Quality

Manual
Conforming to AS9100D,
ISO13485:2016 and
ISO9001:2015
Revision 31
Last Revised: 10/19/2021
 Quality Manual

Table of Contents
i. Foreword ...................................................................................................................................4
ii. Introduction ...............................................................................................................................4
1. Scope .........................................................................................................................................4
1.1 Scope Statement ................................................................................................................................. 4
1.2 Facilities within the Scope................................................................................................................... 5
1.3 Permissible Exclusions ........................................................................................................................ 5
1.4 Scope of the Quality Management System Manual ........................................................................... 5
2. Normative References ................................................................................................................6
3. Terms and Definitions .................................................................................................................6
3.1 Counterfeit Part .................................................................................................................................. 6
3.2 Critical Item ......................................................................................................................................... 6
3.3 Key Characteristics .............................................................................................................................. 6
3.4 Product Safety ..................................................................................................................................... 6
3.5 Special Requirements ......................................................................................................................... 6
4. Context of the Organization ........................................................................................................7
4.1 Understanding the Organization and Its Context ............................................................................... 7
4.2 Understanding the Needs and Expectations of Interested Parties..................................................... 7
4.2.3 Medical Device File .......................................................................................................................... 8
4.3 Determining the Scope of the Quality Management System ............................................................. 8
4.4 Quality Management System and Its Processes ................................................................................. 8
5. Leadership..................................................................................................................................8
5.1 Leadership and Commitment ............................................................................................................. 8
5.2 Policy ................................................................................................................................................... 9
5.3 Organizational Roles, Responsibilities and Authorities .................................................................... 10
6. Planning ................................................................................................................................... 10
6.1 Actions to Address Risks and Opportunities ..................................................................................... 10
6.2 Quality Objectives and Planning to Achieve Them ........................................................................... 10
6.3 Planning of Changes .......................................................................................................................... 10
7. Support .................................................................................................................................... 10
7.1 Resources .......................................................................................................................................... 10
7.2 Competence ...................................................................................................................................... 12
7.3 Awareness ......................................................................................................................................... 12
7.4 Communication ................................................................................................................................. 12

QM-001 Page 2 of 37 Revision 31: 10/19/2021

 Quality Manual

7.5 Documented Information ................................................................................................................. 13

8. Operation ................................................................................................................................. 13
8.1 Operational Planning and Control .................................................................................................... 13
8.2 Requirements for Products and Services .......................................................................................... 16
8.3 Design and Development of Products and Services ......................................................................... 17
8.4 Control of Externally Provided Processes, Products and Services .................................................... 20
8.5 Production and Service Provision ..................................................................................................... 22
8.6 Release of Products and Services...................................................................................................... 26
8.7 Control of Nonconforming Outputs .................................................................................................. 26
9. Performance and Evaluation ..................................................................................................... 27
9.1 Monitoring, Measurement, Analysis and Evaluation........................................................................ 27
9.2 Internal Audit .................................................................................................................................... 28
9.3 Management Review ........................................................................................................................ 28
10. Improvement ........................................................................................................................... 29
10.1 General ............................................................................................................................................ 29
10.2 Nonconformity and Corrective Action ............................................................................................ 30
10.3 Continual Improvement .................................................................................................................. 30
10.3 Preventative Action......................................................................................................................... 30
Appendix A: Quality Manual Revision History .................................................................................. 31
Appendix B: Organizational Descriptors ............................................................................................ 33
Appendix C: Incorporated Documents .............................................................................................. 34
Appendix D: Outsourced Activities ................................................................................................... 34
Appendix E: ISO 13485 Matrix .......................................................................................................... 35

QM-001 Page 3 of 37 Revision 31: 10/19/2021

 Quality Manual

i. Foreword
This manual is issued to describe the quality system employed by Sager Electronics (hereafter
referenced as Sager). The Quality Manual is issued and controlled by Sager’s Director of Quality and
Logistics.
The systems and processes described in this manual serve to ensure conformance to customer
requirements, implementation of Sager’s quality policy, as well as, conformance to the requirements of
AS9100, ISO13485 and ISO9001.
It is the responsibility of the Director of Quality and Logistics to ensure that this manual is maintained as
a current reflection of the Sager Quality System.

ii. Introduction
Sager Electronics, a wholly owned subsidiary of TTI Inc., a Berkshire Hathaway Inc. company, is a North
American distributor of Interconnect, Power and Electromechanical components from leading
manufacturers worldwide and a provider of Custom Solutions. Grounded in over 130 years of innovation
and service, Sager Electronics provides customers and suppliers a unique combination of operational
excellence and innovative business solutions through its Distributing Confidence® business model.
Headquartered in Middleborough, MA, Sager Electronics operates a national network of field sales
representatives and power systems sales engineers, strategically located service centers across North
America, a value-add Power Solutions Center located in Carrollton, TX, and a Battery Solutions Center in
Lisle, IL.
CUSTOMERS
Original Equipment Manufacturers and Contract Electronic Manufacturers primarily in the industrial,
instrumentation, and medical industries as well as the maintenance repair operations and research and
development related markets.
VISION STATEMENT
To be recognized as the leading electronic component distributor and provider of Custom Solutions to
our targeted markets through: High Customer Satisfaction, Highly Developed Employees and High
Levels of Technology Utilization.

1. Scope
1.1 Scope Statement
AS9100 Main site scope: Warehousing and Distribution of electronic components.
AS9100 Custom Solutions sites scope: Design, Manufacture, Warehousing, Assembly and Distribution of
electronic components.
ISO13485 Custom Solutions site scope: The Design and Manufacture of Custom Battery, Power and
Thermal Assemblies for use in medical devices.

QM-001 Page 4 of 37 Revision 31: 10/19/2021

 Quality Manual

1.2 Facilities within the Scope

The quality system applies to all processes, activities and employees within the company facilities
located at Sager Electronics, 19 Leona Drive, Middleborough, MA 02346 (Main Site DC001), 2940
Eisenhower Street, Suite 100, Carrollton, TX 75007 (Power Solutions Center PSC / DC004) & 4642
Western Avenue, Lisle, IL 60532 (Battery Solutions Center BSC / DC005).
HQ/DC001: AS9100 – Warehousing, Distribution, Marketing, Sales, and Support
HQ/DC001: ISO13485 – Marketing, Sales, and Support
PSC/DC004: AS9100 – Design, Manufacture, Warehousing, Distribution, Support, Sales, Marketing
PSC/DC004: ISO13485 – Design, Manufacture, Warehousing, Distribution, Support, Sales, Marketing
BSC/DC005: AS9100 – Design, Manufacture, Warehousing, Distribution, Support, Sales
BSC/DC005: ISO13485 – Design, Manufacture, Warehousing, Distribution, Support, Sales

1.3 Permissible Exclusions

The following clauses of ISO 9001 were determined to be not applicable to the Sager Electronics facility
located at 19 Leona Drive in Middleborough, MA (DC001):
1. Design and Development clause 8.3. Sager Electronics DC001 does not design or develop
products or services. This exclusion does not affect Sager Electronics ability, or responsibility, to
provide product that meets customer and applicable statutory and regulatory requirements.
The following clauses of ISO 13485 were determined to be not applicable to all Sager Electronics
facilities.
1. The requirements for sterility (Section 6.4.2, 7.5.2, 7.5.5, 7.5.7), are not applicable for the
quality management system as the devices manufactured by Sager Electronics are not sterile
devices, nor are the any requirements for product cleanliness.
2. The requirements for installation and servicing activities (Section 4.2.3 e and f, 7.5.3, 7.5.4), are
not applicable to the quality management system as Sager Electronics does not install or service
manufactured devices.
3. The requirements for active implantable medical devices and implantable medical devices
(Section 7.5.9.2) ae not applicable to the quality management system as Sager Electronics does
not manufacture any type of implantable medical device.
If in the future the above sections become applicable to the Quality System of Sager Electronics, then
the Quality System will be updated accordingly.

1.4 Scope of the Quality Management System Manual

This manual is prepared for the purpose of defining the company’s interpretations of the ISO9001,
ISO13485 and AS9100 international standards, as well as to demonstrate how the company complies
with these standards.

QM-001 Page 5 of 37 Revision 31: 10/19/2021

 Quality Manual

2. Normative References
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the reference document (including any amendments) applies.
AS9100:2016
Quality Management Systems – Requirements for Aviation, Space, and Defense Distributors
ISO 9001:2015
Quality Management Systems – Requirements
ISO 13485:2016
Quality Management Systems – Requirements for Medical Devices
AS9496
Counterfeit Mitigation

3. Terms and Definitions

3.1 Counterfeit Part
An unauthorized copy, imitation, substitute, or modified part, which is knowingly misrepresented as a
specified genuine part of an original or authorized manufacturer.
Note: Examples of a counterfeit part can include, but are not limited to, the false identification or
marking or labeling, grade, serial number, date code, documentation, or performance characteristics.

