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NDC Quality Manual

1 Introduction to Nitinol Devices & Components (NDC)

1.1 About NDC
NDC is a developer and manufacturer of Nitinol based components for both
medical and commercial applications. NDC is located in Fremont, California.
1.2 Registrations
ISO 13485: 2003 BSI # FM 78817, NDC, Fremont, Ca
US FDA Registration # 2951217: NDC, Fremont, Ca - Inactive
State of California DHS # Pending (submitted for registration): NDC, Fremont, Ca

1.4 References
ISO 13485: 2003: “Medical Devices – Quality Management Systems –
Requirements for Regulatory Purposes”
ISO 14971:2000, Medical Devices - Application of risk management to medical
devices
Title 21 CFR Part 820, Food and Drug Administration, “Quality System
Regulation”
Title 21 CFR Part 11, Food and Drug Administration, “Electronic Records;
Electronic Signatures”
Ministry of Health, Labor and Welfare (MHLW) Ordinance No. 169, 2004

2 Scope
2.1 Application
NDC designs, develops and manufactures medical device components and raw
materials (for both medical and non-medical uses).
2.2 Exclusions
The exclusions for the business are as follows:
1. The company does not provide installation or servicing for the customers. The
installation and servicing requirements of Sections 7.5.1.2.2 Installation
Activities and 7.5.1.2.3 Servicing Activities are excluded from this quality
system.

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3 Quality System Overview

3.1 NDC Quality Policy
Everyone at NDC is responsible for the quality of his or her work.

NDC will achieve this commitment by:

• Meeting regulatory requirements and integrating quality through innovation,
talent, design and profound process knowledge.
• Focusing talents on monitoring and continuously improving design, quality
systems and processes to better serve our customers, the medical community
and meeting or exceeding worldwide quality and regulatory requirements.

3.2 NDC Quality Objectives

NDC considers the safety, efficacy and quality of our products to be of utmost
importance. These high-level quality objectives are derived from the Quality Policy
and are the foundation from which all quality goals and activities are developed.
The Quality Objectives and goals or changes to them are generated during the
Management Review meetings and recorded on management review meeting notes.
In general, the Quality Objectives include Product Performance, Customer
Communication (Complaints, returns, delivery performance), Supplier
management, Training, Corrective and Preventive Actions, and Environmental,
Health and Safety management and others.
3.3 Organizational Structure
The NDC organizational structure is maintained as a separate document. An
approved copy is maintained by the Quality Systems department.

4 Quality Management System

4.1 General Requirements
The NDC Quality Management System is established to implement the
requirements of ISO 13485:2003, USFDA 21 CFR Part 820, Quality System
Regulation and other standards, and to establish policies and procedures that
support the objectives of the company.
The Management with Executive Responsibility approves initial release and
changes to this document through the Engineering Change Order (ECO) process.
The process needed for the management of the QMS consist of:
• Product Realization, where new product is developed based on customer needs
and transferred to manufacturing,
• Delivery to customers and
• Using customer feedback to make improvements to the Product Realization
process.

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In addition, Internal Audits and Management Review processes are used to evaluate
the effectiveness of quality system and drive improvement by monitoring and
measuring the outcome of these processes.
Management Review also ensures availability of adequate resources and technology
to support the QMS.
This Quality Manual provides policy and other top-level guidance (Level I), and
makes reference to Operating Procedures for detailed procedures on the operation
of the System (Level II). Detailed procedures for manufacturing and supporting
activities are found in Travelers, Work Instructions, Inspection Plans and other
Level III documents.
The authority to perform the tasks identified in this document and other Quality
System documents may not be delegated unless specifically stated otherwise. Such
delegation is to be in writing, and the overall responsibility for proper performance
of the task remains with the individual referred to in the documentation.
The scope of the quality system covers production of standard product and all
supporting activities. Design and development activities are also covered.
The responsibility for the NDC quality system has been assigned to Management
with Executive Responsibility (MWER). The Vice President of Quality Assurance
has been designated by the President of NDC to be the Management Representative
with full responsibility and authority for establishing and maintaining the quality
system in accordance with Quality System requirements.

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The process depicted below provides an overview of the NDC Quality System model. The
closed loop process ensures that NDC has not only established, but also improves processes and
practices on a continuous basis.

CNCC Quality System

5.0 Management Responsibility

OP-9001(series)
OP-9003 (series)
Other procedures TBD

Customer Needs 8.0 Measurement, Analysis

6.0 Resource Management and Improvement
4.0 Quality Customer
Regulatory Organization Chart OP-9010 (series)
Management System
Requirements OP-9009-3,7,8 OP-9013 (series) Satisfaction
Quality Manual
OP-9018 OP-9014 (series)
(ISO, FDA, Safety, OP-9021(series)
OP-9005 (series)
OP-9017
Environmental) OP-9016 NDC
Other procedures TBD OP-9020
Other procedures TBD
Quality Policy

7.0 Product Realization

OP-9003 (series)
OP-9004 (series)
OP-9006 (series)
OP-9008 (series)
OP-9009 (series) Product
OP-9010
OP-9011
OP-9012
OP-9014-2
OP-9015

4.2 Documentation Requirements

4.2.1 General
The NDC quality policy is stated in this Quality Manual. Top
management identifies quality Objectives that meet the requirements of
the quality policy annually. The quality objectives are documented in the
Management Review meeting minutes.
The NDC Quality Manual is the top-level document that describes the
overall quality system in accordance with the stated quality policy, ISO
13485: 2003 and 21 CFR Part 820.
The NDC Operating Procedures (OP) and Quality Plans are the next level
of documentation. Quality Plans provide a summary of all quality
activities in support of a product or product line. OPs establish company-
wide procedures and requirements. They are generally non-technical and
may use a variety of formats, such as flow charts. The OP’s are numbered
in accordance with the twenty elements of ISO 9001:1994. Each section
of this quality manual references the applicable OPs.
The third level of documentation include (but not limited to):

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Travelers establish the process flow and processing instructions for items
produced in the facility. Verification activities are included or
incorporated as steps in the process flow defined by the traveler. Detailed
instructions are normally incorporated in Work Instructions, which are
referenced on the Traveler.
Work Instructions (WI) provide detailed instructions that are too lengthy
to be included on a traveler or other document. Work Instructions may
also be created for detailed or step-by-step instructions for a process
whose policies are described in an OP.
Inspection Plans identify specific inspections or tests to be performed,
sampling plans, and the data or other records to be generated. Detailed
inspection methods are documented in Work Instructions.
Inspection Data Sheets may be developed to record specific measurements
or other quality data.
Product drawings define company products, including dimensional,
material, and functional characteristics.
Tooling drawings define key tools, dies, and other production or
test/inspection equipment.
Product Specifications may be created for products that are not suited for
drawings.
Purchase Specifications define purchased items or material not appropriate
for drawings.
Workmanship Standards provide examples of qualitative references.
Forms are used to define some activities and collect records.
Lab Notebooks record design and development activities.
Protocols and associated Reports define test and validation plans and their
results.
Approved Supplier List shows the suppliers that may be used to purchase
inventory items and certain key manufacturing materials.
The last level of documentation are quality records. These documents
serve as evidence of the performance of all activities that impact product
quality.
Device Master Records (DMRs) containing product specifications,
procedures for manufacture and inspections consist of the Level III
documents and Level IV records (drawings, work instructions,
specifications, travelers, etc.).
Device History Records (DHR) also known as lot history folders at NDC,
consist of process/manufacturing/inspection records for each lot.
Design History File (DHF) contains design and development history for
product, such as product requirements, design and development plan,

