What is the process of ISO certification?
Here we show you how the ISO 9001 certification process works and how you can use this scheme for your own certification. A certificate confirms the successful implementation of the requirements of DIN EN ISO 9001 in the company’s quality management system and has a corresponding external effect. Suppliers and customers receive the certainty in a certificate that a systematic and recognized quality management is being applied within the company. Quality management certification is by no means a process that can be resolved within a few weeks or even days. First of all, a QM system must be set up and established and the specific requirements of ISO 9001 must be dealt with in order to implement them into implement quality management system.
Experience shows that certifications accompanied by experts have a significantly higher chance of success. For this reason, it is advisable to get external help on board at this point. This external consultant, a QM expert, supports you in the planning, development and establishment of your quality management system and, in cooperation with you, creates the prerequisites for successful quality management certification. This page introduces you to the individual steps on the way to your certification. Regardless of whether you want to have your quality management, an environmental or another management system certified, the quality management certification process follows the certification steps presented below – starting with the pre-audit, through the certification audit to the monitoring and recertification audit. It is important to know that not all certification steps always have to be carried out.
What must be done in preparation for ISO 9001 certification?
After you have introduced your quality management system in the company and checked its effectiveness, you can start preparing for ISO 9001 certification. These preparations mainly relate to the following points:
- Select a certification authority
- Application and contract conclusion with the selected certifier
The pre-audit in connection with the certification process
Before the actual certification audit begins, your quality management system is subjected to a pre-audit. This pre-audit is not a compulsory part of the certification process, but represents a voluntary pre-audit. In this pre-audit, you and your external consultant and experts check whether your quality management system and the QM documentation already meet all the requirements of ISO 9001 and whether certification is possible. Companies can uncover any ambiguities in the course of the pre-audit and overcome them before the quality management certification.
A pre-audit is characterized by the following features:
- Not a must-have part of the actual certification
- Does not have to be carried out by a certification authority
- No condition for obtaining certification
The certification audit of a quality management certification
The actual ISO 9001 certification, during which an external certifier checks the implementation of the requirements in your QM system, takes place after the pre-audit, which may have been carried out. The certification audit consists of the two steps of the certification audit stage I and the certification audit stage II. There should be no more than 3 months between the implementation of the certification audit stage I and II.
What is the purpose of the Level I certification audit?
The Stage I certification audit ensures that the auditor carries out a detailed review of the QM documentation at the beginning. The auditor makes sure that the requirements of the standard are met by the QMS. This is followed by a location assessment. The location and location-specific conditions of the quality management system are evaluated. Based on the results obtained, the auditor then determines the readiness for the certification audit stage II. After the documentation of the results, the certification auditor agrees with your company any need for action. In the event of minor deficiencies, you will receive a message to remedy these up to the stage II audit. Corrections can be made to the QM system before the Stage II certification audit. In the event of serious deficiencies, the auditor can also terminate the certification audit prematurely if, according to the current status, no ISO 9001 certification can take place.
- Assessment of the documentation of the quality management system
- Assessment of the location and location-specific conditions
- Determine readiness for the Stage II certification audit
- Collection of necessary information for planning the certification audit stage II
What then happens during the Stage II certification audit?
The Stage II certification audit ultimately serves to check the effectiveness of the ISO 9001 quality management system and its conformity with the ISO 9001 requirements. When checking the effectiveness, the auditor can use various methods, such as employee interviews or inspections of the production or service facilities.
This is followed by a further, even more intensive review of the documentation from the QM system during the Stage II certification audit.
- On-site inspection of the quality management system
- Collection of evidence and information on conformity with the ISO 9001 standard requirements
- Another intensive document review
- Evaluation and testing of the effectiveness of the QM system and the implementation of ISO 9001 requirements
Evaluation of the audit results in the certification process
After the auditor has carried out the certification audit, he then creates an audit report and evaluates the results obtained during the audit. Results that are typically found during the certification audit are:
- Conformity with the requirements of the standard
- Non-conformity with the standard requirements
After the audit report has been drawn up, a final meeting takes place between the auditor and your company. The certification auditor gives you an overview of the certification process and presents the results to you. In addition, you will be informed of any non-conformity of your QM system with ISO 9001 and, in this case, you will also receive suggestions on how you can remedy or improve these non-conformities. If the certification auditor found deviations from the standard, your company must then take the following steps:
- Analyze the causes of the non-conformities
- Define appropriate corrective measures
- Have the corrections assessed by the certification body in a follow-up audit within 90 days
The post-audit – process of an ISO 9001 certification quality management
In the event of deviations, a follow-up audit must be carried out, whereby the effectiveness of the defined corrective measures is assessed by the certification body. Although the follow-up audit only relates to the review of the improvement measures, it increases the certification costs. A re-audit is not necessary if the auditor did not find any deviations from the standard requirements during the ISO 9001 certification audit.
How do I get my ISO 9001 certificate after a successful certification audit?
If all requirements are met, you will receive your quality management certificate. However, the auditor himself does not issue the certificate. Rather, the auditor recommends you to the certification body, which then issues the certificate in the form of a “named person”. This named person first checks the audit documentation, especially the audit report, and finally approves the certification process.
Surveillance audit & recertification in the certification process
A certificate is not to be understood as a perpetual “free ticket”. If your QM system has ISO 9001 certification, the certificate is valid for 3 years. ISO 9001 expressly requires continuous improvement of the QMS so that an annual monitoring audit takes place until the next recertification. Two surveillance audits are therefore necessary before recertification. The aim of these surveillance audits is to determine whether your QMS continues to meet the requirements for quality management certification. After your ISO 9001 certification has expired, your quality management system will be recertified.