ITTC-Sample Quality Manual: Company

ITTC-Sample
Quality Manual
(based on the International Standard ISO 9001:2000)
Company
Copy No.
Subject to revision yes

no
The Quality Manual is property of company’s name

Confidential; no copying or distributing to third parties without authorisation
Company
To the Proceedings of the QSG to the 23rd ITTC
ITTC Sample Quality Manual System was changed to Quality Management

System. The requirements seem to be more
In order to support the member general and provide improved flexibility. ISO
organisations of the ITTC in introducing a 9001:2000 is aimed equally at manufacturing
quality control system according to ISO as well as service organizations, with a strong
9000:2000 or in changing from standard ISO focus on customer satisfaction. The major
9000:1994 to ISO 9000:2000, the QSG of the reasons for the year 2000 revisions of the
23rd ITTC assembled a updated Sample Quality standard include emphasizing the need to
Manual. This Sample Quality Manual provides measure customer satisfaction, meeting the
guidance for quality management and models need for more user-friendly documents,
for quality assurance. assuring consistency between quality
management system requirements and
Compared to ISO 9001/9002:1994 the guidelines, and incorporating generic quality
structure of ISO 9001:2000 was changed management principles into organizations.
completely, including the name from Quality
1 Scope
2 Normative reference
3 Terms and definitions
4 Quality management system
5 Management responsibility
6 Resource management
7 Product realization
8 Measurement, analysis and improvement
The 8 sections of the Quality Manual obligatory by the standard ISO 9000:2000
The QSG hopes by submitting this sample to updated standard ISO 9000:2000 in the
simplify and support the implementation of community of the ITTC.
quality control systems or the adaptation to the
Model of a process-based quality management system
ITTC-Sample Quality Page 1 of 1
Manual
Foreword
FOREWORD
This Sample Quality Manual provides The selection of appropriate elements and
guidance for quality management and models the extent to which these elements are adopted
for quality assurance. Because needs of and applied by an organization depends upon
organizations vary, it is not the purpose of this several factors such as market being served,
Sample Quality Manual to enforce uniformity nature of product, production processes,
of quality systems. The design and clientele, and customer needs.
implementation of a quality management
system necessarily is influenced by the References in this Sample Quality Manual
particular organisation’s objectives, products, to a ‘product’ should be interpreted also as
processes and individual practices. applicable to the generic product categories of
service (such as model tests, calculations, etc.),
hardware, software or process materials.
Prepared, verified and approved

Quality Systems Group
of the 23rd ITTC
Date: 09/2002
ITTC-Sample Quality Section 0
Company Manual Page 1 of 1
Effective Date Revision
Register 09/2002 01
REGISTER
Effective Revision
Section Contents Pages
Date
- Foreword 09/2002 - 1
0 Register 09/2002 01 1
1 Scope 09/2002 01 3
Application and ITTC–Recommended Procedures as

2 09/2002 01 2
normative reference
3 Glossary of terms 09/2002 01 5
4 Quality management system 09/2002 01 8
5 Management responsibility 09/2002 01 9
6 Resource management 09/2002 01 4
7 Product realization 09/2002 01 16
8 Measurement, analysis and improvement 09/2002 01 8
Prepared Verified Approved
Name Name Name

Date Date Date
Scope 09/2002 01
1. SCOPE
Compared to ISO 9001/9002:1994 the A primary concern of any organisation

structure of ISO 9001:2000 was changed should be the quality of its products and
completely, including the name from Quality services. In order to be successful, an
System was changed to Quality Management organisation should offer products and
System. The requirements seem to be more services that:
general and provide improved flexibility. ISO • Meet a well defined need, use, or
9001:2000 is aimed equally at manufacturing purpose
as well as service organizations, with a strong
• Satisfy customer’s expectations
focus on customer satisfaction. The major
reasons for the year 2000 revisions of the • Comply with applicable standards and
standard include emphasizing the need to specifications
measure customer satisfaction, meeting the • Comply with requirements of society
need for more user-friendly documents, • Have an awareness of environmental
assuring consistency between quality needs
management system requirements and
guidelines, and incorporating generic quality • Are made available at competitive
management principles into organizations. prices
• Are provided economically
A quality-management system brings
together people, processes, methods and tools In order to meet its objectives, the
with the aim of constantly improving both the organisation should ensure that the technical,
system and the company's products. All of administrative and human factors affecting
these efforts are geared to the customer and the quality of its products or services will be
customer satisfaction. under control, whether hardware, software or
processed materials. All such control should
This Sample Quality Manual of ITTC, on be oriented towards the reduction, elimination
the basis of the Standard EN ISO 9001:2000, and, most importantly, prevention of quality
provide guidance on quality management and nonconformities.
quality system elements. The quality system
elements are suitable for use in the A quality system should be developed and
development and implementation of a implemented for the purpose of
comprehensive and effective in-house quality accomplishing the objectives set out in the
system, with a view to ensuring customer organisation’s quality policy.
satisfaction.
Each element (or requirement) in a quality
system varies in importance from one type of
Name Name Name

Date Date Date
Scope 09/2002 01
activity to another and from one product to the fulfilment of this aspect is related
another. In order to achieve maximum to the planned and efficient utilization
effectiveness and to satisfy customer of the technological, human and
expectations, it is essential that the quality material resources available to the
system be appropriate to the type of activity organisation.
and to the product being offered.
Benefit, cost and risk considerations have
A quality management system has two great importance for both organisation and
interrelated aspects: customer.
1. The customer’s needs and expectations
For the customer, there is a need for An effective quality management system
confidence in the ability of the should be designed to satisfy customer needs
organisation to deliver the desired and expectations while serving to protect the
quality as well as the consistent organisation’s interests. A well-structured
maintenance of that quality. quality management system is a valuable
management resource in the optimisation and
2. The organisation’s needs and interests.
control of quality in relation to benefit, cost
For the organisation, there is a
and risk considerations.
business need to attain and to maintain
the desired quality at an optimum cost;
Application and ITTC–Recommended Procedures Effective Date Revision
as Normative Reference 09/2002 01
2.1 QUALITY service, and hence affect the manner in which

the products and services are designed,
manufactured, installed, delivered etc. They are
In supplying products or services there are
standards which apply to the management of
three fundamental parameters which determine
the organization and only the management can
their saleability. They are price, quality, and
and should decide how it will respond to these
delivery time. Customers require products and
requirements and recommendations.
services of a given quality to be delivered or be
available in a given time and to be of a price
which reflects value for money. An
2.3 APPLICATION AND ITTC–RECOM-
organization will survive only if it creates and
COMMENDED PROCEDURES AS
retains satisfied customers and this will only be
NORMATIVE
achieved if it offers products or services which
REFERENCE
respond to customers’ needs and expectations.
While price is a function of cost, profit margin,
and market forces, and delivery a function of From the very beginning the ITTC aimed to
the organization’s efficiency and effectiveness, recommend procedures for general use in
quality is determined by the extent to which a carrying out physical model experiments.
product or service successfully serves the Quality Management Systems in accordance to
purposes of the user during usage. Price and ISO 9001 only deal with the management of
delivery are both transient features whereas the quality management and not with quality
impact of quality is sustained long after the requirements. To fix the quality standards for
attraction or the pain of price and delivery has products or services is the responsibility of
subsided. each individual company. Thus ITTC for years
has been acting beyond the scope of quality
management systems as the recommendations
2.2 WHAT IS ISO 9001
refer to the quality of the product or service
itself. As quality management systems become
The standard ISO 9001:2000 has the title more and more obligatory for model basins it
“Quality management systems - was decided to assemble a manual called
Requirements”. It contains specific “ITTC–Recommended Procedures” containing
requirements and recommendations for the all recommendations which have been adopted
development of a quality management system. by the ITTC up to now.
ISO 9001 is not a product standard. The
requirements and recommendations apply to
the organizations that supply the product or
Name Name Name

Date Date Date
Application and ITTC–Recommended Procedures Effective Date Revision
as Normative Reference 09/2002 01
ITTC
QUALITY SYSTEMS MANUAL
ITTC-Sample
Quality Manual
ITTC-Recommended Procedures
The scope of the ITTC–Recommended instructions of their own Quality Manual to the
Procedures is to give the member organizations ITTC–Recommended Procedures.
the possibility to make reference in the work
.
Glossary of Terms 09/2002 01
3 GLOSSARY OF TERMS
This glossary has been prepared to provide a definition of some of the terms used in the field of
quality assurance.
Assurance Evidence (verbal or written) that gives confidence that something will
or will not happen or has not happened.
Audit Systematic, independent and documented process for obtaining audit

evidence and evaluating it objectively to determine the extend to
which audit criteria are fulfilled. The comparison of the practices and
systems with the precisely defined methods, procedures and
instructions it has stated it works to. An examination of records or
activities to verify their accuracy, usually by someone other then the
person responsible for them.
Benchmarking A technique for measuring an organisation’s products, services, and

operations against those of its competitors, resulting in search for best
practice that will lead to superior performance.
Calibration All the operations are engaged in for the purpose of determining the
values of errors of a measuring instrument and, if necessary, of
determining other measurement properties.
Capability Ability of an organization, system or process to realize a product that

will fulfil the requirements for that product.
Certification The authoritative act of documenting compliance with agreed

requirements.
Competence Demonstrated ability to apply knowledge and skills.
Computer software Software covers all instructions and data which are input to a
computer to cause it to function in any mode; it includes operating
systems, compilers and test routines as well as applications programs.
The definition embraces the documents used to define and describe
the program (including flowcharts, network diagrams and program
Name Name Name

