We offer Quality Management System certification against ISO 9001:2015 through a team of auditors based around the world. All have experience in auditing in multiple locations.
Assessment of the Quality Management System is through assessment visits, or audits. The aim of the assessment is to confirm the quality management system and business processes operate effectively. Details are gathered at the quotation stage to establish: the type of business that the quality management system is built around; the size of the business; the main functions and outputs of the business; and the risks associated with the activities.
These assessments can be completed in combination with assessment visits for ATEX Quality Assurance Notification and/or IECEx Quality Audit Reports, reducing the overall number of audits required for up to three QA certificates.
If you have existing Quality Management System certification against ISO 9001 and are considering changing your quality approval body to Eurofins CML, you are welcomed to contact us for a detailed discussion about your requirements.
The completion of an application form is required so that we can gather the necessary information to determine the scope of certification required. If Eurofins CML are able to provide the scope of certification required then a quotation for the assessment and certification of the quality management system will be prepared and issued.
Following acceptance of the quotation, the contract will be reviewed and an auditor will be assigned, a suitable assessment date will be arranged.
In order to provide a comprehensive assessment of the system and processes for clients with a previously uncertified quality management system the initial assessment is separated into two assessments, known as stage 1 and stage 2. Stage 1 is typically conducted during a visit and is to appraise the readiness of the quality system under evaluation, to establish the main business functions and processes, and to confirm the scope of the system. The second part of the assessment, Stage 2, is arranged when any outstanding actions raised at Stage 1 have been cleared and the auditor is satisfied that the quality management system is ready for full assessment.
The assessment is conducted in accordance with ISO/IEC 17021-1:2015, any findings identified during the assessment are provided to the client at the end of the assessment visit. Findings are categorised as major, minor or observations. Any major findings require addressing prior to certification. In the event that significant issues are found during the audit, a second visit may be necessary to confirm the effectiveness of any changes made to the quality system to ensure that it is operating effectively.
Once cleared, the audit report can be completed and reviewed before being submitted for certification.
Certificates will be issued with a validity of 3 years. During this time, two surveillance audits are to be conducted at 12 month intervals. At the end of the cycle a reassessment audit is to be conducted.
Clients operating multiple manufacturing sites will require additional visits or extended visits to cover all the necessary detail.
Training is also offered in QA requirements and compliance.