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Quality Manual
Revised August 28, 2018

2004, 2005, 2006, 2007, 2008, 2009, 2010, 2011, 2012, 2013, 2014 Fluke Corporation, All rights reserved. Printed in U.S.A.
All product names are trademarks of their respective companies

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Fluke Biomedical is a brand name under Fluke Electronics.

6045 Cochran Road

Cleveland, Ohio 44139
440.498.2564

Site Roles: Calibration, Distribution, Service, and Repair of electronic test and measuring equipment, software,
radiation detection instruments, and their accessories

6920 Seaway Blvd.

Everett, WA 98203
425.446.6945
Site Roles: Hardware and Software Design, manufacturing and distribution of Biomedical test equipment Hardware and
Software Design, manufacturing and distribution of Biomedical test equipment

www.flukebiomedical.com

ISO 9001: 20XX

FDA 21 CFR Part 820
Energy 10 CFR Part 50 Appendix B
ISO 13485:20XX
ISO 17025 (parts)
ISO 14971 20XX (parts)
CMDR: XXXX

Revised by: Moe Khosravi, Director of QA/RA

The Management Team’s signed approval sheet is kept in Master Control

Controlled Copy Number

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Table of Contents
Section 1: Quality Policy ................................................................................................................. 1-1
1.1 Company Mission Statement ........................................................................................... 1-1
1.2 Company Background ..................................................................................................... 1-1
Section 2: Amendment Record ....................................................................................................... 2-1
2.1 Amendment Record ......................................................................................................... 2-1
2.2 Controlled Circulation List ................................................................................................ 2-2
Section 3: Glossary .......................................................................................................................... 3-1
3.1 Glossary ........................................................................................................................... 3-1
Section 4: Management Responsibility ......................................................................................... 4-1
4.1 Management Responsibility ............................................................................................. 4-1
4.2 Quality System ................................................................................................................. 4-2
4.3 Contract Review ............................................................................................................... 4-3
4.4 Design Control ................................................................................................................. 4-4
4.5 Document and Data Control ............................................................................................ 4-6
4.6 Purchasing ....................................................................................................................... 4-7
4.7 Control of Customer-Supplied Product ............................................................................ 4-8
4.8 Product Identification and Traceability ............................................................................. 4-8
4.9 Process Control/ Validation .............................................................................................. 4-9
4.10 Inspection and Testing ................................................................................................... 4-10
4.11 Control of Inspection, Measuring and Test Equipment .................................................. 4-11
4.12 Inspection, Test and Operating Status........................................................................... 4-13
4.13 Control of Nonconforming Product ................................................................................. 4-13
4.14 Corrective and Preventive Action ................................................................................... 4-14
4.15 Handling, Storage, Labeling, Packaging, Preservation and Delivery ............................ 4-16
4.16 Control of Quality Records ............................................................................................. 4-17
4.17 Quality Audits ................................................................................................................. 4-17
4.18 Training .......................................................................................................................... 4-18
4.19 Servicing ........................................................................................................................ 4-19
4.20 Statistical Techniques .................................................................................................... 4-19
Appendix A: Fluke Biomedical Organization ................................................................................... A-1
Appendix B: Documentation Structure ............................................................................................. B-1
Appendix C : Quality Management System Flow Charts……………………………………………….C-1

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Section 1
Quality Policy Statement
1.1 Company Mission Statement
Company Mission Statement
To continue as the market leader in providing equipment to clinical engineers, radiation physicists, and
oncologists, while expanding our range of solutions to a broader range of health and safety professionals.
Quality Policy Statement
The personnel of Fluke Biomedical are committed to achieving quality through the following objectives:
• Focusing on the customer by applying innovation and flexibility to meet their needs
• Fostering a controlled atmosphere for continuous improvement and problem prevention
• Identifying the need for, and providing appropriate training to ensure the development and
qualification of our personnel
• Communicating the mission and objectives to our personnel and customers
• Developing relationships with our customers that emphasize continuous improvement in product
quality, service and support
• Promoting a supportive work environment that facilitates the delivery of a quality product on a
consistent basis
• Working in a manner consistent with our documented quality-management system to ensure our
products and services are safe and effective for their intended use

1.2 Company Background

Fluke Biomedical is located at 6045 Cochran Rd., Cleveland, Ohio 44139-3313 and 6920 Seaway Blvd,
Everett, WA 98203.
Fluke Biomedical is brand name of the Fluke Electronics.
Fluke Biomedical designs, manufactures, tests, calibrates, and repairs test and measurement equipment
used in the biomedical and radiation-detection community. These test tools are used by medical device
manufactures and hospital maintenance personnel to install, service, and maintain various types of
medical devices and laboratory equipment. These tools are also used by customers in the medical
diagnostic x-ray industry, the radiation therapy industry, nuclear medicine, health physics and the nuclear
energy industries for calibration and maintenance of x-ray generators, radiation treatment devices such
as linear accelerators, and for radiation detection and measurement in health physics applications,
nuclear medicine and nuclear energy systems. Fluke Biomedical through its Global Calibration Laboratory
(GCL) and service department also provides calibration and repair services to radiation detection and
measurement instruments. It must be noted that Fluke’s manufactured product will not come in contact
with any patient. Thus, no confidential information regarding the patients are communicated to Fluke
Biomedical at any time.

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Section 2
Amendment Record
2.1 Amendment Record
The Amendment Record will be maintained in Master Control in the Notes Section.

2.2 Controlled Circulation List –Maintained in Master

Control

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Section 3
Glossary
PO – Purchase Order

MR – Management Representative

Standards/Requirements – ISO 9001: 20XX, FDA Quality System Regulations for Medical Devices 21
CFR part 820, Energy Regulations 10 CFR part 50 Appendix B, ISO 13485: 20XX; ISO 14971 20XX, and

ISO 17025: 19XX.

QM – Quality Manual

R&A – Responsibility and Authority

Medical Device (ISO 13485)- Any instrument, apparatus, appliance, material or other article, whether
used alone or in combination, including the software necessary for its proper application, intended by the
manufacturer to be used for human beings for the purpose of:
• diagnosis, prevention, monitoring, treatment, or alleviation of disease
• diagnosis, monitoring, treatment alleviation of, or compensation for, an injury or handicap
• investigation, replacement or modification of the anatomy or of a physiological process
• control of conception, and which does not achieve its principal intended action in or on the human
body by pharmacological, immunological, or metabolic means, but which may be assisted in its
function by such means.

Medical Device (FDA 21CFR)- An instrument, apparatus, implement, machine, contrivance, implant, in
vitro reagent, or other similar or related articles, including any component, part or accessory, which is:
• Recognized by the National Formulary, or the United States Pharmacopoeia, or any supplement to
them.
• Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment,
or prevention of disease, in man or other animals.
• Intended to affect the structure or any function of the body of man or other animals, and which does
not achieve any of its principal intended purposes through chemical action within or on the body of
man or other animals and which is not dependent upon being metabolized for the achievement of its
principal intended uses.
Medical Device (CMDR) – A device within the meaning of the Act (Food and Drugs Act, Canadian
Medical Device Regulation), but does not include any device that is intended for use in relation to
animals. (Currently Fluke Biomedical does not market any medical devices in Canada. The CMDR and
MDSAP will be addressed if the company decides to sell medical devices in Canada)

Design History File (DHF) – Means a compilation of records which describes the design history of a
finished device.

