[FULL CLIENT NAME ALL CAPS]

[Quality Manual Doc Title]

Revision [Rev Number]
Issued [Date of Issue]

Conforms to ISO 9001:2015

(c) [Copyright Year] [Full Client Name Reg Caps]; all rights reserved. This document may contain proprietary information and
may only be released to third parties with approval of management. Document is uncontrolled unless otherwise marked;
uncontrolled documents are not subject to update notification.
 [Full Client Name Reg Caps]
[Quality Manual Doc Title]
Revision [Rev Number] - [Date of Issue]

TABLE OF CONTENTS

0.0 Revision History and Approval.................................................................................................................... 3

1.0 Welcome to [Full Client Name Reg Caps]................................................................................................... 4
2.0 About The [Short Client Name] Quality Manual........................................................................................... 4
3.0 Terms and Definitions................................................................................................................................. 4
4.0 The Scope and Context of the [Short Client Name] QMS...........................................................................5
4.1 Determining Our Strategic Direction........................................................................................................ 5
4.2 Scope of the Management System......................................................................................................... 5
4.2.1 Scope Statement............................................................................................................................. 5
4.2.2 Facilities Within the Scope.............................................................................................................. 5
4.2.3 Permissible Exclusions.................................................................................................................... 6
4.2.4 Scope of the [Quality Manual Doc Title].......................................................................................... 6
5.0 Quality Policy............................................................................................................................................... 7
6.0 Management System Processes................................................................................................................. 7
6.1 Process Identification.............................................................................................................................. 7
6.2 Process Controls & Objectives................................................................................................................ 7
6.3 Outsourced Processes............................................................................................................................ 8
7.0 Documentation & Records.......................................................................................................................... 8
7.1 General.................................................................................................................................................... 8
7.2 Control of Documents.............................................................................................................................. 8
7.3 Control of Records.................................................................................................................................. 9
8.0 Management & Leadership......................................................................................................................... 9
8.1 Management Leadership and Commitment............................................................................................. 9
8.2 Customer Focus...................................................................................................................................... 9
8.3 Quality Policy......................................................................................................................................... 10
8.4 Organizational Roles Responsibilities & Authorities..............................................................................10
8.5 Internal Communication......................................................................................................................... 10
8.6 Change Management............................................................................................................................ 11
8.7 Risks and Opportunities........................................................................................................................ 11
8.8 Management Review............................................................................................................................. 11
9.0 Resources................................................................................................................................................. 11
9.1 Provision of Resources.......................................................................................................................... 11
9.2 Human Resources................................................................................................................................. 12
9.3 Infrastructure......................................................................................................................................... 12
9.4 Work Environment................................................................................................................................. 12
9.5 Organizational Knowledge..................................................................................................................... 13
10.0 Operation.................................................................................................................................................. 13
10.1 Operational Planning and Control......................................................................................................... 13
10.2 Customer-Related Activities.................................................................................................................. 13
10.3 Customer Communication..................................................................................................................... 14
10.4 Design and Development...................................................................................................................... 14
10.5 Purchasing............................................................................................................................................ 14
10.6 Provision of [Products or Services Plur.]...............................................................................................15
10.6.1 Control of Provision of [Products or Services Plur.].......................................................................15
10.6.2 Identification and Traceability........................................................................................................ 15
10.6.3 Property Belonging to Third Parties............................................................................................... 15
10.6.4 Preservation.................................................................................................................................. 16
10.6.5 Post-Delivery Activities.................................................................................................................. 16
10.6.6 Process Change Control............................................................................................................... 16
10.6.7 Measurement and Release of [Products or Services Plur.]...........................................................16
10.6.8 Control of Nonconforming Outputs................................................................................................ 16
11.0 Improvement............................................................................................................................................. 16

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11.1 General.................................................................................................................................................. 16
11.2 Customer Satisfaction........................................................................................................................... 17
11.3 Internal Audit......................................................................................................................................... 17
11.4 Corrective and Preventive Action.......................................................................................................... 17
Appendix A: Overall Process Sequence & Interaction.......................................................................................19
Appendix B: ISO 9001:2015 Cross Reference................................................................................................... 20

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[Quality Manual Doc Title]
Revision [Rev Number] - [Date of Issue]

1.0 Revision History and Approval

Rev. Nature of changes Approval Date

[Quality
[Rev Manual
Original release. [Date of Issue]
Number] Approver
Name]

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2.0 Welcome to [Full Client Name Reg Caps]

Add welcome language here. This is the first thing a reader will see, so it’s a good idea to add basic
information about the company. If the intended audience includes customers, you can add marketing
language here, too.

