How to Conduct a QMS Audit in India?

Quality Management System (QMS) audit is not just a compliance requirement; it is a strategic tool for long-term competitiveness. For companies manufacturing in or sourcing from India, conducting a robust QMS audit is essential to ensure regulatory compliance, minimize risks, enhance product reliability, and meet global standards such as ISO 9001. Effective implementation of the QMS audit process in the Indian context is essential for manufacturers, sourcing professionals, and quality assurance managers aiming to ensure compliance, reduce risks, and maintain operational excellence.
This comprehensive guide outlines the complete QMS audit journey in India, from audit planning and on-site execution to corrective actions and continuous improvement.

What Is a QMS Audit?

A QMS audit is a systematic evaluation of an organization’s quality management system. It assesses whether processes, procedures, and documentation comply with applicable standards (such as ISO 9001:2015), company policies, and regulatory requirements.

QMS audits are typically of three types:

• Internal Audit – Conducted by or for the organization itself
• External/Second-Party Audit – Done by customers or stakeholders
• Certification/Third-Party Audit – Conducted by an accredited certification body

Why QMS Audits Matter in India

India’s manufacturing and service sectors have seen tremendous growth, fueled by government initiatives like Make in India and PLI Schemes. However, with rising expectations from international buyers, QMS audits play a vital role in:

• Verifying compliance with global standards like ISO 9001, IATF 16949, or AS9100
• Ensuring supply chain reliability and reducing product recalls
• Improving operational efficiency and reducing waste
• Preparing for external certifications and customer audits

Step-by-Step: How to Conduct a QMS Audit in India

Conducting a QMS audit in India requires a structured approach tailored to local operational realities, regulatory requirements, and global quality standards. To ensure effectiveness and compliance, follow these step-by-step stages of conducting a QMS audit in the Indian manufacturing context:

Step 1: Define the Scope and Objectives

Before initiating the audit, clearly define:

• Audit Scope – What departments, processes, or standards are being audited? (e.g., production, procurement, documentation, ISO 9001 compliance)
• Objectives – What are you trying to verify? Compliance, effectiveness, risk exposure, improvement opportunities?

In India, scopes often vary depending on the type of industry (automotive, electronics, pharma, etc.) and whether the supplier is local or export-oriented.

Step 2: Understand Applicable Standards and Regulations

Most QMS audits in India follow ISO 9001:2015, but industry-specific standards may also apply:

• IATF 16949 – For automotive suppliers
• ISO 13485 – For medical devices
• GMP & WHO-GMP – For pharmaceutical manufacturing
• BIS Regulations – For domestic consumer goods

It’s crucial to review not just ISO clauses, but also national and state-specific laws like:

• Factories Act, 1948
• Environmental regulations (Pollution Control Board norms)
• Labour Welfare Codes (wage, safety, insurance)

Step 3: Plan the Audit

Create an audit plan including:

• Timeline – Set audit dates based on production schedules to minimize disruption
• Audit Team – Ensure auditors are trained and independent of the area being audited
• Checklist Preparation – Based on ISO clauses, internal policies, SOPs, and previous non-conformities
• Document Review – Pre-audit review of QMS manuals, SOPs, work instructions, and records

Tip: In India, local holidays, factory shifts, and linguistic diversity must be considered when scheduling.

Step 4: Conduct the Opening Meeting

An opening meeting sets the tone for the audit. Include:

• Purpose and objectives
• Audit scope and methods
• Roles and responsibilities
• Estimated duration
• Request for necessary resources (documents, personnel access)

This step helps avoid resistance or confusion, especially in Indian SMEs where staff may be unfamiliar with audit protocols.

Step 5: On-site Audit & Process Evaluation

This is the core of the audit, involving:

• Interviews – With operators, supervisors, QA staff, etc.
• Observations – Shop floor practices, 5S implementation, safety protocols
• Record Review – Quality records, training logs, calibration reports, NCRs
• Process Verification – Whether what’s documented is actually practiced

Key areas to audit in Indian factories:

• Incoming material inspection
• In-process quality checks
• Final inspection and dispatch
• Calibration and equipment maintenance
• Training and competency records
• Document and data control

Note: Language barriers may exist. It helps to have bilingual auditors or translators.

Step 6: Identify Non-Conformities and Opportunities

Classify findings as:

• Major Non-Conformance – A serious breach (e.g., missing process control)
• Minor Non-Conformance – A deviation that doesn’t severely impact product quality
• Observations – Areas that may become problems in future
• Opportunities for Improvement (OFI) – Suggestions to enhance efficiency or reduce variation

Use objective evidence for each finding, such as photos, samples, or documentation.

Step 7: Conduct the Closing Meeting

Present your findings to management and relevant stakeholders:

• Highlight major and minor non-conformities
• Acknowledge good practices
• Discuss next steps and timelines for corrective action
• Invite feedback or clarification

In India, this meeting is crucial, especially for smaller firms, as it fosters transparency and collaboration instead of confrontation.

Step 8: Prepare and Submit Audit Report

The report should include:

• Summary of audit scope and team
• Methodology and checklist used
• Detailed findings with evidence
• Risk analysis (if applicable)
• Recommendations for corrective action
• Compliance score or grade (if used)

Timeline: In India, most clients expect audit reports within 2–5 working days.