Date Date Date
listings) and also covers any associated specifications, inspection

plans, inspection data, inspection results and other instructions.
Contract An agreement formally executed by both customer and organisation

(enforceable by law) which requires performance of services or
delivery of products at a cost to the customer in accordance with
stated terms and conditions.
Conformity The fulfilment of a specified requirement by quality characteristic of

an item or service.
Corrective action Action to eliminate the cause of a detected nonconformity or other

undesirable situation.
Customer Organisation or person that receives a product.
Customer satisfaction Customer’s perception of the degree to which the customer’s

requirements have been fulfilled.
Define and document To state in written form, the precise meaning, nature, or characteristics
of something.
Design A process of originating a conceptual solution to a requirement and

expressing it in a form from which a product may be produced or a
service delivered (e.g. design of a test procedure).
Design and development Set of processes that transforms requirements into specified
characteristics or into the specification of a product, process or
system. Design creates the conceptual solution and development
transforms the solution into a fully working model.
Design approval The definitive procedure through which a product design is tested and
procedure reviewed against specification.
Design review A formal documented comprehensive and systematic examination of a

design to evaluate the design requirements and the capability of the
design to meet those requirements and to identify problems and
propose solutions.
Evaluation To ascertain the relative goodness, quality, or usefulness of an entity

with respect to a specific purpose.
Evidence of conformance Documents which testify that an entity conforms with certain
prescribed requirements.
Inspection The inspection of an entity to determine whether it conforms to

prescribed requirements.
Instruction The written and/or spoken direction given in regard to what is to be

done, including the information given in training.
ISO The International Standard Organisation. It is the specialised

international agency for the making of standards. It has a membership
of over 90 countries.
Management The person the management appoints to act on their behalf to manage
representative the quality system.
Management system System to establish policy and objectives and to achieve those
objectives.
Measuring equipment Measuring instrument, software, measurement standard, reference

material or auxiliary apparatus or combination thereof necessary to
realize a measurement process.
Objective evidence Data supporting the existence or verity of something.
Organisation Group of people and facilities with an arrangement of responsibilities,

authorities and relationships.
Preventive action Action to eliminate the cause of a potential nonconformity or other

undesirable potential situation.
Procedure Specified way to carry out an activity or a process. A sequence of

steps to execute a activity.
Process Set of interrelated or interacting activities which transforms inputs

into outputs.
Process capability The ability of a process to maintain product characteristics within

present limits.
Product Result of a process.
Quality Degree to which a set of inherent characteristics fulfils requirements.

The totality of features and characteristics of a product or service that
bear on its ability to satisfy a given need.
Quality assurance All activities and functions concerned with the attainment of quality.
Quality control The operational techniques and activities that sustain the product or
service quality to specified requirements. It is also the use of such
techniques.
Quality manual Document specifying the quality management system of an

organisation.
Quality management Management system to direct and control an organization with regard
system to quality.
Quality plan Document specifying which procedures and associated resources shall
be applied by whom and when to a specific project, product, process
or contract.
Quality policy The overall quality intentions and direction of an organisation as

regards quality as formally expressed by top management.
Quality records Objective evidence of the achieved features and characteristics of a

product or service and the processes applied to its development,
design, production, installation, maintenance, and disposal as well as
records of assessments, audits, and other examinations of an
organization to determine its capability to achieve given quality
requirements.
Quality system The organisation structure, responsibilities, activities, resources and

events that together provide organised procedures and methods of
implementation to ensure the organisation can meet quality
requirements.
Requirement A need or expectation that is stated, generally implied or obligatory.

Review Activity undertaken to determine the suitability, adequacy and

effectiveness of the subject matter to achieve established objectives.
Rework Action on a nonconforming product to make it conform to the

requirements.
Specification The document that describes in detail the requirements with which a
product or service has to comply.
System Set of interrelated or interacting elements.
System audit An audit carried out to establish whether the quality system conforms
to a prescribed standard in both its design and its implementation.
Traceability Ability to trace the history, application or location of that which is

under consideration.
Validation Confirmation, through the provision of objective evidence that the

requirements for a specific intended use or application have been
fulfilled.
Verification Confirmation, through the provision of objective evidence that

specified requirements have been fulfilled.
Work instructions Instructions which describe work to be executed, who is to do it, when
it is to start and be completed, and how, if necessary, it is to be carried
out.
Quality Management System 09/2002 01
4 QUALITY MANAGEMENT SYSTEM
CONTENTS
4.0 INTRODUCTION
4.1 GENERAL REQUIREMENTS
4.2 DOCUMENTATION REQUIREMENTS
4.2.1 General
4.2.2 Quality Manual
The structure of the Quality Manual
Quality system procedures
Work instructions
4.2.3 Control of Documents
4.2.4 Control of Records
4.3 RESPONSIBILITY IN GENERAL
Name Name Name

Date Date Date
4.0 INTRODUCTION 4.1 GENERAL REQUIREMENTS
Leading and operating an organization The organization shall establish, document,

successfully requires managing it in a implement and maintain a quality management
systematic and visible manner. Success should system and continually improve its
result from implementing and maintaining a effectiveness in accordance with the
management system that is designed to requirements of the International Standard ISO
continually improve the effectiveness and 9001.
efficiency of the organisation’s performance
by considering the needs of the interested The organization shall:
parties. Top management should establish a • identify the processes needed for the
customer-oriented organization. quality management system and their
application throughout the organization
Reasons for creating a documented quality
• determine the sequence and interaction
management system:
of these processes
− to ensure products and services satisfy
• determine criteria and methods needed
customer requirements
to ensure that both the operation and
− maintain the standards which have been control of these processes are effective
successful in achieving
• ensure the availability of resources and
− to improve standards in those areas information necessary to support the
where performance is wanting operation and monitoring of these proc-
− to harmonize policies and practices esses
across all departments • monitor, measure and analyse these
− improvement of efficiency processes
− creating stability and minimizing vari- • implement actions necessary to achieve
ance planned results and continual improve-
− eliminating complexity and reducing ment of these processes.
processing time
− benchmarking current performance
− focus on attention on quality
− to ensure products and services are de-
livered on time
− reduction of operating costs.
4.2 DOCUMENTATION REQUIREMENTS Manual to include or make reference to the

quality management system procedures and
4.2.1 General outline the structure of the documentation used
in the system.
The quality management system
documentation shall include: The Quality Manual includes:
• documented statements of a quality pol- • the scope of the quality management
icy and quality objectives system, including details of and justifi-
• a quality manual cation for any exclusions
• documented procedures required by the • the documented procedures established
ISO 9001 for the quality management system, or
reference to them
• documents needed by the organization
to ensure the effective planning, opera- • a description of the interaction between
tion and control of its processes the processes of the quality manage-
ment system.
• records required by the International
Standard ISO 9001.
The Quality Manual defines the company
quality policy in relation to each clause of the
standard ISO 9001. It states the quality policy
4.2.2 Quality Manual to meet the requirements of certification bodies
and clients.
The organization shall prepare a Quality
Manual covering the requirements of the ISO
9000 series and also requires the Quality
The structure of the Quality Manual
Quality Level 1: Defines Approach and Responsibility

Manual
Level 2: Defines Who, What, When
Procedures
Work Instructions Level 3: Answers How

