7 steps in writing QMS policies and procedures for ISO 9001
Mark Hammar
At some point during your implementation of an ISO 9001 Quality Management System (QMS), you will have to write down...
At some point during your implementation of an ISO 9001 Quality Management System (QMS), you will have to write down some policies and procedures. There is no avoiding this. While it is useful and important...
ISO 9001 Horizontal audit vs. vertical audit
In my recent article called First-, Second- & Third-Party Audits, what are the differences? I talked about the different types of...
In my recent article called First-, Second- & Third-Party Audits, what are the differences? I talked about the different types of audits as they relate to who is doing the ISO 9001 audit: an independent company, a...
First-, Second- & Third-Party Audits, what are the differences?
In the world of quality management there are many different names for several different types of audits – so many,...
In the world of quality management there are many different names for several different types of audits – so many, in fact, that the categories can become confusing. Add to this the fact that several...
Gap analysis vs. internal audit in ISO 9001
If you are thinking of implementing a quality management system (QMS) according to the ISO 9001 requirements, even if you...
If you are thinking of implementing a quality management system (QMS) according to the ISO 9001 requirements, even if you are only starting to investigate what is required, you will likely have heard the terms...
Four things you need to start your ISO 9001 project
Want to start implementing ISO 9001 in your company, but don’t know where to start? Especially if this is your...
Want to start implementing ISO 9001 in your company, but don’t know where to start? Especially if this is your first time implementing ISO 9001, you likely have a lot of questions on how you...
Is integrating ISO 9001 and OHSAS 18001 that hard?
Andrea Aulisi
The advantages of integration between multiple management systems are known to everybody, but I have never heard about quantitative measures...
The advantages of integration between multiple management systems are known to everybody, but I have never heard about quantitative measures (or at least estimates!) of the benefit of integrating. According to my data, based on...
Does a QMS ensure 100% quality?
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...
Improving quality through effective training
Ana Meskovska
Very often when people talk about managing quality, at one point they start talking about training. However, that is not...
Very often when people talk about managing quality, at one point they start talking about training. However, that is not because clause 6.2.2 from ISO 9001 refers to competencies and training, relating it to quality...
How ISO 9001 can help you build business relationships
John Nolan
Have you ever wondered whether all the work that goes into ISO 9001 accreditation is justified in terms of the...
Have you ever wondered whether all the work that goes into ISO 9001 accreditation is justified in terms of the rewards and benefits it brings? In a previous job, I worked for a company that...
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...
Managing the QMS after your consultant leaves
Most of us, probably at a time in our career where we were less experienced, have needed the help of...
Most of us, probably at a time in our career where we were less experienced, have needed the help of an ISO 9001 consultant to assist us with the implementation of the standard in the...
Watch Your Language! Don’t confuse processes with procedures
T.D. Nelson
Many industries use industry lingo or jargon to communicate within the industry. It could be jargon used as short-hand to...
Many industries use industry lingo or jargon to communicate within the industry. It could be jargon used as short-hand to convey a variety of work-related information, or it could be a more technical language based...
Using the ISO 9001 Change Log to ensure customer satisfaction
What happens within our process when we are designing a product for a market, and either our expectations or those...
What happens within our process when we are designing a product for a market, and either our expectations or those of our customers constantly change? How do we deal with this to ensure we can...
How to Align Company Culture with ISO 9001
The benefits of gaining ISO 9001:2008 accreditation are well researched and documented. The positives of eliminating waste, becoming more efficient...
The benefits of gaining ISO 9001:2008 accreditation are well researched and documented. The positives of eliminating waste, becoming more efficient and reducing the amount of non-conforming materials in your process are obvious to most observers,...
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...
ISO 9001 vs ISO/TS 16949
As an international standard for implementing a QMS, ISO 9001 is maintained by the International Organization for Standardization (ISO), and as...
As an international standard for implementing a QMS, ISO 9001 is maintained by the International Organization for Standardization (ISO), and as such is intended to be usable by any organization, service or manufacturing, in any industry...
Effective complaints management in a QMS
Dealing with complaints is tricky; however, in a business environment you have to deal with complaints. But, why should you...
Dealing with complaints is tricky; however, in a business environment you have to deal with complaints. But, why should you think about improving your complaints management approach? Because an effective complaints management system can help...
