4 Steps to Achieving ISO 9001 Quality Management System Certification
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.
One word of caution is that if you are not decently familiar with the standard then performing the gap analysis on your own will be slow and painful! There exists ISO 9001 gap analysis templates that we provide or can be found online for free. However, again if you are not familiar with interpreting the requirements of ISO 9001 then you may find yourself struggling to determine if you meet the intent of the standards requirements or not.
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
Based on the results of the gap analysis, the next steps will be to address those gaps. Initially, establishing your QMS documentation will be the next items to tackle. Common QMS documentation will include; A quality manual (not a requirement of the ISO 9001 but still recommended in order to navigate your management system easily), a master document list, a flow chart showing your main processes, and an up-to-date flow chart will be needed. Other documentation may include organization specific standard operating procedures (SOPs) and work instructions. (WI) as deemed necessary for process control. Documentation related to handling customer complaints and feedback, supplier monitoring and control will also be required. Competency and training requirements for staff will need to be determined along with recording keeping for training. The documents necessary to fulfill the standards requirement can be determined from the standard itself or from use of a documentation template package that provides all the necessary templates for certification. The later simply takes the guess work out of what’s needed and expedites the establishment phase.
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.
One of the last items is to conduct the management review. What is to be reviewed (inputs) is quite literally prescriptively laid out in the standard. Additionally, the outputs of the management review meeting are also spelled out. A record of the management review will be retained for the external auditors review to ensure this requirement has been achieved and that all inputs and outputs have been addressed.
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.
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!
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