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Page 1
Quality Manual


Filename:
Quality Manual
Created on :
1/6/03
Revision:
3
Created By:
M. Falco
Page:
Page 1 of 36
Revision Date:
11/17/06
Approved By:
K. Bourne


AMERICAN DIAGNOSTIC CORP. • 55 Commerce Drive, Hauppauge, NY 11788 • Voice: 631-273-9600 • Fax: 631-273-9659 • email: info@adctoday.com


Quality
Manual


Page 2
Quality Manual


Filename:
Quality Manual
Created on :
1/6/03
Revision:
3
Created By:
M. Falco
Page:
Page 2 of 36
Revision Date:
11/17/06
Approved By:
K. Bourne


AMERICAN DIAGNOSTIC CORP. • 55 Commerce Drive, Hauppauge, NY 11788 • Voice: 631-273-9600 • Fax: 631-273-9659 • email: info@adctoday.com


Section Point
TITLE
Page
1
Quality Management System
N/A
1
1.1 General
4
1
1.1.5 Process Flowchart
5
1
1.2 Documentation
6
1
1.3 Quality Manual
7
1
1.4 Control of Documents
7
1
1.5 Control of Quality Records
8
2
Management Responsibility
N/A
2
2.1 Management Commitment
8
2
2.2 Customer Focus
9
2
2.3 Quality Policy
9
2
2.4 Planning
10
2
2.5 Responsibility, Authority, and
Communication
11
2
2.6 Management Review
13
3
Resource Management
N/A
3
3.1 Provision of Resources
14
3
3.2 Human Resources
14
3
3.3 Infrastructure
15
3
3.4 Work Environment
15
4
Product Realization
N/A
4
4.1 Planning of Product Realization
16
4
4.2 Customer Related Processes
17
4
4.3 Design and Development
19
4
4.4 Purchasing
21
4
4.5 Product and Service Provision
22
4
4.6 Cleanliness of Product and
Contamination Control
23
4
4.7 Installation Activities
23
4
4.8 Servicing Activities
24
4
4.9 Particular Requirements for Sterile
Medical Devices
24
4
4.10 Validation of Processes for Product and
Service Provision
24
4
4.11 Identification and Traceability
25
4
4.12 Customer Property
26
4
4.13 Preservation of Product
26
4
4.14 Control of Monitoring and Measuring
Devices
27


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Quality Manual


Filename:
Quality Manual
Created on :
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Revision:
3
Created By:
M. Falco
Page:
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Revision Date:
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Approved By:
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AMERICAN DIAGNOSTIC CORP. • 55 Commerce Drive, Hauppauge, NY 11788 • Voice: 631-273-9600 • Fax: 631-273-9659 • email: info@adctoday.com


5
Measurement, Analysis, and
Improvement
N/A
5
5.1 General
28
5
5.2 Monitoring and Measurement
28
5
5.3 Internal Auditing
29
5
5.4 Monitoring and Measurement of
Processes
30
5
5.5 Monitoring of Measurement of Product
30
5
5.6 Control of Non-conforming Product
31
5
5.7 Analysis of Data
33
5
5.8 Improvement
33
5
5.9 Corrective Action
35
5
5.10 Preventive Action
35


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Quality Manual


Filename:
Quality Manual
Created on :
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Revision:
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Created By:
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Revision Date:
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K. Bourne


AMERICAN DIAGNOSTIC CORP. • 55 Commerce Drive, Hauppauge, NY 11788 • Voice: 631-273-9600 • Fax: 631-273-9659 • email: info@adctoday.com


Section 1: Quality Management System


1.1
General Requirements
1.1.1Executive Management has established and maintains a documented Quality
Management System in order to meet the requirements of the ISO 13485:2003
Standard, the ISO 9001:2000 standard, Canadian CMDR requirements, the
Medical Device Directive 93/42/EEC of the European Union, and the Quality
System Regulations of the FDA.
1.1.2As the business scope of American Diagnostic Corporation expands to encompass
new countries and regions; the Quality Management System will be updated to
incorporate any regulatory requirements mandated by the governments of these
countries/regions. The Quality Management System will also be continually
improved for effectiveness in accordance with the ISO 13485:2003 Standard, the
ISO 9001:2000 standard, Canadian CMDR requirements, the Medical Device
Directive 93/42/EEC of the European Union, and the Quality System Regulations
of the FDA with the goal of this improvement being increased product quality,
process efficiency, and customer satisfaction.
1.1.3Executive Management has:
a) Identified the processes needed for the Quality Management System
and their application throughout the organization (as required the ISO
13485:2003 Standard, the ISO 9001:2000 standard, Canadian CMDR
requirements, the Medical Device Directive 93/42/EEC of the
European Union, and the Quality System Regulations of the FDA.)
b) Determined the sequence and interaction of these processes (Note:
refer to the ADC process flowchart in this Quality Manual)
c) Determined criteria and methods needed to ensure that both the
operation and the control of these processes are effective
d) Ensured the availability of resources and information necessary to
support the operation and monitoring these processes, including the
development of appropriate departments to handle defined
responsibilities as part of the Quality Management System
e) Developed systems to monitor, measure, and analyze these processes
f) Implemented processes necessary to achieve planned results and
developed systems to monitor and provide for continual improvement
of these processes.


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Quality Manual


Filename:
Quality Manual
Created on :
1/6/03
Revision:
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Created By:
M. Falco
Page:
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Revision Date:
11/17/06
Approved By:
K. Bourne


AMERICAN DIAGNOSTIC CORP. • 55 Commerce Drive, Hauppauge, NY 11788 • Voice: 631-273-9600 • Fax: 631-273-9659 • email: info@adctoday.com


1.1.4These processes are managed in accordance with Standard Operating Procedures
(SOPs), work instructions, and other documents developed to meet the
requirements of the ISO 13485:2003 Standard, the ISO 9001:2000 standard,
Canadian CMDR requirements, the Medical Device Directive 93/42/EEC of the
European Union, and the Quality System Regulations of the FDA.
1.1.5Below is a flow chart depicting ADC’s Quality Management System. This
flowchart provides a brief overview of the interaction of various processes that
make up the entire Quality Management System. The flowchart also
demonstrates how customer and regulatory requirements and feedback from
customers and regulatory authorities play a role in ADC’s Quality Management
System.


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Quality Manual


Filename:
Quality Manual
Created on :
1/6/03
Revision:
3
Created By:
M. Falco
Page:
Page 6 of 36
Revision Date:
11/17/06
Approved By:
K. Bourne


AMERICAN DIAGNOSTIC CORP. • 55 Commerce Drive, Hauppauge, NY 11788 • Voice: 631-273-9600 • Fax: 631-273-9659 • email: info@adctoday.com


1.1.6As new products are developed, or new customer and regulatory requirements
come into effect, processes will be designed to incorporate these new
requirements. These new processes will fit into the process flow as illustrated
above.
1.1.7All processes that make up the Quality Management System are interconnected,
with the output of one process becoming the input for the following process. This
process flow ensures that customer and regulatory requirements are met
throughout the creation of products and services.
1.1.8Where processes that might affect product quality are performed through
outsourcing, Executive Management has established processes to ensure that
product quality is maintained and that products conform to requirements.
1.2
Documentation Requirements
1.2.1The Quality Management System is documented and includes a Quality Policy
and Quality Objectives, a Quality Manual, documented procedures, internal
documents, and Quality Records. These documents ensure that all processes are
effectively planned, implemented, and controlled.
1.2.2As part of the Quality Management System documentation, all documents and files
that are required by various regulatory authorities have been created and are
maintained in physical or electronic form. These documents include, but are not
limited to, the following:


•Design History Files (DHF)
•Device Master Records (DMR)
•Production History Reports
•Product Technical Files (TFCE)


1.2.3All documents and files that are required by various regulatory authorities are
discussed throughout ADC’s Standard Operating Procedures and work instructions.
As new requirements become mandatory, additional work instructions will be
created to outline the steps that ADC will take to satisfy those requirements.
1.2.4Documents that make up the Quality Management System are arranged in tiers, with
this Quality Manual representing the most broad, generalized document. Standard
Operating Procedures are associated with this Quality Manual and make reference to
it, but contain more detailed information. Work instructions provide precise, step-
by-step instructions and make reference to the SOP’s. This tiered structure is
described in greater detail in specific work instructions.