3.2 Critical Item

Those items (e.g., functions, parts, software, characteristics, processes) having significant effect on the
provision and use of the products and services; including safety, performance, form, fit, function,
producibility, service life, etc.; that require specific actions to ensure they are adequately managed.
Examples of critical items include safety critical items, fracture critical items, mission critical items, key
characteristics, etc.

3.3 Key Characteristics

An attribute of feature whose variation has a significant effect on product fit, form, function,
performance, service life, or producibility, that requires specific actions for the purpose of controlling
variation.

3.4 Product Safety

Maintaining the state of product so that it is able to perform its designed or intended purpose without
causing unacceptable risk of harm to persons or damage to property.

3.5 Special Requirements

Those requirements identified by the customer, or determined by the organization, which have high
risks of not being met, thus requiring their inclusion in the operational risk management process.
Factors used in the determination of special requirements include product or process complexity, past
experience, and product or process maturity. Examples of special requirements include performance

QM-001 Page 6 of 37 Revision 31: 10/19/2021

 Quality Manual

requirements imposed by the customer that are at the limit of the industry’s capability, or requirements
determined by the organization to be at the limit of its technical or process capabilities.
Note: Special requirements (3.5) and critical items (3.2) along with key characteristics (3.3) are
interrelated. Special requirements are identified when determining and reviewing requirements related
to the product (See 8.2.2 and 8.2.3). Special requirements can require the identification of critical items.
Some critical items will be further classified as key characteristics because their variation needs to be
controlled.

4. Context of the Organization

4.1 Understanding the Organization and Its Context
Sager shall determine external and internal issues that are relevant to its purpose and its strategic
direction and that affect its ability to achieve the intended result of its Quality Management System.
Sager addresses the customer requirements and applicable statutory and regulatory requirements.
Sager shall monitor and review information about these external and internal issues:
a) Issues with possible positive and negative factors or conditions.
b) Issues arising from legal, technological, competitive, market, cultural, social, and economic
environments, whether international, national, regional, or local.
c) Issues related to values, culture, knowledge and performance of the organization.

4.2 Understanding the Needs and Expectations of Interested Parties

Due to their effect or potential effect on the organization’s ability to consistently provide products and
services that meet customer and applicable statutory and regulatory requirements, the organization
shall determine:
a) The interested parties that are relevant to the quality management system.
b) The requirements of those interested parties that are relevant to the quality management
system.

Requirements
Interested Parties
Customers expect quality products delivered on time at the lowest possible
Customers cost. Sager monitors through on time delivery and internal error
percentages.
Employees expect that they be given all required tools, guidance and training
Employees
in order to perform their functions in a safe and diligent manner.
Suppliers expect a fair level of business and proper feedback on their
Suppliers
performance.
Leadership expects all Sager employees perform all their job functions in an
Leadership
ethical manner to create value and to meets its financial objectives.
Regulatory Regulatory Authorities expect Sager to comply with Aviation requirements
Authorities and to maintain all required certifications.
Government Agencies expect Sager to meet all applicable laws about
Government Agencies environment, employment, export compliance, health and safety and fiscal
responsibilities.

QM-001 Page 7 of 37 Revision 31: 10/19/2021

 Quality Manual

Sager monitors and reviews information about these parties and their relevant requirements through
contract review, supplier meetings, Sager’s supplier excellence program, employee interaction and
retention, feedback from the parent company and feedback from auditors, consultants and standards
communities.

4.2.3 Medical Device File

The Device Master Record for the medical device components contains or references documents
including a general description of the components, intended use/purpose, labeling, instructions for use,
specifications for product, specifications or procedures for manufacturing, packaging, storage, handling
and distribution, procedures for measuring and monitoring, requirements for installation, and
procedures for servicing.

4.3 Determining the Scope of the Quality Management System

Based on an analysis of the above issues of concern, interests of stakeholders, and in consideration of its
products and services, Sager Electronics has determined that the scope of the management system as
follows:
The quality manual contains the quality policy and objectives and defines the policies for meeting the
requirements of the ISO 13485:2016 and AS9100D standards.

4.4 Quality Management System and Its Processes

Sager shall establish, implement, maintain, and continually improve a quality management system,
including the processes needed and their interactions.
The quality management system assigns the responsibilities and authorities for these processes (See
Appendix B). These processes are continually reviewed on a regular basis by conducting management
reviews, internal audits, risk assessments, and reviewing and monitoring quality objectives.

5. Leadership
5.1 Leadership and Commitment

5.1.1 General
A major part of Sager’s business philosophy is to be customer-focused. This can be evidenced
throughout Sager’s organization. In addition to the biannual Quality Council management review
meetings, members of the Executive Council participate in regular meetings and conference calls with
departments to identify areas for improvement and reinforce Sager’s customer-centric service and
sales strategies.
Management’s commitment to excellent customer service has been carried through to Sager’s vision
statement, quality policy, quality objectives, performance metrics, corporate presentations and
collateral material, and risk assessments. Quality goals and metrics are posted in both hard and soft
copy throughout the organization to further reinforce Sager’s tag line “Distributing Confidence”.
Sager’s management team is responsible for identifying and procuring the resources needed to fulfill
the requirements of Sager’s Quality System. Managers shall continually validate that their teams are

QM-001 Page 8 of 37 Revision 31: 10/19/2021

 Quality Manual

properly staffed with trained personnel who are committed to Sager’s customer service and quality
objectives.

5.1.2 Customer Focus

The Quality Council employs a number of ways to ensure that customer requirements are identified
and properly fulfilled. Methods include, but are not limited to the following:
Customer Satisfaction – Sager evaluates Customer generated report cards, as well as, responses to
electronic advanced ship notice surveys to determine how well their needs are being met. This data is
compiled and reviewed with the Quality Council. Where appropriate, customers are contacted for
more specific feedback. Areas for improvement are identified and addressed.
The Quality Council ensures that product and service conformity and on time delivery performance
are measured and appropriate actions are taken if results are not or will not be achieved.

5.2 Policy

5.2.1 Establishing the Quality Policy

Sager’s quality policy was developed by the Quality Council to communicate Sager’s commitment to
quality and the associated requirements of AS9100, ISO9001, ISO 13485 and AS6496. The individual
components of the quality policy are routinely reviewed and reinforced in both management and
department meetings.

SAGER’S QUALITY POLICY

As a distributor of electronic components and provider of Custom Solutions, our constant goal is to
ensure that the services provided meet or exceed our customers’ expectations. Through our Quality
System, we monitor both our suppliers and our processes, focusing on continual improvement to
provide safe and effective products to our customers.
We will achieve this by:
Complying with applicable quality, safety, and regulatory requirements
Monitoring our customers’ total experience
Maintaining the effectiveness of our quality management system

5.2.2 Communicating the Quality Policy

The Quality Council meets regularly to review Quality System performance and to discuss current and
future Quality initiatives. Performance metrics, meeting notes and action items are posted
electronically for the management team according to documented Management Review procedures.
Summary metrics are posted, at minimum, on Sager’s portal to ensure that all employees have access
to Sager’s Quality System performance. Weekly and monthly quality metrics are also posted in
common areas of the facility for employee review. The quality policy can be found on Sager’s website
for our interested parties.

QM-001 Page 9 of 37 Revision 31: 10/19/2021

 Quality Manual

5.3 Organizational Roles, Responsibilities and Authorities

Management has defined authority and responsibility for ensuring that the requirements of AS9100,
ISO13485 and ISO9001 as well as this manual are implemented, followed, maintained and
communicated. Sager has designated the Director of Quality and Logistics as the management
representative that has responsibility and authority for the oversight over the QMS with direct access to
senior leadership. An organization chart can be found in Appendix B of this manual.

6. Planning
6.1 Actions to Address Risks and Opportunities
Sager considers risks and opportunities when taking actions within the management system, as well as
when implementing or improving the management system; likewise, these are considered relative to
products and services.
Risks and opportunities are managed in accordance with the document: Risk Management Plan.

6.2 Quality Objectives and Planning to Achieve Them

The goals of Sager’s quality management system have been established and are monitored and
communicated as part of the Management Review process. These objectives are reviewed at each
Management Review meeting for consistency within the quality policy and updated as appropriate. The
Quality Council is responsible for insuring that these requirements are identified and met.
These objectives are listed within Appendix G of this manual and are additionally made available to
employees via the portal and other collateral materials.

6.3 Planning of Changes

When the Quality Council determines the need for changes to the quality management system, the
changes shall be carried out in a planned manner (see section 4.4).
The organization shall consider:
a) The purpose of the changes and their potential consequences;
b) The integrity of the quality management system;
c) The availability of resources;
d) The allocation or reallocation of responsibilities and authorities.

7. Support
7.1 Resources

7.1.1 General
Sager’s management team is responsible for identifying and procuring the resources needed to fulfill
the requirements of Sager’s Quality System. Managers shall continually validate that their teams are
properly staffed with trained personnel who are committed to Sager’s customer-service and quality
objectives.

