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ISO
13485 Quality Manual
Table
of Contents
Approvals
Revision and
Approval Record
1.0 Scope
1.1 General
1.2 Application
1.3 Quality policy
statement
2.0 Company information
3.0 Terms
and definitions
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 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
Feedback
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
General
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 ISO 13485:2003, Medical
devices-Quality management systems-Requirements for regulatory
purposes. 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.
__________________________________
(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.
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, and
permissible exclusions.
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
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 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
ISO
13485 Quality Manual Information
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Copyright 1997, 2008 Quality Systems Innovations, Inc. |
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