Quality Management System Manual

PTW-COR-QMS-ML-00002.02

Updated after
02 July 14, 2022 Anjum Amir Kelly Lauritsen John Cooper
annual review
01 Mar 29, 2021 First issue Anjum Amir Kelly Lauritsen Carolynne Laughy
00 Mar 17, 2021 First draft Anjum Amir Kelly Lauritsen Carolynne Laughy
Rev Date Description Prepared By Checked by Approved by
This document contains information proprietary to PTW Energy Services Ltd. and will not be reproduced or transferred to
other documents or disclosed to others or used for any purpose other than that for which it was created without the written
permission of PTW Energy Services Ltd.
 QMS Manual

Table of Contents
INTRODUCTION ........................................................................................................................ 5
1.0 SCOPE ................................................................................................................................. 7
2.0 NORMATIVE REFERENCES ............................................................................................... 8
3.0 ACRONYMS AND DEFINITIONS......................................................................................... 8
4.0 CONTEXT OF THE ORGANIZATION ................................................................................ 11
4.1 UNDERSTANDING THE ORGANIZATION AND ITS CONTEXT .................................................. 11
4.1.1 Internal Issues ....................................................................................................................... 11
4.1.2 External Issues ...................................................................................................................... 11
4.2 UNDERSTANDING THE NEEDS AND EXPECTATION OF RELEVANT INTERESTED PARTIES ....... 12
4.3 QUALITY MANAGEMENT SYSTEM SCOPE ......................................................................... 12
4.4 QUALITY MANAGEMENT SYSTEM & ITS PROCESSES ......................................................... 12
4.4.1 Interaction of Processes ........................................................................................................ 12
4.4.2 Process Documentations ...................................................................................................... 13

5.0 LEADERSHIP & GOVERNANCE....................................................................................... 13

5.1 LEADERSHIP COMMITMENT ............................................................................................. 13
5.1.1 General .................................................................................................................................. 13
5.1.2 Customer Focus .................................................................................................................... 13
5.2 QUALITY POLICY ............................................................................................................ 14
5.2.1 Establishing the Quality Policy .............................................................................................. 14
5.2.2 Communicating the Quality policy ......................................................................................... 14
5.3 ROLES, RESPONSIBILITIES & AUTHORITIES ...................................................................... 14
5.3.1 Senior Management .............................................................................................................. 14
5.3.2 Quality Representative .......................................................................................................... 15
5.3.3 Department Managers/Process Owners ............................................................................... 15
5.3.4 Employees ............................................................................................................................. 16

6.0 QUALITY MANAGEMENT SYSTEM PLANNING .............................................................. 16

6.1 ACTION TO ADDRESS RISKS & OPPORTUNITIES ............................................................... 16
Supporting documentation: .................................................................................................................. 16
6.2 QUALITY OBJECTIVES AND PLANNING TO ACHIEVE THEM ................................................... 16
6.2.1 Quality Objectives ................................................................................................................. 16
6.2.2 Achieving Quality Objectives ................................................................................................. 17
6.3 PLANNING FOR CHANGE ................................................................................................. 17
7.0 SUPPORT .......................................................................................................................... 17
7.1 RESOURCES .................................................................................................................. 17
7.1.1 General .................................................................................................................................. 17
7.1.2 People ................................................................................................................................... 18
7.1.3 Infrastructure ......................................................................................................................... 18
7.1.4 Operational Environment ....................................................................................................... 19

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7.1.5 Monitoring and Measuring Resources .................................................................................. 19
7.1.6 Organizational Knowledge .................................................................................................... 20
7.2 COMPETENCE ................................................................................................................ 21
7.3 AWARENESS .................................................................................................................. 22
7.4 COMMUNICATION ........................................................................................................... 22
7.4.1 General .................................................................................................................................. 22
7.4.2 Internal Communication ........................................................................................................ 22
7.4.3 External communication ........................................................................................................ 23
7.5 DOCUMENTED INFORMATION .......................................................................................... 23
7.5.1 General .................................................................................................................................. 23
7.5.2 Creating & Updating .............................................................................................................. 23
7.5.3 Controlling Documented Information ..................................................................................... 24

8.0 OPERATION ...................................................................................................................... 24

8.1 OPERATIONAL PLANNING & CONTROL ............................................................................. 24
8.2 REQUIREMENTS FOR PRODUCT AND SERVICES ................................................................ 25
8.2.1 Customer Communication ..................................................................................................... 25
8.2.2 Determining Requirements for Products and Services ......................................................... 25
8.2.3 Review of Requirements for Product and Services............................................................... 26
8.2.4 Changes in Requirements for Product and Services ............................................................ 26
8.3 DESIGN & DEVELOPMENT OF PRODUCT AND SERVICES .................................................... 27
8.3.1 General .................................................................................................................................. 27
8.3.2 Design and Development Planning ....................................................................................... 27
8.3.3 Design and Development Inputs ........................................................................................... 27
8.3.4 Design and Development Controls........................................................................................ 28
8.3.5 Design and Development Outputs ........................................................................................ 28
8.3.6 Design and Development Changes....................................................................................... 28
8.4 CONTROL OF EXTERNALLY PROVIDED PROCESSES, PRODUCT & SERVICES ...................... 29
8.4.1 General .................................................................................................................................. 29
8.4.2 Type and extent of control ..................................................................................................... 29
8.4.3 Information for external providers.......................................................................................... 29
8.5 PRODUCTION & SERVICE PROVISION............................................................................... 30
8.5.1 Control of production & Service Provision ............................................................................. 30
8.5.2 Identification & Traceability ................................................................................................... 30
8.5.3 Property belonging to Customer or External Providers ......................................................... 30
8.5.4 Preservation .......................................................................................................................... 31
8.5.5 Post-delivery Activities .......................................................................................................... 31
8.5.6 Control of Changes ............................................................................................................... 32
8.6 RELEASE OF PRODUCTS & SERVICES .............................................................................. 32
9.0 PERFORMANCE EVALUATION........................................................................................ 33
9.1 MONITORING, MEASUREMENT, ANALYSIS & EVALUATION .................................................. 33
9.1.1 General .................................................................................................................................. 33
9.1.2 Customer Satisfaction ........................................................................................................... 33
9.1.3 Performance Analysis and Evaluation .................................................................................. 34
9.2 INTERNAL AUDIT ............................................................................................................ 34

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9.3 MANAGEMENT REVIEW ................................................................................................... 35
9.3.1 General .................................................................................................................................. 35
9.3.2 Inputs ..................................................................................................................................... 35
9.3.3 Outputs .................................................................................................................................. 36

10.0 IMPROVEMENT ............................................................................................................... 36

10.1 GENERAL ...................................................................................................................... 36
10.2 NON-CONFORMITY & CORRECTIVE ACTION ...................................................................... 36
10.2.1 When a nonconformity occurs ............................................................................................... 36
10.2.2 Documented information for corrective actions ..................................................................... 37
10.3 IMPROVEMENT ............................................................................................................... 37
CORRELATION MATRIX ......................................................................................................... 38

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Introduction
PTW Energy Services Ltd. hereafter referred to as PTW, has developed and implemented
a Quality Management System (QMS), which uses ISO 9001 as the framework that allows
our organization to document and improve our practices to better satisfy the needs and
expectations of our customers, stakeholders and interested parties worldwide.
PTW Energy Services Ltd. is a private company headquartered in Calgary, Alberta,
Canada. Our company provides fabrication, construction and maintenance services
through a network that extends across Canada and the United States. PTW’s approach
to industry-leading energy solutions has connected us with clients around the globe
in a variety of industries like oil and gas, mining & metals, wind & solar,
manufacturing, pulp & paper, agriculture, LNG, food & beverage, emergency
response, utility and life sciences.
PTW has the capability to provide clients with an integrated service offering, allowing
maximized value, reduced lead times and delivery of cost-effective solutions. We ensure
projects are seamlessly managed from concept to completion. Guided by our highly skilled
team of construction specialists we execute complex projects seamlessly. Our one-team
approach will enable us to meet the quality and performance expectations of our clients
through a single point of contact. Our unique culture fosters continued innovation and
growth.

