ISO

ISO 15189 Standards: For Medical and Clinical Laboratories

Discusses the MasterControl solutions that are ideal for medical and clinical laboratories to manage document control, audits, training, deviations CAPA, bills of material and change control.

Ten Signs Your CEO Still Has No Idea About ISO 9001 and Lean

Most CEOs and top managers just don’t get it when it comes to ISO 9001 and all the derivative standards. This white paper offers quality strategies and compliance ideas that can educate executives.

ISO 17025: What it Means for You and Your Laboratory

Keeping up with ISO 17025 standards isn't easy. These standards provide proof that first, second or third-party laboratories are competent enough to test, calibrate and take specified samples.

Meeting ISO 9001:2008 - Standards with Automated Tools

Introduces the requirements of the ISO 9001:2008 standard and the benefits of automating document control and quality management processes that are required to meet the certification standard.

cGMP and ISO 13485 Integrated Quality Management System

The Food and Drug Administration (FDA) has established and maintains Part 820- Quality System Regulation (QSR), also known as 21 CFR 820 or 'Current good manufacturing practice' (cGMP).

Understanding ISO 13485: 2016 — A Brief, Yet Comprehensive, Overview

Examine how obtaining ISO 13485 certification can open doors to untapped domestic and international business opportunities, and obtain recertification to the new revision.

ISO 14000 Standards

This white paper walks through the ISO 14000 series of international standards and explains how MasterControl addresses document control, CAPA, nonconformances and other quality management processes.

FDA/ISO Compliance Toolkit

Medical device managers are complying with FDA requirements and better aligning with evolving industry trends by recognizing the value of moving to a digital quality management system.

ISO 14971 Medical Device Risk Management

This Q&A looks at the requirements and benefits of becoming ISO certified.

Compliance with 21 CFR 820 and ISO 13485 Using MasterControl

ISO 9001 QMS Structure Diagram