Elements Of A Quality System For Medical Devices

Elements of a Quality System for Medical Devices
Raul Soto-Velez1
1 MS in Biotechnology and Bioinformatics program, California State University Channel Islands, Camarillo, California

Introduction
A Quality System is a system of check and balances established to ensure the safety and effectiveness of products. As part of its mandate to ensure the efficacy and quality of medical devices soldin the United States, the Food and Drug Administration (FDA) enacted its Quality Systems Regulations [1] in 21 CFR 802 of the Federal Register. This regulation, which became effective in June 1, 1997, replaced the 1978 Good Manufacturing Practices (GMPs) for medical devices [5].
FDA’S Quality System regulation is harmonized with the ISO 13485:2003 standard, which is based on ISO9001:2000 [4].Harmonization allows regulatory agencies to rely more in other inspections and data from other agencies.
The Quality Systems regulation establishes Good Manufacturing Practices for manufacturers of medical devices in several areas, such as design, manufacturing, packaging, labeling, storage, installation, and servicing [1]. A common misconception is that good product quality depends mainly ingood technology [6]. However, in the context of the Quality System regulation, the concept of quality goes beyond merely product quality [6]. It encompasses a whole mindset that integrates all aspects of the organization.
Elements of 21 CFR 820
FDA’s Quality Systems regulation requires that all domestic and foreign manufacturers of medical devices intended for sale in the United States to put inplace a Quality Management System (QMS) in their operations [5]. This QMS should correspond to the level of risk and complexity offered by the particular device, the complexity of the manufacturing process, and the size and complexity of the company.
The key elements of a quality system are establisehd in 21CRF as the following Subparts [1]:

A. General provisions
B. Quality SystemRequirements, including Management responsibility, Quality Audits, and Personnel requirements
C. Design Controls
D. Document Controls
E. Purchasing Controls
F. Product identification and traceability at all stages of production
G. Controlling and defining production and process, including validation
H. Product Acceptance for incoming, in-process, and finished products
I.Controlling nonconforming product
J. Instituting corrective and preventive action when errors occur
K. Labeling and packaging controls
L. Handling, storage, distribution and installation
M. Records; including the Device Master record, Device History record
N. Servicing
O. Statistical techniques

FDA’s Subsystems Approach
FDA’s audit guidance for its field staff is theQuality System Inspection Technique (QSIT) manual [3]. The QSIT approach divides quality systems into seven key subsystems, as shown in Figure 1:

Figure 1 Seven Subsystems of a Quality System [Trautman, 2011]

As part of its audit approach for Quality Systems, the QSIT instructs FDA auditors to focus on Management, Design Control, Corrective & Preventive Actions, and Production &Process Control [3].
This audit approach ensures coverage of all seven subsystems and of all Subparts of 21 CFR 820. QSIT includes guidance for covering Material Control, and Facility & Equipment control as part of inspecting the Production & Process Control subsystem, and guidance for covering Records, Documents, and Change Controls as part of inspecting the Corrective and Preventive Actionsubsystem [3].
Elements of the Management subsystem
Since one of the main purposes of an FDA audit is to determine if management enforces an adequate and effective quality system, inspections typically start and end with an assessment of the Management subsystem [3].
The Management subsystem audit covers the following Quality System elements: Management Responsibility (820.20), Quality...