3.0 About The [Short Client Name] Quality Manual

This manual is prepared for the purpose of defining the company’s interpretations of the ISO
9001:2015 international standard, as well as to demonstrate how the company complies with that
standard.
This manual is not aligned with the clause numbering scheme of ISO 9001; instead, Appendix B
provides a cross-reference table that shows where, in the manual, each ISO 9001 requirement is
addressed.
This manual presents “Notes” which are used to define how [Short Client Name] has tailored its
management system to suit its purposes. These are intended to clarify implementation approaches
and interpretations for concepts which are not otherwise clearly defined in ISO 9001:2015. Notes
appear in italics, with gray background.
Where subordinate or supporting documentation is reference in this manual, these are indicated by
bold italics.

4.0 Terms and Definitions

[Short Client Name] adopts the following terms and definitions within its Quality Management System.
Where no definition is provided, the company typically adopts the definitions provided in ISO 9000:
Quality Management – Fundamentals and Vocabulary. In some cases, specific procedures or
documentation may provide a different definition to be used in the context of that document; in such
cases, the definition will supercede those provided for in this Quality Manual or ISO 9000.
Add additional terms as you see fit.
General Terminology
[Short Client Name] – [Full Client Name Reg Caps]
Document – written information used to describe how an activity is done.
Record – captured evidence of an activity having been done.
Risk-Based Thinking Terminology
Risk – Negative effect of uncertainty
Opportunity – Positive effect of uncertainty
Uncertainty - A deficiency of information related to understanding or knowledge of an event,
its consequence, or likelihood. (Not to be confused with measurement uncertainty.)
Nonconforming Product Terminology
Rework: Efforts to bring nonconforming product into conformance through additional
operations that do not alter the original design of the product.

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Repair: Efforts to bring nonconforming product into conformance through additional operations
that alter the original design of the product; this may be through the addition of material no
specified in the original design, or through altering pre-existing design features.
Scrap: The discard of nonconforming product in lieu of rework or repair.

5.0 The Scope and Context of the [Short Client Name] QMS
4.1 Determining Our Strategic Direction
[Short Client Name] has reviewed and analyzed key aspects of itself and its stakeholders to determine
the strategic direction of the company. This involves:
 Understanding our core [Products or Services Plur.], and scope of management system (see
4.2 below).
 Identifying “interested parties” (stakeholders) who receive our [Products or Services Plur.], or
who may be impacted by them, or those parties who may otherwise have a significant interest
in our company. These parties are identified in the document [Context of the Org Proc. Title].
 Understanding internal and external issues that are of concern to [Short Client Name] and its
interested parties; also identified in the document [Context of the Org Proc. Title]. Many such
issues are identified through an analysis of risks facing either [Short Client Name] or the
interested parties. Such issues are monitored and updated as appropriate, and discussed as
part of management reviews.
This information is then used by senior management to determine the company’s strategic direction.
This is defined in records of management review, and periodically updated as conditions and
situations change.

4.2 Scope of the Management System

4.2.1 Scope Statement

Based on an analysis of the above issues of concern, interests of stakeholders, and in consideration of
its [Products or Services Plur.], [Short Client Name] has determined the scope of the management
system as follows:
The scope statement must nclude a descrpton of products and/or services,.
Descroption of products and/or services
This is what will appear on any resulting ISO 9001 certificte.
You mayconsult with your certification body for assistance
Add scope statement here. The scope statement must include a description of your products
and/or services. This is what will appear on any resulting ISO 9001 certificate; you may consult
with your certification body for assistance.

4.2.2 Facilities Within the Scope

(If more than one site)

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The quality system applies to all processes, activities, and employees of the following locations within
the company:

[Street Address] Site 2 Address

[City] [STATEABBREV] [Zip]
[Phone]
Site 3 Address Site 4 Address

(If single site)

The quality system applies to all processes, activities and employees within the company. The facility
is located at:
[Street Address]
[City] [STATEABBREV] [Zip]
Phone: [Phone]
Fax: [Fax]
Web: [Website]

4.2.3 Permissible Exclusions

(If exclusions)
The following clauses of ISO 9001 were determined to be not applicable to [Short Client Name].
 List clause exclusions and a justification for each here.

