Quality policy and process scope
Define entities, sites, services, responsibilities, objectives and performance measures.
Quality & process
Connect quality procedures with evidence of daily operations
ISO 9001 certification addresses an organization's quality management system, from customer requirements to delivery and improvement. It does not test every feature of a software product.
Source record updated:
Discuss your certification →Scope and applicability
Quality management system certification
Certification is voluntary but may be a customer or tender requirement. It is not a universal legal obligation for software companies.
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
- Companies asked to demonstrate a quality management system
- Teams standardizing development, delivery and operations
- Organizations managing multiple sites
Documents to prepare
Customer and operational records
Retain contract reviews, design verification, supplier controls and nonconformity records.
Internal audits and management reviews
Record root causes, corrective actions, resource decisions and follow-up.
Preparation process
Define scope and effective personnel
Give the certification body site, activity, design responsibility and staffing information for audit planning.
Operate and evaluate the system
Assess gaps and conduct internal audits and management reviews using actual records.
Complete stage 1 and stage 2 audits
Address findings and plan continuing surveillance and renewal.
Timing
An established system and a new implementation require different schedules. Include operating evidence, internal audits, management review and the body's availability.
Agency fees
Institutional testing and assessment fees
Quotation based on the agreed scope
Confirm scope, assessor days, retesting, travel and VAT in the final quotation. Institutional fees are separate from Specify subscription charges.
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 9001 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 the certificate guarantee product quality?
It demonstrates conformity of the scoped management system, not defect-free products.
Can we use an unchanged template?
Responsibilities, working methods and records must reflect your actual organization.
Is there work after certification?
Yes. Budget and plan for surveillance and renewal audits.