Level 4: Results - shows that the system is
Other Documentation
operating
The Quality Manual should describe, in Quality system procedures

broad terms, the overall adaptation of ISO 9001
to the working environment of the company. It These prescribe the actual detail of how the
needs to describe how each applicable section company operates. They are written in simple,
of the standard is to be implemented. It should straightforward language appropriate to meet
also establish the structure, authority and the needs of internal staff. The listed operating
responsibility for the maintenance of the procedures prescribe in detail how the
company’s Quality Management System. requirements of the Documented Quality
Management System and the customer contract
requirements will be met. The procedures
Contents of the Quality Manual: should be numbered so that they relate to the
section of the Quality Manual that has been
- introduction, covering purpose, scope, implemented. The Operating Procedures in
applicability, and definitions particular are strictly commercial - in
- business, overview describing the nature confidence. Quality Procedures should contain
of the business clear, detailed descriptions of those processes
which are related to the application of ISO
- corporate policy, covering the mission, 9001. These would include such functions as
vision, values, objectives, and quality quality auditing, documentation and its control,
policy customer-complaint handling, Quality
- operational management, covering Management System reviews, etc.
planning, organization, and management
control including quality system
management, audits, reviews, and Contents of procedures
improvement
- operational policies, structured to align An effective procedure would contain some
with the sequence of key processes from or all of the following elements:
receipt of customer enquiry through to - a flowchart of the process that depicts
delivery and customer support, the sequence of actions and decisions,
referencing to implementing control inputs, outputs, and interfaces with other
procedures procedures
- cross reference matrix between manual - paragraphs describing the actions and
and ISO 9001 (in this manual the decisions required, indicating the role
numbering system also is the cross responsible by matching the flowchart in
reference as it corresponds to the the sequence in which they occur
standard). - the minimum information and equipment
needed to perform each activity or make
each decision
- the criteria for decisions as a list of be used, and the registers to be

aspects to be considered or a statement maintained
of requirement which the decision - cross reference to other documents in
should satisfy which essential supplementary
- the criteria for choosing optional routes information can be found.
and the sequence of steps to be taken
- the entry conditions for starting the
process, in terms of the minimum inputs Work instructions
and approvals to be satisfied before the
procedure may commence Work Instructions may be prepared
- the exit conditions for ending the process according to the needs of individual tasks, jobs
or task, in terms of the minimum outputs or contracts. Any instructions need to be
and approvals to be satisfied for written simply and in plain language. They
successful completion of the process may incorporate diagrams or photos if
appropriate. The Quality Policy Manual and
- the source of information or product associated Operating Procedures contain
needed, in terms of from what process, Mandatory requirements on all of the staff.
what procedure, what person (role) or They are 'living' documents and will be
organization it comes continually amended and updated as required.
- the routing instructions for information Work Instructions provide a means by which a
or product emerging from the procedure manager can describe exactly how some
- any precautions needed to prevent function within his authority should be carried
incident, accident, error, problems etc. out. Any work instruction needs to be
- any recording requirements to provide constantly reviewed to ensure it is accurate and
evidence of actions or decisions or to describes the optimum way to carry out the
enable traceability in the event of task.
subsequent problems
- any rules that have to be followed in
4.2.3 Control of Documents
order to ensure that the task is carried
out in a uniform manner and satisfies
A document is an information and its
statutory obligations
supporting medium. Examples are record,
- controls needed to verify the quality of specification, procedure document, drawing,
any products with feedback loops report, standard etc.
- controls needed to verify that the process
or task achieves its purpose and to verify The standard ISO 9001 requires that the
that critical activities and decisions organization establish and maintain
occur when required documented procedures to control all
- any forms to be completed, together with documents and data that relate to the
form-filling instructions and requirements of the standard. There are three
responsibilities, the numbering system to types of controlled documents:
• policies and practices (these include • to ensure that relevant versions of ap-
control procedures, guides, operating plicable documents are available at
procedures, and internal standards) points of use
• documents derived from these policies • to ensure that documents remain legible
and practices, such as drawings, specifi- readily identifiable
cations, plans, work instructions, tech- • to ensure that documents of external
nical procedures, and reports origin are identified and their distribu-
• external documents referenced in either tion controlled
of the above. • to prevent the unintended use of obso-
• A documented procedure shall be estab- lete documents, and to apply suitable
lished to define the controls needed: identification to them if they are re-
• to approve documents for adequacy tained for any purpose.
prior to issue
• to review and update as necessary and
re-approve documents
• to ensure that changes and the current
revision status of documents are identi-
fied
Relationship between documents, data and records:
Input documents and data Output documents and data

Policies, plans, procedures, Reports, records, results of
specifications, contracts, PROCESS operations, tests, reviews,
orders, etc. audits, etc.
4.2.4 Control of Records established to define the controls needed for

the identification, storage, protection, retrieval,
A record is a document stating results achieved retention time and disposition of records.
or providing evidence of activities performed.
Records shall be established and maintained to All quality records have one thing in common:
provide evidence of conformity to they describe the results of activities, the
requirements and of the effective operation of results of inspections, tests, reviews, audits,
the quality management system. Records shall assessments, calculations etc. These are a
remain legible, readily identifiable and number of records to be created and
retrievable. A documented procedure shall be maintained:
- management review records - calibration records

- contract review records - non - conformance records
- design review records - non - conformance investigation records
- design verification measures - subcontract quality records
- process/product change implementation - audit result records
records - follow-up audit records
- records of acceptable subcontractors - training records.
- records of unsuitable customer supplied
products In addition the following records should be
- product identification records maintained:
- qualified process records - calibration status records
- qualified equipment records - procedure change records
- qualified personnel records - customer complaints
- positive recall records - failure analysis reports
- inspection and test records - subcontractor assessments
- verification records for test hardware - contract change records.
and test software
(possible completion:)
Responsibility
Quality Tasks
c d e f
Implementation of the quality management system D A A A
Documentation of the quality management system D A E A
Establishment of the Quality Manual D I E I
Control of documents D E E E
Control of records D E E E
etc. ... ... ... ...
c Management D Î decide
d Commercial department E Î execute
e Management representative A Î advise
f Engineering department I Î inform
Management Responsibility 09/2002 01
5. MANAGEMENT RESPONSIBILITY
CONTENTS
5.1 MANAGEMENT COMMITMENT

5.2 CUSTOMER FOCUS
5.3 QUALITY POLICY
5.4 PLANNING
5.4.1 Quality Objectives
5.4.2 Quality Management System Planning
5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION
5.5.1 Responsibility and Authority
5.5.2 Management Representative
5.5.3 Internal Communication
5.6 MANAGEMENT REVIEW
5.6.1 General
5.6.2 Review Input
5.6.3 Review Output
Name Name Name

Date Date Date
5.1 MANAGEMENT COMMITMENT 5.3 QUALITY POLICY
The top management shall provide evidence The top management shall ensure that the
of its commitment to the development and quality policy:
implementation of the quality management - is appropriate to the purpose of the organiza-
system and continually improving its tion
effectiveness by:
- includes a commitment to comply with re-
• communicating to the organization the im- quirements and continually improve the ef-
portance of meeting customer as well as fectiveness of the quality management sys-
statutory and regulatory requirements tem
• establishing the quality policy - provides a framework for establishing and
• ensuring that quality objectives are estab- reviewing quality objectives
lished - is communicated and understood within the
• conducting management reviews organization
• ensuring the availability of resources. - is reviewed for continuing suitability.
The quality management system, It is the policy of the company to always

introduced by the organization, is monitored supply to the customers products and services
concerning its development, its implementation which conform exactly to stated or agreed
and the constant improvement of its specifications, and also meet the needs and
effectiveness by the top management in the expectations of those customers. It is essential
form of internal audits. that the company and all the staff do this in
order that they meet the goal to survive and
prosper in a competitive market place.
5.2 CUSTOMER FOCUS
Types of quality policy:
The top management shall ensure that - government policy, which applies to any
customer requirements are determined and are commercial enterprise
met with the aim of enhancing customer - corporate policy, which applies to the
satisfaction. Customers need confidence that business as a whole and may cover, for
the organization produces under controlled example:
conditions. Customer-related processes are ∗ environmental policy - our intentions
described in section 7.2 and monitoring and with respect to the conservation of
measurement of customer satisfaction in the natural environment
section 8.2.1. ∗ financial policy - how the business is
to be financed
∗ marketing policy - to what markets
the business is to supply is products
∗ investment policy - how to secure the
future
∗ expansion policy - the way in which The following are some typical quality
to grow, both nationally and policy statements:
internationally ∗ We will perform exactly like the
∗ personnel policy - how to treat the requirement or cause the requirement to
employees and the labour unions be officially changed.
∗ safety policy - intentions with respect ∗ We will satisfy our customers’
to hazards in the work place and use requirements on time, every time, and
of the products within budget.
∗ social policy - how to interface with ∗ Our aim is to give customer satisfaction
society in everything we do.
∗ quality policy - intentions with
respect to meeting customer In order to consistently achieve its
requirements objectives the company is wholly committed to
- operational policy, which applies to the the operation of a management system, with
operations of the business, such as design, the full co-operation of adequately trained staff
procurement, manufacture, servicing, which satisfies the requirements of ISO 9001.
quality assurance etc. And may cover, for
example: The system and policy are regularly
reviewed by the Managing Director or by the
∗ pricing policy - how the pricing of
Executive responsible for Quality, to ensure
products is to be determined
their ongoing effectiveness and efficiency in
∗ procurement policy - how to obtain
meeting the company objectives. It is also
the components and services needed
regularly reviewed to ensure the organisation’s
∗ product policy - what range of
systems and policy continue to meet the current
products the business is to produce
needs and expectations of the customers.
∗ inventory policy - how to maintain
economic order quantities to meet the The Quality Assurance Manager or
production schedules Management Representative has the authority
∗ production policy - how to determine and is responsible for implementing, managing
what to make or buy and how the and maintaining the Quality Policy Manual and
production resources are to be Operating Procedures. S/he also has the
organised authority and organisational freedom to
∗ servicing policy - how to service the identify and investigate problems affecting the
products the customers have quality of the product, services and
purchased Documented Management System.
- department policy, which applies to one
department, such as the particular rules a
department manager may impose to allocate
work, review output, monitor progress etc.
- industry policy, which applies to a particular
industry, such as the codes of practice set by
trade associations for a certain trade.
5.4 PLANNING
The standard requires that quality planning
5.4.1 Quality Objectives which is in accordance with all other
requirements of the quality management
The top management shall ensure that planning is implemented into all standard
quality objectives, including those needed to operating procedures. This is achieved by
meet requirements for product, are established initially carrying out an appropriate, formal and
at relevant functions and levels within the recorded review before tendering for, and on
organization. The quality objectives shall be receipt of, each contract. Also the regular
measurable and consistent with the quality management review considers performance and
policy. future plans for quality. The documented
quality system is designed to build in quality at
The basis for a long-term development of the appropriate stage by:
the organization is the securing of a high - adequate specification of work and in-
degree of performance of the quality spection requirements
requirements and the reaching of the given - use of trained or qualified personnel
quality objectives.
- careful and recorded review of every in-
Important priorities are: dividual contract.
- permanent promotion of quality
consciousness by the management
5.5 RESPONSIBILITY, AUTHORITY AND
- optimally trained and motivated staff COMMUNICATION
- controlled product and service
realization within all areas 5.5.1 Responsibility and Authority
- cooperation with customers and supplier
- control and monitoring of The top management shall ensure that the
implementation and maintenance of the responsibilities and authorities are defined and
quality objectives in planned intervals. communicated within the organization.
There are four principle ways in which