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Quality Manual


Filename:
Quality Manual
Created on :
1/6/03
Revision:
3
Created By:
M. Falco
Page:
Page 7 of 36
Revision Date:
11/17/06
Approved By:
K. Bourne


AMERICAN DIAGNOSTIC CORP. • 55 Commerce Drive, Hauppauge, NY 11788 • Voice: 631-273-9600 • Fax: 631-273-9659 • email: info@adctoday.com


1.3
Quality Manual
1.3.1This Quality Manual includes:


•The scope of the Quality Management System, including details of and


justification for any exclusions,


•The documented procedures established for the Quality Management


System, or references to them, and


•A description of the interaction between the processes of the Quality


Management System.
1.3.2This Quality Manual has been designed as a general guidance on, and description
of, ADC’s Quality Management System. It is intended for general distribution to
external sources.
1.4
Control of Documents
1.4.1Executive Management has established a document control system to ensure that
documents required by the Quality Management System are controlled. They
cannot be adjusted or modified by any ADC personnel without authorization.
1.4.2Quality Records are maintained as indicated in specific work instructions. They
are controlled and stored for at least the lifetime of ADC’s products, as defined in
technical files (TFCE) and other documents. This applies to obsolete revisions of
documents as well as active documents that are in use.
1.4.3Executive Management has established and maintains a documented procedure to
define the controls needed:


•To review, approve, and ensure the adequacy of documents before their


release for use


•To update documents as they become obsolete or require correction, including


a review and approval process for these updates


•To ensure that changes and the current revision status of documents are


identified


•To ensure that documents are distributed to the appropriate personnel and that


they are available as needed


•To ensure that documents remain legible and readily identifiable
•To ensure that documents of external origin are identified and their


distribution controlled where these documents could impact the company’s
Quality Management System


•To prevent the unintended use of obsolete documents by preventing their


distribution, and ensuring that any obsolete documents retained for reference
purposes are clearly marked “obsolete”


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Quality Manual


Filename:
Quality Manual
Created on :
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Revision:
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Created By:
M. Falco
Page:
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Revision Date:
11/17/06
Approved By:
K. Bourne


AMERICAN DIAGNOSTIC CORP. • 55 Commerce Drive, Hauppauge, NY 11788 • Voice: 631-273-9600 • Fax: 631-273-9659 • email: info@adctoday.com


1.4.4Document control will be performed in accordance with SOP 4.0,Quality
Management System. This SOP makes reference to or describes the procedures
used to approve and review documents, as well as discussing document retention.
1.4.5As part of the document control system established by Executive Management,
the process for changing existing documents and the requirements for the review
of these revised documents have been established to ensure that a competent
review is performed that results in proper document revision.
1.5
Control of Quality Records
1.5.1As part of the various processes and procedures that make up ADC’s Quality
Management System, Quality Records will be generated where appropriate to
ensure that proper documentation and record keeping is performed when vital
processes are completed. Quality Records are created and maintained to provide
evidence of conformity to requirements and of the effective operation of the
Quality Management System. These records will remain legible, readily
identifiable, and retrievable.
1.5.2Documented procedures have been established as part of the Quality Management
System that define the controls needed to create and maintain Quality Records.
These procedures define the processes used for identification, storage, protection,
retrieval, retention time, and disposition of quality records. These procedures are
included in various work instructions that apply to the departments that produce
these records.
1.5.3Quality records are controlled in accordance with SOP 4.0,Quality Management
System. Quality Records are maintained for the specified lifetime of each medical
device as defined in the technical documentation for that device or for a period of
at least two years if the expected lifetime of a medical device is less than this
time.


Section 2: Management Responsibility


2.1
Management Commitment


2.1.1


Executive Management has demonstrated a commitment to the development and
implementation of the Quality Management System, and continually improving its
effectiveness by:


•Communicating to the Company the importance of meeting Customer as well


as statutory and regulatory requirements (in particularly, requirements for
safety and performance of ADC devices)


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Quality Manual


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Quality Manual
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Created By:
M. Falco
Page:
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Revision Date:
11/17/06
Approved By:
K. Bourne


AMERICAN DIAGNOSTIC CORP. • 55 Commerce Drive, Hauppauge, NY 11788 • Voice: 631-273-9600 • Fax: 631-273-9659 • email: info@adctoday.com


•Establishing the Quality Policy (Refer to the sections below for more details)
•Establishing Quality Objectives that are meaningful to ADC’s business model,


and reviewing these objectives on a regular basis to ensure that they help to
improve ADC’s overall quality


•Conducting Management Reviews
•Providing the resources needed by the Quality Management System to ensure


its proper operation
2.1.2Management commitment is addressed in SOP 5.0,Management Responsibility, and
is also documented in a variety of work instructions that form the Quality
Management System.
2.2
Customer Focus
2.2.1Executive Management will ensure that Customer requirements are determined and
fulfilled with the aim of enhancing Customer Satisfaction. Through ADC’s contract
review process all customer orders and extended contracts are reviewed to ensure
that ADC can meet all of the customer’s requirements, both stated and unstated.
2.2.2To ensure that customers are satisfied throughout the lifetime of their purchases,
ADC’s Customer Service Department has been established to provide customers
with the services they need. Customers can purchase ADC products with the
knowledge that ADC’s Customer Service Department will be available with
technical support, order information, and to help the customer obtain repairs as
necessary.
2.2.3Customer focus is addressed in SOP 5.0Management Responsibility, and is also
documented in a variety of work instructions that form the Quality Management
System.
2.3
Quality Policy
2.3.1Executive Management will ensure that the Quality Policy is appropriate to the
purpose of the Company, and includes a commitment to comply with the
requirements of both customers AND regulatory authorities and continually improve
the effectiveness of the Quality Management System.
2.3.2The Quality Policy will provide a framework for establishing and reviewing Quality
Objectives as all Quality Objectives are designed to conform to the basic principles
presented in the Quality Policy. Executive Management will ensure that the Quality
Policy is communicated and understood within the Company, and will review the
Quality Policy for adequacy and suitability on a regular basis.


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Created on :
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Revision:
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Created By:
M. Falco
Page:
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Revision Date:
11/17/06
Approved By:
K. Bourne


AMERICAN DIAGNOSTIC CORP. • 55 Commerce Drive, Hauppauge, NY 11788 • Voice: 631-273-9600 • Fax: 631-273-9659 • email: info@adctoday.com


2.3.3The Company Quality Policy is:
“The Company is committed to maintaining and continually improving our
Quality Management System to respond to and meet the expectations of our
Customers.”
2.3.4It is important to note that the above quality policy discussesmaintainingthe
Quality Management System. The use of the wordmaintainingis taken to mean
not only the maintenance of the existing system, but ensuring that the system is
maintained in accordance with the requirements of applicable regulatory
authorities. This policy ensures that ADC’s Quality Management System meets
not only the requirements of our customers, but also all legal requirements in the
countries where ADC conducts business.
2.3.5In addition to the above interpretation,it is also important that the word “customers”
is defined. When the customer is referred to in any documentation relating to ADC’s
Quality Management System, any of the following could apply:


•The distributor, retailer, or reseller that directly purchased the product.
•The end user, including the doctor, nurse, and the healthcare institution


using the device, or the home user.


