ISO 9000

Document your quality system: 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. 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.

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. 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.

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. 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.

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™ automates, streamlines, and effectively manages the audit process. Provides advanced tracking capability, from scheduling and planning to execution and completion. Offers best practice forms for tracking basic audit information and audit findings. Automates scheduling of all recurring audit-related activities and provides analytics and reporting capability for increased management visability.

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

MasterControl Customer Complaints™ streamlines 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 9000:2000 Clause 5.6.2 & 8.3)
(Clause 5.6.2) Requires management reviews, including examination of product conformity data.

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

MasterControl Nonconformance™ 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 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 warrants it.

( ISO 9000:2000 Clause 7.3 )
Design and development: Requirements include establishing a system to identify, document, and control design changes.

MasterControl Change Control™ streamlines the entire change control procedure for faster turnaround. It offers a best-practice form that incorporates priority level and prompts risk assessment and classification of the change as low, medium, or high. Customizable reports provide real-time status of change control tasks and the entire quality system.