5.4.2 Quality Management System Planning responsibilities and authority can be
documented:
The top management shall ensure that: - in an organization structure diagram, or
organigram
• the planning of the quality management
system is carried out in order to meet the - in job descriptions
requirements given in section 4.1, as well as - in terms of reference
the quality objectives - in procedures.
• the integrity of the quality management
system is maintained when changes to the The Directors and all managers and
quality management system are planned supervisors ensure that all the requirements of
and implemented. the Quality Policy Manual and the Operating
Procedures have been fully implemented and are being achieved. It is also necessary to have
are maintained. They also ensure all staff someone who can liaise with customers on
understand the requirements of the Operating quality issues, who can co-ordinate the
Procedures and Work Instructions affecting assessment and subsequent surveillance visits,
their tasks and the requirements of each who can keep abreast of the state of the art in
contract. The Directors, managers and quality management. The person should be an
supervisors also ensure that their staff have the advisor to the top management who can
necessary, procedures, work instructions, measure the overall performance of the
training, specifications, drawings, tools and company with respect to quality.
equipment to effectively carry out the work.
To meet this requirement the management
Each employee of the company is representative needs the right to:
responsible for maintaining the specified - manage the design, development, im-
standards of work for every contract, at all plementation, and evaluation of the qual-
times. Other staff's responsibilities are ity management system including the
adequately covered by the Operating necessary resources
Procedures and Work Instructions. - determine whether proposed policies and
practices meet the requirements of the
standard ISO 9001, are suitable for
5.5.2 Management Representative meeting the business needs, are being
properly implemented, and cause non-
The top management shall appoint a conformity to be corrected
member of management who, irrespective of
other responsibilities, shall have responsibility - determine the effectiveness of the qual-
and authority that includes: ity management system
• ensuring that processes needed for the qual- - report on the quality performance of the
ity management system are established, im- organization
plemented and maintained - identify and manage programs for im-
provement in the quality system
• reporting to top management on the per-
formance of the quality management system - liaise with external bodies on quality
and any need for improvement matters.
• ensuring the promotion of awareness of
The management representative has
customer requirements throughout the or-
specific responsibility for:
ganization.
- administration, control, day to day
The management representative is the running and maintenance of the
system designer for the quality management documented quality management system
system. This person may not produce the - updating, issuing and controlling the
policies and procedures but operate as a system quality policy manual, operating
designer. This person lays down the procedures and work instruction
requirements needed to implement the - formal recording, investigating and
corporate quality policy and verifies that they reporting on customer complaints
- liaison with the customer and between their different functional areas is
certification body on Quality topics guaranteed. This is concerning especially the
- approving and monitoring the effectiveness of the processes of the quality
performance of suppliers management system. Internal communication is
for example:
- responsibility for verification and
recording of goods inward material - periodical consultation in work groups
- ensuring the requirements of ISO 9001 - periodical meetings of the entire staff
are fully addressed and the system - internal audit.
completely and effectively implemented,
maintained and reviewed Additional communication processes can be
- ensuring the quality requirements of executed within the organization for special
customers are met and that the necessary reasons too.
inspection, tests or verification are
carried out. If required by the contract to
prepare or approve a formal Quality Plan 5.6 MANAGEMENT REVIEW
- providing and managing a system of
internal audits using adequately trained 5.6.1 General
staff who are independent of the activity
being audited The standard ISO 9001 requires that the top
management shall review the organization’s
- initiating and controlling projects to quality management system, at planned
prevent recurrence or occurrence of intervals, to ensure its continuing suitability,
nonconforming product or service. Or adequacy and effectiveness. This review shall
initiating and controlling projects to give include assessing opportunities for
improvements to the grade of product, improvement and the need for changes to the
service or lowering the scrap/rework quality management system, including the
rate. Such projects may extend to the quality policy and quality objectives. Records
management of the processes and quality from management reviews shall be maintained.
management systems.
The manage The management review should do several
things:
5.5.3 Internal Communication
- establish whether the system is being
used properly; determine this by
The top management shall ensure that
providing the results of all quality audits
appropriate communication processes are
of the system, of processes and of
established within the organization and that
products
communication takes place regarding the
effectiveness of the quality management - establish whether the audit program is
system. effective; by providing the evidence of
previous audit results and problems
The organization shall establish suitably reported by other means
conditions, by which internal communication
- establish whether customer needs are 5.6.2 Review Input

being satisfied; by providing the
evidence of customer complaints, market The input to management review shall in-
share statistics, competitor statistics, clude information on:
warranty claims etc. • results of audits
- establish whether the defined quality • customer feedback
objectives are being met
• process performance and product confor-
- analysis of the date the system generates mity
should reveal whether the targets are
being achieved • status of preventive and corrective actions
- establish whether there is conflict • follow-up actions from previous manage-
between the state quality policy, the ment reviews
quality objectives and the organisational • changes that could affect the quality man-
goals and expectations and needs of your agement system
customers • recommendations for improvement.
- establish whether the quality philosophy
is being honored
- an analysis of managerial decisions 5.6.3 Review Output
should reveal whether there is constancy
of purpose or lip service being given to The output from the management review
the policy shall include any decisions and actions related
- establish whether the system requires to:
any change to match changing business • improvement to the effectiveness of the
needs; by assessing the proposed quality management system and its proc-
changes in business against the known esses
capability of the system • improvement of product related to customer
- establish whether the system provides requirements
useful data with which to manage the • resource needs.
business; by providing evidence showing
how business decisions have been made.
Those made without using available data
from the quality system show either that
poor data is being produced or
management is unaware of its value.
Management review process
QUALITY RECORDS BUSINESS PLANS

Product verification records Business expansion/reduction plans
Nonconformity records Organization development plans
Concessions Marketing plans
Service reports Sales plans
Customer complaints New product development plans
Warranty claims New technology plans
Process capability studies Production plans
Design review records
Calibration records
Training records
Contract review records BUSINESS RESULTS
Subcontractor records Sales figures
Customer surveys
Profit and loss figures
CORRECTIVE ACTION Market share figures
ANALYSIS Resource availability
Delivery performance
Tendering results
CORRECTIVE ACTION
REPORTS
PREVENTIVE ACTION INTERNAL AUDIT

ANALYSIS REPORTS
PREVENTIVE ACTION
REPORTS
QUALITY SYSTEM
CHANGE REQUESTS
DATA COLLECTION; ANALYSIS AND PRESENTATION
MANAGEMENT REVIEW
CORRECTIVE ACTION MANAGEMENT

QUALITY OBJECTIVES
REQUESTS REVIEW RECORDS
QUALITY IMPROVEMENT
PLANS
Responsibility
Quality Tasks
c d e f
Definition of the quality policy D A A A
Definition of the quality objectives D A A A
Quality management system planning D A E A
Definition of responsibility and authority D I I I
Ensuring of the internal communication D A A A
Conducting of management review E A E A
Ensuring of resources D A I A
etc. ... ... ... ...
Resource Management 09/2002 01
6. RESOURCE MANAGEMENT
CONTENTS
6.1 PROVISION OF RESOURCES

6.2 HUMAN RESOURCES
6.2.1 General
6.2.2 Competence, Awareness and Training
6.3 INFRASTRUCTURE
6.4 WORK ENVIRONMENT
Name Name Name

