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XXXX ISO9001:2015 Quality Manual
Reviewed by:
Approved by:
Version:
Quality is about processes and
data
Page 1
Quality is shared
responsibility within an
organization
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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XXXX ISO9001:2015 Quality Manual
Reviewed by:
Approved by:
Version:
Quality is about processes and
data
Page 2
Quality is shared
responsibility within an
organization
‘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:
1. Tariffs policy; 2. Foreign Trade Regulation;
3. Employment law; 4. Environmental regulations.
Economic factors:
1. Business Cycle Stage; 2. Globalization
3. Interest and exchange rates; 4. Inflation rate.
Social Factors:
1. Lifestyle changes; 2. Chinese New Year Holiday;
3. Consumerism; 4. Brand and company image.
Technological Factors:
1. Impact of internet (Online Sales); 2. Innovation
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
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
1. Gain new customers globally
2. Expand representative neork
1. Engineering capability in USA.
1. Instable currency rate.
2. Weather threats.
3. Uncertain Tariffs policy
Helpful Harmful
ExternalInternal
(orfuture)(orpresent)
S - Strengths
O - Opportunities
W - Weaknesses
T - Threats
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XXXX ISO9001:2015 Quality Manual
Reviewed by:
Approved by:
Version:
Quality is about processes and
data
Page 3
Quality is shared
responsibility within an
organization
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
parties
The needs and expectations Monitoring / Reviewing (Who/When)
Customers
Good quality, On-time delivery, quick response and
support, timely notice of ECR/ECN, and low-cost
Customer survey annually, RMA tracking
External
providers
Payment as agreed, partner relationship, clear &
adequate Reqt. for RFQ & PO, marketing
legal body RoHS, REACH, Conflict Mineral, Certification, declaration
Employees
Professional development, employment security, good
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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XXXX ISO9001:2015 Quality Manual
Reviewed by:
Approved by:
Version:
Quality is about processes and
data
Page 4
Quality is shared
responsibility within an
organization
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.
5. Leadership
5.1 Leadership and commitment
Production and Service
Provision process 8.5
(Warehouse)
Performance evaluation 9
Monitoring, measurement, analysis and
evaluation – 9.1; Internal Audit – 9.2;
Management review – 9.3
(QA/Top Management)
Customer- Related Process 8.2
ERP System
(Including Outlook, and drive P)
Context of the Org. 4
(Internal/External Issues, Interested Parties)
Leadership 5
(Customer focus, Policy, Role ...)
Planning 6
(Risk/Opp., Quality Objective, Change)
Operational Planning 8.1
(Top management / Managers)
External Provider – Related
process 8.4
Quote (RFQ)
(Sales) 8.2
Evaluate, select, monitor and
re-evaluate external provider
(Purchasing/QA/) 8.4.1
Customer Support
(Sales) 8.2
Process Purchasing Order
(Purchasing) 8.4.3
Control external provider
(Purchasing/QA/) 8.4.2
Control of Nonconforming Output 8.7
(QA)
Support 7
Resource – 7.1
Competence – 7.2
Awareness – 7.3
Communication – 7.4
Documented Information – 7.5
(Top management / Managers)
Process customer order
(Sales) 8.2
Release of products
and Service 8.6
(/Boca Warehouse)
Improvement 10 (N.C., C.A. …)
(QA)
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XXXX ISO9001:2015 Quality Manual
Reviewed by:
Approved by:
Version:
Quality is about processes and
data
Page 5
Quality is shared
responsibility within an
organization
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
ensuring
Quality policy and quality objectives are established for QMS and are compatible with the
context and strategic direction of the organization.
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
promoting
the use of the process approach and risk-based thinking
Improvement.
communicating The importance of effective quality management and of conforming to the QMS Requirement.
engaging, directing
and supporting
persons to contribute to the effectiveness of the quality management system
supporting
Other relevant management roles to demonstrate their leadership as it applies to their areas
of responsibility.
5.1.2 Customer focus
Top management shall demonstrate leadership and commitment with respect to customer focus by:
Ensuring
Customer and applicable legal requirements are determined, understood and consistently met.