QM-001 Page 10 of 37 Revision 31: 10/19/2021

 Quality Manual

Resource allocation is done with consideration of the capability and constraints on existing internal
resources, as well as needs related to supplier expectations. Sager’s management team is responsible
for maintaining a proper work environment to ensure achievement of Quality Management System
objectives.

7.1.2 Monitoring and Measuring Resources

Resources and resource allocation are assessed during management reviews.
Sager insures that all measuring tools used to determine product conformance are calibrated per the
Calibration Procedure. All measuring tools are identified with labels showing date of calibration. All
measuring tools are traceable to the national standards. All calibration or verification is carried out
under suitable environmental conditions.
Sager maintains a record of all tools requiring calibration within the facility.

7.1.3 Infrastructure
Management and staff identify, provide and maintain the infrastructure required to provide customer
satisfaction through conformity of product and services to customer requirements, prevent product
mix-up and provide orderly handling of product. Resource needs, including buildings, workspace,
utilities, process equipment, and supporting services such as transport, telecommunications,
equipment, computer systems, software used in the quality system, etc. are identified through the
quality planning, and quality system management review. Identified resources are provided based on
importance in meeting the quality objectives, meeting customer requirements, the contribution to
continuous improvement initiatives, and budget constraints. Records of maintenance are maintained
as appropriate.

7.1.4 Work Environment and Contamination Control

Sager maintains a work environment necessary to achieve conformity to product requirements.
Documents and processes associated with the maintenance of the work environment are to be
retained as quality records.
The work environment is managed to be safe and efficient. In instances where work environment
conditions can have an adverse effect on product quality, the requirements for work environment
conditions and documented procedures or work instructions to monitor and control these work
environment conditions are documented. Requirements and guidelines for safety and health,
protective equipment, workplace ergonomics, and hygiene are defined. The risk of potential
contamination is negligible due to the intended use of the product and contamination control in the
work environment is not required.

7.1.5 Monitoring and Measuring Resources

When monitoring and measuring resources are used by Sager to verify the conformity of products to
requirements those resources will be maintained to ensure their continuing fitness for their purpose.
Documented objective evidence of fitness will be maintained as a quality record.
A register of monitoring and measuring equipment is maintained and includes equipment type,
unique identification, location, the calibration or verification method, frequency, and acceptance
criteria.

QM-001 Page 11 of 37 Revision 31: 10/19/2021

 Quality Manual

7.1.6 Organizational Knowledge

Sager also determines the knowledge necessary for the operation of its processes and to achieve
conformity of products and services. This may include knowledge and information obtained from:
a) internal sources, such as lessons learned, feedback from subject matter experts, and/or
intellectual property;
b) external sources such as standards, academia, conferences, and/or information gathered
from customers or suppliers.
This knowledge shall be maintained, and made available to the extent necessary. When addressing
changing needs and trends, Sager shall consider its current knowledge and determine how to acquire
or access the necessary additional knowledge.

7.2 Competence
Training requirements are determined by job requirements, inputs obtained from employee
performance reviews, audit results, and/or Improvement Initiatives/Corrective Actions generated.
Competence is based on education, training, skills, experience and ongoing job performance.
Sager has documented procedures for determining competence, identifying training needs and
providing for the training of all personnel performing activities affecting the quality of Sager’s service.
Records are maintained as part of the training procedures.

7.3 Awareness
The Quality Council is responsible for ensuring that their employees are aware of the relevance and
importance of their activities and how these tasks contribute to the achievement of Sager’s quality
objectives and compliance to the quality policy. The quality policy is posted throughout the facility.
Employees are aware the implications of nonconformance and also of their contribution to product
safety and the importance of ethical behavior.

7.4 Communication
The Quality Council ensures internal communication takes place regarding the effectiveness of the
quality management system on a biannual basis. Internal communication methods include:
a) Use of corrective and preventive action processes to report nonconformities or suggestions for
improvement.
b) Use of the results of analysis of data.
c) Meetings (periodic, scheduled and/or unscheduled) to discuss aspects of the QMS.
d) Use of the results of the internal audit process.
e) Regular company meetings with all employees.
f) Internal emails or memos to employees.
g) The Quality Council’s “open door” policy which allows any employee access to discussions on
improving the quality system.

QM-001 Page 12 of 37 Revision 31: 10/19/2021

 Quality Manual

7.5 Documented Information

7.5.1 General
In accordance with the requirements of AS9100, ISO 13485, and ISO9001 Sager has established,
implemented and maintains documented procedures to control all documentation and data that relate
to Quality System requirements. The quality procedures define the processes used to meet
requirements. The work instructions define current practices and describe how individual tasks are
performed. The quality procedures and work instructions define the records required for the processes
and activities

7.5.2 Creating and Updating

The appropriate department shall file external documentation as received and remove any obsolete
document upon notification by customer. Revision control will be the responsibility of the issuing
party.
When creating and updating documented information, Sager shall ensure appropriate:
a) Identification and description (e.g. title, date, author, reference number).
b) Format (e.g. language, software version, graphics) and media (e.g. paper, electronic).
c) Review and approval for suitability and adequacy.

7.5.3 Control of Documented Information

All documents directly affecting the quality function are reviewed and approved for adequacy by
designated department personnel prior to issue. This is done according to Document Control
procedures.
Procedures are maintained within Sager’s internal portal according to documented procedures. This
ensures that current revisions are available to all employees at all locations.
The same departments that have performed the original approval normally perform document
changes and these changes are done in accordance with the Document Control procedures.
Revision information is maintained by the Quality Department and is distributed upon request.
The Quality Department maintains a master list for each department indicating the current revision
levels of all quality documents and records. Because current documents are available on the
computer, users can be sure that they are using the latest document issue.

8. Operation
8.1 Operational Planning and Control
Sager plans and develops the processes needed for product requirements and services. Planning of
product requirements is consistent with the other processes of the management system (see QMS
Appendix E). Such planning considers the information related to the context of the organization (see
section 4.0), resources and capabilities, as well as product and service requirements. Sager shall plan,
implement and control the processes to implement the actions determined in clause 6 by:
a) Determination of requirements for the products and services should include consideration of:

QM-001 Page 13 of 37 Revision 31: 10/19/2021

 Quality Manual

- Personal and product safety;

- Producibility and inspectability;
- Reliability, availability, and maintainability;
- Suitability of parts and materials used in the product;
- Selection and development of embedded software, if applicable;
- Product obsolescence;
- Prevention, detection and removal of foreign objects;
- Handling, packaging, and preservation;
- Recycling or final disposal of the product at the end of its life.
b) Establish criteria for
a. The processes
b. The acceptance of products and services

According to the nature of the product and depending on the specific requirements, statistical
techniques can be used to support:
- Design verification
- Process control
o Selection and verification of key characteristics;
o Process capability measurements;
o Statistical process control;
o Design of experiments
- Verification;
- Failure mode, effects and criticality analysis.
c) Determining the resources needs to achieve conformity to the product and service
requirements and to meet on time delivery of products and services;
d) Implementing control of the processes in accordance with the criteria;
e) Determining, maintaining, and retaining documented information to the extent necessary:
a. To have confidence that the processes have been carried out as planned;
b. To demonstrate the conformity of products and services to their requirements;
f) Determining the processes and controls needed to manage critical items, including production
process controls when key characteristics have been identified;
g) Engaging representatives of affected organization functions for operational planning and
control;
h) Determining the process and resources to support the use and maintenance of products and
services;
i) Determining the products and services to be obtained from external providers;
j) Establishing the controls needed to prevent the delivery of nonconforming products and
services to the customer.

8.1.1 Operational Risk Management

Sager shall plan, implement, and control a process for managing operational risks to the achievement
of applicable requirements, which includes:

QM-001 Page 14 of 37 Revision 31: 10/19/2021

 Quality Manual

a) Assignment of responsibility for operational risk management

b) Definition of risk assessment criteria (impact, likelihood and risk acceptance);
c) Identification, assessment, and communication of risks throughout operations;
d) Identification, implementation, and management of actions to mitigate risks that exceed the
defined risk acceptance criteria;
e) Acceptance of risks remaining after implementation of mitigating actions.

8.1.2 Configuration Management

Configuration management consists of unique part numbers assigned to product by both the
manufacturer and by Sager. If a part is changed for any reason, the manufacturer will sell the product
to Sager with another unique part number assigned by the manufacturer. Customer part numbers /
aliases are not part of Configuration Management.

8.1.3 Product Safety

Sager shall plan, implement and control the processes needed to assure product safety during the
entire product life cycle, as appropriate to the organization and the product. Examples of these
processes include:
- Assessment of hazards and management of associated risks (see 8.1.1);
- Management of safety critical items;
- Analysis and reporting of occurred events affecting safety;
- Communication of these events and training of persons.

