Quality Manual: Advanced Monolithic Systems, Inc

Advanced Monolithic Systems, Inc.
Quality
Manual
Document #00-0001 Rev A
Advanced Monolithic Systems, Inc. AMS 9001 Quality Manual Doc. #00-0001 Rev A
Page 1 of 1
Quality Manual
Table of Contents
Name Page #
1.0 Scope ...................................................................................................................... 5

1.1 Introduction .............................................................................................. 5
1.2 Exclusions from ISO Standard ............................................................... 5
2.0 Applicability ......................................................................................................... 6
3.0 Responsibility ....................................................................................................... 6
4.0 Quality Management System .............................................................................. 7
4.1 General Requirements ............................................................................. 7
4.2 Documentation Requirements ................................................................ 7
4.2.1 General ......................................................................................... 8
4.2.2 Quality Manual ............................................................................. 8
4.2.3 Control of Documents .................................................................. 8
4.2.3.1 General ......................................................................... 8
4.2.3.2 Document and Data Approval, Issue and Revision ..... 9
4.2.3.3 Data Back Up ............................................................... 9
4.2.4 Control of Records ....................................................................... 9
5.0 Management Responsibility ................................................................................ 10
5.1 Management Commitment ..................................................................... 10
5.2 Customer Focus ........................................................................................ 10
5.3 Quality Policy ........................................................................................... 11
5.4 Planning .................................................................................................... 12
5.4.1 Quality Objectives ........................................................................ 12
5.4.2 Quality Management System Planning ........................................ 12
5.5 Responsibility, Authority and Communication .................................... 13
5.5.1 Responsibility and Authority ........................................................ 13
5.5.2 Management Representative ........................................................ 14
5.5.3 Internal Communication ............................................................... 14
5.6 Management Review ................................................................................ 15
5.6.1 General ......................................................................................... 15
5.6.2 Review Input ................................................................................ 15
5.6.3 Review Output .............................................................................. 15
Page 2 of 2
Quality Manual
Table of Contents (continued)
Name Page #
6.0 Resource Management ........................................................................................ 16

6.1 Provision of Resources ............................................................................. 16
6.2 Human Resources .................................................................................... 16
6.2.1 General ......................................................................................... 16
6.2.2 Competence, Awareness and Training ......................................... 17
6.3 Infrastructure ........................................................................................... 17
6.4 Work Environment .................................................................................. 18
7.0 Product Realization ............................................................................................. 18
7.1 Planning of Product Realization ............................................................. 18
7.2 Customer-Related Processes ................................................................... 19
7.2.1 Determination of Requirements Related to the Product ............... 19
7.2.2 Review of Requirements Related to the Product .......................... 19
7.2.3 Customer Communication ............................................................ 20
7.3 Design and Development ......................................................................... 20
7.3.1 Design and Development Planning .............................................. 20
7.3.2 Design and Development Inputs .................................................. 20
7.3.3 Design and Development Outputs ................................................ 21
7.3.4 Design and Development Review ................................................ 21
7.3.5 Design and Development Verification ......................................... 21
7.3.6 Design and Development Validation ........................................... 21
7.3.7 Control of Design and Development Changes ............................. 21
7.4 Purchasing ................................................................................................ 22
7.4.1 Purchasing Process ....................................................................... 22
7.4.2 Purchasing Information ................................................................ 22
7.4.3 Verification of Purchased Product ............................................... 22
7.5 Production ................................................................................................ 23
7.5.1 Control of Production ................................................................... 23
7.5.2 Validation of Processes for Production ........................................ 23
7.5.3 Identification and Traceability ..................................................... 24
7.5.4 Customer Property ........................................................................ 24
7.5.5 Preservation of Product ................................................................ 25
7.6 Control of Monitoring and Measuring Devices ..................................... 26
Page 3 of 3
Quality Manual
Table of Contents (continued)
Name Page #
8.0 Measurement, Analysis and Improvement ........................................................ 28

8.1 General ...................................................................................................... 28
8.2 Monitoring and Measurement ................................................................ 29
8.2.1 Customer Satisfaction ................................................................... 29
8.2.2 Internal Audit ............................................................................... 29
8.2.3 Monitoring and Measurement of Processes ................................. 29
8.2.4 Monitoring and Measurement of Product .................................... 30
8.3 Control of Nonconforming Product ....................................................... 30
8.4 Analysis of Data ........................................................................................ 30
8.5 Improvement ............................................................................................ 31
8.5.1 Continual Improvement ................................................................ 31
8.5.2 Corrective Action ......................................................................... 32
8.5.3 Preventive Action ......................................................................... 32
Page 4 of 4
1.0 Scope
1.1 Introduction
This Quality Manual is issued and controlled by Advanced Monolithic Systems, Inc.
(AMS) headquartered in Livermore, CA.
AMS is a designer and manufacturer of semiconductors specializing in the design and

production of analog & power management integrated circuit devices.
This manual describes the AMS Quality System. It provides the authorization and
control of related activities and their associated documentation.
1.2 Exclusions from ISO Standard

The AMS Quality Management System has been designed to be totally compliant to
ISO 9001:2000 in all aspects that apply to the organization’s operations and needs
and does not detract from the ability or responsibility to provide product that fulfills
customer and applicable regulatory requirements. The only elements within clause 7,
Product Realization, of the standard to which an exception applies is in the
application of process elements that deal with “service provisions.” AMS products
are of the nature that, once sold to customers, there are no servicing operations
required to this product. The other is validation of processes (7.5.2). AMS products
can all be verified by subsequent measurement or monitoring. These are addressed as
“standard” AMS processes of product test and reliability monitoring, which are
delineated in the applicable sections of this manual.
Page 5 of 5
2.0 Applicability
The Quality Manual applies to all activities and personnel at the Livermore, CA,
facility, as applicable to AMS products and the necessary internal and external
processes that are defined and controlled.
“Factored Items” (3rd party designed and produced product with AMS name affixed)
are not applicable to AMS. If a change ever occurred, however, the ISO Approval
Certificate would not cover these products and the ISO Management Representative
and Sales will be responsible to notify applicable customers that the ISO certification
coverage does not apply.
3.0 Responsibility
This manual and the AMS Quality Policy are issued under the authority of the Chief
Executive Officer/President of AMS. AMS documentation defines who has the
responsibility for implementation of tasks to ensure conformance to the elements of
the standard. The ISO Management Representative is responsible for ensuring that
the Quality Management System is implemented and maintained to meet the
requirements of this manual.
This manual is maintained by the ISO Management Representative. AMS

departments maintain documented “Level II” process procedures, hereafter referred to
as document numbers 00-01XX, and standard operating instructions detailing
processes, methods and procedures necessary for implementation of the AMS Quality
Management System. All of these documents, however, are controlled through the
AMS document control system.
Page 6 of 6
4.0 Quality Management System
4.1 General Requirements
AMS had developed a Quality Management System that meets the requirements of
ISO 9001:2000 Standard and supports the AMS Quality Policy and objectives. This
system delineates all of the processes necessary for a directed process approach that
will:
a) Identify system processes and their application within AMS.

