The quality manual summarizes LLC's quality system for ensuring compliance with medical device regulations as an importer. It outlines 12 key parts of the quality system including quality policy, management responsibility, process validation, personnel training, management review, supplier quality requirements, shipping/receiving, complaint handling, corrective actions, audits, and revisions. The manual provides policies and procedures to meet FDA regulations and achieve continuous quality improvement through monitoring suppliers and processes.

1. Quality System Manual QP-820.5
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1. Quality Policy
LLC as an importer/relabeler of quality medical device shall ensure that quality are
met from conception, design, build, test to post-market to achieve customer
satisfaction, prompt problem resolution, employee loyalty and continuous quality
improvements which are communicated to all its suppliers and contract manufacturers
who are partners in providing quality products.
2. Quality System
Management details its quality system in this Quality Manual to support the quality
policy on a daily basis and to meet the Quality System Regulations appropriate for ’s
medical device. Management shall review the Quality System on a regular basis and
assure that it is effective with the following management responsibility [Subpart B of
Quality System Regulation]:
• Establish and maintain Quality System
• Assure audits
• Staff up and train
LLC shall comply with good manufacturing practice while ensuring supplier quality
requirements are also met and all customer complaints have been addressed and
necessary corrective and preventive actions were established and monitored for
continuous quality improvement. Specifically, the following standards will be
adhered to with corresponding standard operating procedures:
• Sec. 820.100 Corrective and preventive action Procedure and Form
• Sec. 820.50d Purchasing Procedure
• Sec 820.5.6 Management Review
• Sec 820.90 Complaint Handling Procedure and Form
• Sec 820.100b Medical Device Reporting Form and Procedure
• Sec 820.40 Document Control Procedure
• Sec 820.80 Receiving Procedure
• Sec 820.50c Supplier Quality Agreement and Audit Report/Checklist,
Evaluation Procedure and Vendor List
• Sec 820.170 Service/Install Report Form and Procedure
• Sec 820.100b Returned Parts Authorization
• Sec 820.160 Shipping Procedure
• Sec 820.NN Training Procedure
• Sec 820.22 Quality System Audit Procedure and Form
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3. Management Responsibility: as an Importer
LLC as an importer/relabeler of a medical device in the USA shall:
• Register establishment
• Report serious adverse events to FDA, report MDRs to manufacturer
and report to FDA on corrections and removals
• Implement tracking procedures for specified devices
• Distributor must keep records of complaints and make records
available to the FDA
• Dealers and distributors in some cases must hold such information as
is necessary to identify and locate first purchasers
• Establish good manufacturing practice as defined in Quality Manual
and Supplier Quality Requirements documents
4. Process Validation
shall use its Post-Market Surveillance to obtain general retrospective product
validation through the review and summary report of performance, CAPA and
product failure analyses. During installation and testing at , validation tests are run
per Validation Test Procedure. shall review production and testing data as needed
by its test engineers.
5. Personnel and Training
shall have defined roles and responsibilities for each employee with documented
training and updated training as required by their job function. All the required skills
and responsibilities should be defined by their supervisors and a performance
evaluation should be done once per year with both employee and supervisor rating
their performance. All training in-house and outside training (online, seminars,
readings) should be documented in each employee file. All new hired employee
should attend a 1-hr Quality System Regulation training.
6. Management Review
Management shall conduct periodic reviews to maintain Quality Management System
using the Management Review Procedure SOP 820.5.6.
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7. Supplier/Contract Manufacturer Quality Requirements
(Design Control, Equipment and Calibration, Process and
Document Control, Labeling, DMR, Packaging,
Purchasing and Acceptance Activities, Risk Analysis from
Design to test)
suppliers or contract manufacturers should have established their quality system
based on the sections of the QS regulation as applicable to their products and
operations, 21 CFR 820.5 of the QS regulation. It is the responsibility of each
manufacturer to establish requirements for the medical device that is imported by
that will result in devices that are safe and effective, and to establish methods and
procedures to design, produce, distribute, etc. devices that meet the quality system
requirements.
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The following supplier requirements are reviewed and audited by management on
a regular basis:
1. Supplier quality requirement to comply with Subpart C – Design Controls of
Quality System Regulation. Management (both and Contract Manufacturer
executive management) must assure:
- that a documented process exists for design development which meets the
requirements.