8.1.3.1 Cleanliness of Product

The risk of potential contamination is negligible due to the intended use of the product and
contamination control in the product is not required. The product is supplied to be used non-sterile,
and its cleanliness is not of significance in use. Cleaning is not required prior to shipment or use.

8.1.3.2 Installation Activities

The requirements for device installation and the acceptance criteria for verification of installation, as
appropriate, are documented in procedures and work instructions.

8.1.3.3 Servicing Activities

Service provision is described in procedures and work instructions and the results of service are
recorded. Periodic evaluation of service activities occurs by the management team in conjunction
with the service department to determine if any information is to be handled as a complaint, trend
analysis for input to the improvement process, and risk evaluation.

8.1.3.4 Requirements for Sterile Medical Devices

Products supplied by Sager have no sterilization requirements.

QM-001 Page 15 of 37 Revision 31: 10/19/2021

 Quality Manual

8.1.4 Prevention of Counterfeit Parts

Sager shall only purchase parts for resell from the Manufacturer or from the Manufacturer’s
Authorized Distributor. When Sager purchases from an Authorized Distributor the distributor’s
authorization with the manufacturer shall be verified and documented. Sager’s counterfeit mitigation
procedures are based upon AS6496.
Sager employees receive training on the identification and prevention of counterfeit parts being
introduced in to the supply chain. Throughout all stages of the fulfillment process, inventory is
verified for kind, count and condition. Where Sager proposes to verify purchased product at its
supplier’s premises, Sager shall specify verification arrangements and the method of product release
in the associated Sager purchase orders.
Where specified in the contract, our customer shall be afforded the right to verify at source and/or
upon receipt that purchased product conforms to specified requirements. This may include review of
supplier paperwork.
Acceptance by the customer of products in question does not relieve Sager from ongoing verification
procedures and does not restrict the customer from later rejecting the product.

8.2 Requirements for Products and Services

As a minimum, contracts are reviewed by the Sales Department before acceptance for:

 Order requirements being clearly defined and documented.

 Delivery time required for parts.
 Customer-specific standards and requirements.
 Special packaging and shipping requirements.
 Sager’s ability to meet the customer’s requirements.
 Inventory or credit risks using internal classification system.

The following departments are consulted, as necessary, during the contract review process: Marketing,
Sales, Distribution Center, Finance and Operations.
Any exceptions to the customer’s specifications are agreed upon and communicated with the customer
prior to accepting or altering an order or contract. The results of the contract review process are
documented by the Sales department and retained in the computer database.
Sager maintains documented procedures that describe the customer order maintenance process per the
Sales Key Processes.

8.2.1 Customer Communication

Communication methods are dictated by Sager’s customers. Order requirements are typically
communicated via phone, e-mail or EDI. The same is true with customer complaints. Sager will make
every effort to utilize the required tools and methods to ensure effective communication and
customer satisfaction.
Sager has implemented effective communication with customers in relation to:
a) Providing information relating to products and services;
b) Handling inquiries, contracts or orders, including changes;

QM-001 Page 16 of 37 Revision 31: 10/19/2021

 Quality Manual

c) Obtaining customer feedback relating to products and services, including customer

complaints;
d) Handling or controlling customer property;
e) Establishing specific requirements for contingency actions, when relevant.
Results of any customer communication will be reviewed during Management Review.

8.2.2 Determining the Requirements for Products and Services

During the intake of new business, Sager captures:
a) Requirements specified by the customer, including the requirements for delivery and post-
delivery activities;
b) Requirements not stated by the customer but necessary for specified or intended use, where
known;
c) Statutory and regulatory requirements related to the product;
d) Any additional requirements determined by Sager;
e) Special requirements specified by the customer, or identified by Sager to meet other
customer requirements;
f) Operational risks associated with meeting customer requirements.

8.2.3 Review of the Requirements for Products and Services

Sager maintains documented procedures that describe the customer order maintenance process. Any
exceptions to the customer’s specifications are agreed upon and communicated with the customer
prior to accepting or altering an order or contract. The results of the contract review process are
documented by the Sales department and retained in the computer database.

8.2.4 Changes to Requirements for Products and Service

Any changes or amendments to the original order shall be documented and retained, and all internal
and external parties are informed of the changes.

8.3 Design and Development of Products and Services

8.3.1 General
Sager maintains a design and development process that ensures the subsequent provision of products
and services.

8.3.2 Design and Development Planning

In determining the stages and controls for design and development, Sager considers:
a) The nature, duration, and complexity of the design and development activities;
b) The required process stages, including applicable design and development reviews;
c) The required design and development verification and validation activities;

QM-001 Page 17 of 37 Revision 31: 10/19/2021

 Quality Manual

d) The responsibilities and authorities involved in the design and development process;
e) The internal and external resource needs for the design and development of products and
services;
f) The needs to control interfaces between persons involved in the design and development
process;
g) The need for involvement of customers and users in the design and development process;
h) The requirements for subsequent provision of products and services;
i) The level of control expected for the design and development process by customers and other
relevant interested parties;
j) The documented information needed to demonstrate that design and development
requirements have been met.
Sager divides the design and development effort into distinct activities, and defines the tasks,
necessary resources, responsibilities, design content, and inputs and outputs for each activity.

8.3.3 Design and Development Inputs

Sager determines the requirements essential for the specific types of products and services to be
designed and developed. Sager considers:
a) Functional and performance requirements;
b) Information derived from previous similar design and development activities;
c) Statutory and regulatory requirements;
d) Standards or codes of practice that the Sager has committed to implement;
e) Potential consequences of failure due to the nature of the products and services;
f) The potential consequences of obsolescence.
Inputs shall be adequate for design and development purposes, complete and unambiguous.
Sager retains documented information on design and development inputs.

8.3.4 Design and Development Controls

Sager applies controls to the design and development process to ensure that:
a) The results to be achieved are defined;
b) Reviews are conducted to evaluate the ability of the results of design and development to
meet requirements;
c) Verification activities are conducted to ensure that design and development outputs meet the
input requirements;
d) Validation activities are conducted to ensure that the resulting products and services meet
the requirements for the specific application or intended use;

QM-001 Page 18 of 37 Revision 31: 10/19/2021

 Quality Manual

e) Any necessary actions are taken on problems determined during the review, or verification
and validation activities;
f) Documented information on these activities is retained;
g) Progression to the next stage is authorized.
Participants in the design and development reviews include representatives of functions concerned
with the design and development stage(s) being reviewed.
When tests are necessary for the verification and validation, these tests are planned, controlled,
reviewed and documented to ensure and prove the following:
a) Test plans or specifications identify the test item being tested and the resources being used,
define test objectives and conditions, parameters to be recorded and relevant acceptance
criteria;
b) Test procedures describe the test methods to be used, how to perform the test, and how to
record the results;
c) The correct configuration of the test items is submitted for the test;
d) The requirements of the test plan and the test procedures are observed;
e) The acceptance criteria are met.
Sager controls all monitoring and measuring devices used for testing as defined in clause 7.1.5.
Sager ensures that, at the completion of design and development, reports, calculations and test
results are able to demonstrate that the design for the product or service meets the specific
requirements for all identified operational conditions.

8.3.5 Design and Development Outputs

Sager ensures that design and development outputs:
a) Meet the input requirements;
b) Are adequate for the subsequent processes for the provision of products and service;
c) Include or reference monitoring and measuring requirements, and acceptance criteria;
d) Specify the characteristics of products and services that are essential for their intended
purpose and their safe and proper provision;
e) Specify and critical items, including any key characteristics, and specific actions to be taken for
these items;
f) Are approved by authorized person(s) prior to release.
Sager defines the data required to allow the product to be identified, manufactured, verified, used
and maintained. This data includes:
- The drawings, parts lists and specifications necessary to define the configuration and the
design features of the product;
- The material, process, manufacturing, assembly, handling, packaging and preservation data
needed to provide and maintain a conforming product or service;

QM-001 Page 19 of 37 Revision 31: 10/19/2021

 Quality Manual

- The technical data and repair schemes for operating and maintaining the product.
Sager retains documented information on design and development outputs.

8.3.6 Design and Development Changes

Sager identifies, reviews and controls changes made during and subsequent to, the design and
development of products and services, to the extent necessary to ensure that there is no adverse
impact on conformity to requirements. Sager notifies its customer, prior to implementation, about
changes that could affect the customer requirements.
Sager retains documented information on:
a) Design and development changes;
b) The results of reviews;
c) The authorization of the changes;
d) The actions taken to prevent adverse impacts.
Design and development changes are controlled in accordance with the configuration management
process requirements.

