Mark Hammar 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 can make this work the first time. For most companies, time and resources are precious and the risk of wasting them on a poorly planned project is too great. This is why it is critical to ensure that you properly plan up front in order to avoid costly problems and delays later in the project.
Here are the must-do activities to help ensure a successful implementation for your Quality Management System (QMS):
Start with management support
As I argued in How to get Management Buy-in for ISO 9001 it is critical that you have management fully on board the implementation bandwagon. It is up to your top management to ensure that you have all the necessary resources (time, people, money, and equipment) to follow through on the project of implementing the QMS to completion. If management is not there to support your efforts and remove roadblocks to success (you can be sure there will be some roadblocks), you will suffer setbacks and delays. The full support of top management can be the difference between a very successful and effective QMS, and a QMS that is only there on paper, but unhelpful for the organization.
For some helpful tools for planning and presenting your proposal for implementing ISO 9001, check out these PowerPoint presentations: Project plan for ISO 9001 implementation and Project proposal for ISO 9001 implementation.
Decide how to approach the implementation
Like everything in life, trying to go forward with a project without having the essential knowledge is risky and prone to failure. There are different ways to obtain this knowledge, mostly dependent on how you choose to proceed with your implementation.
- Work by yourself: This option is good if you have the time to invest in training your own people. You will need people trained in the different elements of ISO 9001, how to properly document the processes, and how to perform internal audits as a minimum. Learning this yourself is doable (there are many organizations that provide training on these topics), but might take some time to do. The big benefit is that all the knowledge about your QMS stays in your organization when you move from implementation to maintaining and improving your QMS.
- Hire a consultant: If you have the money, this is probably the quickest option since the consultant, if you choose the right one, will have all the necessary knowledge about ISO 9001. This, of course, comes at a price, and at the end of the implementation the consultant will leave with the knowledge unless you have also trained people to maintain the system.
- Online resources: This can be a good balance between the two options above, but does come with some challenges. If you are going to try to gather separate documents from different online resources, you might have some trouble making them consistent and tailoring them to your organization, and there may not be support to help you along. Make sure you can get the support you need when using online resources, especially if you pay for a package of consistent documents.
Choose the right project manager
Your QMS implementation is a project, and should be treated as such. A good project will have a plan including all tasks required, when they need to be done, and who is doing them. Without this basic control, your implementation can drag on, incomplete, due to confusion among the people who should be on task. In order to have a successful big project, a project manager is necessary to keep everything on track.
While many companies will assign the task of project manager to the manager of quality (or equivalent), this isn’t mandatory. The project manager does not need to be the company expert on quality, but does need to know enough about what a QMS is, the tasks to be done, and how to manage the project. Choosing someone who is good at controlling the project may be your best route to a successful implementation.
Know the steps required for the project
Although there are many individual steps in the process of fully implementing and certifying your quality management system, there are three basic phases that these steps fall into:
1) Assessment and planning: In this phase you will get the support and resources you need and identify the requirements and scope of the implementation project. Any training and knowledge acquisition needed for understanding how to implement the system should happen during this phase.
2) Implementation and operation: Here is when you will write necessary documents and train everyone about the QMS and any process changes required to comply with the standards. You then operate the QMS for a defined amount of time, audit the processes, and have management review the system and address any corrective actions required. This lets you gather the records needed to show successful implementation.
3) Certification: When you have completed your implementation, the auditors from your certification body will come and assess your QMS for compliance against ISO 9001 requirements.
For detailed information on the steps you need for the full implementation of ISO 9001, see Checklist of ISO 9001 implementation & certification steps.
To ensure a successful QMS implementation, the key is to plan and have the appropriate support. Good planning and properly applied resources can increase the chances of success of your project. Plan well and you can weather the storms that will come during implementation and finish your project in a timely, efficient, and cost-effective manner.
Download this free ISO 9001:2015 Implementation Diagram to see the whole implementation project at a glance.