•The patient that the device is being used on.


2.3.6This definition of customer ensures that all safety and reliability concerns are
addressed as part of ADC’s Quality Management System.
2.3.7The Quality Policy is addressed in SOP 5.0Management Responsibility, and is also
documented in a variety of work instructions that form the Quality Management
System.
2.4
Planning
2.4.1 QUALITY OBJECTIVES
2.4.1.1Executive Management has established Quality Objectives at relevant functions and
levels within the Company. These Quality Objectives are measurable and consistent
with the Quality Policy. (Note: Quality Objectives include objectives created for
ADC products that measure quality and other characteristics of ADC’s level of
service.)


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Revision:
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Created By:
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Revision Date:
11/17/06
Approved By:
K. Bourne


AMERICAN DIAGNOSTIC CORP. • 55 Commerce Drive, Hauppauge, NY 11788 • Voice: 631-273-9600 • Fax: 631-273-9659 • email: info@adctoday.com


2.4.1.2Quality Objectives are reviewed by Executive Management during the normal
Management Review process. This ensures that progress towards these goals can be
monitored, and the Quality Objectives can be revised as necessary to more
appropriately match the resources and capabilities of ADC’s various departments.
2.4.1.3The Quality Objectives are addressed in SOP 5.0Management Responsibility.
2.4.2 QUALITY MANAGEMENT SYSTEM PLANNING
2.4.2.1Executive Management will ensure that the planning of the Quality Management
System is carried out in accordance with the ISO 13485:2003 Standard, the ISO
9001:2000 standard, Canadian CMDR requirements, the Medical Device
Directive 93/42/EEC of the European Union, and the Quality System Regulations
of the FDA relevant regulatory requirements, and the Quality Policy. Executive
Management will also ensure that the integrity of the Quality Management
System is maintained when changes to the Quality Management System are
planned and implemented.
2.4.2.2The Quality Management System, and any changes that will be made to the
Quality Management System, will be reviewed during normal Management
Review Meetings prior to implementation. This will ensure that the integrity of
the Quality Management System is maintained at all times.
2.4.2.3Changes to existing processes or the creation of new processes will also be
discussed during Plant Manager Meetings. These meetings provide Executive
Management with an appropriate forum to discuss impending changes to the
Quality Management System. Changes to existing processes can be planned out
prior to implementation, with Executive Management available to provide
guidance.
2.4.2.4Quality Management System planning is performed in accordance with SOP 5.0
Management Responsibility.
2.5
Responsibility, Authority, and Communication
2.5.1 RESPONSIBILITY AND AUTHORITY
2.5.1.1Executive Management has defined and documented the responsibility, authority,
and the interrelation of personnel who manage, perform, and verify work within the
Quality Management System. Part of this documentation includes official job
descriptions, which define the various tasks performed by employees during their
daily activities.


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Filename:
Quality Manual
Created on :
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Revision:
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Created By:
M. Falco
Page:
Page 12 of 36
Revision Date:
11/17/06
Approved By:
K. Bourne


AMERICAN DIAGNOSTIC CORP. • 55 Commerce Drive, Hauppauge, NY 11788 • Voice: 631-273-9600 • Fax: 631-273-9659 • email: info@adctoday.com


2.5.1.2Executive Management has developed an organization chart that depicts the quality
organization. This organizational chart includes official job titles and shows the
interrelation of all ADC employees. It is further addressed in SOP 5.0,Management
Responsibility.
2.5.2 MANAGEMENT REPRESENTATIVE
2.5.2.1Executive Management has appointed theISO Administratoras the Management
Representative for the Quality Management System. The Management
Representative has the responsibility and authority that includes:


•Ensuring that processes needed for the Quality Management System are


established, implemented, and maintained by making use of resources
provided by Executive Management and personnel from various
departments within the company


•Reporting on the performance of the Quality Management System to


Executive Management and any need for improvement (Note: this
reporting is aided by the analysis of quality system data obtained through
normal monitoring and measurement processes.)


•Ensuring the promotion of awareness of Customer requirements


throughout the Company
2.5.2.2Appointment of the Management Representative is addressed in SOP 5.0,
Management Responsibility. An official job description has been created to
describe all of the functions and responsibilities of the Management
Representative.
2.5.3 INTERNAL COMMUNICATION
2.5.3.1Executive Management has established communication processes within the
Company to ensure that processes included as part of the Quality Management
System are effectively implemented and maintained. This communication ensures
that the Quality Management System is effective and accomplishes stated objectives.
2.5.3.2This communication process makes use of all computerized resources that are
available at ADC, and includes the creation and continuous adaptation of an
electronic Information System to provide all departments with the latest information,
controlled documents, and Quality Objectives.
2.5.3.3Responsibility, authority, and communication are addressed in SOP 5.0,
Management Responsibility.


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K. Bourne


AMERICAN DIAGNOSTIC CORP. • 55 Commerce Drive, Hauppauge, NY 11788 • Voice: 631-273-9600 • Fax: 631-273-9659 • email: info@adctoday.com


2.6
Management Review
2.6.1Executive Management will conduct a review of the Quality Management System
on a periodic basis to ensure its continued suitability and effectiveness in
accordance with the Quality Policy and Quality Objectives. This review will
include assessing opportunities for improvement and the need for changes to the
Quality Management System, including the Quality Policy and Quality
Objectives. The Management Review meeting will be attended by a variety of
management staff throughout ADC to ensure that all relevant information is
presented and reviewed.
2.6.2The input to Management Review will be in the form of a report. This report is
prepared using quality system data collected through monitoring and measurement
processes, as well as statistical data obtained during analysis. This report includes:


•Results of audits
•Customer feedback information
•Process performance and product conformity information (from a variety


of sources)


•Status of preventive and corrective actions (as well as previously closed


corrective/preventive actions)


•Follow-up actions from previous management reviews
•Planned changes that could affect the Quality Management System
•Recommendations for improvement
•New or updated regulatory requirements


2.6.3The output from Management Review includes any decisions and actions related
to:


•Improvement of the effectiveness of the Quality Management System and


its processes


•Improvement of product related to Customer requirements
•Resource needs
•Corrective and preventive actions as applicable


This output will be presented in a form that is suitable for the various departments
it may affect. Policies created during normal management review will be
incorporated into existing work instructions and procedures where appropriate, or
documented in new procedures where required.
2.6.4Management Review is performed in accordance with SOP 5.0,Management
Responsibility. Management Review is documented in separate work instructions
that further detail the various inputs and the outputs that are achieved by this
meeting.


