QS MN 001 REV K Quality Systems Manual

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QUALITY SYSTEMS MANUAL

1410 Martin Ave - Santa Clara California 95050

Printed Copies are UNCONTROLLED


Contact Quality Systems Department for the current revision prior to using printed copies

Issue Date: 06/15/2016 QS-MN-001 Revision K


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Table of Contents
Section Element Description Page
N/A Cover Page 1
N/A Table of Contents 2 -3
N/A Introduction 4
N/A Scope of Registration 4
N/A Statement of Commitment 4
N/A Mission Statement 5
N/A Quality Policy 5
N/A Environmental Policy 5
N/A Absence of REACH Substances of Very High Concern 5
N/A Right of Access 5
N/A Counterfeit Electronic Parts, Avoidance, Detection, Mitigation and Disposition 5
N/A Conflict Mineral Policy 6
N/A Quality Manual Distribution & Approvals 7
N/A Organizational Structure and Technical Review Board 8
1 Scope
1.1 General 9
1.2 Application (includes Exclusion Table)
2 Normative Reference
10
2.0 Quality Management Systems References
3 Definitions
11
3.0 Quality Management Systems Definition
4 Quality
4.1 General Requirements
4.2 Documentation Requirements
4.2.1 General
12-15
4.2.2 Quality Manual
4.2.3 Control of Documents
4.2.4 Control of Quality Records
Section Includes: Interaction of Processes Diagram
5 Management Responsibility
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning
5.4.1 Quality Objectives
5.4.2 Quality Management System Planning
5.5 Responsibility, Authority and Communication 16-19
5.5.1 Responsibility and Authority
5.5.2 Management Representative
5.5.3 Internal Communication
5.6 Management Review
5.6.1 General
5.6.2 Review Input
5.6.3 Review Output
6 Resource Management
6.1 Provision of Resources
6.2 Human Resources
20-21
6.2.1 General
6.2.2 Competence, Training and Awareness
6.3 Infrastructure

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6.4 Work Environment

7 Product Realization
7.1 Planning of Product Realization
7.1.1 Project Management
7.1.2 Risk Management
7.1.3 Configuration Management
7.1.4 Control of Work Transfers
7.2 Customer-Related Processes
7.2.1 Determination of Requirements Related to the Product
7.2.2 Review of Requirements Relate to the Product
7.2.3 Customer Communication
7.3 Design and Development (not applicable)
7.4 Purchasing 22-29
7.4.1 Purchasing Process
7.4.2 Purchasing Information
7.4.3 Verification of Purchased Product
7.5 Product and Service Provision
7.5.1 Control of Production and Service Provision
(Includes Cleanliness of Product and Outsourced Processes)
7.5.1.1 Production Process Verification
7.5.1.2 Control of Production Process Changes
7.5.1.3 Control of Production Equipment, Tools and Software Programs
7.5.1.4 Post-Delivery Support
7.5.2 Validation of Process for Production and Service Provision
7.5.3 Identification and Traceability
7.5.4 Customer Property
7.5.5 Preservation of Product
7.6 Control of Measuring and Monitoring Equipment
8 Measurement, Analysis and Improvement
8.1 General
8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction (Feedback and Complaint Handling)
8.2.2 Internal Audit
8.2.3 Monitoring and Measurement of Processes
8.2.4 Monitoring and Measurement of Product
30-34
8.3 Control of Nonconforming Product
8.4 Analysis of Data
8.5 Improvement
8.5.1 Continual Improvement
8.5.2 Corrective Action
8.5.3 Preventive Action

N/A Appendix A Master List of Key QMS Documents


35
N/A Quality Systems Manual Revisions
36

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Introduction
Streamline Circuits is a leading provider of high quality printed circuit boards. We are committed to providing our
customers the most advanced technology, quality and engineering support available. Customers take advantage
of these resources to develop cost effective products in a time sensitive manner. This is critical for today's
customers who want and need to get their quality products first to market.

Streamline Circuits acquired Excel Circuits in September 2003. Excel Circuits was established in 1982 to meet
an ever-increasing demand for complex printed circuit boards.

Streamline Circuits management team has over 300 cumulative years of PCB experience, Streamline Circuits
is led by CEO Chuck Dimick, who is widely recognized throughout the industry, for advanced technology
leadership and superior quality.

Streamline Circuits is register with International Traffic in Arms Regulations (ITAR Part 122) as a manufacture
and exporter (Registration Code M18448).

Streamline Circuits has developed and implemented a QMS (Quality Management System) to document the
companys best business practices, better satisfy the requirements and expectations of its customers, and
improve the overall management of the company.
This quality manual outlines the policies, procedures and requirements of the QMS. The system is structured to
comply with the conditions set forth in the International Standard ISO 9001:2015, AS9100C, ISO 13485:2016,
MIL-PRF-55110, MIL-PRF-31032, NADCAP and ITAR. Registration to these standards is maintained through the
registration program of UL DQS, qualifying activity, Nadcap and the Office of Defense Trade Controls Compliance
and Registration Division (CRD).
This manual is divided into five sections that best correlate with the QMS sections of the ISO 9001:2015, ISO
13485:2016 and AS9100C format. This manual is used internally to guide the companys employees through the
various requirements of the ISO 9001: 2015, ISO 13485: 2016 and AS9100C standards that must be met and
maintained in order to ensure customer satisfaction, continuous improvement, and provide the necessary
instructions that create an empowered workforce.
This manual is used externally to introduce our QMS to our customers and other external organizations. This
manual is used to familiarize those individuals with the controls Streamline Circuits has implemented. It also
assures them that the integrity of the QMS is maintained and that we are focused on customer satisfaction and
continuous improvement.

Scope of Registration
Streamline Circuits interactions are limited since we are a contract manufacturer. Of double-sided, multilayer
rigid, rigid flex and flex, MCM-L, HDI, embedded passive devices and microwave printed circuit boards. For
industrial, commercial, aerospace space, defense, and medical applications.

Statement of Commitment
Management will provide our customers with products and services that meet or exceed expectations

Management will provide leadership and actively participate in the quality process and above all, will make
improvements the focal point of our company

We will promote the spirit of continuous improvement and provide consistent direction in all aspects of our
business

We will invest in our employees in order for them to become educated in total quality improvement process

The quality team, representing management of Streamline Circuits is the approval authority for the Quality
System/Plan operating throughout Streamline Circuits.

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Mission Statement
To provide our customers with products and services that meet or exceed expectations

To provide a safe working environment that promotes honest communication, loyalty, ownership, employee
advancement and the protection of the earths environment

To develop partnerships with suppliers and customers to accelerate product and service advancement

Quality Policy
We the employees of Streamline Circuits make the commitment to first understand our customers expectations,
to meet or exceed our commitment to those expectations by;

Provide a framework for establishing, reviewing, understanding and communicate quality objectives,
Ensuring that we comply, with all applicable internal & external requirements,
Ensuring continuous improvement with the intent to improve processes, product and our customer's total
experience
Maintain the effectiveness of our Quality Management Systems.

Quality Objectives refer to QS-PC-007

Environmental Policy
Streamline Circuits recognizes that the privilege of conducting business in our communities demands excellence
in our environmental, health and safety performance.

Streamline Circuits is committed to the safe operation of our facility, the welfare of our employees and
community, and the protection of the earths environment. Accordingly,

Streamline Circuits will:

comply fully with the requirements of all applicable laws and regulations, and follow relevant industry
standards for safety, engineering, and principles of risk management;

operate our facilities in a manner that continuously improves employee and public safety and
environmental protection;

require, as a condition of employment, that all employees accept personal responsibility and
accountability for safe work behavior, and

provide effective employee environmental, health, and safety training.

Absence of REACH Substances of Very High Concern Policy


As supplied, there are no substances intended to be released from our products as defined by article 7 (1) under
normal or reasonably foreseeable conditions of use.

Streamline Circuits committed to comply in every respect to the requirements of REACH and relevant
amendments. At present we do not expect any anticipated Substances of Very High Concern to be in our
products requiring reporting to the supply chain.

Right of Access
Streamline Circuits grants the right of access to our customer to inspect any or all materials included in their
purchase order.

Counterfeit Electronic Parts, Avoidance, Detection, Mitigation and Disposition


Streamline Circuits has a documented Counterfeit Material Avoidance Plan (QS-PL-005), and we are a active
member Government - Industry Data Exchange Program (GIDEP).

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Conflict Mineral Policy
There has been increased awareness of violence and human rights violations in the mining of certain minerals
from a location described as the Conflict Region, which is situated in the eastern portion of the Democratic
Republic of the Congo (DRC) and surrounding countries. Companies around the globe have been requested to
practice reasonable due diligence with their supply chain to assure that specified metals are not being sourced
from mines in the Conflict Region, which is controlled by non-government military groups, or unlawful military
factions.

Streamline Circuits supports this initiative and has either obtained, or is in the process of obtaining, information
from our current metal suppliers concerning the origin of the metals that are used in the manufacture of
Streamline Circuits products. Based upon information provided by our suppliers, Streamline Circuits does not
knowingly use metals derived from the Conflict Region in our products.

Suppliers of metals used in the manufacture of Streamline Circuits products (specifically gold and tin) must
demonstrate that they understand the conflict minerals laws and will not knowingly procure specified metals that
originate from the Conflict Region.