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Design input – Means the physical and performance requirements of a device that are used as a basis
for device design

Design output – Means the results of a design effort at each design phase and at the end of the total
design effort. The finished design output is the basis for the device master record. The total finished
design output consists of the device, its packaging and labeling, and the device master record

Design review – Means a documented, comprehensive, systematic examination of a design to evaluate

the adequacy of the design requirements, to evaluate the capability of the design to meet these
requirements, and to identify problems

Device History Record (DHR) – Means a compilation of records containing the production history of a
finish device

Device Master Record (DMR) – Means a compilation of records containing the procedures and
specifications for a finished device

Establish – Means define, document (in writing or electronically), and implement

Finished device – Means any device or accessory to any device that is suitable for use or capable of
functioning, whether or not it is packaged, labeled, or sterilized

Harm – Physical injury or damage to the health of people, or damage to property or the environment

Hazard – Potential source of harm

Hazardous situation – Circumstance in which people, property, or the environment are exposed to one
or more hazard(s)

Intended use – Intended purpose use for which a product, process or service is intended according to
the specifications, instructions, and information provided by the manufacturer

Labelling – Written, printed or graphic matter

• affixed to a medical device or any of its containers or wrappers, or
• accompanying a medical device,
related to identification, technical description, and use of the medical device, but excluding shipping
documents
NOTE Some regional and national regulations refer to “labelling” as “information supplied by the
manufacturer.”

Life-cycle – All phases in the life of a medical device, from the initial conception to final decommissioning
and disposal

Lot or batch – Means one or more components or finished devices that consist of a single type, model,
class, size, composition, or software version that are manufactured under essentially the same conditions
and that are intended to have uniform characteristics and quality within specified limits

Management with executive responsibility – Means those senior employees of a manufacturer who
have the authority to establish or make change to the manufacturer’s quality policy and quality system.

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Manufacturer – Natural or legal person with responsibility for the design, manufacture, packaging, or
labeling of a medical device, assembling a system, or adapting a medical device before it is placed on the
market or put into service, regardless of whether these operations are carried out by that person or on
that person's behalf by a third party
NOTE 1 Attention is drawn to the fact that the provisions of national or regional regulations can apply to the definition
of manufacturer.

Nonconformity – Means the non-fulfillment of a specified requirement

Object evidence – Data supporting the existence or verity of something

Note Objective evidence can be obtained through observation, measurement, testing or other means.

Post-production – Part of the life-cycle of the product after the design has been completed and the
medical device has been manufactured
EXAMPLES: transportation, storage, installation, product use, maintenance, repair, product changes,
decommissioning, and disposal.

Procedure – Specified way to carry out an activity or a process

Process – Set of interrelated or interacting activities which transforms inputs into outputs

Product – Means components, manufacturing materials, in-process device, finished devices, and
returned devices

Quality – Means the totality of features and characteristics that bear on the ability of a device to satisfy
fitness-for –use, including safety and performance.

Quality audit – Means a systematic, independent examination of a manufacturer’s quality system that is
performed at defined intervals and at sufficient frequency to determine whether both quality system
activities and the results of such actives comply with quality system procedures are suitable to achieve
quality system objectives.

Quality policy – Means the overall intentions and direction of an organization with respect to quality, as
established by management with executive responsibility

Quality system – Means the organizational structure, responsibilities, processes, and resources for
implementing quality management.

Record – Document stating results achieved or providing evidence of activities performed

Residual risk – Risk remaining after risk control measures have been taken
NOTE 1 Adapted from ISO/IEC Guide 51:1999, definition 3.9.
NOTE 2 ISO/IEC Guide 51:1999, definition 3.9 uses the term “protective measures” rather than “risk control
measures.” However, in the context of this International Standard, “protective measures” are only one option for
controlling risk as described in 6.2.

Rework – Means action taken on nonconforming product so that it will fulfill the specified DMR
requirements before it is released for distribution

Risk – Combination of the probability of occurrence of harm and the severity of that harm

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Risk analysis – Systematic use of available information to identify hazards and to estimate the risk
NOTE Risk analysis includes examination of different sequences of events that can produce hazardous situations
and harm.

Risk assessment – Overall process comprising a risk analysis and a risk evaluation

Risk control – Process in which decisions are made and measures implemented by which risks are
reduced to, or maintained within, specified levels

Risk estimation – Process used to assign values to the probability of occurrence of harm and the
severity of that harm

Risk evaluation – Process of comparing the estimated risk against given risk criteria to determine the
acceptability of the risk

Risk management – Systematic application of management policies, procedures, and practices to the
tasks of analyzing, evaluating, controlling, and monitoring risk

Risk management file – Set of records and other documents that are produced by risk management

Safety – Freedom from unacceptable risk

Severity – Measure of the possible consequences of a hazard

Top management – Person or group of people who direct(s) and control(s) a manufacturer at the highest
level

Use error – Act or omission of an act that results in a different medical device response than intended by
the manufacturer or expected by the user
NOTE 1 Use error includes slips, lapses, and mistakes.
NOTE 3 An unexpected physiological response of the patient is not by itself considered use error.

Validation – Means confirmation by examination and provision of object evidence that the particular
requirement for a specific intended use can be consistently fulfilled

Process Validation – Means confirmation by examination and provision of object evidence that a
process consistently produces a result or a product meeting its predetermined specifications.

Design Validation – Means confirmation by examination and provision of object evidence that device
specification conform to user need and intended use(s)

Verification – Confirmation, through the provision of objective evidence, that specified requirements have
been fulfilled
NOTE 1 The term “verified” is used to designate the corresponding status.
NOTE 2 Confirmation can comprise activities such as:
⎯ performing alternative calculations;
⎯ comparing a new design specification with a similar proven design specification;
⎯ undertaking tests and demonstrations;
Note 3 When :20XX is referenced within the procedures, it means the current revision year to the standard
referenced.

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Section 4
Management Responsibility
4.1 Management Responsibility
4.1.1 Scope and Purpose
The quality system described in this section of the QAM complies with the requirements of the
standard(s): ISO 9001:20XX, 21 CFR 820.20, 10 CFR 50 App. B part I, ISO 13485:20XX, ISO 17025, and
CMDR.
4.1.2 Responsibility and Authority (R&A)
The President, Vice Presidents, Directors, and Managers have the responsibility and authority for the
overall administration and management of the quality system activities at Fluke Biomedical. The
company’s personnel have the responsibility and have been given the authority and freedom to carry out
activities relating to its quality policy, quality system documentation and customer requirements. Director
of regulatory and quality is the management representative at Fluke Biomedical and has the responsibility
to ensure requirements of quality management systems are established and executed.
4.1.3 Quality System Requirements
Internal Communication- Fluke Biomedical has established as a means of internal communication,
regarding the effectiveness of the Quality Management System the following processes: QDIP, Policy
Deployment, Key Process Indicators, Management Review meetings and others as deemed appropriate
by management.
Quality Policy –Fluke Biomedical has established a quality policy that identifies quality system goals and
objectives. This policy is relevant to the company’s goal and the expectations and needs of its customers.
This policy has been communicated to the employees and is maintained as the highest priority within the
company; each associate understands their role.
Responsibility and Authority - The quality system documentation, responsibility matrix, and job
descriptions define the R&A and necessary interrelations for all activities.
Resources - The resources required to complete quality system activities are defined in both the quality
system documentation and job descriptions. Fluke Biomedical has identified and provides for the
resources needed to meet the ISO, QMS, QSR, CMDR and Nuclear System requirements including the
assignment of trained personnel for management, performance of work and verification activities
including internal quality audits.
Management Representative (MR) - The President or General Manager of Fluke Biomedical has
appointed a MR for the establishment, implementation, maintenance and reporting of quality assurance
system activities. The MR is the Director of Regulatory Affairs/Quality Assurance. The deputy MR is the
Quality Manager or the highest-ranking RA/QA personnel at the site designated by RA/QA Director.
Management Review - The MR carries out scheduled Management Review meetings with the
management team at defined intervals. These reviews determine the effectiveness, adequacy and
suitability of the implemented quality system requirements. Minutes of these review meetings are
maintained. The reviews include information on audit results, customer feedback, process performance
and product conformity, status of corrective and preventive actions, follow-up actions from previous
management reviews, changes that could affect the quality management system, promoting regulatory
awareness, new or revised regulatory requirements, decision to report an adverse event to regulatory
authorities and/or customers, and recommendations for improvement. Outputs from the reviews include