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FMEA/risk analysis, quality plan, design change records, validation

documents etc.
4.2.2 Quality Manual
The NDC Quality Manual (this document) defines the policies,
application, scope, exclusions and documentation of the quality
management system.
4.2.3 Control of Documents
Documents that define products, processes, and the quality system are
approved before controlled release and distribution. Documents are
available for use in the locations required as well as online. Obsolete
documents are removed when superseded. External documents such as
industry or agency standards and customer drawings are controlled.
Quality Assurance Document Control provides document control services;
however, all employees are responsible for using correct documents, at the
prescribed revision level, at all times.
Obsolete documents are retained for a period specified in the OP-9016,
Quality Records.
External documents are controlled and issued to ensure use of correct
documents and current revisions. Such documents include external
customer documents (such as drawings and specifications) and other
external documents, such as industry standards.
4.2.3.1 Approval and issue
Documents under ECO control are approved by the individuals
assigned per OP-9005, Document Control, using the Engineering
Change Order (ECO) system. The Development Change Order
(DCO) is used to approve changes in development items.
Controlled copies are issued to the individuals or work areas that
require them for day-to-day use. Uncontrolled reference copies
may also be provided. Control status is indicated by the use of
stamps with red ink on hard copies. Indexes are maintained.
Documents are also maintained on-line as read only in the
document control system.
4.2.3.2 Initial release and changes
With the exception of Engineering Memos and Technical
Reports, initial releases and changes are processed using the
Engineering Change Order (ECO) or the Development Change
Order (DCO). The changes are reviewed and approved per OP-
9005 series, Document Control procedures. Changes to
associated documents are initiated as part of the ECO/DCO
approval cycle. A history of changes is maintained for approved
ECO/DCO documentation.

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4.2.4 Control of Records

Quality records are created and maintained to provide documented
evidence of the conformance of products and systems to specifications and
process requirements. The records are identified, indexed, and stored to
prevent deterioration and provide access in a reasonable period of time.
Secrecy, Confidentiality, and Nondisclosure Agreements may govern
customer access to records.
4.2.4.1 Identification of Quality Records
All documents that establish the history of the product and
supporting systems are considered quality records. Exclusions
include production or inspection tally sheets that are summarized
on other records.
4.2.4.2 Filing and Storage
For product, quality records are filed with the Lot History File.
System records are filed by type.
4.2.4.3 Retention
Records on all media will be maintained that (1) are required by
law; (2) necessary to support the orderly operation of the
Company; or (3) provide the basis for recovery from a disaster.
All other records will be destroyed. Retention guidelines are
stated in OP-9016, Quality Records.
4.2.5 Other Organizations Covered by the Quality Management System
In some cases, NDC provides quality system support for external
companies. In these cases, the quality system requirements are applied to
other companies with variations as authorized by those companies. The
variations from the NDC quality system are to be documented in the
using-company’s Quality Manual.

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4.2.5 References for this section

OP-9005, Document Control
OP-9005-1, Documentation Practice
OP-9005-4, Temporary Process Modification
OP-9005-5, Customer Document Control
OP-9005-7, Software Control – Manufacturing & Test /Inspection
OP-9005-10, Document Changes Approval and Distribution
OP-9005-11, Device Master Record and Quality System Record Process
OP-9016, Quality Records

5 Management Responsibility
5.1 Management Commitment
The progress of the business and the effectiveness of the quality system are
reviewed on a regular basis by Management with Executive Responsibility.
Management with executive responsibility (executive management) is responsible
for establishing, implementing, and continuously improving the quality system.
Personnel and other necessary resources are provided to accomplish the goals of the
quality system.
There are several processes by which executive management communicates to the
rest of the company regarding customer, regulatory and statutory requirements and
the importance of meeting these requirements.
Informational meetings, plant meetings are conducted periodically.
Training is conducted on a regular basis according to the requirements specified in
the training procedure, this includes training to regulations, safety etc. New
employees go through a series of training, so they have a thorough understanding of
the company, product, customer and regulatory requirements.
Management Reviews, internal and external audits are conducted periodically to
ensure that the Quality System is effective.
Management Review is the mechanism by which opportunities to improve are
identified and resources are allocated to achieve those improvements. Quality
objectives are defined at these reviews. Personnel and other necessary resources are
provided to accomplish the goals of the quality system.
5.2 Customer Focus
In addition to communicating the importance of meeting customer requirements,
top management ensures that customer requirements are determined, understood
and met. Processes have been established to ensure device customer safety and
efficacy.

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Within the scope of the quality management system, contracts and agreements are
defined and reviewed between NDC and its customers for work to be performed or
product to be delivered. Requests for Quotations (RFQ) and Purchase Orders (PO)
are reviewed to assure that requirements are defined and understood, and that NDC
can meet the requirements.
The individual receiving the RFQ or PO (the Recipient) sponsors a Contract
Review. Representatives of Sales/Customer Service, Operations (production), QA,
and the Manufacturing Engineering participate in the Review, as necessary. Others
may be included as needed.
The review assures that the customer's requirements are defined, documented, and
understood and that they can be met. Reviews include as a minimum: specification
requirements, documentation, manufacturability, price and delivery. Differences
and/or specification conflicts are resolved before approving the Contract Review
and accepting an order.
Initial reviews are approved by Managers, Directors, or higher levels in the
organization. Repeat orders with previously reviewed requirements may be
reviewed and approved by the Recipient. Results of the Contract Review are
documented and maintained as records and are filed by Sales/Customer Service in
the Customer Order File.
5.3 NDC Quality Policy
The NDC Quality Policy is defined in Section 3.1 of this Quality Manual. The
quality policy is communicated and understood within NDC and is reviewed
periodically by top management.
The quality objectives derived from the quality policy are reviewed annually and
updated as needed by top management to maintain effectiveness of and compliance
to the quality management system. (Section 3.2 of this Quality Manual)
5.4 Planning
5.4.1 Quality Objectives
The company management team is responsible for setting quality
objectives and goals for the company. Functional Managers establish
goals and objectives that are aligned with company goals for their
departments.