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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XXXX ISO9001:2015 Quality Manual
Reviewed by:
Approved by:
Version:
Quality is about processes and
data
Page 6
Quality is shared
responsibility within an
organization
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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XXXX ISO9001:2015 Quality Manual
Reviewed by:
Approved by:
Version:
Quality is about processes and
data
Page 7
Quality is shared
responsibility within an
organization
Position Main Responsibility Main Roles/Authorities
Account
Manager
 Drive customer growth in market served.
 Maintain and satisfy the assigned customers.
 Owner of the relevant process and quality objectives
 Handle RFQ and customer PO.
 Create P/N, RMA/CAR;
 Customer support.
Product
Manager
 Buy the qualified products within lead time.
 Cost down from factories / shipment arrangement.
 Owner of the relevant process and quality objectives
 Review/Release PO
 Approve new created XXXX parts.
 Confirm freight charges and authorize shipment.
Warehouse
Manager
 Make sure the fluency of daily operation.
 Improve the effectiveness / efficiency of warehouse
 Owner of the relevant process and quality objectives
 Accept incoming parts.
 Release the shipping.
 Inventory cycle-count
Quality
Manager
 Establish/implement/maintain/improve the QMS
 Monitor/measure/report performance of QMS
 Coordinate external audit / Organize Internal Audit.
 Create, review, approve QMS document
 Collect/Analysis data for quality objectives
 Process customer complaints /approve suppliers
Sofare / IT
 Maintain/update/improve ERP system;
 Maintain, backup the entire data / IT infrastructure.
 Guarantee security & stability of email & internet.
 Modify and update the system.
 Monitor the IT infrastructure and backup data
 Warning the risk (Virus) from email/internal.
(Outsourcing
in QMS)
 Get best quote from factory for RFQ
 Confirm customer spec, Create/manage XXXX spec
 Source and select new factory
 Work with factory about the CAR/RMA.
 Shipment inspection, support sample & FAI report
 Upload RFQ quote into ERP.
 Create XXXX spec/drawing.
 Source new factory/supplier.
 Work with factory to find root cause of CAR/failure
 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
parties
Risks & Opportunities need to be
addressed
S P
Actions to address these Risks &
Opportunities
Effectiveness
of actions
Customers
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
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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XXXX ISO9001:2015 Quality Manual
Reviewed by:
Approved by:
Version:
Quality is about processes and
data
Page 8
Quality is shared
responsibility within an
organization
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
Employees
Pass wrong info. to customer or factory H L M Improve awareness of Quality/Risks
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
Others
Instable currency rate H M M-H Fix the currency rate for PO to factory.
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:
1. Key customers’ satisfaction;
2. Key customers’ quality complaint;
3. Key ISO customers’ OTD (Prom.)
4. CAR to key suppliers:
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.
2017 Function/Team level:
Sales Team
1) Key customers’ satisfaction
2) Key customers’ quality complaint;
3) Key customer’s OTD (Prom.)
4) Sales Errors of RFQ & SO (DPMO)
team:
1) Errors of RFQ process.
2) Errors of XXXX drawing.
3) Errors of submitted sample
4) Errors of shipment inspection
Purchasing Team
1) CAR to key suppliers
2) Key factories’ OTD
Warehouse team:
1) Errors of Shipping
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XXXX ISO9001:2015 Quality Manual
Reviewed by:
Approved by:
Version:
Quality is about processes and
data
Page 9
Quality is shared
responsibility within an
organization
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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XXXX ISO9001:2015 Quality Manual
Reviewed by:
Approved by:
Version:
Quality is about processes and
data
Page 10
Quality is shared
responsibility within an
organization
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:QualityXXXX - 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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XXXX ISO9001:2015 Quality Manual
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data
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Quality is shared
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organization
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:
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);
Returned Sample
Customer Factory
Sales
Receive, store & ship
Review RFQ.
RFQ
Review/release (Tooling/CNC/sample) P.O.