Quality Management Principles

PTW utilizes seven core values to guide our processes and QMS. These
processes are as follows:
• Customer Focus
• Leadership
• Engagement of People
• Process Approach
• Improvement
• Evidence-based decision making
• Relationship Management

Process Approach
PTW has adopted the “Process Approach” into our daily operations including the
PDCA (Plan-Do-Check-Act) cycle. We have considered the utilization of risk-
based philosophy when developing, implementing and improving the effectiveness
of our QMS. This approach will enable PTW to enhance the overall performance
of the company by effectively controlling the interrelationship among the QMS
processes.

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Plan-Do-Check-Act Cycle
The Figure below illustrates our methodology for the development of our QMS,
using the PDCA process approach, to implement and deliver management system
objectives, stakeholder requirements and regulatory compliance.

PDCA CYCLE

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1.0 Scope
The scope and intent of our QMS is to define and communicate our commitment to
continually enhance customer satisfaction through:
i. Effective process improvements to all systems of the business;
ii. To assure conformity to our customer’s and applicable statutory and
regulatory requirements;
iii. Provide policies, procedures developed and implemented with the primary
focus to assure the continual compliance of the requirements of the
International Standard ISO 9001:2015.
This QMS manual is used to familiarise our customers, interested parties, or individuals
with the controls that have been implemented and to assure them that the integrity of our
QMS is maintained and is focused on meeting its intended outcomes.
This manual also describes the structure and interactions of our QMS, delineates
authorities, interrelationships and responsibilities of personnel who operate within the
boundaries of PTW’s QMS. This manual also references procedures, processes and
activities that comprise our QMS.
The following table illustrates the clause structure of ISO 9001:2015 in more detail and in
the context of the PDCA cycle and a framework that provides a visual reference of PTW’s
QMS.
QMS PLANNING MAP
PLAN DO CHECK ACT

Context of the Performance

Leadership Planning Support Operation Improvement
organization evaluation

Actions to Operations
Understanding Monitoring, Nonconformity &
Leadership & address risks Resources planning &
of organization measurement, corrective
commitment & control
& its context analysis & actions
opportunities
evaluation
Requirements
Understanding Quality Competence for product &
Continual
the needs & Policy objectives & services
improvement
expectations planning to Internal audit
achieve them
Design &
Roles, Awareness development
Determining the
reponsibilities Management
scope of QMS Planning of
& authorities review
changes
Production &
Communication service
QMS and its provision QUALITY KPI s
processes STRATEGIC & OPERATIONAL
PLANNING REALIZATION, EVALUATION & QMS
• Customer requirements IMPROVEMENT
Release of
• Statutory & Regulatory Requirements Documented • Monitoring, Analysis & Continual
products &
• Budgeting information Improvements
• Risk Management
services • Process Monitoring
• Distribution of Authority • Internal Audits Management
• Contract Reviews • Nonconforming Products
• Pre-Production Engineering Control of Management
• Purchases nonconforming • Corrective Actions
• Production Planning outputs • Client Feedback Analysis
• Quality Planning • Management Review
• Analysis by Senior Management

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The QMS is constructed based on the following structure:

Level 1
Policies, Commitments, Best Practices & Manuals

Level 2
Process Description/Best Practices Description
(Processes, Plans & Procedures)
Level 3
The Process Flow and Work Instructions

Level 4
Forms, Checklists, Templates etc.

2.0 Normative References

In addition to ISO 9001:2015 we also refer to other relevant international standards as well
as customer specifications appropriate to our products and market.
Standard Title Description
ISO 9000:2015 Quality Management Systems Fundamentals and Vocabulary
Guidance to Achieve Sustained
ISO 9004:2000 Quality Management Systems
Success
Guidelines for Auditing
ISO 19011:2011 Auditing Management Systems
Management Systems

3.0 Acronyms and Definitions

PDCA Cycle – Plan-Do-Check-Act Cycle
QMS – Quality Management System, an organization’s system which implements policies
and objectives into the processes that help improve a standard of quality.
Policy – Documents that include information about a set of standards.
Risk-based Approach/Thinking – This method of thought is related to reflecting on how
much risk is involved for a certain amount of gain. Typically, you’ll want to find the best
low-risk/high-reward ratio.
Strategy – This is how a person or organization plans to reach a goal successfully.
KPI – Key Performance Indicator, a quantifiable measure of performance over time for a
specific objective.
Leadership – The person, or group of people, who directs and controls our organization
at the highest level.

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Product – The end item resulting from meeting all contract terms and conditions (i.e.:
manufactured goods, merchandise, services, etc.).
Purchase Order – A formal document specifying the precise details of materials and
equipment being purchased and providing specific purchasing conditions.
Quality Records – Documentation of those activities wherein records of said activities
must be maintained will be specified in the procedure or work instruction level documents,
as applicable.
Review – The systematic examination of a document or system and its supporting and
descriptive data, conducted by qualified personnel who are independent of the originator
of the document.
Senior Management – A team of individuals at the highest level of organizational
management who have the day-to-day responsibilities of managing a company or
corporation.
Risk and Opportunity – Risk is an uncertainty that could have an adverse effect leading
to loss, harm or damage. Opportunity is an uncertainty that could have a positive effect
leading to benefits or rewards. A risk with negative impacts is a threat, whereas a risk with
a positive impact is an opportunity.
Relevant Interested Parties – Those that provide significant risk to organizational
sustainability if their needs and/or expectations are not met.
Regulatory Requirements – A rule issued by a regulatory body appointed by a state
and/or government.
Statutory Requirements – A requirement of law passed by a state and/or government.
Quality Objectives – Measurable goals relevant to enhancing customer satisfaction and
are consistent with the quality policy.
Quality Policy – A brief statement that aligns with the organization's purpose and strategic
direction, provides a framework for quality objectives, and includes a commitment to meet
applicable requirements as well as to continually improve.
Customer Satisfaction – A measurement that determines how happy customers are
with a company's products, services, and capabilities.
Preservation – Keeping something as it was, and not allowing changes to affect it in any
way.
Traceability – The ability to be able to track down locations of products and services. It
also refers to how these products or services are distributed.
Documented Information – Meaningful data that is required to be controlled and
maintained by the organization and the medium on which it is contained.
Organizational Knowledge – The necessary information that is used and shared to
achieve organizational goals and to make the organization more effective.
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Acceptance Criteria – Defined limits placed on characteristics of materials, products or
services Terms typically used in standards and regulations as they relate to our QMS or
products;
Post Delivery Activities – These can include actions under warranty provisions,
contractual obligations such as maintenance services, and supplementary services.
Competency – Competence in the context of quality management is developing the ability
to apply appropriate qualifications, skills, and knowledge to the right activities or operations
with the goals of achieving intended results.
QMS Awareness – Awareness is attained when persons understand their responsibilities
and authorities and how their actions contribute to the achievement of the organization's
quality objectives.
QIB – Quality Information Bulletin, an internal publication providing information on
important QA/QC topics.
Performance Evaluation – The critical check step that can determine if the QMS is
functioning properly, or if changes are needed to meet the requirements.
Continual Improvement – The activities of a business that are driven towards the
constant improvement or betterment of their internal systems and processes.
Nonconformity – A term used to describe a process or product that does not meet a
requirement set out by the code/standard.
Corrective Action – This is a term that describes an action that needs to take place to
improve processes to meet standards.
Concession – A type of special approval given to release a nonconforming product or
service to a customer.
Customer Owned Property – Property that is owned or provided by the customer for use
in meeting the requirements of the contract.
Infrastructure – Infrastructures include all the means, applications, interfaces, and
facilities necessary for the realization of products or services from the design stages
through its delivery and post-delivery activities.
Internal Audit – A routine inspection within the company in which an assigned auditor
assesses the organization's processes and QMS based on the criteria provided by the
latest ISO 9001 standard.

