| Regulation | Applicability | Regulatory Authority | Geographic Scope |
|---|---|---|---|
| Quality System Regulation (QSR) | Mandatory for medical device manufacturers distributing products in the United States. | U.S. Food and Drug Administration (FDA) | United States |
| ISO 13485 | Applicable to medical device manufacturers worldwide | International Organization for Standardization (ISO) | Global |
| Medical Device Rules, 2017 (Schedule V) | Mandatory for medical device manufacturers operating in India. | Central Drugs Standard Control Organisation (CDSCO) | India |
A Detailed Overview of Quality System Regulation
|
No |
Subpart |
Subsections |
Description |
|
A |
General Provision |
Scope Definitions Quality System |
This quality system regulation outlines current good manufacturing practice (CGMP) requirements for the design, manufacture, packaging, labeling, storage, installation, and servicing of finished devices for human use. It ensures compliance with the Federal Food, Drug, and Cosmetic Act and applies to manufacturers of finished medical devices. Failure to comply with any provision renders a device adulterated under section 501(h) of the act, and the manufacturer and any person responsible for the failure are subject to regulatory action. Exemptions or variances from device quality system requirements are subject to the FDA's administrative procedures. |
|
B |
Quality System Requirements |
Management Responsibility Quality Audit Personnel |
The quality policy requires executive responsibility to establish & maintain it at all levels of the organization. Manufacturers must establish an adequate organizational structure, assign appropriate responsibility & authority, provide adequate resources, appoint a management representative, review the quality system, establish a quality plan, and quality system procedures. This ensures devices are designed and produced according to the manufacturer's quality policy. Manufacturers must conduct quality audits to ensure compliance with requirements and assess system effectiveness, conducted by non-directly responsible individuals, and documented for review by management. Manufacturers must have adequate personnel with education, background, training, and experience, establish training procedures, and ensure personnel are aware of device defects and errors in their job functions. |
|
C |
Design Controls |
Design Controls |
Manufacturers of class III or II devices and some class I devices must establish and maintain control procedures to ensure design requirements are met. Class I devices, including automated devices, are subject to design controls. Design and development planning is crucial to define responsibility for implementation and ensure design requirements are appropriate. Design output is defined and documented, and formal reviews are conducted. Design verification and validation ensure devices conform to user needs and intended uses. Design transfer ensures correct translation into production specifications, and a design history file is maintained for each device type. |
|
D |
Document controls |
Document Controls |
Manufacturers must establish and maintain procedures for controlling required documents. These procedures include document approval and distribution, and document changes. An individual must review and approve documents for adequacy, documenting the approval and distribution. Obsolete documents must be removed from use. Changes to documents must be reviewed and approved by the same individual, communicated to personnel, and documented. Records should include change description, identification, signature, approval date, & effective date. |
|
E |
Purchasing Controls |
Purchasing Controls |
Manufacturers must establish procedures to ensure product and service conformity to specified requirements. They must evaluate suppliers, contractors, and consultants based on their ability to meet these requirements, define control over them, and maintain records of acceptable suppliers. They must also maintain purchasing data that clearly outlines requirements, including quality requirements, and includes agreements for suppliers to notify the manufacturer of changes. Purchasing data must be approved in accordance with § 820.40. |
|
F |
Identification & Traceability |
Identification Traceability |
Manufacturers are required to establish and maintain procedures for product identification throughout the entire process of receipt, production, distribution, and installation to prevent any potential mixups. Manufacturers of surgical implants or life support devices that could cause significant injury to users should establish and maintain procedures for identifying each unit, lot, or batch of finished devices and their components with a control number, facilitating corrective action and documenting this in the DHR. |
|
G |
Production & Process Control |
Production and Process Control Inspection, Measuring and Test Equipment Process Validation |
Manufacturers must develop, control, and monitor production processes to ensure devices conform to specifications. They must establish and maintain process control procedures, including documented instructions, SOP, monitoring of process parameters, compliance with reference standards, approval of processes, and criteria for workmanship. Manufacturers must also establish and maintain procedures for changes to specifications, environmental control, personnel health, cleanliness, and contamination control. Buildings must be suitable, equipment must meet specifications, and maintenance schedules must be documented and also ensure the use and removal of manufacturing materials and validate automated processes. Manufacturers must ensure their inspection, measuring, and test equipment is suitable for its intended purpose and capable of producing valid results. They must establish and maintain procedures for routine calibration, inspection, checking, and maintenance, including handling, preservation, and storage. Calibration procedures should include specific directions and limits for accuracy and precision, with remedial action if limits are not met. Calibration standards should be traceable to national or international standards, and calibration records should be documented and displayed. In cases where a process cannot be fully verified, it must be validated and approved according to established procedures. Manufacturers must establish monitoring and control procedures for validated processes, ensure they are performed by qualified individuals, and document monitoring methods and data. If changes occur, manufacturers must review and evaluate the process, perform revalidation, and document these activities. |
|
H |
Acceptance Activities |
Receiving, in Process and Finished Device Acceptance Acceptance Status |
