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1. Scope
XXXX establish, implement and maintain this ISO9001:2015 QMS to consistently provide products that meet
customer and applicable legal requirements, and to continuously improve customer’s satisfaction and the
performance of QMS. We strive to understand the dynamic external and internal context, and the changing
need & expectation of relevant interesting parties, to identify and address the risks & opportunities, by
utilizing process approach, PDCA and risk-based thinking, data analysis and quality management principles.

2. Normative reference
ISO 9000:2015, Quality management systems – Fundamentals and vocabulary
 Characteristic - A characteristic is a distinctive feature or property of something.
 Context of the organization – all of the internal and external factors and conditions that affect its products
and services, have an influence on its QMS, and are relevant to its purpose and strategic direction.
 Correction – any action that is taken to eliminate a nonconformity, but to address root causes.

 Corrective action – steps that are taken to eliminate the causes of existing nonconformities in order to
prevent recurrence of the existing nonconformities and potentially undesirable situations.
 Interested party – anyone who can affect, be affected by, or believe that they are affected by a decision or
activity. It is a person, group, or organization that has an interest or a stake in a decision or activity.
 Outsource – when an outside organization to perform part of a function or process of organization.
 Process approach – manage and control the processes that make up their organization, the interaction
beeen these processes, and the inputs and outputs that tie these processes together.
 Process-based quality management system – using process approach to manage and control how its
quality policy is implemented and how its quality objectives are achieved. A process-based QMS is a neork
of interrelated and interconnected processes.
 Quality - the degree to which a set of inherent characteristics fulfills a set of requirements of an objective.
 Risk – the “effect of uncertainty on an expected result” and an effect is a positive or negative deviation
from what is expected.
 Risk-based thinking refers to a coordinated set of activities and methods that organizations use to manage
and control the many risks that affect its ability to achieve objectives.

3. Terms and definitions

‘Purchased Product’ is replaced by ‘Externally Provided Processes, Products and Services’

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‘Work Environment’ is replaced by ‘Environment for the Operation of Processes’

4. Context of the organization

4.1 Understanding the organization and its context
XXXX determine external and internal issues that are relevant to its purpose and its strategic direction and
that affect its ability to achieve the intended result(s) of its quality management system through PEST and
SWOT. The external and internal issues identified through PEST and SWOT are continuously being monitored
and reviewed.
4.1.1 External issues – PEST Analysis:
Political Factors: Economic factors:
1. Tariffs policy; 2. Foreign Trade Regulation; 1. Business Cycle Stage; 2. Globalization
3. Employment law; 4. Environmental regulations. 3. Interest and exchange rates; 4. Inflation rate.
Social Factors: Technological Factors:
1. Lifestyle changes; 2. Chinese New Year Holiday; 1. Impact of internet (Online Sales); 2. Innovation
3. Consumerism; 4. Brand and company image. 3. Speed of Technology Transfer; 4. New Discoveries

4.1.2 Internal issues:

1) Product and service offerings
2) Organizational structure, roles, and accountability
3) Availability of reliable qualified and competent work force.
4) Policies and goals, and the strategies that are in place to achieve them
5) Assets (e.g., facilities, property, equipment and technology, information system)
6) Financial capability, Solvency of customers, Payment terms from customers
7) Organization’s culture

4.1.3 SWOT Analysis

Helpful Harmful

S - Strengths W - Weaknesses
(or present)

1. Engineering capability in USA.

Internal

1. Good products to sale

2. Strong relationship with customer.
3. Good partner relationship with factories.
4. Strong support from Top management
5. Effective ERP system

O - Opportunities T - Threats
(or future)
External

1. Gain new customers globally 1. Instable currency rate.

2. Expand representative neork 2. Weather threats.
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3. Uncertain Tariffs policy
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4.2 Understanding the needs and expectations of interested parties

XXXX determine relevant interested parties and their requirements relevant to XXXX QMS, in order to prevent
potential effect on our ability to consistently provide products and services which meet the customer and
applicable legal requirements, XXXX will keep on monitoring and reviewing their requirements.
Interested
The needs and expectations Monitoring / Reviewing (Who/When)
parties
Good quality, On-time delivery, quick response and
Customers Customer survey annually, RMA tracking
support, timely notice of ECR/ECN, and low-cost
External Payment as agreed, partner relationship, clear &
providers adequate Reqt. for RFQ & PO, marketing
legal body RoHS, REACH, Conflict Mineral, Certification, declaration
Professional development, employment security, good
Employees
working relationships and environment.
Bank Good financial credit, good Inventory control Excellent credit rating, high inventory turn

