ISO 13485

ISO 13485: International Quality Management Standard for Medical Devices

ISO 13485 is an international management standard developed specifically for medical device manufacturers. It provides a harmonized model for creating and maintaining an effective quality management system (QMS) for the design and manufacture of medical devices. In 2016, ISO 13485 was revised to address suppliers and incorporate risk. ISO 13485:2016 explicitly requires device makers to apply a risk-based approach to all quality processes, including outsourced processes, as well as more structure to validation, verification and design transfer. ISO 13485:2003-certified companies have three years to transition to ISO 13485:2016.



How MasterControl Helps Device Makers Meet the Latest Requirements of ISO 13485

The MasterControl quality management suite is an integrated, configurable, and easy-to-use software solution especially designed to facilitate adherence to the latest ISO 13485 standard. Here's how MasterControl can help meet key requirements and at the same time increase efficiency and keep compliance costs down:

ISO13485要求事項ISO 13485コンプライアンスを保証するマスターコントロールの機能
(ISO 13485 -- Clause 4)

医療機器のための品質管理システムを構築すること。製造業者は、文書化され、管理され、効果的に実施され、維持されるISO 13485に準拠した品質手順を用意すること。

MasterControl Documents™ helps medical device companies comply with ISO 13485 by automating routing, escalation, approval, and delivery of standard operating procedures SOPs, policies, and other documentation. MasterControl provides automatic revision control to ensure that only the current version of an SOP is available. When a user makes a change in the InfoCard (the MasterControl tool that provides basic information for every record), the user must enter a reason for the change. The system tracks these changes and makes them available through reports which ultimately helps in meeting these standards.

Requires written supplier agreements and risk-based control of outsourced products.

With MasterControl Supplier™, all supplier management statuses and quality information is automatically contained in a single, easy to access location. In addition to providing an easily maintainable AVL, MasterControl Supplier features a user-friendly interface for accessing all documentation and records related to each supplier.

MasterControl Risk™ provides employees from different departments with a simple and efficient method for participating in risk assessment and mitigation activities. MasterControl's risk management software offers electronic workflows and signatures for execution, review, and approval of risk activities and documentation. Personnel can leverage a risk-based approach in multiple processes including supplier qualification activities.

(ISO 13485 -- Clause 6)


MasterControl Training™では、トレーニング業務の割り当てやモニタリング、オンライン試験のグレーディングの自動化により、医療機器会社によるISO 13485への準拠をサポートします。トレーニングコースの順番付けが可能で、必要条件のコースが完了すると次のコースが自動的に開始されます。グループサインオフ機能を搭載しているため、規模の大きな担当者グループのトレーニングの検証にも対応可能です。

Effectiveness of training must be commensurate with risk.

MasterControl's risk analysis software solutions include triggers to perform a risk analysis. This enables a methodology that establishes objective risk metrics. These can then be used as thresholds for decision-making.

(ISO 13485 -- Clause 8)


MasterControl CAPA™ helps medical device manufacturers comply with 13485 by integrating the corrective and preventive action process with other quality processes. The software provides best-practice "8D" process that guides the quality team through every step of CAPA. A CAPA form can be launched directly from another form (i.e., a nonconformance report). Automatically enters relevant data into a CAPA form, reducing data entry and eliminating errors from manual transfer of information. Provides customizable reporting capabilities to help managers monitor entire quality management life cycle.

(ISO 13485 -- Clause 8)


MasterControl Audit™ は、監査プロセスの自動化や合理化、効果的な管理によって、医療機器製造業者がISO 13485に準拠するのをサポートします。この監査ソフトウェアは、スケジューリングから計画の実施、完了までの高度なトラッキング機能を備えています。 基本的な監査情報及び監査結果をトラッキングするベストプラクティスフォームを提供します。繰り返し行われる全ての監査関連活動のスケジューリングを自動化し、分析とレポート作成機能を提供して管理の視認性を向上させます。

(ISO 13485 -- Clause 8)


MasterControl Customer Complaints™ helps medical device manufacturers comply by streamlining the complaint-handling process and reduces the lifecycle from submission to resolution. A simple, three-step process is incorporated in a pre-configured, multi-page form that starts with processing of a complaint, moving to internal investigation, and culminating with issue resolution.

(ISO 13485 -- Clause 5)

The organization shall document procedures for timely complaint handling in accordance with applicable regulatory requirements.

MasterControl Nonconformance™ は、不適合材料やコンポーネント、パーツ、完成品の同定や評価、レビュー、処理に関するプロセスを自動化、管理、合理化することにより、医療機器製造業者によるISO 13485への準拠をサポートするように設計された強固なソリューションです。 ソリューションのベストプラクティスフォーム及び5段階プロセスにより、責任担当者全員を連携させ、不適合品の効果的かつタイムリーな処理を実現します。

ISO 13485規格の詳細情報

マスターコントロールの詳細情報、及びマスターコントロールソリューションでISO 13485規格に関するコンプライアンスを合理化する方法について詳しくは、マスターコントロールの担当者までお気軽にお問い合わせください。