(If no exclusions)
The company claims no exclusions from the ISO 9001 standard.
(Optional: site exclusion table)
The following sites are excluded from the company quality system at this time; in the future, these may
be incorporated into the company QMS, and this manual will be updated accordingly.

Site 1 Address Site 2 Address

Site 3 Address Site 4 Address

4.2.4 Scope of the [Quality Manual Doc Title]

This manual is prepared for the purpose of defining the company’s interpretations of the ISO
9001:2015 international standard, as well as to demonstrate how the company complies with that
standard.
This manual does not strictly follow the numbering structure of ISO 9001. Instead, Appendix B
presents a cross reference between the sections of this manual and the clauses of ISO 9001:2015.

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This manual presents “Notes” which are used to define how [Short Client Name] has tailored its
management system to suit its purposes. These are intended to clarify implementation approaches
and interpretations for concepts which are not otherwise clearly defined in ISO 9001:2015. Notes
appear in italics, with gray background.
Where subordinate or supporting documentation is reference in this manual, these are indicated by
bold italics.

6.0 Quality Policy

The Quality Policy of [Short Client Name] is as follows:

Add Quality Policy here.

7.0 Management System Processes

6.1 Process Identification
[Short Client Name] has adopted a process approach for its management system. By identifying the
top-level processes within the company, and then managing each of these discretely, this reduces the
potential for nonconforming [Products or Services Plur.] discovered during final processes or after
delivery. Instead, nonconformities and risks are identified in real time, by actions taken within each of
the top-level processes.
Note: not all activities are considered “processes” – the term “process” in this context indicates the activity has been elevated
to a higher level of control and management oversight. The controls indicated herein are applicable only to the top-level
processes identified.

The following top-level processes have been identified for [Short Client Name]:
 List processes here
 List processes here
Each process may be supported by other activities, such as tasks or sub-processes. Monitoring and
control of top level processes ensures effective implementation and control of all subordinate tasks or
sub-processes.
Each top-level process has a [Process Definition Doc Title] document which defines:
 applicable inputs and outputs
 process owner(s)
 applicable responsibilities and authorities
 applicable risks and opportunities
 critical and supporting resources
 criteria and methods employed to ensure the effectiveness of the process
The sequence of interaction of these processes is illustrated in Appendix A.
Note: Appendix A represents the typical sequence of processes, and may be altered depending on customer or regulatory

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requirements at the job or contract level, as needed.

6.2 Process Controls & Objectives

Each process has at least one objective established for it; this is a statement of the intent of the
process. Each objective is then supported by at least one “metric” or key performance indicator (KPI)
which is then measured to determine the process’ ability to meet the quality objective.
Note: some processes have multiple objectives and multiple metrics. This is determined by the nature of the process, it’s
impact on [Products or Services Plur.], and associated risks.
Note: Whereas ISO 9001 discusses process measurements and “quality objectives” as separate concepts, [Short Client
Name] combines them; i.e., quality objectives are used to control the processes. Additional objectives for [Products or
Services Plur.] may be assigned, but these will also be used to measure process effectiveness.

Throughout the year, metrics data is measured and gathered by process owners or other assigned
managers, in order to present the data to [Senior Management Team Name]. The data is then
analyzed by [Senior Management Team Name] in order that [Senior Management Team Name] may
set goals and make adjustments for the purposes of long-term continual improvement.
The specific quality objectives for each process are defined in the minutes of Management Review,
per section 8.8.
Metrics, along with current standings and goals for each objective, are recorded in records of
management review.
When a process does not meet a goal, or an unexpected problem is encountered with a process, the
corrective and preventive action process is implemented to research and resolve the issue. In addition,
opportunities for improvement are sought and implemented, for the identified processes.

6.3 Outsourced Processes

Any process performed by a third party is considered an “outsourced process” and must be controlled,
as well. The company’s outsourced processes, and the control methods implemented for each, are
defined in [Outsourced Processes Title].
The type and extent of control to be applied to the outsourced process take into consideration:
a) the potential impact of the outsourced process on the company’s capability to provide product
that conforms to requirements,
b) the degree to which the control for the process is shared,
c) the capability of achieving the necessary control through the purchasing contract requirements.
8.0 Documentation & Records
7.1 General
The management system documentation includes both documents and records.
Note: the ISO 9001:2015 standard uses the term “documented information”; [Short Client Name] does not use this term, but
instead relies on the terms “document” and “record” to avoid confusion. In this context the terms are defined per section 3.0
above. Documents and records undergo different controls as defined herein.

