Here at DocXellent, we aim to make your compliance process uncomplicated and efficient. One of the standards we know many of our customers must abide by is ISO 17025. ISO 17025 is the international standard that sets out the general requirements for the competent, impartial, and consistent operation of laboratories.
The table below demonstrates how our ENSUR Document Management Software meets each requirement of ISO 17025 to help your company avoid non-compliance.
| ISO 17025 | ENSUR | |
|---|---|---|
| Requirement | Outline/summary | Compliance Summary |
| Management System | The laboratory shall establish, implement and maintain a QMS management system appropriate to the scope of its activities. The laboratory shall document its policies, systems, procedures and instructions to the extent necessary to assure the quality of the test results. The system’s documentation shall be communicated to, understood by, available to, and implemented by the appropriate personnel. | ENSUR is a document control and quality management software application that automates the management of documents and their workflows, helping you streamline your business processes and improve quality practices across your organization. The software provides a secure repository for storing and organizing your critical business documents with tools for collaboration, version control, corrective and preventative action, training, incidents, reporting and much more. ENSUR is available in both a validated and non-validated solution and helps you meet and exceed your various regulatory compliance requirements, including FDA, ISO, GxP, OSHA and SQF. |
| Quality Manual | The laboratory's management system policies related to quality, including a quality policy statement, shall be defined in a quality manual (however named). The overall objectives shall be established, and reviewed during management review. The quality policy statement shall be issued under the authority of top management. The quality manual shall include reference to the supporting procedures including technical procedures and describe the structure of the documentation utilized in the laboratory. | The ENSUR out of the box electronic Binder Content Type and linking capability is the perfect solution for establishing a Quality Manual. Every document created and stored in ENSUR can be linked to other documents in the system via various link types, the most common being Referential or Dependent. |
| Document Control | The lab shall have a documented procedure (paper based, electronic or a combination) to control all documents that form the quality management system. | ENSUR automates the management of documents, their workflows and version control, helping you streamline your business processes and improve quality practices across your organization. |
| Review & Approval | The laboratory shall assure that all documents (including Standards) issued to or used by personnel in the laboratory as part of the management system are reviewed and approved for use by authorized personnel prior to issue. | ENSUR automates the workflow process for the Document product type through multi-tiered Review and Approval routings and Periodic Reviews with electronic signatures. Content can be manually made obsolete or through automation. |
| Complaints | The laboratory shall document, evaluate and adequately follow up on all customer complaints. | The ENSUR Incident product type allows laboratories to create custom forms utilizing the Incident workflow where items can be tracked as they are reported, Opened and Closed. |
| Control of Nonconforming Testing and/or Calibration Work | The laboratory shall have a procedure that shall be implemented when any aspect of its testing or the results of this work, do not conform to its own procedures or the agreed requirements of the customer. | ENSUR CAPA & Incident: ENSUR document control solution grants you commanding flexibility when you find nonconformance, accidents, incidents, supplier issues, and customer complaints with your products or production processes. The ability to collect, correlate, investigate, and make informed improvements can be electronically executed within ENSUR. Now you have streamlined quality and control throughout your manufacturing process. The ENSUR document control solution provides you a configurable, comprehensive anytime, anywhere Corrective Action Preventative Action (CAPA) and Incident tracking. The web forms help guide business and quality people to fully identify, record, define, investigate and correct any nonconformance found. The configurable workflow allows companies to monitor the solution from draft through effective implementation and verification of your corrective action/preventative action and from draft through open and closed for Incidents. |
| Corrective Action | The laboratory shall establish a procedure and shall designate appropriate authorities for implementing corrective action when nonconforming work or departures from the policies and procedures in the management system or technical. | |
| Preventive Action | Needed improvements and potential sources of nonconformities, either technical or concerning the management system, shall be identified. When improvement opportunities are identified or if preventive action is required, action plans shall be developed, implemented and monitored to reduce the likelihood of the occurrence of such nonconformities and to take advantage of the opportunities for improvement. | |
| Continuous Improvement & Audits | The laboratory shall continually improve the effectiveness of its management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management reviews. Additional audits where the identification of nonconformities or departures casts doubts on the laboratory’s compliance with its own policies and procedures, or on its compliance with this international standard, the laboratory shall ensure that the appropriate areas of activity are audited as soon as possible. | ENSUR provides the ability to manage, schedule, and record all audit activities. Both internal and external audits can be recorded and tracked through its custom Form, CAPA, linking and action item features. ENSUR allows easily collaboration between different company departments in order to resolve and deviations or findings that may occur from an audit. |
| Training | The ENSUR Training feature allows you to easily meet training requirements through established training rosters including Users, Groups and Job Titles. ENSUR also features integrated Training Management capabilities, including internal & external training events and configurable training reports all while automating the tracking of your employees’ electronic training records. ENSUR training management monitors your training program with full and complete compliance and effectiveness. ENSUR employee training management software delivers the right knowledge and credentials throughout your organization using a fully documented and regulatory compliant solution. |