When beginning an ISO 9001 implementation, organizations often ask whether they should tackle the project on their own or if it would be worthwhile to bring a consultant in to help accomplish the task.

When Should You Hire a QMS Consultant

Steven Severt | isoTracker QMS

Organizations decide to become certified against ISO 9001 for several reasons, but once the decision is made, they are always left with some additional decisions to make regarding their understanding of the standard, their ability to complete a gap analysis or to conduct internal audits, and whether they have the resources internally to complete the implementation, among others.  

A quick Google search will show that the question as to whether a consultant should be brought in to help is answered in countless blog posts and articles, but many of which are written by consultants who stand to benefit financially from your organization deciding that hiring outside help is the best route to ensure that the QMS is properly implemented and will provide the best chance at gaining certification following the CB audit – not exactly the most objective of sources.

These articles often start with statements like, “Well, it is true that you don’t need a consultant to implement your QMS, but if you start the project and along the way realize that you didn’t have the expertise to perform gap analysis, lead cross-functional teams to implement system requirements, or that your resources are stretched too thin to complete the task, you might end up finding that you would have saved a lot more time and money by bringing in a consultant from the start.”  

All these articles seem to indicate that your organization will find that implementing with a consultant is more efficient and cost effective, but what happens when you hire a consultant that helps you to implement a system that you still do not understand and that you’re not likely to actually use?  

None of these articles really entertain the idea that the consultant might provide a QMS that meets the Standard’s requirements but is not actually useful within the context of the organization, thus providing financial benefit for the consultant only, and, aside from the certification hanging on the wall, providing very little actual value for your organization.

Are consultants really better at understanding your business processes?  Do they really understand your customer’s needs better than you do?  Can they really do a better job than you can of leading a cross-functional team within your organization to implement change?

We should be a little more critical before deciding to hand over implementation activities to consultants.  We should try to understand that their best interest is in their ability to maintain profitability for their consultancy and that maintaining efficient implementation methods is the easiest way for this to happen.  They need to ensure that your organization gets certified quickly, with little costly disruption.  Consulting is often all about the needs of the consultant or consulting agency with the needs of the client organization taking a backseat.  

It will be your responsibility, manager, to first understand why you chose to implement the QMS, then, second, to understand if a consultant’s goals align with the goals of your organization.  

I am definitely not saying that you shouldn’t hire one, merely that you really need to understand the needs of your organization and how you might be able to leverage services of consultants to support your needs.  There are a lot of things that I think you, as a management representative for your organization, should consider prior to bringing in outside help, and many of these will come from the “top management shall…” statements of Paragraph 5.1.1 in the ISO 9001 Standard.

These are: ”Top management shall demonstrate leadership and commitment with respect to the quality management system by:…taking accountability for the effectiveness of the quality management system…ensuring that the quality policy and quality objectives are established…and are compatible with the context and strategic direction of the organization…ensuring the integration of the quality management system requirements into the organization’s business processes…communicating the importance conforming to the quality management system requirements...etc.”


  • Before you bring in a consultant, ask yourself why you are implementing a QMS.  This is very important.  You need to understand your organization’s goals and strategic direction.  If you cannot answer this, don’t hire a consultant.  Don’t let them put something in print in your QMS documentation that doesn’t truly reflect your business or its goals.

  • Before you hire an outsider, ask yourself if you are expecting them to own the QMS implementation, or if you just need their support to help understand, perform gap analysis, audit, or coordinate the resources to help you to own the system.  Ask yourself whether you are truly taking accountability for the effectiveness of the QMS.  If you haven’t committed to the QMS and ensuring its effectiveness, it’s not time to hire a consultant.

  • Before spending your earnings on the technical writing skills of someone who is not personally invested in your business, ask yourself if you are able to define your own quality policy and quality objectives that make sense within the context of your own business.  A quality policy and set of quality objectives that meet requirements but are not aligned with your actual business goals aren’t worth very much.  If you can’t write your own policy that aligns with your business strategy, it’s not a good idea to bring in an outsider to do it for you.

  • If you think that having an outsider communicating the importance of conforming to QMS requirements will ensure that the QMS will be embraced, you’re wrong.  Your people need to hear this from you.

I am a bit of a contrarian, I know, but it is my opinion that you absolutely should not, manager, rush off to bring in an outside resource to implement your QMS.  You should make sure that you understand your business and the reasons that you are implementing the system.  You should commit to its implementation and its effectiveness, and actively communicate that commitment throughout your organization, whilst also demonstrating that commitment by actively working to ensure that your business processes meet quality system requirements.  They need to hear and see it from you, not some outsider.

Trickle-down might not actually work in economics, but absolutely does in organizational management.

This means that you, as a leader in your organization, need to understand the requirements of the Standard that you are planning to certify against.  If you are going to expect those who work within your organization to conduct business in a way that meets QMS requirements and advertise to your customers that you have a QMS that is compliant to ISO 9001, it is generally a good idea that you know what that means. 

So that brings us to the answer as to when you should bring in a consultant.  Like most things related to implementing ISO 9001, you should do this when it makes sense for you within the context of your organization and is in alignment with your strategic goals.  

You need to bring in outsiders when it provides value for your organization, not just profit for the consultant and a framed piece of paper on your front lobby wall.  When you have already committed to implementing a QMS to increase value for your customers and to continually improve your business processes, but you need support to ensure that requirements are properly understood and implemented.  Bring in some outside help would you need some experienced professionals to train your team or some support to objectively audit your system.  

You should bring in outside help when it is help; when it buttresses your own efforts to implement the system that you have already committed to.  Otherwise, you might be adding to the consultant’s revenue and padding his resume, while you find yourself with a worthless certificate that means nothing to you and even less to your employees and customers.




About Steven Severt
Steven Severt, who writes for isoTracker QMS, is a Quality Management professional with nearly two decades of experience in the automotive and medical device industries.  He has extensive experience launching and supporting manufacturing processes to supply automotive OEMs as well as developing, supporting, and auditing Quality Management Systems that adhere to the requirements of ISO 9001, IATF 16949, ISO 13485, and 21 CFR 820.

The content & opinions in this article are the author’s and do not necessarily represent the views of ManufacturingTomorrow

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