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K. Bourne


AMERICAN DIAGNOSTIC CORP. • 55 Commerce Drive, Hauppauge, NY 11788 • Voice: 631-273-9600 • Fax: 631-273-9659 • email: info@adctoday.com


Section 3: Resource Management


3.1
Provision of Resources
3.1.1Executive Management has determined and provided the resources needed to
implement and maintain the Quality Management System and continually improve
its effectiveness. These resource requirements are reviewed during normal
management review to ensure that they are adequate for all of ADC’s various
departments.
3.1.2Executive Management has provided the resources necessary to enhance
Customer Satisfaction by meeting customer requirements as well as all applicable
regulatory requirements for ADC’s products and services.
3.1.3Provision of resources is addressed in SOP 6.0,Resource Management,and is also
documented in a variety of work instructions that form the Quality Management
System.
3.2
Human Resources
3.2.1Personnel performing work affecting product quality will be competent on the
basis of appropriate education, training, skills, and experience. Executive
Management has established a Human Resources Department to organize the
process of hiring new employees.
3.2.2Executive Management:


•Determines the necessary competence for personnel performing work


affecting product quality (This information is included in relevant job
descriptions)


•Provides training or takes other actions to satisfy these needs
•Evaluates the effectiveness of actions taken through regular training


review


•Ensures that its personnel are aware of the relevance and importance of


their activities and how they contribute to the achievement of the Quality
Objectives. This is accomplished through incentive programs, training
sessions, and the appropriate communication of the Quality Policy and
Quality Objectives.


•Has established a system to maintain appropriate records of education,


training, skills, and experience


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K. Bourne


AMERICAN DIAGNOSTIC CORP. • 55 Commerce Drive, Hauppauge, NY 11788 • Voice: 631-273-9600 • Fax: 631-273-9659 • email: info@adctoday.com


3.2.3Human resources are addressed in SOP 6.0,Resource Management.This topic is
also documented in a variety of work instructions that form the Quality Management
System. This documentation includes official job descriptions, which contain the
educational and training requirements needed to perform specific tasks.
3.3
Infrastructure
3.3.1Executive Management has provided and maintains the infrastructure needed to
achieve conformity to product requirements. Infrastructure includes:


•Building, workspace, and associated utilities
•Process equipment, both hardware and software
•Supporting services such as transport or communication


3.3.2As part of Executive Management’s commitment to provide adequate
infrastructure a dedicated IT Department has been created to safeguard all
electronic data and ensure the uninterrupted operations of ADC’s computer
systems.
3.3.3For those processes that affect product quality, Executive Management has
established documented work instructions and procedures to ensure that any
equipment that can have an impact on product quality is maintained in an
adequate fashion.
3.3.4Infrastructure is discussed in more detail in SOP 6.0,Resource Management.
3.4
Work Environment
3.4.1Executive Management has established the work environment criteria needed to
achieve conformity to product requirements. These criteria include procedures and
processes for building cleanliness, process efficiency, and employee safety.
3.4.2Where the health, cleanliness, or clothing of ADC personnel could adversely affect
the quality and/or safety of ADC’s products, criteria have been established to ensure
product quality.
3.4.3Any products produced by ADC that could be adversely affected by environmental
conditions will be protected to ensure that product quality and safety does not suffer.
Environmental controls necessary to safeguard these products will be documented
and maintained as appropriate.


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K. Bourne


AMERICAN DIAGNOSTIC CORP. • 55 Commerce Drive, Hauppauge, NY 11788 • Voice: 631-273-9600 • Fax: 631-273-9659 • email: info@adctoday.com


3.4.4Where environmental controls are necessary, the training and skill of employees
working in these controlled areas will be documented to ensure the safety of both the
employees as well as ADC products.
3.4.5Executive Management has established a Safety Committee to ensure that relevant
employee safety issues are discussed and resolved. This committee is responsible
for overseeing all aspects of employee safety, including the handling and/or storage
of any hazardous materials.
3.4.6As part of the procedures and documents created to control the cleanliness and work
environment of ADC, contamination (with hazardous OR non-hazardous materials)
of product will be controlled to prevent the spread of contamination to other
products, the environment, or ADC employees.
3.4.7Work environment is addressed in SOP 6.0,Resource Management, and is also
documented in a variety of work instructions that form the Quality Management
System.


Section 4: Product Realization


4.1
Planning of Product Realization
4.1.1Executive Management plans and develops the processes needed for product
realization. These processes include the steps necessary to design and develop new
products, as well as the implementation of procedures and work instructions to detail
the processes used to create and inspect the products. Planning of product
realization is consistent with the requirements of the other processes of the Quality
Management System and includes any services provided by ADC to our customers.
4.1.2In planning product realization, Executive Management determines and documents
the following, as appropriate:


•Quality Objectives and requirements for the product (In particularly


regulatory requirements for the various regions that the product will be
sold in.)


•The need to establish processes, documents, and provide resources


specific to the product


•Required verification, validation, monitoring, inspection, and test


activities specific to the product and the criteria for product acceptance.
This includes, as appropriate, any necessary training for inspection
personnel.


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•Records needed to provide evidence that the realization processes and


resulting product fulfill requirements
4.1.3It is important to note that included within the requirements for a product are all
technical/regulatory documentation requirements that ADC must meet in order to
market a product.
4.1.4Executive Management has established appropriate communication processes
and/or committees to ensure that all relevant information relating to product
development and the planning of product realization is discussed and presented to
every department of ADC prior to implementation.
4.1.5Executive Management has established appropriate risk management programs to
ensure that risk assessment is included as part of the planning of product
realization. Records of risk analysis are maintained as Quality Records.
4.1.6The output from product realization planning includes all of the forms, work
instructions, technical documentation, and other records associated with the
development of products and processes. These materials are incorporated into
ADC’s Quality Management System.
4.1.7Additional information about the planning of product realization is available in
SOP 7.0,Product Realization.
4.2
Customer Related Processes
4.2.1Executive Management has created a contract review system employed by ADC’s
Customer Service Department and sales force that ensures customer requirements
are understood prior to accepting an order. The purpose of this system is to
ensure order accuracy and reduce errors when customers place orders. This
system also insures that specific contracts are reviewed appropriately before
acceptance. This system has been designed to determine:


•Requirements specified by the Customer, including the requirements for


delivery and post-delivery activities


•Requirements not stated by the Customer but necessary for specified use


or known and intended use


•Statutory and regulatory requirements related to the product
•Any additional requirements necessary to ensure the customer’s


satisfaction, such as providing technical information or specific
documentation


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4.2.2Executive Management has created a contract review system to review the
requirements related to the product. This review will be conducted prior to the
Company’s commitment to supply a product to the Customer and will ensure that:


•Product requirements are defined and documented in physical form or


using electronic systems. In most cases ADC customers will purchase
existing ADC products as defined and documented in ADC’scatalog,
when new products are proposed, the design requirements will be
documented in specific Design History Files.


•Contract or order requirements differing from those previously expressed


are resolved


•ADC’s current products (or proposed new product designs) meet the


defined requirements, including the requirements for quantity as
appropriate
4.2.3Records of the results of contract review and actions arising from the review will be
maintained as Quality Records and are available to appropriate departments so that
revisions to existing contracts can be evaluated before implementation. (Ref. SOP
7.0,Product Realization)
4.2.4In instances where a customer provides no documented statement of
requirements, the customer requirements will be confirmed by ADC’s Customer
Service Department prior to the acceptance of any orders as part of the contract
review process. Where product requirements are changed, ADC will ensure that
relevant documents are amended and that relevant personnel are made aware of
the changed requirements as appropriate.
4.2.5As part of the process of reviewing customer requirements, ADC conducts regular
reviews of catalogs and product information that is provided to the public. This
review ensures a continual improvement and clarification of relevant product
information.
4.2.6Executive Management has implemented effective arrangements for
communicating with Customers in relation to:


•Product information, including technical details about ADC’s products,


sales information, and service information.


