Additional Content
ISO 13485 - Change? Do I Have To??
Review the conundrum companies are experiencing if they want to maintain both ISO 9001 and ISO 13485 certification: How to comply with the varied requirements within only one quality system.
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.
36:51ISO 13485: 2016 Part 2: Getting Ready for Changes
In part two of a three-part series about ISO 13485:2016, Walt Murray outlines the principal differences in the new quality management system (QMS) standard for medical device companies. As of March 20
15:40ISO 13485: 2016 Part 1: Getting Ready for Changes
What, why, when and how the ISO 13485 standard for medical device manufacturers will change in 2016.
9:11ISO 9001: 2015 (Part 3): Risk-based Thinking Goes from Implicit to Explicit
Risk will take center stage in the new version of ISO 9001, which is scheduled to be released in late 2015.
9:11ISO 9001: 2015 (Part 3): Risk-based Thinking Goes from Implicit to Explicit
In the conclusion of this ISO 9001:2015 series, Walt Murray and Peter Knauer focus on the risk-based thinking that pervades the newest version of this ISO standard.
18:11ISO 9001:2015 Part 1: Introduction & Overview
In this first of a three-part series, Walt Murray and Peter Knauer give a brief overview of the new ISO 9001:2015 standard. Learn what’s new in this version and how to adapt.