Step 1 - Assessment of current documentation and management system
One of the initial steps in implementing your ISO 9001 quality management system (QMS) is determining your starting point. Generally, it is recommended that you perform what’s called a Gap Analysis.
The Gap analysis will assess your current documentation status and determine where you are currently meeting the standards requirements and where you are deficient. As the name implies the gap analysis is performed to uncover the gaps in the system. Once you find the holes in your management system you can begin addressing them.
If you are comfortable with navigating the ISO 9001 standards requirements, then the gap analysis will be straight forward. If you aren’t, then it is recommended that you hire an ISO 9001 consultant. A consultant will be able to assess your system rapidly and give you an accurate picture of where your organization stands with regard to the QMS being audit ready.
One note is that the gap analysis different from the internal audit that will be required to be performed in that the gap analysis is a high-level review of the QMS documentation to determine your system readiness for the more robust and in-depth internal and external audits.
Step 2 – Establish and Implement the Quality Management System
Once the QMS documentation has been written and established you will begin to train and implement any of the SOP’s and WI’s developed if staff is not already following these procedures. A quick note is that the ISO 9001 standard does not require the development or use of work instructions per se. It simply states that a process must be carried out in a controlled manner. If you think work instructions are necessary for control of your processes, then develop them. If not, don’t sweat it!
Step 3 – Checking the QMS
Performing the required internal audit to check the status of your newly implemented management system is critical. It is important that the individual conducting the audit be competent on the QMS requirements. The standard also states that you deem what your organization considers to be competent. Generally, most internal auditors are intimately familiar with the standards requirements and have taken an internal auditor course. Although, this is not a hard requirement of the ISO 9001 standard.
The internal audit consists of doing a deep dive into the organizations QMS to ensure all requirements have been adequately address. This will include employee interviews, document review, and sampling records to provide objective evidence of conformance with the requirements of the standard. Any nonconformance will need to be addressed prior to the external certification body audit and effectively closed.
Step 4 – Certification / Registration Audit
At some point during the prior three steps, you should be working with a Registrar and scheduling your certification aka registration audit. This is an external audit with an independent auditor who will assess your QMS’s for conformance to the ISO 9001 standard. Any issues discovered at this point will be documented as a minor nonconformance and major nonconformance and will be required to be addressed and closed in order to become ISO 9001 certified.
Certification Success
The above 4 steps are the basic steps to move your organization toward successful ISO 9001 certification. There is a lot of nuisances to this process that will be specific to the organization implementing the system. The resources available and your comfort level with the standard requirements will be the main factors in determining whether you need to hire a consultant to aid you in your audit preparation.
For most small businesses, resources are limited and hiring a consultant can expedite the process significantly as well as give you piece of mind that you have implemented everything correctly. This project can most certainly be done on your own but factors such as timeline, cost, and available resources will have to be considered.
Schedule a call with us today to get all the details nailed down. Getting a proposal is free of charge and we can run through your current situation and make some determinations on what will be best fit to you and your organization’s needs. We are here to help!