b) Provide for development of sequential/interactive processes within the system that
are adequately communicated throughout AMS for their implementation.
c) Describe those criteria and methods that define areas of responsibility to ensure
effective: operation, control and continual improvement of the system.
d) Ensure resources and information are made available to support operation and
monitoring of the system.
e) Monitor, measure and analyze the system to implement: action necessary to
achieve planned results and continual improvement of these processes.
4.2 Documentation Requirements

AMS Quality Management System documentation adheres to the following structure:
Level I — AMS Quality Manual
Level II — Processes in flow chart format and as defined on Master Lists.

(Documents in 00-01XX series.)
Level III — All Standard Operating Procedures and Instructions and forms, as
defined on Master Lists.
Level IV — Completed records as defined in Level II documents as “QR” and in

00-0005, Quality Records Matrix.
To provide for internal communication and effectiveness of the utilization of the

above documentation, they are all accessible through the AMS office network. Care
should be exercised to ensure any copies made are always in accord with the revision
status as shown on the Master Lists that are provided in “Corporate Quality
Documents” of the Intranet home file.
Page 7 of 7
4.2.1 General
The AMS Quality Management System documentation includes the following in
compliance with ISO standard requirements:
a) Quality Policy & Objectives (Ref. paragraph 5.3.)

b) Quality Manual (Ref. paragraph 4.2.2.)
c) Documented procedures required by the ISO standard and, as needed, to ensure
effective planning, operation and control of AMS processes. (Ref. paragraph 4.2.)
d) Quality records (Ref. paragraph 4.2.4.)
4.2.2 Quality Manual

The requirements contained within the quality manual are compliant with
ISO 9001:2000 — Quality management systems – Requirements. AMS
documentation identifies requirements to be met and specifies when, where and how
these requirements are fulfilled. These are referenced herein in this manual. The
quality manual is released through Document Control after necessary management
approvals are obtained on the document release. It is thereafter maintained as a
controlled document. Exclusion from ISO 9001:2000 requirements are as stated in
paragraph 1.2 of this manual.
4.2.3 Control of Documents

4.2.3.1 General
Documented processes are developed to maintain control of all documents and data.
AMS acknowledges acceptance of customer-imposed requirements, specifications

and standards. Customer and vendor documents are recorded and controlled upon
receipt.
Document Control is responsible for making documents available at their points of

use. The AMS NETWORK will be utilized to maintain and distribute master lists
and make documents accessible. This is a secured file that is only accessible to
Document Control for changes. “Hard copy” documents not maintained in the
NETWORK will be controlled by Document Control. If (hard copy) paper
documents are issued, Document Control indicates these controlled/distributed
documents using ink-stamped copies. Documents held in the secured files within
Document Control are considered as masters and do not require ink-stamp
identification. AMS personnel have been instructed to consider unstamped copies as
uncontrolled documents, which must be verified against the respective master list for
current revision status.
Product proposal documents are considered to be preliminary working copies and, as

such, are not required to be under document control.
Page 8 of 8
4.2.3.2 Document and Data Approval, Issue and Revision
AMS uses qualified personnel for writing/creating and revising documentation and
recommending the peer/management personnel whom are required for review and
approval. Document owners, department managers and/or Document Control selects
the personnel to review and approve the documents and the distribution required. For
processes developed and implemented for all of the various elements of document
control activities, the following shall be followed:
00-0110, Document Control; 00-0111, Test Hardware and Software Control;

00-0112, Design Data Control; 00-0113, Design Rule Document Control; 00-0114,
MIS Network Control; and 00-0137, Product Data Sheet Control.
Controlled distribution of up-to-date revisions (so dated and revision numbered) are
issued to the individual distributes or location(s) as indicated on a distribution list, as
applicable. Obsolete revision documents are either destroyed or marked “History,”
“For Reference Only” or “Revised.”
4.2.3.3 Data Back Up

Back ups of networked data files are performed on a weekly basis, as a minimum.
Individual desktop data files are backed up on an “as needed” basis.
4.2.4 Control of Records

Legible quality records are generated, collected and maintained by AMS in
accordance with established procedures (see Doc. #00-0131, Control of Quality
Records). These records demonstrate the achievement of the required quality
management activities and the effective operation of the Quality Management
System. Specific records are listed in the Quality Records Matrix (Doc. #00-0005)
and are designated in the Level II documents that define the AMS processes.
The Quality Records Matrix provides a list of each type of quality record, the location
of the active and archived records, the method of indexing, and the minimum storage
time. Contractual agreements, as applicable, are used as a basis of establishing
quality records retention requirements and/or providing requested records to
customers.
Storage of records is in a suitable environment that prevents damage, deterioration

and loss. These records are readily retrievable from the location(s) identified in the
Matrix. Records in an electronic media are controlled in accordance with the
document and data control requirements of paragraph 4.2.3.
NOTE: The terms “records” in the ISO standard and “quality records” as used in AMS
documentation is deemed to be synonymous in that they are both intended to provide
objective evidence of conformity to the requirements of the quality management system (i.e.,
audit trail).
Page 9 of 9
5.0 Management Responsibility
5.1 Management Commitment
Chief Executive Officer/ President and all management at AMS have endorsed and
are committed to the Quality Management System as presented in this Quality
Manual. This commitment is not limited to the initial development of this system, but
to its continual improvement through the implementation of necessary management
responsibilities. There are many activities encompassed within the scope of these
responsibilities, but the primary ones that are necessary to achieve our quality
objectives are:
a) Communicating to all AMS personnel the importance of meeting customer,

regulatory and/or legal requirements. This is emphasized in the “ISO Awareness
Training” (Doc. #03-0002) that is required of all AMS employees in their
orientation training.
b) The establishment of an AMS quality policy and quality objectives. These are
stated in paragraph 5.3 of this document.
c) Conducting management reviews to review the Quality Management System.
This is further delineated in paragraph 5.6 of this document.
d) Providing resources to achieve all of the AMS goals and objectives, customer
requirements and a structure for preventive measures to be implemented and for
continual improvement activities.
5.2 Customer Focus