Suppliers must review and agree in writing to the following conflict minerals contractual language:

Supplier represents and warrants that it is in full compliance with conflict minerals laws, including, without
limitation, Section 1502 of the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010 as it may be
amended from time to time and any regulations, rules, decisions or orders relating thereto adopted by the
Securities and Exchange Commission or successor governmental agency responsible for adopting regulations
relating thereto (collectively, (Dodd-Frank Section 1502).

Supplier must cooperate with Streamline Circuits to make available to Streamline Circuits and/or its
agents, full material declarations that identify the sources of and amount of all substances contained in
the Products. Unless Streamline Circuits specifically agrees in writing that a particular Product may
contain a particular material, Supplier will also provide a statement that the Products do not contain
various materials at issue in applicable laws and regulations.

Supplier must declare each Products compliance to all applicable hazardous material legislation and
identify any substances that are banned or must be declared under applicable laws. In addition, Supplier
will make available any documentation that supports the declaration. Without limiting the generality of the
foregoing, Supplier agrees to disclose to Streamline Circuits, upon Streamline Circuits request, to the
extent known or discoverable by Supplier following inquiry, the original source of all minerals contained in
the Product.

If Supplier does not know the original source of the minerals, Supplier agrees to cooperate with
Streamline Circuits, including disclosing from whom Supplier purchased the minerals and urging others
to disclose such information, so that the original source of minerals can be accurately determined and
reported. Supplier shall comply with all laws regarding the sourcing of minerals, including, without
limitation, laws prohibiting the sourcing of minerals from mines controlled by combatants and Dodd-Frank
Section 1502.

Without any further consideration, Supplier shall provide such further cooperation as Streamline Circuits
may reasonably require in order to meet any obligations it may have under conflict minerals laws,
including, without limitation, under Dodd-Frank Section 1502.

As a leading global company in the manufacturing of printed wiring boards, Streamline Circuits is committed to
ensuring the safety, health and protection of people and the environment worldwide. We promote these principles
in our global business practices and our code of conduct.

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Quality Manual Distribution & Approvals

The Quality Manual shall be distributed to the following:

Chief Executive Officer,


President/CTO,
Vice President of Marketing/Sales,
Operations Manager,
Manufacturing Manager,
Director of Quality/Management Representative,
Director of Engineering,
Front-End Manager,
Purchasing Manager,
Sales Manager,
Customer Service Manager,
Information Systems Manager,
Human Resources

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Organizational Structure and Technical Review Board

CEO

Controller President/CTO
Human Resources
Accounting

Operations Manager* V.P. of Sales/Marketing Director or Information Director of Quality* Director of Quality Systems*
Purchasing Marketing/Sales inside/Outside Technology (Management Representative) (Management Representative)
Engineering Customer Service Receiving Inspection UL / GIDEP
IT
Pre-Engineering ITAR AOI & Final Inspection
Maintenance Electrical Test
Environmental/Safety Wet/Dry Lab Analysis

Director of Engineering* Manufacturing Manager* Maintenance Manager Purchasing Manager Environmental Manager Pre-Engineering
Process Engineers Shift Manager Infrastructure Purchasing Safety/Training Engineering Manager*
Product Development Production Control Housekeeping Inventory Conflict of Minerals Planning/ Cam
Application Engineers Facilities PMS Waste Treatment
REACH

Roles are documented within their job descriptions (refer to section 5.5.1 in this manual).

TRB Members are identified by an asterisk (*) refer to MIL-PRF-31032 Quality Management Plan

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Section 1: Scope

1.1 General
Streamline Circuits is a manufacturer of rigid and flex, high speed, signal integrity printed circuit boards for
commercial, aerospace, microwave, medical and military applications. The scope of the QMS includes all
processes that produce the products and/or services. Our QMS is our means of assuring the printed boards we
manufacture meet applicable aviation, space, defense, medical, industry, customer and applicable regulatory
requirements for safety and performance. Streamline Circuits follows all required City, State and Federal
statutory and regulatory guidelines and UL regulatory support when applicable.

The special requirements and needs of Streamline Circuits customers (external and internal) require a special
emphasis on pre-production engineering and quality review. Customer data is verified using design rule software,
which ensures manufacturability. Quick turn volumes are produced with production ready tooling, which ensures
consistency from prototyping to production volumes. The special needs of customers are documented in
customer and part number specific quality plans. The quality plan identifies the processes and controls required to
meet these special requirements and needs. We are a contract manufacturer life-cycles of products we build at
Streamline Circuits are controlled by our customer. The quality plan identifies the processes and controls
required to meet these special requirements and needs.
The product is manufactured and certified to meet the performance specifications and class, as specified by the
customer. If a class is not specified Streamline Circuits will default to IPC Class 2. Streamline Circuits
considers information shared confidential and proprietary.

1.2 Application
Streamline Circuits QMS meets the requirements of the AS9100, ISO 9001:2015 and ISO 13485:2016. The
following table identifies ISO 9001:2015 and ISO 13485:2016 requirements not applicable to our organization and
provides a brief narrative justifying their exclusion from the scope of our QMS:
These sub-clauses may or may not align with the clause numbering scheme
Clause or Sub-Clause Exclusion Justification
ISO 13485:2016 Medical device files Streamline Circuits products do not
4.2.3 require installation or servicing
activities.
ISO 13485:2016 For sterile medical devices Streamline Circuits products do not
6.4.2 require sterilization.

AS9100 - ISO 9001:2015 7.3 Design and Development Streamline Circuits does not
ISO 13485:2016 7.3 participate in design or development.

ISO 9001:2015 - 8.3


ISO 13485:2016 Control of Production and Service Streamline Circuits products do not
Provision require sterilization, installation or
Cleanliness of product and servicing activities.
7.5.2
contamination control a), b) and c)
7.5.3
Installation activities
7.5.4
Servicing activities
7.5.5
Particular requirements for sterile
medical devices
Particular requirements for validation of
processes for sterilization and sterile
barrier systems
Particular requirements for implantable
7.5.9.2
medical devices

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Section 2: Normative Reference

2.0 Quality Management System References

The following documents were used as reference during the preparation of the Quality Management System:
American National Standard ANSI/AS 9001/ASQ Q9000 latest revision, Quality Management Systems
Fundamentals and Vocabulary
American National Standard ANSI/AS 9001/ASQ Q9001latest revision, Quality Management Systems
Requirements
American National Standard ANSI/AS 9001/ASQ Q9004 latest revision, Quality Management Systems
Guidelines for performance Improvements
SAE Aerospace SAE AS9100 latest revision - Quality Management Systems Requirements
MIL-PRF-31032 latest revision - Certification and Qualification Information for Manufacturers
International Standard ISO 13485:2016 Medical Devices Quality Management Systems
Requirements for Regulatory Purposes

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Section 3: Definitions
3.0 Quality Management System Definitions

This section is for definitions unique to Streamline Circuits.

Customer owned property - Any type of instrumentation, accessories, manuals, or shipping containers
that belong to a customer.
Customer supplied product - Any type of service or material supplied to be utilized in the manufacture,
modification or repair of customer-owned property.
Product The end item result of meeting all contracts (terms and conditions).
Quality Records Documentation of those activities wherein records of said activities must be maintained
will be specified in the procedure or work instruction level documents, as applicable.
Key Characteristics An attribute or features whose variation has a significant effect on product fit, form,
function, performance, service life, or producibility, that requires specific actions for the purpose of
controlling variation.
Risk - An undesirable situation or circumstance that has both a likelihood of occurring and a potentially
negative consequence.
Special requirements - Those requirements identified by the customer, or determined by the organization,
which have high risks to being achieved thus, requiring their inclusion in the risk management process.
Factors used in the determination of special requirements include product or process complexity, past
experience and product or process maturity.
Critical items - Those items (e.g., functions, parts, software, characteristics, processes) having significant
effect on the product realization and use of the product; including safety, performance, form, fit, function,
producibility, service life, etc.; that require specific actions to ensure they are adequately managed.
Advisory notices Organizations often issue advisory notices after their medical devices have been
delivered. These advisory notices provide supplementary information about the device or specify actions
that should be taken. Streamline Circuits is a contract manufacturer we build to customer drawing. We
do not issue advisory notices. This would be the responsibility of the customer.
QM Plan Is the documentation used to describe the QM program implementation. It is a controlled
document with, at a minimum, a separate section for each element noted in paragraph A.3.2.1 of MIL-
PRF-31032.
Technical Review Board (TRB) Is a cross-functional team made up of responsible individuals selected
from different areas covered by the QM program.
Self-Validation Is the manufacturers means of determining compliance to MIL-PRF-31032 and the QM
program
Use-As-Is Means in accordance with specifications and/or customer requirements.

Refer to additional terms and definitions

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Section 4: Quality Management System

4.1 General Requirements


Streamline Circuits has determine external and internal issues that are relevant to purpose and its strategic
direction and that affect its ability to achieve the intended result(s) of its QMS.

Streamline Circuits has established documented and implemented Quality Management System (QMS) in
accordance with the requirements of AS9100, ISO 9001:2015, ISO 13485:2016 and MIL-PRF-31032 latest
revisions. The system is maintained and continually improved through the use of the quality policy, quality
objectives, audit results, analysis of data, corrective and preventive action, and management review.

