Certification scope and quality manual
Define sites, activities, product families, requirements, objectives and process responsibilities.
Medical & healthcare
Connect medical device quality procedures with operating evidence
ISO 13485 addresses quality management for medical device organizations. Define the sites, activities and product families, then substantiate design, supplier and quality controls with records.
Source record updated:
Discuss your certification →Scope and applicability
Third-party medical device quality management system certification
ISO 13485:2016 does not itself require certification. Overseas regulation, customers or contracts may require it; check accreditation and target-market acceptance. It does not automatically replace Korean product approval or GMP.
Korean certification schemes and international standards are different. A translated guide does not extend a Korean certificate to other countries. Confirm the target market, product classification and current requirements with the relevant body.
Who this is for
- Medical device and software manufacturers
- Suppliers responding to international QMS requirements
- Teams improving medical device design and quality controls
Documents to prepare
Design, risk and verification records
Connect requirements, design reviews, verification, risk controls and changes.
Operations and improvement records
Prepare supplier evaluation, training, complaints, corrective actions, internal audits and management reviews.
Preparation process
Select scope and certification body
Confirm target markets and request technical-scope, audit-day and maintenance quotations.
Build and operate the QMS
Close gaps, accumulate records and check readiness through internal audit and management review.
Audit and maintain certification
Address staged audits and findings, then plan surveillance and renewal.
Timing
Preparation depends on QMS maturity and records. Plan document work separately from institutional audits and corrections.
Agency fees
Initial, surveillance and renewal audits
Individual certification body quotation
Personnel, sites, technical areas, activities and audit days affect fees. Confirm travel, certificate issuance and annual maintenance inclusions.
Sources and references ↗Document automation and management cost KRW 300,000 per month. Expert services and certification body testing or assessment fees are separate. Specify supports preparation; the relevant authority or certification body makes the final decision.
Pricing and certification costs →Optional expert consulting
Expert review and consulting are optional, separately scoped services. Choose support for ISO 13485 based on your team's readiness and the evidence or assessment preparation you need.
- Confirm institutional testing, assessment and registration fees separately in the contract.
- Development fixes, clinical studies where applicable, security equipment and infrastructure operations may require separate budgets.
- Confirm internal staffing, travel, translation, VAT, surveillance and renewal costs in the quotation.
Questions and answers
Does ISO issue the certificate?
No. Independent certification bodies perform certification. Check accreditation and customer or regulatory acceptance.
Does ISO 9001 make certification automatic?
Existing documents may help, but medical device design, risk, traceability and regulatory differences need attention.
What should a consulting quote include?
Define writing, review, operational preparation and nonconformity support. Confirm audit fees, extra sites, overseas markets and design support separately.