The AMS Quality Management System provides specific direction toward ensuring
that customer requirements are determined and that these requirements are addressed.
Implementation of customer-related processes, as defined in paragraph 7.2 of this
document, are to be performed with the aim of meeting AMS Quality Policy of:
achieving complete customer satisfaction. This shall include, where applicable, any
regulatory or legal requirements that may be imposed. The management review
process, as further addressed in paragraph 5.6 of this document, will provide added
emphasis toward ensuring that an acceptable level of customer satisfaction is being
achieved.
Page 10 of 10
5.3 Quality Policy
Advanced Monolithic Systems, Inc. Quality Policy
Advanced Monolithic Systems, Inc. is dedicated toward
achieving:
defect-free performance and complete customer satisfaction.
In support of the Quality Policy, the following quality objectives are applicable to
AMS operations:
• To provide excellent semiconductor product design, manufacturing and related

services for our worldwide customer base.
• To initiate and maintain mutually beneficial long-term partnerships with both our
suppliers and our customers.
• Dedicate AMS resources within every facet of the company to achieve a culture
of continuous improvement with objectives of assuring customer satisfaction and
driving toward the goal of defect-free performance in everything that we do.
The Chief Executive Officer/President and all management at AMS have endorsed
the Quality Policy as an effective statement, commensurate with AMS purpose.
Each functional organization ensures that personnel at all levels are fully
knowledgeable of the Company Quality Policy.
The processes contained within the AMS Quality Management System provide for
review of quality policy and objectives for performance and continuing suitability.
(Ref. paragraph 5.6.)
Page 11 of 11
5.4 Planning
5.4.1 Quality Objectives
The CEO/President and his staff shall establish measurable quality objectives on a
continuing basis as a part of the management review process. These objectives,
results of attaining these objectives and actions taken, shall also be part of the
management review quality records.
Actions taken as a result of the review of these measures may take the form of
corrective actions, preventive actions or revising goals for purpose of continuous
improvement efforts. These may relate to any of the internal processes that are
inherent to the Quality Management System or to address ongoing activities that will
impact requirements to attain customer satisfaction.
5.4.2 Quality Management System Planning

A comprehensive system has been established through the development of the
necessary Level II process documents. These documents provide the necessary part
of providing the plans for implementation of all of the processes inherent in the AMS
Quality Management System. These are delineated as follows:
00-0101 Plan for implementation of Management Reviews.
00-0102 & -0103 Plan for implementation of customer communication requirements.
00-0104 through 0108 Design-related activity plans and flow.
00-0109 Design planning and implementation relative to design changes.
00-0110 through –0114 and –0137 Document Control plans for implementation
relative to: Documentation, Test Hardware & Software, Design Data, Design Rules,
MIS electronic files and Product Data Sheets.
00-0115, -0116, -0135 & -0138 Supplier control plans related to selection and
review.
00-0117 & –0140 Planned activities for procurement functions.
00-0118 Plan for implementing the control of customer-supplied material.
00-0119 Identification and traceability plan and flow.
00-0120 & -0121 Pre-Production/production plans and flow.
00-0122, -0123, and -0124 Inspection and test planning and implementation flow.
Page 12 of 12
00-0125 Calibration implementation plans.
00-0127 & -0128 Nonconforming product control planning and implementation

flow.
00-0129 Corrective/Preventive Action implementation plans.
00-0130 Shipping functions planning and flow.
00-0131 Plan for the control of quality records.
00-0132 & -0136 Plan for conducting internal audits.
00-0133 Plan and flow for conducting employee training.
00-0134 Planned method for measurement of processes and product and analysis of
data.
00-0139 Planned activities related to customer satisfaction determination.
5.5 Responsibility, Authority and Communication

5.5.1 Responsibility and Authority
AMS management has defined the responsibilities and authority to its employees in
organizational charts, procedures and work instructions as appropriate. This authority
includes, but is not limited to, the freedom and responsibility to identify, record and
begin actions necessary to prevent or correct non-conforming conditions, products
and processes. (Refer to Doc. #00-0002, Corporate Management, AMS organization
chart.)
Personnel at all levels are empowered with the responsibility to identify suspect
nonconforming situations so that they may be addressed in accordance with
applicable procedures.
AMS management encourages all employees to recommend or provide preventive or

correction action solutions through approved channels.
Communication of the Quality Management System shall be provided to all AMS

employees via EMAIL notification and made available through the AMS
communication system (NETWORK).
Page 13 of 13
5.5.2 Management Representative
The Director of Quality Assurance is the appointed ISO Management Representative
responsible for ensuring compliance to ISO 9001, reporting directly to the Chief
Executive Officer/President of AMS. Responsibilities and authority given to the
Management Representative are to:
— Ensure that the processes of the Quality Management System are established,
implemented and maintained. Delegation of process maintenance is delegated to
process owners, as identified on process flow documents, but all changes must be
reviewed by the Management Representative before being revised to ensure ISO
conformance.
— Reporting to top management on the performance and any need for improvement
of the Quality Management System. As a minimum, this shall be done at the
scheduled management reviews as outlined in paragraph 5.6.
— Ensure the promoting of customer requirements throughout the organization.
5.5.3 Internal Communication

Communication between various levels within AMS shall be maintained to provide
for information regarding the Quality Management System processes and their
effectiveness. As a minimum it will consist of:
a) Defining the system through the Quality Manual (paragraph 4.2.2) and related
Level II/Level III documents that delineate system process details, as required.
b) Establishing and maintaining a communications network (INTRANET) that

provides for control of documents in use and their availability to all users.
c) Providing ongoing communication regarding the effectiveness of processes that

make up the quality management system. These are further outlined in
paragraph 5.6, Management Reviews and paragraph 8.0, Measurement, Analysis
and Improvement.
d) Provide intra-company wide communication to all employees via e-mail

notification of the Quality Management System effectiveness relative to meeting
designated performance indicators in attaining quality policy goals and objectives.
Page 14 of 14
5.6 Management Review
5.6.1 General
Management reviews the entire Quality Management System to include the elements
as outlined in sections 5.6.2, Review Input, and 5.6.3, Review Output, of this manual.
Management review is further documented in Doc. #00-0101, Management Review.

