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Quality
Manual for Medical DevicesOrder Quality
Manual for Medical Devices
Table of Contents
Approvals
Revision and Approval Record
1.0 General
1.1 Introduction
1.2 Exclusions
1.3 Quality Policy Statement
2.0 Company History
3.0 Company Contact Information
4.0 Quality Management System
4.1 General Requirements
4.2 Documentation Requirements
4.2.1 General
4.2.2 Quality Manual
4.2.3 Control of Documents
4.2.4 Control of Quality Records
5.0 Management Responsibility
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning
5.4.1 Quality Objectives
5.4.2 Quality Management System Planning
5.5 Responsibility, Authority, and Communication
5.5.1 Responsibility and Authority
5.5.2 Management Representative
5.5.3 Internal Communication
5.6 Management Review
5.6.1 General
5.6.2 Review Input
5.6.3 Review Output
6.0 Resources
6.1 Provision of Resources
6.2 Human Resources
6.2.1 General
6.2.2 Competence, Awareness, and Training
6.3 Infrastructure
6.4 Work Environment
7.0 Product Realization
7.1 Planning of Product Realization
7.2 Customer-Related Processes
7.2.1 Determination of Requirements Related to the Product
7.2.2 Review of Requirements Related to the Product
7.2.3 Customer Communication
7.3 Design and Development
7.3.1 Design and Development Planning
7.3.2 Design and Development Inputs
7.3.3 Design and Development Outputs
7.3.4 Design and Development Review
7.3.5 Design and Development Verification
7.3.6 Design and Development Validation
7.3.7 Control of Design and Development Changes
7.4 Purchasing
7.4.1 Purchasing Process
7.4.2 Purchasing Information
7.4.3 Verification of Purchased Product
7.5 Production and Service Provision
7.5.1 Control of Production and Service Provision
7.5.2 Validation of Processes for Production and Service
Provision
7.5.3 Identification and Traceability
7.5.4 Customer Property
7.5.5 Preservation of Product
7.6 Control of Monitoring and Measuring Devices
8.0 Measurement, Analysis and
Improvement
8.1 General
8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction
8.2.2 Internal Audit
8.2.3 Monitoring and Measurement of Processes
8.2.4 Monitoring and Measurement of Product
8.3 Control of Nonconforming Product
8.4 Analysis of Data
8.5 Improvement
8.5.1 Continual Improvement
8.5.2 Corrective Action
8.5.3 Preventive Action
1.1 INTRODUCTION
XYZ COMPANY recognizes its responsibility as
a provider of quality products/services. To this end, XYZ
COMPANY has developed and documented a quality management system.
The quality system complies with the FDA's
CFR 21 Part 820: Quality System Regulation. This manual provides
comprehensive evidence to all customers, suppliers and employees of
what specific controls are implemented to ensure product/service
quality.
This manual also governs the creation of
quality related documents. It will be revised, as necessary,
to reflect the quality system currently in use. It is issued
on a controlled copy basis to all internal functions affected by the
quality system and on an uncontrolled copy basis to customers and
suppliers. It may be issued to customers on a controlled copy
basis upon customer request.
1.3 QUALITY POLICY
XYZ COMPANY accepts responsibility for the
complete satisfaction of its customers. We exercise this
responsibility through adequate training of our employees, adherence to
proven procedures, and total commitment to meeting and exceeding
customer requirements, and to maintaining an organizational culture
that fosters continuous improvement.
__________________________________
(Name), President
4.2.3 CONTROL OF DOCUMENTS
4.2.3.1 XYZ Company has
established and maintains a Control of Documents Procedure.
It ensures that documents:
a) are reviewed and approved for adequacy
prior to issue;
b) are updated, reviewed and approved for
re-issue as necessary;
c) are identified with their current
revision status;
d) are available at point of use;
e) are legible, readily identifiable and
retrievable;
f) of external origin are identified and
their distribution is managed;
g) that are obsolete are prevented from
unintended use and are suitably identified if they are retained for any
purpose.
Documents defined as quality records are
managed per the Control of Quality Records Procedure.
4.2.3.2 Device Master Record File
A Device Master Record (DMR) file is created
and maintained for each type/model of medical device. The DMR
for each type of device shall include or refer to the location of the
following information:
· Device specifications including
appropriate drawings, composition, formulation, component
specifications, and software specifications;
· Production process specifications
including the appropriate equipment specifications, production methods,
production procedures, and production environment specifications;
· Quality assurance procedures and
specifications including acceptance criteria and the quality assurance
equipment to be used;
· Packaging and labeling specifications,
including methods and processes used; and
· Installation, maintenance, and servicing
procedures and methods.
All documents are technically correct,
contain and/or reflect the approved device and process designs, are
under change control, contain the release or other control date,
contain an approval signature, and are directed toward the intended
user.
5.0
MANAGEMENT RESPONSIBILITY
5.1 Management Commitment
The management of XYZ COMPANY is committed
to implementing, and maintaining a documented quality system.
This commitment includes: ensuring that customer, regulatory
and legal requirements are understood and appropriately addressed, the
quality policy is understood and implemented at all levels of the
organization, quality objectives and plans are established as necessary
and that the responsibilities of all functions affecting quality are
clearly defined. Management will make provisions for the necessary
resources and personnel to maintain the system, including a management
representative, who will ensure that the requirements of this manual
are met. Management will review the system annually to
determine its effectiveness.
5.4 PLANNING
5.4.1 QUALITY OBJECTIVES
The management of XYZ COMPANY establishes
annual key initiatives, which include quality objectives. The
objectives are established via the Management Review Procedure and
communicated to all levels of the organization for use in establishing
each function's and employee's annual key objectives. Quality
objectives are measurable, include business performance indicators
reflecting requirements for products/services, and are consistent with
the quality policy including the commitment to continuous improvement.