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any decision and actions related to improvement of the effectiveness of the system and its processes,
product improvements related to customer requirements, and resource needs.
4.1.4 Related and Support Documentation
QSP- NN Quality system procedures
QSP-102 Responsibility and Authority Matrix
QSP-201 Procedure for Management Review of the Quality System
Appendix A Organization Structure
Job Descriptions

4.2 Quality Management System

4.2.1 Scope and Purpose
The quality system described in this section of the QM complies with the requirements of the standard(s)
and: ISO 9001:20XX, 21 CFR 820.20, 10 CFR 50 App. B part II, ISO 13485:20XX, ISO 14971 20XX, and
ISO 17025, CMDR.
4.2.2 Responsibility and Authority (R&A)
The Director of RA/QA is responsible for execution of all activities pertaining to this QM. Directors and
Managers have the responsibility and authority for carrying out quality system activities in their respective
functions. The business partners have the responsibility and have been given the authority and freedom
to carry out activities in accordance with the quality policy, quality system documentation and specified
requirements. Verification of these activities are carried out by RA/QA Department via matrix reviews.
Exclusions/Not Applicable: Fluke Biomedical does not perform the following activities and claims
exclusion to these requirements: The Installation, Sterilization and Implant of medical devices.
NOTE: Fluke Biomedical products does not come in contact with patients. Thus, there are no
confidential information relating to patients.
4.2.3 Organizational Process Requirements
Fluke Biomedical has identified the processes needed for the quality management system and their
application throughout the organization. The sequence and interaction of these processes, and the
criteria and methods for their operation and control have been addressed. Resources and information for
the support and monitoring of these processes is available. Analysis of these processes is done, and
actions to achieve planned results and continual improvement are implemented as needed.
Outsourced processes are monitored and controlled to ensure that product conformity with requirements
is not adversely affected.
4.2.4 Quality System Requirements
A Quality Assurance Manual and Procedures have been created to address all requirements of the ISO
9001, 13485, and 14971 standards, the Quality System Regulations of the FDA, the Nuclear System
requirements, ISO 17025, and CMDR standards as a means of ensuring that product/service conforms to
specified requirements. The Quality Manual includes or makes reference to the quality system
procedures and outlines the structure of the documentation used in Fluke Biomedical’s quality system.
The specified requirements, including regulatory requirements, for products, components and accessories
that are medical devices are established and documented. The interactions of the various processes for
the quality management system are described.

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The Quality System Procedures are consistent with the requirements of the sited ISO and EN standards,
the QSR Regulation, the Nuclear System requirements and the company’s Quality Policy. The range and
detail of these procedures is dependent on the complexity of the work, the methods used, and the skills
and training needed by the associates involved. The procedures may make reference to other device
master records/work instructions that define how an activity is performed.
Quality Planning activities are carried out to ensure that processes are established and continually
improved to enhance customer satisfaction and to meet the objectives of the Fluke Biomedical quality
management system. The integrity of the system is maintained when changes are planned and
implemented. Quality planning is also done to plan and develop the processes needed for product
realization including the definition and documentation of how specified requirements have been or will be
addressed and met. Quality System Documentation controls the processes and methods used to meet
these requirements. Quality planning methods and practices identify and control the following:
▪ Acquisition of equipment, fixtures, resources and skills needed
▪ Ensuring design, process, installation, servicing and inspection compatibility with the applicable
documentation
▪ Risk management throughout realization through documented procedures
▪ Quality objectives and requirements for the products
▪ Updating of QC inspection and testing techniques
▪ Identification of measurement requirements
▪ Identification of suitable verification activities
▪ Standards of acceptability
▪ Identification and preparation of quality records
For each type/model of medical device, a file is established and maintained that contains or references
the location of a document that defines the product specifications and quality system requirements for
processing and quality assurance of the device. This technical file, or device master record, includes
specifications for the complete manufacturing of each product and its installation and servicing, if
appropriate.
4.2.5 Related and Support Documentation
QSP-NN Quality System Procedures
QSP-202 Procedure for Quality Planning
Structure of Documentation- Appendix B

4.3 Contract Review / Customer-Related Processes

4.3.1 Scope and Purpose
The quality system described in this section of the QAM complies with the requirements of the
standard(s): ISO 9001:2008, 21 CFR 820.20, 10 CFR 50 App. B part IV, ISO 13485:2003, ISO 14971
2012, and ISO 17025, CMDR.
4.3.2 Responsibility and Authority (R&A)
Depending on the nature of contract, Director of Regulatory and Quality shall review the quality
agreement part of the contract., Director of the Global Calibration Laboratory, the Systems Manager, the
Customer Services Manager and Representatives have the responsibility and authority for carrying out

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contract review activities so that customer requirements are determined and met. The Director of
Engineering or Engineering Manager is responsible for reviewing contract requirements when the
contract requires design activities related to nonstandard specifications. The President or Designee
reserves the right to review contracts which involve a significant or unusual amount of revenue or
resources. The business partners have the responsibility and have been given the authority and freedom
to carry out activities in accordance with the quality policy, quality system documentation and specified
requirements of QSR, QMS, CMDR and 17025
4.3.3 Contract Review Requirements
Contract Review - Procedures exist to control the methods and practices used to complete customer
contract reviews and contract amendments. Contracts (verbal and written) are reviewed to ensure that
they adequately define the specified requirements; that differences between the contract and tender are
resolved; and that the company is capable of meeting the contract or order requirements in order to
enhance customer satisfaction.
Amendments – The amendments to contracts are defined, documented and communicated to affected
functional groups.
Records of contract reviews and amendments are maintained. Channels for communication and
interfaces with the customer’s organization in these contract matters are established.
4.3.4 Related and Support Documentation
QSP-203 Procedure for Contract Review

4.4 Design and Development Control

4.4.1 Scope and Purpose
The quality system described in this section of the QAM complies with the requirements of the
standard(s): ISO 9001:20XX, 21 CFR 820.20, 10 CFR 50 App. B part III, ISO 13485:20XX, ISO 14971
20XX, and ISO 17025, CMDR.

4.4.2 Responsibility and Authority (R&A)

The Director of R&D, Engineering Manager and the V.P of Marketing have the responsibility and authority
for carrying out design control/product development activities. The Director of Operations, the Director of
the Global Calibration Laboratory, and the Manager of Regulatory/Quality or Designee and Systems
Manager provide a supportive function for this requirement. The company associates have the
responsibility and have been given the authority and freedom to carry out activities in accordance with the
quality policy, quality system documentation and specified requirements.
4.4.3 Design Control
Documented procedures exist to control all of the following quality system activities and requirements:
Design and Development Planning - Plans outlining design activities and their associated schedules are
developed for each design project; these plans define various R&A and are used to ensure that
personnel, with appropriate skills, and adequate resources, are assigned to each design project. Plans
are formally documented and are modified as the design activities are evolving. Throughout the design
process, the need for risk analysis is evaluated and if performed, records of the analyses are maintained.
Organizational and Technical Interfaces – The company’s various functional groups are involved in
reviewing and evaluating the aspects of the design through its stages; the assigned project group has the
R&A for defining these interfaces, documenting and transmitting their input and seeing that the
information received is regularly reviewed.

