ISO 9001:2015 Quality Management System Certification is an important step for any business looking to gain a competitive edge. The decision to begin pursuing certification ultimately rests with the organization’s management team and their commitment to this endeavor. One of the most frequently asked questions, during the initial consultation, when we work with organizations is how long is this project going to take? Of course, the answer to this question is that it depends on many factors. One major factor is the commitment of the management team in pursuing this certification project.
Factors for time to ISO 9001 certification:
- Size of facility and staff
- Complexity of processes
- Existing quality system in place
- Are you measuring key processes (data for key process indicators)
- Management commitment
- Resource allocation
- Current knowledge of standard requirements
Management Commitment and Resource Allocation to ISO 9001 Certification
When it comes to establishing and implementing a quality management system such as ISO 9001 the commitment from top management is very critical. Once the decision has been made to get certified, resources then must be allocated to make that decision a reality. The organization must evaluate its resources and knowledge pertaining to the ISO 9001 requirements. If there are individuals within the organization who are experienced with the standard’s requirements and how to implement them then the organization can pull from within. However, if the goal is to be certified rapidly then the question needs to be asked if there is room for this individual or team to allocate the time required to get certified.
Typically, the organization does not have staff well versed enough, with enough time in their schedule to devote to this certification project. Additionally, even if they are well versed on the requirements, the question must be asked if they have experience with QMS implementation. It has been our experience that the individual tasked with preparing and implementing the QMS will be pulled in multiple directions during the course of the project and eventually the project will stall or take three to four times longer than expected.
Scope and Nature of the QMS Certification
Several other elements need to be considered when estimating the effort and time to get all the QMS requirements in place. First, is there any existing quality management system in place? If there are some elements already in place these will have to be reviewed and assessed for conformance to the standard’s requirements. The best approach to determining if you are meeting some of the requirements already is to perform a gap analysis on your current system.
We also regularly perform rapid gap analyses for our clients to help them gain an accurate picture of where they are in their QMS implementation.
Once the gap analysis is completed the organization will have a clear picture of the current system and gaps that still need to be addressed.
The scope and nature of the QMS also plays into the length of time needed to prepare the QMS for certification. The employee count, facility size and process complexity are key factors that will play into the time commitment. Once processes are nailed down to be included in the QMS scope then the organization can develop documentation to control the risks associated with those processes. Measuring and data collection for core or key processes to the organization is critical for your ISO audits. Generally, registrars’ auditors are looking for 2-3 months of data measuring key processes. Key performance indicators (KPIs) should be measurable with established targets or goals along with plans to achieve those goals.
Minimum Time to ISO 9001 QMS Certification
For a small organization with an employee count between 1-50, low complexity processes, and limited risks we can generally have them prepared for their stage 1 certification audit in as little as two to three months. If the QMS is partially implemented the timeline could be expedited but a gap analysis would initially be performed to determine the level of implementation.
In contrast, using internal resources and staff to implement has historically taken a minimum, from our experience, at least six to eight months to implement.
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