The extent of the management system documentation has been developed based on the following:
a) The size of [Short Client Name]
b) Complexity and interaction of the processes

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c) Risks and opportunities

d) Competence of personnel

7.2 Control of Documents

Documents required for the management system are controlled in accordance with procedure
[Control of Documents Proc. Title]. The purpose of document control is to ensure that staff have
access to the latest, approved information, and to restrict the use of obsolete information.
All documented procedures are established, documented, implemented and maintained.

7.3 Control of Records

A documented procedure [Control of Records Proc. Title] has been established to define the
controls needed for the identification, storage, retrieval, protection, retention time, and disposition of
quality records. This procedure also defines the methods for controlling records that are created by
and/or retained by suppliers.
These controls are applicable to those records which provide evidence of conformance to
requirements; this may be evidence of [Product or Service Sing.] requirements, contractual
requirements, procedural requirements, or statutory/regulatory compliance. In addition, quality records
include any records which provide evidence of the effective operation of the management system.

9.0 Management & Leadership

8.1 Management Leadership and Commitment
[Senior Management Team Name] of [Short Client Name] provides evidence of its leadership and
commitment to the development and implementation of the management system and continually
improving its effectiveness by:
a) taking accountability of the effectiveness of the management system;
b) ensuring that the Quality Policy and quality objectives are established for the management
system and are compatible with the strategic direction and the context of the organization;
c) ensuring that the quality policy is communicated, understood and applied within the
organization;
d) ensuring the integration of the management system requirements into the organization’s other
business processes, as deemed appropriate (see note);
e) promoting awareness of the process approach;
f) ensuring that the resources needed for the management system are available;
g) communicating the importance of effective quality management and of conforming to the
management system requirements;
h) ensuring that the management system achieves its intended results;
i) engaging, directing and supporting persons to contribute to the effectiveness of the
management system;
j) promoting continual improvement;

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k) supporting other relevant management roles to demonstrate their leadership as it applies to

their areas of responsibility.
Note: “business processes” such as accounting, employee benefits management and legal activities are out of scope of the
QMS.

8.2 Customer Focus

[Senior Management Team Name] of [Short Client Name] adopts a customer-first approach which
ensures that customer needs and expectations are determined, converted into requirements and are
met with the aim of enhancing customer satisfaction.
This is accomplished by assuring:
a) customer and applicable statutory and regulatory requirements are determined, understood
and consistently met;
b) the risks and opportunities that can affect conformity of [Product or Service Sing.] and the
ability to enhance customer satisfaction are determined and addressed;
c) the focus on enhancing customer satisfaction is maintained.

8.3 Quality Policy

[Senior Management Team Name] has developed the Quality Policy, defined in section 5.0 above,
that governs day-to-day operations to ensure quality.
The Quality Policy is released as a standalone document as well, and is communicated and
implemented throughout the organization.

8.4 Organizational Roles Responsibilities & Authorities

[Senior Management Team Name] has assigned responsibilities and authorities for all relevant roles in
the company. These are communicated through the combination of the [Org Chart Title] and [Position
Description Title]s.
The [Senior Management Team Name] accepts responsibility and authority for:
a) ensuring that the management system conforms to applicable standards;
b) ensuring that the processes are delivering their intended outputs;
c) reporting on the performance of the management system;
d) providing opportunities for improvement for the management system;
e) ensuring the promotion of customer focus throughout the organization;
f) ensuring that the integrity of the management system is maintained when changes are planned
and implemented.

8.5 Internal Communication

[Senior Management Team Name] of [Short Client Name] ensures internal communication takes place
regarding the effectiveness of the management system. Internal communication methods include
(modify as appropriate):
a) use of corrective and preventive action processes to report nonconformities or suggestions for

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improvement
b) use of the results of analysis of data
c) management review
d) meetings (periodic, scheduled and/or unscheduled) to discuss aspects of the QMS
e) use of the results of the internal audit process
f) regular company meetings with all employees
g) internal emails
h) management review
i) memo notice
j) memos to employee
k) [Short Client Name]’s “open door” policy which allows any employee access to [Senior
Management Team Name] for discussions on improving the quality system
l) Internal emails
m) Managmenet review
n) Internal emails
o) Corrective Action Request

Close door policy an

8.6 Change Management

When [Short Client Name] determines the need for changes to the management system or its
processes, these changes planned, implemented, and then verified for effectiveness; see the
document [Change Mgmt Doc Title].
Documents are changed in accordance with procedure [Control of Documents Proc. Title].