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4.0 Context of the Organization

4.1 Understanding the Organization and its Context

PTW management is committed to defining our position in the marketplace and
understanding how relevant factors arising from legal, political, economic, social
and technological issues influence our strategic direction and our organizational
context.
Senior Management identifies, analyses, monitors and reviews factors that may
affect our ability to satisfy our customers and stakeholders, as well as; factors that
may adversely affect the stability of our process or our management system’s
integrity.
To ensure that our QMS is aligned with our strategy, whilst taking account of
relevant internal and external factors; we initially collate and analyse pertinent
information in order to determine the potential impact on our context and
subsequent business strategy. Such issues include factors that are capable of
being affected by, or capable of affecting our organization. Broadly, these issues
are defined as:
4.1.1 Internal Issues
Conditions related to our organizational activities, products, services,
strategic direction, culture, people, knowledge, processes and systems.
4.1.2 External Issues
Conditions related to cultural, social, political, legal, regulatory, financial,
technological, economic, and competition at local, national or international
levels.

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PTW then monitors and reviews this information to ensure that a continual
understanding of each group’s requirements is derived and maintained.
4.2 Understanding the Needs and Expectation of Relevant Interested Parties
PTW recognizes that we have a unique set of interested parties whose needs and
expectations change and develop over time, and furthermore; that only a limited
set of their respective needs and expectations are applicable to our operational
purpose. Such needs and expectations broadly include those shown in the table
below.

Interested Parties Needs & Expectations

Customers Price, reliability & value
Distributors & Retailers Quality, price & logistics
Owners/Shareholders Profitability & growth
Employees Shared values & security
Suppliers Beneficial relationships
Regulatory & Statutory Compliance & reporting

To ensure that our products and processes continue to meet all relevant
requirements, we identify and assess the potential impact of any relevant needs
and expectations that may be elicited from interested parties.
Where appropriate, to ensure that our processes are aligned to deliver the
requirements of our interested parties; we convert relevant needs and expectations
into requirements which become inputs to our QMS and to our product and service
designs.
4.3 Quality Management System Scope
PTW has established the scope of our QMS in order to implement our objectives
and our policies that are relevant to our context, products and any interested
parties.
This document describes our QMS and delineates authorities, inter-relationships
and responsibilities of process owners and personnel that operate within the
system. Although we recognize that ISO 9001 does not require a quality manual,
we have decided to retain and update our quality manual, as our employees,
customers, suppliers and other stakeholders perceive it to add value to our
operations. There are no exclusions of any clause declared within this quality
system.
This document also demonstrates the relationship between our QMS and the
sequence and interaction of our key processes.
4.4 Quality Management System & Processes
4.4.1 Interaction of Processes

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PTW has established, documented and implemented a Quality
Management System (QMS) in accordance with the requirements of ISO
9001:2015.
PTW has:
i. Identified the inputs required and the outputs expected from the
process. These are monitored using process focused KPI’s (Key
Performance Indicators).
ii. Identified the sequence and interaction of processes needed for the
QMS.
iii. Determined criteria and methods needed to ensure the operation
and control of the processes are effective.
iv. Determined the resources needed for these processes and ensured
their availability.
v. Assigned responsibility and authorities for these processes.
vi. Established systems to evaluate risks and opportunities.
vii. Established processes to identify and implement actions necessary
to achieve planned results.
viii. Evaluated results to improve the processes within the QMS.
ix. Maintained documented information to support the operation of its
processes.
4.4.2 Process Documentation
PTW maintains documented information (e.g., procedures and work
instructions) to support the operation of processes and retain documented
information (e.g., records) to have confidence that the processes are being
carried out as planned.

5.0 Leadership & Governance

5.1 Leadership Commitment
5.1.1 General
The senior management team is responsible for:
i. Implementing, providing resources, reviewing and maintaining the
QMS.
ii. Being actively involved in establishing the quality policy and quality
objectives that parallel PTW’s strategic vision and direction.
iii. Ensuring the integration of the QMS in business methods through
a process approach and risk-based thinking.
5.1.2 Customer Focus
PTW strives to identify current and future customer needs, to meet their
requirements and to exceed their expectations. Senior Management
ensures that:

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i. The customer and applicable statutory and regulatory requirements
are determined, understood and consistently met.
ii. The risks and opportunities that can affect conformity of products
and services and the ability to enhance customer satisfaction are
determined and addressed.
iii. The focus on enhancing customer satisfaction is maintained.
5.2 Quality Policy
5.2.1 Establishing the Quality Policy
Senior management has established, implemented and maintains a quality
policy that:
i. Is appropriate to the purpose and context of PTW and supports its
strategic direction;
ii. Provides a framework for setting quality objectives;
iii. Includes a commitment to satisfy applicable requirements; and
iv. Includes a commitment to continual improvement of the QMS;
5.2.2 Communicating the Quality policy
The Quality Policy:
i. is available and maintained as documented information;
ii. is communicated, understood and applied within the organization;
and
iii. is available to relevant interested parties, as appropriate.
Our policies are communicated to all employees at all levels throughout our
organization via training and regular internal communications.
Understanding of our policies and objectives is determined during internal
audits and other methods deemed appropriate.
5.3 Roles, Responsibilities & Authorities
The organization chart shows the interrelation of personnel within our organization,
whilst job descriptions define the responsibilities and authorities of each role. Job
descriptions and the organizational structure are reviewed and approved by Senior
Management for adequacy as determined by the changing needs and expectations
of the interested parties identified and any risk and opportunities presented through
the risk management process.
Senior management ensures that the responsibilities and authorities for relevant
roles are assigned, communicated and understood within PTW.
5.3.1 Senior Management
Senior Management is responsible for business planning, development
and the communication of our quality policies, QMS planning, the
establishment and deployment of objectives, the provision of resources

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needed to implement and improve the QMS and for undertaking
management reviews. Senior Management is also responsible for:
i. Ensuring that the QMS is established, implemented and
maintained;
ii. Ensuring that the responsibilities and authorities for relevant roles
are assigned;
iii. Allocating resources to ensure that continual improvements can be
achieved;
iv. Chairing the Management Reviews to ensure the QMS remains
effective, suitable and adequate.
v. Increasing the competence and awareness of staff at all levels
through the development of training and awareness initiatives and
sharing of best practice;
vi. Ensuring that customer focus is promoted throughout the
organization;
vii. Ensuring that responsibilities and authorities within the QMS are
communicated and delegated;
5.3.2 Quality Representative
The Quality Representative is responsible, as delegated by Senior
Management, for ensuring that any identified risks to quality are eliminated
or reduced at source to As-Low-As-Reasonably-Practicable (ALARP) and
that our organization’s strategic development does not compromise the
intended outcomes of our QMS by;
i. Providing advice, information, instruction and training on quality
management matters to employees and others as applicable;
ii. Ensuring document control of QMS documentation;
iii. Coordinating and completion of audits according to the internal
audit program;
iv. Reporting on the performance of the QMS progress against
objectives and identifying any opportunities;
v. Make recommendations for improvement to Senior Management
via the agreed governance structure;
vi. Ensuring that improvement is taking place;
vii. Ensuring that whenever changes to the QMS are planned, they are
properly implemented;
viii. Ensuring the integrity of the system is maintained during changes;
5.3.3 Department Managers/Process Owners
All department managers/ process owners demonstrate their commitment
to the development, implementation and improvement of the QMS through
the provision of necessary resources, through their involvement in the
internal audit process and through their proactive involvement in continual

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improvement activities. They ensure that their direct reports are adequately
following the QMS Processes. Emphasis is placed on improving both the
effectiveness and efficiency of key system processes.
5.3.4 Employees
All employees are responsible for the quality of their work and
implementation of our policies and procedures applicable to the processes
that they perform. Personnel responsible for product quality have the
authority to stop production to correct problems. Employees are motivated
and empowered to identify and report any known or potential problems and
to recommend solutions to aid subsequent risk management and corrective
action activities.