4.3 Determining the scope of the quality management system

 Scope: ####
 Location: ####
 Justification for “no applicable” requirements: 8.3 - XXXX does not design or develop products & services.
Statement of justification - - - - - -
4.4 Quality management system and its processes

XXXX establish, implement, maintain and continually improve this QMS. The below XXXX QMS Figure shows
the processes needed, and their sequence and interaction, and XXXX will:

a) Determine the inputs required and the outputs expected from these processes;

b) Determine and apply the criteria and methods needed to ensure the effectiveness of the processes;

c) Determine the resources needed for these processes and ensure their availability;

d) Assign the responsibilities and authorities for these processes;

e) Address the risks & opportunities as determined in accordance with the requirements of 6.1

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f) Evaluate these processes and implement any changes needed to ensure achieving their intended results;

g) Improve the processes and the quality management system by matrix / quality objectives.

Support 7
Customer- Related Process 8.2 Resource – 7.1 Context of the Org. 4
Competence – 7.2 (Internal/External Issues, Interested Parties)
Awareness – 7.3 Leadership 5
Quote (RFQ) Communication – 7.4 (Customer focus, Policy, Role ...)
(Sales) 8.2 Documented Information – 7.5 Planning 6
(Top management / Managers) (Risk/Opp., Quality Objective, Change)
Process customer order Operational Planning 8.1
(Sales) 8.2 (Top management / Managers)

Customer Support
(Sales) 8.2
Improvement 10 (N.C., C.A. …)
(QA)
ERP System
Performance evaluation 9
(Including Outlook, and drive P) Monitoring, measurement, analysis and
External Provider – Related evaluation – 9.1; Internal Audit – 9.2;
process 8.4 Management review – 9.3
(QA/Top Management)

Evaluate, select, monitor and

re-evaluate external provider Control of Nonconforming Output 8.7
(Purchasing/QA/) 8.4.1
(QA)

Control external provider

(Purchasing/QA/) 8.4.2
Production and Service Release of products
Provision process 8.5 and Service 8.6
Process Purchasing Order (Warehouse) (/Boca Warehouse)
(Purchasing) 8.4.3

5. Leadership
5.1 Leadership and commitment

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5.1.1 General
Top management shall demonstrate leadership and commitment with respect to the QMS by:
taking accountability for the effectiveness of the QMS
Quality policy and quality objectives are established for QMS and are compatible with the
context and strategic direction of the organization.
ensuring The integration of the QMS requirements into the Org.’s business processes.
the resources needed for the QMS are available
the QMS achieves its intended results
the use of the process approach and risk-based thinking
promoting
Improvement.
communicating The importance of effective quality management and of conforming to the QMS Requirement.
engaging, directing
persons to contribute to the effectiveness of the quality management system
and supporting
Other relevant management roles to demonstrate their leadership as it applies to their areas
supporting
of responsibility.

5.1.2 Customer focus

Top management shall demonstrate leadership and commitment with respect to customer focus by:
Customer and applicable legal requirements are determined, understood and consistently met.
Ensuring The risks and opportunities that can affect conformity of products and services and the ability to enhance
customer satisfaction are determined and addressed.

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The focus on enhancing customer satisfaction is maintained.

5.2 Policy
5.2.1 Establishing the quality policy
Top management establish, implement and maintain the quality policy as below:
Total Customer satisfaction through meeting customers and applicable legal requirements, and pursuing
Continual Improvement of provided products and service.

5.2.2 Communicating the quality policy

The quality policy is posted in the office, and communicated within organization, and posted in XXXX website.
All of the XXXX employees shall understand and applied the quality policy during the daily operation.

5.3 Organizational roles, responsibilities and authorities

The Top Management assign Quality manager the responsibility and authorities to:
-- ensure the QMS conforms to the requirements of ISO9001 2015;
-- ensure the processes are delivering their intended outputs;
-- report the performance of QMS and the opportunities for improvement to top management;
-- ensure the promotion of customer focus throughout the organization;
-- ensure the integrity of the QMS when change to the QMS is planned and implemented.
The responsibilities and authorities for relevant roles/functions is assigned as below:

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Position Main Responsibility Main Roles/Authorities