8.7 Risks and Opportunities

Note: [Short Client Name] deviates slightly from the approach towards risk and opportunity presented in ISO 9001. Instead,
[Short Client Name] views “uncertainty” as neutral, but defines “risk” as a negative effect of uncertainty, and “opportunity” as
a positive effect of uncertainty. [Short Client Name] has elected to manage risks and opportunities separately, except where
they may overlap. Formal risk management may not be utilized in all instances; instead, the level of risk assessment,
analysis, treatment and recordkeeping will be performed to the level deemed appropriate for each circumstance or
application.

[Short Client Name] considers risks and opportunities when taking actions within the management
system, as well as when implementing or improving the management system; likewise, these are
considered relative to [Products or Services Plur.]. Risks and opportunities are identified as part of the
“Context of the Organization Exercise” defined in [Context of the Org Proc. Title], as well as
throughout all other activities of the QMS.

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Risks and opportunities are managed in accordance with the document [Risk Management Proc.
Title]. This procedure defines how risks are managed in order to minimize their likelihood and impact,
and how opportunities are managed to improve their likelihood and benefit.

8.8 Management Review

The [Senior Management Team Name] reviews the management system, at planned intervals, to
ensure its continuing suitability, adequacy and effectiveness. The review includes assessing
opportunities for improvement, and the need for changes to the management system, including the
Quality Policy and quality objectives.
Management review frequency, agenda (inputs), outputs, required members, actions taken and other
review requirements are defined in the documented procedure [Management Review Proc. Title].
Records from management reviews are maintained.

10.0 Resources
9.1 Provision of Resources
[Short Client Name] determines and provides the resources needed:
a) to implement and maintain the management system and continually improve its effectiveness
b) to enhance customer satisfaction by meeting customer requirements
Resource allocation is done with consideration of the capability and constraints on existing internal
resources, as well as needs related to supplier expectations.
Resources and resource allocation are assessed during management reviews.

9.2 Human Resources

Senior management ensures that it provides sufficient staffing for the effective operation of the
management system, as well its identified processes.
Staff members performing work affecting product quality are competent on the basis of appropriate
education, training, skills and experience. The documented procedure [Training Proc. Title] defines
these activities in detail.
Training and subsequent communication ensure that staff are aware of:
a) the quality policy;
b) relevant quality objectives;
c) their contribution to the effectiveness of the management system, including the benefits of
improved performance;
d) the implications of not conforming with the management system requirements.
Note: the management system does not include other aspects of Human Resources management, such as payroll, benefits,
insurance, labor relations or disciplinary actions.

9.3 Infrastructure
[Short Client Name] determines, provides and maintains the infrastructure needed to achieve

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conformity to product requirements. Infrastructure includes, as applicable:

a) buildings, workspace and associated facilities;
b) process equipment, hardware and software;
c) supporting services such as transport;
d) information and communication technology.
Equipment is validated per the procedure [Equipment Validation Proc. Title] and maintained per the
procedure [Preventive Maintenance Proc. Title].
Where equipment is used for critical measurement activities, such as inspection and testing, these
shall be subject to control and either calibration or verification; see the procedure [Calibration Proc.
Title].
Note: Calibration and measurement traceability is not employed for all measurement devices. Instead, [Short Client Name]
determines which devices will be subject to calibration based on its processes, products and services, or in order to comply
with specifications or requirements. These decisions are also based on the importance of a measurement, and
considerations of risk.

9.4 Work Environment

[Short Client Name] provides a clean, safe and well-lit working environment. The [Senior Management
Team Name] of [Short Client Name] manages the work environment needed to achieve conformity to
product requirements. Specific environmental requirements for products are determined during quality
planning and are documented in subordinate procedures, work instructions, or job documentation.
Where special work environments have been implemented, these shall also be maintained per 9.3
above.
Human factors are considered to the extent that they directly impact on the quality of [Products or
Services Plur.].
Note: Social, psychological and safety aspects of the work environment are managed through activities outside of the scope
of the management system. Only work environment aspects which can directly affect process efficiency or product and
service quality are managed through the management system.