Date Date Date
6.1 PROVISION OF RESOURCES - determine the necessary competence for

personnel performing work affecting
The organization shall determine and product quality
provide the resources needed: - provide training or take other actions to
• to implement and maintain the quality satisfy these needs
management system - evaluate the effectiveness of the actions
• to improve continually its effectiveness taken
• to enhance customer satisfaction by - ensure that its personnel are aware of the
meeting customer requirements. relevance and importance of their
activities and how they contribute to the
achievement of the quality objectives
6.2 HUMAN RESOURCES - maintain appropriate records of
education, training, skills and
6.2.1 General experience.
The management of the organization shall Particular attention should be given to the
provide personnel for performing of activities, qualification, selection and training of newly
which influence the product quality, for the recruited personnel and personnel transferred
solution of quality management functions as to new assignments.
well as for internal quality audits who are
particularly suitable due to their appropriate Training should be given which will
education, training, talents, skills and provide executive management with an
experiences for leading, executing and understanding of the quality management
checking work. Appropriate members of the system together with the tools and techniques
staff have the necessary training and expertise needed for full executive management
to undertake self-checking and checking of participation in the operation of the system.
others as specified in the operating procedures. Executive management should also understand
the criteria available to evaluate the
The implementation of the quality policy as effectiveness of the system.
well as the compliance with all actions
securing quality are a principle task of each Training should be given to the technical
employee. personnel to enhance their contribution to the
success of the quality management system.
Training should not be restricted to personnel
6.2.2 Competence, Awareness and Training with primary quality assignments, but should
also include assignments such as marketing,
In order to secure that all staff are able to procurement, and process and product
fulfill their tasks in accordance with the quality engineering.
objectives the organization shall:
Motivation of personnel begins with their 6.4 WORK ENVIRONMENT

understanding of the tasks they are expected to
perform and how those tasks support the The organization shall determine and
overall activities. Personnel should be made manage the work environment needed to
aware of the advantages of proper job achieve conformity to product requirements.
performance at all levels, and of the effects of The work environment includes:
poor job performance on other people,
• work environment in offices
customer satisfaction, operating costs, and the
• work environment in workshops
economic well-being of the organization.
• work environment in test facilities
• work environment in laboratories
6.3 INFRASTRUCTURE • regulations over the access and over the use
of work areas.
The organization shall determine, provide
and maintain the infrastructure needed to Process operations under controlled
achieve conformity product requirements. conditions includes suitable production,
Infrastructure includes, as applicable: installation, and servicing equipment, and a
suitable working environment.
• buildings, workspace and associated
utilities
• process equipment (both hardware and
software)
• supporting services (such as transport or
communication).
Responsibility
Quality Tasks
c d e f
Provision of resources D A A A
Human resources E A A A
Infrastructure E A I A
Work environment E A I A
etc. ... ... ... ...
Product Realization 09/2002 01
7. PRODUCT REALIZATION
CONTENTS
7.0 INTRODUCTION
7.1 PLANNING OF PRODUCT REALIZATION
7.1.1 Process Control Model
7.2 CUSTOMER-RELATED PROCESSES
7.2.1 Determination of Requirements Related to the Product
7.2.2 Review of Requirements Related to the Product
7.2.3 Customer Communication
7.3 DESIGN AND DEVELOPMENT
7.3.1 Design and Development Planning
7.3.2 Design and Development Inputs
7.3.3 Design and Development Outputs
7.3.4 Design and Development Review
7.3.5 Design and Development Verification
7.3.6 Design and Development Validation
7.3.7 Control of Design and Development Changes
7.4 PURCHASING
7.4.1 Purchasing Process
7.4.2 Purchasing Information
7.4.3 Verification of Purchased Product
7.5 PRODUCTION AND SERVICE PROVISION
7.5.1 ITTC Recommended Procedures
7.5.2 Validation of Processes for Production and Service Provision
7.5.3 Identification and Traceability
7.5.4 Customer Property
7.5.5 Preservation of Product
7.6 CONTROL OF MONITORING AND MEASURING DEVICES
7.6.1 Work Instructions in the ITTC-Recommended Procedures
Name Name Name

Date Date Date
7.0 INTRODUCTION process network so that the organization has the

capability of satisfying its interest parties.
The top management should ensure the
effective and efficient operation of realization
and support of processes and the associated
Market requirements Organization Customer requirements
Determine of
specified, necessary, statutory, regulatory and other
Product
7.2.1, 7.2.2 requirements
Assess of Clearness of requirements, authority, technical
requirements foundations, resources, costs and risks
Design / development planning (7.3.1)
Determine of responsibilities and

authorities (7.3.1)
Design / development inputs (7.3.2)
Design / development outputs (7.3.3)
Phases of Design / development review(7.3.4)

the develop- Design / development changes (7.3.7)
ment
process Design / development verification (7.3.5)
Design / development validation (7.3.6)
Assessment of product
realization
Product:
Market: Customer:
requirements
reaction satisfaction
criteria
analysis appreciation
specifications
7.1 PLANNING OF PRODUCT REALIZATION no matter how many steps are involved, has
carefully planned and documented procedures
The standard ISO 9001 requires that the and that adequate check points have been
organization identifies and plans the designated throughout the process so as to
production, installation, and servicing verify that the end product will be of
processes which directly affect quality. Each satisfactory quality.
step of the production process follows a
predetermined plan. It expects that the process,
7.1.1 Process Control Model
PROCESS QUALITY PRODUCT QUALITY

CONTROL CONTROL
Information Information
Action on the Action on the
about the about the
process product
process product
People Equipment Materials
The Process The Product
Methods Environment Measurement
The organization shall plan and develop the • quality objectives and requirements for the
processes needed for product realization. product
Planning of product realization shall be
• the need to establish processes, documents,
consistent with the requirements of the other
and provide resources specific to the
processes of the quality management (see
product
section 4.1).
• required verification, validation,
In planning product realization, the monitoring, inspection and test activities
organization shall determine the following, as specific to the product and the criteria for
appropriate: product acceptance
• records needed to provide evidence that the • inspection or Quality Assurance checks
realization processes and resulting product during and after appropriate steps or key
meet requirements ( see section 4.2.4). stages in the process.
All processes that affect the quality of the In general all processes and controls are
product or of the service that the organization continually reviewed. It is expected that over a
to meet its contractual obligations (or the period of time, they will be modified, either to
implied contractual needs or requirements of its improve the standard of workmanship, to meet
customers) carry out under management new or additional customer requirements, to
control which include: maintain the lead over competitors or to meet
• formally documented, controlled and new legislation.
authorised operating procedures; also where
required appropriate checklists, proformas,
record books, etc.; 7.2 CUSTOMER-RELATED PROCESSES
• where found to be appropriate or necessary,
7.2.1 Determination of Requirements
additional work instructions or possibly
Related to the Product
quality plans; these may include one-off
instructions to cater for specific contract
The organization must determine the
conditions, reworks, etc.; all such
requirements of the customer regarding the
instructions will be formally documented,
product or the service before it bid an offer or
identifiable to the process/or contract, be
accept a contract or an order. The organization
signed for authorisation and dated;
shall determine:
• specifying where necessary experienced or
• requirements specified by the customer,
trained staff, appropriate tools, instruments,
including the requirements for delivery and
equipment and also the materials and
post-delivery activities
components required;
• requirements not stated by the customer but
• definition of acceptable standard of
necessary for specified or intended use,
workmanship; where appropriate or
where known
desirable these may include drawings,
visual aids, photos, or comparative • statutory and regulatory requirements
representative standards of actual product; related to the product
such visual aids or comparative standards • any additional requirements determined by
will be carefully labelled, authorised and the organization.
controlled (or- placed in the controls of the
calibration system);
• additional process controls, verification, or 7.2.2 Review of Requirements Related to the
restrictions to trained operatives for critical Product
or 'special processes', in particular for those
which cannot be easily checked when the The organization shall review the
process is complete; requirements related to the product. This
review shall be conducted prior to the
organization’s commitment to supply a product standards, quality plans, reports,