Review and approve RMA
S.O.
RMA
Follow up sample with factory / deliver sample to customer/Boca
Inspect major shipment @ factory
site
Support
Review/Upload Quote (DFM)
PM
Sample
Sample
OK
Warehouse
QA Review CAR and release SCAR to factory / ()
Receive/review returned sample, and follow up analysis/8D report
CAR
QA Review Analysis/8D report and release it to customer
Dand release SCAR to factory
Factory
Customer
PPAP/ECR/ECN
RoHS/REACH/Conflict Mineral
Others
Work with factory
QA Work with factory
QA Review the report
Team Work Work with factory
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XXXX ISO9001:2015 Quality Manual
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Version:
Quality is about processes and
data
Page 12
Quality is shared
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organization
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:QualityXXXX - 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).
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;
Back up flow chart
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XXXX ISO9001:2015 Quality Manual
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Quality is about processes and
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Quality is shared
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organization
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
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
Customer
Sales
RFQ
S.O.
RMA
Other Support
CAR
Providing info. Relating to products / services DFM. Change of RFQ
Handing the orders, including changes
Feedback relating to products and services, including complaints
Customer Spec.
Such as PPAP, ECR/ECN, and contingency actions, when relevant.
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Quality is shared
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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.
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.
Ok
Ok
HS
Fan
No
Spec./EAU/
Project info.
Enter RFQ & share the
customers email if needed
(Sales)
Create Part
(Sales/PM)
XXXXCustomer
Review RFQ.
()
Submit DFM to Sales
Upload customer confirmed email / new Spec + follow up /Sales
Send RFQ to factory
()
Review/compare/upload
quotation + (upload
necessary reports)/ ()
Quote customer
(Sales)
Update landed cost
(PM)
Ask for
Sample Send sample request / ()
Factory
Enter Tooling
(CNC or
Sample)
order (Sales)
Submit sample to customer (Sales)
Enter Tooling (CNC
or Sample) PO / (PM)
Follow up & inspect Tooling
(CNC or Sample) / ()
Ok
No
Confirming with customer / Sales
1st
/Trail order Create PO (PPAP is
requested?) / (Sales) Request PPAP from Factory
Review submitted PPAP / ()
Release PO/P.M.
Submit & upload PPAP/Sales
Review/QA
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.
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Version:
Quality is about processes and
data
Page 15
Quality is shared
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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 Customer
1-1 Review the change requested 1-4 Confirm with customer the new XXXX spec, if needed.
1-2 Confirm with factory
1-5
Upload new spec, and remove the old spec if P/N isn’t changed.
1-3 Create new XXXX spec. Upload new spec, if new P/N is created.
2 Factory
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
2-3 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 8D report
3-1 Confirm the expected change from 8D report with customer
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
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
Sourcing Set up new external provider
and upload requested files*
(P.M.)
Review and approve the new
external provider
(QA (Accounting)
Collect & submit
info to P.M.
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XXXX ISO9001:2015 Quality Manual
Reviewed by:
Approved by:
Version:
Quality is about processes and
data
Page 16
Quality is shared
responsibility within an
organization
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 /
provided processes
How to control the resulting output of External providers
/ provided processes
How to control the External
providers / provided processes
##### A
Real-time feedback from internal team about the
daily operation
Quality objective
##### 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.
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
Follow up sample making process,
and inspect provided sample & FAI
report and shipments of major parts
Enter sales order
(Sales)
Factory
Review entered Sale order,
enter / release PO (Sample
/Tooling/M.P.) to factory
(P.M.)
Logo
XXXX ISO9001:2015 Quality Manual
Reviewed by:
Approved by:
Version:
Quality is about processes and
data
Page 17
Quality is shared
responsibility within an
organization
8.5.1 Control of production and service provision
XXXX implement production and service provision under controlled conditions.
8.5.2 Identification and traceability
XXXX use suitable means to identify products to ensure the conformity of products and services.
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.
@ XXXX factory
Shipment inspection
for major parts
Receive, store
and ship per P.M.