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5.4.2 Quality Management System Planning

The planning for Quality Management System is carried out by executive
management during management review meetings. Quality objectives are
set and reviewed during these meetings. When a change is made to the
quality system as a result of an internal audit or management decision, it is
reviewed for effectiveness and appropriate justification and approvals are
required to implement the change.
5.5 Responsibility, authority and communication
The Company is organized as shown on the NDC organization chart. Approved
organization charts are maintained by the Quality Systems department. Some
individuals perform multiple roles; however, the roles and responsibilities relating
to quality are clearly defined in later sections of this Manual, job descriptions, or in
other procedures. Independence and authority necessary to manage, perform, and
assess tasks affecting quality is maintained by top management.
Job descriptions are assigned by department managers, and are available in the
manager’s offices. Local supplementation by individual supervisors is permitted as
required.
5.5.1 Responsibility and Authority
5.5.1.1 Executive Management
Establish and support the quality policy by providing the
necessary resources.
Establish quality goals and objectives for the company.
5.5.1.2 Engineers
5.5.1.2.1 Process Engineers
Establish and document production processes that
consistently meet product requirements.
Install and qualify/validate production processes.
Train, verify, and certify skills of operators on
assigned processes.
Review and approve process and supporting
documents for initial release and changes.
5.5.1.2.2 Product (Design) Engineers
Coordinate functional and other technical
requirements with customers or design sponsor.
Design and initiate specification documentation for
NDC-designed products.
Review and approve product and supporting
documents for initial release and changes.

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Coordinate Design Control activities on assigned

products.
Initiate travelers and other required documents for
prototype or developmental products.
5.5.1.2.3 Manufacturing Engineers
Support ongoing manufacturing, through capability
and quality improvement activities.
Initiate, review, and approve manufacturing and
supporting documents.
Maintain validation status of processes in assigned
areas.
5.5.1.3 Operations Vice-President
Management of planning, throughput, production resources,
process improvement activities for manufactured products and
other requirements as necessary.
5.5.1.4 Operations Manager
Maintain positive identification and traceability of product in the
areas managed.
Manage production resources.
Monitor and control production processes.
Implement production documentation.
Assign trained/certified personnel to standard production
processes.
Initiate production travelers for standard products.
Facilities Management for NDC building
Report utilities usage and cost to executive management
Manage Safety and Environmental compliance matters
5.5.1.5 Vice President, Quality Assurance and Regulatory Affairs
Management Representative for NDC reports directly to the
President of NDC.
Coordinate and manage company quality assurance and
regulatory issues.
Establish and maintain the quality management system.
Develop Quality Plans for principle products and product lines.
Develop Inspection Plans and supporting documents that specify
inspection and test requirements and sampling levels.

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Maintain positive control of nonconforming material and

product.
Coordinate and carry out supplier quality assessments.
Maintain the calibration system.
Maintain the document control system.
Initiate and monitor corrective/preventive actions.
Review and analyze returned material.
Assess and improve measurement capability.
Coordinate internal audits and associated corrective actions.
Prepare certifications and other required quality documentation
in support of shipping.
Qualify and approve personnel performing verification activities.
5.5.2 Management Representative
The Vice President, Quality Assurance and Regulatory Affairs, is the
company's Management Representative. The Management Representative
is responsible for:
• Acting as executive management’s agent in establishing,
implementing, maintaining, the effectiveness of and improving the
quality system;
• Reporting the performance of the quality system and any need for
improvement to executive management; and
• Promote awareness of regulatory and customer requirements
throughout NDC; and
• Serving as the company's liaison with customers and other outside
concerns on matters related to product quality and reliability.
5.5.3 Internal Communication
Management Indicators are established by Management with Executive
Responsibility to provide visibility of key operations and performance.
Indicators are added, deleted, and modified to suit current conditions and
areas of emphasis. The indicators are generated periodically, distributed
electronically and hard copies are also posted.
On a periodic basis, Management with Executive Responsibility will
disseminate information regarding the state of the business.
5.6 Management Review
5.6.1 General
Executive management, and others as required, formally reviews the
quality system for compliance and effectiveness at least quarterly. The

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Vice-president of Quality Assurance and Regulatory Affairs (or delegate)

is responsible for calling and facilitating the review.
Management Review Meeting Minutes are prepared and circulated by the
VP QA/RA (or delegate) as required to provide pertinent information
regarding quality of product and services or the effectiveness of the
quality management system.
Management Indicators are established by Management with Executive
Responsibility to provide visibility of key operations and performance.
Indicators are added, deleted, and modified to suit current conditions and
areas of emphasis.
5.6.2 Management Review Input
On a periodic basis, the VP QA/RA, or designee will call a Management
Review Meeting for the group of people identified as Management with
Executive Responsibility. Others may be invited to participate as
required.
The agenda includes the topics such as Management Indicators, customer
service and feedback, audit results, corrective and preventive action.
Other topics may be added as deemed appropriate.
5.6.3 Management Review Output
The VP QA/RA or designee takes minutes of the meeting including a
record of those attending, action items assigned, progress on ongoing
actions, recommended improvements to product related to customer
requirements, quality system and processes, resource needs and other
pertinent summary information. A management review report is generated
for each meeting and approved by Management with Executive
Responsibility. Unless otherwise indicated, the report should include a
statement to the effect that the Quality System is suitable and effective
based on information reviewed and actions taken or assigned.
5.7 References for this section
OP-9001, Management Review
OP-9001-1, Regulatory Agency Inspection
OP-9001-3, Environmental, Safety and Health Management
OP-9003, Contract Review

6 Resource Management
6.1 Provision of resources
6.1.1 General
Top Management determines and provides the resources necessary for the
implementation, maintenance, and continual improvement of the entire
quality system. Top Management assigns appropriate resources to
enhance customer satisfaction through meeting customer requirements.

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6.1.2 Resource Determination

Top Management determines appropriate resource needs during periodic
business reviews and during Management Review. Resource needs are
established through consideration of customer satisfaction and quality
management improvements. Top Management considers all resources
necessary to accomplish these needs, including personnel, facilities,
equipment and finances.
6.2 Human Resources
6.2.1 General
6.2.1.1 Qualification Documentation
Written job descriptions are in place for all activities affecting
product quality to document the qualifications and duties of the
positions determined to be necessary by Top Management.
6.2.1.2 Assignment of Resources
Resources are assigned based on experience, education, skills
and training to appropriate tasks to meet established business and
quality objectives.
6.2.2 Competence, Awareness and Training
6.2.2.1 Competence
Competency requirements are determined for each position
through establishment of appropriate performance goals for the
written job description. Performance monitoring and
performance management are integrated into operations to ensure
that assigned personnel are fulfilling requirements satisfactorily.
In the case where personnel are not performing satisfactorily,
performance management tools and appropriate training are used
to correct unsatisfactory performance.
6.2.2.2 Awareness
The required training for each position includes training on the
impact of their position on quality objectives and the quality
management system.
6.2.2.3 Training
Training needs are documented for each position via supervisor
input and specific minimum requirements detailed in the training
operating procedure. Completion of training requirements is
verified prior to assignment to work. Training activities include
a verification of training effectiveness and appropriate refresher
training.
The training procedure (OP-9018) ensures that personnel
understand both the job function and the GMP requirements,
including how the job relates to the overall quality system. In