To design and implement the QMS Streamline Circuits has:


determine the inputs required and the outputs expected from the processes needed for the QMS and their
application throughout the organization. Documented on the Interaction of Process Diagram at the end
of this section page 14;
apply a risk based approach to the control of the appropriate processes needed for the QMS;
determined the sequence and interaction of these processes. Documented on the Interaction of Process
Diagram at the end of this section page 14;
determined criteria and methods needed to ensure that the operation and control of the processes are
effective, these are documented in quality plans and/or work instructions;
ensured the continuing availability of resources and information necessary to achieve planned results and
continual improvement of these processes;
assign the responsibilities and authorities for these processes;
established systems to monitor, measure where applicable and analyze these processes;
established processes to identify and implement actions necessary to achieve planned results and
continual improvement of these processes, and
establish and maintain records needed to demonstrate conformance to the standards and compliance
with applicable regulatory requirements.
Printed Circuits Board Process Flow Charts are available upon request. Charts may not necessarily depict all
steps needed dependent upon the complexity of the products technology. Additional flow are available upon
request (MF-PL-003, MF-PL-004, MF-PL-005 and MF-PL-006).

Streamline Circuits manages the quality management system processes in accordance with the requirements of
the standards and applicable regulatory requirements. Changes to be made to these processes shall be:
evaluated for their impact on the QMS, and
evaluated for their impact on product produced under this QMS.

Outsource processes are managed by Streamline Circuits it does not absolve us of the responsibility of
conformity to all customer, statutory and regulatory requirements. Regulatory requirements are met by meeting
customers requirements. The controls shall be proportionate to the risk involved and the ability of the external
part to meet the requirements in section 7.4 in this manual. Our controls included flow-down requirements.

Streamline Circuits has documents procedures for validation of the application of computer software used in the
QMS. Such software applications are validated prior to initial sue and as appropriate, after changes to such
software. The specific approach and activities associated with software validation and revalidation are
proportionate to the risk associated with the use of the software. Records of such activities are maintained.

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4.2 Documentation Requirements
4.2.1 General

The QMS documentation includes:


a documented quality policy and quality objectives;
this quality manual;
documented procedures and records required by the standards;
documents, including records determined by Streamline Circuits to be necessary to ensure the effective
planning, operation and control of our processes;
a description of the interaction between the processes of the QMS and
other documentation specified by national or regional regulations.

Streamline Circuits ensures that personnel have access to, and are aware of, relevant QMS documentation and
changes. We also provide customer or statutory and regulatory authorities access to QMS documentation.

Level 1
Quality Manual

Level 2
QMS Procedures

Level 3
Standard Operating Procedures

Level 4
Records

4.2.2 Quality Manual

This Quality Manual has been prepared to describe Streamline Circuits QMS. The scope and permissible
exclusions of the QMS are described in section one of this manual. Each section of the manual references
documented QMS procedures relating to the requirements outlined in that section. The QMS Systems Diagram at
the end of section 4 provides a description of the interaction between the processes of the QMS system.

4.2.3 Control of Documents

We are a contract manufacturer Medical device files are maintained within our configuration management
(QS-PR-039). Tool file is created with a unique identifier assigned to single customer part number, revision and
/or process change to said part number.

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Documents required by the QMS shall be controlled according to the Document Control Procedure (QS-PR-
001). Records are special type of document (see 4.2.4) and shall be controlled according Control Quality
Records Procedure (QS-PR-002). This procedure defines the process for:
reviewing and approving documents for adequacy prior to issue;
reviewing and updating as necessary and re-approving documents;
ensuring that changes and current revision status of documents are identified;
ensuring that relevant versions of applicable documents are available at points of use;
ensuring that documents remain legible and readily identifiable;
ensuring that documents of external origin determined by Streamline Circuits to be necessary for the
planning and operation of the QMS are identified and their distribution controlled;
prevent deterioration or loss of documents;
preventing the unintended use of obsolete documents, and to apply suitable identification to them if they
are retained for any purpose, and
obtaining customers and/or regulatory agency approvals when required by contract or statutory and
regulatory requirements. Regulatory requirements are met by meeting customers requirements.

Streamline Circuits ensures that changes to documents are reviewed and approved either by the original
approving function or another designated function.
Documents are maintained is Q-Pulse QMS database within document module. Obsolete documents are retained
indefinitely and only the document administrator as access to these documents.

4.2.4 Control of Records

Records established to provide evidence of conformity to requirements and of the effective operation of the QMS
are controlled. The records, including certification information of QML product and those created by or maintained
according to the Control of Quality Records Procedure (QS-PR-002). The procedure defines the controls
needed for the identification, storage, protection, retrieval, retention time and disposition of records. Records
remain legible, readily identifiable and retrievable.
Streamline Circuits is a contract manufacturer record retention is based upon industry standards and/or
customer requirements documented in Records Table (QS-ML-001).
Records are made available to customers / regulatory agencies when required by contract or statutory and
regulatory requirements. Regulatory requirements are met by meeting customers requirements.

Related Procedures
Document Control Procedure QS-PR-001
Control Quality Records Procedure QS-PR-002
Quality Objectives QS-PC-007
Records Table QS-ML-001
Flex Type 1 & 2 Printed Circuit Board Process Flow Chart MF-PL-003
Flex Type 3 & 4 Printed Circuit Board Process Flow Chart MF-PL-004
Rigid Type 1 & 2 Printed Circuit Board Process Flow Chart MF-PL-005
Rigid Type 3 & 4 Printed Circuit Board Process Flow Chart MF-PL-006

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Interaction of Processes Diagram

5.1 Management Responsibility


8.5.1 Continuous Improvement

1.Receive Order from Sales, Contract & Customer Service (1, 2 & 3)
7.2.2 Review of Requirements/Risk Management
Customer 7.2.3 Customer Communication

7.1 Planning of Product Realization

2. Is Customer Supplied 3. Contact Customer for


No
Package complete? Clarification
Receiving/Receiving Inspection (6, 7, 8 & 9)
7.5.4 Customer Property
Yes

6. Receive Material from 4. Buy Material or Purchasing (4 & 5)


7.4 Purchasing
Customer when applicable Pull from Stock
4.2.3 Control of Documents

7.4.3 Verification of Purchased Product


7. Receive Material 8.5.2 Corrective Action
8.2.4 Monitoring & Measurement
of Product

6.2.2 Competency, Awareness & Training


8.5.2 Corrective Action

9. Inspection
8.2.2 Internal Audits

4.2.4 Control, of Records


8.4 Analysis of Data Results 8. Is Material Acceptable? No 5. Return to Supplier

8.5.3 Preventive Actions


7.6 Control of Monitoring & Measuring Production (10 & 11)
Yes
Devices 4.2.4 Control of Records
7.5.3 Identification & Traceability
7.1 Product Service Realization Seven Core Processes
10. Build to Requirements
1. Pre-Engineering
Seven Core Processes Sh op 2. Drill
8.2.3 Monitor Measure Process
8.2.4 Monitor / Measure Product Travelers are Customized 3. Dry Film
4. Lamination
5. Wet Process /Plating
6. Solder mask/Legend
7. Rout/Fabrication
8.2.4.2 First Article Inspection
11. Verify Build to
Requirements

8.2.4 Monitor / Measure Product


8.1 Statistical Techniques 7.5.3 Identification & Traceability

Final Inspection (12, 13 & 14)


8.2.4.1 Inspection 13. Inspection
Documentation 14. Rework to
Results 12. Is Product Acceptable? No
8.2.4.2 First Article Inspection Requirements
4.2.4 Control, of Records
8.4 Analysis of Data
8.4.1 Root Cause Analysis 8.3 Non-Conforming Product
Yes
8.5.2 Corrective Action
8.5.3 Preventive Action
15. Package & Ship Finished Shipping (15)
Product 7.5.5 Preservation of Product

16. Provide Customer


Support Sales, Contract & Customer Service (16, 17, 18 &
19) 7.5.1 Servicing

18. Monitor Customer 17. Is Additional Support 19. Based on Customer Feed-
Satisfaction Required
Yes Back Determine Course of
Action

5.4 Quality Planning


5.2 Customer Focus

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Section 5: Management Responsibility

5.1 Management Commitment


Streamline Circuits top management has been actively involved in implementing the Quality Management
System (QMS). It has provided the vision and strategic direction for the growth of the QMS, and established
quality objectives and the quality policy.

To continue to provide leadership and show commitment to the improvement of the QMS, Streamline Circuits
management will do the following:
taking accountability for effectiveness of the QSM;
ensuring that the quality policy and quality objectives are established for the QMS. They are compatible
with the context and strategic direction of Streamline Circuits;
ensuring the integration of the quality management system requirements into Streamline Circuits
business processes;
promotes the use of the process approach and risk-based thinking;
ensure the availability of resources
communicating the importance of effective QMS and of conforming to QMS requirements;
ensuring that the QMS achieves its intended results;
engaging, directing and supporting employees to contribute to the effectiveness of the QMS;
promoting improvement;
supporting other relevant management roles to demonstrate their leadership as it applies to their areas of
responsibility;
communicating to the organization the importance of meeting customer, statutory and regulatory
requirements, and
conduct annual management reviews.