•Inquiries, contracts, or order handling, including amendments
•Customer feedback, including customer complaints


4.2.7Executive Management has established a documented system to ensure that
customers are aware of advisories or recalls that apply to ADC products. This
ensures end-user safety by allowing for the quick distribution of information
relating to problems associated with a particular device or batch of devices.


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4.2.8Customer related processes are further addressed in SOP 7.0,Product Realization.
4.3
Design and Development
4.3.1Executive Management plans and controls the design and development of
products. During the design and development planning, various departments
within the company will determine the following:


•The design and development stages (including the departments and


resources that will be required for each stage)


•The review, verification, and validation that are appropriate to each design


and development stage


•The responsibilities and authorities for design and development


Note: ADC’s established design and development
4.3.2Executive Management has established a system that manages the interfaces
between different groups involved in design and development to ensure effective
communication and clear assignment of responsibility for various design related
activities. Planning output will be updated, as appropriate, as the design and
development progresses.
4.3.3All stages of the design and development process are recorded in relevant Design
History files, ensuring that a complete history of a product’s development is
available for review.
4.3.4During the planning phase of product development, inputs related to product
requirements will be determined. These inputs will form the basis for a Design
History File (DHF) for that design. These Design History Files will become the
main record of all product development performed at later stages of the design
process. (Ref. SOP 7.0,Product Realization.) The DHF will include:


•Functional, performance, and safety requirements as applicable
•Any regulatory requirements that apply to the product
•Information relating to existing designs that are similar to the new product
•Other requirements essential for design and development, including ADC


specifications or components lists as applicable


•Risk assessment information as applicable (Note: risk assessment


information may be contained within product specific technical files as
well as/instead of product Design History Files.)


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4.3.5Inputs of the design development process will be reviewed after they have been
determined. Throughout the process of product development this information is
reviewed by relevant departments to ensure that the implementation of new
processes during product realization meets all stated requirements.
4.3.6Where requirements are found to be incomplete, ambiguous, or in conflict with
one another, these requirements will be clarified and corrected before any product
is manufactured or processes are implemented.
4.3.7Design and development output will include all relevant information necessary to
verify that the new product meets all stated requirements. Through the design and
development system established by Executive Management, this verification is
performed and the results are approved and recorded.
4.3.8In addition to design verification, the design and development system also ensures
that product designs are validated during the final stages of the development process.
This validation ensures that the final product is able to meet all of the performance
and safety requirements for the intended use/application of the product. Records of
this validation are maintained as part of a Design History File.
4.3.9Validation of a product design may include clinical evaluations as required by
national or international standards.
4.3.10The outputs from the design and development system include relevant work
instructions, forms, procedures, and other documentation to ensure that purchasing,
production, customer service, quality control (product acceptance criteria), and
service processes are established. These outputs will also include documentation
related to the safety and performance characteristics of the product where
appropriate. All design output records are included in product Design History Files.
4.3.11During the course of design development, reviews of existing information about a
new design will be discussed and reviewed with appropriate departments to ensure
that any problems are identified and corrected so that the product can meet all stated
requirements. Executive Management has established a design communication
system that includes checklists and committee meetings to ensure designs are
thoroughly reviewed.
4.3.12The review of a new design will include representatives from Executive
Management as well as members of ADC’s design team to ensure that all aspects of
the design are properly communicated to those departments that require specific
information. Records of all design reviews are included in Design History Files.


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4.3.13As part of ADC’s design and development process, changes to existing designs are
reviewed, verified, and validated before they are approved and implemented. This
review will ensure that the finished product, as well as components for the product
will continue to function as intended. All reviews are conducted in the same fashion
as reviews for new product designs.
4.3.14All stages of the design development process are documented within individual
Design History Files. Additional procedures and processes for product design and
development can be found in SOP 7.0,Product Realization,and throughout ADC’s
Quality Management System.
4.4
Purchasing
4.4.1Executive Management has established a Quality Control Department to ensure
that purchased product conforms to specified purchase requirements. All
products and components arriving at ADC are inspected and tested to verify the
quality of each shipment.
4.4.2Executive Management has established a documented sampling plan to ensure
that inspected items are randomly sampled during the inspection process. This
sampling plan is based upon supplier performance and item or component impact
on product realization or the final product.
4.4.3Executive Management has established a supplier survey and evaluation system to
ensure that supplier quality is monitored and measured. This system includes
documented procedures for supplier selection, evaluation, and re-evaluation.
Records of the results of evaluations and any necessary actions arising from the
evaluation are maintained as part of this system.
4.4.4Additional information relating to supplier selection and evaluation can be found
in SOP 7.0,Product Realization.
4.4.5Executive Management has established the Purchasing Department to purchase
items and components used in ADC products. The Purchasing Department ensures
that all relevant purchasing information is described in the documentation supplied
to the vendor. This information includes:


•Product identification, including quantity and price
•Requirements for product approval
•Requirements for the approval of a vendor’s procedures, processes, and/or


equipment


•Training requirements applicable to product related processes
•Quality Management System requirements if applicable


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•Traceability requirements necessary for the purchased product or


components (where applicable)
4.4.6Purchase requirements are verified by the Purchasing Department prior to their
communication to ADC’s vendors. In instances where ADC will perform
verification of purchased products at a vendor’s premises, the details of this
verification will be included in the purchasing information supplied to the vendor.
Records of this type of verification are maintained as part of ADC’s Quality
Records.
4.4.7Additional procedures and processes related to ADC’s Purchasing Department
and product verification activities can be found in SOP 7.0,Product Realization.
4.5
Product and Service Provision
4.5.1Executive Management has established the processes and procedures necessary to
plan and carry out production and service processes under controlled conditions.
These processes and procedures are interrelated, as described in the basic ADC
process flowchart presented in this Quality Manual. Controlled conditions may
include, but are not limited to, the following (as applicable):


•The availability of information that describes the characteristics of the


product, including relevant documentation required by national or
international regulations (such as Device Master Records or Technical
Files)


•The availability of work instructions to the employees that require them,


including reference materials and/or measurement standards


•The requirements for equipment where that equipment could affect the


performance or safety of the product or the safety of ADC personnel


•The availability and use of monitoring and measuring devices, particularly


for the testing and/or verification of medical devices that have a
measurement function


•The implementation of monitoring and measurement, including the


inspection of incoming materials, in process products, and finished
products


•The implementation of release, delivery, and post-delivery activities
•Labeling and packaging requirements and any special environmental


controls or employee training necessary to ensure product conformity


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4.5.2Executive Management has established the necessary processes to record traceability
information related to ADC products on the market to ensure that safety or
performance issues can be appropriately addressed. These records include
production history and inspection status information and are verified at the time of
their creation.
4.5.3Additional information relating to the control of production and service provision
can be found in SOP 7.0,Product Realization,and is documented in various work
instructions and procedures that make up ADC’s Quality Management System.
4.6
Cleanliness of Product and Contamination Control
4.6.1Executive Management has established environmental controls to ensure that the
cleanliness of ADC products is maintained throughout the manufacturing and
storage processes. These controls ensure that products with special cleanliness
requirements are handled appropriately to avoid contamination of new or existing
products.
4.6.2As part of the design and development process, the cleanliness requirements for new
products will be evaluated prior to any production of these products. Where new
environmental controls are needed, Executive Management will ensure that these
controls are in place before any products are produced. These controls may include
environmental controls for sterility of products if applicable to a new product’s
design, although ADC currently does not produce sterile products.
4.6.3Additional information relating to product cleanliness and contamination control
may be found in SOP 6.0,Resource Management,and in various work instructions
and procedures that make up ADC’s Quality Management System.
4.7
Installation Activities
4.7.1ADC does not currently produce products that require special installation processes.
As part of the design and development processes, new products that are developed
will be evaluated in order to determine whether or not installation will be necessary
for the end-user.
4.7.2Should it be determined that a new product produced by ADC will require additional
installation processes, these processes will be clearly documented, including
acceptance criteria as well as verification activities to ensure that the installation of
the medical device was completed correctly.


