ISO
13485:2016 Quality Manual
Order Quality Manual
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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
5.0 Management responsibility
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning
5.5 Responsibility, authority, and communication
5.6 Management review
6.0 Resources
6.1 Provision of resources
6.2 Human resources
6.3 Infrastructure
6.4 Work environment and contamination control
7.0 Product realization
7.1 Planning of product realization
7.2 Customer-related processes
7.3 Design and development
7.4 Purchasing
7.5 Production and service provision
7.6 Control of monitoring and measuring equipment
8.0 Measurement, analysis and
improvement
8.1 General
8.2 Monitoring and measurement
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement
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 13485:2016, Medical devices-Quality management
systems-Requirements
for regulatory purposes and 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.
__________________________________
(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.
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.
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ISO
13485 Information
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