8.4 Control of Externally Provided Processes, Products and Services

8.4.1 General
Sager has established, implemented and maintains a process to plan and control the temporary or
permanent transfer of work and has a process in place to verify the conformity of the transfer to
requirements. Typically, this applies to Sager transferring product from our main Distribution Center
to one of our third party warehouse locations.
Sager identifies and manages risks associated with external providers of processes, products and
services through periodic review of key metrics. Sager accepts accountability and responsibility for
conformance of products from customer approved providers. All suppliers of parts to Sager must
accept Sager’s Supplier Quality Requirements (QLT009) prior to accepting a purchase order from
Sager.
It is the responsibility of the Marketing Department to purchase, from preferred and approved
suppliers, products and services that conform to specified requirements.
a) Sager maintains a register of suppliers, which includes their current approval status.
Authorized suppliers are Sager’s preferred supplier, which is identified on Sager’s line card.
Approved suppliers are designated as Non-Authorized suppliers that are authorized for the
sale of their product. Supplier Marketing is responsible for maintaining and updating the
Approved Suppliers Register.
b) Suppliers are selected and maintained based upon their ability to meet Sager Quality
standards and specifications. Selection is done by Sager’s Management using various criteria
including: product offering and technology, quality, exclusivity, representation network,
service, profitability and where appropriate, records of previously demonstrated capability
and performance. There are documented procedures outlining this process. Our customers
mandate which products and suppliers they want to purchase. As a distributor, it is our job to

QM-001 Page 20 of 37 Revision 31: 10/19/2021

 Quality Manual

monitor supplier performance and take action, as required, to provide customers with the
best level of service and satisfaction possible.
c) Supplier Quality Meetings are held throughout the year to monitor supplier performance,
which includes, but is not limited to, on-time delivery, acknowledgement rating and quality
specific issues. Action items are created if the suppliers do not meet Sager’s performance
criteria. Corrective Actions are initiated for any supplier that is determined to be failing to
meet customer product requirements.
d) Sager will ensure, when appropriate, that all applicable suppliers as well as Sager use
customer-approved special process sources.
e) Suppliers and items are categorized based on various risk factors. Business strategies are
created and adjusted based on these classifications.
f) Sager’s supplier selection process is designed to prevent the purchase of counterfeit/suspect
unapproved products. Sager only sells products that we are contractually authorized to sell.
Any exceptions are documented with the customer at time of quotation and are noted with
an asterisk on shipping paperwork.

8.4.2 Type and Extent of Control

Sager ensures that externally provided processes do not adversely affect the organization’s ability to
consistently deliver conforming products. Sager also ensures that externally provided processes
remain within control of Sager’s QMS. The external provider performance is reviewed and discussed
monthly by Supplier Marketing and bi-annually during management review.
Sager inspects incoming product for kind, count and condition and processes discrepancies via the
Receiving Exceptions work instructions. Sager does not currently receive raw materials.

8.4.3 Information for External Providers

Sager management shall communicate to external providers its requirements for:
a) The processes, products and services to be provided;
b) The approval of:
a. Products and services:
b. Methods, processes and equipment:
c. The release of products and services.
c) Competence, including any required qualification of persons;
d) The external providers’ interactions with Sager;
e) Control and monitoring of the external providers’ performance to be applied to Sager;
f) Verification or validation activities that Sager, or its customer, intends to perform at the
external providers’ premises;
g) Design and development control;
h) Special Requirements, critical items, or key characteristics;

QM-001 Page 21 of 37 Revision 31: 10/19/2021

 Quality Manual

i) Test, inspection and verification;

j) The use of statistical techniques for product acceptance and related instructions for
acceptance by Sager;
k) The need to:
a. Implement a quality management system or demonstrate the ability to meet the
requirements of the Sager Supplier Quality Manual if the external provide does not
possess an ISO certification.
b. Use customer designated or approved external providers, including process sources;
c. Notify Sager of nonconforming processes, products or services and obtain approval
for their disposition;
d. Prevent the use of suspected unapproved and counterfeit parts;
e. Notify Sager of changes to processes, products or services, including changes to their
external providers or locations of manufacture;
f. Flow down to external providers applicable requirements including customer
requirements;
g. Provide a certificate of conformity, test reports, or authorized release certificate, as
applicable;
h. Retain documented information, including retention periods and disposition
requirements.
l) The right of access by Sager, their customer, and regulatory authorities to the applicable areas
of facilities and to applicable documented information, at any level of the supply chain.
m) Ensuring that persons are aware of:
a. Their contribution to product or service conformity;
b. Their contribution to product safety;
c. The importance of ethical behavior.

8.5 Production and Service Provision

8.5.1 Control of Production and Service Provision

To control its provision of parts or services, Sager considers, as applicable, the following:
a) The availability of information or records that define the characteristics of the parts, as well as
the results to be achieved;
b) The availability and use of suitable monitoring and measuring resources;
c) The implementation of monitoring and measurement activities;
d) The use of suitable infrastructure and environment;
e) The appointment of competent persons, including any required qualifications;

QM-001 Page 22 of 37 Revision 31: 10/19/2021

 Quality Manual

f) The validation, and periodic revalidation, of the ability to achieve planned results of the
processes for production and service provision, where the resulting output cannot be verified
by subsequent monitoring or measurement. These processes can be referred to as special
processes;
g) The implementation of actions to prevent human error;
h) The implementation of release, delivery and post-delivery activities;
i) The establishment of criteria for workmanship;
j) The accountability for all products;
k) The control and monitoring of identified critical items, including key characteristics, in
accordance with the established processes;
l) The determination of methods to measure variable data;
m) The identification of in-process inspection/verification points when adequate verification of
conformity cannot be performed at later stages;
n) The availability of evidence that all production, inspection, and verification operations have
been completed as planned, or as otherwise documented and authorized;
o) The provision for prevention, detection, and removal of foreign objects;
p) The control and monitoring of utilities and supplies;
q) The identification and recording of products released for subsequent production use pending
completion of all required measuring and monitoring activities, to allow recall and
replacement if it is later found that the product does not meet requirements.
At this time, Sager does not utilize any in-house “special processes” where the result of the process
cannot be verified by subsequent monitoring or measurement.

8.5.1.1 Control of Equipment, Tools and Software Program

Equipment, tools and software programs used to automate, control, monitor, or measure
processes are validated and maintained. Storage requirements are defined for distribution
equipment or tooling including any necessary periodic preservation or condition checks.

8.5.1.2 Validation and Control of Special Processes

For processes where the resulting output cannot be verified by subsequent monitoring or
measurement, the organization shall establish arrangements for these processes including, as
applicable;
a) Definition of criteria for the review and approval of the processes;
b) Determination of conditions to maintain the approval;
c) Approval of facilities and equipment;
d) Qualification of persons;
e) Use of specific methods and procedures for implementation and monitoring of the
processes;

QM-001 Page 23 of 37 Revision 31: 10/19/2021

 Quality Manual

f) Requirements for documented information to be retained.

8.5.1.3 Production Process Verification

The organization shall implement production process verification activities to ensure the
production process is able to produce products that meet the requirements. These activities can
include risk assessments, capacity studies, capability studies, and control plans. The organization
shall use a representative from the first production run of a new part or assembly to verify that the
production processes, production documentation, and tooling are able to produce parts and
assemblies that meet requirements. This activity shall be repeated when changes occur that
invalidate the original results. This activity can be referred to as First Article Inspection (FAI). The
organization shall retain documented information on the results of the production process
verification.

8.5.2 Identification and Traceability

Received product is identified by purchase order, part number and quantity. If further identification is
required, the product shall be delivered to the Non-Conforming area. Inventory Control personnel
may contact the supplier or appropriate buyer to complete the verification process.
Purchase order information does not provide lot traceability. Product identification and traceability is
maintained using bar-code labels during every phase of the warehouse process (receiving, put away,
picking, packaging/shipping). Traceability beyond the source of supply is treated as a customer
special request and handled according to the documented sales procedures. Records are maintained
where applicable.
Traceability of data and materials are accomplished to the degree required by the customer including
statutory and regulatory agencies, using suitable documentation per documented procedures.

8.5.3 Property Belonging to Customers or External Providers

Sager shall exercise care with customer / external provider property while it is under Sager’s control
or if it is being used by Sager. Sager shall identify, verify, protect and safeguard customer / external
provider property provided for use. If customer / external provider property becomes lost, damaged
or otherwise made unusable, Sager will identify and record the issue as well as report such to the
customer / external provider.

8.5.4 Preservation
Sager’s processes for handling, storing, packaging, preserving and delivering inventory are described
in the Warehouse and Inventory Control procedures.
Only authorized personnel may handle product. Inventory shall be handled in such a fashion as to
protect against damage and preserve its integrity as a quality product. Whenever possible, product is
kept in the manufacturer’s original packaging in order to minimize handling.
Preservation of product shall also include, where applicable in accordance with product specifications
and applicable statutory and regulatory requirements, provisions for:
a) Cleaning – Sager does not sell product that needs cleaning.
b) Prevention, detection and removal of foreign objects.