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4.7.3Records of any installation processes will be maintained as Quality Records by
ADC.
4.8
Servicing Activities
4.8.1Executive Management has established the Service Department to ensure that ADC
products are properly serviced and maintained. These servicing activities occur on
ADC’s premises only, and at this time do not include any repairs or maintenance at
customer owned facilities.
4.8.2The Service Department has a number of established procedures and work
instructions to ensure that ADC products are repaired to acceptable levels of
performance and safety. Additional information relating to these procedures may be
found in SOP 7.0,Product Realization.
4.8.3Records of repair/maintenance work performed by the Service Department are
maintained as Quality Records.
4.9
Particular Requirements for Sterile Medical Devices
4.9.1At this time, ADC does not produce sterile medical devices. Should a product be
developed that requires sterilization by ADC, the requirements for sterility will be
clearly documented, with process parameters clearly defined and sterilization
records maintained that are traceable to each batch of product produced. Verification
and validation of these sterilization processes would be included in the documented
procedures and work instructions.
4.10 Validation of Processes for Product and Service Provision
4.10.1Although most processes performed by ADC to manufacture finished products can
be verified by subsequent monitoring or measurement, any process that is
established for production purposes that cannot be verified will be validated prior to
its acceptance as a standard manufacturing process.
4.10.2This validation includes any processes where deficiencies become apparent only
after the product is in use or a service has been delivered. This validation will
demonstrate the ability of the processes to achieve planned results. Records of any
validation will be maintained as part of ADC’s Quality Management System.


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4.10.3Where production and service processes that do not have easily verifiable outputs,
these processes are reviewed and approved periodically. This review includes a
review of equipment, personnel, record keeping, and specified procedures used in
various departments at ADC. This review will allow these processes to be
revalidated where applicable.
4.10.4If a process is created utilizing computer software that could affect the ability of
the product to conform to requirements, this software will also be validated prior
to its use for manufacturing processes.
4.11 Identification and Traceability
4.11.1Executive Management has established an item numbering system to ensure that
products, sub-assemblies, and component parts are easily identified throughout
the product realization process.
4.11.2Executive Management has established inspection status procedures to ensure that
products are identified with respect to monitoring and measurement requirements.
This includes all aspects of the inspection process, from received goods to
finished products. These procedures ensure that only products that have passed
through specific monitoring and measurement processes are provided to the
customer.
4.11.3Executive Management has established a lot numbering system to ensure product
traceability. While traceability is not a requirement for any of ADC’s existing
products, it allows ADC to easily recall potentially non-conforming products from
the market. This lot numbering information is recorded and maintained as part of
ADC’s Quality Records.
4.11.4Executive Management has established service and repair processes to ensure that
returned items are clearly identifiable and are not confused with conforming
product. Additional processes also ensure that non-conforming components and
other materials are not used in manufacturing processes.
4.11.5ADC currently does not produce active implantable medical devices or
implantable medical devices with additional record keeping requirements.
4.11.6Additional information about product identification and traceability is available in
SOP 7.0,Product Realization,and is also documented in various procedures and
work instructions that make up ADC’s Quality Management System.


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4.12 Customer Property
4.12.1Care will be exercised with Customer property while it is under ADC’s control or
being used by ADC. Customer property for use or incorporation into finished
products will be identified, verified, protected, and safeguarded.
4.12.2Any Customer property that is lost, damaged, or otherwise found to be unsuitable
for use, will be reported to the Customer. Records shall be maintained relating to
the status of customer property. Refer to SOP 7.0,Product Realizationfor
additional information about procedures dealing with customer property.
4.12.3It is important to note that “customer property” can be interpreted to mean
intellectual property or confidential health information as well as physical
property.
4.13 Preservation of Product
4.13.1All products and components will be preserved throughout the manufacturing
process to ensure product conformity with specifications. These preservation
processes will be in effect up to and including the time of delivery to the intended
destination.
4.13.2Preservation of product includes all procedures and work instructions necessary to
describe the identification, handling packaging, storage, and protection requirements
for ADC products. Where applicable, these processes also include environmental
controls to ensure that factors in the environment do not degrade the quality of ADC
products or components.
4.13.3Executive Management has established processes to ensure that products with
limited shelf lives or components with limited shelf lives are monitored to ensure
that expired products or components are not used in manufacturing processes.
4.13.4Additional information relating to preservation process can be found in SOP 7.0,
Product Realization, and is also available in various work instructions and
procedures that make up ADC’s Quality Management System.


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4.14 Control of Monitoring and Measuring Devices
4.14.1Executive Management has established the necessary monitoring and measurement
processes needed to ensure that products and components conform to specified
requirements. These processes include detailed instructions for the use of test
equipment to verify product conformity and, where necessary, verification of the
environmental conditions necessary to perform testing. These processes ensure that
monitoring and measurement activities can and are carried out to meet all stated
requirements.
4.14.2As part of the processes established to control measuring equipment, this equipment
is calibrated or verified at specific intervals against measurement standards traceable
to the National Institute of Standards and Technology (NIST). Procedures have been
created to ensure that all equipment is within calibration prior to use. Where no
standards exist to indicate the calibration requirements for measuring equipment, the
basis used for calibration or verification is recorded in various work instructions or
procedures.
4.14.3Measuring equipment will be adjusted or re-adjusted as necessary to ensure that it is
within acceptable calibration prior to use. In addition, all equipment will be
identified to enable the calibration status to be determined, safeguarded from
adjustments that would invalidate the measurement result, and protected from
damage and deterioration during handling, maintenance, and storage.
4.14.4Executive Management has established procedures and processes to ensure that
measurement results that were based on non-conforming (out of calibration)
equipment are assessed and the validity of these results are recorded to ensure that
product quality and customer safety has not deteriorated as a result of the non-
conforming equipment. This system includes the process of correcting non-
conforming product and ensuring customer satisfaction.
4.14.5As part of the processes used to control monitoring and measurement equipment,
Executive Management has established a Calibration Database to ensure that all
calibrated and controlled equipment is recorded, and the results of calibration and/or
verification are maintained as Quality Records.
4.14.6Included within ADC’s process for controlling monitoring and measurement
equipment is any computer software used for these purposes. This software
would require verification in the same fashion as physical equipment.


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4.14.7Additional information about ADC’s monitoring and measurement equipment can
be found in SOP 7.0,Product Realization,and in various work instructions and
procedures that make up ADC’s Quality Management System.