Customers (Asia)+
Receive, store
and ship per ERP
Customers (USA)
Location
Activities
Documented
information
1. Spec. of part.
2. Picture of part.
3. Inspection report
1. Receive/ship record
2. Inventory condition data (T. & H.)
PO No. and Date Code
PO No.
Above + 2D code.
Logo
XXXX ISO9001:2015 Quality Manual
Reviewed by:
Approved by:
Version:
Quality is about processes and
data
Page 18
Quality is shared
responsibility within an
organization
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;
Logo
XXXX ISO9001:2015 Quality Manual
Reviewed by:
Approved by:
Version:
Quality is about processes and
data
Page 19
Quality is shared
responsibility within an
organization
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.
8.4 Analysis of data
Internal operation NC
Review 8D report/
QA (+ Engineer)
Close the CAR /QA
Key point – Record of CAR (root cause analysis, CAPA), rework/re-inspection and scrapping shall be kept in ERP/drive P.
Submit 8D report to
customer / Sales
Create and approve RMA/ (Sales/P.M.)
Quality Hold +
Quarantine
(QA/Warehouse)
Return to supplier / Purchasing & QA
Customer complaints
Key point – The evidence of concession by authority must kept, such email or signed document, if there are concession
Check the suspected lots in
stock / (Warehouse & QA)
Review the entered CAR / (QA)
Create RMA / team
Communicate &Analyze /QA+ Propose Solution /QA+
Part Quality issue
Verify the issue /QA
Create/Send CAR
form to factory / (QA)
Ok
NG
Scrap onsite / Purchasing & Warehouse & QA
Rework onsite (or outsourcing) / Warehouse & QA
If Concession by Customer/CEO
Scrap
Re-inspection (report) / (QA or Sale / Warehouse Mr.)
Unlock quality
hold /QA
Ok
No
Or
Receive + ship to factory for analysis
XXXX
IQC
Sample
For dimension or
appearance issue
Factories
Ok
Full Qty.
Scrap @ customer
or return to
XXXX
Replacement or Credit to Customer
Check the returned lot / (Warehouse & QA)
Or
Notice QA /NC finder
Package + label issue
Issue CAR
Lot issue
Alert vendor
/ notice Sales
Audit NC
Create CAR / QA Record the defect + close CAR / QA
CAPA /QA+ Submit SGS CAR form
Sales collect details for
preliminary evaluation
Logo
XXXX ISO9001:2015 Quality Manual
Reviewed by:
Approved by:
Version:
Quality is about processes and
data
Page 20
Quality is shared
responsibility within an
organization
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
& measured
The Methods for monitoring,
measurement, analysis & evaluation
When/Who performing
monitoring & measuring
When the data being
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.
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;
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.
Select key customers
(Sales Mr.)
Release & collect Survey
(QA + Sale team)
Analyze data
(QA)
Follow-up action
(QA + relevant team)
Summary
(QA)
Logo
XXXX ISO9001:2015 Quality Manual
Reviewed by:
Approved by:
Version:
Quality is about processes and
data
Page 21
Quality is shared
responsibility within an
organization
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.
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
c)
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
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.
Inform schedule
(QA)
Audit plan +
checking list
(QA)
Select auditors
(QA)
Conduct audit
(Audit team)
Follow-up
finding
(Audit Team)
Audit report
(Audit Team)
Logo
XXXX ISO9001:2015 Quality Manual
Reviewed by:
Approved by:
Version:
Quality is about processes and
data
Page 22
Quality is shared
responsibility within an
organization
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.
Note: Corrective actions shall be appropriate to the effects of the nonconformities encountered.
