ISEP Training & Consultation Sdn. Bhd.
Consultation Services
We helps individuals and companies obtain and maintain Quality Assessment Notification (QAN) and Quality Assurance Report (QAR) certifications. Our services ensure compliance with IECEx standard, allowing businesses to safely manufacture, repair, and maintain explosion-protected equipment. We support companies with documentation, quality management, and audit preparation to reduce risks and improve global market access.
Customise Equipment Certification
Our Customize Equipment Certification service is designed to ensure that your specialized or non-standard equipment meets the highest safety and regulatory standards. Whether you are manufacturing bespoke machinery or importing niche products, we streamline the certification process through a range of internationally recognized conformity assessment procedures such as:
Unit Verification
Unit Verification is a conformity assessment module used for one-off equipment, where the entire inspection, testing, and conformity assessment is carried out on each individual product unit rather than on a batch or type basis.
Why It Matters
This certification route is ideal when the cost or relevance of Type Certification and QMS audits isn’t justified. It ensures your customized equipment is compliant, traceable, and market-ready without needing a full production conformity pathway.
When to Use It
• Unique equipment or prototypes not intended for series production.
• Custom-made machines or installations tailored to specific client needs.
• High-risk applications where individual unit compliance is required (e.g., offshore, explosive zones).
What It Involves
• Review of technical documentation (manuals, drawings, risk assessments).
• On-site or lab functional and safety testing of the individual unit.
• Direct certification and labeling of the tested unit, often with CE or ATEX marking.
• On-site or lab functional and safety testing of the individual unit.
• Direct certification and labeling of the tested unit, often with CE or ATEX marking.
Type Examination Certification
Type Examination is a design verification process where a representative sample, also called a “type,” is evaluated to ensure it meets the essential health, safety, and technical requirements of the applicable directives or standards.
Why It Matters
This certification is the backbone of market access for many product types, particularly those in industrial or hazardous sectors. It ensures the product’s design meets required regulations before mass production begins, avoiding costly recalls or compliance failures.
When to Use It
• For mass production or batch manufacturing of machinery or equipment.
• For products under EU legislation (e.g., Machinery Directive, EMC Directive, ATEX).
• As a required first step before production-based modules (e.g., QAN, QAR).
What It Involves:
• In-depth assessment of the product’s technical file, including:
– Construction drawings
– Bill of materials
– Exploded diagrams
– Risk analysis
– Testing protocols
• Laboratory or on-site testing and measurement
• Issuance of a Type Examination Certificate by a Notified Body (for CE/ATEX) or IECEx CB (for IECEx CoC)
Quality Assessment Notification (QAN)
QAN is a certification issued after a successful audit of the manufacturer’s Quality Management System (QMS), confirming it is compliant with the specific modules required under EU directives, especially the ATEX Directive.
Why It Matters
With a valid QAN, manufacturers can produce and self-certify products based on the previously approved type, speeding up compliance processes and reducing certification costs over time. It also strengthens internal quality control systems and builds regulatory trust.
When to Use It
• After obtaining Type Examination Certification (Module B).
• When entering or maintaining access to EU markets for Ex equipment.
• For companies seeking to self-declare conformity under Modules D, E, or H.
What It Involves:
• An initial QMS audit by a Notified Body.
• Verification that production processes consistently comply with:
– ISO 9001 (adapted for regulatory directives)
– ATEX 2014/34/EU Annexes
• Review of internal documentation, non-conformance procedures, and test equipment.
• Issuance of a QAN certificate, allowing the use of Notified Body numbers on CE marks.
• When entering or maintaining access to EU markets for Ex equipment.
• For companies seeking to self-declare conformity under Modules D, E, or H.
What It Involves:
• An initial QMS audit by a Notified Body.
• Verification that production processes consistently comply with:
– ISO 9001 (adapted for regulatory directives)
– ATEX 2014/34/EU Annexes
• Review of internal documentation, non-conformance procedures, and test equipment.
• Issuance of a QAN certificate, allowing the use of Notified Body numbers on CE marks.
Quality Assurance Report (QAR)
QAR is a mandatory surveillance tool under the IECEx Scheme, confirming the ongoing compliance of the manufacturer’s QMS related to the production of Ex equipment (equipment intended for explosive atmospheres).
Why It Matters
QAR ensures your company remains in good standing within the IECEx framework, enabling uninterrupted international trade of hazardous area equipment. It also provides assurance to regulators and clients that your systems consistently deliver safe, compliant, and quality-assured products.
When to Use It
• For companies seeking or maintaining IECEx Certification of Conformity (CoC).
• As part of ongoing approval processes for Ex-related products.
• Required for exporting products to IECEx member countries, including Australia, New Zealand, Singapore, UAE, and South Korea.
What It Involves:
• Audits carried out by an IECEx-accredited Certification Body (ExCB).
• On-site verification of:
– Design and production controls
– Supplier evaluations
– Traceability and documentation
– Non-conformance management
• Periodic renewal based on IECEx Operational Document OD 005.
• As part of ongoing approval processes for Ex-related products.
• Required for exporting products to IECEx member countries, including Australia, New Zealand, Singapore, UAE, and South Korea.
What It Involves:
• Audits carried out by an IECEx-accredited Certification Body (ExCB).
• On-site verification of:
– Design and production controls
– Supplier evaluations
– Traceability and documentation
– Non-conformance management
• Periodic renewal based on IECEx Operational Document OD 005.