to the customer (e.g. submission of tenders, customer surveillance, and concessions.
acceptance of contracts or orders, acceptance
of changes to contracts or orders) and shall Initial enquiries may be received by letter,
ensure that fax, telephone, e-mail, formal 'invitations to
• product requirements are defined tender', or personal contact. The initial enquiry
is logged e.g. into a contract register and
• contract or order requirements differing
reviewed according to documented procedures.
from those previously expressed are
resolved
A formal review is carried out before
• the organization has the ability to meet the submission of a tender and also on receipt of
defined requirements. every contract to ensure that:
- there are no unresolved discrepancies
Customers need confidence that the between any tender and proposed
organization’s tender was produced under contract
controlled conditions. In ensuring that the
contract requirements are adequately defined - all documents, specifications and
one should establish where applicable that: drawings stipulated within the contract,
or invitation to tender documents, are
- there is a clear definition of the purpose readily available and are of the correct
of the product or of the service issue; that any standards stipulated are
- the conditions of use are clearly practically achievable and can be met
specified - the company is able to meet all the
- the requirements are specified in terms requirements of the proposed contract, or
of the features that will make the has ensured outside capacity by certified
product or of the service fit for its sub-contractors
intended purpose - any additional requirements are
- the quantity and delivery are specified addressed with regards to 'customer
- the contractual requirements are supplied material' or 'verification by the
specified, including: warranty, payment customer of purchased material at
conditions, acceptance conditions, source'
customer supplied material, financial - if the proposed contract makes a
liability, legal matters, penalties, requirement to temporarily amend the
subcontracting, licenses, and design Documented Quality Management
rights System, that this is formally addressed
- the management requirements are and controlled
specified, such as points of contract, - all review of tenders and contracts are
program plans, work breakdown recorded in the contract register and are
structure, progress reporting, meetings, signed and dated.
reviews, interfaces
- the quality assurance requirements are Records of the results of the review and
specified, such as quality system actions arising from the review shall be
maintained (see 4.2.4). Each order or contract 7.3.1 Design and Development Planning
should be signed by a person authorised to
accept orders or contracts on behalf of the During the design and development planning,
organisation. A register should be maintained the organization shall determine:
of all contracts or orders and in the register • the design and development stages
indicate which were accepted and which
• the review, verification and validation that
declined.
are appropriate to each design and
development stage
Where product requirements are changed,
the organization shall ensure that relevant • the responsibilities and authorities for
documents are amended and that relevant design and development.
personnel are made aware of the changed
requirements. The organization shall manage the
interfaces between different groups involved in
design and development to ensure effective
7.2.3 Customer Communication communication and clear assignment of
responsibility.
The organization shall determine and
implement effective arrangements for The design and development plannings
communicating with customers in relation to: should identify:
• product information - the design requirements
• enquiries, contracts or order handling, - the design and development program
including amendments showing activities against time
• customer feedback, including customer - the work packages and names of those
complaints. who will execute them (work packages
are the parcels of work that are to be
handed out either internally or to
7.3 DESIGN AND DEVELOPMENT subcontractors)
- the work breakdown structure showing
Design and development of products will the relationship between all the parcels
be conducted in a model basin normally as a of work
scientific method, a technical solution or a test - the reviews to be held for authorizing
design. The result is an optimisation or a new work to proceed from stage to stage
awareness for design or construction of ships, - the resources in terms of finance,
propulsion systems and other. Services will be manpower, and facilities
conducted in the form of surveys, calculations
- the risks to success and the plans to
of profitability, help for reasons for decisions,
minimize them
test reports and other topics.
- the controls (quality plan or procedures
and standards) that will be exercised to
keep the design on course.
Design and development schedule as an - the special features and characteristics

example: which the customer requires the product
- design requirement review or service to exhibit
- conceptual design review - the constrains in terms of timescale,
- preliminary design review operating environment, or other factors
- critical design review - the standards with which the product or
service needs to comply
- final design review.
- the products or service with which it will
directly and indirectly interface, and
7.3.2 Design and Development Inputs their features and characteristics
- the documentation required of the design
The principal aim of design input is to output necessary to manufacture,
make sure that what the management or the procure, inspect, test, install, operate,
customer want from the product or service has and maintain a product or a service.
been adequately specified at the outset. The
design input should embrace every aspect of
the requirement and give consideration to the 7.3.3 Design and Development Outputs
factors and parameters that the service is to
meet, once it becomes part of the business. The standard ISO 9001 requires that the
outputs of design and development be provided
Inputs relating to product requirements in a form that enables verification against the
shall be determined and records maintained. design and development input and be approved
These inputs shall include: prior to release.
• functional and performance requirements
Design and development outputs shall:
• applicable statutory and regulatory
requirements - meet the input requirements for design
and development
• where applicable, information derived from
previous similar designs - provide appropriate information for
purchasing, production and for service
• other requirements essential for design and provision
development.
- contain or reference product acceptance
criteria
Design input requirements could be:
- specify the characteristics of the product
- the purpose of the product or service
that are essential for its safe and proper
- the conditions under which it will be use.
used
- the skills and category of those who will
use and maintain the product or service
- the countries to which it will be sold
7.3.4 Design and Development Review 7.3.6 Design and Development Validation
At suitable stages, systematic reviews of Design and development validation be

design and development shall be performed in performed in accordance with planned
accordance with planned arrangements like arrangements (see 7.3.1) to ensure that the
described in section 7.3.1 “Design and resulting product is capable of meeting the
Development Planning” requirements for the specific application or
- to evaluate the ability of the results of intended use. Records of the results of the
design and development to meet validation and any necessary actions shall be
requirements maintained (see 4.2.4).
- to identify any problems and propose
necessary actions. Design and development validation be
performed to ensure that product conforms to
The standard requires that participants at defined user needs and/or requirements:
each design review include representatives of - design validation follows successful
all functions concerned with the design and design verification
development stage being reviewed, as well as - validation is normally performed under
other specialist personnel as required. Records defined operating conditions
of the results shall be maintained. - validation is normally performed on the
final product, but may be necessary in
earlier stages prior to product
7.3.5 Design and Development Verification completion
- multiple validations may be performed if
Verification shall be performed in
there are different intended uses.
accordance with planned arrangements (see
7.3.1) to ensure that the design and
development outputs have met the design and
7.3.7 Control of Design and Development
development requirements. Records of the
Changes
results of the verification and any necessary
actions shall be maintained (see 4.2.4).
Design and development changes shall be
identified and records maintained. The changes
At appropriate stages of design, design and
shall be reviewed, verified and validated, as
development verification shall be performed to
appropriate, and approved before
ensure that the design stage output meets the
implementation.
design stage input requirements:
Records of the results of the review of
- recording design verification measures changes and any necessary actions shall be
- alternative design calculations maintained (see 4.2.4):
- comparing similar designs - identification of design and development
- undertaking tests and demonstrations changes
- reviewing design stage documents - identification of modifications
before release.
- documenting design and development selection, evaluation and re-evaluation shall be

changes established. Records shall be maintained.
- documenting modifications
Evaluation of subcontractors:
- review and approval of design and
development changes - evaluation and selection of
subcontractors
- review and approval of modifications.
- purchasing from approved
subcontractors
7.4 PURCHASING - control of subcontractors
- defining subcontractor controls
As bought-in materials or services have a - selecting the degree of control
direct affect on the output of the company, the
selection of suppliers or subcontractors is of - records of acceptable subcontractors.
obvious importance. Of equal importance is
that the staff of the company correctly specify
the exact requirements. 7.4.2 Purchasing Information
The procedures controlling the selection of Purchasing information shall describe the
suppliers and for purchasing are mandatory for product to be purchased, including:
the procurement of all products or services that • requirements for approval of product,
affect the quality of the product or service. The procedures, processes and equipment
organization shall establish and maintain • requirements for qualification of personnel
records of acceptable subcontractors. The
• quality management system requirements.
records may include:
- details of each order placed
The organization shall ensure the adequacy
- the performance in supplying against of specified purchase requirements prior to
orders their communication to the supplier.
- control records
- information on defects Purchasing data can be:
- corrective actions. - product identification
- purchasing specifications
- subcontract quality management system
7.4.1 Purchasing Process requirements
- review and approval of purchasing
The organization shall ensure that
documents.
purchased product conforms to specified
purchase requirements. The organization shall
evaluate and select suppliers based on their
ability to supply products in accordance with
the organization’s requirements. Criteria for
7.4.3 Verification of Purchased Product Controlled conditions include too:

- Documented procedures which should
The organization establishes and define:
implements necessary inspection or other ∗ the qualifications required for the
activities and scrutinizes the purchased person carrying out the procedure, if
products or the services ensuring that any special qualifications are required
purchased products or the services meet ∗ the preparatory steps to be taken to
specified requirements. Results of verification prepare the product for processing
will be recorded and used for evaluation of the ∗ the preparatory steps to be taken to
subcontractors. set up any equipment
∗ the steps to be taken to process the
Possible verification can be too: product
- verification of organization at ∗ the precautions to observe
subcontractor's premises ∗ the settings to record.
- customer verification of subcontracted
product. - Suitable production, installation, and
servicing equipment, and a suitable
working environment.
7.5 PRODUCTION AND SERVICE ∗ documentation from the standards
PROVISION that are to be maintained
∗ providing training for staff
7.5.1 Control of Production and Service ∗ providing procedures for maintaining
Provision the equipment to these standards
∗ maintenance of records of the
The organization shall plan and carry out conditions as a means of
production and service provision under demonstrating that the standards are
controlled conditions. Controlled conditions being achieved.
shall include, as applicable:
• the availability of information that - Compliance with reference
describes the characteristics of the product standards/codes, quality plans and/or
• the availability of work instructions, as documented procedures
necessary - Monitoring and control of process
parameters and product characteristics
• the use of suitable equipment
- Approval of processes and equipment
• the availability and use of monitoring and - Workmanship criteria, can comprise:
measuring devices ∗ a list of the equipment upon which
• the implementation of monitoring and process capability depends
measurement ∗ defined maintenance requirements
• the implementation of release, delivery and specifying maintenance tasks and
post-delivery activities. their frequency
∗ a maintenance program that schedules 7.5.2 Validation of Processes for Production

