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Pilgrim Software Inc., a world-leading provider of Enterprise Compliance and Quality Management (ECQM) solutions, has pioneered effective, integrated software solutions for highly regulated industries since 1993. More than 300 customers and 750,000 end users globally, work with Pilgrim every day to meet the diverse challenges of the world's highly competitive marketplace. Pilgrim's fully web-based solutions, built on industry best practices, help businesses centrally manage domestic and international operations to ensure product safety and regulatory compliance, reduce manufacturing costs, increase overall productivity, and improve customer satisfaction.
Pilgrim's Integrated Compliance & Quality Platform provides an enterprise-wide solution for managing corrective and preventive actions, complaint handling, internal and external assessments, document control, SOP enforcement, engineering collaboration, change management, employee certification/training, equipment/calibration, supplier quality management, advanced quality planning and risk management.
Pilgrim's ECQM platform provides the ability to deploy sound enterprise quality management strategies as prescribed by standards such as ISO 9000, ISO 14000, FDA QSR/QSIT, EC Directives, cGMP, etc., and many other globally recognized standards using a singular application framework. This powerful solution enables businesses to manage compliance and quality across the entire business, helping meet regulatory requirements, increase efficiency and reduce costs. Pilgrim Software's solutions provide the bottom-line results that customers demand.
The purpose of this field guide is to assist organizations, step by step, in implementing a quality management system (QMS) in conformance with ISO 9001:2008, whether from scratch or by transitioning from ISO 9001:2000. It examines each sub-clause of Sections 4–8 of ISO 9001:2008, which contain the requirements, and gives a list of the documentation/documents required, internal audit questions, a summary of management’s responsibilities, and a flowchart of the steps that need to be undertaken to satisfy the requirements.
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