The results of reviews are documented in management review meeting minutes.
Implementation of any resulting actions is verified by the Management
Representative or other designee. The Management Representative maintains the
records of management reviews in accordance with section 4.2.4 of this manual.
5.6.2 Review Input

Agenda for the management reviews shall include AMS to assess current
performance and improvement opportunities. These are as delineated in process
Doc. #00-0101, Management Review. The objectives of these reviews are to ensure
suitability, adequacy and effectiveness of the Quality Management System including
the AMS Quality Policy and objectives (paragraph 5.3) to determine whether there is
a need for change. Measurable elements shall be used for this review for
management-designated activities.
5.6.3 Review Output

The meeting minutes shall provide a record of all of the agenda input information
presented and will also address improvement needs to: the Quality Management
System/processes and to product relative to customer requirements. In addition,
resource needs will be addressed if action is necessary to meet quality system,
customer and/or regulatory requirements. Review outputs and their subsequent status
shall be used in successive management reviews as a means of continued system
assessment.
Page 15 of 15
6.0 Resource Management
6.1 Provision of Resources
AMS management of resources is controlled within the budgeting cycle occurring
annually. Department/section managers have the opportunity to request required
resources that are necessary to implement and/or improve the Quality Management
System or to address needs to achieve customer satisfaction. These include
equipment as well as human resources. If special needs arise during the course of the
year, between budget cycles, budget allocations are reviewed with top management in
order to make necessary adjustments.
6.2 Human Resources

The responsibility for obtaining competent, qualified personnel is a joint
responsibility of departmental managers and the Human Resources department.
6.2.1 General
The competency of assigned personnel shall be addressed on the basis of determining
applicable education, training, skills and experience required. Training records for
specific job responsibilities shall be used by requisitioning managers to document
minimum job entry requirements. These may be used by Human Resource
management along with job requisitions to obtain potential candidates.
Page 16 of 16
6.2.2 Competence, Awareness and Training
All AMS employees, including temporary employees who could affect quality,
receive overview training on the ISO 9001 Standard and the AMS Quality
Management System. (Ref. paragraph 5.1.)
The methods employed in the training process (see Doc. #00-0133, Training) for
assessing required skills, identifying, planning, conducting and documenting
employee training activities include:
• Identifying specific skills for jobs, delineating tasks required, and communicating
their relevance to achieve quality objectives.
• Defining training needed to bring employees to the required skill level.
• Performing the training and keeping records.
• Periodic retraining (including re-certification, where required).
As a minimum, supervisors and managers initially review training and experience

needs to ensure that qualified personnel are performing assigned tasks and annually to
assess ongoing training needs. Effectiveness of prior training is taken into account
when making determinations of ongoing training needs and conducting performance
reviews.
6.3 Infrastructure
AMS management is committed to provide and maintain suitable facilities that are
necessary to implement the Quality Management System that will achieve conformity
of product. These shall include: office areas and labs with adequate space to fulfill
job requirements and equipment/hardware/software that currently exists and is
defined as needed in annual budgeting cycles. In addition, the supporting services for
production such as: sub-contract suppliers, failure analysis laboratories, etc. shall be
obtained and utilized so as to obtain acceptable product to satisfy customer
expectations. The maintenance of equipment that is needed to achieve the conformity
of product is addressed in Doc. #00-0125 that delineates the process of calibration
and preventive maintenance.
Page 17 of 17
6.4 Work Environment
AMS management is committed to: establish, provide and maintain an infrastructure
that is needed to comply with product requirements. Due to the nature of AMS
operations, this is predominantly related to office, laboratory or storage areas where
standard heating/cooling systems are employed and maintained. Safety committees
are established to address any employee safety issue. Where chemicals may be used,
Material Safety Data Sheets are maintained to provide instruction relative to physical
and environmental issues.
In maintaining an acceptable work environment, AMS is committed to maintain its

facilities in a safe and healthy manner that is in compliance with all applicable laws
and regulations.
AMS complies with applicable environmental laws and regulations regarding

hazardous materials, air emissions, and waste water discharges, including those
regarding the manufacture, transportation, storage, disposal, and release to the
environment of such materials. All of the AMS suppliers providing resalable product
are required to provide to AMS those certifications attesting that they are also in
compliance with these environmental regulations. Quality Assurance maintains the
certifications as quality records.
7.0 Product Realization

7.1 Planning of Product Realization
Quality plans for product realization have been prepared in the form of collaborative
processes involving many functions and departments. These are in the form of
Level II Process Flow charts that address the requirements and interactive needs.
These are further delineated in each of the appropriate sections of 7.0 and fully
referenced in paragraph 5.4.2 to list all of the Quality Management System process
documents.
The quality planning elements specifically determine quality objectives for products;
the need for processes, facilities, documentation and other resources required for
product realization; product verification and validation, monitoring, inspection and
test activities; criteria for product acceptability; and the records to demonstrate
product and process conformance.
Page 18 of 18
7.2 Customer-Related Processes
7.2.1 Determination of Requirements Related to the Product
AMS has documented procedures that provide for the determination/identification of
customer requirements, to include those that are not specified, but are necessary for
intended use or compliance with applicable laws and regulations. It is recognized that
in order to achieve customer satisfaction objectives, the customer requirements must
be determined and identified. Typically, customer requirements shall be recorded to
include such items as: availability, product description, delivery requirements and
any other supportive activity that is required to satisfy AMS requirements.
Reviews of customer specifications shall be performed when received and any

requirements documented for implementation, as applicable. These may take the
form of Quality Assurance Instructions (QAIs), standard comments for specific
customer orders, instructions for design implementation or the use of Industry
Standards for: design, product fabrication, validation (characterization) and/or
verification (qualification) processes (i.e., JEDEC Standards, EIC/JESD Standards,
etc.). Records of customer documentation are maintained on the INTRANET file,
which defines customer name, applicable documents received and revision/date, and
are accessible to all AMS personnel requiring this information. Original documents
are retained in Document Control files.
7.2.2 Review of Requirements Related to the Product