9.5 Organizational Knowledge

[Short Client Name] also determines the knowledge necessary for the operation of its processes and
to achieve conformity of [Products or Services Plur.]. This may include knowledge and information
obtained from:
a) internal sources, such as lessons learned, feedback from subject matter experts, and/or
intellectual property;
b) external sources such as standards, academia, conferences, and/or information gathered from
customers or suppliers.
This knowledge shall be maintained, and made available to the extent necessary.
When addressing changing needs and trends, [Short Client Name] shall consider its current
knowledge and determine how to acquire or access the necessary additional knowledge.

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11.0 Operation
10.1 Operational Planning and Control
[Short Client Name] plans and develops the processes needed for [Product or Service Sing.]
realization. Planning of [Product or Service Sing.] realization is consistent with the requirements of the
other processes of the management system. Such planning considers the information related to the
context of the organization (see section 4.0 above), current resources and capabilities, as well as
[Product or Service Sing.] requirements.
Changes to operational processes are done in accordance with the document [Change Mgmt Doc
Title].

10.2 Customer-Related Activities

During the intake of new business [Short Client Name] captures:
a) requirements specified by the customer, including the requirements for delivery and post-
delivery activities;
b) requirements not stated by the customer but necessary for specified or intended use, where
known
c) statutory and regulatory requirements related to the [Product or Service Sing.];
d) any additional requirements determined by [Short Client Name].
Once requirements are captured, [Short Client Name] reviews the requirements prior to its
commitment to supply the [Product or Service Sing.]. This review ensures that:
a) [Product or Service Sing.] requirements are defined,
b) contract or order requirements differing from those previously expressed are resolved,
c) the organization has the ability to meet the defined requirements, and/or the claims for the
[Products or Services Plur.] it offers, and
d) risks have been identified and considered.
These activities are defined in greater detail in the procedure [Quoting and Orders Doc Title].

10.3 Customer Communication

[Short Client Name] has implemented effective communication with customers in relation to:
a) providing information relating to [Products or Services Plur.];
b) handling enquiries, contracts or orders, including changes;
c) obtaining customer feedback relating to [Products or Services Plur.], including customer
complaints;
d) handling or controlling customer property;
e) establishing specific requirements for contingency actions, when relevant.

10.4 Design and Development

For new designs and for significant design changes, [Short Client Name] ensures the translation of
customer needs and requirements into detailed design outputs. These address performance,

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reliability, maintainability, testability, and safety issues, as well as regulatory and statutory
requirements.
This process ensures:
a) Design planning is conducted
b) Design inputs (requirements) are captured
c) Design outputs are created under controlled conditions
d) Design reviews, verification and validation are conducted
e) Design changes are made in a controlled manner.
These activities are further defined in the document [Design Procedure Doc Title].

10.5 Purchasing
[Short Client Name] ensures that purchased products or services conform to specified purchase
requirements. The type and extent of control applied to the supplier and the purchased products or
services is dependent on the effect on subsequent [Product or Service Sing.] or the final [Product or
Service Sing.].
[Short Client Name] evaluates and selects suppliers based on their ability to supply product and
service in accordance with the organization's requirements. Criteria for selection, evaluation and re-
evaluation are established.
Purchases are made via the release of formal purchase orders and/or contracts which clearly describe
what is being purchased. Received products or services are then verified against requirements to
ensure satisfaction of requirements. Suppliers who do not providing conforming products or services
may be requested to conduct formal corrective action.
These activities are further defined in the documents [Purchasing Proc. Title] and [Receiving Proc.
Title].

10.6 Provision of [Products or Services Plur.]

10.6.1 Control of Provision of [Products or Services Plur.]

To control its provision of [Products or Services Plur.], [Short Client Name] considers, as applicable,
the following:
a) the availability of documents or records that define the characteristics of the [Products or
Services Plur.] as well as the results to be achieved;
b) the availability and use of suitable monitoring and measuring resources;
c) the implementation of monitoring and measurement activities;
d) the use of suitable infrastructure and environment;
e) the appointment of competent persons, including any required qualifications;
f) the implementation of actions to prevent human error;
g) the implementation of release, delivery and post-delivery acti
h)