Manufacturers must establish and maintain acceptance activities, including inspections, tests, and verifications. They must also establish procedures for receiving acceptance, in-process acceptance, and final acceptance. Incoming products must be inspected, tested, and documented. In-process products must be controlled until required verifications are completed. Finished devices must be held in quarantine or controlled until released. Release authorizations must be authorized by a designated individual. Manufacturers must document acceptance activities, including the dates, results, signatures, and equipment used, as part of the DHR. Manufacturers must maintain product acceptance status throughout manufacturing, packaging, labeling, installation, and servicing to ensure only products that pass required activities are distributed, used, or installed. |
|
I |
Nonconforming Product |
Nonconforming Product |
Manufacturers must establish and maintain procedures to control nonconforming products, including identification, documentation, evaluation, segregation, and disposition. These procedures should be documented, including the need for an investigation and notification of responsible parties. Manufacturers must also establish procedures for review and disposition of nonconforming products, including justification for use and signatures. Additionally, manufacturers must establish procedures for rework to ensure the product meets approved specifications. |
|
J |
Corrective and Preventive action |
Corrective and Preventive Action |
Manufacturers must establish and maintain procedures for corrective and preventive action, including analyzing processes, investigating causes of nonconforming products, identifying necessary actions, verifying and validating actions, implementing changes, disseminating information, and submitting relevant information for management review. These procedures also involve work operations, and quality records, recording changes. All activities must be documented. |
|
K |
Labeling and Packaging Control |
Device Labeling Device Packaging |
Manufacturers must establish and maintain procedures to control labeling activities, including label integrity, inspection, storage, operations, and control numbers. Labels must remain legible and affixed during processing, storage, handling, distribution, and use. Labeling must be released for storage or use after an individual examines it for accuracy. Labeling storage should provide proper identification and prevent mixups. Control numbers must be on or accompany devices through distribution. Manufacturers must ensure device packaging and shipping containers are designed to prevent device alteration or damage during customary processing, storage, handling, and distribution conditions. |
|
L |
Handling, Storage, Distribution, and Installation |
Handling Storage Distribution Installation |
Manufacturers are required to establish and maintain procedures to prevent product damage, deterioration, or contamination during handling. Manufacturers must control storage areas and stock rooms to prevent mixups, damage, and contamination. If a product's quality deteriorates over time, it should be stored in a way that facilitates proper stock rotation. Authorization for receipt and dispatch to storage areas and stock rooms must be documented. Distribution of finished devices must be controlled and distributed only to approved devices, with purchase orders reviewed to resolve ambiguities and errors. If a device's quality deteriorates over time, expired or deteriorated devices should not be distributed. They must maintain distribution records including the initial consignee's name, device identification, date, and control number(s). Installation instructions and test procedures must be established and maintained by manufacturers for devices requiring installation. The person installing the device must ensure proper installation, inspection, and testing, documenting inspection and test results. |
|
M |
Records |
General Requirements Device Master Record (DMR) Device History Record (DHR) Quality System Record Complaint Files |
This part requires all records to be kept at a location accessible to FDA employees and manufacturers. Records must be legible, minimize deterioration, and backed up. Confidentiality is maintained for records deemed confidential by the manufacturer. Records must be retained for at least 2 years from the device's release for commercial distribution. A designated FDA employee must certify the completion of these procedures upon request. Manufacturers must maintain DMRs which include device specifications, production process specifications, quality assurance procedures, packaging and labeling specifications, and installation, maintenance, and servicing procedures for each device type, including appropriate drawings, composition, formulation, component, and software specifications. Manufacturers must maintain DHRs to demonstrate compliance with the DMR and other requirements. DHRs should include manufacturing dates, quantity, acceptance records, primary identification labels, unique device identifiers, and control numbers for each batch, lot, or unit. These records are crucial for ensuring device quality and compliance. Manufacturers must maintain a quality system record (QSR) containing procedures and documentation for non-specific device types, and ensure it's prepared and approved in accordance with § 820.40. Manufacturers must maintain complaint files and procedures for receiving, reviewing, and evaluating complaints. These procedures ensure uniform processing, documented receipt, and evaluation of complaints. If no investigation is necessary, the manufacturer must maintain a record. Complaints involving possible device failure must be reviewed and investigated. If an investigation is made, a record of the investigation must be maintained. Records must be accessible to the manufacturing establishment and the initial distributor. |
|
N |
Servicing |
Servicing |
Manufacturers must establish and maintain procedures for servicing specified requirements, analyze service reports using statistical methodology, and process complaints to FDA. Service reports must include the device name, unique device identifier, control number, date of service, individual servicing, service performed, and test and inspection data. Manufacturers must also consider service reports as complaints and process them in accordance with § 820.198. |
|
O |
Statistical Techniques |
Statistical Techniques |
Manufacturers must establish and maintain procedures for identifying valid statistical techniques for assessing process capability and product characteristics. They must also create valid sampling plans based on statistical rationale, ensure adequate methods are used, and review plans when changes occur, all of which must be documented. |