AMS has documented procedures that define the review process (see Doc. #00-0102,
Customer Requirements and Communications and Doc. #00-0103, Order Entry).
AMS review shall ensure that:
• the requirements are adequately defined and documented,

• the Company has the resources to meet the requirements, and that
• any differences between the contract and the tendered quotation are resolved to
the mutual satisfaction of the involved parties before formal acceptance of the
contract, and that
• in the event of product/contract requirement amendments, that appropriate
notification is given to affected departments within AMS and that relevant
documentation is revised.
Record requirements from these reviews are shown on the quote, e-mail, the Order
Acknowledgement and/or within the AMS Business/MRP system, as applicable.
Page 19 of 19
7.2.3 Customer Communication
AMS recognizes the necessity for customer communication and feedback as a major
contributing element of customer satisfaction. Responsiveness is a key indicator of
AMS commitment to customer needs. The implementation of customer responses as
related to order issues, as well as those not specifically related to an order of product,
are addressed in AMS documents 00-0102 and 00-0103. In order to ensure the
validity of production information provided to customers, product data sheets are
maintained and made available on a WEB page and controlled by Doc. #00-0137,
Product Data Sheet Control.
7.3 Design and Development

7.3.1 Design and Development Planning
AMS reviews and evaluates design requirements to ensure that the products it designs
and develops meet or exceed customer specifications. (See Doc. #00-0102, Customer
Requirements and Communications; Doc. #00-0104, Design; Doc. #00-0105, Test
Development; Doc. #00-0106, Prototyping; Doc. #00-0107, Design Characterization;
Doc. #00-0108, Design Qualification; Doc. #00-0109, Engineering Change.)
In the course of addressing technical, logistical/managerial and financial concerns

that impact its design-process activities, AMS consistently exercises its organizational
interfaces. (See Doc. #00-0104, Design.) Planning shall be maintained to its most
current status, as appropriate, as the design activity progresses. This is necessary to
communicate with responsible groups in their implementation of activities related to
the design or development processes such as: test, design verification
(characterization), design validation (qualification), procurement of prototypes, etc.
7.3.2 Design and Development Inputs

AMS identifies design input and any applicable statutory or regulatory requirements
during contract review, AMS/customer meetings, marketing surveys or inputs from
AMS employees. Ambiguous, conflicting, changing and unclear/incomplete
requirements are clarified by reviews of the design at various stages of the designing
process. Design requirements are amended to accurately capture all pertinent design
input information. (See Doc. #00-0104, Design.)
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7.3.3 Design and Development Outputs
AMS captures design-output data in design review minutes and customer reviews, as
needed. These reviews are performed specifically to verify that design-output meets
or exceeds design-input requirements. Acceptance criteria shall be based on the test
development, product characterization and qualification plans, which shall be
implemented per paragraphs 7.3.5 and 7.3.6. These plans will include, as required,
those characteristics of the design that are crucial to the safe and proper functioning
of the product. The design output review must occur before the design is permitted to
progress further in the product release process. This review will ascertain that
information is available to define product acceptance criteria and that all of the
information necessary for production of the device has been provided.
7.3.4 Design and Development Review

AMS design teams review every design at key times based on the design plan and
design review checklist. (See Doc. #00-0104, Design.) Design review includes:
manufacturing requirements, cost/performance/risk trade-offs, test methodology and
conditions, guardbands, and data from previous designs. Design Characterization
(Doc. #00-0107) and Design Qualification (Doc. #00-0108) data results are reviewed
by appropriate personnel representing all concerned departmental functions to
evaluate the designed products’ ability to fulfill design input requirements. In the
event of problems being uncovered, follow-up proposals and actions will be identified
as a part of the design review minutes. Records of these design reviews shall be
maintained by the responsible Business Unit to document these reviews.
7.3.5 Design and Development Verification

AMS verifies product designs by performing in-depth “bench” tests that assess the
product’s output compliance to the design specifications. (See Doc. #00-0107,
Design Characterization.)
7.3.6 Design and Development Validation

AMS verifies product designs by performing laboratory tests to confirm that the
product is capable of meeting the requirements for the intended use of the product.
(See Doc. #00-0108, Design Qualification.)
7.3.7 Control of Design and Development Changes

All design changes either initiated by AMS or requested by the customer are
reviewed and implemented per Doc. #00-0109, Engineering Change. Changes that
impact device form, fit or function shall have applicable verification and/or validation
testing performed. This data shall be included in process change notice (PCN)
documents per Doc. #11-0005.
Page 21 of 21
7.4 Purchasing
7.4.1 Purchasing Process
AMS uses documented processes to control its purchasing activities. The process is
defined in Doc. #00-0115, Purchasing, that delineates elements of: supplier
selection, Approved Vendor List (AVL) generation, issuance of purchase orders and
other tasks related to the Purchasing process. Doc. #00-0116, Supplier Approval,
provides direction for implementation of those activities that are necessary to evaluate
and select suppliers with the ability to supply product meeting AMS requirements.
For the purchase of product that is procured to meet IC prototyping needs, the
process, as defined in Doc. #00-0140, Purchasing IC Products - Prototypes, is
applied; and for IC Production, Doc. #00-0117, Purchasing IC Products.
For periodic reviews of supplier performance, evaluations that are conducted are
outlined in Doc. #00-0135, Supplier Review and in Doc. #00-0138, Reliability Data
Review & Monitors. These provide for adequate assessment of suppliers and
determination of their acceptability to remain on the AVL as a source of supply
to AMS.
7.4.2 Purchasing Information