Section 5: Measurement, Analysis, and Improvement


5.1
General
5.1.1Executive Management plans and implements the monitoring, measurement,
analysis, and improvement of processes needed to demonstrate product
conformity, ensure conformity of the Quality Management System, and to
maintain the effectiveness of the Quality Management System.
5.1.2A variety of procedures and process have been established to document this
improvement and maintenance process. The creation of these procedures and
processes includes the determination of applicable methods, including statistical
techniques, necessary to maintained and improve the Quality Management System,
and the extent of their use.
5.1.3Refer to SOP 8.0,Measurement, Analysis, and Improvement,for additional
information relating to these processes.
5.2
Monitoring and Measurement
5.2.1As part of ADC’s Quality Management System, several systems have been
established by Executive Management to ensure that product and customer related
information from the field is recorded, reviewed, and acted upon.
5.2.2An electronic Complaint System has been established to monitor customer feedback
and to record customer complaints. This system has been designed to ensure that all
customer complaints are investigated in a timely fashion and that the results of this
investigation are recorded as part of ADC’s Quality Records.
5.2.3In addition to this complaint system, processes have been established that allow
ADC to monitor customer feed back and customer satisfaction levels. This feedback
is analyzed by Executive Management to allow ADC to improve its Quality
Management System.
5.2.4Executive Management has direct overview of both the Complaint System and the
feedback processes. This allows any quality issues or potential safety problems to
be addressed in a timely fashion through ADC’s corrective/preventive action system.
Complaints and feedback form an early warning system about product issues.


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5.2.5ADC’s Quality Management System will make use of experience gained from post-
production feedback to ensure that our products continue to meet all of their
requirements, and to ensure that our level of service continues to satisfy our
customers.
5.2.6Additional information relating to ADC’s monitoring and measurement system can
be found in SOP 8.0,Measurement, Analysis, and Improvement,and in various work
instructions and procedures that make up ADC’s Quality Management System.
5.3
Internal Auditing
5.3.1Executive Management has established an internal auditing process to audit the
Quality Management System. This auditing process ensures that the Quality
Management System has been effectively implemented and is maintained. Through
continuous monitoring of internal processes, the auditing process will also:


•Ensure that ADC is compliant with the ISO 13485:2003 Standard, the ISO


9001:2000 standard, Canadian CMDR requirements, the Medical Device
Directive 93/42/EEC of the European Union, and the Quality System
Regulations of the FDA.


•Ensure that ADC is compliant with national quality management system


requirements


•Ensure that ADC meets the requirements of the Medical Device Directive as


it applies to the Quality Management System


•Ensure that skills, training, and/or departmental performance does not


degrade by re-auditing departments on a pre-scheduled basis
5.3.2As part of ADC’s internal auditing process, audits will be conducted for every
department within the company. As each audit is planned the importance of the
processes being reviewed will be evaluated to ensure that audits are conducted
appropriately. Auditors will be selected to ensure that all audits are conducted in an
impartial fashion, and so that auditors will not audit their own work.
5.3.3ADC’s auditing process includes work instructions and procedures that define audit
frequency, scope, and auditing methods. This documentation also defines the
responsibilities of planning and conducting audits, as well as the reporting
requirements.


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AMERICAN DIAGNOSTIC CORP. • 55 Commerce Drive, Hauppauge, NY 11788 • Voice: 631-273-9600 • Fax: 631-273-9659 • email: info@adctoday.com


5.3.4Departments that have non-conformities detected during the internal auditing
process will correct those non-conformities in accordance with ADC’s established
corrective/preventive action system. These non-conformities will be corrected in a
timely manner (including the underlying cause of the non-conformity). Follow-up
audits and/or inspections as required by corrective/preventive actions will verify that
corrections have been made and that they are effective in eliminating the detected
non-conformities.
5.4
Monitoring and Measurement of Processes
5.4.1Executive Management has established various monitoring and measurement
techniques to ensure that the processes associated with the Quality Management
System are monitored. This ensures that processes can achieve planned results.
5.4.2These monitoring and measurement techniques are reviewed regularly with
management staff so that all departments are aware of their status in terms of quality
and the achievement of planned objectives. Issues that are discovered during this
review of process data allows corrective and preventive actions to be taken to ensure
that there is no adverse impact on product conformity.
5.5
Monitoring and Measurement of Product
5.5.1Products manufactured by ADC are monitored and measured to ensure that all
products conform to documented specifications. As determined by Executive
Management, this monitoring and measurement is performed at three stages of
product realization; incoming inspections, in-process inspections, and finished
product inspections.
5.5.2All monitoring and measurement processes result in Quality Records that provide
evidence of product conformity to acceptance criteria. These records indicate the
date of the inspections and the person(s) authorizing the release of finished
product as applicable. The requirements for these records are included in
individual work instructions that detail specific inspections performed throughout
ADC’s Quality Management System.


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AMERICAN DIAGNOSTIC CORP. • 55 Commerce Drive, Hauppauge, NY 11788 • Voice: 631-273-9600 • Fax: 631-273-9659 • email: info@adctoday.com


5.5.3Products are not released and shipped to customers until these inspections have
been completed and all products have been determined to comply with the stated
requirements. Where products have been produced that do not meet all of the
requirements that were originally stated, these products will only be authorized
for release by Executive Management and, where appropriate, by the customer.
(Note: the concept of releasing “products that do not meet stated requirements” is
taken to mean products that have cosmetic defects only, it doesn’t refer to non-
conforming product that could affect the health or safety of the end-user or
patient.)
5.5.4At this time, ADC does not currently manufacture implantable or active
implantable medical devices that would require additional record keeping during
the inspection/testing activities prior to product release. Even without the
production of these products, as part of the record keeping processes that make up
ADC’s Quality Management System, the identity of the personnel performing
inspection and testing activities is recorded during IQC and FQC inspections.
5.5.5Additional information relating to ADC’s inspection and testing processes can be
found in SOP 8.0,Measurement, Analysis, and Improvement, and in various work
instructions and procedures that make up ADC’s Quality Management System.
5.6
Control of Nonconforming Product
5.6.1Executive Management has established documented procedures and work
instructions to control the disposition, retention, and marking or product that does
not conform to requirements. This system is designed to ensure that non-
conforming products or components are not used in finished products or delivered
to customers.
5.6.2The departments responsible for handling non-conforming products or
components, as well as the controls used to identify these materials and to
quarantine them, are included in various work instructions and procedures that
make up ADC’s Quality Management System.
5.6.3Nonconforming product is dealt with in one or more of the following ways:


•By taking action to eliminate the detected nonconformity, either through


the re-work of affected materials or the replacement of affected
components/products


•By authorizing its use, release, or acceptance under concession by


Executive Management and, where applicable, by the Customer


•By taking action to preclude its original intended use or application


through reject marking procedures and quarantine of affected stock


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AMERICAN DIAGNOSTIC CORP. • 55 Commerce Drive, Hauppauge, NY 11788 • Voice: 631-273-9600 • Fax: 631-273-9659 • email: info@adctoday.com


5.6.4Due to the fact that ADC products are medical devices, non-conforming product
will be accepted for use through concession only after it has been determined that
all applicable regulatory requirements for the product have been met. (In other
words, while a non-conforming product with a cosmetic defect might be accepted
for use through concession, a non-conforming product that did not meet
applicable safety requirements would not.)
5.6.5Records of the nature of nonconformities and any subsequent actions taken,
including concessions obtained, are maintained as part of ADC’s Quality
Management System. These records include the identity of any personnel
authorizing the use of non-conforming product (with the customer’s concession
where appropriate).
5.6.6As part of ADC’s system for handling non-conforming materials, any materials
that are re-worked to make them conforming to ADC requirements will be
subjected to re-inspection to ensure that the re-work has succeeded in correcting
the detected non-conformities.
5.6.7ADC’s Complaint System, as well as customer feedback and information
obtained from the Service Department are used to help detect any potential non-
conforming product in the field. When nonconforming product is detected after
delivery or use has started, appropriate actions to the effects, or potential effects,
of the nonconformity will be taken through ADC’s corrective/preventive action
system. These actions will be documented and records will be included as
Quality Records.
5.6.8As part of the process of handling non-conforming materials, materials that
require re-work will be re-worked in accordance with established work
instructions and procedures. If a documented work instruction is not adequate to
cover the processes required to adequately re-work a product, a new work
instruction will be created (with the same authorization and approval process as
other work instructions) to document the re-work process. This work instruction
that details the rework will be evaluated to ensure that the rework process does
not adversely affect the finished product.
5.6.9Additional information relating to the control of nonconforming product may be
found in SOP 8.0,Measurement, Analysis, and Improvement, and in various work
instructions and procedures that make up ADC’s Quality Management System.


