Creating a Quality Management System (QMS) that fulfills the requirements of the ISO 9001:2008 Standard can seem like a daunting task. But starting ISO 9001 Certification doesn’t have to be.
Starting ISO 9001 Certification
The first step in starting ISO 9001 Certification is to create 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 I get started? These are the questions we will answer in this article series. To simplify the discussion, we will divide the ISO QMS implementation project into four distinct phases, and cover phase one here.
At Bizmanualz, we have helped a number of small and medium sized businesses with starting ISO 9001 certification. These businesses move from having no real 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. A project typically includes establishing all the required elements of the ISO Quality Management System and assisting them in getting it off ground functionally.
One way to establish priorities and milestones is to use the organization of the ISO 9001:2013 QMS Requirements itself as a pro-forma project plan. The project we describe in this series is heavily influenced by the layout of the requirements.
The ultimate goal, however, of an ISO 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 QMS is just the beginning to starting ISO 9001 Certification.
Create an ISO Implementation Plan
Since the best approach is to treat your ISO implementation as a project, you should start with a project plan that estimates the resources needed (people, materials, expertise) and the project timeline from 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 9001:2008 Standard, then perhaps the first step to starting ISO 9001 Certification 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 like Sales & Marketing, Design & Development, Human Resources, Production, and Accounting. The Steering Committee members provide valuable input to the ISO 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. While you’re starting ISO 9001 Certification, be sure to build such delays into your project plan.
Start with Clause Four in the ISO 9001 Standard
The QMS really starts where the ISO 9001 General Requirements begin – in Clause 4, and that is where the efforts of phase one are focused. It is well established that ISO 9001 is a process-based standard, and the General Requirements listed in 4.1 establish this clearly:
- Determine the processes of the QMS
- The sequence and interaction of the processes
- The criteria and methods to ensure process are effective
- Ensure availability of resources and information to operate and monitor the processes
- Monitor and measure and analyze the processes
- Continually improve the processes
The first two items are the focus while setting up your ISO QMS. The remaining four become central as you maintain the ISO QMS and use it to improve the organization. After you’ve accomplished this, you want to think about starting ISO 9001 Certification.
Therefore, step one in creating the ISO QMS is to understand and define the processes of the QMS. Understanding your processes is key to a functional QMS. There is a scope question each organization has to answer (which will also eventually be included in the Quality Manual). Exactly what processes will be part of the ISO QMS? The ISO QMS could encompass the entire organization, a particular facility, or perhaps just a single product line.
One way to get started defining processes is to consider the over-arching, top level processes that convert supplies and resources (i.e. materials, knowledge, and capital equipment) into customer deliverables. Figure 1 shows the top level processes of a typical organization. If necessary, once top level processes are defined, you can identify key sub-processes that make up the top level process. Notice that Figure 1 also displays the interaction of the top level processes.
Be sure to identify the process owners who have ultimate responsibility.
Creating the First Level of ISO 9001 Documents such as the Quality Manual
Once the QMS processes are defined, you are ready to start the next step in phase 1: creating the first level of documentation. The first document tier in the QMS consists of the Quality Manual, the Quality Policy, and the Quality Objectives.
By having already clearly defined the QMS processes, creating a draft of the Quality Manual becomes easier because you have already determined much of the key content. Remember, the description and interaction of the processes in the Quality Manual does not have to be large amounts of text. Diagrams, process maps, and flow charts all describe processes just as well, if not better, than verbal descriptions. Also, be sure to list all exclusions your organization has to the ISO QMS.
Completing Phase One with Quality Policy, Quality Objectives, and Document Control
At this point you have completed two crucial steps on your way to ISO compliance — defined processes and a draft of the Quality Manual. The next step after starting ISO 9001 Certification is to write drafts of the quality policy and quality objectives. Remember, the quality objectives should be measurable and align/fulfill the quality policy.
The last step for phase one of your ISO QMS project is to create the document/record control system that will be used for the QMS documents. How are they reviewed and released, updated, stored, and retrieved? These questions should be addressed in ways that meet the requirements for document and record control established in Clauses 4.2.3 and 4.2.4. This also includes writing the drafts of the required Document Control and Record Control procedures that will define your system of documents and records.
Now, at the end of phase one, you have fulfilled most of the requirements established in Clause 4 of the ISO 9001 Requirements, and you have also created the framework for meeting the additional requirements in other clauses of the ISO 9001 Standard. While you may only have drafts of the quality manual and document and record control procedures, having a good draft in place represents a majority of the effort, and is essentially when starting ISO 9001 Certification.