ISO 17025 Compliance

 ISO 17025 ENSUR
RequirementOutline/summaryCompliance 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 ManualThe 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.
ComplaintsThe 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.
TrainingThe 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.