Does a QMS ensure 100% quality?
Mark Hammar
Every year we hear about product recalls and consumer alerts about manufactured goods that have major problems, and need to...
Every year we hear about product recalls and consumer alerts about manufactured goods that have major problems, and need to be returned to the company for replacement or refund. In this past year of 2014,...
Similarities and differences between ISO 9001:2015 and ISO 13485:2016
Note: This article was updated according to the ISO 13485:2016 revision. ISO 13485 is the international standard requirement for a...
Note: This article was updated according to the ISO 13485:2016 revision. ISO 13485 is the international standard requirement for a medical device quality management system. Like many other quality management system requirements for special purposes...
ISO 9001 vs. Baldrige National Quality Award (BNQA)
If you are a company in the United States of America you will probably have heard of the Baldrige National...
If you are a company in the United States of America you will probably have heard of the Baldrige National Quality Award; however, international companies outside of the USA may not know about this award...
Writing an Audit Checklist for ISO 9001 Processes
For many people who perform internal audits, there is always a question of the best way to create an audit...
For many people who perform internal audits, there is always a question of the best way to create an audit checklist when preparing your internal audit. Unfortunately, there is no one best way to do...
Understanding dispositions for ISO 9001 nonconforming product
ISO 9001 section 8.3 on control of nonconforming product identifies four ways that you can deal with the nonconforming product,...
ISO 9001 section 8.3 on control of nonconforming product identifies four ways that you can deal with the nonconforming product, but what do these sentences mean? Many companies call this action of identifying what to...
Understanding Product & Service Provision in ISO 9001
Updated according to ISO 9001:2015. Many people are confused by ISO 9001 section 8.5 on production and service provision. Some...
Updated according to ISO 9001:2015. Many people are confused by ISO 9001 section 8.5 on production and service provision. Some of this confusion probably comes from the fact that the international standard is trying to...