- that the design teams have the necessary training/skills to implement the design
process effectively.
Management to audit procedures for design control comprising of the design plan
and processess with focus on customer requirements and user interfaces and risk
analysis.
Management to audit design input requirements, design output specifications and
design transfer to production documents (DHF, DHR, DMR).
Management to audit processes necessary to move between each phase:
- V&V
- Hazard/risk analysis
- design reviews
- change control
2. Supplier quality requirement to comply with Subpart D – Document Controls of
Quality System Regulation. Management to audit documentation system to
support QS requirements and assure prompt communication of adequate
procedures. Management to review on a regular basis procedures with defined
approvals and track changes.
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3. Supplier quality requirement to comply with Subpart E – Purchasing Controls of
Quality System Regulation. Management must assure an appropriate mix of
assessment controls to assure that the product received is what was specified in
the product order process.
4. Supplier quality requirement to comply with Subpart F – Identification and
Traceability of Quality System Regulation. Management must assure
identification procedure to prevent mix-ups and to assure traceability if deemed a
“critical device”. Management must be able to get “bad” product back.
Management must review the following to prevent mix-ups: procedures for
identifying product and traceability requirements for critical devices and recalls
during all stages of receipt, production, distribution and installation
5. Supplier quality requirement to comply with Subpart G – Production and Process
Control of Quality System Regulation. Management must assure that production
processes are controlled and monitored. Management must audit the
development, conduct, control and monitoring of production processes:
- control changes and verify or validate when necessary
- environmental conditions, where necessary
- personnel practices
-contamination control
- buildings to prevent mix-ups
- equipment and necessary preventive maintenance including periodic inspections
- manufacturing material
- calibrations, standards, limits and records
- automated processes and validation of software and equipment
- process validation and records
- monitoring and control of processes
- revalidation
6. Supplier quality requirement to comply with Subpart H – Acceptance Activities
of Quality System Regulation. Management must assure that only “good”
components go into product and only “good” product gets released to customers.
Management to review in an audit established and maintained procedures:
- receiving acceptance activities
- in-process acceptance activities
- final acceptance activities
- acceptance records
- acceptance status
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7. Supplier quality requirement to comply with Subpart I – Nonconforming Product
of Quality System Regulation.
Management must review nonconforming material and take the necessary steps to
correct and prevent the problem from occurring.
Management shall audit procedures to control nonconforming product:
- components, in-process and final product
- review and disposition
- rework
8. Supplier quality requirement to comply with Subpart J– Corrective and Preventive
Action of Quality System Regulation.
Management must assure that the workforce has an understanding of root cause
analysis and that the appropriate techniques are used to correct and prevent
quality problems. Management must assure that quality problems are investigated.
Management shall audit procedures for:
- analyzing
- investigating
- identifying the action
- implementing and recording changes
- disseminate to those responsible
- submit relevant info on identified quality problems
- correlate corrective and preventive actions to risk
9. Supplier quality requirement to comply with Subpart K – Labeling and Packaging
Control of Quality System Regulation. Management must assure that the product
is labeled and packaged correctly to assure that the customers receive the product
with the intended specifications.
Management to review the procedures to control labeling activities:
- labeling integrity
- labeling inspection
- labeling storage
- labeling operations
Management to review control numbers for traceability where necessary
Management to review procedures to control packaging:
- protect device
- for handling product
- for control of storage areas and stock rooms
- for receipt and dispatch
10. Supplier quality requirement to comply with Subpart L – Handling, Storage,
Distribution and Installation of Quality System Regulation.
Management must assure that the handling, storage, distribution and installation is
controlled.
Management must audit procedures for control and distribution, review customer
purchase orders before distribution via a contract review requirement, review
distribution records and review installation instructions and procedures
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11. Supplier quality requirement to comply with Subpart M – Records of Quality
System Regulation. Management must assure that the record requirements for
this QS Regulation are met and enforced.
Management must met the general requirements for record retention of two years
with the exceptions of management reviews, internal audits and supplier audits.
Management must audit DMR, DHR, DHF and QSR.
Management must review complaint files:
- review and evaluate all complaints
- investigate “possible” failure
- MDRs
- Investigations
12. Supplier quality requirement to comply with Subpart N – Servicing of Quality
System Regulation. Management must assure that product is serviced properly
and documented to meet requirements.