 Drive customer growth in market served.  Handle RFQ and customer PO.
Account
 Maintain and satisfy the assigned customers.  Create P/N, RMA/CAR;
Manager
 Owner of the relevant process and quality objectives  Customer support.
 Buy the qualified products within lead time.  Review/Release PO
Product
 Cost down from factories / shipment arrangement.  Approve new created XXXX parts.
Manager
 Owner of the relevant process and quality objectives  Confirm freight charges and authorize shipment.
 Make sure the fluency of daily operation.  Accept incoming parts.
Warehouse
 Improve the effectiveness / efficiency of warehouse  Release the shipping.
Manager
 Owner of the relevant process and quality objectives  Inventory cycle-count
 Establish/implement/maintain/improve the QMS  Create, review, approve QMS document
Quality
 Monitor/measure/report performance of QMS  Collect/Analysis data for quality objectives
Manager
 Coordinate external audit / Organize Internal Audit.  Process customer complaints /approve suppliers
 Maintain/update/improve ERP system;  Modify and update the system.
Sofare / IT  Maintain, backup the entire data / IT infrastructure.  Monitor the IT infrastructure and backup data
 Guarantee security & stability of email & internet.  Warning the risk (Virus) from email/internal.
 Get best quote from factory for RFQ  Upload RFQ quote into ERP.
 Confirm customer spec, Create/manage XXXX spec  Create XXXX spec/drawing.
(Outsourcing  Source and select new factory  Source new factory/supplier.
in QMS)  Work with factory about the CAR/RMA.  Work with factory to find root cause of CAR/failure
 Shipment inspection, support sample & FAI report  Inspect part (sample/trail run/M.P.) & FAI report

6. Planning
6.1 Actions to address risks and opportunities.
After considering the external & internal issues (4.1) and the requirements of interested parties (4.2) of XXXX,
We determine the below risks & opportunities need to be addressed to assure the intended results of QMS,
and enhance desired effects, and prevent/reduce undesired effects, and achieve improvement.
We also plan the actions to address these risks and Opportunities (see the below), and those actions shall be
integrated and implemented into XXXX QMS, and shall be proportionate to the potential impact on the
conformity of product and services.
We shall evaluate the effectiveness of those actions to Risks and Opportunities at least annually.
Interested Risks & Opportunities need to be Actions to address these Risks & Effectiveness
S P
parties addressed Opportunities of actions
Customer don’t/can’t pay H L M Customer credit limit need approval
Business loss due to quality issue H L M Inspect shipment for major products
Customers Business loss due to cost down issue H L M Share the cost down with factory
OTD issue during Chinese New Year M L M-L Arrange the shipment in advance
Gain new customer globally
External Cost up request from factory M M M Share the increased cost with customer

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providers Delivered products don’t meet Spec. H L M Inspect shipment for major products
Lead time can’t meet promise. M L M-L Good communicate with factory/customer
Misunderstand the Reqt. of RFQ / P.O. M L M-L Show clear/adequate info on PO…
Don’t know the change of key factory H L M Visit/Audit key factory annually
Legal body Fail to meet RoHS, REACH and CRMT. H L M Collect data from supply chain
Pass wrong info. to customer or factory H L M Improve awareness of Quality/Risks
Employees Human error during daily operation M L M-L Improve “ERP” error-proof function
Leave the position/company suddenly. M L M-L Manage the Organization Knowledge
Bank Can’t get the loan when it is needed. H L M Keep excellent company credit
Instable currency rate H M M-H Fix the currency rate for PO to factory.
Others Uncertain Tariffs policy M M M Observe and communicate with customer
Loss of electric power M L M-L Ensure back-up power generator valid
Note: S – Severity; P – Possibility; H – High; M – Medium; L – Low; M-L: Medium to Low; M-H: Medium to High Review 2017/

6.2 Quality objectives and planning to achieve them

XXXX establish company level quality objectives to support the quality policy, and establish function level
quality objectives to support the company level quality objectives.
Those quality objectives is posted within the organization for communication, and monitored & measured by
QA, and updated after annual management review when it is needed for continuous improvement.
The ownership, resource needed, the timeframe and evaluation of these quality objectives are determined.
2017 Company level: 2017 Function/Team level:

1. Key customers’ satisfaction; Sales Team team:

2. Key customers’ quality complaint; 1) Key customers’ satisfaction 1) Errors of RFQ process.
2) Key customers’ quality complaint; 2) Errors of XXXX drawing.
3. Key ISO customers’ OTD (Prom.) 3) Key customer’s OTD (Prom.) 3) Errors of submitted sample
4. CAR to key suppliers: 4) Sales Errors of RFQ & SO (DPMO) 4) Errors of shipment inspection
Purchasing Team Warehouse team:
1) CAR to key suppliers 1) Errors of Shipping
2) Key factories’ OTD

6.3 Planning of changes

We will control the change to QMS in a planned manner by considering:
a) The purpose of the changes and their potential consequences;
b) The integrity of the quality management system;
c) The availability of resources;
d) The allocation or reallocation of responsibilities and authorities.