5.4.2 QUALITY MANAGEMENT SYSTEM
PLANNING
The management of XYZ COMPANY ensures that
the resources needed to achieve the quality objectives are identified
and planned. All quality plans are documented and include:
the required recourses; the processes of the quality system,
permissible exclusions; continuous improvement of the quality system.
7.0
PRODUCT REALIZATION
7.1 PLANNING OF PRODUCT REALIZATION
XYZ COMPANY has established and maintains
documented procedures to ensure that the sequence of processes is
conducted in a controlled manner. Planning of the realization
processes is consistent with other requirements of the organization's
quality system. Plans of product and service realization
determine the following:
· quality objectives for the
product/service, project or contract;
· the need to establish processes and
documentation, and provide resources and facilities specific to the
product/service;
· verification and validation activities,
and the criteria for acceptability;
· the records that are necessary to evidence
conformity of the processes and resulting product/service to specified
requirements.
8.0
MEASUREMENT, ANALYSIS AND IMPROVEMENT
8.1 GENERAL
XYZ COMPANY has established and maintains a
documented Continuous Improvement Procedure to define, plan and
implement the measurement and monitoring activities needed to assure
conformity and achieve improvement. This includes the
determination of the need for, and use of, applicable methodologies
including statistical methods.
8.2.3 MONITORING AND MEASUREMENT OF
PROCESSES
XYZ COMPANY applies suitable methods for
measurement and monitoring of those realization processes necessary to
meet customer requirements. These methods confirm the
continuing ability of each process to satisfy the intended purpose.
8.2.4 MONITORING AND MEASUREMENT OF
PRODUCT
XYZ COMPANY measures and monitors the
characteristics of the product/service to verify that requirements for
the product/service are met. This is carried out at
appropriate stages of the product/service realization process.
Evidence of conformity with the acceptance criteria is
documented. Records include the authority responsible for
release of the product/service.
Inspection and Test
Procedure
1.0 Receiving Inspection and Test
1.1 All purchased material which influences
the manufacture of, or is intended for use as part of, deliverable
products is subject to inspection and/or testing by Receiving
Inspection. Upon receipt of products, receiving personnel
verify the quantity of delivered units, check marking and
identification of packages, and inspect all packages for any signs of
tampering or damage. If all these checks and inspections are
satisfactory, receiving personnel signs the delivery receipt.
If not, any shortages or damages are noted on all copies of
the delivery receipts.
1.2 The received containers are then moved
to the designated inspection area, a copy of the purchase order is
retrieved, and the packing slips are removed from the containers.
Upon opening the containers, the goods are verified against
the purchase order and the packing slip, and are examined visually for
any signs of damage. The purchase order is stamped "RECEIVED"
and is signed and dated by the receiving inspector. All
receiving inspections are logged in the Receiving Inspection
Log.
1.3 On critical parts and components, as
determined by the Quality Manager, a precision inspection/test is
performed. This type of inspection includes:
· Review of material certificates, supplier
inspection records, compliance certificates, and any other relevant
documentation delivered with the product
· Random sampling based on statistical
technique specified
· Visual inspection to detect any damage or
other visible problems
· Performing measurements and testing
against specified requirements as required
· Recording the sample size, actual
measurements, and inspection test results on the Inspection/Test
& Audit Report
1.4 Where it is not practical to perform
receiving inspection upon receipt, provisions are made to perform
source inspection at the supplier's facility.
1.5 The Quality Manager determines the
extent and scope of receiving inspection based on the importance of the
item and the suppliers' control methods and performance. The
Quality Manager may request that suppliers provide objective evidence
of conformance (i.e., material certifications, certificates of
conformance, test data, first article inspection, and SPC data).
Objective evidence provided by suppliers may be used as the basis for
reducing/waiving receiving and source inspection.
1.6 Upon acceptance, products are identified
with an "ACCEPT" tag [green sticker] and moved to stock. In
the event that product which is designated for receiving inspection is
released to production due to urgency, it shall be positively
identified and recorded in receiving inspection records.
2.0 In-process Inspection and Test
2.1 In-process inspection/testing is
conducted to ensure that the product/process conforms to specified
requirements. The inspection/testing is normally carried out
by production personnel. Random audits of the in-process
inspection/testing process are conducted by quality control personnel.
2.2 The Quality Manager determines the
extent and scope of in-process inspection/testing based on the
importance of the item, control methods, and previous performance.
3.0 Final Inspection and Test
3.1 For acceptance of completed products,
final inspection/testing is utilized. This includes a
verification of satisfactory receiving and in-process
inspections/tests, as well as completion of the remaining
inspections/tests to assure that the finished products/processes
conform to specified requirements. Products are not released,
and processes are not approved until all inspection/test activities
have been satisfactorily completed and the appropriate documentation is
available and authorized. All final inspections are logged in
the Final Inspection Log. On critical
parts and components, as determined by the Quality Manager, a Final
Inspection/Test & Audit Report is completed.
3.2 The Quality Manager determines the
extent and scope of final inspection/testing based on the importance of
the item, control methods, and previous performance.
4.0 Inspection and Test Records
4.1 Inspection/test records, which show
clearly whether the product/process has passed or failed the defined
acceptance criteria, are established and maintained.
5.0 Nonconforming Material/Products
5.1 All material/products that are found to
be nonconforming are identified and segregated and/or quarantined, and
appropriately dispositioned per the Control of Nonconforming
Product Procedure.
Sample quality form
Order Quality
Manual for Medical Devices
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