QM-001 Page 24 of 37 Revision 31: 10/19/2021

 Quality Manual

c) Special handling for sensitive products – Sager has ESD procedures in place as well as a
segregated ESD/Moisture Sensitive stocking area.
d) Marking and labeling including safety warnings - Products are shipped in packages that clearly
identify the part number. Each product is identified by a unique Sager part number that
references the supplier and the manufacturer’s part number, ensuring segregation of similar
products. Shipping documentation is printed out and affixed to the shipment.
e) Shelf-life control and stock rotation – Sager routinely performs cycle counts and stock
rotations. Stock rotation schedules are created based upon product age and excess
availability. At this time, the condition of the product is assessed. Damaged and/or
questionable material will be segregated and handled as non-conforming product.
f) Sager provides special handling and storage for hazardous materials.
Inventory shall be stored in structurally sound and well-maintained warehousing facilities. Storage
methods are determined by the product’s manufacturer, size, quantity and type. Whenever possible,
material is kept in the manufacturer’s original packaging. When necessary, inventory shall be stored
in appropriate containers to prevent deterioration.
Where contractually specified, Sager shall extend protection to include delivery to destination.

8.5.5 Post-Delivery Activities

As applicable, Sager conducts the following activities which are considered “post-delivery activities”:
 Customer surveys;

 Statutory and regulatory requirements;

 Customer requirements;

 Corrective actions;
 Returns processing;
 Collection and analysis of in-service data;
 Control, updating, and provision of technical documentation relating to product use,
maintenance, repair, and overhaul;
 Controls required for work undertaken external to the organization;

 Product/Customer support
 Advisory notices
Post-delivery activities are conducted in compliance with the management system defined herein
which includes investigation and reporting.
In instances when regulatory requirements require that regulatory authorities be notified of
complaints that meet specified reporting criteria of adverse events or issuance of advisory notices,
such reporting will be accomplished via documented procedures. Records of reporting to regulatory
authorities will be maintained. No reporting to regulatory agencies is currently required for parts
provided by Sager to medical customers.

QM-001 Page 25 of 37 Revision 31: 10/19/2021

 Quality Manual

8.5.6 Control of Changes

Sager reviews and controls both planned and unplanned changes to processes to the extent necessary
to ensure continuing conformity with all requirements.
Service provision changes are authorized by sales, the Director of Operations Service and Logistics,
and the manager responsible for Special Programs.

8.6 Release of Products and Services

Acceptance criteria for parts are defined in appropriate subordinate documentation. Reviews and
inspections are conducted at appropriate stages to verify that the product and service requirements
have been met. This is done before parts are released or services are delivered. Requested documents
can be obtained from the external provider. Each shipment is provided with a certificate of conformity
which identifies product conformance to customer requirements and manufacturer’s specifications.
When required to demonstrate product qualification, the organization shall ensure that retained
documented information provides evidence that the products and services meet the defined
requirements.

8.7 Control of Nonconforming Outputs

Sager has Inventory Control Procedures for identifying, documenting, evaluating, segregating, and
dispositioning of nonconforming product.
Product that has been identified as possibly nonconforming, receiving exceptions, and all customer
returns are stored in a separate Inventory Control area that is physically isolated from regular stock. The
computer system prohibits products in Inventory Control from shipping to customers.
Qualified Inventory Control, Quality, or Engineering personnel perform determination of
nonconformance. Product is inspected for kind (correct manufacturer part number), count, and
condition (visual inspection). Where failure of a technical nature is suspected, material is treated as
nonconforming. Only product found to be conforming is returned to regular stock.
Qualified personnel notify Sales and Marketing of the presence and disposition of nonconforming
product when appropriate. Customers are notified when previously shipped product may present a risk
to them.
Sager Distribution does not repair, re-work, re-grade or accept product by concession. The Power
Solutions Center (PSC) only repairs product if it is a Qualified VAR for the Supplier of for the VA content
added by the PSC. Product found to be nonconforming is returned to the original supplier for repair or
replacement, or it is scrapped. Where appropriate, a Corrective Action will be issued to address non-
conformity.
In situations where product passes kind, count and condition inspections but does not meet customer-
specific requirements, associated shipments will be held until the account is contacted and customer
authorization is received. If the product is not accepted, it will be moved to the Inventory Control and
handled according to documented Inventory Control procedures.
Product dispositioned for scrap is conspicuously and permanently marked, or positively controlled, until
physically rendered unusable.

QM-001 Page 26 of 37 Revision 31: 10/19/2021

 Quality Manual

9. Performance and Evaluation

9.1 Monitoring, Measurement, Analysis and Evaluation

9.1.1 General
Sager maintains monitoring, measurement, analysis and improvement processes needed to ensure
quality system conformity and effectiveness. These processes also ensure customer expectations are
continually achieved. These are monitored through the established Sager Quality Objectives.
Statistical techniques may be employed to collect, analyze, and interpret data relating to the
performance of both Sager and its suppliers. Any statistical measurements used shall be incorporated
within the departmental procedures that verify the acceptability of process and product. These
measurements shall be reviewed as part of the Management Review process.

9.1.2 Customer Satisfaction

As one of the measurements of the performance of the quality management system, Sager monitors
information relating to customer perception as to whether Sager has fulfilled customer requirements.
The methods used to obtain this information are through customer surveys, customer report cards
and Sager management visits.
 Recording customer complaints;
 Product rejections or returns;
 Repeat orders for product;
 Changing volume of orders for product;
 Trends in on-time delivery;
 Obtain customer scorecards from certain customers;
 Submittal of customer satisfaction surveys.
The Corrective Action system shall be used to develop and implement plans for customer satisfaction
improvement that address deficiencies identified by these evaluations, and assess the effectiveness of
the results.

9.1.3 Analysis and Evaluation

Sager shall analyze and evaluate appropriate data and information arising from monitoring and
measurement. The results of the analysis shall be used to evaluate:
a) Conformity of products and services;
b) The degree of customer satisfaction;
c) The performance and effectiveness of the Quality Management System
d) The effectiveness of planning;
e) The effectiveness of actions taken to address risks and opportunities;
f) The performance of external providers;

QM-001 Page 27 of 37 Revision 31: 10/19/2021

 Quality Manual

g) Other improvements to the management system.

9.2 Internal Audit

Internal quality audits are planned and conducted for each identified key process a minimum of once
every year to monitor the effectiveness of the overall system and to ensure that all quality-related
activities comply with written procedures and the requirements of AS9100, ISO 13485, ISO9001 and
AS6496.
Audit frequency is scheduled, and shall be adjusted, to give priority and heightened attention to areas
based on the status and importance of their activities. Results of previous audits are also used to
determine frequency of area audits.
The Director of Quality and Logistics is responsible for the creation and maintenance of the internal
audit schedule. The internal audit schedule will be reviewed with the Quality Council during
Management Review.
When outside consultants are used to complete Sager’s internal audits, the Quality Council shall review
the results of the audit in the meeting immediately following the completion of the audit. The Quality
Council shall complete a review of the internal audit procedures follow and determine if they were
effective. The consultant may not perform the audit on the internal audit processes.
Internal auditors shall not audit their own work in order to remain impartial and insure objectivity. The
results of the audit shall be documented according to Sager’s Internal Audit Procedure, and brought to
the attention of the personnel having responsibility for the area being audited. It is the area manager’s
responsibility to take timely action on the deficiencies found by the audit.
The results of audits are recorded and maintained according to the Quality Records procedure. These
audit reports are used to help plan follow up audits and verify the effectiveness of any action taken
against non-conformances noted in previous audits.

9.3 Management Review

9.3.1 General
Management Review meetings are held with the Quality Council on a bi annual basis to review the
Quality System and ensure that it is effectively satisfying the requirements of AS9100, ISO9001, ISO
13485 and AS6496, the quality policy, and Sager’s business needs. Records are maintained for each
management review meeting.

9.3.2 Management Review Inputs

The management review shall be planned and carried out, taking in to consideration;
a) The status of actions from previous management reviews.
b) Changes in external and internal issues that are relevant to the Quality Management System.
c) Information on the performance and effectiveness of the Quality Management System,
including trends in;
a. Customer satisfaction and feedback from relevant interested parties.
b. The extent to which quality objectives have been met.

QM-001 Page 28 of 37 Revision 31: 10/19/2021

 Quality Manual

c. Process performance and conformity of products and services.

d. Non-conformities, corrective actions and preventative actions.
e. Monitoring and measurement of processes, product and results.
f. Audit results.
g. The performance of external providers.
h. On time delivery performance.
i. Reporting to regulatory authorities, if necessary.
j. Applicable new or revised regulatory requirements.
d) The adequacy of resources.
e) The effectiveness of actions taken to address risks and opportunities.
f) Opportunities for improvement.

9.3.3 Management Review Outputs

During Management Review meetings, management will make appropriate decisions and take actions
regarding the following:
a) Opportunities for improvement.
b) Any need for changes to the Quality Management System.
c) Resource needs.
d) Risks identified.
e) Improvements of product related to customer requirements
f) Changes needed to respond to applicable new or revised regulatory requirements
The responsibility for required actions is assigned to members of the management team. Decisions
made regarding action items (due dates, description of action item, action taken) are recorded on a
Management Review Action Item List. Meeting notes are also recorded.

