ISO 13485:2016

医療機器品質マネジメントシステム

ISO 13485は、医療機器の品質マネジメントシステム（MDQMS）の要求事項を定めた、国際的に認められた規格です。

ISO 13485の認証を取得した組織は、顧客要求事項と規制要求事項を一貫して満たす医療機器および関連サービスを提供できることを示します。

この規格は、製品ライフサイクル全体を通じたリスクマネジメント、プロセスバリデーション、トレーサビリティ、文書化を重視しており、世界各国で規制要求事項を満たすための基盤として広く活用されています。

健康データを背景に、デジタルの地球儀を手にする医療従事者
  • 対象となる組織 設計、製造、保管、流通、サービスなど、医療機器のライフサイクルのいずれかの段階に関わる組織。
  • 基本となる考え方 製品ライフサイクル全体にわたるリスクマネジメント。
  • 重点 規制への適合、トレーサビリティ、文書化されたプロセス。

見積もりを依頼

ISO 13485への取り組みを始めましょう。

ご関心のある認証またはコースを選択してください。お客様に合わせたお見積もりをご連絡いたします。

認証審査
社内研修 · 最少5名
公開研修 · 最少10名

個人データ保護に関する通知：お客様の情報は本お問い合わせおよび関連するご連絡のためにのみ使用し、安全に保管し、販売することは一切ありません。お見積りの作成または認証書の発行に必要な場合に限り、CCBは提携認証機関と情報を共有することがあります。情報のご提供は任意ですが、ご提供がない場合は回答できません。個人データの開示・訂正、または同意の撤回については rita@concb.com までご連絡ください。 PDPA通知とプライバシーポリシーを読む

* 必須項目

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.