Free Whitepaper: Checklist of Mandatory Documentation Required by ISO 13485:2016
The latest version of ISO 13485 was published in 2016, which means medical device companies need to transition from the previous version of the standard and comply with the new requirements. One of the most important steps in the transition process, as well as in the initial implementation, is determining what documents and records are […]
Free Whitepaper: Clause-by-Clause Explanation of ISO 13485:2016
Striving towards quality and compliance with all applicable regulations is the mission of every modern medical device company. ISO 13485 provides a framework for how to achieve this, and the first step in the implementation is to understand what the standard really requires. This whitepaper is designed to help top management and employees in organizations […]
Free Whitepaper: Checklist of Mandatory Documentation Required by IATF 16949:2016
The latest version of IATF 16949 was published in 2016 and the transition from the previous version is ahead. One of the most important steps in the transition process, as well as in the initial implementation, is determining what documents and records are needed for an effective Quality Management System (QMS) based on IATF 16949. […]
Free Whitepaper: Basics of ISO 9001:2015 Risk Management
Risk-based thinking is a new concept in the ISO 9001:2015 standard, and this has caused many companies to search for an easy way to manage the risk in their companies. By focusing on understanding your risks through a simple risk management process, you can focus your attention more on addressing the risks that are present […]
Free Whitepaper: 9001 Academy vs. a Consultant
Quickly determine your best option for implementing ISO 9001: the 9001Academy or an outside consultant, with our convenient 9001Academy vs. a consultant comparison matrix. You’ll learn the benefits and risks of hiring a consultant, compared with leveraging our extensive knowledge here at the 9001Academy. Using our comparison matrix, your decision will be an informed decision. […]
A Registrar’s Perspective on the Effectiveness of Remote QMS Auditing
We’ve written extensively about remote auditing in the wake of nearly two years of the pandemic, but primarily from the perspective of an auditor or a client organization. Watch the video from Quality Digest as they interview Paul Butcher, CEO of LRQA, to get some insight on remote auditing from a registrar’s perspective.
Mike McLean of ISO/TC 176 on the Possibility of New Changes to ISO 9001
Watch Mike McLean, Managing Director of McLean Management Consultants Pty Ltd. and longstanding member of ISO/TC 176 discuss the possible future of ISO 9001. Mr. McLean seems to dodge actually explaining with clarity what upcoming changes might be, but seems to speak more generally about the constantly changing landscape that makes content in Annex SL […]
Understanding Sampling Plans and Acceptable Quality Limits (AQL) for eCommerce Businesses
If you are planning on starting an eCommerce business by finding suppliers for your products overseas and offering them to your customers through your website, you’re going to want to make sure that you’ve selected the right suppliers for your products, that you have a good quality plan in place to control the processes and […]
Document Control: More Than Adding a Revision Level
Written by: Steven Severt, originally posted at Inside Standards on 10/15/2021 When you think of your quality management system (QMS), do you instantly think of document control, as if the two terms are synonymous? Do you have designated staff within your organization who are responsible for document control and who are handling all QMS documentation […]