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Design Input - the project group interfaces with the sales/marketing and regulatory functions in order to
ensure a complete understanding of the customer(s) and other requirements (industry and
governmental). The input takes into consideration the results of contract review activities. For medical
devices, requirements that are related to the safety of the device are identified and included as design
inputs and the outputs of risk management.
The design inputs are then documented and reviewed for adequacy. Incomplete, ambiguous or conflicting
requirements are resolved with those responsible for imposing these requirements.
Design Output – The output of the design process is documented in various forms. The design output
must be expressed in terms that can be verified and, where necessary, validated against the design
inputs using suitable methods. The design output must meet the specified design input requirements, and
contain or make reference to the appropriate acceptance criteria. In addition, those characteristics that
are crucial to the safe and proper functioning of the product such as operation, storage, handling etc.
must be identified. Prior to release, the results of design output activities are reviewed by objective design
review committee personnel.
Design Review - At appropriate stages of the design, formal, structured and documented design reviews
activities are held; these reviews are carried out to determine if all specified requirements for the phase
being reviewed have been addressed. Representatives from the functional groups concerned with the
design phase being reviewed, as well as other specialist personnel are asked to participate. Records of
these reviews are maintained with the design history file for the project.
Design Verification –At appropriate stages of design, design verification is performed to ensure that the
design stage output meets the design stage input requirements. The design verification measures are
recorded and maintained with the design history file. Design verification may include tests to compare
new designs to proven designs. Alternate experiments, tests and demonstrations and a review of design
documents before their release are also conducted. For items subject to the requirements of 10CFR 50
Appendix B, where a test program is used to verify the adequacy of a specific design feature in place of
other verifying or checking processes, it must include suitable qualification testing of the prototype unit
under the most adverse conditions. Independent design verification, performed by someone independent
of the design or activity being verified, is to be performed when needed to meet regulatory or customer
requirements. All design verification activities for medical devices are documented and maintained,
including those where clinical investigation was involved.
Design Validation- Design validation is performed to ensure that the product conforms to defined user
needs and/ or requirements. This quality system activity is performed when appropriate and follows
successful design verification. When conducted, it follows defined operating conditions, and normally is
performed using product made in manufacturing which represents the proposed final product. Multiple
validations may be performed if there are different intended uses. Medical devices may require clinical
evaluation as part of the design validation. When performed, records of the evaluation are maintained.
The clinical evaluation may include a compilation of scientific literature and historical evidence that similar
designs and/or materials are clinically safe, or a clinical investigation or trial, to ensure that the device
performs as intended.
Design Transfer- Procedures are in use to ensure that the device design is correctly translated into
production specifications.
Design Changes - Design modifications are identified, documented, reviewed and approved by the
various functional organizations affected by the associated changes. These activities are carried out prior
to design change implementation. These controls apply to design changes regardless of the origin or
ownership of the design. Changes to established products must be handled according to the regular
change/engineering control procedures (see sections 4.5 and 4.14)

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Design History/Technical File- A design history file (DHF) is maintained for each type of device. This file
contains or references the records necessary to demonstrate that the design was developed in
accordance with the approved design plan and the requirements of the standards.
Software Development – As appropriate, the design procedures and requirements for software
development are the same as for other designs.
Documents and records relating to product development/design control requirements are kept in the
design history file.
4.4.4 Related and Support Documentation
QSP-204 Product Development/Design Control Procedure

4.5 Document and Data Control

4.5.1 Scope and Purpose
The quality system described in this section of the QAM complies with the requirements of the
standard(s): ISO 9001:20XX, 21 CFR 820.20, 10 CFR 50 App. B part VI, ISO 13485:20XX, ISO 14971
20XX, and ISO 17025, CMDR.
4.5.2 Responsibility and Authority (R&A)
The Manager of Regulatory/Quality or Designee and the Director of Operations have the responsibility
and authority for carrying out document and data control activities. The business partners have the
responsibility and have been given the authority and freedom to carry out activities in accordance with the
quality policy, quality system documentation and specified requirements.
4.5.3 Document and Data Control
Fluke Biomedical adheres to documented procedures controlling aspects of the creation, review,
approval, modification, issue, release, and other activities associated with document and data control.
These controls apply to documents regardless of their origin, and whether they are hard copies or
electronic records. Device master records and labeling masters are covered by these procedures.
Documents and data are reviewed and approved for adequacy by authorized personnel prior to issue. A
listing of quality-related documentation is maintained. This listing includes current revision-level
information, and is available to associates that need this information to carry out their activities, to
preclude the use of invalid or obsolete documents.
Current revision levels of procedural and policy documents are maintained in the areas where the work
described in the documents is being carried out. Manufacturing, testing and labeling, forms, and labeling
materials are issued as needed from the appropriate Document Control person or Materials Management
person in order to maintain control.
Down-level (previous version) and obsolete documents are removed from points of issue and use in
manufacturing to ensure that they are not used to make decisions that may affect quality. These
documents are segregated and archived. Historical data is maintained for reference purposes. Obsolete
documents may be needed in order to conduct repairs and may be used for that purpose. Retention
periods for the various types of documents and records are documented. For medical devices, the
retention period ensures that specifications to which the products have been manufactured are available
for at least two years past the expected lifetime of the medical device, as defined by the company.
Documents that are to be retained for legal and/or knowledge preservation purposes indefinitely are
identified.
Changes to documents and data are reviewed and approved by the same functions/organizations that
performed the original review and approval, unless specifically designated otherwise. Pertinent

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information or background is provided upon which to base their review and approval. Where practicable,
the nature of the change is identified in the change request documents or attachments.
4.5.4 Related and Support Documentation
QSP-205 Document and Data Control Procedure
QSP-103 Document/Quality Record Matrix
QSP-05-08 Procedure Index

4.6 Purchasing
4.6.1 Scope and Purpose
The quality system described in this section of the QAM complies with the requirements of the
standard(s): ISO 9001:20XX, 21 CFR 820.20, 10 CFR 50 App. B part IV, VII, ISO 13485:20XX, ISO
14971 20XX, and ISO 17025, CMDR.
4.6.2 Responsibility and Authority (R&A)
The Materials/Purchasing Manager and designated purchasing personnel have the responsibility and
authority for carrying out purchasing activities. The business partners have the responsibility and have
been given the authority and freedom to carry out activities in accordance with the quality policy, quality
system documentation and specified requirements.
4.6.3 Purchasing
Documented procedures are in use to ensure that purchased product and services conform to specified
requirements. The type and extent of control applied to the supplier and the purchased product or service
is dependent on the effect of the product or service on subsequent product realization activities and the
final product.
Vendors, contractors and consultants are evaluated on the basis of their ability to meet the requirements
of the quality system and any specific quality assurance requirements. Records of acceptable vendors,
contractors and consultants are maintained.
The procedures also define the type and extent of control to be exercised over the vendors, contractors
and consultants dependent upon the type of product or service supplied, its impact on the quality of the
final products, and where applicable, the audit reports or performance record of the vendor.
Purchase order (PO) information contains adequate detail to ensure that all specified requirements have
been adequately described. Reviews and approvals of all PO and related information are carried out by
purchasing personnel in advance of the PO being placed with the vendor, to ensure adequacy of the
specified requirements. When appropriate, the purchasing information includes requirements for approval
of the product, procedures, processes and equipment, requirements for qualification of personnel, and
quality management system requirements. Copies of relevant purchasing documents are retained as
needed to the extent required by the particular requirements for traceability discussed in section 6.8 of
this manual.
Activities are conducted to ensure that the purchased product or service meets specified purchase
requirements. When purchased product is to be verified at the vendor’s premises, the verification
arrangements and the method of product release are in the purchasing documents.
When it is a condition of the contract, the customer has the right to verify that the product conforms to
specified requirements on our premises or that of our vendor. Such verification is not used as evidence of
effective control of the subcontractor’s quality system. The verification by the customer does not absolve
Fluke Biomedical of the responsibility to provide acceptable product, nor does it preclude subsequent
rejection by the customer.