6.0 Quality Management System Planning

6.1 Action to Address Risks & Opportunities
PTW uses a strategic planning process to evaluate the mission and vision of the
company, to analyse markets and competitors, to identify strengths, weaknesses,
opportunities, threats and develop key strategic goals.
Planning activities for the QMS focus on how to effectively meet quality objectives,
customer and legal requirements. In addition, planning activities also identify risk,
opportunities and define actions to assure that:
i. Actions are integrated and implemented into processes
ii. The QMS can achieve its intended results
iii. Desirable effects will be enhanced
iv. Undesired effects will be reduced or prevented
v. Improvement is fostered
vi. Effectiveness of actions are evaluated
Supporting documentation:
Ref. Title & Description
00032 Risk & Opportunities Management Procedure

6.2 Quality Objectives and Planning to Achieve Them

6.2.1 Quality Objectives
i. Quality Objectives are established at all corresponding levels and
processes throughout the organization to implement the quality policy,
meet and exceed requirements for processes, product and services, and
to improve the QMS and its performance. Quality objectives are strategic,
apply to the entire PTW organization and shall:
a) be consistent with the Quality Policy;

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b) be measurable and monitored;
c) take into account applicable requirements;
d) be communicated;
e) be updated as appropriate;
f) be relevant to conformity of products, services and enhance
customer satisfaction.
ii. When Quality Objectives are established the following will be taken into
consideration:
a) The current and future needs of the business, industry and
interested parties;
b) Relevance to findings from internal audits and management
reviews;
c) Monitoring of product and process performance (effectiveness,
efficiency, conformance);
d) Monitoring of customer satisfaction;
e) Results of Strategic Planning; and
f) Quality performance
6.2.2 Achieving Quality Objectives
In order to achieve quality objectives, senior management ensures that the
business follows a process to determine what actions need to be taken and
resources required, who will be responsible, what are the target dates /
timelines and how the results will be evaluated.
Establishing an action plan for each objective may require effort on the part
of the personnel at relevant levels. To ensure the progress of the action
plan and a coordinated effort, a target leader/s should be selected for each
target. The target leader will be responsible for ensuring a target is
achieved within the specified timeframe.
6.3 Planning for Change
Changes to the QMS will be developed and implemented in a planned manner.
When changes to the QMS are deemed necessary, PTW shall ensure the change
will comply with the requirements of ISO 9001 and shall consider:
i. the purpose of the changes and their potential consequences;
ii. the integrity of QMS;
iii. the availability of resources;
iv. the allocation or reallocation of responsibilities and authorities

7.0 Support
7.1 Resources
7.1.1 General

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PTW is fully committed to providing adequate resources required for the
establishment, implementation, maintenance, and continual improvement
of our QMS. Our committed resources include competent employees,
industry applicable equipment, well maintained work environments and
financial resources. The process for determining and communicating
resource requirements is an integral part of our management review
process. Our infrastructure resource considerations include:
i. Management review meeting inputs and outputs;
ii. Capabilities and constraints on existing internal and external
resources;
iii. Requirements and expectations provided by our external
providers/vendors
7.1.2 People
PTW identifies personnel training needs, provides required training, and
evaluates the effectiveness of the training provided. Personnel assigned to
perform specific tasks, operations and processes are qualified on the basis
of appropriate education, experience and/or training. Employees are made
aware of the relevance and importance of their activities and how they
contribute to the achievement of quality objectives. Records of personnel
qualifications and training are maintained as per Control of Documented
Information Procedure.
The requirements for training are communicated by the Control of
Competence & Awareness Procedure.
Supporting documentation:
Ref. Title & Description
00036 Control of Competence & Awareness Procedure

7.1.3 Infrastructure
PTW has determined and provided resources necessary for the
establishment, implementation, maintenance, and continual improvement
of the QMS. Our infrastructure resource considerations include:
i. Facilities management (buildings, workspace, and associated
utilities) maintenance and repair.
ii. Equipment management maintenance and repair.
iii. Process and production equipment management, maintenance,
and repair.
iv. Transportation resources and material handling.
v. Information and communication technology.

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7.1.4 Operational Environment
Senior Management has identified the human and physical factors of the
work environment to be important to control processes and to achieve
conforming of products and services. Evaluations include:
i. Assessment of product requirements to identify where human
and/or physical factors will affect product quality. This is also
conducted during advanced product quality planning,
ii. Assessment of current working environment conditions to
determine if the work environment is suitable to achieve conforming
product.
iii. Implementation of work environment improvements needed to
achieve conforming product.
iv. Continual assessment of work environment to ensure that adequate
human and physical factors are maintained.
v. Factors considered determining the type of environment required is
based on the:
a) Business culture, social and psychological needs
b) Processing performed in the location
c) Equipment requirements
d) Level of skill, number of employees working in the area
e) Type of environmental conditions, e.g. lighting, heat, humidity,
sound levels, and air quality
f) Risk associated with processing or equipment operation
(Safety)
g) Monitoring & Measurement Tools
7.1.5 Monitoring and Measuring Resources
7.1.5.1 General
PTW has determined and provided the resources needed to ensure valid
and reliable results when monitoring or measuring is used to verify the
conformity of products and services to requirements.
7.1.5.2 Measurement Traceability
Documented procedure outlining the processes that control monitoring
and measurement equipment used to accept products during production
and service operations. The Quality department manages the system for
equipment calibrations to ensure that monitoring and measurement
activities to verify product conformity are valid and reliable. PTW ensures
that measuring and test equipment:
i. Is provided to those performing measuring activities;
ii. Is suitable for the type of monitoring and measurement activities
being undertaken; and

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iii. Is maintained and calibrated to ensure their fitness for their
purpose.
iv. To ensure validation of results, monitoring/measuring equipment
are:
a) Calibrated or verified, or both, adjusted periodically or prior to
use against equipment traceable to international or national
standards. If such standards do not exist, the basis for
calibration is recorded; and,
b) Adjusted or re-adjusted as necessary; and,
c) Identified to enable determination of calibration status; and,
d) Safeguarded from adjustments that would invalidate proper
calibration; and,
e) Protected from damage and/or deterioration during use
Where equipment is found to be out of calibration, the significance of the
error is reviewed, and the validity of previous inspection/test results are
assessed. The equipment shall be removed from service until it is
recalibrated. The results of all re-verifications and re-calibrations are
recorded.
Software used for monitoring/measuring is validated for adequacy prior to
use and reconfirmed as necessary. IT shall provide maintenance of
software.
Method for controlling, monitoring and measuring equipment are
communicated by the control of calibrated equipment procedure. Records
of the results of calibration and validation are maintained as documented
information.
Supporting documentation:
Ref. Title & Description
00008 Control of Calibrated Equipment Procedure

7.1.6 Organizational Knowledge

PTW has recognized that organizational knowledge is a valuable resource
that supports our QMS activities and ensures continual product and service
conformity. There is a strong link between organizational knowledge and
the competence of our people, the latter being peoples’ ability to apply
knowledge to their work.
To ensure that organizational knowledge is retained and transferred,
organizational knowledge is recorded and is embedded in our processes,
products, and services if required. Examples of organizational knowledge
include:
i. Documented information regarding a process, product or service;

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ii. Previous specifications and work instructions;
iii. The experience of skilled people and their processes and
operations;
iv. Knowledge of technologies and infrastructure relevant to our
organization, etc.
Sources of internal knowledge also include our intellectual property;
knowledge gained from experience and coaching; lessons learnt from
failures and successes; capturing and sharing undocumented knowledge
and experience; the results of improvements in processes, products, and
services.
Sources of external knowledge often include other standards; research
papers; webinars from conferences; or knowledge gathered from
customers, stakeholders, or other external parties.
7.2 Competence
PTW has determined to the extent necessary the below elements of competence
for people performing work that may influence the effectiveness of the QMS.
i. Ensure employees are competent on the basis of their education, training
and experience;
ii. Initiate job descriptions including specific competency provisions;
iii. Measure job performance for each employee on an annual basis;
iv. Provide job and career training programs to the extent necessary;
v. Take actions when necessary to assist employees that exhibit less than
desirable results.
vi. The Human Resources department shall:
a. Determine competency requirements by role;
b. Document competency requirements in the job description;
c. Ensure personnel performing specific roles are qualified on the
basis of appropriate education, training and/or experience;
d. Evaluate an employee’s competency through an annual
management assessment and performance evaluation process;
e. Take actions to acquire the necessary competence when gaps or
needs are identified;
f. Evaluate the effectiveness of action taken; and
g. Retain records to provide evidence of competence.
The Human Resource and respective manager identify training required for
personnel performing activities affecting quality and provides the required training
to satisfy competency needs.
Records of personnel training are maintained as per Control of Documented
Information Procedure.