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addition, personnel are trained to ensure that the consequences of

improper performance are understood so that employees are
aware of defects that they should look for and of the effect their
actions can have on the safety and effectiveness of the device.
Training Records for both internal and external training are
maintained. The Human Resources department maintains
records of education, skills and experience in personnel files.
6.3 Infrastructure
Top Management establishes the facilities, workspace, hardware, equipment,
software and supporting services necessary to achieve conformity of product.
These requirements are monitored through various metrics to ensure adequacy and
modified when appropriate to ensure conformity of product.
6.4 Work Environment
Top Management is responsible for establishing appropriate work methods, safety
rules, protective equipment and ergonomics to ensure conforming product. The
adequacy of these controls is periodically assessed and corrective actions taken as
needed.
6.5 References for this Section
OP 9001, Management Review
OP 9004-10, Quality Plan
OP-9009, Process Control
OP-9009-1, Preventive Maintenance
OP-9009-2, Manufacturing Process Validation
OP 9009-3, Workstation Practices
OP-9009-4, Manufacturing Tooling Qualification
OP-9009-5, Laser Processing Area Operations
OP-9009-7, Hazardous Energy Control (Lockout/Tagout)
OP-9009-8, Contractor Safety Program
OP-9009-9, Process Improvement Control
OP-9009-12, Software Validation
OP-9011, Calibration - Inspection, Measuring and Test Equipment
OP-9014, Corrective Actions
OP-9018, Training

7 Product Realization
7.1 Planning of product realization
Quality planning occurs throughout the product life cycle. Typical planning
activities and the responsible people are defined in detailed Operating Procedures
and Quality Plans and include:

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• Review and documentation of customer requirements, including Design

Inputs for new products.
• Identification and acquisition of necessary resources (equipment, personnel
and associated skills, processes, controls, monitoring devices, inspection and
test equipment, etc.).
• Identification of advanced measurement requirements that must be developed
or acquired.
• Risk management throughout the product realization cycle.
• Identification of verification activities at appropriate steps in the process.
• Identification of Design Verification and Validation activities
• Establishment of workmanship standards.
• Identification of required records (including records of risk management
activities).
• Identification of certification and test report requirements.
Inspection and testing is planned and conducted when purchased materials and
components are received, at key stages of processing, and before release of product.
Inspections are conducted according to approved plans. Qualified individuals from
any organization may perform inspections and record results. Inspections may
utilize data prepared by others to make decisions when specified in the Inspection
Plan. Employees of QA/QC, or those specifically delegated, must close out all
Inspection Plans. Records are made of inspections specified in the Inspection Plan.
7.2 Customer related processes
7.2.1 Determination of requirements related to the product
Within the scope of the quality management system, contracts are defined
as any agreement between NDC and a customer that defines work to be
performed or product to be delivered. Requests for Quotations (RFQ) and
Purchase Orders (PO) are reviewed to assure that requirements are defined
and understood, and that NDC can meet the requirements.
For new product development design requirements or inputs are collected
from many sources, including customers, suppliers, professionals in the
field of use, similar products, and others. The inputs are documented,
subject to initial approval, and modifications are approved at later reviews
as required.
7.2.2 Review of requirements related to the product
Contract review assures that the customer's requirements are defined,
documented, and understood and that they can be met. Reviews include as
a minimum: specification requirements, documentation, manufacturability,
price and delivery. Differences and/or specification conflicts are resolved
before approving the Contract Review and accepting an order.

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A Specification Review is conducted when a technical review of customer

specifications is required.
Records of Contract Review and Spec reviews are maintained.
7.2.3 Customer communication
If customer requirements or specifications cannot be met, the information
is communicated to the customer. Amendments to the contract may be
made with the approval of the customer. Where no change agreements are
in place, proper notification and authorization is required prior to
implementation of improvements.
Where a component is included in a finished medical device sold by
medical device companies, the company will respond to requests and
inquiries in support of the complaint investigation led by the seller. Such
requests are entered into the complaint system for tracking and into the
Corrective and Preventive Action system if action is required.
The complaint handling procedure is also used to manage the resolution of
complaints received on company products that are not finished medical
devices.
7.3 Design and Development
As a developer and manufacturer of components for both medical and commercial
applications (with the exception of NDC finished devices), NDC does not complete
full design and development cycles for new products. The designs typically
originate at other sites and the overall design control responsibility lies with them.
However, within the scope of our involvement with the overall development
project, NDC will adhere to design control procedures. Where NDC yields to
another site’s design control procedures, a copy of the Design History File (DHF)
index or table of contents will be maintained at NDC.
In the case of NDC finished devices (NDC sponsored design), Design Control
procedures including Design Verification and Validation procedures are followed.
The company Design Control/New Product Development procedures are intended
to balance the freedom to innovate and the discipline required to consistently meet
customer and regulatory requirements. Design activities before the formal
documentation of Design Inputs are at the discretion of the engineer, and records
are kept in laboratory notebooks. After the formal establishment of the Design
Inputs, design activities are planned, controlled, and regularly reviewed/approved.
The Design History File is maintained by the design team leader during the
development process and then turned in to Document Control for archiving after the
project is complete.
The procedures apply to design activities for which NDC is solely or partly
responsible. For those design activities in which NDC is supporting other
companies, the procedures of the sponsoring company may be used.

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7.3.1 Design and development planning

The new product development team leader is responsible for documenting
and updating the overall plan, which identifies activities, schedules, and
responsibilities. The new product development team leader coordinates
organizational and technical interfaces, including information transfers
and reviews.
7.3.2 Design and development inputs
Design inputs are collected from many sources, including customers,
suppliers, professionals in the field of use, similar products, and others.
The inputs are documented, subject to initial approval, and modifications
are approved at later reviews as required.
Product requirements are defined, documented and approved. The
requirements are generally maintained in the Design History File (DHF)
during the development phase.
7.3.3 Design and development outputs
Design outputs are documented and are compared to design inputs to
assure that input requirements are met. Design outputs include, but are not
limited to, design and material specifications, testing and technical reports,
drawings, work instructions and quality assurance procedures. Design
outputs are reviewed and approved during design reviews that occur at
various stages of the design effort, but particularly before sales release.
Design output documentation is contained in the Device Master Record
(DMR).
7.3.4 Design and development review
Design Reviews are held at key milestones. Individuals and management
with responsibility for design activities participate and approve the results
and plans. Minutes of the reviews are published, and identify all
outstanding action items and who is responsible for resolving them. Initial
and final reviews are required, but others may be scheduled as necessary,
depending upon the scope of the project.
An initial review is done that formally establishes the basic concept
feasibility, Design Inputs, and assigns resources.
An intermediate review may be done during product design and process
development. The review confirms that design output meet design input
requirements. For medical applications, a review is done prior to
beginning human-use trials (first-in-man or clinical use). The review
specifically focuses on confirmation of product safety.
A final review is done before product launch (sales release). The review
confirms that Design Outputs meet Design Input requirements.
For NDC sponsored designs involving NDC controlled clinical studies, a
Clinical Release Design Review is also required to assure the safety of the
pre-production material for human use.