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4.6.4 Related and Support Documentation

QSP-206 Purchasing Procedure
4.7 Control of Customer-Supplied Product
4.7.1 Scope and Purpose
The quality system described in this section of the QAM complies with the requirements of the
standard(s): ISO 9001:20XX, 21 CFR 820.20, and ISO 13485:20XX, ISO 14971 20XX, and ISO 17025,
CMDR.
4.7.2 Responsibility and Authority (R&A)
Management of recipient of customer supplied products have the responsibility and authority for carrying
out control of customer-supplied product activities. The business partners have the responsibility and
have been given the authority and freedom to carry out activities in accordance with the quality policy,
quality system documentation and specified requirements.
4.7.3 Control of Customer-Supplied Product
Procedures for identification, verification, protection, storage, and maintenance of customer-supplied
product are in use. These products may be for incorporation into the final product or for related activities
or services.
Any such product that is lost, damaged or is otherwise unsuitable for use is recorded and reported to the
customer.
Verification by Fluke Biomedical does not absolve the customer of the responsibility to provide acceptable
product.
4.7.4 Related and Support Documentation
QSP-207 Control of Customer-Supplied Product Procedure

4.8 Product Identification and Traceability

4.8.1 Scope and Purpose
The quality system described in this section of the QAM complies with the requirements of the
standard(s): ISO 9001:20XX, 21 CFR 820.20, 10 CFR 50 App. B part VIII, ISO 13485:20XX, ISO 14971
20XX, and ISO 17025, CMDR.
4.8.2 Responsibility and Authority (R&A)
Area managers and their designee have the responsibility and authority for carrying out product
identification and traceability activities. The business partners have the responsibility and have been
given the authority and freedom to carry out activities in accordance with the quality policy, quality system
documentation and specified requirements.

4.8.3 Product Identification and Traceability

Documented procedures exist for identifying product from receipt and during stages of production,
delivery and installation. These procedures ensure that medical devices received for refurbishing or
reprocessing to specified requirements are identified and distinguished at all times from normal
production.

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There are also documented procedures for the unique identification of individual products or batches
where traceability is a requirement, as for medical devices. The identification is recorded on the
applicable documents and may enable traceability to certain components used in the product. Traceability
is maintained for the distribution of the devices and ensures that the record of the original consignee for
the device is maintained to facilitate corrective or preventive action if needed.
4.8.4 Related and Support Documentation
QSP-208 Product Identification and Traceability Procedure

4.9 Process Control

4.9.1 Scope and Purpose
The quality system described in this section of the QAM complies with the requirements of the
standard(s): ISO 9001:20XX, 21 CFR 820.20, 10 CFR 50 App. B part V, IX, and X, ISO 13485:20XX, ISO
14971 20XX, and ISO 17025, CMDR.
4.9.2 Responsibility and Authority (R&A)
All area managers engaged in any activities that effect quality of products or services have the
responsibility and authority for carrying out process control activities. The business partners have the
responsibility and have been given the authority and freedom to carry out activities in accordance with the
quality policy, quality system documentation and specified requirements.
4.9.3 Process Control
Documented controls, plans and procedures exist to govern the methods and practices used to complete
and monitor manufacturing, installation and servicing processes. These controlled conditions include the
following:
• Provision and maintenance of the appropriate infrastructure including buildings, workspace and
utilities
▪ Documented procedures defining the manner of these activities, when they affect quality
▪ Use of suitable process equipment, both hardware and software,
▪ Use of a suitable working environment if the environmental conditions are of significance in the
manufacture of the products. Under such conditions, the requirements are established and
documented, and if appropriate controlled and monitored.
▪ Personnel requirements for health, cleanliness and clothing if contact between such personnel and
the product or environment could adversely affect the quality of the product. Personnel who are
required to work under special environmental conditions are appropriately trained, or supervised by a
trained person.
▪ Compliance with reference standards/codes, quality plans and/ or documented procedures
▪ Requirements for the cleanliness of the product if process agents are to be removed from product
during manufacture.
▪ Monitoring and control of suitable materials, process parameters and product characteristics
▪ Approval and change control of processes and equipment, as appropriate
▪ Criteria for workmanship, clearly defined
▪ Suitable maintenance, monitoring and measurement on equipment with established requirements
when such activities may affect quality. Records of such maintenance are kept.

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▪ Appropriate procedures for installation when performed, and documentation of such activities.
▪ Use of documented procedures for the validation of the application of computer software used for
process control. The results of the validation are recorded.
▪ Implementation of release, delivery and post-delivery activities
▪ Supporting services such as transportation and communication
Where the results of processes cannot be fully verified by subsequent monitoring, inspection, measuring
or testing of the product and where, for example, processing deficiencies may become apparent only after
the product is in use, process validation is performed. Validation is performed to demonstrate the ability of
these processes to achieve planned results. The documented validation program includes, where
appropriate, installation qualification, operation qualification, performance qualification and process
validation, software validation, continuous monitoring of processes, and qualification of operators. The
use of specific methods and procedures is defined as applicable. Revalidation is done when needed due
to a design change, new product, and new application for the process or as indicated by process
monitoring or feedback from customers.
The quality records of such validated special processes identify the work instruction or procedure used
the date the special process was performed and the identity of the operator of the special process.
The requirements for any qualification of process operations, including associated equipment and
personnel are specified.
Records are maintained of the process control and validation activities, and for qualified processes,
equipment and personnel.
4.9.4 Related and Support Documentation
QSP-209 Process Control Procedure

4.10 Inspection and Testing / Analysis and Improvement

4.10.1 Scope and Purpose
The quality system described in this section of the QAM complies with the requirements of the
standard(s): ISO 9001:20XX, 21 CFR 820.20, 10 CFR 50 App. B part VII, X, XI, ISO 13485:20XX, ISO
14971 20XX, and ISO 17025, CMDR.
4.10.2 Responsibility and Authority (R&A)
The Manager of Regulatory/Quality or Designee, Director of Operations and the Director of the Global
Calibration Laboratory, the Managers of Calibration Service and Systems, and the Business Unit
Directors have the responsibility and authority for carrying out inspection, testing and measuring activities.
The business partners have the responsibility and have been given the authority and freedom to carry out
activities in accordance with the quality policy, quality system documentation and specified requirements.
4.10.3 Inspection and Testing (I &T)
Documented procedures for inspection and testing activities exist in order to verify that the specified
requirements for the products are met. The required inspection and testing activities are detailed in
documented procedures or in quality plans.
Incoming product is not used or processed (except for products where pilot testing is specified prior to
acceptance) until it has been inspected or otherwise verified as conforming to specified requirements
according to documented procedures. The amount and nature of the incoming inspection is based on the
nature of the material and its importance in the final product, but also on the amount of control exercised
at the vendor’s premises and the recorded evidence of conformance available.

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Where incoming material is released for urgent production purposes prior to verification, it is positively
identified and recorded in order to permit immediate recall and replacement in the event it is found to be
nonconforming to specified requirements.
In-process materials and products are inspected and tested as required by documented procedures.
Product is held until the required inspection and/or test has been completed or necessary reports and
records have been received and verified, except when product is released to the next production stage
under positive-recall procedures as described above. Such a conditional release does not preclude the
performance of the in-process inspection and test activities.
Final inspection and testing is carried out in accordance with documented procedures to complete the
evidence of conformance to the specified requirements. The procedures for the final inspection and
testing require that all previously required inspections and tests have been performed and that the results
meet specified requirements. No products are released for distribution until the activities specified in the
documented procedures have been satisfactorily completed and the associated data and documentation
have been approved and accounted for.
Records to demonstrate that the product has been inspected and/or tested are maintained. These
records clearly show whether the product has passed or failed according to defined acceptance criteria.
Where the product fails to pass any inspection and/or test, the procedures for control of nonconforming
product are followed.
The inspection authority responsible for the release of product is identified on the records. Inspection and
test activities are performed by individuals other than those who performed the activity being checked.
4.10.4 Measurement, Analysis and Improvement
Fluke Biomedical has implemented monitoring, measurement, analysis and improvement processes not
only to demonstrate conformity of the product, but also to ensure conformity of the quality management
system and to continually improve the effectiveness of the quality management system. Information
relating to customer perception and satisfaction is monitored by customer service, sales, quality and
marketing, and shared at the Management Review meetings. Internal audits are conducted according to
part 6.17 of this manual. Processes are monitored and measured to demonstrate the ability of the
processes to achieve planned results. When planned results are not achieved, corrective actions are
taken, as appropriate, to ensure conformity of the product.
4.10.5 Related and Support Documentation
QSP-210 Inspection and Testing Procedure
Metrics from Management Review Meetings

