February 25, 2019

What Documented Information is Required for ISO 9001:2015

The ISO 9001 quality standard has a number of document requirements and specifically calls out 7.5.3 Control of Documented information. To understand what documents or a records are required (the new standard does not make a distinction) first let’s clarify what are documents and records.
October 9, 2017

What’s a Lean ISO Quality System?

It may be a lot easier than you think to create a lean ISO quality system, and it will save you an untold amount of work (and grief) later on.
October 2, 2017

What Does ISO Mean?

ISO is not an acronym.
March 6, 2017

Quality Management System in 10 Easy Steps

Whether you realize it or not, the management system you are using is a quality management system. So why not do it right and build a QMS to produce products with real quality.
October 17, 2016

How Much Time Does an ISO System Require Annually?

There is no simple answer to the question of the time commitment for an ISO Quality Management System. There are a number of variables to consider including the ISO standard, number of employees, the capability of your management team, the complexity of your business processes, and your knowledge of quality. The answers to such questions will determine the level of effort required to maintain an ISO system.
September 16, 2016

ISO 9001 Clause 5 & 7 Leadership

Phase three if implementing an ISO system is as much about understanding and awareness as it is about creating new processes and documentation.
August 22, 2016

ISO 9001 2015 Changes

While previous changes to ISO 9001 varied in significance, the latest ISO 9001:2015 changes to the ISO 9001:2008 standard introduced some new important changes.
March 7, 2016
Planning for Quality

What is Quality Planning?

Quality planning is how we plan to make a product (or deliver a service) correctly. Think of it as planning to make the perfect product (or deliver the perfect service) experience for your customer. Ah, the perfect order, from the perfect customer…
February 15, 2016
Reduce Document Control Audit Findings

Document Control Audit Findings and How to Eliminate Them

Of all the types of findings a quality auditor can write up in an audit, Document Control Audit Findings are one of the most common. In this day and age, there’s really no excuse for getting a document control audit finding. How can I say that? Easy, most document control findings are the result of reliance on a manual review-and-control process. Do you rely on memory, handwritten notes, a “prompt” function on your PC or cellphone, or an assistant to tell you when to review documents? If you have to make a change to a company document, are you hunting people down […]