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AMERICAN DIAGNOSTIC CORP. • 55 Commerce Drive, Hauppauge, NY 11788 • Voice: 631-273-9600 • Fax: 631-273-9659 • email: info@adctoday.com


5.7
Analysis of Data
5.7.1As part of the Quality Management System, Executive Management has
established processes for the collection and analysis of quality related data. (Note:
this data also includes relevant customer satisfaction information.)
5.7.2The data collected is used to determine the suitability and effectiveness of ADC’s
Quality Management System and to note areas where improvement can be made.
This data is reviewed by Executive Management and specified department
supervisors to ensure that trends and quality issues detected during analysis is
properly communicated and addressed. This data is presented in several different
forums, including, but not limited to:


•Regularly scheduled Management Review Meetings
•Plant Manager Meetings (including plant departmental supervisors)
•New Product Meetings (focusing on new product development or existing


product issues)
5.7.3The data analyzed as part of ADC’s Quality Management System includes, but is
not limited to:


•Customer satisfaction (including customer feedback)
•Conformity to product requirements
•Characteristics and trends of processes and products, including


opportunities for preventive action (Note: process analysis includes all
aspects of ADC’s product realization cycle as well as after-market
services)


•Supplier evaluations


5.7.4Analysis of data is performed in accordance with SOP 8.0,Measurement,
Analysis, and Improvement. Additional information relating to this process can
also be found in various procedures and work instructions that make up ADC’s
Quality Management System.
5.8
Improvement
5.8.1The purpose of ADC’s Quality Management System, beyond the basic concept of
product quality and customer satisfaction, is to ensure that ADC continues to grow
as an organization and improve its operations both to increase efficiency, and to
increase product quality and customer satisfaction levels.
5.8.2ADC’s Quality Management System incorporates various different tools that help
make this continual improvement effort possible. Some of these tools are detailed
below:


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AMERICAN DIAGNOSTIC CORP. • 55 Commerce Drive, Hauppauge, NY 11788 • Voice: 631-273-9600 • Fax: 631-273-9659 • email: info@adctoday.com


•ADC’s Quality Policy has been designed to outline the basic quality goals


that the company hopes to achieve


•ADC’s Quality Objectives outline more specific improvement objectives,


and are reviewed by Executive Management to ensure that they are suitable
for the company and to gauge their effectiveness


•ADC’s internal quality auditing system ensures that departments are


performing processes as determined by written work instructions and other
documents, areas of concern are noted and corrected


•Data analysis allows for trending of potential quality issues and customer


satisfaction levels


•ADC’s corrective/preventive action systems allow issues to be averted


before a quality issue develops, or to correct existing problems and improve
efficiency


•The Management Review process allows Executive Management to review


the whole Quality Management System and make improvements where
appropriate.
5.8.3As part of ADC’s commitment to quality, a system has been implemented to allow
ADC to issue advisory notices or recalls on ADC products that have been supplied
to our customers. This system can be implemented whenever necessary to ensure
that customers are aware of any urgent quality issues that relate to ADC products.
This system is further supplemented by ADC’s Customer Service and Quality
Assurance Departments, which provide customers with up-to-date, accurate
technical and/or regulatory information as necessary.
5.8.4ADC’s continual improvement initiative includes a Complaint System. This system
is designed to record the details of all customer complaints, and allows for this
information to be routed to the departments responsible for the complaint so that
investigation may be performed. All complaints are investigated and reviewed so
that the customer’s satisfaction is guaranteed, and the actions taken to resolve the
complaint (and underlying issues relating to the complaint where appropriate) will
be documented so that they can be easily reviewed.
5.8.5Where investigation indicates that a customer complaint may have been caused by
activities that are outside of ADC’s direct control, ADC’s advisory notice system
ensures that this information is shared with all relevant parties, allowing for the
resolution of any quality issues.
5.8.6ADC’s Quality Management System includes a process for notifying relevant
regulatory authorities when adverse events occur that involve ADC devices. The
criteria for reporting these events and the method of reporting are included in
documented work instructions and procedures.


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AMERICAN DIAGNOSTIC CORP. • 55 Commerce Drive, Hauppauge, NY 11788 • Voice: 631-273-9600 • Fax: 631-273-9659 • email: info@adctoday.com


5.9
Corrective Action
5.9.1Executive Management has established corrective action systems to ensure that
corrective actions are issued and implemented to effectively handle customer
complaints and product non-conformities, investigate the causes of non-
conformity, record the results if the investigation determines action(s) must be
taken to alleviate the problems, and devise methods for ensuring corrective
action(s) are effective. (It is important to note that ADC’s Complaint System is a
stand-alone corrective action system specifically for dealing with customer
complaints.)
5.9.2ADC’s corrective action system includes processes for reviewing nonconformities
and determining their cause. Once this determination has been made, actions to
correct the nonconformity can be developed. Actions are also developed to
prevent a recurrence of the nonconformity in the future. These actions are then
implemented, and are available to Executive Management for review at any time.
5.9.3As part of the implementation of corrective actions, it may be necessary to update
existing Quality Management System documentation to prevent future
recurrences of the detected non-conformity. Updates to existing documentation
that are required during corrective actions are performed in the same fashion as
regular document revisions.
5.9.4Corrective action files will contain records detailing the entire corrective action
process, from the identification of the problem and root cause analysis to the
details of the actions taken to correct the problem including the results of any
investigations performed. These records allow for the review of the corrective
action files before they are closed to ensure that they have been effective.
5.9.5Additional information relating to the corrective action system can be found in
SOP 8.0,Measurement, Analysis, and Improvement, and in various work
instructions and procedures that make up ADC’s Quality Management System.
5.10 Preventive Action
5.10.1Executive Management has established a preventive action system to ensure that
preventive actions will be issued and implemented to detect, analyze, and
eliminate potential causes of problems. Actions will include the steps to
implement preventive actions, methods to ensure implemented actions are
effective, and procedures to maintain records of all preventive actions for
Management Review.


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AMERICAN DIAGNOSTIC CORP. • 55 Commerce Drive, Hauppauge, NY 11788 • Voice: 631-273-9600 • Fax: 631-273-9659 • email: info@adctoday.com


5.10.2As with the corrective action system, the preventive action system will involve
the creation of preventive action files that contain all relevant information about
specific preventive actions. These files will include the initial potential problem,
root cause analysis, and investigation results, and will allow a review of the
preventive action file before it is closed to ensure that the preventive action has
been successful.
5.10.3The preventive action system includes processes for:


•Determining potential nonconformities and their causes
•Evaluating the need for action to prevent occurrence of nonconformities,
•Determining and implementing action needed
•Recording the results of action taken
•Reviewing preventive action taken


5.10.4Additional information relating to the preventive action system can be found in
SOP 8.0,Measurement, Analysis, and Improvement, and in various work
instructions and procedures that make up ADC’s Quality Management System.