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ISO 13485 Certification

Assistance with achieving ISO 13485 certification, the internationally recognised quality management standard for medical device manufacturers. — Chartered Solution.

ISO Certification & QMS

ISO 13485 Certification - Overview

Assistance with achieving ISO 13485 certification, the internationally recognised quality management standard for medical device manufacturers.

What We Provide

Gap assessment
QMS documentation & SOPs
Risk management file support
Certification audit coordination
Corrective action & closure

Who Needs This Service?

Manufacturers and exporters needing ISO certification
Companies responding to tenders and large clients
Businesses building quality and management systems

Eligibility

Any organisation of any size implementing a management system
Entities with committed management and defined processes

Documents Required

Organisation chart & process maps
Existing policies and SOPs
Quality / environment / safety records
Internal audit reports (if any)

Our Process

1
Gap assessment
Identify gaps against the ISO standard.
2
Documentation
Build the management system documents & SOPs.
3
Internal audit
Conduct internal audits and close findings.
4
Certification audit
Coordinate with the certification body.

Pricing & Timeline

Government / Authority Fees

No government fee; certification body audit fees are paid directly to the certification body.

Professional Fees

Consultancy fees depend on standard, scope, and headcount - quoted upfront.

Estimated Timeline

ISO certification typically 4–12 weeks depending on readiness.

Why Choose Chartered Solution?

Dedicated expert assigned to every engagement
Transparent, all-inclusive professional fees - no hidden charges
End-to-end documentation, filing and follow-up support
PAN-India service, delivered 100% online where possible

Frequently Asked Questions

Professional fees depend on the scope, entity type, and documents required. Contact us at +91 88155 53899 for a transparent, all-inclusive quote before you start.

Timelines vary by authority and department. We share an expected timeline before starting and keep you updated at every step on WhatsApp.

Yes. Chartered Solution serves clients across India - most registrations and filings are completed 100% online with doorstep delivery of certificates.

A basic document set is listed on this page. Our team sends a complete, service-specific checklist after your enquiry.

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