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7.3 Awareness
PTW ensures that employees are aware of:
i. The Quality Policy;
ii. Quality objectives and results;
iii. Their contribution to the effectiveness of the QMS;
iv. The benefits of improved Quality Management System performance;
v. The implications of nonconformance to our QMS requirements; and
vi. All employees are trained on the relevance and importance of their
activities and how they contribute to the achievement of our policies and
objectives. Awareness training and monitoring is conducted in-house when
required.
Supporting documentation:
Ref. Title & Description
00036 Control of Competence and Awareness Procedure

7.4 Communication
7.4.1 General
PTW has identified the necessary internal and external communications
that are required for the operation of the QMS. All managers and
supervisors are responsible for establishing regular formal and informal
communications as needed to convey to their direct reports the relevance
and importance of their activities; typically, this information is conveyed
through emails, QIB’s and team meetings.
7.4.2 Internal Communication
PTW internally communicates information relevant to the QMS among the
various levels and functions of the organization, including changes to the
QMS, as appropriate.
Issues pertaining to our QMS that may be communicated internally include:
i. Day-to-day operations and general awareness;
ii. Quality policy;
iii. Information on achieving objectives and targets;
iv. Risk and opportunities.
Senior management is responsible for communicating the corporate
policies as well as the importance of meeting customer, statutory and
regulatory requirements to employees within their respective departments.
They ensure the quality policy is understood and applied to the daily work
of the organization through the establishment of measurable goals and

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objectives. Internal communication occurs on an on-going basis and is
achieved through various mechanisms as appropriate:
i. Regular meetings and briefings;
ii. Training sessions and training material;
iii. Display boards, memorandums, letters;
iv. Website, intranet, internal e-mails;
v. Product and process performance data analysis and audit results;
vi. Targets, objectives, scorecards, KPIs, management system
manual and procedures;
vii. Corrective action and non-conformance reports.
7.4.3 External communication
Our organization has determined the need to communicate information
externally to our interested parties regarding the effectiveness of our QMS.
In most instances, external interested parties (such as consumers,
stockholders, neighboring communities, etc.) are the main driving force for
our organization to implement our QMS.
Our organization ensures that all external communications are authorized
prior to release. Where required, advice appropriate to the context of the
communication may be sought concerning the content and dissemination
of certain external communications.
In each case, the response is retained and controlled in accordance with
the requirements for documented information.
7.5 Documented Information
7.5.1 General
PTW ensures that our QMS includes the documented information that is
required to be maintained and retained to be in compliance with ISO 9001
and additionally, any documented information identified by our organization
that demonstrates the effective operation. Refer to the Control of
Documented information Procedure.
7.5.2 Creating & Updating
Our organization ensures that when we create documented information it
is appropriately identified and described (e.g. title, date, author, reference
number) and is available in an appropriate format (e.g. language, software
version, graphics, etc.) and on appropriate media (e.g. paper, electronic).
All documented information is reviewed and approved for suitability and
adequacy. Where permanent changes to a document are required, a
Document Change Request form is completed and submitted to the
document owner for consideration and implementation.

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7.5.3 Controlling Documented Information
Documented information is retained to provide evidence of conformity to
the requirements specified by ISO standards, customer requirements and
of the effective operation of our integrated management system.
PTW uses standard forms and templates that are accessed via a local area
network computer system. A document management system is used to
retain documented information ensuring only the current versions are
available to users. All management system documents are controlled and
communicated according to the Control of Documented Information
Procedure which defines the process for:
i. Approving documents for adequacy prior to issue;
ii. Reviewing and revising as necessary and re-approving documents;
iii. Ensuring that changes and current revision status of documents are
identified;
iv. Ensuring that relevant versions of applicable documents are
available at points of use;
v. Ensuring that documents remain legible and readily identifiable;
vi. Ensuring that documents of external origin are identified, and their
distribution controlled;
vii. Preventing the unintended use of obsolete documents;
viii. Ensuring that documents of external origin are identified, and their
distribution controlled.
Supporting documentation:
Ref. Title & Description
00003 Control of Documented Information Procedure

8.0 Operation
8.1 Operational Planning & Control
PTW has established and implemented documented procedures that describe the
processes identified and the controls required for the provision of products and
services. During the planning phase, Senior management, the Quality
Representative, and other responsible personnel identified the following
parameters:
i. Requirements for the products and services;
ii. Criteria for the processes and the acceptance of products and services;
iii. Resources needed to achieve conformity to the product and service
requirements;
iv. Implementing control of the processes in accordance with the criteria;
v. Determining, maintaining and retaining documented information to the
extent necessary;

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a) to have confidence that the processes have been carried out
as planned
b) to demonstrate the conformity of products and services to their
requirements.
8.2 Requirements for Product and Services
8.2.1 Customer Communication
i. PTW has implemented an effective system for communicating with
customers. This system includes, but is not limited to:
a) Information relating to product and service information;
b) Inquiries, contracts and order handling, including
amendments;
c) Customer feedback, including customer complaints;
d) Handling and control of Customer Property
e) Specific requirements for contingency actions, when relevant.
ii. Appropriate handling of customer communication helps to reduce
customer dissatisfaction. Customer communication occurs through
the following formats, events, and processes:
a) Brochures, specifications or technical data sheets relating to
our products and services;
b) Enquiries, quotations and order forms, invoices and credit
notes;
c) Confirmation of authorized orders and amended orders;
d) Delivery notes and certificates of conformity;
e) E-mails, letters and general correspondence;
f) When customer property is handled or controlled;
g) Customer feedback and complaints management process;
8.2.2 Determining Requirements for Products and Services
PTW develops appropriate requirements to ensure that we satisfy the
needs and expectations across the technical environment including those
of our customers, stakeholders, or relevant interested parties. Senior
management ensures that customer requirements are clearly articulated
and that their requirements are captured and understood before the
acceptance of an order.
During the inquiry, quotation, and order acceptance stages of customer
contact, PTW gathers pertinent information related to the customer
requirements and expectations as well as any applicable statutory and
regulatory requirements.
Customer requirements include the following:

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i. Previous customer requirements which pertain to current parts
being ordered;
ii. Statutory and regulatory obligations related to the product’s
lifecycle;
iii. Other non-customer specified performance requirements;
iv. Any additional requirements determined by PTW;
v. Requirements not stated by the customer, but which are necessary
for specified or intended use.
8.2.3 Review of Requirements for Products and Services
8.2.3.1. Ability to meet the requirements
PTW conducts a contract review to confirm its ability to supply the
required product and services.
The review process at a minimum includes:
i. Requirements specified by the customer, including the
requirements for delivery and post-delivery activities;
ii. Requirements not stated by the customer, but necessary for the
intended use, when known;
iii. Requirements specified by the organization;
iv. Statutory and regulatory requirements applicable to the products
and services;
v. Contract or order requirements differing from those previously
expressed.
8.2.3.2. Documented Information
Results of the review process and of any subsequent actions, including
changes to the contract, are retained as documented information.
Customer requirements are confirmed before acceptance by the
exchange of contracts, purchase orders via appropriate electronic or hard
copy formats.
8.2.4 Changes in Requirements for Products and Services
PTW ensures that all relevant documented information relating to changes
in product or service requirements are authorized and amended where
necessary and that all relevant personnel are made aware of the
documented requirement changes. The change process is communicated
using Design & Development Procedure and Control of Documented
Information Procedure
Supporting documentation:
Ref. Title & Description
00045 Control of Design & Development Procedure

