QUALITY AND CERTIFICATIONS

Overview

At Prokyor, quality is not an inspection step — it’s built into every process.
From design validation to final shipment, every product passes through structured quality assurance (QA) and quality control (QC) stages governed by international standards.

Our systems are certified for ISO 9001:2015 and ISO 13485:2016, making us a trusted manufacturing partner for MedTech, IoT, telecom, and consumer electronics industries worldwide.

We combine process discipline, documentation, and technology to ensure every product meets the highest standards of reliability, safety, and performance.

Our Quality Management Framework

Incoming Quality Control (IQC)

Verification of all raw materials, components, and supplier documentation.

In-Process Quality Control (IPQC)

Continuous inspection during fabrication, assembly, and testing.

Final Quality Control (FQC)

Visual, functional, and environmental validation before shipment.

Process Validation

Ongoing audits and equipment calibration for consistent output.

Corrective & Preventive Action (CAPA)

Root cause analysis and continual improvement initiatives.

Certifications & Compliance

Prokyor maintains international certifications and adheres to stringent global standards:

ISO 9001:2015: Quality Management System for electronics and mechanical assemblies.
ISO 13485:2016: Medical Device Manufacturing Quality System.
RoHS Compliance: Restriction of hazardous substances in all materials and components.
CE & FDA Support: Documentation, testing, and validation for regulatory submissions.
BIS, UL & IP Rating Tests: Support for India-specific and international product certifications.

These certifications allow Prokyor to serve regulated industries with complete confidence and transparency.

Inspection & Testing Capabilities

Our quality infrastructure includes advanced testing and validation tools:

Automated Optical Inspection (AOI) for PCB assemblies.
X-Ray inspection for BGAs and multilayer PCBs.
Functional and burn-in testing for electronic modules.
Dimensional inspection (CMM) for mechanical components.
Surface finish and coating adhesion tests for enclosures.
Environmental stress and vibration testing for reliability.

This combination ensures that every part — electronic or mechanical — meets the functional and cosmetic standards of global OEMs.

Documentation & Traceability

We maintain complete batch-level documentation for all builds, including:

Our document-controlled environment ensures audit readiness and accountability for every shipped unit.

Commitment to Continuous Improvement

Quality at Prokyor is an evolving discipline.
We invest in:

This culture of improvement ensures that our partners receive consistent quality — not just in one order, but in every order.

Why Choose Prokyor for Quality Manufacturing

Certified for ISO 9001:2015 and ISO 13485:2016.
Proven track record in CE/FDA-ready device production.
Multi-layer inspection and testing protocols.
Strong documentation and export compliance systems.
Continuous improvement and training culture.

At Prokyor, quality is not negotiable — it’s our commitment to every client.

Frequently Asked Questions (Quality & Certifications)

What certifications does Prokyor hold?

We are certified for ISO 9001:2015 and ISO 13485:2016, and comply with RoHS, CE, and FDA standards.

Does Prokyor manufacture medical devices under ISO 13485?

Yes. Our ISO 13485 certification covers medical and diagnostic device manufacturing, ensuring full traceability and validation control.

How do you ensure PCB and electronic assembly quality?

We use AOI, X-ray, ICT, and functional testing at every stage to verify solder joints, electrical performance, and reliability.

Do you provide quality documentation for every batch?

Yes. Each batch includes inspection reports, test records, and compliance certificates for audit and shipment purposes.

What environmental tests do you perform?

We perform temperature, humidity, vibration, and drop testing to confirm product durability in operating environments.

Can clients audit Prokyor’s facility?

Absolutely. We encourage client audits and virtual inspections to verify our quality systems and documentation firsthand.

Are your materials RoHS compliant?

Yes. All components and materials are RoHS and REACH compliant, ensuring eco-friendly and safe manufacturing.

Do you help clients achieve CE or FDA certification?

Yes. We assist with testing documentation, reports, and validation data required for CE/FDA submissions.

How often is equipment calibrated?

All critical instruments are calibrated quarterly or per usage hours and tracked through internal calibration records.

How does Prokyor handle quality non-conformance?

Any non-conformance triggers a root-cause analysis, corrective action, and preventive follow-up, logged within our CAPA system.