The information necessary for suppliers to implement AMS purchase orders are
provided either in the specific order or transmitted as controlled documents that are
retained by the suppliers and used, as applicable, for orders being placed.
Information that is provided to suppliers is referred to in Doc. #00-0106, Prototyping,
Doc. #00-0120, Pre-Production, and Doc. #00-0121, Production. Records of
documents issued and their revision status are maintained by Document Control.
7.4.3 Verification of Purchased Product

The verification of product is performed in accordance with Doc. #00-0122,
Receiving Inspection; Doc. #00-0123, Vendor Testing or Doc. #00-0124, In-House
Testing as is applicable to the purchase order delivery requirements. These processes
for verification apply to: AMS-US office. Where the verification elements of
receiving inspection and test shall be performed by them using their processes, which
are coordinated to include: AMS and AMS customer requirements. In the event that
AMS or customer verification of product is required at the sub-contracting source(s),
this shall be invoked by means of a supplier notification that would delineate
verification arrangements and product release conditions.
Page 22 of 22
7.5 Production
7.5.1 Control of Production
AMS maintains documentation for the control of processes that directly affect
product quality. Specifically, major processes affecting production include:
Doc. #00-0120; Pre-Production and Doc. #00-0121, Production.
Due to the nature of procurement of AMS product, it is necessary to use only

qualified sources for the fabrication, assembly and test of AMS products. Process
control elements are assessed and evaluated in the supplier selection process and
include suitability of the subcontracted source from the standpoint of production
capabilities and controls implemented, equipment, and work environment. The
supplier selection process is initiated to constitute, as a minimum, the approval of
processes, equipment and the workmanship criteria that is applicable to the services
performed and the product involved.
AMS product test processes are performed in an acceptable work environment,

utilizing approved hardware and software as evaluated and issued for production test
through the Test Development process. (Ref. Doc. #00-0105, Test Development.)
Product acceptance criteria is as defined by the applicable Level III documentation
that is released at the time of production release of the product and is used in test per
Doc. #00-0123, Vendor Testing or Doc. #00-0124, In-House Testing.
To ensure efficient and safe equipment operation, AMS utilizes a preventive

maintenance program for its test equipment, which is included in the calibration of
equipment activity.
The nature of AMS product does not require special monitoring and control of
process parameters to isolate processing deficiencies that are undetectable by
acceptance test of the product. “Special monitoring” does not exclude those process
controls, however, that are implemented by the fab and assembly sub-contractors that
are an integral part of their approved production processes.
7.5.2 Validation of Processes for Production

This requirement of the ISO standard is not applicable to AMS as stipulated in
paragraph 1.2 of this quality manual.
Page 23 of 23
7.5.3 Identification and Traceability
Identification and traceability requirements are established and procedures are in
place to ensure compliance.
Product is identified with a sales part number at the start of design of the part and is
used in conjunction with a cross-referenced manufacturing part number for
subsequent part and manufacturing activities. The AMS manufacturing part number
is used by the supplier during production. For additional traceability to the process,
wafer lot numbers and assembly date codes are assigned by the subcontractors at the
start of their respective production processes. The product is tracked through the
various stages of processing, storage and distribution using these assigned
identifications. The identification is recorded on all documents, such as process,
inspection and test records as defined in appropriate procedures. The supplier has the
responsibility to supply AMS with inputs of traceability records for all IC product
material. Documents related to product handled by AMS are maintained by AMS in
the appropriate lot folders and/or records maintained within the MRP system. (See
Doc. #00-0119, Product Identification and Traceability.
The status of material inspection and test is maintained by each approved supplier and
within the AMS MRP System. When product is tested at AMS, controls are provided
to give positive identification of inspection and test status. Controls include: color-
coded tubes/trays, use of travelers, physical location designations and updates to the
MRP System.
7.5.4 Customer Property

AMS by the nature of its business does not utilize customer-supplied product or
tooling. In the event the customers supply product, AMS would handle the product as
any other purchased product, as long as both are in concurrence with the tendered
contract. If not, the contract requirements would prevail. AMS does occasionally
receive customer-supplied items for the purpose of evaluation. These samples are
handled per Doc. #00-0118, Control of Customer-Supplied Items.
Page 24 of 24
7.5.5 Preservation of Product
The methods used for handling, storing, packaging, preserving and delivery of
material to ensure it is not damaged and that it is maintained in an acceptable
condition is documented in various processes, procedures and AMS Quality
Assurance Instructions (Q.A.I.s). Damaged or nonconforming material is controlled
and dispositioned according to established procedures as described in Doc. #00-0127,
Control of Nonconforming Product.
− Handling. The necessary resources have been made available for the proper
and safe handling of material.
− Storage. Areas within Receiving, Finished Goods and work-in-process are

designated for storage of material. Receipt and transfer of material
is performed by authorized personnel according to established
procedures.
Examination of stored material occurs at appropriate intervals. This

examination determines if any deterioration has occurred and
assesses the continued usability of the item(s).
− Packaging. Industry standard practices establishes the packaging and

identification requirements for material. Special customer
requirements are reflected in Quality Assurance Instructions
(Q.A.I.s). Prior to shipment, material is identified and packed to
meet AMS requirements to prevent damage. (See Doc. #00-0130,
Shipping.)
− Delivery. Material is delivered to customers using customer-designated

carriers or AMS-approved carriers, as applicable.
Page 25 of 25
7.6 Control of Monitoring and Measuring Devices
Measuring and Test Equipment
All measuring and test equipment is maintained and calibrated on a pre-scheduled
basis. Details are documented in: Doc. #00-0125, Calibration, Test Equipment.
AMS utilizes a positive recall calibration schedule to ensure identified equipment is

calibrated. Copies of calibration records for each piece of equipment are maintained
per section 5.5.7 of this manual. Calibration data is evaluated for drift in calibration
parameters as needed. The accuracy and precision of measuring, test, and inspection
equipment is addressed by the user or person(s) delegated with the responsibility for
equipment selection prior to the intended use ensuring measurement integrity.
Inspection and measuring equipment is selected for use based on the accuracy
required for the specific inspection/measurement being taken.
A complete inventory of measuring, inspection and test equipment used within AMS
is maintained on a Calibration List at each AMS US office.
Outside calibration laboratories, when used, are certified by approved facilities