each of the maintenance tasks on a and Service Provision
calendar
∗ procedures defining how specific Such processes of production and service
maintenance tasks are to be provision requiring pre-qualification of their
conducted process capability are frequently referred to as
∗ procedures governing the special processes. The standard defines special
decommissioning of plant prior to processes as processes, the results of which
planned maintenance cannot be fully verified by subsequent
∗ procedures governing the inspection and testing of the product and
commissioning of plant following where, for example, processing deficiencies
planned maintenance may become apparent only after the product is
∗ procedures dealing with the actions in use. The standard ISO 9001 requires special
required in the event of equipment processes to be carried out by qualified
malfunction operators and/or continuous monitoring and
∗ maintenance logs which record both control of process parameters to ensure that the
the preventive and corrective specified requirements are met.
maintenance work carried out.
Validation shall demonstrate the ability of
these processes to achieve planned results. The
7.5.1 ITTC Recommended Procedures organization shall establish arrangements for
these processes including:
ITTC Recommended Procedures as a rule • defined criteria for review and approval of
are descriptions of special processes for towing the processes
tanks and hydrodynamic facilities. All the • approval of equipment and qualification of
adopted recommended procedures and personnel
summary descriptions of bench mark data and
• use of specific methods and procedures
test cases since 1955 are contained in the
ITTC-Recommended Procedures. Additionally, • requirements for records
the respective list of parameters, • revalidation.
recommendations of the ITTC for some of the
parameters, the corresponding benchmark tests, Within the quality management system a
validation procedures, and uncertainty analyses list should be produced and maintained of all
have been added, if mentioned in the processes that have been qualified and a list of
proceedings. The ITTC-Recommended the personnel who are qualified to operate
Procedures should be used as reference for them. The records of qualified personnel using
basic internal procedures and work special processes should be governed by the
instructions. training requirements covered in section 6.2.2.
7.5.3 Identification and Traceability measurement requirements. The requirements

for inspection and test status are identification
Where it is appropriate it should be possible requirements that enable conforming product to
for a company to trace any product back be distinguishable from nonconforming
through the manufacturing or testing process to product. Inspection and test status is either
the specifications and drawings. The ‘reject’ or ‘accept’. If not fully conforming the
organization shall establish and maintain product should be rejected and identified as
documented procedures where appropriate for such. If conforming the product should be
identifying the product by suitable means from accepted and identified as such.
receipt and during all stages of production,
delivery, and installation. The identification of inspection and test
status shall be maintained, as defined in the
Documented procedures are needed where quality plan and/or documented procedures,
the product identity is not inherently obvious. throughout production, installation and
Procedures for identifying product should start servicing of the product to ensure that only
at the design stage when the product is product (report, software) that has passed the
conceived. The design should be given an required inspections and tests is dispatched,
unique identity, a name or number, and that used or installed.
should be used on all related documents. Apart - define and document what inspections
from the name or number given a product you are to be carried out
need to identify the version and the
modification state so that you can relate the - define what constitutes an acceptable
issues of the drawing and specifications to the item
products they represent. - list who is authorised to do the
inspections
The organization shall where, and to the - carry out the inspections and identify
extent that traceability is a specified who did them
requirement, establish and maintain - place the Test Status on the item itself if
documented procedures for unique at all possible
identification of individual product or batches
- reject those which failed the test criteria
and goes on to require this identification to be
recorded. Traceability to the original - keep detailed records of fail or pass to
subcontractor’s material or document is not a form useful statistics
common requirement. But traceability is - review the failures for possible
important to control processes. You may need corrective and preventive action.
to know which products have been through
which processes and on what date, if a problem
is found some time later. The same is true of 7.5.4 Customer Property
test and measurement equipment.
Customer property are materials, services,
The organization shall identify the product or intellectual property provided by the client,
status with respect to monitoring and and are the property of the client. The materials
are needed to supply the product or service and
are either built into the product or service, or damage or deterioration. These are important
are needed as a related activity or, in the case especially for:
of documents to provide information. - measuring and test equipment
- products (models)
The organization shall exercise care with
customer property while it is under the - customer supplied products.
organization’s control or being used by the
organization. The organization shall identify, In order to detect deterioration, the
verify, protect and safeguard customer property condition of equipment and products shall be
provided for use or incorporation into the assessed at appropriate intervals. If necessary
product, by: the organization should:
- receipt inspection to check that the items - control packing, packaging and marking
agree with any information supplied by processes to the extent necessary to
the customer; ensure conformance to specified
requirements
- identification to ensure that the items are
not inadvertently used on the wrong - apply appropriate methods for
contract or work; preservation and segregation of product
when the product is under the
- any shortages or damage identified is organization’s control
reported in writing immediately to the
customer; - arrange for the protection of the quality
of product after final inspection and test.
- checks and precautions as required, to
protect and prevent deterioration;
- any defective material received, or 7.6 CONTROL OF MONITORING AND
arising during processing or excess MEASURING DEVICES
material left over at the end of the
contract will be returned to the client, The integrity of products depend upon the
unless formal written authority is quality of the devices used to create and
received for disposal. measure their characteristics. ISO 9001
specifies requirements for ensuring the quality
of such devices. If the devices used to create
7.5.5 Preservation of Product and measure characteristics are inaccurate,
unstable, damaged, or in any way defective
The organization shall preserve the then the product may not possess the required
conformity of product during internal characteristics.
processing and delivery to the intendent
destination. This preservation shall include Devices that one used for product
identification, handling, packaging, storage and verification at all stages in the quality loop
protection. need to be controlled and this includes devices
used for inspection and test on receipt of
The organization shall provide methods of product, in-process, and final acceptance
handling product and storage that prevent before release to the customer. It also includes
devices used during design and development • be protected from damage and deterioration
for determining product characteristics and for during handling, maintenance and storage.
design verification. Some characteristics
cannot be determined by calculation and have Control of monitoring and measuring
to be derived by experiment. In such cases the devices in this instance can mean several
accuracy of the used devices must be things, for example:
controlled.
- knowing where the equipment is located
so that one can recall it for calibration
The organization shall determine the
and maintenance
monitoring and measurement to be undertaken
and the monitoring and measuring devices - knowing what condition the equipment
needed to provide evidence of conformity of is in so that one can prohibit its use if the
product to determined requirements. The condition is unsatisfactory; one will need
organization shall establish and maintain a defect report for this purpose
documented procedures to control, calibrate, - knowing when the instrument’s accuracy
and maintain inspection, measuring, and test was last checked so that there can be
equipment including test software. confidence in its results; calibration
records and labels fulfil this need
Procedures for the control, calibration, and - knowing what checks have been made
maintenance of measuring devices will need to using the instrument since it was last
cover the various types of devices employed checked, so that one can repeat them
for measurement purposes, such as: should the instrument be subsequently
- electronic measuring equipment found out of calibration
- mechanical measuring devices - knowing that the measurements made
- test software using the instrument are accurate so that
- forming tools and equipment. one can rely on the results; a valid
calibration status label will fulfil this
Where necessary to ensure valid results, purpose
measurement equipment shall: - knowing that the instrument is only
• be calibrated or verified at specified being used for measuring the parameters
intervals, or prior to use, against for which it was designed, so that results
measurement standards traceable to are reliable and equipment is not abused.
international or national measurement
standards; where no such standards, the In addition to calibrating the devices one
basis used for calibration or verification will need to carry out preventive and corrective
shall be recorded maintenance in order to keep them in good
condition. Preventive maintenance is
• be adjusted or re-adjusted as necessary maintenance to reduce the probability of
• be identified to enable the calibration status failure, such as cleaning, testing, inspecting
to be determined etc. Corrective maintenance is concerned with
• be safeguarded from adjustments that restoring a device after a failure has occurred
would invalid the measurement result
to a condition in which it can perform its When used in the monitoring and
required function. measurement of specified requirements, the
ability of computer software to satisfy the
Calibration operations included: intended application shall be confirmed. This
- calibration against certified equipment shall be undertaken prior to initial use and
- documenting the basis for calibration reconfirmed as necessary.
- defining the calibration process
- indicating calibration status
- maintaining calibration records. 7.6.1 Work Instructions in the ITTC-
Recommended Procedures
Protection of measuring equipment
included: For test laboratories the control of
- ensuring that environmental conditions inspection, measuring and test equipment is of
are suitable vital importance. Therefore several working
- ensuring that accuracy and fitness for instructions were prepared by the ITTC Quality
use is maintained Systems Group describing the most important
- safeguarding inspection, measuring, and aspects of this task which are contained in the
test equipment. ITTC-Recommended Procedures. The purpose
of these working instructions is to ensure that
Records for control of monitoring and the measuring equipment used in standard tests
measurement devices are quality documents. is efficient and its metrological characteristics
The results of calibration and verification shall ensure test results with the intended accuracy.
be maintained like described in section 4.2.4 These working instructions are to be
"Control of Records". considered as examples.
Responsibility
Quality Tasks
c d e f
Planning of product realisation D A A A
Determination and review of requirements related to the product D I I E
Customer communication D E E E
Design and development planning and inputs D A A A
Review, verification and validation of design and development outputs D I I E
Purchasing of products E A I A
Control of Production and service provision D A I E
Identification and traceability D E E E
Handling and exercise with customer property D A I E
Control of monitoring and measurement devices D I A E
etc. ... ... ... ...
Measurement, Analysis and Improvement
09/2002 01
8. MEASUREMENT, ANALYSIS AND IMPROVEMENT
CONTENTS
8.1 GENERAL
8.2 MONITORING AND MEASUREMENT
8.2.1 Customer Satisfaction
8.2.2 Internal Audit
8.2.3 Monitoring and Measurement of Processes
8.2.4 Monitoring and Measurement of Product
8.3 CONTROL OF NONCONFORMING PRODUCT
8.4 ANALYSIS OF DATA
8.5 IMPROVEMENT
8.5.1 Continual Improvement
8.5.2 Corrective Action
8.5.3 Preventive Action
8. 6 RESPONSIBILITY IN GENERAL
Name Name Name