Management must review instructions and procedures, 4.19 Servicing, and
analyze service reports.
13. Supplier quality requirement to comply with Subpart O – Statistical Techniques
of Quality System Regulation.
Management must assure that the statistical tools are appropriate for the operation
or process being monitored.
Management must review procedures, 4.20 Statistical Technique, for identifying
valid statistical techniques for establishing, controlling and verifying the
acceptability of process capability and product characteristics and review
sampling plans procedures and control.
_____ defines its supplier quality requirements in the Supplier Quality Requirements
document. Quality Director shall perform quarterly quality audit to ensure that supplier
quality requirements are met. For all non-conformance needing immediate actions,
effective communication and documentations are followed by both Quality Director and
the supplier Quality management. See Complaint Handling and CAPA sections of this
Quality Manual for issues regarding non-conformance, deficiencies or quality
improvements. Quality Director shall ensure that the supplier or contract manufacturer
has established its Risk Analysis process based on the following standards:
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8. Quality System Manual QP-820.5
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8. Shipping, Receiving and Installations
shall follow the following procedures:
• Shipping Procedure to control shipping information per customer
• Receiving and Inspection Report procedure when receiving incoming materials
and to ensure that these materials are properly dispositioned after evaluation and
inspection.
Accounting and Quality Assurance departments shall have a copy of inspection
records.
9. Complaints Handling
shall follow its Complaints Handling procedure for all non-conformance and
deficiencies related to the product, process or quality. It is the responsibility of
Complaint Handling Coordinator to communicate to management, FDA and the
supplier or manufacturer all related complaints from all sources and monitor
corrective actions from the supplier/contract manufacturer to field service.
Complaint Handling Procedure is based on the 21 CFR 820.198 Complaint Files
regulatory standard. All complaints (including reportable events, MDRs) are logged
using the Complaints Handling form. Each complaint and its corresponding
supporting documents or investigations should be stored in a separate folder. A
summary of all complaints are stored in Excel spreadsheet for easy monitoring.
Another form for MDR , reportable events, shall be created in addition to the
Complaints Handling form and a duplicate folder should be created for each MDRs.
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10. Corrective Action and Preventive Action
shall follow its Corrective Action and Preventive Action (CAPA) procedure for all
CAPA-related complaints related to the product, process or quality. It is the
responsibility of Complaint Handling Coordinator to communicate to management,
FDA and the supplier or manufacturer all related complaints from all sources such as
quality audit or other management approved CAPAs.
Reference: Sec. 820.100 Corrective and preventive action.
(a) Each manufacturer shall establish and maintain procedures for implementing
corrective and preventive action. The procedures shall include requirements for:
(1) Analyzing processes, work operations, concessions, quality audit reports, quality
records, service records, complaints, returned product, and other sources of quality
data to identify existing and potential causes of nonconforming product, or other
quality problems. Appropriate statistical methodology shall be employed where
necessary to detect recurring quality problems;
(2) Investigating the cause of nonconformities relating to product, processes, and the
quality system;
(3) Identifying the action(s) needed to correct and prevent recurrence of
nonconforming product and other quality problems;
(4) Verifying or validating the corrective and preventive action to ensure that such
action is effective and does not adversely affect the finished device;
(5) Implementing and recording changes in methods and procedures needed to correct
and prevent identified quality problems;
(6) Ensuring that information related to quality problems or nonconforming product is
disseminated to those directly responsible for assuring the quality of such product or
the prevention of such problems; and
(7) Submitting relevant information on identified quality problems, as well as
corrective and preventive actions, for management review.
(b) All activities required under this section, and their results, shall be documented.
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11. Quality System Audit
_____ shall perform internal quality system audit per SOP-820.22/FRM-820.22 and
supplier/contract manufacturer quality requirements audit per FRM-820-50c once a
year. A summary report of the quality audit shall be communicated to both and its
supplier/contract manufacturer. These audit findings can be a source of CAPA and
can be used as feedback mechanism for customers, and its suppliers for continuous
quality improvement and to provide proactive measures for all its operations and the
operations of its suppliers. Quality metrics will be tracked regularly by both and its
suppliers.
12. Revision History and Approval
Revision Date Name Change
00 6/7/2010 Connie Dello Buono Initial release
Approved by: President____________________ Date ___________
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