10. Improvement
10.1 General
Sager uses the management system to improve its processes, products and services. Such improvements
aim to address the needs and expectations of customers as well as other interested parties, to the
extent possible.
Improvement shall be driven by an analysis of data related to:
a) Conformity of products and services;

QM-001 Page 29 of 37 Revision 31: 10/19/2021

 Quality Manual

b) The degree of customer satisfaction;

c) The performance and effectiveness of the management system;
d) The effectiveness of planning;
e) The effectiveness of actions taken to address risks and opportunities;
f) The performance of external providers;
g) Other improvements to the management system;
h) Correcting, preventing, or reducing undesirable effects.

10.2 Nonconformity and Corrective Action

Sager maintains documented procedures that describe how a corrective action is implemented. The
Director of Quality and Logistics is responsible for overseeing this process and ensuring that the action
taken is commensurate with the amount of risk encountered.
Sager has a comprehensive corrective action program, which includes the investigation and correction
of product and process complaints. The system handles corrective action, customer complaints,
suppliers and quality system non-conformances. Failure of product, process or quality requirements is
an indication that the process or system was not followed or is inadequate. The process determines the
causes of the nonconformity, including, as applicable, those related to human factors.
There are procedures in place describing the corrective action process. These procedures include a
process for escalation to a higher level of management should a timely corrective action not be
implemented.
Any changes to documented procedures, as a result of corrective action requests, will be handled
according to Document Control procedures.
The Director of Quality and Logistics receives copies of all corrective action requests and is responsible
for follow-up to ensure that the corrective action is in place and that it is effective

10.3 Continual Improvement

Sager is continuously looking for ways to improve customer satisfaction as well as its business practices.
Sager relies heavily on its Quality Management System to drive these improvements.
Internal audits are used to evaluate compliance to AS9100, ISO 13485 a ISO9001 and documented
system requirements. These reviews are also conducted to identify ways to improve Sager’s operational
processes and related systems. By doing this, the auditors and management team validate that Sager’s
Quality System is not only conforming but also functional and effective.
Management Review is another process used to drive continuous improvement. Various sources of data
are reviewed and discussed. Issues are prioritized and action items are established all with the goal of
fulfilling Sager’s quality policy.

10.3 Preventative Action

Potential non-conformances are identified from the review of quality control activities, customer
feedback, analysis of audit findings, and other sources such as remake/rework trends and analysis.
Preventive action is taken to identify the root cause of these potential non-conformances, evaluate the
need for action, and implement the appropriate action to prevent occurrence. The effectiveness of the
action is reviewed. Records of preventive action and any investigations are maintained

QM-001 Page 30 of 37 Revision 31: 10/19/2021

 Quality Manual

Appendix A: Quality Manual Revision History

Rev Revised By Date Nature of Revision

0 06/21/93 Original Version
1 M. Norton 02/09/94 Complete Re-write
Removed all references to North Star due to 09/01/94 consolidation.
Changed ASQC standard from 1987 to 1994.
Customer complaints are handled according to documented procedures –
2 M. Norton 08/29/94
not necessarily the Corrective Action process. Modified inspection process
to include the use of computerized information. Changed Organization Chart
and Descriptors
Major re-write to reflect changes in the ISO standard and Lloyd’s Non-
3 M. Norton 12/05/94 Conformance Notes. Replaced “Document Control personnel” with the
Quality Department.
Changed Sager Electrical Supply to Sager Electronics.
Added Revision pages for each appendix.
Added Related Documents (Appendix D).
4 M. Norton 05/10/95 Changed ASQC Q92 to Q9002.
Changed 4.1.2.3 from Quality Department to Quality Mgr.
Changed 4.5.2 to remove or mark obsolete documents.
Clarified lot traceability policy in 4.8.
Changed “site” reference to include references to “Service Centers”
throughout manual.
Changed 4.1.2.3 to reflect Quality Rep accountability and role of line
management in reporting quality system performance.
Changed several clauses to account for current Purchasing/Marketing
structure.
5 D. Ratay 03/14/96 Changed reference from “Warehouse” to “Distribution Center” throughout
manual.
Changed 4.9.2 to include Moisture Sensitive Components in Special
Processes.
Changed 4.17 to include preventive action.
Changed Appendix B to current organizational chart.
Changed Appendix C to current organizational descriptors.
Changed 4.1.3 to reflect the type of CARs reviewed at the Management Rev.
6 D. Ratay 10/09/96
Meeting.
Revised 4.1.2.3 to include new role of Quality Committee.
7 T. Fraser 09/08/97
Revised all references of QAM to SQSR.
Revised 4.1.3 to reflect roles in evaluation of supplier’s, revised how often
locations are audited, explained new Improvement Initiative process, and
updated Corrective Action process. Revised 4.17 to reflect how often sales
8 T. Fraser 09/28/98
locations are audited, took out mention of corrective action. All internal
non-conformances are now documented via Improvement Initiatives.
Revised 4.18 to reflect Improvement Initiative process.
Revised all references of Sr. Quality System Rep to Director of Operations &
Quality Systems. Revised all references to the Purchasing Department to the
Product Marketing Department. Sager has combined both the Marketing &
Purchasing Departments into one department.
9 J. Briggs 02/02/99
Revised 4.1.3 (Discrepant Material or Product)
Revised 4.10.2.1 (Included Quality Committee as a means of generating
supplier corrective action)
Revised 4.10.4 (Final Inspection & Testing to reflect current process)

QM-001 Page 31 of 37 Revision 31: 10/19/2021

 Quality Manual

Rev Revised By Date Nature of Revision

Revised 4.10.5 (Inspection & Test Records to reflect current process)
Revised Introduction: Added Vision Statement and Mission Statement
Revised 4.1 (Lotus Notes databases for Corrective Actions and Improvement
Initiatives)
Revised 4.5 (Document and Data Control)
Revised 4.13 (Control of Non-conforming Product) to reflect current process.
10 S. Mattern 09/29/00 Revised 4.15 (Unique Product Identification)
Revised references from Dir. Of Operations and Quality Systems to Director
of Quality, from Product Marketing to Purchasing, from Product Manager to
Buyer.
Removed references to Quality Committee
Removed references to Work Instructions
Revised 4.1.3 (Management Review) removed reference to quarterly
11 L. Kimball 09/25/01
updates.
11A L. Kimball 01/18/02 Updated Vision Statement and removed Mission Statement.
12 M. Mahoney 10/01/02 Complete rewrite. Changed to reflect the requirements of ISO9001:2000.
Revised 4.1 – Added paragraph to explain reason for design control
12A M. Mahoney 11/11/02
exclusions.
Revised 4.1 – More clearly identified exclusions.
13 M. Mahoney 06/20/03 Revised 8.2.4 – Added text to more clearly indicate what happens to rejected
product.
Revised 4.2.1 – Added reference to process flow diagram in Appendix E
14 M. Mahoney 07/28/04 Revised 7.5.4 – Added sentence to further clarify customer property
exclusion.
Revised – Added references to Appendices F and G.
Revised – Added reference to Business Solutions group.
15 M. Mahoney 01/28/05 Revised – 5.2 Removed references to the Distributing Confidence Sales
model.
Minor verbiage changes.
Added Scope Statement to the Introduction
16 M. Mahoney 08/01/05 Revised – 7.5.1 to clarify that Sager does not engage in any post-sale
activities or servicing
Revised – 5.6.3 removed reference to “Distributing Confidence” Meetings
7.4.2 – removed (duplicate paragraph)
17 T. Condon 12/11/07 Revised – 8.5.1 removed reference to verification audits.
Removed reference to Senior Management and updated to Executive
Council
Revised Quality Manual to reflect the new version of ISO9001:2008 as well as
18 T. Condon 09/15/09
to incorporate AS9100 (the aerospace standard).
19 T. Condon 11/15/11 Revised Quality Manual to reflect the new version AS9120 Rev A standard.
Revised Quality Manual to reflect changes due to TTI acquisition and some
20 T. Condon 06/28/12
“title” changes at Sager.
Updated Quality Manual and included reference of conforming to
21 T. Condon 10/15/15
Counterfeit Standard/AS6496
Major re-write of Quality Manual to reflect the new version AS9120 Rev B
22 J. Favaloro 08/25/17
standard
Updated section 1.3 to provide justification to the design and development
23 J. Favaloro 11/09/17 exclusion taken in section 8.3.
Update organizational chart
Major re-write of Quality Manual to reflect the new version AS9100 Rev D
24 J Favaloro 03/09/18
Standard. Updated Organizational Chart and Interaction of Processes

QM-001 Page 32 of 37 Revision 31: 10/19/2021

 Quality Manual

Rev Revised By Date Nature of Revision

Updated manual to include section 8.3 Design and Development of Products
and Services for PSC. Middleborough will continue to take the exclusion to
25 J. Favaloro 04/18/18
that section. Updated Interaction or Processes (IOP) and Organizational
Chart, for PSC.
26 J. Favaloro 08/14/18 Updated IOP to reflect PSC processes as part of overall process flow map.
Updated Appendix B with Current Org Chart. Updated Appendix G with 3
27 J. Favaloro 09/13/19
new Quality Objectives and changes in existing objectives goals.
Updated Appendix B and Appendix E to include BSC. Updated scope
28 J. Favaloro 03/13/20
statement and facilities within scope to include BSC.
29 J. Favaloro 04/12/21 Updated Appendix G to reflect the new Quality Objective goals
Updated Appendix E IOP, Updated Appendix B Organizational Chart, Added
30 J Favaloro 06/14/21 Appendix H 13485 to 9100 Matrix, Multiple changes to add information
allowing manual to conform to ISO 13485.
Removed Appendix E IOP and Appendix B Organization Chart. Added Scope
31 J Favaloro 10/19/21 Exclusions to 13485. Updated Quality Policy. Multiple wording changes to
correct conformity to ISO 13485.