Step 9: Implement Corrective Actions

After receiving the audit report:

• Assign responsibility for each non-conformity
• Conduct root cause analysis (e.g., 5 Why, Fishbone diagram)
• Define corrective actions and timelines
• Document actions taken

In India, timely follow-up is essential, especially in regulated sectors (e.g., pharmaceuticals), where non-compliance can lead to license suspension.

Step 10: Verification and Follow-up Audit

Re-audit or verify:

• Whether corrective actions have been implemented
• Effectiveness of those actions in preventing recurrence

A follow-up can be a desk audit (document review) or on-site, depending on the severity of non-conformities.

Common Challenges in QMS Audits in India

Conducting Quality Management System (QMS) audits in India comes with its own unique set of challenges. Understanding these obstacles is the first step toward addressing them effectively and ensuring a successful audit outcome.

1. Documentation Gaps

A frequent issue encountered in Indian manufacturing facilities, especially small and medium enterprises (SMEs), is the lack of proper documentation. Many companies do not maintain complete Standard Operating Procedures (SOPs), calibration records, quality manuals, or traceability logs. In some cases, documentation may exist but not be updated or aligned with ISO 9001 or industry-specific standards. These gaps make it difficult for auditors to verify process control and compliance, ultimately affecting certification and customer confidence.

Solution: Encourage suppliers to implement a document control system, conduct periodic internal reviews, and maintain version control and approval records.

2. Training Gaps

Many Indian manufacturers face training-related challenges, particularly on the shop floor. Employees may not fully understand ISO, GMP (Good Manufacturing Practices), or other regulatory requirements. This lack of awareness can lead to inconsistent process execution and non-compliance during audits.

Solution: Invest in regular training programs tailored to the roles and responsibilities of each employee level. Use simple language, visual aids, and hands-on demonstrations to reinforce key concepts.

3. Cultural Resistance

In some cases, audits are viewed with suspicion or fear, especially in family-owned or traditional manufacturing settings. There can be a perception that audits are meant to “find faults” rather than identify opportunities for improvement. This mindset can hinder transparency and openness during the audit process.

Solution: Reframe audits as collaborative tools for growth. Communicate their value in improving efficiency, reducing waste, and meeting global customer expectations. Encourage management to model a positive attitude toward audits.

4. Language Barriers

India is a linguistically diverse country, and auditors may need to interact with employees who are more comfortable in regional languages like Hindi, Tamil, Telugu, Marathi, or Bengali. Without effective communication, interviews and process observations can suffer, potentially resulting in misunderstandings or inaccurate findings.

Solution: Use bilingual auditors when possible or bring a local interpreter to facilitate communication. Preparing translated checklists and training materials can also help bridge the gap.

5. Overloaded Quality Staff

In many Indian SMEs, a single quality assurance (QA) manager may be responsible for all quality-related activities such as documentation, compliance, inspections, customer communication, and audits. This multitasking leads to fatigue, missed updates, and incomplete follow-ups, weakening the overall QMS framework.

Solution: Encourage the creation of a dedicated quality team with clear role segregation. If resources are limited, consider outsourcing certain quality functions or hiring part-time specialists during peak audit periods.

Want to understand how quality assurance strengthens your overall quality system? Don’t miss our in-depth article on The Importance of Quality Assurance in Quality Management for key insights and practical takeaways.

Best Practices for QMS Auditing in India

To overcome these challenges and conduct effective QMS audits in India, consider the following best practices:

1. Use ISO-Certified or IRCA-Registered Auditors

Engage professional auditors with ISO certification or those registered with the International Register of Certificated Auditors (IRCA). Their expertise in international standards, audit methodologies, and local challenges ensures a thorough and objective audit process.

2. Tailor the Checklist to Industry and Indian Regulations

A one-size-fits-all audit checklist does not work in India’s diverse manufacturing landscape. Customize your audit criteria to reflect the specific industry (automotive, pharmaceuticals, electronics, etc.), applicable Indian laws, and international client requirements. Consider adding checks for local labor laws, environmental regulations, and safety compliance.

3. Document Everything Thoroughly

Maintaining complete and accurate audit records is vital. This includes checklists, interview notes, photographic evidence, document reviews, and any verbal communications with staff. Comprehensive documentation strengthens the audit’s credibility and provides a clear trail for corrective action tracking.

4. Train Suppliers in Advance

Before conducting formal audits, offer training or awareness sessions to your Indian suppliers. This helps align their processes with your quality expectations and prepares them for what to expect during the audit. Training can cover basic ISO concepts, audit objectives, and how to respond to findings professionally.

5. Build Long-Term Relationships with Suppliers

QMS audits should not be a one-time event. Build ongoing relationships with your suppliers to foster continuous improvement. Share audit findings constructively, provide support for corrective actions, and recognize positive changes. A collaborative approach builds trust, transparency, and lasting quality gains.

Looking to enhance your quality improvement strategy? Explore our detailed overview of Total Quality Management Tools to discover practical methods like Pareto charts, control charts, and root cause analysis that drive real results.

Making QMS Audits Work for You

Conducting a QMS audit in India is not just about ticking checkboxes; it is about driving quality, consistency, and customer satisfaction. Whether you are auditing your own facility or a supplier's, a structured approach backed by the right people, tools, and insights can make the difference between compliance and excellence.

By partnering with manufacturing experts like AMREP, who understand India’s cultural nuances, regulatory frameworks, and industry-specific challenges, you can turn your QMS audit into a powerful tool for sustainable business growth and global competitiveness.