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7.3.5 Design and development verification

Design verification is the confirmation that the design output is
appropriate to produce a product that meets product specification
requirements. Records of verifications performed are approved and
maintained indicating the acceptability of inspection and test results.
7.3.6 Design and development validation
Design validation means establishing by objective evidence that device
specifications conform with user needs and intended use. Records of
design validations are approve and maintained indicating the acceptability
of the studies.
7.3.7 Control of design and development changes
Changes are evaluated as to the impact on the design’s safety and efficacy
as well as on regulatory strategy / issues. The appropriate verification /
validation, review, and approval of the change is required before the
implementation of the change. Design changes are documented and
maintained in the Design History File.
7.3.8 Design and development transfer
Design transfer is the process of assuring that the design is correctly
translated into production specifications. All specifications released to
production are approved and under formal change control. Operators are
trained. The Device Master Record (DMR) is complete. Processes are
validated via equipment qualification (installation and operational
qualification), process qualification and product performance
qualification.
7.3.9 Design History File (DHF)
A DHF is maintained for all designs, with all records necessary to
demonstrate that the design was developed according to the design plan, to
established procedures and to applicable regulatory requirements. Where
NDC does not have primary design responsibility, NDC will maintain a
copy of the project Design History File index (table of contents) as well as
copies of all design-related items generated by NDC.
7.4 Purchasing
NDC purchases supplies and subcontracted products/services from those that can
satisfy quality, technical, and delivery requirements. Within the Scope, suppliers
and subcontractors are evaluated to determine their capability, and approved
suppliers are used to purchase items and services. Purchasing documents clearly
describe the product or service to be purchased, including quality requirements.
Purchasing documents are reviewed and approved prior to release.
7.4.1 Purchasing process
The provisions of this section apply to materials, products, and services
incorporated into NDC products, typically referred to as inventory items.
It also applies to value-added services, key manufacturing supplies, and

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services required by the quality management system. Common operating

supplies and consumables use the same purchasing execution systems;
however, controls are modified.
Suppliers are evaluated and approved based on their demonstrated or
potential ability to meet quality, delivery, and price requirements.
Evaluation and approval methods are defined.
Results of the evaluation aid in determining the approach to assuring the
quality of a supplier's product; i.e., the level and intensity of inspection to
be performed on receipt.
Approved Suppliers are documented in the purchasing system and the
approved supplier list is managed in that system.
7.4.2 Purchasing information
Requirements for purchased products are defined in the Purchase Order
(PO) and referenced documents. Referenced documents must include the
Revision Level, if applicable. The reviewer/approver of the PO is
responsible for reviewing the adequacy of the data, such as:
- description of item/material/service purchased
- quality or performance requirements
- certification and other documentation requirements
- indication of Company requirements, such as calibration, inspection, etc.
- use of approved suppliers
The reviewer/approver signs the Purchase Order indicating the
accomplishment of the above review.
Reviewer/approver status is established.
Suppliers are requested to enter into an agreement to notify the company
of any process or material changes that may affect the quality of the
company’s product.
7.4.3 Verification of purchased product
Within the scope, purchased product is inspected upon receipt to the extent
necessary to verify conformance to requirements. Records of the
inspection are kept.
Inspection and testing is planned and conducted when purchased materials
and components are received. Inspections are conducted according to
approved plans. Qualified individuals from any organization may perform
inspections and record results. Inspections may utilize data prepared by
others to make decisions when specified in the Inspection Plan. Qualified
inspectors or those specifically delegated must close out all Inspection
Plans. Records are made of inspections specified in the Inspection Plan.

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For serious or repeated quality problems with a supplier, a Supplier

Corrective Action Request (SCAR) is prepared and sent to the supplier for
corrective action and response. Follow-ups are performed as required.
Verification at Subcontractor’s Premises – When necessary or desirable to
verify product at a subcontractor’s facility, that requirement is cited in the
Purchase Order.
Customer Verification of Subcontracted Product – Verification of
subcontracted product by customers may be arranged on a case-by-case
basis, and should be specified in the Purchase Order or contract.
7.5 Production and Service Provision
7.5.1 Control of production and service provision
Production operations that affect quality are planned and carried out under
controlled conditions. Adequate processes and documented procedures
are used. Work instructions are prepared to provide for uniform
accomplishment of processes where the traveler cannot provide sufficient
detail. Processing equipment is checked and maintained to provide
consistent performance. Production areas are appropriately clean and
suitable for the operation performed and the material processed.
Key processing equipment is evaluated prior to use / installation and/or
during its lifetime to determine or change maintenance schedules. The
engineer is responsible for identifying equipment to be included in the
schedule, the frequency of maintenance or verification, and the acceptable
operating tolerances. The Operations (Production) Manager is responsible
for execution of the schedule and any required actions, and the collection
of records. Records indicate the action performed, the date performed,
who performed it, and any actions taken. The schedule is maintained by
the Operations (Production) Manager. When equipment which has missed
a maintenance due date is used for production, a nonconformance is
generated. The NCR includes an investigation of the reason(s) that the
equipment has not been maintained and a disposition for use of the
equipment and any material that was produced on the equipment after the
due date.
The operations group is responsible for producing and maintaining
demand schedules for the manufacturing areas. This is accomplished
through the coordination of sales activities with material availability and
manufacturing capabilities. A backlog of deliverable orders is generated
and reviewed. As a result of these reviews, manufacturing and inspection
activities are coordinated and performed.
The traveler is a controlled document that defines the source material(s),
the sequence of operations, processing instructions, and verification steps.
When processing instructions are lengthy (usually when they exceed three
lines on a traveler), or an inspection/test procedure is complicated, a Work
Instruction is prepared and available at the work site. The traveler or
Inspection Plan references the Work Instruction at the appropriate step.

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Workmanship standards are created as retained samples, photographs, or

written descriptions. The preferred sample is the "worst acceptable"
condition. Establishment of and changes to standards are performed as
needed. The approval is on a tag or other document physically attached to
the sample.
Inspection Plans are used to perform receiving, in-process and final
inspections. Based on the result of the inspections, product is
dispositioned.
The mode of delivery is as specified by the customer. Requirements are
entered with the order and appear on the Packing Slip.
Servicing does not apply to NDC’s products, as mentioned in the
exclusion section.
7.5.2 Validation of processes for production and service provision
Where characteristics cannot be checked after processing, processes are
validated (qualified) and/or monitored to assure adequate results are
obtained. Software that is used to make decisions in the manufacture or
evaluation of product that directly affects product quality is validated.
Software that is used to control manufacturing processes or perform
calculations is verified to ensure it performs as intended.
When changes are made to a process, revalidation may be required.
Revalidation procedures are documented in OP-9009-9, Process
Improvement Control.
Validated equipment shall be identified after validation is complete. Such
equipment shall be operated by trained personnel only.
7.5.3 Identification and traceability
Products are identified by description and the lot number. Traceability
from the lot number to precursor lot numbers and the source material is
maintained.
The part and/or product description is assigned, and typically provides a
description of the item and/or a link to the technical documentation. All
product is identified to that description and a unique lot number through
the use of tags or labels. Batches may be assigned within a lot. Devices
and components are serialized when necessary or appropriate.
Assigned descriptions are recorded in the company system (Parts module).
Lot numbers are assigned by the Inventory module in the company system
for received and manufactured items. Production lots are made from the
same source material and the same setup. Batch numbers may be
established within a production lot as required to expedite or facilitate
processing. The Lot History File (Device History Record for finished
devices) contains all pertinent records of lot, batch, and serial number
assignment.

