Our approach to QUALITY
At QUAMED, we strive for high-quality of our services to meet or exceed our members’ and customers’ expectations. QUAMED aims to continually improve the services we provide to meet our client’s requirements and to produce finished products that we can justifiably be proud of.
Our Quality Policy
QUAMED has developed a comprehensive Quality Management System. We are also in the process to implement a Customer Relation Management (CRM) software that will improve our internal and external processes. An independent internal audit committee is in place to regularly assess and audit our operations and processes.
Our Quality Management System (QMS) is organized in a documentation pyramid of 4 levels.
Our Quality Policy describes our commitment to Quality.
QUAMED is certified ISO 9001:2015 (Quality management systems — Requirements) since October 2022.
-> to ISO certificate. Name: ISO 9001:2015 FS 766975
We are in the process to be accredited ISO 17065:2015 (Product Certification Bodies Accreditation) for the certification scheme (QCP) that QUAMED is implementing. The scope of the ISO 17065:2015 accreditation will be the pharmaceutical audits that we will conduct within our QCP program. The audits will refer to the following World Health Organization (WHO) standards : Good Storage and Distribution Practices guidelines (GSDP), the Model Quality Assurance System for procurement agencies (MQAS) guidelines and Good Manufacturing Practices guidelines (GMP).
Some key aspects of our Quality Management System (QMS)
Conflict of interest management
QUAMED is aware of the importance of impartiality and of potential conflicts of interest in carrying out its assessments, audits, certifications, training, and technical assistance activities.
QUAMED requires all its contracted staff and experts, as well as members of the Board of Directors and internal QUAMED committees to adhere to its conflict-of-interest policy and standard operating procedure as well to QUAMED’s code of conduct.
Our QMS describes:
- The recruitment process of external auditors.
- The validation process that external candidates will have to go through to become validated QUAMED auditors.
- The validation renewal and the suspension of the status of validated auditors.
The auditor validation, the renewal of validation and the suspension of validation is managed by the QUAMED operational team, jointly with the QUAMED Technical Committee. QUAMED’s Technical Coordinator (QUATC) manages the process.
Potential candidates who would like to become QUAMED-validated auditors are screened on the basis of their CV and the list of audits performed.
The screened candidates are invited to take part in a written test.
When the written test is concluded successfully, the candidate is invited for an interview.
When the interview is successful, the candidate is pre-validated and s/he is invited to a training on the QUAMED QMS.
To become validated, a pre-validated auditor must conduct at least one joint audit with a member of the QUAMED technical team to evaluate on site his/her auditing practices and knowledges of the WHO standards.
Then the report and the audit outcomes are evaluated by the QUATC and QUAMED’s Quality Compliance Coordinator (QCC). When the result of the first audit is positive the auditor will be validated and added to the QUAMED roster.
For the validated auditors, regular meetings are organised to discuss auditing techniques and processes, as well as technical issues such as procedures that have been updated or changed.
Each validated auditor is required to participate in an annual performance appraisal. The auditors’ participation in the regular meetings and her/his performance appraisal determines whether to renew or suspend her/his status.
Quality assurance of reports
Before our reports are shared with the auditees or with our customers, they are reviewed and quality assured by qualified staff members of the QUAMED operational team. This will ensure our standards are met. In regard to audit and technical visit reports, it also makes them comparable. The auditors and our operational team can at any time consult our Technical Committee.
Management of complaints
QUAMED is committed to providing high-quality services to the users of its services. Although QUAMED’s procedures are run under a Quality Management System which includes processes to avoid mistakes and issues, it may happen that the products and services delivered by QUAMED do not have the expected quality. QUAMED has implemented a process to enable the reporting and handling of complaints. Once a complaint is lodged, QUAMED implements a procedure that includes corrective and preventive actions to avoid the recurrence of the particular incident(s). Further information as well as the complaint form are provided below:
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