Take action to control & correct
it, and deal with the consequence
(QA/relevant parties)
Create the CAR
(Problem
finder/receiver)
Determine & implement
action needed
(QA/relevant parties)
FactoriesCustomers
Analyze & determine
the root cause(s) of NC
(QA/relevant parties)
Determining if
similar NC exist
(QA/relevant parties)
Review the effectiveness
of the action taken
(QA/relevant parties)
Update risks and opportunities
determined during planning, if necessary
(QA)
Make changes to the QMS, if necessary
(QA)
Logo
XXXX ISO9001:2015 Quality Manual
Reviewed by:
Approved by:
Version:
Quality is about processes and
data
Page 23
Quality is shared
responsibility within an
organization
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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ISO9001 Quality Manual Summary

  • 1. Logo XXXX ISO9001:2015 Quality Manual Reviewed by: Approved by: Version: Quality is about processes and data Page 1 Quality is shared responsibility within an organization 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’
  • 2. Logo XXXX ISO9001:2015 Quality Manual Reviewed by: Approved by: Version: Quality is about processes and data Page 2 Quality is shared responsibility within an organization ‘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: 1. Tariffs policy; 2. Foreign Trade Regulation; 3. Employment law; 4. Environmental regulations. Economic factors: 1. Business Cycle Stage; 2. Globalization 3. Interest and exchange rates; 4. Inflation rate. Social Factors: 1. Lifestyle changes; 2. Chinese New Year Holiday; 3. Consumerism; 4. Brand and company image. Technological Factors: 1. Impact of internet (Online Sales); 2. Innovation 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 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 1. Gain new customers globally 2. Expand representative neork 1. Engineering capability in USA. 1. Instable currency rate. 2. Weather threats. 3. Uncertain Tariffs policy Helpful Harmful ExternalInternal (orfuture)(orpresent) S - Strengths O - Opportunities W - Weaknesses T - Threats
  • 3. Logo XXXX ISO9001:2015 Quality Manual Reviewed by: Approved by: Version: Quality is about processes and data Page 3 Quality is shared responsibility within an organization 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 parties The needs and expectations Monitoring / Reviewing (Who/When) Customers Good quality, On-time delivery, quick response and support, timely notice of ECR/ECN, and low-cost Customer survey annually, RMA tracking External providers Payment as agreed, partner relationship, clear & adequate Reqt. for RFQ & PO, marketing legal body RoHS, REACH, Conflict Mineral, Certification, declaration Employees Professional development, employment security, good 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
  • 4. Logo XXXX ISO9001:2015 Quality Manual Reviewed by: Approved by: Version: Quality is about processes and data Page 4 Quality is shared responsibility within an organization 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. 5. Leadership 5.1 Leadership and commitment Production and Service Provision process 8.5 (Warehouse) Performance evaluation 9 Monitoring, measurement, analysis and evaluation – 9.1; Internal Audit – 9.2; Management review – 9.3 (QA/Top Management) Customer- Related Process 8.2 ERP System (Including Outlook, and drive P) Context of the Org. 4 (Internal/External Issues, Interested Parties) Leadership 5 (Customer focus, Policy, Role ...) Planning 6 (Risk/Opp., Quality Objective, Change) Operational Planning 8.1 (Top management / Managers) External Provider – Related process 8.4 Quote (RFQ) (Sales) 8.2 Evaluate, select, monitor and re-evaluate external provider (Purchasing/QA/) 8.4.1 Customer Support (Sales) 8.2 Process Purchasing Order (Purchasing) 8.4.3 Control external provider (Purchasing/QA/) 8.4.2 Control of Nonconforming Output 8.7 (QA) Support 7 Resource – 7.1 Competence – 7.2 Awareness – 7.3 Communication – 7.4 Documented Information – 7.5 (Top management / Managers) Process customer order (Sales) 8.2 Release of products and Service 8.6 (/Boca Warehouse) Improvement 10 (N.C., C.A. …) (QA)
  • 5. Logo XXXX ISO9001:2015 Quality Manual Reviewed by: Approved by: Version: Quality is about processes and data Page 5 Quality is shared responsibility within an organization 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 ensuring Quality policy and quality objectives are established for QMS and are compatible with the context and strategic direction of the organization. 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 promoting the use of the process approach and risk-based thinking Improvement. communicating The importance of effective quality management and of conforming to the QMS Requirement. engaging, directing and supporting persons to contribute to the effectiveness of the quality management system supporting Other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility. 5.1.2 Customer focus Top management shall demonstrate leadership and commitment with respect to customer focus by: Ensuring Customer and applicable legal requirements are determined, understood and consistently met. The risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed.
