OUR services
Internal Auditing
ISO, FDA and EU regulations require that companies conduct Internal Audits to ensure that the appropriate regulations are being followed. Unless there are company dedicated Internal Auditors, there may be a risk of conflict of interest if internal auditors are conducted by company employees. PQS Auditors are highly experienced and will provide an internal audit experience that is guaranteed to improve and optimize your processes. We conduct Internal audits to the following standards:
- ISO 9001:2015; AS9100:2016
- ISO 13485:2016
- 21 CFR 820
- EU-MDR
- Other regulatory standards.
Supplier Auditing
The regulatory bodies expect that the critical suppliers are audited periodically to prevent supply chain issues. PQS can perform your supplier audits and ensure that your critical suppliers are compliant to the applicable regulations and/or quality agreements. We provide supplier audits to the following standards:
- ISO 9001: 2015; AS9100: 2016
- ISO 13485:2016
- cGMP 21 CFR 820, 21 CFR 210 &211
- EU-MDR
- Other regulatory standards
Quality Consulting
PQS provides Quality Systems and Quality Assurance and Compliance consulting services. Our consulting services are as follows:
- QMS Implementation
- QMS Optimization
- Quality remediation and Compliance
QMS Training
PQS provides QMS training to companies that are desirous of implementing or optimizing an ISO 9001 or ISO 13485 Quality Management Systems. Our highly experienced trainers will go the extra mile to ensure trainees' goals are met. We offer training to the following standards:
- ISO 9001: 2015; AS9100: 2016
- ISO 13485:2016
- cGMP 21 CFR 820, 21 CFR 210 &211
- EU-MDR
- Other regulatory standards