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00003 Control of Documented Information Procedure

8.3 Design & Development of Product and Services

8.3.1 General
PTW has established, implemented, and maintained a design and
development process that is appropriate to ensure the subsequent
provision of products and services.
8.3.2 Design and Development Planning
At the start of the design process, our organization reviews the available
requirements and specifications and identifies the key stages of the design
process. Design and development stages including organization, task
sequence, mandatory steps, significant stages, and methods of
configuration control are established. In order to ensure the design,
verification, and validation activities are done correctly, those activities are
planned and assigned to qualified staff equipped with adequate resources.
In determining the stages and controls for design and development, where
appropriate, PTW considers the following:
i. The nature, duration and complexity of the activities
ii. The required process stages, including applicable reviews
iii. The required verification and validation activities
iv. The responsibilities and authorities involved in the process
v. The internal and external resource needs for the products and
services
vi. The need to control interfaces between persons involved in the
process
vii. The need for involvement of customers and users in the process
viii. The requirements for subsequent provision of products and
services
ix. The level of control expected for the process by customers and
other relevant interested parties
x. The documented information needed to demonstrate that
requirements have been met.
8.3.3 Design and Development Inputs
In order to avoid confusion about the inputs to the design and to ensure
complete understanding of what the customer wants, it is our policy to
identify the design scope, determine the design process through all
necessary means, and review the project relative to the performance
specifications or outcome requirements and any external regulations for

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adequacy of the design. Any incomplete, ambiguous, and/or conflicting
requirements are discussed and resolved at the earliest possible stage and
the outcome retained as documented information. PTW considers the
following:
i. Functional and performance requirements
ii. Information derived from previous similar designs and development
activities
iii. Statutory and regulatory requirements
iv. Commitments to implement any standards or codes practice
v. Potential consequences of failure due to the nature of the products
or services.
8.3.4 Design and Development Controls
PTW controls the design and development process to ensure that:
i. The results to be achieved are defined
ii. Reviews are conducted to evaluate the ability of the results of
design and development to meet requirements
iii. Verification activities are conducted to ensure that the design and
development outputs meet the input requirements
iv. Validation activities are conducted to ensure that the resulting
products and services meet the requirements for the specified
application or intended use
v. Any necessary actions are taken on problems determined during
the reviews, or verification and validation activities
vi. Documented Information of these activities are retained
8.3.5 Design and Development Outputs
PTW ensures that the design and development outputs:
i. Meet the input requirements
ii. Are adequate for the subsequent processes for the provision of
products and services
iii. Include and/or reference monitoring and measuring requirements,
as appropriate, and acceptance criteria
iv. Specify the characteristics of the products and services that are
essential for their intended purpose and their safe and proper
provision.
PTW retains documented information on design and development output.
8.3.6 Design and Development Changes
PTW ensures that changes made during or after the design and
development requirements are identified and retained as documented
information. Any changes are reviewed, verified, validated, and approved.
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Supporting documentation:
Ref. Title & Description
00045 Control of Design & Development Procedure

8.4 Control of Externally Provided Processes, Product & Services

8.4.1 General
The purchasing process is essential to our organization’s ability to provide
our customers with products and services that meet their requirements.
PTW ensures that all purchased products or services that are incorporated
into our final products conform to our specified requirements. PTW ensures
that purchased products conform to:
i. Purchase orders and delivery notes,
ii. Product specifications,
iii. National or international standards.
Potential suppliers are selected based on their ability to supply products or
services in accordance with specified quality requirements. Quality shall
be assessed through vendor evaluation (for both new and existing).
The criteria for the selection, evaluation and re-evaluation are defined and
communicated in the Purchasing & Procurement Procedure.
8.4.2 Type and extent of control
PTW ensures that externally provided processes, products and services
remain within the control of its management system and do not adversely
affect our ability to consistently deliver conforming products and services
to our customers. PTW has a receiving inspection and a non-conforming
process in place to ensure and verify that incoming materials, components,
or services comply with purchase order requirements. Vendors
demonstrating inadequate performance will be required to implement
corrective actions. Poor performing vendors will be replaced.
8.4.3 Information for external providers
PTW ensures the adequacy of the requirements prior to issuing a purchase
order for outside materials, components, or processes. Purchase orders
define the product or services to be purchased. Purchase Orders are
created by the designated individuals within the company. Purchasing
documents clearly describe the product or service to be provided.
Vendors are provided with all required data that is pertinent to the item or
service requested. Information regarding the quality system and inspection
requirements are clearly defined prior to commencing work.

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Supporting documentation:
Ref. Title & Description
00040 Control of Purchasing & Procurement Procedure

8.5 Production & Service Provision

8.5.1 Control of Production & Service Provision
PTW plans and implements production and service provisions under
controlled conditions and as required by job specific requirements.
Examples of the controls include:
i. Availability of information that define characteristics and results to
be achieved
ii. Availability of competent and effectively trained personnel with the
use of adequate equipment
iii. Availability and use of suitable monitoring and measuring devices
and resources
iv. Evidence that all manufacturing and inspection operations have
been completed as planned
Manufacturing processes are documented, verified, monitored, and
audited. Manufacturing procedures, work instructions, ITPs (Inspection &
Test Plans), and other documents deemed necessary, define the
acceptance for manufacturing and service operations. The ITP provides
detailed instruction and guidance for all production and service phases
including the methods, acceptance criteria and verification documents. An
ITP sets out critical control points or 'hold points' at various stages within a
process. Each control point is a scheduled inspection or verification activity.
8.5.2 Identification & Traceability
Throughout production operations, PTW identifies both the product and its
status with respect to monitoring and measurement requirements. Further,
where traceability is required or appropriate, the unique identification of the
product is controlled and recorded. The documented information is retained
as necessary to enable traceability.
Procedures are established for providing identification and traceability of
the product throughout the production and delivery cycle to ensure
conformity to customer, regulatory, and applicable requirements.
8.5.3 Property Belonging to Customer or External Providers
Customer supplied property or material will be handled as mandated by the
customer /vendor contract. If customer property is provided to PTW for use

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in processes or for incorporation into products, it is identified, verified,
protected, safeguarded, and, where appropriate, maintained.
Loss, damage, or unsuitability for use is immediately recorded and reported
to the customer.
Items found to be non-conforming are quarantined, tagged, and recorded
as defined in accordance with the Control of Non-conformity & Corrective
Action Procedure and brought to the immediate attention of the customer.
No customer property is released for further processing or storage until
such time as all required verification and testing activities are completed
and the results are found to be acceptable.
PTW retains documented information on property belonging to customer or
external provider.
8.5.4 Preservation
PTW ensures that all products and materials are handled and stored
appropriately at all stages of the development cycle to prevent damage or
deterioration. Products and materials are stored in designated storage
areas with appropriate control of inbound receipts and outbound releases.
Products in storage are periodically assessed to detect deterioration. All
packaging is sufficient to ensure product quality while in storage and during
delivery to the customer:
i. Components and products are handled and stored in a manner that
prevents damage or deterioration, pending use or delivery;
ii. Each department ensures controls are implemented to prevent
mixing conforming and non-conforming materials;
iii. Packing ensures specified or original manufacturing packaging is
utilized;
iv. All products are suitably packed to prevent deterioration or damage
during storage and delivery.
8.5.5 Post-delivery Activities
PTW determines customer requirements before acceptance of an order.
Customer requirements include the following:
i. Previous customer requirements which pertain to current part
numbers being ordered;
ii. Requirements not stated by the customer but necessary for
specified use or intended use;
iii. Statutory and regulatory requirements related to the product;
iv. Requirements required for delivery and post-delivery activities such
as product support.
v. Any additional requirements determined by our organization.