5.2 Customer Focus


Streamline Circuits strives to identify current and future customer needs, to meet customer requirements and
exceed customer expectations.
Top management ensures that customer requirements are understood and consistently met. The risks and
opportunities that can affect conformity of products and ability to enhance customer satisfaction are determined,
addressed and communicated to the appropriate people in our organization. They ensure that product conformity
and on-time delivery performance are measured and that appropriate action is taken if planned results are not, or
will not be achieved

5.3 Quality Policy


Top management ensures that the quality policy is communicated to all employees. It is included in new
employee training and training on the QMS. The Quality Policy (QS-PC-001) is posted in prominent places
throughout our facility to maintain high standards within our organization. The Quality Policy is also located on
page 5 of this manual.
Management reviews the quality policy requirements at each management review meeting to determine the
policys continuing suitability for our organization. It provides the framework for establishing and reviewing our
quality objectives.

5.4 Planning
5.4.1 Quality Objectives

Quality objectives are established to support our organizations efforts in achieving our quality policy and reviewed
annually for suitability.

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Objectives are established at relevant functions and levels within the organization. Quality objectives are
consistent with the quality policy, measurable, take into account applicable requirements, relevant to conformity of
products to enhancement of customer satisfaction, monitored, communicated and updated as required refer to
Quality Objective (QS-PL-007).

5.4.2 Quality Management System Planning

Our quality system has been planned and implemented to meet our quality objectives and requirement of the ISO
9001:2015, AS9100, ISO 13485:2016 and MIL-PRF-31032. We determine the risks and opportunities that need
to be addressed to give assurance that the QMS can achieve its intended results(s) and enhance desirable
affects. Quality planning takes place, as changes that affect the quality system are planned and implemented. To
prevent, or reduce, undesirable effects and achieve improvement. Refer to MIL-PRF-31032 Quality Management
Plan Procedure (QS-PR-041).

5.5 Responsibility, Authority and Communication


5.5.1 Responsibility and Authority

The Chief Executive Officer (CEO) and President sets direction and ensures the success of Streamline Circuits.
An organizational chart has been established to show the interrelation of personnel in the organization. Job
descriptions define the responsibilities and authorities of each of the positions on the organizational chart. Job
descriptions and the organizational chart are reviewed and approved by top management for adequacy. These
documents are available to help employees understand responsibilities and authorities. Refer to Organizational
Structure and Technical Review Board (QS-CH-001) and page 8 of this manual.

Top Management: Members of top management are ultimately responsible for the quality of Streamline Circuits
products and services since they control the systems and processes by which work is accomplished. Top
management is responsible for strategic planning, development and communication of our quality policy, QMS
Planning, including the establishment and deployment of corporate level objectives, and the provision of
resources needed to implement and improve the quality system.

Management: All officers, managers, engineers and floor supervisors are responsible for execution of the
strategic plan and implementation of the policies, processes and systems described in this manual. They are
responsible for planning and controlling quality system processes within their area(s) of responsibility, including
the establishment and deployment of operational level objectives, and the provision of resources needed to
implement and improve these processes. Managers also conduct employee performance reviews as needed.

Employees: All employees are responsible for the quality of their work and implementation of the policies and
procedures applicable to processes they perform. Employees also identify and report any know or potential
problems and recommend related solutions through the internal audit and/or corrective/preventive action
processes.

The President shall appoint members to the Technical Review Board. The members in total shall have the
experience and knowledge to make decisions regarding printed circuit board acceptability and certification. Refer
to Organizational Structure and Technical Review Board (QS-CH-001) and page 8 of this manual.

5.5.2 Management Representative

The Director of Quality has been appointed by top management as our management representative. As
Management Representative, he/she has the following responsibility and authority:
ensure that processes needed for the QMS are established and implemented;
report to top management on the performance of the QMS, and note needed improvements;
promote awareness of customer requirements throughout the organization;

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act as a liaison with external parties such as customers or auditors on matters relating to the QMS
Resolve matters pertaining to quality issues;
organizational freedom and unrestricted access to top management to top management to resolve to
quality management issues and
ensuring the promotion of awareness of regulatory and customer requirements throughout the
organization.

5.5.3 Internal Communication

Streamline Circuits ensures communication within the organization between its various levels and functions
regarding the effectiveness of the QMS. Methods of communicating the effectiveness of the QMS include, but are
not limited to training, organizational meetings, internal audits, and management reviews and other routine
business communication.

The Quality group may post information throughout the facility to convey information regarding customer
requirements and the status and importance of quality activities. The Environmental group may post information
on safety throughout the facility to convey information regarding the status of the Safety and Environmental
Management Program, and related statutory/regulatory requirements. Regulatory requirements are met by
meeting customers requirements.

5.6 Management Review


5.6.1 General

Streamline Circuits top management reviews the QMS annually at Management Review meetings (or more
frequently, as is determined by top management). This review assesses the continuing QMS suitability, adequacy
and effectiveness, identifying opportunities for improvement, and as-needed changes. Records are maintained for
each management review meeting (see 4.2.4).

Streamline Circuits Technical Review Board shall meet quarterly (or more frequently, as is determined by TRB)
to evaluate the status of the QM program.

5.6.2 Review Input

Assessment of the QMS is based on a review of information inputs to Management Review. These inputs include
the following:
results of audits;
customer feedback this includes complaint handling;
process performance and product conformity;
status of preventive and corrective actions;
follow-up actions from previous management reviews;
changes that could affect the QMS;
recommendations for improvement and
new or revised regulatory requirements are met by meeting customers requirements.

5.6.3 Review Output

During our review meetings, Streamline Circuits management will identify appropriate actions to be taken
regarding the following issues:
improvement on the effectiveness of the QMS and its processes;
Improvement of products related to our customer requirements,
changes needed to respond to applicable new or revised regulatory requirements and

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resource needs.

Responsibilities for required actions are assigned to members of the management review team. Any decisions
made during our management review process actions are assigned, and their due dates are recorded in the
minutes of management review. Refer to Management Responsibility Procedure (QS-PR-006).

Related Procedures:
Quality Policy QS-PC-001
Management Responsibility Procedure QS-PR-006
Organizational Structure and Technical Review Board QS-CH-001
Quality Objectives QS-PC-007
MIL-PRF-31032 Quality Management Plan QS-PR-041

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Section 6: Resource Management

6.1 Provision of Resources


Streamline Circuits has implemented a QMS that complies with ISO 9001:2015, AS9100, ISO 13485:2016 and
MIL-PRF-31032. This implementation was achieved with management commitment and with sufficient resources
for the implementation. To effectively maintain and continually improve the system, Streamline Circuits
management determines and provides necessary resources, to enhance customer satisfaction by meeting
regulatory and customer requirements.

6.2 Human Resources


6.2.1 General

Personnel performing work affecting conformity to product requirements are competent on the basis of
appropriate education, training, skills and experience. To ensure competence of our personnel, job descriptions
have been prepared by identifying the qualifications required for each position. We believe that our employees are
our most valuable asset and we do our best to help them achieve their full potential through continuous education
and training.

6.2.2 Competence, Training, and Awareness

Qualifications are reviewed upon hire, when an employee changes positions, or the requirements for a position
change. Human Resources or Training Coordinator maintains the records of employee qualifications. If any
differences between the employees qualifications and the requirements for the job are found, training or other
action will be taken to provide the employee with the necessary competence for the job.
determine the necessary competence for personnel performing work affecting conformity to product
requirements;
where applicable, provide training or take other actions to achieve the necessary competence;
evaluate the effectiveness of the actions taken;
ensure that our personnel are aware of the relevance and importance of their activities and how they
contribute to the achievement of the quality objectives, and
maintain appropriate records of education, training, skills and experience (see 4.2.4).
The methodology used to check effectiveness is proportionate to the risk associated with the work for which the
training or other action is being provided.

All Streamline Circuits employees are trained on the relevance and importance of their activities including how
they contribute to the achievement of the quality objectives. This is achieved through daily communication with
internal customers, supervisors, engineers and management. Refer to Competence, Training, and Awareness
Procedure (QS-PR-007).

6.3 Infrastructure
To meet quality objectives and product requirements Streamline Circuits has determined the infrastructure
needed. The CEO and President have overall responsibility for identifying, providing and maintaining the
resources needed to achieve product conformance, prevent product mix-up, ensure orderly handling of product
(refer to Preservation of Product QS-PR-017) including workspace, associated facilities, equipment, hardware and
software, and supporting services. The Systems Administrator has overall responsibility for establishing and
maintaining our information management systems. The Maintenance Manger has the overall responsibility of
maintaining the preventative maintenance activities.

The infrastructure has been provided, and includes:


buildings, workspace and associated utilities;

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process equipment, both hardware and software, and
supporting services such as transport or communication, as applicable
As new infrastructure requirements arise, they will be documented. Existing infrastructure is maintained to ensure
product conformity. Maintenance activities are documented including their frequency; records are maintained (see
4.2.4). Refer to Infrastructure Procedure (QS-PR-020).

