Basically, the ISO 9001 implementation process is based on the PDCA. The PDCA comes from the acronyms in English: P = Plan (plan), D = Do (do, carry out), C = Check (check, verify), A = Action (act, carry out).
First we develop a Plan, then We carry out what was planned, We check to verify that what was carried out was put into practice as planned, and finally we take Actions to improve our system and/or correct flaws (NC), which were found during audits.
See below the details of the process for implementing the ISO 9001 standard:
Step 1 – Making the decision to certify the company;
Step 2 – Choose a Consulting company;
Step 3 – Choose the best deployment method;
Step 4 – ISO 9001:2015 Standard Interpretation Training;
Step 5 – Planning the quality management system;
Step 6 – Operational activities;
Step 7 – Performance evaluation;
Step 8 – Continuous improvement;
Step 9 – Certification.
Step 1 – Making the decision to certify the company according to the ISO 9001 standard
It is the moment when the company understands or decides that obtaining the ISO 9001 Certificate is essential to improve processes, increase performance and satisfy customer needs.
Step 2 – Choosing a Consulting Firm
Implementing a quality management system requires experience and knowledge in the subject, so it is essential to choose a company you trust to help you achieve your goal.
Step 3 – Choose the best deployment method
There are 3 types of deployment: face-to-face, online and through a self-deployment system. Knowing each method and knowing which is the best for you and your company is very important, each one has a particularity and being satisfied with the chosen method contributes to the success of the implementation.
Step 4 – ISO 9001 Standard Interpretation Training
It is of paramount importance that all those involved receive the proper training in the Interpretation of the ISO 9001 Standard, in order to be able to develop their functions and roles within the quality management system.
Step 5 – Planning the quality management system
Step 5 is where we effectively start the QMS implementation process. The items of the ISO 9001:2015 Quality Management System planning standard are:
Item 4 – Context of the organization and all interested parties;
Item 5 – Leadership;
Item 6 – Planning;
Item 7 – Support.
Step 6 – Operational Activities
Item 8 of the ISO 9001:2015 standard establishes the operational activities:
8.1 – Operational controls;
8.2 – Requirements for products and services;
8.3 – Design and development of products and services;
8.4 – Control of processes, products and services provided externally;
8.5 – Production and service provision;
8.6 – Release of products and services;
8.7 – Control of non-conforming outputs.
Step 7 – Performance evaluation
After the previous steps, it’s time to evaluate the performance of your management system, and through the items below we evaluate the performance of our ISO 9001:2015 Quality Management system.
9.1 Monitoring, measurement, analysis and evaluation;
9.1.2 Customer satisfaction;
9.1.3 Analysis and evaluation.
Items that are part of the performance appraisal.
Item 9.2 – Internal Audit
The organization needs to carry out Internal Audits at planned intervals by qualified and certified professionals in order to identify failures that may affect the performance of the quality management system processes.
Item 9.3 – Critical analysis
The critical analysis meeting aims to evaluate the performance of the quality management system, and its result will serve to improve the system.
Step 8 – Continuous Improvement
After implementation, it’s time to think about the improvements we can make, the incessant search for continuous improvement of your processes, products and services is one of the goals that must always be pursued. No matter how good your Quality management system is today, there will always be areas for improvement tomorrow.
Item 10.2 – Non-compliance and corrective action
If by chance what was planned cannot be achieved for some reason, this means that there was a failure, and we identify failures in the system through the Non-conformities process. To correct, mitigate and eliminate these non-conformities that we have identified, we deal with corrective actions to prevent the same problems from recurring. It is better to learn from our mistakes than to make them again.
Step 9 – Certification
After the implementation of the quality management system, an audit is carried out by the certification body to certify that the system meets all the requirements of the standard.