  • 6. Logo XXXX ISO9001:2015 Quality Manual Reviewed by: Approved by: Version: Quality is about processes and data Page 6 Quality is shared responsibility within an organization 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:
  • 7. Logo XXXX ISO9001:2015 Quality Manual Reviewed by: Approved by: Version: Quality is about processes and data Page 7 Quality is shared responsibility within an organization Position Main Responsibility Main Roles/Authorities Account Manager  Drive customer growth in market served.  Maintain and satisfy the assigned customers.  Owner of the relevant process and quality objectives  Handle RFQ and customer PO.  Create P/N, RMA/CAR;  Customer support. Product Manager  Buy the qualified products within lead time.  Cost down from factories / shipment arrangement.  Owner of the relevant process and quality objectives  Review/Release PO  Approve new created XXXX parts.  Confirm freight charges and authorize shipment. Warehouse Manager  Make sure the fluency of daily operation.  Improve the effectiveness / efficiency of warehouse  Owner of the relevant process and quality objectives  Accept incoming parts.  Release the shipping.  Inventory cycle-count Quality Manager  Establish/implement/maintain/improve the QMS  Monitor/measure/report performance of QMS  Coordinate external audit / Organize Internal Audit.  Create, review, approve QMS document  Collect/Analysis data for quality objectives  Process customer complaints /approve suppliers Sofare / IT  Maintain/update/improve ERP system;  Maintain, backup the entire data / IT infrastructure.  Guarantee security & stability of email & internet.  Modify and update the system.  Monitor the IT infrastructure and backup data  Warning the risk (Virus) from email/internal. (Outsourcing in QMS)  Get best quote from factory for RFQ  Confirm customer spec, Create/manage XXXX spec  Source and select new factory  Work with factory about the CAR/RMA.  Shipment inspection, support sample & FAI report  Upload RFQ quote into ERP.  Create XXXX spec/drawing.  Source new factory/supplier.  Work with factory to find root cause of CAR/failure  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 parties Risks & Opportunities need to be addressed S P Actions to address these Risks & Opportunities Effectiveness of actions Customers 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 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
  • 8. Logo XXXX ISO9001:2015 Quality Manual Reviewed by: Approved by: Version: Quality is about processes and data Page 8 Quality is shared responsibility within an organization 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 Employees Pass wrong info. to customer or factory H L M Improve awareness of Quality/Risks 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 Others Instable currency rate H M M-H Fix the currency rate for PO to factory. 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: 1. Key customers’ satisfaction; 2. Key customers’ quality complaint; 3. Key ISO customers’ OTD (Prom.) 4. CAR to key suppliers: 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. 2017 Function/Team level: Sales Team 1) Key customers’ satisfaction 2) Key customers’ quality complaint; 3) Key customer’s OTD (Prom.) 4) Sales Errors of RFQ & SO (DPMO) team: 1) Errors of RFQ process. 2) Errors of XXXX drawing. 3) Errors of submitted sample 4) Errors of shipment inspection Purchasing Team 1) CAR to key suppliers 2) Key factories’ OTD Warehouse team: 1) Errors of Shipping
  • 9. Logo XXXX ISO9001:2015 Quality Manual Reviewed by: Approved by: Version: Quality is about processes and data Page 9 Quality is shared responsibility within an organization 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
  • 10. Logo XXXX ISO9001:2015 Quality Manual Reviewed by: Approved by: Version: Quality is about processes and data Page 10 Quality is shared responsibility within an organization 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:QualityXXXX - 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;
  • 11. Logo XXXX ISO9001:2015 Quality Manual Reviewed by: Approved by: Version: Quality is about processes and data Page 11 Quality is shared responsibility within an organization 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: 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); Returned Sample Customer Factory Sales Receive, store & ship Review RFQ. RFQ Review/release (Tooling/CNC/sample) P.O. Review and approve RMA S.O. RMA Follow up sample with factory / deliver sample to customer/Boca Inspect major shipment @ factory site Support Review/Upload Quote (DFM) PM Sample Sample OK Warehouse QA Review CAR and release SCAR to factory / () Receive/review returned sample, and follow up analysis/8D report CAR QA Review Analysis/8D report and release it to customer Dand release SCAR to factory Factory Customer PPAP/ECR/ECN RoHS/REACH/Conflict Mineral Others Work with factory QA Work with factory QA Review the report Team Work Work with factory