6.4 Work Environment


Work Environment suitable for achieving product conformance is maintained by Streamline Circuits
management team. The work environment is managed for continuing suitability and providing the elimination of
FOD (Foreign Object Damage/Debris) refer to Foreign Object Elimination (FOE) Plan (QS-GL-002). Data from
the quality system is evaluated to determine if the work environment is sufficient for achieving product
conformance, or if preventive or corrective action related to the work environment is required.

Requirements are determined during quality planning and documented in the Quality Plan:
established documented requirements for health, cleanliness and clothing of personnel in contact
between such personnel and the product or work environment could adversely affect the quality of the
product;
established documented requirements for work environment conditions and documented procedures or
work instructions to monitor and control these work environment conditions;
ensure that all personnel who are required to work temporary under special environmental conditions
within the work environmental are appropriately trained or supervised by trained person and
if appropriate, special arrangements shall be established and documented for the control of contaminated
product in order to prevent contamination of other product the work environment or personnel.

Related Documents
Competence, Awareness and Training Procedure QS-PR-007
Preservation of Product Procedure QS-PR-017
Infrastructure Procedure QS-PR-020
Foreign Object Elimination (FOE) Plan QS-GL-002
Hazard Communication Program Training Manual ES-MN-002
Injury and Illness Prevention Program for High Hazard Employers Manual ES-MN-003

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Section 7: Product Realization

7.1 Planning of Product Realization


Quality planning is required before new products or processes are implemented. The quality planning may take
place as a design project, or according to the Planning of Product Realization Procedure (QS-PR-037). During
this planning, management or assigned personnel identify:
the quality objectives and requirements for the product;
the need to establish processes, and documents and to provide resources specific to the product;
required verification, validation, monitoring, measurement, inspection and test activities specific to the
product and the criteria for product acceptance;
records needed to provide evidence that the realization processes and resulting product meet
requirements (see 4.2.4);
configuration management appropriate to the product, and
the identification of resources to support the use and maintenance of the product

The output of quality planning includes documented quality plans, processes, procedures and design outputs.

7.1.1 Project Management


Streamline Circuits plans and manages product realization in a structured and controlled manner to meet the
requirements at acceptable risk, within resource and schedule constraints.

7.1.2 Risk Management


Streamline Circuits has established, implemented and maintains a process for maintaining risk to the
achievement of applicable requirements that includes as appropriate to the organization and the product. Refer to
Risk Management Procedure (QS-PR-038) and Customer Related Processes (QS-PR-009).
assignment of responsibilities for risk management;
definition of risk criteria (e.g. likelihood, consequences, risk acceptance);
identification, assessment and communication of risks throughout product realization;
identification, implementation and management of actions to mitigate risks that exceed the defined risk
acceptance criteria;
acceptance of risks remaining after implementation of mitigating actions and
records arising from risk management shall be maintained (see 4.2.4)

7.1.3 Configuration Management


Streamline Circuits has established, implemented and maintains a configuration management process that
includes, as appropriate to the product Refer to Configuration Management Procedure (QS- PR-039).
The plan defines the process for:
configuration management planning;
configuration identification;
change control;
configuration status accounting, and
configuration audit.

7.1.4 Control of Work Transfers


Streamline Circuits has established, implemented and maintains a process to plan and control the temporary or
permanent transfer of work (e.g. from one facility to another facility) and to verify the conformity of the work to
requirements. Any outside processing steps to be completed are also listed on the traveler.

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When products are sent out to be processed utilizing an approved service registered on Streamline Circuits AVL
listing, a purchase order with flow-down requirements is generated and provide to outside service. When product
is returned from the outside service, an evaluation is performed and recorded on the traveler.

7.2 Customer-Related Processes

7.2.1 Determination of Requirements Related to the Product


Streamline Circuits determines customer requirements before acceptance of an order.
Customer requirements include those:
requested by the customer;
required for delivery and post-delivery activities;
not stated by the customer but necessary for specified use or known and intended use;
statutory and regulatory requirements are met by meeting customers requirements that are applicable to
the product;
any user training needed to ensure specified performance and safe use of the medical device, and
any additional requirements considered necessary by Streamline Circuits
Customer requirements are determined according to the Customer Related Processes Procedure (QS-PR-009)
and International Traffic Arms Regulation Policy "ITAR" Procedure (QS-PR-033)

7.2.2 Review of Requirements Related to the Product


Streamline Circuits has a process in place for the review of requirements related to the product Quote
Preparation. The review is conducted before the order is accepted. The process ensures that:
product requirements are defined and documented;
contract or order requirements differing from those previously expressed are resolved;
applicable regulatory requirements are met;
any user training identified in accordance with 7.2.1 is available or planned to be available;
have the ability to meet the defined requirements;
special requirements of the product are determined;
risks design guidelines and manufacturing capabilities shall be utilizes to mitigate risk during the quoting
process. This is based on technology (Standard = No/Low Risk, Advanced = Medium Risk and Emerging
= High Risk);
where a customer does not provide a documented statement of requirement, the customer requirements
are confirmed before acceptance, and
when product requirements are changed, Streamline Circuits communicates changes to relevant
personnel and amends relevant documents.
Records are maintained showing the results of the review and any actions arising from the review, (see 4.2.4)

7.2.3 Customer Communication


Streamline Circuits has implemented an effective procedure, Customer Related Processes Procedure (QS-
PR-009) for communicating with customers in relation to;
Product information,
Enquiries, contracts and order handling, including amendments, and
Customer feedback, including customer complaints
Advisory notices (not applicable refer to section 8.5.1)

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7.3 Design and Development
This Quality System Element exclusion applies. This sub-clause is included to align the clause numbering
scheme with that of ISO 9001:2015, AS9100 and ISO 13485:2016. Streamline Circuits does not participate in
design or development therefore it is not applicable to the operations at this site.

7.4 Purchasing

7.4.1 Purchasing Process


Purchasing Procedure (QS-PR-012) is followed to ensure that purchased product conforms to the specified
purchase requirements.

The procedure outlines the extent of control required for suppliers. Suppliers are evaluated and selected based on
their ability to supply product in accordance with requirements as outlined in the Purchasing Procedure.
Responsibilities and criteria for selection, evaluation and re-evaluation, status and status change and risk analysis
are documented in the procedure. Non-fulfilment of purchasing requirements shall be addressed with the supplier
proportionate to the risk associated with the purchased product and compliance with applicable regulatory
requirements.

Records of the evaluation and any necessary actions are maintained as quality records (see 4.2.4). The
organization is responsible for the quality of all products purchased from suppliers, including customer-designated
sources.

Streamline Circuits:
maintains a register of its suppliers that includes approved status (e.g., approved, conditional,
disapproved) and the scope of the approval (e.g., product type, process family);
periodically review supplier performance; the results of these reviews shall be used as a basis for
establishing the level of controls to be implemented,
define the necessary actions to be taken when dealing with suppliers that do not meet requirements;
ensure where required that both the organization and all suppliers use customer-approved special
process sources,
define the process, responsibilities and authority for the approval status decision, changes of the approval
status and conditions for a controlled use of suppliers depending on the suppliers approval status, and
determine and manage the risk when selecting and using suppliers (refer to 7.1.2)

7.4.2 Purchasing Information


Purchasing information describes the product to be purchased, including where appropriate:
requirements for approval of product, processes and equipment;
requirements for qualification of personnel;
QMS requirements outlined in the Purchasing Procedure;
the identification and revision status of specifications, drawings, process requirements,
inspection/verification instructions and other relevant technical data;
requirements for test, inspection, verification (including production process verification (including
production process verification, use of statistical techniques for product acceptance, and related
instructions for acceptance by the organization, and as applicable critical items including key
characteristics;
requirements for test specimens (e.g. production method, number, storage conditions) for inspection,
investigation or auditing;

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requirements regarding the need for supplier to:
- notify Streamline Circuits of nonconforming product;
- obtain Streamline Circuits approval for nonconforming product disposition;
- notify Streamline Circuits of changes in product and/or process, changes of suppliers, changes of
manufacturing facility location and where required, obtain Streamline Circuits approval, and
- flow down to the supply chain the applicable requirements including customer requirements;
record retention requirements (see 4.2.4), and
right of access by the organization, their customer, and regulatory authorities to the applicable area of all
facilities, at any level of the supply chain, involved in the order and to all applicable records
The purchasing documents are reviewed to ensure the adequacy of requirements before orders are placed with
the supplier.

7.4.3 Verification of Purchased Product


Purchasing Procedure describes the process used to verify that purchased product meets specified purchase
requirements. The extent of verification activities shall be based on the supplier evaluation results and
proportionate to the risks associated with the purchased product.

Verification activities can include:


obtaining objective evidence of the conformity of the product from suppliers (e.g. accompanying
documentation, certificate of conformity, test reports, statistical records, process control);
inspection and audit at suppliers premises;
review of the required documentation;
inspection of products upon receipt;
avoidance, detection, mitigation, and disposition of counterfeit parts/material/chemistry refer to
Counterfeit Material Avoidance Plan (QS-PL-005), and
delegation of verification to the supplier, or supplier certification.

Where purchased product is released for production use pending completion of all required verification activities,
it shall be identified and recorded to allow recall and replacement if it is subsequently found that the product does
not meet requirements.

When Streamline Circuits becomes aware of any changes to the purchased product, we shall determine
whether these changes affect the product realization process.

