ISO 13485:2016

의료기기 품질경영시스템

ISO 13485는 의료기기 품질경영시스템(MDQMS)의 요구사항을 규정하는, 전 세계적으로 인정받는 국제 표준입니다.

ISO 13485 인증을 받은 조직은 고객 요구사항과 규제 요구사항을 일관되게 충족하는 의료기기 및 관련 서비스를 제공할 수 있음을 보여 줍니다.

이 표준은 제품 수명주기 전반에 걸친 리스크 관리, 프로세스 밸리데이션, 추적성 및 문서화를 강조하며, 전 세계에서 규제 요구사항을 충족하기 위한 기반으로 널리 활용됩니다.

건강 데이터 앞에서 디지털 지구본을 들고 있는 의료 전문가
  • 적용 대상 설계, 생산, 보관, 유통, 서비스 등 의료기기 수명주기의 모든 단계에 있는 조직.
  • 기반 제품 수명주기 전반의 리스크 관리.
  • 중점 규제 준수, 추적성, 문서화된 프로세스.

견적 요청

ISO 13485 인증을 시작하십시오.

관심 있는 인증이나 과정을 선택하시면 맞춤 견적을 보내 드립니다.

인증심사
사내 교육 · 최소 5명
공개 교육 · 최소 10명

개인정보 보호 고지: 귀하의 정보는 이 문의 및 관련 후속 연락에만 사용되며, 안전하게 보관되고 절대 판매되지 않습니다. CCB는 견적 준비 또는 인증서 발행에 필요한 경우에 한해 협력 인증기관과 정보를 공유할 수 있습니다. 정보 제공은 자발적이나, 제공하지 않으시면 답변드릴 수 없습니다. 개인정보 열람·정정 또는 동의 철회는 rita@concb.com로 이메일을 보내 주십시오. PDPA 고지 및 개인정보 처리방침 보기

* 필수 항목

Personal Data Protection Notice and Privacy Policy

Last updated: 29 October 2026

This notice explains how Continental Certification Body Sdn. Bhd. (“CCB”, “we”) collects, uses and protects your personal data under Malaysia’s Personal Data Protection Act 2010 (“PDPA”). It applies to everyone who contacts us, requests a quotation, attends our training, applies to work with us or is involved in a certification audit.

1. What personal data we collect

Your name, job title, company, email address, phone or mobile number, business address, country and website, and anything you tell us in an enquiry. For audits and training we may also hold attendance, assessment and audit records. For auditor applicants we hold your CV, qualifications, audit log and expected fees. We do not ask for sensitive personal data unless the law or a certification scheme requires it.

2. How we obtain it

Directly from you through our website forms, email, WhatsApp, phone or in person; from your organisation when it engages us; and from our partner certification bodies when they need to work with us on your certificate.

3. Why we use it

To respond to your enquiry and prepare your quotation; to plan and carry out audits and training; to arrange the issue, maintenance and verification of certificates with our partner certification bodies; to assess auditor applications; to keep the records that certification and accreditation rules require; and to meet our legal obligations. We will only send you marketing messages with your consent, and you can opt out at any time.

4. Who we may share it with

Our partner certification bodies, INTERCERT Certification and BSCIC Certifications, when needed to issue or verify your certificate; accreditation bodies reviewing our work; auditors and trainers engaged by us, who are bound by confidentiality; service providers that host or support our systems; and authorities where the law requires it. We never sell your personal data.

5. Transfers outside Malaysia

Some partners and service providers are located outside Malaysia. When your data is transferred, we take reasonable steps to ensure it is protected to a standard comparable to the PDPA.

6. Is it compulsory?

Fields marked * on our forms are needed for us to respond. Providing your personal data is voluntary, but if you do not, we may be unable to answer your enquiry, prepare a quotation or provide our services.

7. Your rights

You may ask to access the personal data we hold about you and to correct it if it is inaccurate, incomplete or out of date. You may withdraw your consent, ask us to limit how we process your data, ask us to stop direct marketing and, where it applies, ask for your data to be transmitted to another organisation. We will reply within 21 days of receiving your request. A fee permitted by law may apply to access requests.

8. Security and retention

We protect your data with reasonable technical and organisational measures against loss, misuse and unauthorised access. We keep it only for as long as needed for the purposes above and for the record periods that certification and accreditation rules require, and then delete or anonymise it.

9. Data breaches

If a personal data breach occurs, we will notify the Personal Data Protection Commissioner and, where required, the people affected, as the PDPA requires.

10. How to contact us

For access, correction, withdrawal of consent or any question or complaint about your personal data, contact our Data Protection Officer at rita@concb.com or write to Continental Certification Body Sdn. Bhd., D-1-3, Avenue Two, Persiaran Suarasa 3, Bandar Tun Hussein Onn, 43200 Cheras, Selangor, Malaysia. You may also complain to the Personal Data Protection Commissioner of Malaysia.

11. Language and changes

This notice is published in English, Chinese and Malay. If the versions differ, the English version prevails. We may update this notice; the date at the top shows the latest version.