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The status of product is clearly identified to assure that only product of

known conforming quality is used, installed, or shipped. The status of
product is identified by use of labels or tags, the completion status of
travelers and quality plans, or its presence in a labeled location.
7.5.4 Customer property
Customer-supplied product is treated in the same manner as other received
material or components. Verification is performed and traceability is
maintained as required. Customer supplied product is clearly identified
and segregated from similar, non-customer supplied material.
Customer supplied material is labeled and entered into the inventory
system in a RESTRICTED status, indicating the ownership. Product
provided for conversion (value-added processing) is maintained with the
customer’s identification until the conversion is complete.
Traceability is maintained to the material or product received from
customers.
If there are discrepancies noted at any time, the customer is notified for
disposition instructions.
7.5.5 Preservation of product
The company operates in a clean industrial environment. Materials and
products are managed to prevent damage and significant contamination
during all stages of post-manufacturing.
Where special handling is required to prevent damage, precautions are
taken on a case by case basis. Requirements are specified on
specifications, travelers, packing slips, or other documents as appropriate.
Material and parts are stored in locations tracked by the company system.
All material in storage is clearly identified as to description and inspection
status.
Standard packaging procedures are described in Work Instructions or
Travelers. Unique, customer-specific requirements are entered with the
order and appear on the Packing Slip at time of shipment.
Generally, preservation, is not applicable or an issue due to the nature of
the material.
7.6 Control of monitoring and measuring devices
All inspection, measuring, and test equipment that affects product quality is
controlled, calibrated, and maintained. Personally owned equipment within that
scope is included. Calibration is traceable to the NIST or appropriate physical
standard. All equipment is labeled as to its status in the calibration system.
Equipment is selected to support the accuracy required by the product drawing or
specification. Test equipment software is controlled.
Inspection, measuring, and test equipment is selected to provide the appropriate
level of accuracy and precision required.

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A master list is maintained in the company database of all equipment in the

calibration system. Items excluded from the calibration system are recorded and a
rationale for that exclusion is recorded. Items are labeled with the corresponding
calibration status.
Items that require maintenance are listed on the Preventive Maintenance Database,
which shows the identification, location, tasks to be performed, and the
maintenance cycle. The database reflects the accomplishment of the maintenance;
detailed records may be kept at the location of the maintained item.
Calibration services may be performed internally by controlled procedure or
through outside services in compliance to Purchase Specifications.
7.7 References for this section
OP-9003, Contract Review
OP-9003-1, Order Entry
OP-9003-2, Specification Review
OP-9004, Design Control
OP-9004-1, Process FMEA
OP-9004-7, Laboratory Notebook
OP-9004-9, Manufacturing Readiness Review
OP-9004-10, Manufacturing Quality Plan
OP-9004-11, Design Verification & Design Validation Requirements for NDC-
Designated Medical Devices and Components
OP-9004-13, Product Risk Analysis
OP-9004-14, Design Inputs and Design Outputs
OP-9005-5, Customer Document Control
OP-9006, Purchasing
OP-9006-1, Supplier Management
OP-9008, Product Identification & Traceability
OP-9009, Process Control
OP-9009-1, Preventive Maintenance
OP-9009-2, Manufacturing Process Validation
OP-9009-4, Manufacturing Tooling Qualification
OP-9009-9, Process Improvement Control
OP-9010, Inspection and Testing
OP-9010-1, Receiving Inspection
OP-9011, Calibration - Inspection, Measuring and Test Equipment
OP-9012, Inspection and Test Status
OP-9014-2, Complaints
OP-9015, Handling, Storage, Packaging, Preservation, and Delivery
OP-9015-1, Material Management
OP-9015-3, Receiving

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8 Measurement, Analysis and Improvement

8.1 General
To ensure product conformity to specification, inspection and testing is planned and
conducted when purchased materials and components are received, at key stages of
processing, and before release of product. Inspections are conducted according to
approved inspection plans. Records are made of inspections specified in the
Inspection Plan.
Customer satisfaction is monitored and measured using several sources. The
information from these sources are reviewed at the management review meetings.
Internal Audits are conducted to ensure conformity and effectiveness of the quality
management system. The results of such audits are reviewed at the management
review meetings.
Statistical techniques are used to define process parameters, optimize product
performance, and to identify root causes of problems. Statistical Process Control
(SPC) and Design of Experiment (DOE) techniques are applied where appropriate
for measurement, analysis and improvement.
Statistically valid sampling plans are selected to assure the adequate control of
quality. Statistically valid methods are used to determine sample sizes in the
evaluation of processes and product characteristics.
8.2 Monitoring and measurement
8.2.1 Customer Satisfaction
Customer satisfaction is monitored and measured primarily through
customer complaints, returned goods and delivery information. The
information from these sources is reviewed at the management review
meetings. Other indicators or sources for customer satisfaction used at
NDC include sales volume tracking, customer audits, customer provided
supplier ratings, etc.
8.2.1.1 Customer Complaint Handling
Procedures are established to manage the resolution of
complaints received on all NDC products. Where a product is
included in a finished medical device sold by medical device
manufacturing companies, the company will respond to requests
and inquiries in support of the complaint investigation led by the
seller. Such requests are entered into the complaint system for
tracking, and into the Corrective and Preventive Action system if
action is required. A complaint may also be issued when a
corrective action request is initiated by a customer.
US FDA Medical Device Reporting requirements are
coordinated by the medical device manufacturer. EU Vigilance
Reporting is coordinated by the medical device manufacturer.

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Customer complaints are examined for systemic issues during

Management Review and when appropriate, Management issues
Corrective Actions to address identified issues.
8.2.1.2 Returned Goods
Customer satisfaction is also tracked through the number of
returns from the customer. Returns to the company are
authorized by a Return Authorization (RA) number. The percent
returns and the dollar amount of returns vs. shipments are tracked
and trended. Target goals have been set for both indicators. The
reason for the return is also recorded. The data is reviewed at
management review meetings and appropriate actions taken as
necessary.
8.2.1.3 Delivery
The mode of delivery of product is specified by the customer.
The delivery requirements are entered with the order and appear
on the Packing Slip. Delivery information is tracked and trended.
Target goals have been set.
Delivery indicators that are tracked and trended are % on-time
delivery and average days late. The data is reviewed at
management review meetings and appropriate actions taken as
necessary.
8.2.1.4 Other Customer Satisfaction Indicators
Other indicators or sources used to monitor customer satisfaction
are:
• Sales forecast and volume reviewed periodically to determine
if sales plan is being met or if adjustments are necessary
based on specific customer feedback.
• Customer Audits performed by some customers will be
documented at the customer’s discretion. These customer
audit results are reviewed by management and retained.
• Customer supplier ratings provided by some customers
8.2.2 Internal Audit
Audits of the quality system are performed on a scheduled basis to
measure compliance to applicable standards and the effectiveness of the
quality system. Qualified employees or outside consultants perform the
audits. The auditor must have no direct responsibility for the area audited.
Audit results are subject to Management Review.
8.2.2.1 Audit Schedules
All elements of the quality system are audited on an annual basis.
A tolerance of plus or minus one calendar quarter is permitted.