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8.5.6 Control of Changes
Changes to the design and development requirements are identified and
recorded. Any changes are reviewed, verified, validated, and approved.
The review of design development changes includes evaluating the effects
of those changes upon constituent products already delivered. All results
relating to the review of changes are retained as documented information.
8.6 Release of Products & Services
PTW has implemented methods for monitoring and measuring the characteristics
of the product to verify product requirements are fulfilled. These methods are used
at appropriated stages of the product realization process. Products are not
released to the customer until all planned processes have been satisfactorily
completed. Documented procedures have been established for product inspection.
Documented Records and information of inspection include evidence of conformity
with the acceptance criteria and traceability to the person authorizing the release.
Records of inspection are maintained.
Measurement and acceptance criteria that are necessary for product acceptance
are retained as documented information.
8.7 Control of Non-conforming Outputs
It is our organization’s policy to detect, control and rectify any aspect of an output
that does not conform as quickly and efficiently as possible. Where necessary, any
product or service output that does not conform to requirements is properly
identified and controlled to prevent unintended use or delivery. The non-conformity
is analysed, and the cause(s) are investigated.
PTW maintains an effective system for controlling non-conforming material
through its Control of Non-Conforming and Corrective Action Procedure.
Disposition of non-conforming material and customer contact shall be handled and
documented in accordance with this procedure.
When a non-conforming product is corrected, it is re-inspected to the original
specifications and requirements to ensure it conforms to customer stated
requirements.
Improvement actions are implemented to ensure the non-conformance does not
reoccur. Once the non-conforming outputs are corrected, the outputs are then
verified for conformity against requirements. Documented information concerning
the nature of any non-conformances, the resolving authority, and the resulting
corrective actions is retained. Where necessary, details concerning any authorized
concessions are documented as evidence of acceptance.
Supporting documentation:
Ref. Title & Description
00012 Control of Non-conforming and Corrective Action Procedure

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9.0 Performance Evaluation
9.1 Monitoring, Measurement, Analysis & Evaluation
9.1.1 General
PTW has applied suitable methods for determining which aspects of the
QMS and its processes are to be monitored, measured, and evaluated.
The frequency and methods by which our processes are monitored,
measured, and evaluated is determined and informed by:
i. Statutory and regulatory requirements;
ii. Customer feedback and specification requirements;
iii. Process and QMS requirements;
iv. Process performance and audit results;
v. Level of risk and types of control measure;
vi. Trends in non-conformities or corrective actions;
vii. Criticality for product conformity;
All monitoring, measuring and evaluation outputs are analyzed to
determine process effectiveness and to ensure their effectiveness in
achieving in-tolerance results and to identify opportunities for improvement.
Where applicable records are retained as documented information
Products are not normally released or delivered until all planned
inspections and tests have been completed and that documented
information exists to provide evidence of conformity with acceptance
criteria and identifying the person(s) authorizing release
Services are not normally delivered until all compliance has been
completed and that documented information exists to provide evidence of
conformity with acceptance criteria and identifying the person(s)
authorizing release.
9.1.2 Customer Satisfaction
Maintaining customer satisfaction is one of the principal objectives of our
QMS. PTW monitors information relating to customer perception, in regard
to, our continual ability to fulfill their requirements. We utilize several
sources to collect data about customer perception. The level of customer
satisfaction is monitored using various customer data points:
i. Product returns and warranty claims;
ii. Repeat customers and trends in market share;
iii. Analysis of customer complaints and customer satisfaction surveys;
iv. Recognition and consumer awards

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The data above is also used by management to identify opportunities for
improvement. A documented procedure describes how PTW obtains,
analyzes, and uses customer feedback as a continuous improvement tool.
Supporting documentation:
Ref. Title & Description
00009 Customer Satisfaction Procedure

9.1.3 Performance Analysis and Evaluation

PTW analyzes and evaluates data using appropriate statistical and non-
statistical techniques to determine the suitability and effectiveness of QMS
processes. The data may be analyzed and evaluated for the below areas:
i. Conformity of products and services
ii. Degree of customer satisfaction
iii. Performance and effectiveness of the QMS
iv. Effective implementation of planning elements
v. Effectiveness of actions taken to address risks and opportunities
vi. Performance of external providers, and
vii. Improvements within the QMS
Any record with data that is an established part of the QMS may be
considered relevant for analysis. Records are evidence of system
performance and should be analyzed for potential improvements.
Our organization undertakes corrective action when the data shows a trend
toward the pre-defined control limit. Employees, who utilize statistical tools
to analyze, measure and verify outputs, are sufficiently competent to
ensure proper deployment of these techniques.
9.2 Internal Audit
PTW has planned, established, implemented, and maintained an audit program
including the frequency, methods, responsibilities, planning requirements and
reporting. Internal audits are conducted to verify quality activities comply with
planned expectations including customer contractual requirements and other QMS
requirements as deemed necessary and applicable. The Quality Department
selects and leads an Audit Team. This activity is defined by the Control of Internal
Audits Procedure.
The audit system includes the following:
i. Planning that considers the status and importance of the processes and
areas to be audited, and the results of previous audits;
ii. Criteria, scope, frequency and methods of audit that are defined;

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iii. Auditor selection and conduct is monitored to assure objectivity and
impartiality of the audit process;
iv. Auditors do not audit their own processes; and
v. Reporting audit results to senior management through scheduled
management meetings.
This procedure includes responsibilities and requirements for planning and
conducting audits to ensure their independence, recording audit results, and
maintaining appropriate records.
Supporting documentation:
Ref. Title & Description
00024 Internal Audit Procedure

9.3 Management Review

9.3.1 General
To ensure the continuing suitability, adequacy, and effectiveness of our
QMS in meeting our organization’s strategies, Senior Management
conducts formal management review meetings at planned intervals. The
requirements for conducting management review are defined and
communicated using the Control of Management Reviews Procedure.
9.3.2 Inputs
Assessment of the QMS is based on a review of information inputs
provided to management for review. The management review meeting
inputs include:
i. Any changes in external and internal issues (organisational context)
that are relevant to the QMS;
ii. Results of internal, and customer audits;
iii. Positive and negative customer feedback;
iv. The extent to which quality objectives have been met;
v. Process performance and product conformance;
vi. Status of non-conformities and corrective actions;
vii. Follow-ups on action items from previous reviews;
viii. Business changes which could affect the QMS;
ix. Recommendations for improvement to the QMS.
In addition, management review inputs shall include the adequacy of
resources, the effectiveness of actions taken to address risks and
opportunities for improvement. Results of management review meetings
shall be retained as documented information.