4.11 Control of Monitoring, Inspection, Measuring and Test

Equipment
4.11.1 Scope and Purpose
The quality system described in this section of the QAM complies with the requirements of the
standard(s): ISO 9001:20XX, 21 CFR 820.20, 10 CFR 50 App. B part XII, ISO 13485:20XX, ISO 14971
20XX, and ISO 17025, CMDR.
4.11.2 Responsibility and Authority (R&A)
The Director of the Global Calibration Laboratory, the Calibration Service Manager, the Director of RA/QA
or Designee have the responsibility and authority for carrying out control of monitoring, inspection,
measuring and test equipment activities. The business partners have the responsibility and have been

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given the authority and freedom to carry out activities in accordance with the quality policy, quality system
documentation and specified requirements.
4.11.3 Inspection, Measuring and Test Equipment (I, M, & TE)
Documented procedures to control, maintain, and calibrate monitoring, inspection, measuring and test
equipment (including test software) are in use to demonstrate the conformance of product to the specified
requirements. Such equipment is used in a manner, which ensures that the measurement uncertainty is
known and is consistent with the required measurement capability.
Where test software or comparative references are used as suitable forms of inspection, they are
checked to prove that they are capable of verifying the acceptability of product, prior to release for use
during production, installation or servicing. Periodic rechecks are done according to a procedure and
records of such checks are maintained. Technical data, pertaining to the inspection, measuring or test
equipment, is made available to a customer when required by their contract or to verify the equipment is
functionally adequate.
In order to ensure the control of the equipment, Fluke Biomedical does the following:
• Selection of I, M & TE is based on analysis and determination of the precision required;
• Equipment affecting quality is identified and handled according to the appropriate procedures
• Procedures are established according to equipment type, frequency of use, and nature of use, and
include acceptance criteria and reference to actions for nonconforming equipment.
• I, M & TE is identified by either a controlled equipment label, calibration sticker or inscribed identifier
number. The calibration status of each piece of equipment is determined by either a calibration sticker
or record of calibration status, based on the equipment identification number;
• Calibration status of equipment is determined by equipment vendor documentation, actual calibration
of equipment by plant maintenance personnel, calibration personnel or QC/QA personnel, or by the
equipment operator when done as part of the work instructions.
• Calibration status for all I, M & TE is traceable to industry, national or international equipment
standards, whenever possible;
• Methods and practices of calibration are documented and these documents are adhered to in
carrying out calibration activities;
• Documented procedures detail methods and practices to be used for assessing I, M &TE found to be
out of calibration and the actions related to product(s) that were inspected or tested using this
equipment;
• Suitable environmental conditions are maintained to ensure the accurate operation of I, M & TE and
for product that will be inspected in these environmental conditions;
• Methods of handling, preservation and storage exist to ensure that I, M &TE are used in a manner
that will ensure measurement accuracy and fitness for use; and
• Measures have been taken to protect I, M & TE, including software and hardware, from unauthorized
adjustment that may affect the accuracy of the equipment.
4.11.6 Related and Support Documentation
QSP-211 Control of Inspection, Measuring and Test Equipment Procedure

4.12 Inspection, Test and Operating Status

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4.12.1 Scope and Purpose

The quality system described in this section of the QAM complies with the requirements of the
standard(s): ISO 9001:20XX, 21 CFR 820.20, 10 CFR 50 App. B part XIV, ISO 13485:20XX, ISO 14971
20XX, and ISO 17025, CMDR.
4.12.2 Responsibility and Authority (R&A)
The Manager of Regulatory/Quality or Designee, Systems Manager, Calibration Service Manager,
Material Logistics Supervisor, and the Directors of Operations and the Global Calibration Laboratory,
have the responsibility and authority for carrying out inspection and test status activities. The Quality
Engineers and the Facilities Engineer have a supportive role for this function. The business partners have
the responsibility and have been given the authority and freedom to carry out activities in accordance with
the quality policy, quality system documentation and specified requirements.
4.12.3 Inspection and Test Status
Documented procedures are in use to control the methods for identifying accepted or released
(conforming) product and product on hold (which may be nonconforming product) based on their
inspection and test results.
The identification of inspection and test status is maintained, as defined in the documented procedures,
throughout the production, packaging, labeling, installation and servicing of the product. Only product that
has passed the required inspections and tests and is released, is distributed, used or installed.
To meet safety or other requirements, measures are taken for indicating the operating status of
equipment, such as by tagging valves and switches, to prevent inadvertent operation.
4.12.4 Related and Support Documentation
QSP-212 Inspection and Test Status Procedure

4.13 Control of Nonconforming Product

4.13.1 Scope and Purpose
The quality system described in this section of the QAM complies with the requirements of the
standard(s): ISO 9001:20XX, 21 CFR 820.20, 10 CFR 50 App. B part XV, ISO 13485:20XX, ISO 14971
20XX, and ISO 17025, CMDR.
4.13.2 Responsibility and Authority (R&A)
The Directors of the Global Calibration Laboratory and Operations, the Material Logistics Supervisor, and
Purchasing Manager, Manufacturing Engineering, Systems Manager, Service/Repairs Manager, and the
Director of RA/QA or Designee have the responsibility and authority for carrying out control of
nonconforming product activities. The business partners have the responsibility and have been given the
authority and freedom to carry out activities in accordance with the quality policy, quality system
documentation and specified requirements.
4.13.3 Control of Nonconforming Product
Documented procedures are in use to ensure that materials, parts, components or finished product that
does not conform to specified requirements is prevented from unintended use or installation. These
procedures specify the methods for the identification, documentation, evaluation, segregation (when
practical), and disposition of such nonconforming product, and the notification to the functions or
departments concerned.

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Responsibility for review and the authority for the disposition are defined. Nonconforming product is
reviewed in accordance with documented procedures to determine the appropriate action to take, which
may include:
• rework or repair to specifications
• re-inspection or retest if there is reason to believe the initial results may be due to operator or
equipment error
• scrapping or recycling,
• acceptance through customer concession (not an option for FDA-regulated product)
• rejection/return to vendor
Rework and repair are carried out in accordance with documented instructions and product is retested
according to the documented procedures. Rework for medical devices is documented in a work
instruction that has undergone the same authorization and approval procedure as the original work
instruction.
For product not regulated by the FDA and where contractually required, Fluke Biomedical reports the
proposed use of nonconforming product to the customer for concession. Descriptions of the accepted
nonconformity are recorded to denote the actual condition. Nonconforming product is accepted for
concession only if regulatory requirements are met. The identity of the person authorizing concession is
recorded.
4.13.4 Related and Support Documentation
QSP-213 Control of Nonconforming Product Procedure