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7 Support
7.1 Resources
7.1.1 General
XXXX determine and provide the resources needed for the QMS, and we consider:
a) The capabilities of, and constraints on, existing internal resources;
b) What needs to be obtained from external providers?

7.1.2 People
XXXX determine and provide the persons necessary for the QMS, refer to 5.3 – Role/Responsibility...

7.1.3 Infrastructure
XXXX determine, provide and maintain the infrastructure necessary for the operation of its processes and to
achieve conformity of products and services, including building, warehouse equipment, computer,
telecommunication, ERP system, and so on.

7.1.4 Environment for the operation of processes

XXXX determine, provide and maintain the environment necessary for the operation of its processes and to
achieve conformity of products and services, including:
a) Non-discriminatory, calm, non-confrontational;
b) Stress-reducing, burnout prevention;
c) Comfortable temperature, humidity, light, airflow, hygiene to employee;
d) Suitable temperature (≤ 80 ⁰F) and humidity (≤ 60 % RH) to warehouse for protection of products.

7.1.5 Monitoring and measuring resources

XXXX determine and provide the measuring equipment to ensure valid and reliable results to verify the
conformity of products and services to requirements. (See the below list of XXXX measuring equipment.)
XXXX conduct the external and internal calibration to ensure their continuing fitness for their purpose and

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keep the calibration records/data. The interval of calibration is defined by XXXX based on risk-thinking.
XXXX label the calibration status and prevent unintended adjustments and damage of measuring equipment.
Measuring Equipment Use for Frequency Location Calibration interval

Note: the validity of previous measurement results shall be verified when measuring equipment is found to be
unfit for its intended purpose, and shall take appropriate action as necessary.

7.1.6 Organizational knowledge

XXXX determine the knowledge necessary for the operation of its processes and to achieve conformity of
products and services.
We maintain the organizational knowledge @ P:\Quality\XXXX - ISO9001, and all XXXX team can access it.
When addressing changing needs and trends, XXXX shall consider our current knowledge and determine how
to acquire or access any necessary additional knowledge and required updates.

NOTE: Organizational knowledge can be based on:

a) Internal sources (e.g. intellectual property; knowledge gained from experience; lessons learned from failures and
successful projects; capturing and sharing undocumented knowledge and experience; the results of improvements in
processes, products and services);
b) External sources (e.g. standards; academia; conferences; gathering knowledge from customers or external providers).
7.2 Competence
XXXX determine the necessary competence of person(s) doing work under our control that affects the
performance and effectiveness of the quality management system; (Job description)
XXXX ensure these persons are competent on the basis of appropriate education, training, or experience; and
where applicable, we will take actions to acquire the necessary competence, and evaluate the effectiveness of
the actions taken; and we retain appropriate documented information as evidence of competence.

7.3 Awareness
XXXX ensure that persons doing work under the organization’s control are aware of:
a) The quality policy;

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b) Relevant quality objectives;

c) Their contribution to the effectiveness of the QMS, including the benefits of improved performance;
d) The implications of not conforming to the quality management system requirements.

7.4 Communication
XXXX determine the internal and external communications (What/When/Whom/How/Who) relevant to the QMS:
OK
Customer Factory Warehouse
Receive, store & ship
Review RFQ. Sample
RFQ Review/Upload Quote (DFM)

S.O. PM Review/release (Tooling/CNC/sample) P.O.

Follow up sample with factory / deliver sample to customer/Boca
Inspect major shipment @ factory QA Review the report
site Sample

RMA Review and approve RMA

Sales

CAR QA Review CAR and release SCAR to factory / ()

Receive/review returned sample, and follow up analysis/8D report
QA Review Analysis/8D report and release it to customer
Dand release SCAR to factory Returned Sample

PPAP/ECR/ECN Work with factory

Support

RoHS/REACH/Conflict Mineral QA Factory

Work with factory
Others Team Work Work with factory
Customer

7.5 Documented information

7.5.1 General
XXXX ISO9001 2015 QMS include,
a) Documented information required by ISO9001 2015;
b) Documented information determined by XXXX as being necessary for the effectiveness of the QMS.