If Streamline Circuits or the customer intends to perform verification at the suppliers premises, the verification
arrangements and method of product release are documented in the purchasing information. Verification by the
customer shall not be used by Streamline Circuits as evidence of effective control of quality by the supplier and
shall not absolve the organization of the responsibility to provide acceptable product, nor shall it preclude
subsequent rejection by the customer. Records of the verification shall be maintained (see 4.2.4)

7.5 Production and Service Provision

7.5.1 Control of Production and Service Provision


Streamline Circuits plans and carries out production and service provision under controlled conditions
Controlled conditions include, as applicable:
the availability of information that describes the characteristics of the product. Resulting in the conversion
of customer requirements (e.g. purchase order, master drawing, electronic data files, etc.) and assure
customers needs are met;
the availability of standard operating procedures, work instructions (e.g., manufacturing plans, travelers
and inspection documents), as necessary;

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qualification of infrastructure;
the availability and use of monitoring and measuring equipment;
the implementation of monitoring and measurement;
the implementation of product release, delivery and post-delivery activities:
accountability for all product during production (e.g., parts quantities, split orders, nonconforming
product);
evidence that all production and inspection/verification operations have been completed as planned, or as
otherwise documented and authorized;
provision for the prevention, detection, and removal of foreign objects;
monitoring and control of utilities and supplies (e.g., water, compressed air, electricity and chemical
products) to the extent they affect conformity to product requirements;
criteria for workmanship, specified in the clearest practical manner (e.g., written standards, representative
samples, illustrations);
the implementation of defined operations for labeling and packaging, and
Implementation of product release, delivery and post-delivery activities.
Planning considers, as appropriate:
establishing, implementing and maintaining appropriate processes to manage critical items, including
process controls where key characteristics have been identified;
identifying in-process inspection/verification points when adequate verification of conformance cannot be
performed at later stage of realization, and
special processes
Cleanliness of product:

Streamline Circuits has documents requirements in regards to cleanliness of product and/or contamination
control in regards to the product we manufacture.

product is supplied to be used non-sterile, and its cleanliness is of significance in use, and
process agents are to be removed from product during manufacturing

Outsourced processes:

Streamline Circuits shall ensure that externally provided processes, products and services conform to requirements.
Outsourced processes include mass lamination, hot air leveling. Refer to Outsource Processes (QS-PR-040);

outsourcing is controlled through the purchasing process. Purchase orders for outsourcing clearly
describe or reference the work to be done and any needed specifications;
confirmation that the requirements have been met is by review of any required documentation and any
required additional testing or inspection;
product outsourcing is defined on the traveler;
incoming verification results are recorded on the traveler, and
validation results (Certificates of Conformance, Inspection Reports, etc.) are filed and become part of the
traveler record.

7.5.1.1 Production Process Verification


Streamline Circuits uses a representative item from the first production run (first article) of a new part to verify
that the production processes, production documentation and tooling are capable of producing conforming parts
that meet requirements. This verification shall be repeated when changes occur that invalidates the original
results (e.g., engineering changes orders, manufacturing process changes, tooling changes).

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7.5.1.2 Control of Production Process Changes:
Personnel authorized changes to production processes are identified Engineering Change Notice (ECN) Form
(PE-FM-005). Streamline Circuits identifies and obtains acceptance of changes that require customer or
regulatory authority approval in accordance with contract or regulatory requirements. Regulatory requirements are
met by meeting customers requirements.
Streamline Circuits, controls and documents changes affecting processes, production equipment, tools or
software programs.

The results of changes to production processes are assessed to confirm that the desired effect has been
achieved without adverse effects to product conformity.

7.5.1.3 Control of Production Equipment, Tools and Software Programs


Production equipment, tools and software programs used to automate and control/monitor product realization
processes are validated prior to release for production and maintained. Storage requirements, including periodic
preservation/condition checks, have been be defined for production equipment or tooling in storage.

7.5.1.4 Post-Delivery Support


Post-delivery support shall provide as applicable for the:
collection and analysis of in-service data;
actions to be taken where problems are identified after delivery, including investigation, reporting
activities, and actions on service information consistent with contractual and/or statutory and regulatory
requirements. Regulatory requirements are met by meeting customers requirements;
control and updating of technical documentation;
approval, control, and use of repair schemes, and
controls required for off-site work (e.g. organizations work undertaken at the customers facilities).

7.5.2 Validation of Processes for Production and Service Provision


Streamline Circuits validates any processes for production and service provision where the resulting output can
not be verified by subsequent monitoring or measurement. This includes any processes where deficiencies
become apparent only after the product is in use or the service has been delivered. Validation demonstrates the
ability of these processes to achieve planned results.

Streamline Circuits has documented the process for validation including:


defined criteria for review and approval of the processes;
approval of equipment and qualification of personnel;
use of specific methods and procedures;
requirements for records (see 4.2.4), and
revalidation

7.5.3 Identification and Traceability


Streamline Circuits identifies the product throughout product realization according to the Identification and
Traceability Procedure (QS-PR-015) includes unique identification as required per customer or applicable
regulatory requirements.

Streamline Circuits has established documented procedure to ensure that product(s) returned to the
organization are identified and distinguished from conforming product Return Material Authorization (RMA) Work
Instruction (QC-WI-010).

Streamline Circuits maintains the identification of the configuration of the product in order to identify any
differences between the actual configuration and the agreed configuration Configuration Management
Procedure (QS-PR-039).

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Product is identified with respect to monitoring and measurement requirements. Throughout production and
storage to ensure the only product that has passed the required inspections and test. When acceptance authority
media such as stamps, electronic signatures or passwords are used.

Streamline Circuits establishes and documents controls for the media. Where traceability is a requirement, the
organization shall control the unique identification of the product and maintain records (see 4.2.4).

Streamline Circuits system provides for:


identification to be maintained throughout the product life;
the ability to trace all products manufactured from the same batch of raw material or from the same
manufacturing batch, to the destination (delivery, scrap), and
for a product, a sequential record of its production (manufacture and inspection/verification) to be
retrieved.

7.5.4 Customer Property


Streamline Circuits exercises care with customer property while it is under the organization's control or being
used. The Customer Property Procedure (QS-PR-016) outlines the identification, verification, protection and
safeguarding of customer property provided for use. If any customer property is lost, damaged or otherwise found
to be unsuitable for use, Streamline Circuits will report this to the customer and maintain records (see 4.2.4).
Customer property can include intellectual property, and personal data.

7.5.5 Preservation of Product


Streamline Circuits preserve the product during internal processing and delivery to the intended destination in
order to maintain conformity to requirements. Refer to Preservation of Product Procedure (QS-PR-017). This
preservation includes identification, handling, packaging, storage and protection. Preservation also applies to the
constituent parts of a product.
Preservation of product also includes, where applicable in accordance with product specifications and applicable
statutory and regulations requirements, provisions for:
cleaning;
prevention, detection and removal of foreign objects Foreign Object Elimination (FOE) Plan (QS-GL-002);
special handling for sensitive products;
suitable packaging and shipping containers
marking and labeling including safety warnings;
self-life control and stock rotation;
special handling for hazardous materials, and
establish documented procedures or documented work instruction for the control of product with limited
shelf-life, requiring special storage conditions or special conditions needed if packaging alone cannot
provide preservation. Such special storage conditions shall be controlled and recorded (see 4.2.4)

7.6 Control of Monitoring and Measuring Equipment

Streamline Circuits has determined the monitoring and measurement to be undertaken and the monitoring and
measuring equipment needed to provide evidence of conformity of product to determined requirements. Control
of Monitoring and Measuring Equipment Procedure (QS-PR-018) outlines the process used to ensure that
monitoring and measurement to be carried out are carried out in a manner that is consistent with the monitoring
and measurement requirements;
be calibrated or verified , or both at specified intervals, or prior to use, against measurement standards
traceable to international or national measurement standards; where no such standards exist, the basis
used for calibration or verification shall be recorded (see 4.2.4);

be adjusted or re-adjusted as necessary;

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have identification in order to determine its calibration status;
be safeguarded from adjustments that would invalidate the measurement result, and
be protected from damage and deterioration during handling, maintenance and storage.

Streamline Circuits has established, implemented and maintains a process for the recalled of monitoring and
measuring equipment requiring calibration or verification.
In addition, Quality Control assesses and records the validity of the previous measuring results when the
equipment is found not to conform to requirements. Streamline Circuits takes appropriate action on the
equipment and any product affected.

Records of the results of calibration and verification are maintained (see 4.2.4)

Streamline Circuits maintains a register of the monitoring and measuring equipment. The process used for their
calibration/verification are defined in procedures, work instructions, equipment manuals, includes details of
equipment type, unique identification, location, frequency of checks, check method and acceptance criteria.

When used in the Monitoring and Measurement of specified requirements, the ability of computer software to
satisfy the intended application is used for confirmation. This is undertaken prior to initial use and reconfirmed as
necessary.

Streamline Circuits ensures that environmental conditions suitable for the calibrations, inspections,
measurements, and testing are being carried out.