  • 12. Logo XXXX ISO9001:2015 Quality Manual Reviewed by: Approved by: Version: Quality is about processes and data Page 12 Quality is shared responsibility within an organization 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:QualityXXXX - 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). 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; Back up flow chart
  • 13. Logo XXXX ISO9001:2015 Quality Manual Reviewed by: Approved by: Version: Quality is about processes and data Page 13 Quality is shared responsibility within an organization 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 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 Customer Sales RFQ S.O. RMA Other Support CAR Providing info. Relating to products / services DFM. Change of RFQ Handing the orders, including changes Feedback relating to products and services, including complaints Customer Spec. Such as PPAP, ECR/ECN, and contingency actions, when relevant.
  • 14. Logo XXXX ISO9001:2015 Quality Manual Reviewed by: Approved by: Version: Quality is about processes and data Page 14 Quality is shared responsibility within an organization 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. 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. Ok Ok HS Fan No Spec./EAU/ Project info. Enter RFQ & share the customers email if needed (Sales) Create Part (Sales/PM) XXXXCustomer Review RFQ. () Submit DFM to Sales Upload customer confirmed email / new Spec + follow up /Sales Send RFQ to factory () Review/compare/upload quotation + (upload necessary reports)/ () Quote customer (Sales) Update landed cost (PM) Ask for Sample Send sample request / () Factory Enter Tooling (CNC or Sample) order (Sales) Submit sample to customer (Sales) Enter Tooling (CNC or Sample) PO / (PM) Follow up & inspect Tooling (CNC or Sample) / () Ok No Confirming with customer / Sales 1st /Trail order Create PO (PPAP is requested?) / (Sales) Request PPAP from Factory Review submitted PPAP / () Release PO/P.M. Submit & upload PPAP/Sales Review/QA 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.
  • 15. Logo XXXX ISO9001:2015 Quality Manual Reviewed by: Approved by: Version: Quality is about processes and data Page 15 Quality is shared responsibility within an organization 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 Customer 1-1 Review the change requested 1-4 Confirm with customer the new XXXX spec, if needed. 1-2 Confirm with factory 1-5 Upload new spec, and remove the old spec if P/N isn’t changed. 1-3 Create new XXXX spec. Upload new spec, if new P/N is created. 2 Factory 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 2-3 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 8D report 3-1 Confirm the expected change from 8D report with customer 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 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 Sourcing Set up new external provider and upload requested files* (P.M.) Review and approve the new external provider (QA (Accounting) Collect & submit info to P.M.
  • 16. Logo XXXX ISO9001:2015 Quality Manual Reviewed by: Approved by: Version: Quality is about processes and data Page 16 Quality is shared responsibility within an organization 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 / provided processes How to control the resulting output of External providers / provided processes How to control the External providers / provided processes ##### A Real-time feedback from internal team about the daily operation Quality objective ##### 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. 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 Follow up sample making process, and inspect provided sample & FAI report and shipments of major parts Enter sales order (Sales) Factory Review entered Sale order, enter / release PO (Sample /Tooling/M.P.) to factory (P.M.)
  • 17. Logo XXXX ISO9001:2015 Quality Manual Reviewed by: Approved by: Version: Quality is about processes and data Page 17 Quality is shared responsibility within an organization 8.5.1 Control of production and service provision XXXX implement production and service provision under controlled conditions. 8.5.2 Identification and traceability XXXX use suitable means to identify products to ensure the conformity of products and services. 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. @ XXXX factory Shipment inspection for major parts Receive, store and ship per P.M. Customers (Asia)+ Receive, store and ship per ERP Customers (USA) Location Activities Documented information 1. Spec. of part. 2. Picture of part. 3. Inspection report 1. Receive/ship record 2. Inventory condition data (T. & H.) PO No. and Date Code PO No. Above + 2D code.