having standards traceable to the National Institute of Standards and Technology
(NIST). Other sources, such as manufacturers’ reps servicing testers for calibration
and/or preventive maintenance (PM), shall have recorded procedures to perform these
activities.
Evaluation of results takes place after calibrations are performed to check the
adequacy of the calibration intervals presently in use.
All measuring, test, and inspection equipment bear a tag, sticker or other
identification showing calibration status.
New equipment used for measurement or inspection receives an initial calibration or

verification before release for use.
Where equipment is found to be out of calibration, an analysis is initiated to assess

impact on previously tested product and a Corrective Action Request (CAR) is issued
to initiate appropriate action.
Page 26 of 26
At all times, during both handling and use of equipment, care is taken to ensure that
damage is not sustained and that the calibrated accuracy of the equipment is not
adversely affected. Equipment is handled, stored and used under suitable
environmental conditions to sustain equipment integrity for its intended applications
and use.
If required by customers or their representatives, the necessary technical data

pertaining to applicable measuring/test equipment is available for the verification of
its functional adequacy.
Employee-owned equipment is not used for inspection, test or acceptance of any

product.
Software
The software that is developed for measurement or monitoring use is validated prior
to its release for pre-production or production use. (Ref. Doc. #00-0105, Test
Development.)
If changes are required to test hardware and/or software, it is validated prior to its re-
release for pre-production or production test use. (Ref. Doc. #00-0111, Test
Hardware and Software Control.)
Page 27 of 27
8.0 Measurement, Analysis and Improvement
8.1 General
AMS has the necessary methods in place to initiate those elements of measurements
and analysis to facilitate the assessment of product conformance and to achieve
improvement in whatever areas are deemed necessary within the Quality
Management System. The specifically-planned activities to achieve these objectives
are: Doc. #00-0101, Management Review, which is the primary function to assess the
performance levels and make necessary decisions regarding improvement
requirements. It also establishes improvement goals and objectives. Doc. #00-0139,
Customer Satisfaction Determination, which provides an action plan to obtain
information, analyze and take required action.
Doc. #00-0128, Return Material Authorization, which designates the plan of

obtaining information regarding product acceptability and taking corrective and/or
preventive action to improve detrimental conditions.
Doc. #00-0132, Internal Audits and Doc. #00-0136, Resolution to Internal Audit
Findings, which provides a plan for continuous assessment of the quality
management system to identify deficiencies that could impede meeting AMS
objectives.
Doc. #00-0107, Design Characterization; Doc. #00-0135, Supplier Review; and

Doc. #00-0138, Reliability Data Review & Monitors, which provides planned
activities that are used to measure, monitor and take remedial action on both process
and/or product deficiencies.
Doc. #00-0127, Control of Nonconforming Product, which provides for segregation

of suspected unsatisfactory product and allows for evaluation and
corrective/preventive action implementation.
Doc. #00-0134, Statistical Techniques, which provides a basic planning document for
analysis purposes.
Page 28 of 28
8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction
Customer satisfaction is determined by means of customer communications and
feedback. Major elements of this process are implemented through: Doc. #00-0102,
Customer Requirements and Communications; Doc. #00-0128, Return Material
Authorization; and Doc. #00-0139, Customer Satisfaction Determination. In the
implementation and analysis of the resultant information, management reporting is
initiated and action(s) taken that are necessary to either remedy customer
dissatisfaction or further improve on levels of customer satisfaction.
8.2.2 Internal Audit

Internal quality audits are planned and performed using documented procedures. (See
Doc. #00-0132, Internal Audits, and Doc. #00-0136, Resolution to Internal Audit
Findings.) The audits are performed by trained personnel on areas of which they
have no direct responsibility and can, therefore, conduct impartial, objective audits.
The audits objectively evaluate the effectiveness of all aspects of the Quality
Management System. Internal audits are scheduled on the basis of status and
importance of the activities involved.
Supervision/management of the area audited is responsible for reviewing any findings

found by the auditors and taking appropriate action to correct them. The Internal
Quality Auditors review and verify actions taken to ensure adequate and effective
corrective action of the findings. Findings, actions and closure are documented.
The Lead Auditor generates and distributes the audit report according to procedures.
The ISO Management Representative provides internal audit report summaries to
Executive Management for their review and assessment of the continued
effectiveness of the Quality Management System and the determination and
assignment of any remedial action that may be necessary.
8.2.3 Monitoring and Measurement of Processes

AMS activities related to the monitoring and measurement of realization processes
address those elements of design and sub-contractor control, as applicable. Design
monitoring is implemented through Doc. #00-0107, Design Characterization and
Doc. #00-0108, Design Qualification. Measurement and monitoring of supplier
processes is conducted through the analysis of data by the application of
Doc. #00-0138, Reliability Data Review & Monitors. Statistical process control
techniques are utilized as addressed in Doc. #00-0134, Statistical Techniques.
Primary objectives are to: determine that processes have the ability to achieve
planned results and to initiate corrective action if nonconformances are detected.
Page 29 of 29
8.2.4 Monitoring and Measurement of Product
The product measurement and monitoring activities are conducted to ensure that
product characteristics are maintained. As applicable to the production plan for
devices that are fabricated (Ref. Doc. #00-0120, Pre-Production or Doc. #00-0121,
Production), receiving inspection and tests are performed to verify acceptability.
These activities are performed in accordance with: Doc. #00-0122, Receiving
Inspection; Doc. #00-0123, Vendor Testing and/or Doc. #00-0124, In-House Testing.
8.3 Control of Nonconforming Product

AMS procedures ensure that items found to be non-conforming are clearly identified.
The nonconforming items are segregated and action taken to prevent use, shipment or
mixing with conforming products until properly dispositioned. (See Doc. #00-0127,
Control of Nonconforming Product.) In any instance where a rework/retest is
performed, it is re-inspected for acceptance prior to being directed to the next level.
AMS authorized personnel review and disposition nonconforming material and

products according to one or more of the actions listed. Disposition results are
documented as described in Doc. #00-0127. If required by contractual commitments,
any product deviation or rework not conforming to specified requirements is to be
reported to and approved by the customer before authorization to release for
shipment.
If a nonconformity is detected after delivery, AMS will take those actions that are
necessary, as appropriate, to the effects or potential effects of the nonconformance.
8.4 Analysis of Data

