The purpose of a quality audit is to assess or examine a product, the process used to produce a particular product or line of products or the system supporting the product to be produced. A quality audit is also used to determine whether or not the subject of the audit is operating in compliance with applicable laws and regulations, etc.
The objective of Audit: To ensure continuing suitability, adequacy, improvement & effectiveness of Quality Management System.
AQC Auditors perform System, Process, Product and Compliance audits.
AQC provides Auditing, Assessment and Inspection of:
- ISO 9001
- ISO 13485
- WHO GMP
- 21CFR 820
- ISO 14001
- ISO 18001
- Schedule M
- EU Directives for Medical Devices
TRANSITION
- Schedule- Vth Medical Device Rule 2017
INTERNAL AUDIT
We at AQC provide internal auditing services for those organization who do not have the time, knowledge or experience to handle internal audit activity. As a result, regulatory compliance and ongoing quality management system/improvement often do not receive the attention it requires.
STRENGTHS OF INTERNAL AUDIT SERVICE ARE:
- Providing guidance to develop internal audit/ self-inspection procedure as per applicable regulation for the organization.
- Preparation of Audit Schedule considering the process risk basis.
- Providing training to staff how to handling Quality Audits.
- Conducting Audit and preparation of report considering the unstated rules for taking appropriate CAPA.
- Providing the best suggestive CAPA on low cost to compiles all applicable regulation.
CUSTOMER OR SUPPLIER AUDIT
We at AQC provide supplier audit and qualification services by highly qualified, experienced and certified professional Auditors and inspectors with respect to applicable requirements of an organization.
STRENGTHS OF CUSTOMER ON SUPPLIER AUDIT SERVICE ARE:
- Providing guidance to develop Supplier Audit & Qualification procedure as per applicable regulation for the organization.
- Preparation of Audit Schedule considering the product risk basis.
- Providing training to staff how to conduct supplier audits.
- Business risk base assessments- If a supplier have a very attractive price and delivery, they would not be given a contract where the risk
was involved due to weakness in their Quality Management System.
PRE-AUDIT/ ASSESSMENT
We at provide Independent or pre-certification assessments by highly qualified, experienced and certified professional Auditors with respect to full compliance and successful certifications.
STRENGTHS OF PRE- AUDIT/ ASSESSMENT SERVICE ARE:
- Gap analysis with suggestive Corrective Action to compliance as applicable regulation.
- Providing complete support during inspection and audit.
- Provide audit-readiness assessments on competitive pricing within the Industry.
- Assessments by Certified Auditors and Experts.