Related Documents
Planning of Product Realization Procedure QS-PR-037
Risk Management Procedure QS-PR-038
Configuration Management Procedure QS-PR-039
Customer Related Processes Procedure QS-PR-009
International Traffic Arms Regulation Policy ITAR Procedure QS-PR-033
Purchasing Procedure QS-PR-012
Engineering Change Notice (ECN) Form PE-FM-005
Identification and Traceability Procedure QS-PR-015
Control of Customer Property Procedure QS-PR-016
Preservation of Product Procedure QS-PR-017
Foreign Object Elimination (FOE) Plan QS-GL-002
Control of Monitoring and Measuring Equipment Procedure QS-PR-018
Return Material Authorization (RMA) Work Instruction QC-WI-010
Outsource Processes QS-PR-040
Counterfeit Material Avoidance Plan QS-PL-005

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Section 8: Measurement, Analysis and Improvement
8.1 General
Streamline Circuits plans and implements the monitoring, measurement, analysis and improvement processes
as needed:
to demonstrate conformity to product requirements;
to ensure conformity of the QMS, and
to continually improve the effectiveness of the QMS.

Processes are identified in documented and include determination of applicable methods, including statistical
techniques, and the extent of their use.
According to the nature of the product built and depending on the specified requirements, statistical techniques
can be used to support:
process control;
- selection and inspection of key characteristics;
- process capability measurements;
- statistical process control;
inspection, and
failure mode, effect and critically analysis.

8.2 Monitoring and Measurement


8.2.1 Customer Satisfaction
As one of the measurements of the performance of the QMS, Streamline Circuits monitors information relating
to customer perception/feedback as to whether the organization has fulfilled customer requirements.

Feedback
Information to be gather and used for the evaluation of customer satisfaction includes, but is not limited to,
product conformity, on-time delivery performance, customer complaints/compliments and corrective action
requests. The method for obtaining and using this information is identified in the Customer Satisfaction
Procedure (QS-PR-023).
Feedback should come from production and post-production activities. The information shall serve as potential
input into risk management for monitoring and maintaining the product requirements as well as the product
realization or improvement processes.

Complaint Handling
Streamline Circuits has a documented procedure for timely complaint handling in accordance with applicable
regulatory requirements:
Procedure includes at a minimum requirements and responsibilities for:
receiving and recording information;
evaluating information to determine if the feedback constitutes a complaint;
investigating complaints;
determining the need to report the information to the appropriate regulatory authorities;
handling of complaint-related product, and
determining the need to initiate corrective actions.

When complaint is not investigated, justification is documented, any correction or action resulting from compliant
handling process is documented. If an investigation determines activities outside the company contributed to the
complaint, relevant information shall be exchanged between the organization and the external party involved.
Refer to Return Material Authorization (RMA) and Complaint Handling (QC-WI-010).
Records of complaint handling are maintained (see 4.2.4)

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Reporting to Regulatory Authorities
If applicable regulatory requirements require notification of complaints that meet specified reporting criteria of
adverse events. Streamline Circuits shall document procedures for proving notification to the appropriate
regulatory authorities. Refer Notification Process for Recalling Product and Reporting to Regulatory Authorities
(MF-WI-001).

8.2.2 Internal Audit


Streamline Circuits conducts internal audits at planned intervals to determine whether the QMS:
conforms to the planned arrangements (refer to 7.1), to the requirements of International Standard,
customer contractual requirements and to the QMS requirements established by the Streamline Circuits,
and
is effectively implemented and maintained.

An audit program has been designed and implemented and identifies an audit schedule based on the importance
of the areas to be audited, as well as the results of previous audits. The selection of auditor(s) and conduct of
audits shall ensure objectivity and impartiality of the audit process. The criteria, scope, frequency, methods,
responsibilities and requirements for planning and conducting audits, and for reporting and maintaining results,
are defined and documented in the Internal Audit Procedure (QS-PR-024).

The management responsible for the area being audited is responsible for ensuring that any necessary
corrections and corrective actions are taken. Without undue delay and to eliminate detected nonconformities and
their causes. Follow-up activities include the verification of the actions taken and the reporting of verification
results. Records of the audits and their results are maintained (see 4.2.4).

8.2.3 Monitoring and Measurement of Processes


Streamline Circuits applies suitable methods for monitoring and, where applicable, measurement of the QMS
processes. These methods demonstrate the ability of the processes to achieve planned results. When planned
results are not achieved, correction and corrective action is taken, as appropriate, to ensure conformity of the
product. In the event of process nonconformity, we follow the Nonconforming Material Control and Review
Procedure (QS-PR-029):

takes appropriate action to correct the nonconforming process;


evaluates whether the process nonconformity has resulted in product nonconformity;
determine if the process nonconformity is limited to a specific case or whether it could have affected other
processes or products, and
identify and controls the nonconforming product (refer to 8.3).

The process for identifying and carrying out the required Monitoring and Measuring of Processes is documented
in the Statistical Techniques Procedure (QS-PR-022).

8.2.4 Monitoring and Measurement of Product


Streamline Circuits monitors and measures the characteristics of the product to verify that product requirements
are fulfilled. This is carried out at appropriate stages of the product realization process identified in Monitoring,
Measuring and Analysis of Product Realization Processes. Evidence of conformity with the acceptance criteria is
maintained. Refer to Receiving Inspection Procedure (QS-PR-025), In-Process Inspection Procedure (QS-PR-
026) and Final Inspection Procedure (QS-PR-027).

Measurement requirements for product acceptance are documented and includes:


criteria for acceptance and/or rejection;
where in the sequence measurement and testing operations are performed;

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required records of the measurement results (at a minimum, indication of acceptance or rejection and
identity of personnel performing any inspection or testing);
any specific measurement instruments required and any specific instructions associated with their use,
and
identity of the person authorizing release of product

When critical items, including key characteristics have been identified Streamline Circuit ensures we controlled
and monitored in accordance with the established processes. When we use sampling inspection as a means of
product acceptance, the plan is justified on the basis of recognized statistical principles and appropriate for use
(e.g., matching the sampling plan to the criticality of the product and to the process capability).

Where product is released for production use pending completion of all required measurement and monitoring
activities, it shall be identified and recorded to allow recall and replacement if it is subsequently found that the
product does not meet requirements.

The release of product to the customer shall not proceed until the planned arrangements (refer to 7.1) have been
satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable by the
customer. Streamline Circuits ensures that all documents required to accompany product are present at
delivery.

Records indicate the person authorizing release of product, and provide evidence that the product meets
requirements (see 4.2.4).

8.3 Control of Nonconforming Product


Streamline Circuits ensures that product which does not conform to product requirements is identified and
controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for
the identification, documentation, segregation, evaluation and disposition of nonconforming product. Refer to
Nonconforming Material Control and Review Procedure (QS-PR-029).

The term nonconforming product includes nonconforming product returned by a customer.

Where applicable Streamline Circuits deals with nonconforming product by one or more of the following ways:
by taking action to eliminate the detected nonconformity;
by authorizing its use, release or acceptance under concession by a relevant authority and, where
applicable, by the customer;
by taking action to preclude its original intended use or application, and
by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming
product is detected after delivery or use has stated.

Streamline Circuits ensures nonconforming product control process shall provide for timely reporting of
delivered nonconforming product. By taking actions necessary action:
taking action to eliminate the detected nonconformity;
taking action to preclude its original intended use or application, and
authorizing its use, release or acceptance under concession/ and/or (AABUS).

Streamline Circuits has incorporated the use of use-as-is which refers to in accordance with
specifications. The allowance of and the requirements for repair of bare printed circuits boards shall be As
Agreed Between User and Supplier (AABUS). Streamline Circuits does not perform repair on medical, military,
space or military avionics product.

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If product needs to be reworked (one or more times), the organization shall document the rework process in a
work instruction that has undergone the same authorization and approval procedure as the original work
instruction. Prior to authorization an approval of the work instruction, a determination of any adverse effect of the
rework upon product shall be made and documented.

When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the
requirements. Product disposition for scrap is conspicuously and permanently marked, or positively controlled,
until physically rendered unusable.

When nonconforming product is detected after delivery or use has started, Streamline Circuits shall take action
appropriate to the effects, or potential effects, of the nonconformity. Process steps are defined in Return Material
Authorization (RMA) and Complaint Handling (QC-WI-010) and Notification Process for Recalling Product and
Reporting to Regulatory Authorities (MF-WI-001).

Records of the nature of nonconformities and any subsequent actions taken, including any concessions obtained,
are documented and maintained (see 4.2.4).

8.4 Analysis of Data


Streamline Circuits determines collects and analysis appropriate data to demonstrate the suitability and
effectiveness of the QMS and to evaluate where continual improvement of the QMS can be made. The process
for determining, collecting and analyzing this data is defined in Management Responsibility Procedure (QS-PR-
006) and MIL-PRF-31032 Quality Management Plan (QS-PR-041).
Appropriate data includes data generated as a result of monitoring and measurement and from other relevant
sources. Analysis is performed using Statistical Techniques Procedure (QS-PR-022).
The analysis of data provides information relating to:
customer satisfaction/feedback;
conformance to product requirements;
characteristics and trends of processes and products including opportunities for preventive action;
suppliers:
audits, and
service reports, as appropriate
If the analysis of data shows that the QMS is not suitable, adequate or effective, Streamline Circuits will use this
analysis as input for improvement as required in (see 8.5). Records of the results of the analysis of data shall be
maintained (see 4.2.4)

8.5 Improvement

8.5.1 Continual Improvement


Streamline Circuits continually improves the effectiveness of the QMS through the use of the quality policy,
quality objectives, audit results, analysis of data, corrective and preventive actions and management review.
Management monitors the implementation of improvement activities and evaluates the effectiveness of results.
Refer to Continuous Advancement of Product and Services (CAPS) (QS-MN-002).

