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E & E Medicals: FDA, ISO, Licensing & Compliance, Mark Approval, QA, Medical Supplies and ConsultingE & E Medicals: FDA, ISO, Licensing & Compliance, Mark Approval, QA, Medical Supplies and ConsultingE & E Medicals: FDA, ISO, Licensing & Compliance, Mark Approval, QA, Medical Supplies and Consulting

Audits

Quality Assurance Audits

To maintain quality system, it is essential that you carry on routine quality assurance audits to eliminate the reduction in product quality, improve processes, eliminate loss of third party certifications of FDA enforcement.

Three Different Types of Quality Assurance Audits

ISO 9001 defines an audit as a “systematic, independent and documented process for obtaining audit evidence [records, statements of fact or other information which are relevant and verifiable] and evaluating it objectively to determine the extent to which the audit criteria [a set of policies, procedures or requirements] are fulfilled.”

Quality assurance audits could be carried out through Process, Product, and Systemic verification.

Process Audit: This form of audit examines whether the processes operate within the defined limits. This assesses the method for measuring the compliance within requirements and reliability of the instructions against pre-determined guidelines and standards.
Product Audit: An audit that examines a product or service to evaluate its conformance to established requirements such as specifications, performance standards, and customer requirements.
System Audit: These are audits conducted on management systems. Verifiable activities relate to examination and evaluation of objective evidence through documentation or observations.

QMS audits help to evaluate the quality management program of a company or organization based on its conformance to company policies, contract commitments, and regulatory requirements.

Medical Devices

ISO 13485:2016
US FDA 21 CFR Part 820
European MDD / AIMDD / IVDD
ISO 14971 Risk Management
IEC 60601 Electrical Equipment
Brazil ANVISA
EU MDR / AIMDR / IVDR
Canada CMDR
Australian TGA
Japan MHLW Ordinance 169 Pharmaceutical
US FDA 21 CFR 210 & 211
PIC/S GMP Guide
ICH Q7 GMP Guide for APIs
ICH Q10 Pharmaceutical Quality Systems
PS 9000:2016 Pharmaceutical Packaging

Quality Management

ISO 9001:2015
ISO 17025 Testing & Calibration

Other Management Systems

ISO 14001:2015 Environmental Health & Safety
OHSAS 18001 & ISO 45001 Occupational Health & Safety
ISO 27001 Information Security