ISO Certification without Quality Dept?

Suppliers, supplier management


There were some changes recently in the company where I work. Now, a quality manager or quality function does not exist in the our company; however, we do maintain the ISO certification.  Our ISO certification applies to our corporate office and it applies also to the manufacturing facility located in a different city.

Is acceptable to have an ISO certification and not have a quality function?


There is no requirement for a quality function in ISO 9001:2015. I believe that this can be a positive move for your organization as it puts the job of quality upon the process owners, especially top management.  This is where it should be.

It can be a little messy as these responsibilities are passed back to the process owners; but, it’s right!

George Hummel

For more on this topic, please visit ASQ’s website.

Making Management Review Meaningful

Training, completed training, competance


I’m looking for assistance with Management Review requirement of ISO 9001:2015. We’ve been following an agenda that covers 9.3.2 a-f, but Senior Management believes that they cover much of this information in other meetings.

I found a few articles through the ASQ website, but wanted to see if there are suggestions for other resources to help make the Reviews relevant and useful rather than just checking off a box.


Management Review does not have to happen in one session but can be addressed over several meetings.  It is required that all the inputs and outputs (not addressed in your question) are recorded and accessible.

It is important that the inputs/outputs are not “checking off a box.” Management Review should be seen as “due diligence.”  For example, it is not designed to say, “internal audits were performed on xx/xx/2019.” Here is the opportunity for top management to review the audit results for improvement opportunities and determine how risks uncovered can be mitigated.

Note that the standard does not say “a meeting.” You may wish to gather the materials into one document and send it back to top management for review and approval.  This would also allow you to determine if there are any gaps to be addressed.

Try to ensure that top management notes changes in the QMS or needed. For example, does the QMS still support the strategic directions of the organization, have the requirements of interested parties changed, has corrective action found the root cause of problems, have complaints been adequately addressed and, have there been any changes in statutory requirements?

Following the review of the information, it would be my advise to publish the results to communicate these to the entire organization.

George Hummel

Creating a Culture of Quality

ASQ Global State of Quality 2016


I was introduced to Quality Management (& ISO 9001:2015) recently. The culture of the organization that I am concerned with has not embraced Quality Management, and it is often the subject of outright and unprofessional antagonism. I seek direction in order to arm myself with greater knowledge or qualifications as well as change attitudes toward Quality Management at all levels within the organization. I thought that ASQ would be a good resource. Since there are so many channels, a plethora of literature, and various certifications and conferences, I am a bit overwhelmed. I need to focus my efforts, and I hope to be able to do so with some direction from a professional who can relate to such growing pains. Thank you.

Answer 1

Thank you for your question.  I can certainly to relate to you and your plight – I was in a similar circumstance early in my career.   If you were introduced to ISO 9001 this year, I have to assume that your company is not yet registered.   Most manufacturing companies are required by their customers to have registration, but if you are not in that situation, you have to sell Quality Management on its own merit.  The bad news is, that if your senior management doesn’t want a Quality Management System, there is nothing you can do about that.  Now, that being said, you can begin by examining some of the “pain points” in your organization and showing how quality tools can help to solve them.  Management will never embrace quality until they see what is in it for them.   You can start with an analysis of the Cost of Poor Quality.  When your leadership sees the cost of nonconformance, they will be keen to bring those costs down.  COPQ typically includes the cost of external customer complaints, replacing products, late deliveries, and internal costs such as scrap, rework, re-makes etc.  If there has ever been a problem that traces back to not properly understanding a customer’s needs, that is a text-book example of how Quality Management can help.  Start with that.   Look at the costs of poor quality, and sell the idea of using quality tools to bring those costs down.  You will have no chance of selling your management on quality until they can see what’s in it for them.  Good Luck!

Denis J. Devos, P.Eng
A Fellow of the American Society for Quality
Devos Associates Inc.
(519) 476-8951

Answer 2

It sounds like this company needs a culture change. This change can happen only at the direction of the company’s leadership.
Here’s some suggestions:

  1. Each department head has to establish three (3) measurable goals on how his/her department is improving on the quality of their department’s output/work.  These are to be reported at each executive monthly meeting.  Department manager’s must be held accountable for lack of quality improvements.
  1. Every individual’s performance review must include “quality performance.”  This also needs to be measurable (less than last year, improved customer satisfaction from surveys, reduced ‘cost-of-quality’, reduced audit nonconformance observations, etc.)
  1. If the company has a bonus program, individuals/departments bonus is tied into quality performance.  ISO observation means 10% or more cut in bonus.
  1. Have top executives hold meetings on the need for quality and it’s everyone’s responsibility – not just the QA department.  If employees don’t like it they are welcomed to find employment elsewhere.


Jim Werner
Voting member to the U.S. TAG to ISO TC 176 Quality Management and Quality Assurance
Medical Device Quality Compliance (MDQC), LLC.
ASQ Senior Member

Fore more on this topic, please visit ASQ’s website.

Resources about Quality Culture

ASQ Global State of Quality 2016

Q: I am a senior member of ASQ.  I plan on giving a two to three hour workshop on quality culture at my company.  Do you have any audiovisual materials and/or examples from other successful companies that I could use for my slide presentation?  I would really appreciate it if you could provide me with more information on creating a quality culture.

A: According to The Quality Improvement Glossary by Donald L. Siebels, quality culture “consists of employee opinions, beliefs, traditions, and practices concerning quality within an organization”.

For more on this topic, please visit ASQ’s website.