The organization shall establish documented procedures for issue. These procedures shall be capable of being
implemented at any time. Implementations of advisory notices are not applicable. Streamline Circuits is a
contract manufacturer we build to customer drawing. We do not issue advisory notices. This would be the
responsibility of the customer.
Records of customer complaints investigations shall be maintained (see 4.2.4). If investigation determines that the
activities outside the organization contributed to the customer complaint, relevant information shall be exchanged
between the organizations involved (see 4.2.4).
If any customer complaint is not followed by corrective action and/or preventive action the reason shall be
authorized and recoded (see 4.2.4).

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If national or regional require notification of adverse events that meet specified reporting criteria the organization
shall establish documented procedures to such notification to regulatory authorities.

8.5.2 Corrective Action


Streamline Circuits takes action to eliminate the causes of nonconformities in order to prevent recurrence.
Corrective actions are appropriate to the effects of the nonconformities encountered. Corrective Action
Procedure (QS-PR-031) defines requirements for:
reviewing nonconformities (including customer complaints);
determining the causes of nonconformities;
evaluating the need for action to ensure that nonconformities do not recur;
determining and implementing action needed;
reviewing the effectiveness of the corrective action taken;
flowing down corrective action requirements to a supplier, when it is determined that the supplier is
responsible for the nonconformity;
specific actions where timely and/or effective corrective actions are not achieved;
determining if additional nonconforming product exists based on the causes of the nonconformities and
taking further action when required;
verifying that the corrective action does not adversely affect the ability to meet applicable regulatory
requirements or the safety and performance of the product, and
records of the results of action taken (see 4.2.4).

8.5.3 Preventive Action


Streamline Circuits determines action to eliminate the causes of potential nonconformities in order to prevent
their occurrence. Preventive actions are appropriate to the effects of the potential problems. Preventive Action
Procedure (QS-PR-035) defines requirements for:
determining potential nonconformities and their causes;
evaluating the need for action to prevent occurrence of nonconformities;
determining and implementing action needed;
verifying that the action does not adversely affect the ability to meet applicable regulatory requirements
or the safety and performance of the product;
reviewing the effectiveness of the preventive action taken, and
records of results of action taken (see 4.2.4).

Related Documents
Customer Satisfaction Procedure QS-PR-023
Internal Audit Procedure QS-PR-024
Receiving Inspection Procedure QS-PR-025
In-Process Inspection Procedure QS-PR-026
Final Inspection Procedure QS-PR-027
Nonconforming Material Control and Review Procedure QS-PR-029
Management Responsibility Procedure QS-PR-006
MIL-PRF-31032 Quality Management Plan QS-PR-041
Statistical Techniques Procedure QS-PR-022
Corrective Action Procedure QS-PR-031
Preventive Action Procedure QS-PR-035
Notification Process for Recalling Product and Reporting to Regulatory Authorities MF-WI-001
Return Material Authorization (RMA) and Complaint Handling QC-WI-010
Continuous Advancement of Product and Services (CAPS) QS-MN-002
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Appendix A
Master List of Key QMS Documents
Document Number Document Title
QS-CH-001 Organizational Structure and Technical Review Board
QS-GL-002 Foreign Object Elimination (FOE) Plan
QS-ML-001 Records Table
QS-ML-005 Preventive Action Organizer Worksheet
QS-MN-001 Quality Systems Manual
QS-MN-002 Continuous Advancement of Product and Services
(CAPS) Manual
QS-PC-001 Quality Policy
QS-PL-002 Quality Plan & Process Control Checkpoints
QS-PL-004 Calibration Process Plan
QS-PL-005 Counterfeit Material Avoidance Plan
QS-PC-007 Quality Objectives
QS-PR-001 Document Control
QS-PR-002 Control of Quality Records
QS-PR-006 Management Responsibility
QS-PR-007 Competence Awareness and Training
QS-PR-009 Customer Related Processes
QS-PR-012 Purchasing
QS-PR-015 Product Identification and Traceability
QS-PR-016 Control of Customer Property
QS-PR-017 Preservation of Product
QS-PR-018 Control of Monitoring and Measuring Devices
QS-PR-020 Infrastructure
QS-PR-022 Statistical Techniques
QS-PR-023 Customer Satisfaction
QS-PR-024 Internal Audits
QS-PR-025 Receiving Inspection
QS-PR-026 In-Process Inspection
QS-PR-027 Final Inspection
QS-PR-029 Nonconforming Material Control and Review
QS-PR-031 Corrective Action Procedure
QS-PR-033 International Traffic Arms Regulation Policy ITAR
QS-PR-035 Preventive Action
QS-PR-036 Gage R & R Procedure
QS-PR-037 Planning of Product Realization
QS-PR-038 Risk Management
QS-PR-039 Configuration Management
QS-PR-040 Outsourced Processes
QS-PR-041 MIL-PRF-31032 Quality Management Plan
MF-WI-001 Notification Process for Recalling Product and
Reporting to Regulatory Authorities
QC-WI-010 Return Material Authorization (RMA) and Complaint
Handling
PE-FM-005 Engineering Change Notice (ECN) Form
ES-MN-002 Hazard Communication Program Training Manual
ES-MN-003 Injury and Illness Prevention Program for High Hazard
Employers Manual
XX-WI-XXX Work Instructions
XX-PC-XXX Pictorials
XX-PL-XXX Quality Plans
XX-GL-XXX Guidelines
XX-FM-XXX Forms
XX-LG-XXX Logs

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QUALITY SYSTEM MANUAL REVISIONS

REV. SECTION SUB-SEC. COMMENTS DATE AUTHORIZED BY


A All ALL New 10/01/03 Lorraine Hook
B 6.2 6.2.1 Add Job Descriptions 03/31/05 Lorraine Hook
C All All Upgrade to AS9100 & MIL-PRF-31032 09/15/06 Lorraine Hook
D All All Minor Changes Spelling Errors 01/15/08 Lorraine Hook
E 5.3, 5.4 5.4.1 Updated due to Obsolete or Title 07/13/08 Lorraine Hook
8.5 8.5.2 Changes of Related Procedures
8.5.3
F All All Updates to add AS9000 Rev C Changes, 11/01/2010 Lorraine Hook
Grammar and Spelling Errors
G 1.2, 2.0 7.1.1, Update to 1.2 added justification for 11/01/2011 Lorraine Hook
4.1, 5.3, exclusion, 2.0 & 4.1 removed revisions
7.1, 7.3, and changed to latest revision. 4.1 added
8.2.4 last bullet on outsource. 7.3 added
justification for exclusion. 7.5.2 Removed
as exclusion and added. 8.2.3 & 8.2.4
removed QS-PR-040. 8.2.4 added QS-
PR-025, 026 & 027 updated related
documents.
Change work program management to
project
H All All Updates added information on MIL-PRF- 08/31/2013 Lorraine Hook
31032, added ISO 13485:2003. New lay-
out added Environmental, Conflict Mineral
Policy, and Absence of REACH
Substances of Very High Concern Policy,
Exclusion Table and Appendix A Master
List of Key QMS Documents.

I 1, 3, 4, 5, 7 1.1, 1.2, 3.0, Added scope of registration, updated 11/26/13 Lorraine Hook
&8 4.1,4.2.3, 4.2.4, Quality Policy, exclusions 7.5.1.2.1,
5.1, 5.5.3, 5.6.2, 7.5.1.2 .2, 7.5.1.2.3, 7.5.3.2.2, added note
7.1.4, 7.2.1, 7.2.3,to Advisory notices page 11, updated
7.5.1, 7.5.1.2, policy on regulatory requirements on
7.5.1.4, 8.3,, page 12,13 , 17, 19, 23, 26, 27 added
8.5.1, Outsourced Processes page 26, added
repair statement page 31 and updated
appendix 4
J 4 4.2.2 Updated page 14 adding Core Processes 01/29/2015 Lorraine Hook
at Build Requirements. Also removed ISO
off title
K All Cover, pages 5, Update to align with changes in ISO 06/05/2016 Lorraine Hook
8, 9 & sections 13485:2016 and ISO 9001:2015 cover,
1.1, 1.2 2.0, 3.0, added Right to Access, Counterfeit
4.1, 4.2.1, 4.2.3, Electronics Parts, Avoidance, Detection,
4.2.4, 5.1, 5.2, Mitigation and Disposition, Organizational
5.4.1, 5.4.2, 5.5.1, Structure and Technical Board. Added
5.6.2, 5.6.3, 6.6.2, Use-As-Is, added document diagram,
6.3, 6.4, 7.1.4, updated related documents and appendix
7.2.1, 7.2.2, 7.4.1, A. Changes are in blue on master copy.
7.4.2, 7.4.3, 7.5.1,
7.5.3, 7.5.5, 8.2.1,
8.2.4, 8.3, 8.4,
8.5.2., 8.5.3 &
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