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i) vities.
If no in-house special processes, but some done by suppliers
At this time, Asem Technology Sdn Bhd does not utilize any in-house “special processes” where the
result of the process cannot be verified by subsequent monitoring or measurement. Any such special
processes are sent to outside suppliers, and controlled and an outsourced process per [Outsourced
Processes Title].
If there are in-house special processes:
[Short Client Name] utilizes some “special processes” where the result of the process cannot be
verified by subsequent monitoring or measurement. The special processes in use and the methods of
validation of each are defined in the document SOP-98097 Design Verification

10.6.2 Identification and Traceability

Where appropriate, Asem Technology Sdn Bhd identifies its [Product or Service Sing.] or other critical
process outputs by suitable means. Such identification includes the status of the [Product or Service
Sing.] with respect to monitoring and measurement requirements. Unless otherwise indicated as
nonconforming, pending inspection or disposition, or some other similar identifier, all [Product or
Service Sing.] shall be considered conforming and suitable for use.
If unique traceability is required by contract, regulatory, or other established requirement, [Short Client
Name] controls and records the unique identification of the [Product or Service Sing.].
The documented procedure [Identification & Traceability Proc. Title] defines these methods in
detail.

10.6.3 Property Belonging to Third Parties

[Short Client Name] exercises care with customer or supplier property while it is under the
organization’s control or being used by the organization. Upon receipt, such property is identified,
verified, protected and safeguarded. If any such property is lost, damaged or otherwise found to be
unsuitable for use, this is reported to the customer or supplier and records maintained.
For customer intellectual property, including customer furnished data used for design, production and /
or inspection, this is identified by customer and maintained and preserved to prevent accidental loss,
damage or inappropriate use.
This activity is defined in greater detail in the document [Customer Property Proc. Title].

10.6.4 Preservation
[Short Client Name] preserves conformity of product or other process outputs during internal
processing and delivery. This preservation includes identification, handling, packaging, storage, and
protection. Preservation also applies to the constituent parts of a product.
The documented procedure SOP-08-04 Preservation defines the methods for preservation of product

10.6.5 Post-Delivery Activities

As applicable, Asem Technology Sdn Bhd conducts the following activities which are considered
“post-delivery activities”:
 Service Support

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 Warranty
 Customer Feedback/ Complaint
Post-delivery activities are conducted in compliance with the management system defined herein.

10.6.6 Process Change Control

[Short Client Name] reviews and controls both planned and unplanned changes to processes to the
extent necessary to ensure continuing conformity with all requirements.
Process change management is defined in the document [Change Mgmt Doc Title].

10.6.7 Measurement and Release of [Products or Services Plur.]

Acceptance criteria for [Products or Services Plur.] are defined in appropriate subordinate
documentation. Reviews, inspections and tests are conducted at appropriate stages to verify that the
[Product or Service Sing.] requirements have been met. This is done before [Products or Services
Plur.] are released or delivered.
Each process utilizes different methods for measuring and releasing [Products or Services Plur.].
These methods are defined in [Process Definition Doc Title]s.

10.6.8 Control of Nonconforming Outputs

[Short Client Name] ensures that [Products or Services Plur.] or other process outputs that do not
conform to their requirements are identified and controlled to prevent their unintended use or delivery.
The controls for such nonconformances are defined in [Control of NCP Proc. Title] and [Control of
Nonconforming Service Proc Title].  delete whichever do not apply.

12.0 Improvement
11.1 General
Asem Technology Sdn Bhd uses the management system to improve its processes, products and
services. Such improvements aim to address the needs and expectations of customers as well as
other interested parties, to the extent possible,
Improvement shall be driven by an analysis of data related to:
The results of analysis shall be used to evaluate:
a) conformity of [Products or Services Plur.];
b) the degree of customer satisfaction;
c) the performance and effectiveness of the management system;
d) the effectiveness of planning;
e) the effectiveness of actions taken to address risks and opportunities;
f) the performance of external providers;
g) other improvements to the management system.

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11.2 Customer Satisfaction

As one of the measurements of the performance of the management system, [Short Client Name]
monitors information relating to customer perception as to whether the organization has met customer
requirements. The methods for obtaining and using this information include:
 EDIT LIST AS NEEDED
 recording customer complaints
 product rejections or returns
 repeat orders for product
 changing volume of orders for product
 trends in on-time delivery
 obtain customer scorecards from certain customers
 submittal of customer satisfaction surveys
 Submittal of customer order
 Recording or customer feedback
 Corrective Action and Preventive Action
The corrective and preventive action system shall be used to develop and implement plans for
customer satisfaction improvement that address deficiencies identified by these evaluations, and
assess the effectiveness of the results.