The various sections of this Quality Manual and their related process flow documents
address the need for, and implementation of, analyzing data in order to achieve and
measure the effectiveness of the Quality Management System in achieving the quality
policy and objectives. It is necessary to be addressed in this manner since it is a
collaborative process involving many departments and functions. Examples of data
collection and analysis and how it is integrated into the overall Quality Management
System are as delineated in the various following paragraphs of this Quality Manual.
• Paragraphs 7.3.5 and 7.3.6, Design Activities

• Paragraph 7.4.3, Verification of Purchased Product
• Paragraph 8.0, Activities Related to Analysis and Improvement
Page 30 of 30
The use of Doc. #00-0134, Statistical Techniques, provides direction for application
of various SPC methodologies for the analysis of data where it is advantageous to be
utilized. Final use of the data analysis results may be in the generation of
corrective/preventive action requests. A major agenda item for all management
reviews (Ref. Doc. #00-0101) is analysis results.
8.5 Improvement
8.5.1 Continual Improvement
Continual improvement is not a discrete process or element of the Quality
Management System, but rather a way of managing the system. The Quality
Management System has all of the necessary elements of establishing the policy and
objectives for quality, for implementing operational controls to achieve the objectives
and for measuring the results. The basic methodology and plan is that if the results
fail to meet the objectives, it is the fault of the system. Therefore, the system must be
improved so that it becomes more effective in reaching the objectives. When the
objectives are achieved, new objectives are set and the Quality Management System
is improved to meet the new challenges.
Identification of continual improvement needs are determined by analyzing customer

satisfaction information, product and process conformance data, supplier performance
data, internal audit results, and other data and information relevant to quality
performance. Management review considers all relevant information and defines
priorities for improving the quality system. The corrective action and/or auditing
processes are used to formally identify, respond to, verify acceptability of actions and
track the corrective action requests or internal audit findings.
Page 31 of 31
8.5.2 Corrective Action
The process utilized by AMS for the implementation of corrective action is as defined
within Doc. #00-0129, Corrective/Preventive Action. This correction action process
provides for: defining non-conformities, determining root cause, evaluating action to
ensure non-recurrence and implementing, recording and reviewing actions taken.
More detailed instructions related to the corrective action process are found in the
AMS procedure Doc. #02-0010.
8.5.3 Preventive Action

Preventive action is defined as an action taken based on the observance of a systemic
condition or the result of a corrective action where further action is deemed necessary
to curtail the same or similar occurrences within other processes or realization
activities. Implementation of preventive action measures are as defined in
Doc. #00-0129, Corrective/Preventive Action. The preventive action initiated is to be
appropriate to the potential impact of the problem. Similar to the corrective action
process, the process employed identifies potential nonconformities and their cause(s),
determines and ensures implementation, and records and reviews preventive actions
taken.
Page 32 of 32
Quality Manual
REVISION HISTORY AND DOCUMENT APPROVAL
Rev Description Date ECR #

A Initial Release 06/19/02
QUALITY MANUAL APPROVAL

The release/change document, “Document Change Request,” that is maintained in
Document Control provides the approval signatures of: CEO/President, CFO, and
management representatives from: Business Units, Sales, Engineering Services,
Operations and Quality Assurance.
Page 33 of 33

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Advanced Monolithic Systems, Inc.

Document #00-0001 Rev A

Advanced Monolithic Systems, Inc.

1.0 Scope ...................................................................................................................... 5

Table of Contents (continued)

6.0 Resource Management ........................................................................................ 16

Table of Contents (continued)

8.0 Measurement, Analysis and Improvement ........................................................ 28

AMS is a designer and manufacturer of semiconductors specializing in the design and

1.2 Exclusions from ISO Standard

This manual is maintained by the ISO Management Representative. AMS

a) Identify system processes and their application within AMS.

4.2 Documentation Requirements

Level I — AMS Quality Manual

Level II — Processes in flow chart format and as defined on Master Lists.

Level IV — Completed records as defined in Level II documents as “QR” and in

To provide for internal communication and effectiveness of the utilization of the

a) Quality Policy & Objectives (Ref. paragraph 5.3.)

4.2.2 Quality Manual

4.2.3 Control of Documents

AMS acknowledges acceptance of customer-imposed requirements, specifications

Document Control is responsible for making documents available at their points of

Product proposal documents are considered to be preliminary working copies and, as

00-0110, Document Control; 00-0111, Test Hardware and Software Control;

4.2.3.3 Data Back Up

4.2.4 Control of Records

Storage of records is in a suitable environment that prevents damage, deterioration

a) Communicating to all AMS personnel the importance of meeting customer,

5.2 Customer Focus

• To provide excellent semiconductor product design, manufacturing and related

5.4.2 Quality Management System Planning

00-0101 Plan for implementation of Management Reviews.

00-0102 & -0103 Plan for implementation of customer communication requirements.

00-0104 through 0108 Design-related activity plans and flow.

00-0109 Design planning and implementation relative to design changes.

00-0117 & –0140 Planned activities for procurement functions.

00-0118 Plan for implementing the control of customer-supplied material.

00-0119 Identification and traceability plan and flow.

00-0120 & -0121 Pre-Production/production plans and flow.

00-0127 & -0128 Nonconforming product control planning and implementation

00-0129 Corrective/Preventive Action implementation plans.

00-0130 Shipping functions planning and flow.

00-0131 Plan for the control of quality records.

00-0132 & -0136 Plan for conducting internal audits.

00-0133 Plan and flow for conducting employee training.

00-0139 Planned activities related to customer satisfaction determination.

5.5 Responsibility, Authority and Communication

AMS management encourages all employees to recommend or provide preventive or

Communication of the Quality Management System shall be provided to all AMS

— Ensure the promoting of customer requirements throughout the organization.

5.5.3 Internal Communication

b) Establishing and maintaining a communications network (INTRANET) that

c) Providing ongoing communication regarding the effectiveness of processes that

d) Provide intra-company wide communication to all employees via e-mail

Management review is further documented in Doc. #00-0101, Management Review.

5.6.2 Review Input

5.6.3 Review Output

6.2 Human Resources

As a minimum, supervisors and managers initially review training and experience