4.14 Corrective and Preventive Action

4.14.1 Scope and Purpose
The quality system described in this section of the QAM complies with the requirements of the
standard(s): ISO 9001:20XX, 21 CFR 820.20, 10 CFR 50 App. B part XVI, ISO 13485:20XX, ISO 14971
20XX, and ISO 17025, CMDR.
4.14.2 Responsibility and Authority (R&A)
The Director of Regulatory and Quality or designee is responsible to ensure an effective CAPA system
and mechanism is in place to address nonconformities. All area Directors and Managers and their
respective teams are are responsible to process CAPAs assigned to them in a timely and effective
manner.. The business partners have the responsibility and have been given the authority and freedom to
carry out activities in accordance with the quality policy, quality system documentation and specified
regulatory requirements.
4.14.3 Corrective and Preventive Action
A documented feedback system is established to provide early warning of quality problems and for input
into the corrective and/ or preventive action system. Experience gained from post-production, or post-
marketing surveillance, is reviewed as part of this feedback system when required.
Documented procedures for implementing corrective and preventive action are in use. The determination
of action to be taken to eliminate the causes of actual or potential nonconformities is appropriate to the
magnitude of the problem and the risks. Changes made to the device master records as a result of
corrective and preventive action are handled through established change control procedures for review,
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The procedures for corrective action include methods for documenting and handling customer complaints,
returned product, deviations in production, and reports of product nonconformities. An investigation of the
cause and the associated risk of the nonconformities, relating to the product, process or quality system is
done and the results recorded. The feedback information is investigated, interpreted, collated, and
communicated in accordance with defined procedures by designated personnel.
A record is kept of all customer complaint investigations. When the investigation determines that the
activities at remote premises contributed to the customer complaint, a copy of the report is sent from
Fluke Biomedical to the remote premises. The corrective action needed is then determined and followed
up to ensure the action is implemented and effective. If any customer complaint is not followed by
corrective and/or preventive action, the reason is recorded.
The procedures for preventive action include the use of information from various sources including
internal operation reports, audit results, quality records, service reports and customer complaints to
detect, analyze and eliminate potential causes of nonconformities. These procedures include steps to
deal with problems requiring preventive action, the initiation of such actions and instructions for follow-up
to ensure implementation and effectiveness. Again, such proposed actions are handled according to the
established change control procedures, which include management review.
If a customer alleges that one of our medical device products has caused or contributed to a serious
injury or death, or that it has malfunctioned, and if that malfunction were to recur it could cause or
contribute to a serious injury or death, the Medical Device Reporting regulations are followed as
described in 21CFR 803, the Canadian Medical Device Regulations are followed as described in Sections
59-65 Mandatory Problem Reporting, and the requirements of Regulatory Authorities in other countries as
applicable. Procedures for the notification of such regulatory authorities are established to meet the
reporting criteria.
If a correction or removal of distributed medical devices is needed, then the requirements of the FDA’s
21CFR 806, and those of applicable foreign Regulatory Authorities are followed. Procedures are
established for the issue of such advisory notices or recalls, which can be implemented at any time.
For items subject to regulation by the Nuclear Regulatory Commission or the Atomic Energy Act of 1954,
a defect or nonconformance is deemed to exist if anyone obtains information reasonably indicating that a
basic component, licensed activity or a portion of the facility has a defect or failure that could be
associated with a substantial safety hazard. A notification of failure to comply or existence of a defect
must be made according to 10 CFR part 21.21.
NOTE 1: Risk Management is conducted from Product Development to the Post Market Surveillance.
This may include any Risks or opportunities associated with Non-Conformances, Complaints, and
CAPA’s that may affect product integrity, safety and or any other regulatory requirements.
NOTE 2: The corrective and preventive actions shall be examined to ensure product safety and
effectiveness has not been affected. The need for decision to inform regulatory authorities or customers
are evaluated.
4.14.3.1 "Continual Improvement" in the concept of ISO-9001 (part 10.3). Where
possible and applicable, opportunity for continuous improvement shall be evaluated and
implemented. During the improvement process, it must be established that the safety and
efficacy of the product(s) and intended use will not be affected.

4.14.4 Related and Support Documentation

QSP-214 Corrective and Preventive Action Procedure
EOP-04-12 Risk Management

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QSP-14-02 Medical Device and Nuclear Reporting Procedure

QSP-14-01 Complaint Handling Procedure

4.15 Handling, Storage, Labeling, Packaging, Preservation

and Delivery
4.15.1 Scope and Purpose
The quality system described in this section of the QAM complies with the requirements of the
standard(s): ISO 9001:20XX, 21 CFR 820.20, 10 CFR 50 App. B part III, ISO 13485:20XX, ISO 14971
20XX, and ISO 17025, CMDR..
4.15.2 Responsibility and Authority (R&A)
The Materials Logistic Supervisor, Director of Operations, and the Radiation Safety Officer have the
responsibility and authority for carrying out handling, storage, labeling, packaging, preservation and
delivery activities. The business partners have the responsibility and have been given the authority and
freedom to carry out activities in accordance with the quality policy, quality system documentation and
specified requirements.
4.15.3 Handling, Storage, Labeling, Packaging, Preservation and Delivery
Documented procedures are in use for the handling, storage, packaging, preservation and delivery of
product, as well as for returned product. These procedures control the following activities:
Handling - Handling methods and practices are intended to prevent damage and deterioration of material
and products throughout the receiving, manufacturing, packaging, preservation and shipping, and return
process.
Storage - Receiving, in-process and pre-shipment areas have been identified and are used; these areas
have the intended purpose of preventing damage and deterioration to product(s) and or material(s) and
for segregating materials released from those that are to be held. Clearly defined methods and practices
are in use for the receipt and dispatching of items from these areas. The condition of product in stock is
assessed at appropriate intervals.
Packaging and Labeling- Methods of packing, packaging, labeling and marking of packaging materials
are controlled to ensure that all specified requirements have been met.
Preservation - Measures are taken to preserve materials and products to prevent damage and
deterioration, and to segregate materials released for distribution from those to be held.
Delivery - Practices and procedures are in use that provide for the protection of products after final
inspection and testing; as required, this protection applies to the delivery of the product to the customer.
Procedures are established and maintained for the control of product with a limited shelf- life or requiring
special storage conditions. Such special storage conditions for medical devices are controlled and
recorded as applicable.
If appropriate, special arrangements are established and maintained for the handling and control of used
product in order to prevent the contamination of other product, the manufacturing environment or
personnel.
4.15.4 Related and Support Documentation
QSP-215 Handling, Storage, Packaging, Preservation and Delivery Procedure

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4.16 Control of Quality Records

4.16.1 Scope and Purpose
The quality system described in this section of the QAM complies with the requirements of the
standard(s): ISO 9001:20XX, 21 CFR 820.20, 10 CFR 50 App. B part XVII, ISO 13485:20XX, ISO 14971
20XX, and ISO 17025, CMDR.
4.16.2 Responsibility and Authority (R&A)
The Directors, Managers, Supervisors and the Manager of Regulatory/Quality or Designee have the
responsibility and authority for carrying out control of quality record activities. The business partners have
the responsibility and have been given the authority and freedom to carry out activities in accordance with
the quality policy, quality system documentation and specified requirements.
4.16.3 Control of Quality Records
Procedures for identification, collection, indexing, access, filing, storage, maintenance, and disposition of
maintained to demonstrate conformance to specified requirements and the effective operation of the
quality system. Applicable records from vendors are also considered and handled as quality records.
The quality records are legible and maintained in a retrievable manner. The records are kept in a storage
environment that prevents damage, deterioration and loss. Electronic records are backed-up, via
electronic means, and stored to prevent loss or damage. Record retention periods are specified and
conform to regulatory and contract requirements. For medical devices, the quality records are retained for
a period of time at least equivalent to the lifetime of the device as defined by the supplier; but not less
than 2 years from the date of dispatch.
A record for each batch, unit or run of medical devices is maintained that provides traceability to the
extent required by section 4.8 and identifies the quantity manufactured and the quantity released for
distribution. The record is verified and authorized.
Records are available for review by regulatory authorities, quality system auditors, company personnel,
and by a customer when specified as part of their contract. Management review and internal or external
audit records are not to be provided to FDA inspectors for review.
4.16.4 Related and Support Documentation
QSP-216 Control of Quality Records Procedure
QSP-103 Document/Quality Record Matrix

4.17 Quality Audits

4.17.1 Scope and Purpose
The quality system described in this section of the QAM complies with the requirements of the
standard(s): ISO 9001:20XX, 21 CFR 820.20, 10 CFR 50 App. B part VI, XIII, ISO 13485:20XX, ISO
14971 20XX, and ISO 17025, CMDR.
4.17.2 Responsibility and Authority (R&A)
The Regulatory/QA Manager or Designee have the responsibility and authority for carrying out quality
audit activities. The business partners have the responsibility and have been given the authority and
freedom to carry out activities in accordance with the quality policy, quality system documentation and
specified requirements.
4.17.3 Quality Audits