7.5.2 Creating and updating

When creating and updating documented information, XXXX ensure appropriate:
a) Identification and description (e.g. a title, date, author, or reference number);
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b) Format (e.g. language, sofare version, graphics) and media (e.g. paper, electronic);
c) Review and approval for suitability and adequacy.

7.5.3 Control of documented information

7.5.3.1 XXXX will control the documented information required by ISO9001 standard and QMS to ensure:
a) It is available and suitable for use, where and when it is needed;
b) It is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).
7.5.3.2 XXXX address the following activities for the control of documented information, as applicable:
a) Distribution, access, retrieval and use;
b) Storage and preservation, including preservation of legibility;
c) Control of changes (e.g. version control);
d) Retention and disposition.
XXXX identify the external document needed for QMS, and control them @ P:\Quality\XXXX - ISO9001.
Preventing unauthorized alteration or change the entered data was built into (security) system.
XXXX back up the data as below, and retain operational data in ERP/P Drive for long time (>10 years).

Back up flow chart

8 Operation
8.1 Operational planning and control
XXXX plan, implement and control the processes (see 4.4) needed to meet the requirements for the provision
of products and services, and to implement the actions determined in planning phase, by:
a) Determining the requirements for the products;
b) Establishing criteria for:
1) The processes;

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2) The acceptance of products;

c) Determining the resources needed to achieve conformity to the product and service requirements;
d) Implementing control of the processes in accordance with the criteria;
e) Determining, maintaining and retaining documented information to the extent necessary:
1) To have confidence that the processes have been carried out as planned;
2) To demonstrate the conformity of products and services to their requirements.
We assure the output of our planning is suitable for our operations.
XXXX will control planned changes and review the consequences of unintended changes, and take action to
mitigate any adverse effects, as necessary.
XXXX ensure that outsourced processes related to ### are controlled (see 8.4).

8.2 Requirements for products and services

8.2.1 Customer communication

Customer

RFQ Providing info. Relating to products / services Customer Spec. DFM. Change of RFQ

S.O. Handing the orders, including changes

Sales

RMA CAR Feedback relating to products and services, including complaints

Other Support Such as PPAP, ECR/ECN, and contingency actions, when relevant.

Note: XXXX define Customer Spec as customer property, we save the customer spec. in xxx
When change to customer spec happen, we will update it (xxx) on time to prevent unintended misuse.

8.2.2 Determining the requirements for products and services

When determining the requirements for the products/services to be offered to customers, XXXX ensure that:
a) The product requirements are defined, including applicable legal requirements & those necessary for XXXX.
b) The claims for the products and services it offers can be met.

8.2.3 Review of the requirements for products and services

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8.2.3.1 XXXX ensure that we has the ability to meet the requirements for products/services to be offered to
customers. XXXX conduct a review before committing to supply products/services to a customer, to include:
a) Requirements specified by the customer, including the requirements for delivery & post-delivery activities;
b) Requirements not stated by the customer, but necessary for the specified or intended use, when known;
c) Applicable statutory / regulatory requirements and requirements specified by the organization;
d) Contract or order requirements differing from those previously expressed.
For applicable customer non-written requirement, XXXX will confirm it before acceptance.

Enter RFQ & share the

Spec./EAU/
Project info.
customers email if needed Review RFQ. Ok Send RFQ to factory
(Sales) () ()

No
Upload customer confirmed email / new Spec + follow up /Sales

Confirming with customer / Sales Submit DFM to Sales

Ok Review/compare/upload
Quote customer Update landed cost
(PM) quotation + (upload
XXXX Customer

(Sales)
necessary reports)/ ()
No
Ask for Fan
Sample Enter Tooling Send sample request / ()
(CNC or
Create Part Sample) HS Enter Tooling (CNC
(Sales/PM) order (Sales) or Sample) PO / (PM)
Factory
Follow up & inspect Tooling
Ok
Submit sample to customer (Sales) (CNC or Sample) / ()

1st/Trail order Release PO/P.M.

Create PO (PPAP is
requested?) / (Sales) Request PPAP from Factory
Review submitted PPAP / ()
Review/QA
Submit & upload PPAP/Sales

Key points – Records of approval from customer must be kept, such as email, approved drawings and info.in ERP.
Key point – Records showed requirements can be met shall be kept, such as email, and information in ERP.

8.2.3.2 XXXX retain documented information in ERP

a) On the results of the review; (such as: RQF – Status in ERP; Customer order – entered Sales Order in ERP)
b) On any new requirements for the products and services.