Appendix B: Organizational Descriptors

The overall responsibility for quality in the organization rests with President of Sager Electronics. He has
defined the Quality Policy for the company and is committed to its implementation.
The responsibility for further detailing of the quality program and for its execution is delegated to the VP
of Operations.
The Quality Representative is responsible for the following:
 Planning the overall Quality Program.
 Ensuring the Quality System is properly implemented and maintained.
 Verifying that AS9100, ISO9001, ISO13485 and AS6496 requirements are being satisfied within
the confines of Sager’s Quality System.
 Overseeing the Internal Audit process.

 Overseeing the Corrective and Preventive Action/Improvement Initiative processes.

 Overseeing the Document Control process.

 Overseeing the Management Review process.

 Ensuring that the documents and data that relate to AS9100, ISO9001, ISO13485 and AS6496
requirements are controlled.
 Ensuring that necessary documents are approved by appropriate personnel.
 Ensuring that current issues of documents are available where necessary.
 Ensuring that obsolete documents are promptly removed from all points of use.

QM-001 Page 33 of 37 Revision 31: 10/19/2021

 Quality Manual

Each department manager is responsible for the following:

 Ensuring that the requirements of the Quality System are implemented, understood, and
maintained within their assigned area.
 Ensuring proper maintenance of quality procedures and supporting metrics.
 Handling of quality issues that are initiated within or involve their assigned area.

 Maintaining open and continual lines of communication with the Operations Support
Coordinator.
 Participating in the Corrective & Preventive Action/Improvement Initiative processes in order to
prevent and correct Quality System problems.
 Overseeing Quality training within their department or location.

Each Internal Auditor is responsible for the following:

 Performing systematic and independent examinations to determine whether quality activities
and related results comply with planned arrangements and whether these arrangements are
implemented effectively and are suitable to achieve objectives.
 Recording the findings of their audits and submitting them to the Director of Quality and
Logistics

Appendix C: Incorporated Documents

Section Procedure
Creating and Updating(7.5.2) Document Control
Control of Documented Information (7.5.3 ) Quality Records
RMA Processing in IC001
Control of Non-Conforming Outputs (8.7, 10.2)
Withdrawal of Suspect Product
Internal Audit (9.2) Internal Audit Process
Nonconformity and Corrective Action (10.2) Corrective Action Process
Actions to Address Risks and Opportunities (6.1, 10.3 ) Risk Assessment
Improvement Initiative

Appendix D: Outsourced Activities

Process Responsible Department Corresponding Procedure(s)

Calibration Distribution Center Calibration
Third-Party Warehousing Distribution Center Third-Party Warehousing
Internal Audit Quality Internal Audit
Equipment Maintenance / PM Distribution Center Maintenance

QM-001 Page 34 of 37 Revision 31: 10/19/2021

 Quality Manual

Appendix E: ISO 13485 Matrix

ISO ISO Quality

13485 9100D Manual ISO 13485 Clause Description
Clause Clause Page
1 / 4.1.1 1 & 4.3 4&5 Scope
4 4 - 4.4 7&8 Context of the organization
4.1 4.4 & 8.4 8 General requirements
4.2 7.5 13 Documentation requirements
4.2.1 7.5.1 13 General
4.2.2 4.3 - 4.4 4 Quality Manual
4.2.3 4.2.3 8 Medical Device File
4.2.4 7.5.2 - .3 13 Control of documents
4.2.5 7.5.2 - .3 13 Control of records
5 5 10 Management responsibility
5.1 5.1 8 Management commitment
5.2 5.1.2 9 Customer focus
5.3 5.2 9 Quality policy
5.4 6 10 Planning
5.4.1 6.2 9 Quality Objectives
5.4.2 6 – 6.2 8 – 10 Quality management system and planning
5.5 5 9 & 10 Responsibility, authority and communication
5.5.1 5.3 10 Responsibility and authority
5.5.2 5.3 10 Management representation
5.5.3 7.4 12 Internal communication
5.6 9.3 28 & 29 Management review
5.6.1 9.3.1 28 General
5.6.2 9.3.2 28 & 29 Review input
5.6.3 9.3.3 29 Review output
6 7.1 10 &11 Resource management
6.1 7.1.1 11 Provision of resources
6.2 7.2 & 7.3 12 Human Resources
6.3 7.1.3 11 Infrastructure
6.4 7.1.4 11 Work environment and contamination control
7 8 13-16 Product realization
7.1 8.1 13-16 Planning of product realization
7.2 8.2 16 Customer related processes
7.2.1 8.2.2 17 Determination of requirements related to product
7.2.2 8.2.3 17 Review of requirements related to product
7.2.3 8.2.1 16 & 17 Communication
7.3 8.3 17-20 Design and development
7.3.1 8.3.1 17 General

QM-001 Page 35 of 37 Revision 31: 10/19/2021

 Quality Manual

ISO ISO Quality

13485 9100D Manual ISO 13485 Clause Description
Clause Clause Page
7.3.2 8.3.2 17 & 18 Design and development planning
7.3.3 8.3.3 18 Design and development inputs
7.3.4 8.3.5 18 & 19 Design and development outputs
7.3.5 8.3.4 18 & 19 Design and development review
7.3.6 8.3.4 18 & 19 Design and development verification
7.3.7 8.3.4 18 & 19 Design and development validation
7.3.8 8.3.4 18 & 19 Design and development transfer
8.3.6 &
7.3.9 20 Control of design and development changes
8.5.6
7.3.10 7.5.3 7 & 13 Design and development files
7.4 8.4 20 Purchasing
8.4 &
7.4.1 20-22 Purchasing process
8.4.1 - .2
7.4.2 8.4.3 21 & 22 Purchasing information
8.4.2 - .3 21–22 &
7.4.3 Verification of purchased product
& 8.6 26
7.5 8.5 22 & 23 Production and service provision
7.5.1 8.5.1 23 Control of production and service provision
7.5.2 8.1.3.1 15 Cleanliness of product
7.5.3 8.1.3.2 15 Installation activities
7.5.4 8.1.3.3 15 Servicing activities
7.5.5 8.1.3.4 15 Particular requirements for sterile medical devices
7.5.6 8.5.1 22 & 23 Validation of processes for production and service provision
Particular requirements for validation of processes for sterilization and
7.5.7 8.1.3.4 15
sterile barrier system
7.5.8 8.5.2 24 Identification
7.5.9 8.5.2 24 Traceability
7.5.10 8.5.3 24 Customer property
7.5.11 8.5.4 24 & 25 Preservation of product
7.6 7.1.5 11 Control of monitoring and measuring equipment
8 9 – 9.1 27 Measurement, analysis and improvement
8.1 9.1.1 27 General
8.2 9.1 27 Monitoring and measurement
8.5.5 &
8.2.1 25 & 27 Feedback
9.1.2
8.2.2 9.1.2 27 Complaint Handling

QM-001 Page 36 of 37 Revision 31: 10/19/2021

 Quality Manual

ISO ISO Quality

13485 9100D Manual ISO 13485 Clause Description
Clause Clause Page
8.2.3 8.5.5 25 Reporting to regulatory authorities
8.2.4 9.2 28 Internal audit
8.2.5 9.1.1 27 Monitoring and measurement of processes
8.2.6 8.6 26 Monitoring and measurement of product
8.3 8.7 26 Control of nonconforming product
8.3.1 10.2 30 General
8.3.2 8.7 25 & 26 Actions in response to nonconforming product detected before delivery
8.3.3 8.7 25 & 26 Actions in response to nonconforming product detected after delivery
8.4 9.1.3 27 & 28 Analysis of Data
8.5 10 29 & 30 Improvement
10.1 &
8.5.1 29 & 30 General
10.3
8.5.2 10.2 30 Corrective Action
6.1 &
8.5.3 10.1 & 30 Preventative Action
10.3

QM-001 Page 37 of 37 Revision 31: 10/19/2021