Role of Omega QMS Pvt Ltd in Facilitating BIS Certification under Scheme X with Reference to IS 16819:2018/ISO 12100:2010

Komal16 June 2025

Introduction In today’s industrial landscape, ensuring machinery safety is a critical priority — both for compliance and to protect human life. With the enforcement of the Bureau of Indian Standards (BIS) mandate through Scheme X, manufacturers must now adhere to specific standards, including IS 16819:2018, for selected machinery and electrical equipment. This article outlines the importance of IS 16819 and how Omega QMS Pvt Ltd plays a vital role in guiding organizations through the BIS certification process under Scheme X.

Understanding IS 16819:2018 (ISO 12100:2010) – Safety of Machinery

IS 16819:2018 is the Indian equivalent of the international standard ISO 12100:2010, titled “Safety of Machinery — General Principles for Design — Risk Assessment and Risk Reduction.” It is categorized as a Type-A standard, setting the foundational safety principles for machinery design.

Key Objectives:

To provide a framework for identifying and mitigating risks during the machine’s entire life cycle.
To establish a common language and methodology for designers, manufacturers, and regulators.
To support the development of Type-B and Type-C safety standards for more specific machinery categories.

Core Elements:

Risk Assessment Process:

Determine the machinery’s functional, environmental, and operational limits.
Identify all foreseeable hazards.
Estimate the probability and severity of harm.
Evaluate whether existing safety measures are adequate.

Three-Step Risk Reduction Strategy:

Inherently Safe Design: Eliminate hazards at the design stage.
Safeguarding: Use physical guards, interlocks, and sensors.
Information for Use: Provide clear user instructions, warnings, and safety procedures.
Life Cycle Focus: Covers all machine stages — from design and installation to operation, maintenance, and disposal.
Terminology & Guidance: Offers detailed definitions and practical methods to identify hazards and evaluate risks.

IS 16819 in the Context of BIS Certification (Scheme X)

The Ministry of Heavy Industries, through its 28 August 2024 Gazette Notification, mandates IS 16819 compliance for multiple categories of machinery listed under the First Schedule. Certification under Scheme X involves:

Compliance with applicable Type-A, B, and C safety standards.
Fulfillment of labeling, documentation, and marking requirements.
Risk assessment aligned with IS 16819 guidelines.
Submission of a Technical Construction File (TCF).
Pre-certification registration with BIS.

Role of Omega QMS Pvt Ltd in Facilitating BIS Certification

Omega QMS Pvt Ltd, a recognized consultancy in certification and compliance, plays a strategic role in helping manufacturers achieve BIS certification under Scheme X. Their comprehensive support spans technical, procedural, and compliance aspects.

Initial Gap Analysis & Risk Assessment:

Omega QMS conducts a thorough evaluation of client machinery based on IS 16819’s risk framework — identifying hazards and mapping out suitable mitigation strategies.

Documentation & Technical File Preparation:

They assist in compiling the Technical Construction File (TCF), including design drawings, risk analysis, compliance checklists, and testing data — crucial for BIS audits.

3. Standard Mapping & Compliance Guidance:

Omega QMS ensures that the machinery aligns not only with IS 16819 (Type-A) but also with relevant Type-B and Type-C standards as listed in the Second and Third Schedules.

4. Application & Certification Process Management:

Omega QMS acts as a liaison between the manufacturer and BIS — submitting applications, coordinating inspections, and addressing any non-conformities flagged during assessment.

5. Training & Awareness Programs:

They provide structured training sessions to the client’s team on safety design principles, risk reduction practices, and compliance maintenance post-certification.

6. Post-Certification Compliance Support:

Omega QMS continues to monitor compliance through surveillance support, document updates, and preparation for periodic audits.

Conclusion

The adoption of IS 16819:2018 under Scheme X reflects India’s growing emphasis on machinery safety, aligning with international practices. Through expert consultancies like Omega QMS Pvt Ltd, manufacturers can navigate the complex landscape of BIS certification with confidence. By combining technical know-how with regulatory expertise, Omega QMS ensures machinery not only complies with standards but also exemplifies operational safety, reliability, and quality.