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8.2.4 Changes to requirements for products and services

XXXX ensure that relevant documented information is amended, and that relevant persons are made aware of
the changed requirements, when the requirements for products and services are changed.
Request from Engineering Sales
1-1 Review the change requested 1-4 Confirm with customer the new XXXX spec, if needed.
1 Customer 1-2 Confirm with factory Upload new spec, and remove the old spec if P/N isn’t changed.
1-5
1-3 Create new XXXX spec. Upload new spec, if new P/N is created.

2-1 Review ECR/ECN from factory 2-4 Send XXXX ECR/ECR to customer for approval
2-2 Create XXXX ECR/ECN form 2-5 Confirm the result from customer, and notice XXXX
2 Factory
2-3 Send XXXX ECR/ECR to Sales 2-7 Confirm with customer new XXXX spec, if needed.
2-6 Create new XXXX spec. if need 2-8 Upload the new spec into ERP, as 1-5.
3-1 Confirm the expected change from 8D report with customer
3 8D report 3-2 Review the factory’s ECR 3-4 Confirm with customer the new XXXX spec, if needed.
3-3 Create new XXXX spec. 3-5 Upload the new spec into ERP, as 1-5.

8.3 Design and development of products and services

Justification for “no applicable” requirements: 8.3 - XXXX does not design or develop products & services.

8.4 Control of externally provided processes, products and services

8.4.1 General
XXXX ensure that externally provided processes, products and services conform to requirements.
XXXX determine the controls to be applied to externally provided processes, products and services, see 8.4.2.
XXXX determine and apply below process/criteria for the evaluation, selection, monitoring of performance,
and re-evaluation of external providers, based on their ability to provide processes or products and services.

Process 1: Selecting and evaluating external provider. Owner: PM/QA/Accounting

Sourcing Collect & submit Set up new external provider Review and approve the new
info to P.M. and upload requested files* external provider
(P.M.) (QA (Accounting)

Requested files* -- Survey, ISO Form/certificate

* For external provider with low quality risk/approved by Customer, CEO/QA can approve it without requested files.

Process 2: Monitoring of performance and re-evaluating of external provider Owner: QA/ (PM)
Monitoring of the performance Re-evaluating
CAR Shipment inspection OTD CAR (Qty.) Major Delivered Quality (PPM) OTD (%) Support/others

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Note 1: the monitoring and re-evaluating is focused on key external providers based on the risk-thinking.
Note 2: QA will take suitable actions to the key external providers based on the result of re-evaluating,
including the notice, or annual auditing to evaluate their capability and potential change onsite.
XXXX retain documented information related to this o processes in and P drive.

8.4.2 Type and extent of control

XXXX ensure that externally provided processes, products and services do not adversely affect our ability to
Consistently deliver conforming products and services to our customers.
XXXX ensure that externally provided processes (####) remain within the control of its QMS;
XXXX define how to control the external provider and the resulting output from the external provider,
including the verification to ensure the externally provided processes, products & services meet requirements.
External providers / How to control the resulting output of External providers How to control the External
provided processes / provided processes providers / provided processes
Real-time feedback from internal team about the
##### A Quality objective
daily operation
##### B Real-time feedback from customer /P.M/ factory Quality objective
factories Major shipment inspection; feedback from customer Quality objective

8.4.3 Information for external providers

XXXX ensure the adequacy of requirements prior to their communication to the external provider.

Review entered Sale order, Follow up sample making process,

Enter sales order enter / release PO (Sample and inspect provided sample & FAI Factory
(Sales) /Tooling/M.P.) to factory report and shipments of major parts
(P.M.)

XXXX will communicate to external providers its requirements for:

a) The processes, products and services to be provided;
b) The approval of products & services / Methods, processes & equipment / release of products & services.
c) Competence (including any required qualification of persons) and the interactions with XXXX;
d) Control and monitoring of the external providers’ performance to be applied by the organization;
e) Verification/validation activities XXXX/customer intends to perform at the external providers’ premises.

8.5 Production and service provision

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8.5.1 Control of production and service provision

XXXX implement production and service provision under controlled conditions.

Location @ XXXX factory + Customers (Asia)

Activities Shipment inspection Receive, store Receive, store Customers (USA)

for major parts and ship per P.M. and ship per ERP

Documented 1. Spec. of part. 1. Receive/ship record

information 2. Picture of part. 2. Inventory condition data (T. & H.)
3. Inspection report

8.5.2 Identification and traceability

XXXX use suitable means to identify products to ensure the conformity of products and services.
PO No. and Date Code

PO No.