  • 18. Logo XXXX ISO9001:2015 Quality Manual Reviewed by: Approved by: Version: Quality is about processes and data Page 18 Quality is shared responsibility within an organization 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;
  • 19. Logo XXXX ISO9001:2015 Quality Manual Reviewed by: Approved by: Version: Quality is about processes and data Page 19 Quality is shared responsibility within an organization 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. 8.4 Analysis of data Internal operation NC Review 8D report/ QA (+ Engineer) Close the CAR /QA Key point – Record of CAR (root cause analysis, CAPA), rework/re-inspection and scrapping shall be kept in ERP/drive P. Submit 8D report to customer / Sales Create and approve RMA/ (Sales/P.M.) Quality Hold + Quarantine (QA/Warehouse) Return to supplier / Purchasing & QA Customer complaints Key point – The evidence of concession by authority must kept, such email or signed document, if there are concession Check the suspected lots in stock / (Warehouse & QA) Review the entered CAR / (QA) Create RMA / team Communicate &Analyze /QA+ Propose Solution /QA+ Part Quality issue Verify the issue /QA Create/Send CAR form to factory / (QA) Ok NG Scrap onsite / Purchasing & Warehouse & QA Rework onsite (or outsourcing) / Warehouse & QA If Concession by Customer/CEO Scrap Re-inspection (report) / (QA or Sale / Warehouse Mr.) Unlock quality hold /QA Ok No Or Receive + ship to factory for analysis XXXX IQC Sample For dimension or appearance issue Factories Ok Full Qty. Scrap @ customer or return to XXXX Replacement or Credit to Customer Check the returned lot / (Warehouse & QA) Or Notice QA /NC finder Package + label issue Issue CAR Lot issue Alert vendor / notice Sales Audit NC Create CAR / QA Record the defect + close CAR / QA CAPA /QA+ Submit SGS CAR form Sales collect details for preliminary evaluation
  • 20. Logo XXXX ISO9001:2015 Quality Manual Reviewed by: Approved by: Version: Quality is about processes and data Page 20 Quality is shared responsibility within an organization 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 & measured The Methods for monitoring, measurement, analysis & evaluation When/Who performing monitoring & measuring When the data being 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. 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; 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. Select key customers (Sales Mr.) Release & collect Survey (QA + Sale team) Analyze data (QA) Follow-up action (QA + relevant team) Summary (QA)
  • 21. Logo XXXX ISO9001:2015 Quality Manual Reviewed by: Approved by: Version: Quality is about processes and data Page 21 Quality is shared responsibility within an organization 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. 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 c) 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 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. Inform schedule (QA) Audit plan + checking list (QA) Select auditors (QA) Conduct audit (Audit team) Follow-up finding (Audit Team) Audit report (Audit Team)
  • 22. Logo XXXX ISO9001:2015 Quality Manual Reviewed by: Approved by: Version: Quality is about processes and data Page 22 Quality is shared responsibility within an organization 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. Note: Corrective actions shall be appropriate to the effects of the nonconformities encountered. Take action to control & correct it, and deal with the consequence (QA/relevant parties) Create the CAR (Problem finder/receiver) Determine & implement action needed (QA/relevant parties) FactoriesCustomers Analyze & determine the root cause(s) of NC (QA/relevant parties) Determining if similar NC exist (QA/relevant parties) Review the effectiveness of the action taken (QA/relevant parties) Update risks and opportunities determined during planning, if necessary (QA) Make changes to the QMS, if necessary (QA)
  • 23. Logo XXXX ISO9001:2015 Quality Manual Reviewed by: Approved by: Version: Quality is about processes and data Page 23 Quality is shared responsibility within an organization 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