Creating ISO 9001:2015 Quality Management Systems (QMS) that fulfills the requirements of the ISO Standard can seem like a daunting task. But it doesn’t have to be. Creating an ISO 9001-based QMS should be done like all projects. Priorities need to be established, responsibilities determined, and milestones set. But what priorities? What are the key milestones? How do you get started?
The four critical steps to successful ISO 9001 implementation
They tell me the way to eat an elephant is in bite-sized chunks. The same with your ISO 9001 Quality management system.
By presenting one possible approach to implementing ISO 9001, we will answer these questions in this section of the introduction. To simplify the discussion, we will divide the ISO QMS implementation project into four distinct phases. By breaking the implementation into stages, it becomes more manageable and less overwhelming.
Phase One Foundation Processes
Phase Two Continual Improvement Processes
Phase Three Management Resources
Phase Four Data Management
Don’t underestimate the time it takes
At Bizmanualz, we have helped a number of small and medium sized businesses move from having no QMS to becoming ISO 9001 certified. It is a process that usually takes about six months, but it can be done in three to four months for very small companies. It could take 12 to 18 months for a larger company. This includes establishing all the required elements of the ISO Quality Management System and getting it off the ground functionally using ISO 9001 Quality Procedures Manual.
Continuous improvement is the goal
One way to establish priorities and milestones is to use the organization of the ISO 9001:2015 QMS Requirements itself as a pro-forma project plan. The project we describe in this section is heavily influenced by the layout of the requirements. Recall, however, that the ultimate goal of ISO 9001 QMS is continual improvement. So, to gain the benefits of improvement, an organization has to be committed to maintaining and modifying the system over time to best suit its needs. Creating the ISO 9001 QMS is just the beginning.
Create an ISO Implementation Plan
Since the best approach is to treat your ISO 9001:2015 transition plan as a project, you should start with a project plan that estimates the resources needed (people, materials, expertise) and the project timeline from the beginning until the certification audit. If you have experience and knowledge of the ISO 9001 requirements, you might begin with a gap assessment, which provides input into the project plan. A gap assessment is just as the name describes – comparing current systems and documentation to what is needed for a system that is ISO 9001 compliant.
If you don’t feel comfortable with the ISO 9001:2015 Changes to the standard, then perhaps the first step is ISO training for you and members of the project team or ISO Steering Committee. The ISO Steering Committee includes key members from the quality department along with representatives from other departments such as Sales & Marketing, Design & Development, Human Resources, Production, and Accounting.
The Steering Committee members provide valuable input to the ISO 9001 QMS development project about systems and processes, they divide up tasks and actions items, and assist in distributing important information throughout the organization. But remember, involving a committee can also take more time as you wait for meetings in order to make decisions and follow-up on actions. So be sure to build such delays into your project plan.
Editors note:
Can the food safety team be the steering committee?
As a food company, it is very likely you have a food safety team in place. A special word of caution regarding only using this team for the implementation of ISO 9001. The scope of most HACCP or FSSC 22000 systems starts at receiving – but this is not the start of your core business process. The involvement of sales, marketing and procurement may have been limited – now their input is critical. The focus of the flow diagram has been the production processes – the core business process is much more than that.
One system – not two
The ISO steering committee should consider integrating the ISO 9001 QMS with other management systems from the outset. There should be no duplication of effort or documentation for food safety, health and safety or quality.
Be sure to look out for part 2 in Starting the Journey to ISO 9001 Certification series below.
Author
Chris Anderson