Above + 2D code.

XXXX retain the relevant documented information (PO No., Date Code and 2D code) to enable traceability.

8.5.3 Property belonging to customers or external providers

Valid customers Spec. are upload into ERP/Inventory/Part.

8.5.4 Preservation
XXXX preserve the products to ensure conformity to requirements, including:
 Request factory to use suitable package to prevent the unexpected damage during sea transportation.
 Use ESD tray to prevent unexpected ESD damage to those fan which requested specially by customer.
 Control the temperature and humidity in the warehouse to protect the stored parts.

8.5.5 Post-delivery activities

XXXX will provide post-delivery service associated with the products and services, including:
a) Applicable RoHS, REACH, Conflict Mineral Declaration;
b) Engineering or application support, when it is requested from key customer.
c) Customer feedback, including RMA, quality complaint.

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d) Others
8.5.6 Control of changes
XXXX review and control changes for production or service provision, to the extent necessary to ensure
continuing conformity with requirements. Please refer to 8.2.4 Changes to requirements for products and services
XXXX retain documented information describing the results of review of changes, the person(s) authorizing the
change, and any necessary actions arising from the review @ ERP and P drive.

8.6 Release of products and services

XXXX implement planned arrangements, to verify that the product requirements have been met.
The release of products to the customer shall not proceed until the planned arrangements have been
satisfactorily completed, unless otherwise approved by the customer or top management/QA manager.
XXXX Parts For Sample For Mass Production Note
FAI report Inspection report SQE conduct necessary inspection
Test report COC, or FQC/OQC Collect and review the requested quality file from factory

Note: based on the risk-thinking, no all the shipment is requested for shipment inspection.
XXXX retain these documented information to show evidence of conformity and traceability to authorization.

8.7 Control of nonconforming outputs

8.7.1 XXXX ensure nonconformance are identified and controlled to prevent the unintended use or delivery.
XXXX will take appropriate action based on the nature of the nonconformity and its effect on the conformity.
XXXX deal with nonconforming outputs in one or more of the following ways:
a) Correction;
b) Segregation, containment, return or suspension of provision of products and services;
c) Informing the customer;
d) Obtaining authorization for acceptance under concession.
Conformity to the requirements shall be verified when nonconforming outputs are corrected.

8.7.2 XXXX will retain documented information that:

a) Describes the nonconformity;
b) Describes the actions taken;

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c) Describes any concessions obtained;

d) Identifies the authority deciding the action in respect of the nonconformity.
Note: The below flow chart shows the process how to control of nonconforming outputs in XXXX.

Sample
Customer complaints Create and approve RMA/ (Sales/P.M.) Receive + ship to factory for analysis

Factories
Sales collect details for Full Qty. Create/Send CAR
preliminary evaluation Review the entered CAR / (QA)
form to factory / (QA)

For dimension or Scrap @ customer

appearance issue or return to Ok Review 8D report/
Submit 8D report to
XXXX customer / Sales QA (+ Engineer)

Ok
Replacement or Credit to Customer Close the CAR /QA

Check the suspected lots in

stock / (Warehouse & QA)

NG Check the returned lot / (Warehouse & QA)

Return to supplier / Purchasing & QA

Quality Hold +
Or
Quarantine Scrap onsite / Purchasing & Warehouse & QA
(QA/Warehouse) Or
Rework onsite (or outsourcing) / Warehouse & QA

Lot issue

Ok
Re-inspection (report) / (QA or Sale / Warehouse Mr.)
Unlock quality
No
If Concession by Customer/CEO hold /QA
Scrap
Issue CAR
Part Quality issue
8.4 Analysis of data
XXXX Notice QA /NC finder Verify the issue /QA Alert vendor
Package + label issue
IQC / notice Sales

Internal operation NC Create RMA / team Create CAR / QA Record the defect + close CAR / QA

Audit NC Communicate &Analyze /QA+ Propose Solution /QA+ CAPA /QA+ Submit SGS CAR form

Key point – Record of CAR (root cause analysis, CAPA), rework/re-inspection and scrapping shall be kept in ERP/drive P.

Key point – The evidence of concession by authority must kept, such email or signed document, if there are concession
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Note – QA will review all the entered CARs, only valuable CARs (including involving in key customer and important quality
issue) will follow the above procedure, others, QA can handle by suitable method or close it based on the risk.