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9.3.3 Outputs
The primary outputs of management review meetings are actions that are
taken to make changes or improvements to our QMS. During management
review meetings, Senior Management will identify appropriate actions to be
taken regarding the following issues:
i. Improvement of the effectiveness of the QMS and its processes;
ii. Improvement of products related to customer requirements;
iii. Opportunities and risks;
iv. Resource needs.
The primary outputs of management review meetings are the actions
necessary to make changes or improvements to our QMS and the provision
of resources needed to implement these actions. Responsibilities for
required actions are assigned to members of the management review
team. Any decisions made during the meeting, assigned actions and their
due dates are recorded in the management review meeting minutes.
Supporting documentation:
Ref. Title & Description
00030 Control of Management Reviews Procedure

10.0 Improvement
10.1 General
PTW determines and selects opportunities using quality objectives, audit results,
analysis of data and data trends, corrective actions, and management reviews for
improvement and implements any necessary actions to meet customer
requirements and enhance customer satisfaction. These include:
i. Improving products and services to meet requirements, as well as, to
address future needs and expectations;
ii. Correcting, preventing, or reducing undesired effects;
iii. Improving the performance and effectiveness of the QMS;
PTW also ensures that opportunities for improvement from daily feedback on
operational performance are evaluated by the quality department, which are
typically implemented through the corrective action system.
10.2 Non-conformity & Corrective Action
10.2.1 When a non-conformity occurs
When non-conformities occur, PTW will take action to control, correct,
address the resulting consequences, and evaluate the need for change to

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prevent reoccurrence. Further, PTW will review the effectiveness of any
corrective action taken, evaluate the risks and opportunities that could arise
due to the action taken, and make changes to the QMS if necessary.
A documented procedure describes methods that ensure that a non-
conforming product is identified and controlled to prevent unintended use
or delivery. The controls, responsibilities, and authorities that implement
are discussed in this procedure.
10.2.2 Documented information for corrective actions
A documented procedure describes the process of managing corrective
actions to resolve issues within the QMS. Corrective action is appropriate
to the impact of the issues being resolved and is taken to eliminate the
results and the causes of non-conformities to prevent their recurrence.
PTW retains the documents associated with the non-conformity and the
results of the corrective action in accordance with Control of Documented
Information Procedure.
Supporting documentation:
Ref. Title & Description
00012 Control of Non-Conforming & Corrective Action Procedure

10.3 Improvement
PTW continually improves the effectiveness of its QMS through the application of
the corporate policies, objectives, auditing and data analysis, corrective actions
and management reviews.
The continual improvement process begins with the establishment of our corporate
policies and objectives for improvement, based on objectives contained in our
business plan and customer targets and goals. Customer satisfaction, internal
audit data, process and product performance data, and the cost of poor quality or
risk control are then compared against objectives or KPIs to identify additional
opportunities for improvement.
The overall effectiveness of the continual improvement program, including
corrective actions taken, as well as the overall progress towards achieving
corporate-level improvement objectives, are assessed through our management
review process.

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Correlation Matrix
This section provides a matrix to correlate the requirements of ISO 9001:2015 against the relevant
sections in this document and should be used to determine where the new and amended clauses
are located.
ISO 9001:2015 Clauses This Document Page
1.0 SCOPE SCOPE 7-8
2.0 NORMATIVE REFERENCES NORMATIVE REFERENCES 8
3.0 TERMS AND DEFINITIONS ACRONYMS AND DEFINITIONS 8-10
4.0 CONTEXT OF THE ORGANIZATION CONTEXT OF THE ORGANIZATION 11-13
4.1 Understanding the Organization and its Context Organizational Context 11-12
Understanding the needs and expectations of 12
4.2 Needs and Expectations of Interested Parties
Relevant Interested Parties
4.3 Scope of the QMS QMS Scope 12
4.4 QMS and its Processes QMS and its Processes 12
4.4.1 Interaction Interaction of Processes 12-13
4.4.2 Process documentation Process Documentation 13
5.0 LEADERSHIP LEADERSHIP 13-16
5.1 Leadership and Commitment Leadership and Commitment 13-16
5.1.1 General General 13
5.1.2 Customer Focus Customer Focus 13-14
5.2 Quality Policy Quality Policy 14
5.2.1 Establishing the Quality Policy Establishing the Quality Policy 14
5.2.2 Communicating the Quality Policy Communicating the Quality Policy 14
5.3 Roles, Responsibilities and Authorities Roles, Responsibilities and Authorities 14
5.3.1 Senior Management 14-15
5.3.2 Quality Representative 15
5.3.3 Department Managers 16
5.3.4 Employees 16
6.0 QUALITY MANAGEMENT SYSTEM PLANNING QUALITY MANAGEMENT SYSTEM PLANNING 16-17
6.1 Actions to Address Risk & Opportunities Actions to Address Risk & Opportunities 16
Quality Objectives & Planning to Achieve 16-17
6.2 Quality Objectives & Planning to Achieve them
them
6.2.1 Quality Objectives Quality Objectives 16-17
6.2.2 Achieving Quality Objectives Achieving Quality Objectives 17
6.3 Planning of Changes Planning for Change 17
7.0 SUPPORT SUPPORT 17-24
7.1 Resources Resources 17-20
7.1.1 General General 17-18
7.1.2 People People 18
7.1.3 Infrastructure Infrastructure 18
7.1.4 Environment for the Operation of Processes Operational Environment 19
7.1.5 Monitoring and Measuring Resources Monitoring and Measuring Resources 19
7.1.5.1 General General 19
7.1.5.2 Traceability Measurement Traceability 19-20
7.1.6 Organizational Knowledge Organizational Knowledge 20-21
7.2 Competence Competence 21
7.3 Awareness Awareness 22
7.4 Communication Communication 22
7.4.1 General General 22

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7.4.2 Internal Communication Internal Communication 22-23
7.4.3 External Communication External Communication 23
7.5 Documented Information Documented Information 23-24
7.5.1 General Management System Documents 23
7.5.2 Creating and Updating Creating and Updating 23
7.5.3 Control of Documented Information Controlling Documented Information 24
8.0 OPERATION OPERATION 24-33
8.1 Operational Planning and Control Operational Planning and Control 24-25
8.2 Requirements for Products and Services Requirements for Products and Services 25
8.2.1 Customer Communication Customer Communication 25
Determining Requirements Related to Products & Determining Requirements Related to Products & 25-26
8.2.2
Services Services
Review of Requirements Related to the Review of Requirements Related to the Products 26-27
8.2.3
Products & Services & Services
8.2.3.1 Ability to meet Requirements Ability to meet Requirements 26
8.2.3.2 Documented Information Documented Information 26
8.2.4 Changes to Requirements for Products/Services Changes in Requirements 26-27
Design and Development of Products and Design and Development of Products and 27-29
8.3
Services Services
8.3.1 General General 27
8.3.2 Design and Development Planning Planning 27
8.3.3 Design and Development Inputs Inputs 27-28
8.3.4 Design and Development Controls Controls 28
8.3.5 Design and Development Outputs Outputs 28
8.3.6 Design and Development Changes Changes 28-29
8.4 Externally Provided Products & Services Control of Suppliers & External Processes 29-30
8.4.1 General General 29
8.4.2 Type & Extent of Control of External Provision Type & Extent of Control of External Provision 29
8.4.3 Information for External Providers Information for External Providers 29-30
8.5 Production and Service Provision Production & Service Provision 30-32
8.5.1 Control of Production and Service Provision Control of Production & Service Provision 30
8.5.2 Identification and Traceability Identification & Traceability 30
Property belonging to Customer or External Property belonging to Customer or External 30-31
8.5.3
Providers Providers
8.5.4 Preservation Preservation 31
8.5.5 Post-Delivery Activities Post-Delivery Activities 31
8.5.6 Control of Changes Control of Changes 32
8.6 Release of Products and Services Release of Products and Services 32
8.7 Non-conforming Process Outputs and Products Control of Non-conforming Outputs 32
9.0 PERFORMANCE EVALUATION PERFORMANCE EVALUATION 33-36
9.1 Monitoring, Measurement, Analysis & Evaluation Monitoring, Measurement, Analysis & Evaluation 33-35
9.1.1 General General 33
9.1.2 Customer Satisfaction Customer Satisfaction 33-34
9.1.3 Analysis and Evaluation Analysis and Evaluation 34
9.2 Internal Audit Internal Audit 34-35
9.3 Management Review Management Review 35-36
9.3.1 General General 35
9.3.2 Management Review Inputs Inputs 35
9.3.3 Management Review Outputs Outputs 36
10.0 IMPROVEMENT IMPROVEMENT 36-37

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10.1 General General 36
10.2 Non-Conformity and Corrective Action Non-Conformity & Corrective Action 36-37
10.3 Continual Improvement Improvement 37

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