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8.2.2.2 Audit Plans

Checklists are created to allow systematic and efficient auditing.
Known issues and the history of the area or element audited may
be used to develop areas of concentration.
8.2.2.3 Audit Results
Each audit generates a report and requests for corrective action,
if necessary. Audit corrective actions are logged and managed
according to the Corrective and Preventive Action system;
however, the records of the Internal Audits are considered
company-confidential.
8.2.2.4 Follow-up
Where corrective action is required, it is verified by the original
auditor or another qualified individual. The adequacy of follow-
up is audited during subsequent audits and/or during the annual
audit of the internal audit system. Records of the follow-up are
kept.
8.2.3 Monitoring and Measurement of Processes
The key quality management system processes at NDC have been
identified as:
• Supplier Management
• Process Control
• Handling, Storage, Packaging and Delivery
• Resources (Personnel, Facilities, Equipment)
• Document Control
• Regulatory Requirements
The following methods are in place to measure and monitor the above
processes:
• Internal Quality Audits
• Other internal audits (workstation practices audit, line clearance audits,
etc)
• Customer Satisfaction (Complaints, Delivery and Returns)
• Product Acceptance/ non-conformance
• Management Review process
The intended purpose of the above key processes are quantified by output
of the processes, such as conformance to product specifications, yields,
etc.

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Statistical techniques are used to define process parameters, optimize

product performance, and to identify root causes of problems. Statistical
Process Control (SPC) and Design of Experiment (DOE) techniques are
applied where appropriate.
Statistically valid sampling plans are selected to assure the adequate
control of quality. Statistically valid methods are used to determine
sample sizes in the evaluation of processes and product characteristics.
Procedures are developed and used to assure uniform application of the
techniques selected.
Processes are evaluated to determine the statistical capability, and
improvements and/or the application of SPC are utilized to provide
capable processes. DOE techniques are applied to optimize processes and
to improve them where capability does not meet requirements. Sampling
plans are selected according to results of risk analysis and other analyses
of product and process. Sampling plans are reviewed as needed, based
upon frequency of nonconformances and other feedback information to
assure their adequacy.
8.2.4 Monitoring and Measurement of Product
8.2.4.1 Receiving Inspection
Material intended for use in final product (inventory item) is
subject to inspection according to an Inspection Plan. Urgently
required material may be pre-released to production. In that
case, the traveler for the job is annotated "PRE-RELEASED
MATERIAL" or similar, and the acceptability of the material is
verified before the traveler is completed and the product is
released.
8.2.4.2 Inprocess Inspection
Inprocess inspections are performed as required at specified
points on the Traveler or as required by a Work Instruction.
These may be performed by qualified production or inspection
personnel. Records are maintained.
8.2.4.3 Final Inspection
Final inspections are performed to confirm that all production
operations are complete and that product meets requirements.
The final inspections are performed before the product is shipped
or placed in finished goods inventory. Verification of the
acceptability of pre-released material is performed before final
acceptance. Quality Assurance personnel, or others specifically
delegated, must close out the inspection by signing the
Inspection Plan indicating the inspection is complete and all
required actions accomplished.

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8.2.4.4 First Article Inspection

First Article Inspections are performed at the discretion of the
Production Manager unless the Traveler or other specifying
document specifically requires the performance of the First
Article.
8.2.4.5 Inspection and Test Records
Records are made of inspections specified in the Inspection Plan.
8.3 Control of nonconforming product
To prevent unintended use or installation, nonconforming product is clearly
identified by labeling of the product and/or its placement in an area specifically
reserved for nonconforming material. Responsibility for dispositioning is defined.
Use-As-Is dispositions for specified requirements require the approval of the
customer and the VP QA/RA. Use-As-Is dispositions typically require the
establishment or revision of specifications, workmanship standards, or other
requirements documents.
8.3.1 Physical Controls
“REJECTED” or “SCRAP” labels/tags are used to identify nonconforming
material. That material is labeled and/or placed in a location reserved for
nonconforming or suspect material. “HOLD” or “QC HOLD” labels are
used for material that has been found to be discrepant during inspections
but not yet dispositioned.
8.3.2 Review And Disposition
Nonconforming material is documented on a Nonconformance Report
(NCR). Each document requires review, evaluation, and disposition .
Where Work Instructions contain specific nonconformance identification
and disposition actions, the material may be rejected, properly identified
(labeled "REJECTED") and accounted for on the Traveler by the operator
without further approvals.
8.3.3 Waivers and Deviations
Where nonconforming material is to be offered to a customer, a waiver or
deviation (customer concession) must be obtained from the customer’s
authorized representative prior to shipment. Where a written confirmation
is unavailable, the documentation must show the name of the customer
representative granting the verbal waiver, and the dated signature of the
company representative documenting the verbal communication. All
waivers and deviations are limited by time, quantity, or lot number.
8.3.4 Referral for Corrective and Preventive Action
Some nonconformances may dictate the generation of a formal Corrective
Action Request. Corrective and preventive actions process is described in
OP-9014.

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8.4 Analysis of Data

NDC has determined the appropriate data to be collected to demonstrate the
suitability and effectiveness of the quality management system and determine
where improvement is needed. This data consists of Internal Audits results,
Customer Satisfaction information (customer complaints, on time delivery, and
returns), Non-conformance and product yields.
The monitoring and measurement methods for key processes are the input to
Management Review. The continuing suitability of these processes are confirmed
at the Management Review meetings and documented in the meeting notes.
The data analysis and review may also result in generating and corrective and
preventive actions, identification of improvements, supplier information, trends and
determining the suitability and effectiveness of the QMS based on Quality policies
and objectives.
Statistical techniques are used to define process parameters, optimize product
performance, and to identify root causes of problems. Statistical Process Control
(SPC) and Design of Experiment (DOE) techniques are applied where appropriate.
Statistically valid sampling plans are selected to assure the adequate control of
quality. Statistically valid methods are used to determine sample sizes in the
evaluation of processes and product characteristics.
8.5 Improvement
8.5.1 Continual Improvement
Management with executive responsibility (executive management) is
responsible for establishing, implementing, and continuously improving
the quality system.
Executive management, and others as required, formally reviews the
quality system for compliance and effectiveness at least quarterly. Results
and actions taken are documented.
Procedure for advisory notices and regulatory notification is not required,
as NDC is currently not manufacturing finished medical devices.
Customer complaints are recorded and investigated. If a corrective
action/preventive action is not issued for a device complaint, the reason
should be recorded. Results of all investigations must be documented.
8.5.2 Corrective Action
Corrective action is recognized as a key element in the continued
improvement in quality Corrective Actions are taken to eliminate the
causes of an existing nonconformance, defect, or other undesirable
situation in order to prevent recurrence. Corrective actions are put into
place once something has been identified as having gone wrong.
Corrective action definition and details are documented in OP-9014,
Corrective and preventative action. The management team assures
adequate resources are available to identify and implement corrective and
preventive actions.