9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
XXXX determine below about monitoring, measurement, analysis and evaluation activities:
What needs to be monitored The Methods for monitoring, When/Who performing When the data being
& measured measurement, analysis & evaluation monitoring & measuring analyzed and evaluated
1 Customer Satisfaction Customer survey Before internal audit Before internal audit
2 Conformity of product CAR from customer & Delivered quality Daily operation (SQE/QA) Monthly + Yearly
3 OTD to key customers OTD data (promising lead time) Daily operation (Sales) Monthly + Yearly
4 OTD from key factories OTD data (promising lead time) Daily operation (P.M.) Monthly + Yearly
5 Error of W.H. shipment Qty. of error happened in warehouse Daily operation (QA) Monthly + Yearly

XXXX retain appropriate documented information as evidence of these results – Data Analysis.
9.1.2 Customer Satisfaction

For the important customers, we will conduct the customer satisfaction survey annually.

Select key customers Release & collect Survey Analyze data Follow-up action Summary
(Sales Mr.) (QA + Sale team) (QA) (QA + relevant team) (QA)

Note: the action of continuous improvement shall be followed up by QA and shown in the summary report.

9.1.3 Analysis and evaluation

XXXX analyze and evaluate appropriate data and information arising from monitoring and measurement.
The results of analysis shall be used to evaluate the below.
a) Conformity of products and services;
b) The degree of customer satisfaction;
c) The performance and effectiveness of the quality management system;
d) If planning has been implemented effectively;
e) The effectiveness of actions taken to address risks and opportunities;
f) The performance of external providers;

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g) The need for improvements to the quality management system.

Note: The result of the above evaluation shall be shown on the management review report.

9.2 Internal audit

Internal audit will be performed once a year to confirm the effectiveness of QMS.

Inform schedule Select auditors Audit plan + Conduct audit Audit report Follow-up
(QA) (QA) checking list (Audit team) (Audit Team) finding
(QA) (Audit Team)

Note: * Audit plan, audit checking list, audit report and CAR shall be kept in drive P;
* Internal auditor shall complete the internal auditor training, and auditor shall not audit their own work.

9.3 Management review

9.3.1 General
Top management officially review the QMS yearly to ensure its continuing suitability, adequacy, effectiveness
and alignment with the strategic direction of XXXX.

9.3.2 Management review inputs

9.3.3 Management review outputs
Management review inputs Management review outputs
a) The status of actions from previous management reviews. a) Opportunities for improvement
b) Changes in external & internal issues that are relevant to QMS. b) Any need for changes to the QMS
Information on the performance and effectiveness of the QMS. c) Resource needs.
1) Customer satisfaction + feedback from interested parties.
2) The extent to which quality objectives have been met;
3) Process performance and conformity of products and services
c)
4) Nonconformities and corrective actions
5) Monitoring and measurement results;
6) Audit results (internal + external);
7) The performance of external providers;
d) The adequacy of resources;
e) The effectiveness of actions taken to address risks & opportunities
f) Opportunities for improvement.

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XXXX retain documented information as evidence of the results of management reviews.

10 Improvement
10.1 General
XXXX determine and select opportunities for improvement and implement any necessary actions to meet
customer requirements and enhance customer satisfaction, these shall include:
a) Improving products / services to meet requirements as well as to address future needs and expectations;
b) Correcting, preventing or reducing undesired effects;
c) Improving the performance and effectiveness of the QMS.

10.2 Nonconformity and corrective action

10.2.1 When a nonconformity occurs, XXXX will follow up below process to react to the consequences and to
the cause(s) of nonconformity.

Create the CAR Take action to control & correct Analyze & determine Determining if
(Problem it, and deal with the consequence the root cause(s) of NC similar NC exist
finder/receiver) (QA/relevant parties) (QA/relevant parties) (QA/relevant parties)

Customers Factories

Review the effectiveness Determine & implement

Update risks and opportunities of the action taken action needed
determined during planning, if necessary (QA/relevant parties) (QA/relevant parties)
(QA)

Make changes to the QMS, if necessary

(QA)

Note: Corrective actions shall be appropriate to the effects of the nonconformities encountered.

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10.2.2 XXXX retain documented information @ P drive as evidence of

a) The nature of the nonconformities and any subsequent actions taken;
b) The results of any corrective action.

10.3 Continual improvement

XXXX will continually improve the suitability, adequacy and effectiveness of the QMS.
XXXX will consider the results of analysis and evaluation, and the outputs from management review, to
determine if there are needs or opportunities that shall be addressed as part of continual improvement.
Important change of new version log
Version Important change Date

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