11.3 Internal Audit

[Short Client Name] conducts internal audits at planned intervals to determine whether the
management system conforms to contractual and regulatory requirements, to the requirements of ISO
9001, and to management system requirements. Audits also seek to ensure that the management
system has been effectively implemented and is maintained.
These activities are defined in the document [Internal Auditing Proc. Title].

11.4 Corrective and Preventive Action

[Short Client Name] takes corrective action to eliminate the cause of nonconformity in order to prevent
recurrence. Likewise, the company takes preventive action to eliminate the causes of potential
nonconformities in order to prevent their occurrence.
These activities are done through the use of the formal Corrective Action ([CAR Form Abbreviation])
system, and are defined in the document [Corrective Preventive Action Proc. Title].

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Appendix A: Overall Process Sequence & Interaction

Add diagram of sequence flow here.

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Appendix B: ISO 9001:2015 Cross Reference

ISO 9001:2015 Clause Section in Manual
4.0 Context of the Organization (all)
4.1 Understanding the Organization & Its Context 4.1 Determining Our Strategic Direction
4.2 Understanding the needs & expectations of interested
4.1 Determining Our Strategic Direction
parties
4.3 Determining the scope of the QMS 4.2 Scope of the Management System
4.4 Management system and its processes 6.0 Management System Processes
5.0 Leadership
5.1 Leadership & Commitment 8.1 Management Leadership and Commitment
5.1.1 General 8.1 Management Leadership and Commitment
5.1.2 Customer focus 8.2 Customer Focus
50 Quality Policy
5.2 Policy
8.3 Quality Policy
5.4 Organizational Roles and Responsibilities and
5.3 Organizational Roles Responsibilities and Authorities
Authorities
6.0 Planning
6.1 Actions to address risks and opportunities 8.7 Risks and Opportunities
6.2 Quality objectives and planning to achieve them 6.2 Process Controls & Objectives
6.3 Planning of changes 8.6 Change Management
7.0 Support
7.1 Resources
7.1.1 General 9.1 Provision of Resources
7.1.2 People 9.2 Human Resources
7.1.3 Infrastructure 9.3 Infrastructure
7.1.4 Environment for the operation of processes 9.4 Work Environment
7.1.5 Monitoring and measuring resources 9.3 Infrastructure
7.1.6 Organizational knowledge 9.5 Organizational Knowledge
7.2 Competence 9.2 Human Resources
7.3 Awareness 9.2 Human Resources
7.4 Communication 8.5 Internal Communication
7.5 Documented information 7.0 Documentation & Records
8.0 Operation
8.1 Operational planning and control 10.1 Operational Planning and Control
8.2 Requirements for products and services
8.2.1 Customer communication 10.3 Customer Communication
8.2.2 Determining the requirements related to products &
10.2 Customer Related Activities
services
8.2.3 Review of requirements related to products & services 10.2 Customer Related Activities
8.2.4 Changes to requirements for products and services 10.2 Customer Related Activities
8.3 Design and development of products and services 10.4 Design and Development
8.4 Control of externally provided processes, products &
10.5 Purchasing
services
8.5 Production and service provision
8.5.1 Control of production and service provision 10.6.1 Control of Provision of [Products or Services Plur.]

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ISO 9001:2015 Clause Section in Manual

8.5.2 Identification and traceability 10.6.2 Identification and Traceability
8.5.3 Property belonging to customers or external providers 10.6.3 Property Belonging to Third Parties
8.5.4 Preservation 10.6.4 Preservation
8.5.5 Post-delivery activities 10.6.5 Post-Delivery Activities
8.5.6 Control of changes 10.6.6 Process Change Control
10.6.7 Measurement and Release of [Products or Services
8.6 Release of products and services
Plur.]
8.7 Control of nonconforming outputs 10.6.8 Control of Nonconforming Outputs
9.0 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General 11.1 Improvement: General
9.1.2 Customer satisfaction 11.2 Customer Satisfaction
9.1.3 Analysis and evaluation 11.1 Improvement: General
9.2 Internal audit 11.3 Internal Audit
9.3 Management review 8.8 Management Review
10.0 Improvement
10.1 General 11.1 Improvement: General
10.2 Nonconformity and corrective action 11.4 Corrective and Preventive Action
10.3 Continual improvement 11.1 Improvement: General
10.4 Improvement

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