03List of manufacturing machinery with specifications and capacity 04Quality manual describing quality policy and objectives 05Organizational chart showing quality reporting structure 06Job descriptions for quality control personnel 07Calibration records for all testing and measuring equipment 08Incoming material inspection procedures and records 09In-process inspection checkpoints and acceptance criteria 10Final product testing procedures and record format 11Non-conforming product handling procedure 12Customer complaint handling procedure 13Internal audit records (if any) ## Audit day checklist ### Management representative available Ensure your management representative who signed the application is present and available throughout the audit. ### Quality personnel present Quality control personnel named in the application should be on-site and able to demonstrate their work. ### Production running Ideally, have production running during the audit so the inspector can observe actual manufacturing processes. ### Testing equipment operational All testing equipment should be in working condition with current calibration certificates visible. ### Records accessible Have inspection records, test reports, and calibration certificates organized and readily accessible. ### Product samples ready Have representative product samples available for the inspector to collect for independent testing. ## Common non-conformities to avoid Missing or expired calibration certificates for testing equipment No documented procedure for handling non-conforming products Production records don't match actual manufacturing processes observed Quality control personnel cannot explain inspection procedures Inadequate segregation of tested and untested products No evidence of incoming material inspection Test equipment accuracy insufficient for standard requirements ## Post-audit steps to license grant 1 ### Address non-conformities promptly If the inspector identifies non-conformities, you typically have 30-60 days to submit evidence of corrective actions. Respond quickly with detailed action plans. 2 ### Submit additional documents if requested BIS may request additional documentation after the audit. Submit these promptly to avoid delays in license processing. 3 ### Await sample test results Product samples collected during audit undergo independent testing. Results typically take 2-4 weeks. You cannot influence this process. 4 ### Receive license grant letter Once audit and testing are satisfactory, BIS issues the license grant letter with your CM/L number and ISI Mark usage authorization. 5 ### Implement license mark on products Begin applying the ISI Mark with your CM/L number to products manufactured at the licensed facility. Maintain license compliance. ## Frequently asked questions ### How should I prepare my factory for BIS audit? Preparation should start weeks before the scheduled audit. Organize all quality records, ensure calibration certificates are current, brief your quality personnel on audit procedures, clean and organize the production area, and conduct a mock audit if possible. The inspector will verify that your actual practices match your documented procedures, so ensure consistency throughout. ### What happens if the auditor finds non-conformities? Non-conformities are categorized as major or minor. Major non-conformities (affecting product safety or standard compliance) must be corrected before license grant. Minor non-conformities require corrective action plans. You will receive a Non-Conformity Report (NCR) and must submit evidence of correction within the stipulated timeframe, typically 30-60 days. ### Can I use consultants to prepare for the audit? Yes, BIS documentation consultants can help prepare your quality manual and procedures. However, the audit evaluates your actual practices, not just paperwork. Ensure your team understands and can demonstrate the documented procedures. Some consultants also provide mock audit services which can be valuable for first-time applicants. ### What if my factory fails the audit? If significant non-conformities prevent immediate license grant, BIS will provide a detailed report. You must implement corrective actions and may need a re-audit (at additional cost) or verification visit depending on the nature of non-conformities. Most failures are due to inadequate quality systems rather than product issues, and can be corrected with proper effort. **Disclaimer:** This guide reflects typical BIS factory audit procedures based on industry experience. Specific audit requirements may vary by product category and BIS regional office practices. Always confirm current requirements with your local BIS office. [ Map your product, free Every standard, document, and test that applies — free, no account required. 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Get the book — $24.99](/books/04-bis-certification-for-electronics) Related guides * [BIS ISI Mark CertificationComplete guide to BIS ISI Mark certification: factory audit requirements, application process, documentation, license maintenan…](/guides/bis-isi-mark-certification) * [BIS CRS vs ISI MarkLearn the difference between BIS CRS and ISI Mark certification.](/guides/bis-crs-vs-isi-mark) * [India Market Compliance OverviewComprehensive overview of India's regulatory landscape: BIS, CDSCO, WPC, TEC, FSSAI, customs, and DGFT requirements for market …](/guides/india-compliance-overview)