Auditing
Quality Systems Compliance, LLC provides auditing support including GAP ASSESSMENTS, INTERNAL AUDITS, SUPPLIER AUDITS, ASQ AUDITS, DUE DILIGENCE, MOCK FDA INSPECTIONS, and MDSAP AUDITS.
A GAP ASSESSMENT is a PROACTIVE approach which can provide an accurate picture for the management of the current quality management system. This type of audit can assist in formulating action plans prior to visits from Notified Bodies or Competent Authorities.
INTERNAL AUDITS are a REQUIREMENT for most ISO and Regulatory quality systems. Internal Audits are performed at least annually to internally identify potential compliance gaps. Internal Audits can also be used to assess the effectiveness of process interactions.
SUPPLIER AUDITS are a REQUIREMENT for most ISO based and Regulatory quality systems. Effectively managing the Supply Chain is crucial to ensure compliance in the Global Marketplace. Assessing and monitoring supplier capabilities and performance can help prevent unwanted surprises and regulatory compliance issues.
DUE DILIGENCE AUDITS are a must when considering a merger or acquisition. Before signing the agreement, ensure that the quality system and associated records are compliant with quality and regulatory requirements.
Commodities
Quality Systems Compliance Inc. provides SUPPLIER AUDITING and CONTRACT MANUFACTURING ORGANIZATION (CMO) AUDITING, experience with the following commodities:
-
- Machining…Manual and CNC (Milling, Turning, Grinding, EDM)
- Casting (Lost Wax, Die Casting, Sand Casting)
- Extrusion (Metal, Plastic, Tubing)
- Powdered Metals and Sintering
- Sheet Metal Stamping
- Welding (Metal and Plastic)
- Fabrication
- Blown Film
- Plating, Coating, Cladding, and Finishing
- Compression Molding
- Injection Molding
- Vacuum Molding
- Rotational Molding
- Raw Materials
- Plastic Resins
- Printing
- Blow Molding (Extrusion and Injection)
- Automated and Manual Assembly
- Wiring Harness
- Fiber Optics
- Printed Circuit Boards (PCB’s)
- Active Pharmaceutical Ingredients (API’s)
- Excipients
- Container and Closure Systems
- Dispensing and Weighing Systems
- HCT/P Human Tissue
- Animal Tissue
- Bulk Chemicals (Liquid and Dry)
- Translation and Localization Services
- Inspection and Sorting Services
- Laboratory Services
- Calibration Services
- Research, Development, and Design Services
- Primary and Secondary Packaging
- Food Ingredients
- Transportation, Storage, and Distribution
Standards
Quality Systems Compliance Inc. provides AUDITING with expertise with
the following STANDARDS:
-
- ISO 9001 Quality Management Systems – Requirements
- ISO 13485 Medical devices – Quality Management Systems- Requirements for Regulatory Purposes
- ISO 14001 – Environmental management systems — Requirements with guidance for use
- ISO 14971 Medical devices—Application of Risk Management to Medical Devices
- ISO 15378 Primary packaging materials for medicinal products – Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
- IATF 16949 Quality management system requirements for automotive production and relevant service parts organizations
- Medical Device Single Audit Program (MDSAP)
- ISO 17025 General Requirements for the Competence of Testing and Calibration Laboratories
- ISO 22000 Food Safety Management Systems— Requirements for any Organization in the Food Chain
- ISO 22442-1 Medical Devices Utilizing Animal Tissues and Their Derivatives – Application of Risk Management
- ISO 22442-2 Medical Devices Utilizing Animal Tissues and Their Derivatives – Controls on Sourcing, Collection and Handling
- ISO 22442-3 Medical Devices Utilizing Animal Tissues and Their Derivatives – Validation of the Elimination and/or Inactivation of Viruses and Transmissible Spongiform Encephalopathy (TSE) Agents
- 21 CFR Part 4 Regulation of Combination Products
- 21 CFR Part 11 Electronic Records; Electronic Signatures
- 21 CFR Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies
- 21 CFR Part 110 Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food
- 21 CFR Part 111 Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
- 21 CFR Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General
- 21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals
- 21 CFR Part 801 Labeling
- 21 CFR Part 803 Medical Device Reporting
- 21 CFR Part 806 Medical Devices; Reports of Corrections and Removals
- 21 CFR Part 820 Quality System Regulation
- 21 CFR Part 1271 Human Cells, Tissues, and Cellular and Tissue-Based Products
- MDD 93/42/EEC Medical Device Directive
- CMDR SOR/98-282 Canadian Medical Device Regulations
- American Association of Tissue Banks (AATB) Standards for Tissue Banking
Training
Quality Systems Compliance provides CUSTOMIZED COURSES delivered to meet your training requirements available in the following topics:
-
- Statistical Process Control
- Design of Experiments (DOE)
- Introduction to Quality Systems
- Sampling Plans (Variable and Attribute)
- Introduction to Metrology
- Introduction to Process Validation
- Documentation & Audit Preparation
- Mechanical Blueprint Reading
- Welding Blueprint Reading
- Introduction to Measurement System Analysis (MSA)
- FDA Inspection Readiness
- Good Documentation Practices (GDP)
- Good Manufacturing Practices (GMP)
- ASQ Certification Preparation
- Corrective and Preventive Actions (CAPA)
- Quality System Requirements (QSR Overview)
- ISO 22442 Animal Tissue Training
- ISO 9001:2015 Quality Management System
- ISO 13485:2016 Medical Devices Quality Management System
- ISO 15378:2017 System Overview
Consulting
Your company or facility can take advantage of consultation services covering the following areas of expertise :
-
- FDA Consulting
- Internal Audits
- Supplier Audits
- Gap Assessments
- FDA 483 and Warning Letter responses
- FDA 483 and Warning Letter remediation
- Risk-based auditing systems (internal & supplier)
- External regulatory and certification audit support
- Document and Procedure Writing & Review
- Process Optimization
- Management Review
- Regulatory Affairs support
- Mock FDA Inspections
- Design of Experiments (DOE)
- Measurement System Analysis (MSA)
- Test Method Validations (TMV)
- Corrective and Preventive Actions (CAPA)
- Process Validations
- Process Monitoring
- Quality Metrics
- Procedures and Work Instructions
- Sampling Plans (Variable and Attribute)
- Training