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Documented procedures for planning and implementing internal and external quality audits are in use.
Quality audits are carried out to verify that planned and documented procedures, quality and control
plans, and other quality system documentation are in conformance, and to assess their effectiveness.
The internal audits are scheduled based on the departments or regulatory element’s impact on quality
and quality performance, and are carried out against the requirements of the standard(s) that apply to the
operation being audited. External audits are done at intervals consistent with the importance, complexity,
performance history and quantity of the product or services obtained from the vendor. Trained and
qualified personnel who understand the standard(s), auditing requirements, and basic communication
skills, and who are independent of the functional area being assessed, conduct the audits.
The results are documented and are communicated to the personnel having responsibility for the area
audited. The management of the audited area must determine and implement timely corrective action.
Follow-up activities are carried out to verify the implementation and effectiveness of corrective action.
Records of quality audits are maintained.
4.17.4 Related and Support Documentation
QSP-217 Quality Audit Procedure

4.18 Training
4.18.1 Scope and Purpose
The quality system described in this section of the QAM complies with the requirements of the
standard(s): ISO 9001:20XX, 21 CFR 820.20, 10 CFR 50 App. B part II ISO 13485:20XX, ISO 14971
20XX, and ISO 17025, CMDR.
4.18.2 Responsibility and Authority (R&A)
All area Directors and Managers have theresponsibility and authority for carrying out training activities
and to ensure all personnel in their respective areas are trained properly. . The business partners have
the responsibility and have been given the authority and freedom to carry out activities in accordance with
the quality policy, quality system documentation and specified requirements.
4.18.3 Training
The necessary competence for personnel performing work affecting product quality has been determined
through the job descriptions. Documented procedures for identifying training needs are in use. Training,
including Quality System requirements, is provided for personnel performing activities affecting quality.
Personnel who perform specific assigned tasks are qualified on the basis of appropriate education,
training and/or experience, as required. Records of training and qualifications are maintained.
Personnel are made aware of the relevance and importance of their activities and how they contribute to
the achievement of the Fluke Biomedical quality objectives.
Personnel who are required to work under special environmental conditions or who perform special
processes or functions are appropriately trained or supervised by a trained person.
4.18.4 Related and Support Documentation
QSP-218 Training Procedure

4.19 Servicing
4.19.1 Scope and Purpose

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The quality system described in this section of the QAM complies with the requirements of the
standard(s): ISO 9001:20XX, 21 CFR 820.20, and ISO 13485:20XX, ISO 14971 20XX, and ISO 17025,
CMDR.
4.19.2 Responsibility and Authority (R&A)
The Director of the Global Calibration Laboratory, the Calibration Service Manager and the Customer
Service/Repair Manager, have the responsibility and authority for carrying out servicing activities. The
business partners have the responsibility and have been given the authority and freedom to carry out
activities in accordance with the quality policy, quality system documentation and specified requirements.

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4.19.3 Servicing
Where servicing is a specified requirement, documented procedures for scheduling, performing, verifying
and reporting the servicing are in use. These procedures ensure that the servicing activities are done
under controlled conditions, meet the specified requirements for the product and that the servicing
activities are documented. Servicing, like production, is done using correct information for the product,
work instructions (as necessary), suitable equipment, monitoring and measuring devices, measuring and
monitoring of the service itself, and proper release, delivery and post-delivery activities.
4.19.4 Related and Support Documentation
QSP-219 Servicing Procedure
QSP-101 Quality Manual for Calibration Services (Cleveland)

4.20 Statistical Techniques

4.20.1 Scope and Purpose
The quality system described in this section of the QAM complies with the requirements of the
standard(s): ISO 9001:20XX, 21 CFR 820.20, and ISO 13485:20XX, ISO 14971 20XX, and ISO 17025,
CMDR.
4.20.2 Responsibility and Authority (R&A)
The Directors and Managers have the responsibility and authority for carrying out statistical technique
activities where applicable. The business partners have the responsibility and have been given the
authority and freedom to carry out activities in accordance with the quality policy, quality system
documentation and specified requirements.
4.20.3 Statistical Techniques
Fluke Biomedical has implemented monitoring, measurement, analysis, and improvement processes
needed to demonstrate conformity of the product, and the quality management system, and to continually
improve the effectiveness of the quality management system.
Where appropriate, procedures are in use to identify the need for valid statistical techniques required for
establishing, controlling and verifying process capability, product characteristics and the ability of the
processes to achieve planned results. Where such needs have been identified, procedures or practices
are in use to control the application of the statistical techniques and to define the appropriate sampling
methods and plans. The sampling methods chosen are adequate for their intended use and are reviewed
when there are changes in a product or process. Sampling methods are reviewed in light of the
occurrence of nonconforming product, quality audit reports, feedback information and other appropriate
considerations. Activities related to these requirements for statistical techniques are documented.
Data analysis provides information relating to customer satisfaction, conformity to product requirements,
characteristics and tends of processes and products, and suppliers. This data is typically reviewed as part
of the Management Review meetings.
4.20.4 Related and Support Documentation
QSP-220 Statistical Techniques Procedure
QSP-201 Management Review

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Appendix A
QSP-100

See QSP-105, Organizational Structure, for Organization Chart.

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Appendix B
QSP-100
FLUKE Biomedical,
Documentation Structure

• Quality System Manual QSP-100

• Quality System Procedures QSP-201 THRU QSP-

220

• Department Specific Procedures, Work

Instructions, Forms
• Engineering Operating Procedures EOP’s
• Manufacturing Operating Procedures MOP’s
• Quality System Operating Procedures QSP’s
• Customer Service Operating Procedures CSOP’s
• Test Procedures- TP’s
• Calibration Procedures- CLP’s
• Standard Operating Procedures SOP’s

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Fluke Biomedical
6045 Cochran Road
Cleveland, Ohio 44139
440.498.2564

6920 Seaway Blvd.

Everett, WA 98203
425.446.6945

www.flukebiomedical.com

Appendix C
High Level Quality Management System Flow Chart

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Continual Improvement of the Fluke Biomedical

Quality Management System

Resource Management

Regulatory Compliance

(Contract Review QSP-203 – Cont. Next Page)

Regulatory Requirements
(Quality Manual QSP-100)
(Contract Review QSP-203)
Customer Requirements

Customer Requirements
Marketing Competency / Training
QSP-218

Design & Development

QSP-204
Internal Requirements
(Management Review QSP-201)

International
Marketing Quality Records / Document Controls
QSP-205

Management

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Continual Improvement of the Fluke Biomedical

Quality Management System

Customer Order

Yes Create Order to Customer Satisfaction -

In Stock
ship Cont. Next Page

Customer Service
No Shipping picks order Packaging Distribution
check inventory level

Materials in Yes Pass

Pass / Fail
stock
(Contract Review QSP-203)
Customer Requirements

Fail Finished Goods

Planning creates Process Order No Manufacturing Quality Control
Inventory
Yes Rework

No

Destroy

Pass
Pass / Fail

Approved Suppliers Receiving Fail

Purchasing Quality Control Raw Material Inventory

Replace

No

Destroy

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 Customer Requirements QSP-203

Sales

Customer
Marketing

Technical Service
Title: Quality Manual

No

Product
QSP-213
Control of
Customer
Satisfaction

Nonconforming
Document Number: QSP-100

Quality Assurance
Yes

Inspection and Test QSP-210

23

Product Control &

Rev.

Analysis of Data Supplier Performance

Validation QSP-209
QSP-202 QSP-206
Traceability QSP-208

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Internal Audits QSP-217
Quality Management System

Corrective Action and Preventive Action QSP-214

Continual Improvement of the Fluke Biomedical

Management Review QSP-201

Design and Development QSP-204