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How long does it take to implement an ISO 9001-based QMS?

Gap analysis and definition of the implementation steps can help you estimate length of the QMS set-up. See what else could help to do the estimate.

When you are implementing a Quality Management System (QMS) according to the requirements of ISO 9001:2015, you will probably wonder how long this will take. There is no simple answer to this question because ISO 9001 implementation differs so much from company to company, but there are a number of things you can do to get a good idea of what needs to be done and how long it will take.

How long will it take?

The durations for implementation will vary from company to company, but company size is often a big predictor of the time it will take to implement ISO 9001:2015. Some rules of thumb would be:

  • Companies of up to 10 employees – up to 3 months.
  • Up to 50 employees – 3 to 6 months.
  • Up to 200 employees – 6 to 10 months.
  • More than 200 employees – 10 to 20 months.

These estimates do not include any required time to operate your QMS before your certification audit as dictated by your certification body. The time that you need to operate your QMS and perform these tasks will be set by your certification body; i.e., all certification bodies have a pre-determined timeframe that they want the Quality Management System to operate and accumulate records for them to be able to satisfactorily audit and determine it is in compliance with the ISO 9001:2015 standard requirements. These timeframes differ between certification bodies, but I have not heard of them accepting less than six months of QMS operation before the certification audit.

How can you speed up implementation?

The most important activity to have in place to speed up implementation is management support. When management is behind the implementation, you will find that roadblocks can be removed more easily and quickly. Additionally, if you already have many processes and procedures existing, or if you already have another management system in place, such as ISO 14001 or ISO 27001, you may find the time to implement is reduced.

Here are a few simple things to consider when you are calculating how long ISO 9001 implementation will take for you:

Thorough gap analysis: a key tool to determine what needs to be done – A good gap analysis is critical when deciding how much needs to be done during your implementation. This is very often the best place to start when you are trying to determine how much work it will be to implement the requirements of ISO 9001:2015. With a gap analysis tool, you compare what you already have in place in your company with the requirements of the ISO 9001:2015 standard and identify what processes and procedures you already have in place that meet the requirements and what you are missing. Then you identify what you need to close the gap. If your company is already very process based, rather than using ad-hoc activities, you will find it easier to implement an ISO 9001:2015 QMS.

For a simple, yet effective gap analysis, check out this online ISO 9001:2015 Gap Analysis Tool.

  • Know the overall implementation to better judge time – Apart from analyzing the gap between your system and the requirements, it is important to have a good handle on what the overall process of implementation will entail. For this, it is best to consult a good ISO 9001 Implementation Diagram that will give you the steps to follow for a successful implementation. If you don’t know what steps will need to happen, it becomes impossible to budget the time necessary to make them happen, since you will always have a surprise activity popping up.
  • Do you have the right implementation project manager? One of the best ways to manage your ISO 9001:2015 implementation is to treat it as a project, so this would mean having a project manager. So, how capable is your project manager? How well do they understand a Quality Management System and the ISO 9001:2015 requirements? An experienced QMS project manager will be able to help your company implement your QMS much more quickly than someone who needs to learn as they go along.

For more information on choosing a project manager, see this article on How to choose a project manager for your ISO 9001:2015 implementation.

  • Do you start from nothing, or bring in outside help? Of course, it will take longer to implement if you need to gather all the information about implementation yourself and gain the knowledge to make the implementation work. An expensive way to supplement your own work is to hire a consultant, and there are many good consultants out there, or you could find templates for your procedures that can help you to more quickly and easily document the processes you need to document.

Budget, but take the time you need

This can be hard to sell to top management, but it is important to take the time required for implementation and not rush certain steps. There are many ways you can help yourself along, such as documentation toolkits to make it easier to implement the necessary procedures, but some things need to be done fully to gain the benefits. For instance, it is not good enough that 90% of your workforce understand and know what is happening with your QMS and the procedures that affect them; everyone needs to know how they fit into the Quality Management System for it to work.

When it comes down to it, the reason you are implementing a Quality Management System is to empower your employees to find improvements that will improve customer satisfaction; so you want to take the time needed to make sure this happens and your QMS works for you to make things better.

To estimate the time needed for your ISO 9001 implementation try using this free ISO 9001 Implementation Duration Calculator.

Advisera Mark Hammar
Mark Hammar
Mark Hammar is a Certified Manager of Quality / Organizational Excellence through the American Society for Quality and has been a Quality Professional since 1994. Mark has experience in auditing, improving processes, and writing procedures for Quality, Environmental, and Occupational Health & Safety Management Systems, and is certified as a Lead Auditor for ISO 9001, AS9100, and ISO 14001.