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8.5.3 Preventive Action

Preventative action is recognized as a key element in the continued
improvement in quality. Preventive Actions are taken to eliminate the
cause of a potential nonconformance, defect, or undesirable situation to
prevent occurrence. The degree of preventative action taken should be
dependent upon and related to the risk, size, and nature of the problem and
its effect(s) on product quality. Preventive actions are more proactive and
are put in place once something has been identified as having the
possibility of going wrong.. Preventive action definition and details are
documented in OP-9014, Corrective and preventative action. The
management team assures adequate resources are available to identify and
implement preventive actions. .
8.6 References for this section
OP-9001, Management Responsibility
OP-9009 series, Process control
OP-9010-1, Receiving Inspection
OP-9010-2, In-Process Inspection
OP-9010-3, Final Inspection
OP-9013, Nonconforming Material
OP-9014, Corrective and Preventive Actions
OP-9014-2, Complaints
OP-9015, Handling Storage, Packaging and Delivery
OP-9015-3, Receiving
OP-9017, Internal Audits
OP-9020, Statistical Techniques

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APPENDIX A: Table of Contents

1 Introduction to Nitinol Devices & Components (NDC) ......................................................................................... 1

1.1 About NDC .................................................................................................................................................. 1
1.2 Registrations ................................................................................................................................................ 1
1.3 References ................................................................................................................................................... 1
2 Scope ...................................................................................................................................................................... 1
2.1 Application .................................................................................................................................................. 1
2.2 Exclusions .................................................................................................................................................... 1
3 Quality System Overview....................................................................................................................................... 2
3.1 NDC Quality Policy ..................................................................................................................................... 2
3.2 NDC Quality Objectives .............................................................................................................................. 2
3.3 Organizational Structure .............................................................................................................................. 2
4 Quality Management System.................................................................................................................................. 2
4.1 General Requirements ................................................................................................................................. 2
4.2 Documentation Requirements...................................................................................................................... 4
4.2.1 General .......................................................................................................................................... 4
4.2.2 Quality Manual ........................................................................................................................... 5
4.2.3 Control of Documents ................................................................................................................ 6
4.2.4 Control of Records ........................................................................................................................ 7
4.2.5 References for this section............................................................................................................. 7
5 Management Responsibility ................................................................................................................................... 8
5.1 Management Commitment .......................................................................................................................... 8
5.2 Customer Focus ........................................................................................................................................... 8
5.3 NDC Quality Policy ..................................................................................................................................... 9
5.4 Planning ....................................................................................................................................................... 9
5.4.1 Quality Objectives ......................................................................................................................... 9
5.4.2 Quality Management System Planning ....................................................................................... 10
5.5 Responsibility, authority and communication ........................................................................................... 10
5.5.1 Responsibility and Authority ....................................................................................................... 10
5.5.2 Management Representative........................................................................................................ 12
5.5.3 Internal Communication .............................................................................................................. 12
5.6 Management Review ................................................................................................................................. 12
5.6.1 General ........................................................................................................................................ 12
5.6.2 Management Review Input.......................................................................................................... 13
5.6.3 Management Review Output ....................................................................................................... 13
5.7 References for this section ......................................................................................................................... 13
6 Resource Management ......................................................................................................................................... 13
6.1 Provision of resources................................................................................................................................ 13
6.1.1 General ........................................................................................................................................ 13
6.1.2 Resource Determination .............................................................................................................. 14
6.2 Human Resources ...................................................................................................................................... 14
6.2.1 General ........................................................................................................................................ 14
6.2.2 Competence, Awareness and Training ........................................................................................ 14
6.3 Infrastructure ............................................................................................................................................. 15
6.4 Work Environment .................................................................................................................................... 15
6.5 References for this Section ........................................................................................................................ 15
7 Product Realization .............................................................................................................................................. 15
7.1 Planning of product realization .................................................................................................................. 15
7.2 Customer related processes........................................................................................................................ 16
7.2.1 Determination of requirements related to the product ......................................................... 16
7.2.2 Review of requirements related to the product..................................................................... 16
7.2.3 Customer communication........................................................................................................ 17
7.3 Design and Development ........................................................................................................................... 17
7.3.1 Design and development planning ......................................................................................... 18

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7.3.2 Design and development inputs.............................................................................................. 18

7.3.3 Design and development outputs ........................................................................................... 18
7.3.4 Design and development review ............................................................................................ 18
7.3.5 Design and development verification .................................................................................... 19
7.3.6 Design and development validation ....................................................................................... 19
7.3.7 Control of design and development changes ........................................................................ 19
7.3.8 Design and development transfer ........................................................................................... 19
7.3.9 Design History File (DHF)...................................................................................................... 19
7.4 Purchasing ................................................................................................................................................. 19
7.4.1 Purchasing process ................................................................................................................... 19
7.4.2 Purchasing information ............................................................................................................ 20
7.4.3 Verification of purchased product .......................................................................................... 20
7.5 Production and Service Provision .............................................................................................................. 21
7.5.1 Control of production and service provision ........................................................................ 21
7.5.2 Validation of processes for production and service provision ........................................... 22
7.5.3 Identification and traceability ................................................................................................. 22
7.5.4 Customer property .................................................................................................................... 23
7.5.5 Preservation of product ............................................................................................................ 23
7.6 Control of monitoring and measuring devices ........................................................................................... 23
7.7 References for this section ......................................................................................................................... 24
8 Measurement, Analysis and Improvement ........................................................................................................... 25
8.1 General....................................................................................................................................................... 25
8.2 Monitoring and measurement .................................................................................................................... 25
8.2.1 Customer Satisfaction .............................................................................................................. 25
8.2.2 Internal Audit ............................................................................................................................ 26
8.2.3 Monitoring and Measurement of Processes .......................................................................... 27
8.2.4 Monitoring and Measurement of Product ............................................................................. 28
8.3 Control of nonconforming product ............................................................................................................ 29
8.3.1 Physical Controls ......................................................................................................................... 29
8.3.2 Review And Disposition.............................................................................................................. 29
8.3.3 Waivers and Deviations............................................................................................................... 29
8.3.4 Referral for Corrective and Preventive Action ............................................................................ 29
8.4 Analysis of Data ........................................................................................................................................ 30
8.5 Improvement .............................................................................................................................................. 30
8.5.1 Continual Improvement ............................................................................................................... 30
8.5.2 Corrective Action ........................................................................................................................ 30
8.5.3 Preventive Action ........................................................................................................................ 31
8.6 References for this section ......................................................................................................................... 31

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Document History Page:

ECO No. Effectivity Rev Description of Changes Released By/Date

Date
6053 5 Dec 03 A Initial Release Naila Pena 12/4/03

6213 9 Mar 04 B Modified title, 1.2, 1.3, 2.2, 3.2, Naila Pena 3/8/04
4.1, 4.2.1, 4.2.3, 4.2.4.3, 5.2, 5.3,
5.5, 5.5.1.1, 5.5.1.7, 5.5.2, 5.6.1,
6.2.2.3, 7.1, 7.3.1, 7.3.2, 7.3.3,
7.6, 8.3.4, 8.5.1.
***History Page will not be completed, Please see document control system for Description of
Changes***

NDC Confidential QM-0000, Rev. P.doc