ISO 9000

ISO 9000 Quality Standards Fulfill Customer and Regulatory Requirements

From the cars we drive to the home appliances we use, it is likely that they were all manufactured according to the requirements of ISO 9000, a family of quality standards developed by the International Organization for Standardization, commonly known as ISO (derived from the Greek word isos, meaning equal).


ISO 9000, first published in 1987, is widely used by manufacturers and companies throughout the world. Adherence to ISO standards is voluntary, although certain countries require ISO certification and many customers prefer vendors and suppliers that are ISO-certified. In the series of standards for ISO 9000, ISO 9001 2000 is among the most popular because it applies to all types of organizations. This ISO standard is primarily concerned about quality management and fulfilling customer and regulatory requirements through continuous improvement of the ISO 9001 2000 quality system.

The MasterControl™ quality management suite is an integrated, configurable, and easy-to-use software solution especially designed to facilitate adherence to the quality standards of ISO 9000. Here's how MasterControl can help meet key ISO 9001 2000 requirements and at the same time increase efficiency and keep compliance costs down:

ISO 9000:2000 RequirementsMasterControl ISO 9000 Features
(ISO 9000 2000要求事項4.2)

Document your quality system: ISO 9000 Requirements include: (1) approve documents before distribution; (2) provide correct version of documents at points of use; (3) use your records to prove that requirements have been met; (4) develop a procedure to control your records.

MasterControl Documents™automates routing, escalation, approval, and delivery of SOPs, policies, and other documentation according to quality standards of ISO 9000. Provides a centralized Web-based repository that's secure, but at the same time accessible to all authorized users. MasterControl's "check out" and "check in" feature provides revision control to ensure that only the current version of 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 and confirms if they comply with ISO 9000 standards or not, thereby meeting all document control requirements of ISO 9000 that are related to clause 4.2 in section 2000.

( ISO 9000 2000 Clause 6.2 )

The personnel responsible for collection, processing, compatibility testing, storage or distribution of blood and blood components shall be adequate in number, educational background, training and experience, including professional training as necessary-to assure competent performance-and to ensure that the final product has the purity, safety, potency, identity and effectiveness it purports or represent to possess.

MasterControl Training™ automates assignment and monitoring of training tasks and grading of online exams which helps in achieving ISO 9000 compliance. Allows sequencing of training courses, so after a prerequisite is completed, the next course is automatically launched. Provides group sign-off feature for verifying training of large groups of employees. In this manner, MasterControl Training meets all requirements of ISO 9000 that are relevant to training as described in clause 6.2 of section 2000.

( ISO 9000 2000 Clause5.6 )

Perform management reviews: Requirements include examination of all corrective and preventive actions by management.

(ISO 9000 2000 Clause 8.3 )

Control of Nonconformity. Requires documentation pertaining to nonconforming product, corrective actions, concessions, and customer reports.

MasterControl CAPA™ integrates the corrective and preventive action process with other quality processes compliant to ISO 9000. 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 according to ISO 9000. In this manner, MasterControl CAPA meets all requirements of ISO 9000 that are relevant to CAPA and nonconformity control as described in clause 5.6 and clause 8.3 of section 2000.

(ISO 9000 2000 Clause 5.6 )

Perform management reviews: Requirements include evaluation of the performance of the quality system and examination of audit results by management.

(ISO 9000 2000 Clause 8.1 )

Measurement, Analysis and Improvement Planning: Requirements include internal audit process.

MasterControl Audit™(監査ソフトウェア)は、監査プロセスの自動化や合理化、効果的な管理を実現します。スケジューリングや計画から実行や完了までの高度なトラッキング機能があります。基本的な監査情報及び監査所見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。監査に関連するすべての繰り返しアクティビティのスケジューリングを自動化して高度な分析及びレポート作成機能を提供するため、管理者は可視性が高まります。このように、MasterControl Auditはセクション2000の要求事項5.6で説明されているISO監査に関連するISO 9000のすべての要件を満たします。

( ISO 9000 2000 Clause 5.6 )

Perform management reviews: Requirements include examination of customer feedback by management.

MasterControl Customer Complaints™(品質報告ソフトウェア)は、ISO 9000の規制に従って苦情管理プロセスを合理化して、申請から解決までのライフサイクルを短縮します。事前構成済みの複数ページからなるフォームにはシンプルな3段階プロセスが反映されており、苦情処理から始まり、内部調査へと移行し、問題の解決に至ります。このように、MasterControl Auditはセクション2000の要求事項5.6で説明されている苦情管理に関連するISO 9000のすべての要件を満たします。

( ISO 9000 2000 Clause 5.6.2 8.3)(Clause 5.6.2)


Clause 8.3 Organization must ensure that product which does not conform to product requirements of ISO 9000 is identified and controlled to prevent its unintended use or delivery.

MasterControl Nonconformance™ (nonconformance software) is a robust solution designed to automate, manage, and streamline the process for identifying, evaluating, reviewing, and handling of nonconforming materials, components, parts, and finished products. The solution's best-practice form and five-step process connect all responsible personnel for effective and timely disposition of a nonconformance. This ISO 9000 solution offers the choice of maintaining a stand-alone nonconformance process for small-scale, localized incidents, or you may connect it to the CAPA process for automatic escalation when the situation warrantsit. In this manner, MasterControl Nonconformance meets all requirements of ISO 9000 that are relevant to a nonconformity as described in clause 5.6.2 and clause 8.3 of section 2000.

( ISO 9000 2000 Clause 7.3 )

Design and development: Requirements include establishing a system to identify, document, and control design changes.

MasterControl Change Control™(変更管理ソフト)は、ターンアラウンドをより速くするために変更管理手順全体を合理化します。優先度レベルを取り込み、リスクアセスメントと変更の分類(高、中、低)が組み込まれたベストプラクティスフォームを提供します。カスタマイズ可能なレポートにより、ISO 9000に準拠した変更管理タスクと品質システム全体のリアルタイムな状況が提供されます。このように、MasterControl Change Controlはセクション2000の要求事項7.3で説明されている変更管理についてISO 9000のすべての要件を満たします。

Compliant - Sustained Compliance with ISO 9000

マスターコントロールはISO 9000を遵守し、ISO品質基準を永続的に満たすようサポートする一方で、コンプライアンスコストを低く抑えます。

Connected - Integrated ISO 9000 Quality Management Suite


Complete - Enterprise-wide Product Application for Compliance With ISO 9000


Other ISO 9000 Solutions you may be Interested In

Other ISO solutions you may be interested in that MasterControl can help with include: ISO 13485, ISO 14000, ISO 14971, and ISO 9001 among many others.

For More Information on ISO 9000

To learn more about MasterControl and how MasterControl solutions can streamline compliance with the standards of ISO 9000, please feel free to contact a MasterControl representative.