Free Whitepaper: Checklist of Mandatory Documentation Required by ISO 9001:2015
It is easy to become overwhelmed with documentation in the belief that every single process that is in place in an organization must be documented, without realizing that this is not necessary to meet the requirements of the ISO 9001 standard. The 2015 revision of the standard become more liberal regarding documentation requirements, meaning that […]
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: 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. […]
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 […]
ISO 9001: More Than Doing What You Say and Saying What You Do
Written by: Steven Severt, originally published by Inside Standards on 9/10/2021 The adage of “do what you say and say what you do” is tossed around so often when talking about ISO 9001 that many people think that the two are synonymous. Somehow, many people who operate a business that either is or is trying to become […]