Date Date Date
09/2002 01
8 MEASUREMENT, ANALYSIS AND IM- system, the organization shall monitor

PROVEMENT information relating to customer perception as
to whether the organization has met customer
requirements.
8.1 GENERAL
The measurement and monitoring of the
The organization shall plan and implement customer satisfaction are based on the
the monitoring, measurement, analysis and evaluation of customer’s information, which
improvement processes needed: can be collected actively or passively. The
• to demonstrate conformity of the product methods for obtaining and using this
• to ensure conformity of the quality man- information shall be determined.
agement system
• to continually improve the effectiveness of
the quality management system. 8.2.2 Internal Audit
This shall include determination of In evaluating the effectiveness of a quality

applicable methods, including statistical management system, audits are an important
techniques, and the extend of their use. element. Audits may be conducted by, or on
behalf of, the organization itself (internal
Deviations become promptly detected by quality audit), its customers, or independent
planned monitoring, measurement, analysis and bodies.
improvement before, while and after the
service contribution or the product creation. If The standard requires that the organization
necessary corrective actions are arranged. The shall conduct internal audits at planned
executed checks should be adapted at the intervals to determine whether the quality
sequence in the work areas. The later the check management system
the more costly the rework. But type and scope • conformed to the planned arrangements, to
of activities of the checks must be the requirements of ISO 9001 and to the
economically justifiable. The application of quality management system requirements
statistical methods is possible only in very established by the organization, and
limited measure for a ship model basin because • is effectively implemented and maintained.
performance essentially consists of scientific-
technical performances and products in one-off Procedures for both planning and
production. implementing internal audits should exist and
these should cover the following:
- preparing an annual audit program
8.2 MONITORING AND MEASUREMENT
- the selection of auditors and a team
8.2.1 Customer Satisfaction leader if necessary
- planning audits of each type
As one of the measurements of the - conducting the audit
performance of the quality management
09/2002 01
- recording observations three actions which the responsible manager

- determining corrective actions should take:
- reporting audit findings - remedial action to correct the particular
nonconformity
- implementing corrective actions
- research for other examples of
- confirming the effectiveness of correc-
nonconformity and to establish how
tive actions
widespread the problem is
- the forms on which you plan the audits
- establish the root cause of the
- the forms on which you record the ob- nonconformity and prevent its
servations and corrective actions. recurrence.
The standard requires that the selection of Follow-up audit activities shall verify and
auditors and the conduct of audits shall ensure record the implementation and effectiveness of
objectivity and impartiality of the audit the corrective action taken.
process. Auditors shall not audit their own
work. To ensure their independence, auditors
need not be placed in separate organizations. 8.2.3 Monitoring and Measurement of
Although it is quite common for quality Processes
auditors to reside in a quality department it is
by no means essential. There are several ISO 9001 requires that the organization
solutions: apply suitable methods for monitoring and
- Auditors can be from the same measurement of the quality management
department as the activities being processes.
audited, provided they are not
responsible for the activities being For the evaluation of the effectiveness of
audited. the quality management processes may be
- Separate independent quality audit executed on the internal audit a self-assessment
departments could be set up, staffed with for selected areas of the organization by top
trained auditors. management following the standard DIN EN
ISO 9004 Appendix A. The evaluation of the
The responsibilities and requirements for requirements and expectations of the interested
planning and conducting audits, and for parties are to be the centre of attention like
reporting results and maintaining shall be
defined in a document procedure. - abilities of the organization
- response time to inquiries
The audit report should state the results of
the audit, what was found compliant as well as - use of technologies
what was found noncompliant. The - input-output ratio.
management personnel responsible for the area
shall take timely corrective action on
deficiencies found during the audit. There are
09/2002 01
8.2.4 Monitoring and Measurement of Prod- on before and the other one is accepting the
uct product or service.
In agreement with the planned regulations Final inspection and test checks should de-
in the quality management manual chapter 7.1 tect whether:
"Planning of Product Realization" in suitable - all previous inspections and checks have
phases of the product realization or service been performed
provision checks are executed. Recordings of - the product (draft, drawing, program
these checks are created in accordance with etc.) bears the correct identification, part
quality management manual chapter 4.2.4 numbers, serial numbers, modification
"Control of records". status etc.
Type and scope of the monitoring and - all recorded non conformances have
measurement of product as well as the compe- been resolved and remedial action taken
tencies for execution and the evaluation of the and verified
results are to be determined. - all concession applications have been
approved
The product monitoring and measurement - all inspection and test results have been
plans should: collected
- identify the product to be inspected and - all documentation to be delivered with
tested the product or service has been produced
- define the specification and acceptance and conforms to the prescribed stan-
criteria to be used and the issue status dards.
which applies
- define the inspection aids and test No product shall be dispatched until all the
equipment to be used; standard measur- activities specified in the quality plan and/or
ing equipment would not need to be documented procedures have been satisfacto-
specified as your inspectors and testers rily completed and the associated data and
should be trained to select the right tools documentation are available and authorized.
for the job; any special equipment
should be identified
8.3 CONTROL OF NONCONFORMING
- define the environment for the measure-
PRODUCT
ments to be made if critical to measure-
ment accuracy
A nonconforming product is one that does
- identify the organization which is to per- not conform to the specified requirements.
form the inspections and tests Specified requirements are either requirements
- make provision for the results of the in- prescribed by the customer and agreed by the
spections and test to be recorded. organization in a contract for products or ser-
vices, or are requirements prescribed by the
Final inspection is the last inspection of the organization which are perceived as satisfying
product or service. There are two aspects to a market need.
final inspection. One is checking what has gone
09/2002 01
The standard ISO 9001 requires that the or-

ganization ensures that products which do not Records of the nature of nonconformities
conform to product requirements are identified and any subsequent actions taken, including
and controlled to prevent their unintended use concessions obtained, shall be maintained (see
or delivery. 4.2.4).
The top management should empower peo-

ple in the organization with the authority and 8.4 ANALYSIS OF DATA
responsibility to report nonconformities at any
stage of a process in order to ensure timely The organization determines, collects and
detection an disposition of nonconformities. analyses appropriate data to demonstrate the
Authority for response to nonconformities suitability and effectiveness of the quality man-
should be defined to maintain achievement of agement system and to evaluate.
process and product requirements. The organi-
zation should effectively and efficiently control The analysis of data shall provide informa-
nonconforming product identification, segregation relating to
tion and disposition in order. The controls and - customer satisfaction (see 8.2.1)
related responsibilities and authorities for deal-
- conformity to product requirements and
ing with nonconforming product shall be de-
service requirements (see 7.2.1)
fined in a document procedure.
- characteristics and trends of processes
The organization shall deal with noncon- and products including opportunities for
forming product by one or more of the follow- preventive action
ing ways - evaluation of suppliers
• by taking action to eliminate the detected - market-analysis.
nonconformity
• by authorizing its use, release or acceptance
8.5 IMPROVEMENT
under concession by a relevant authority
and, where applicable, by the customer
8.5.1 Continual Improvement
• by taking action to preclude its original in-
tended use or application The organization continually improves the
effectiveness of the quality management sys-
Nonconforming product shall be reviewed tem through the use of the quality policy, qual-
in accordance with documented procedures. It ity objectives audit results, analysis of data,
may be: corrective and preventive actions and manage-
- reworked to meet the specified requirement review.
ments, or
- accepted with or without repair by con- The requirements for quality improvement
cession, or can be related to any aspect such as effective-
- regarded for alternative applications, or ness, efficiency or traceability.
- rejected or scrapped.
09/2002 01
Model of a process-based quality management system
8.5.2 Corrective Action

Non-conformities are caused by one or
The organization shall take action to elimi- more of the following:
nate the cause of nonconformities in order to - deficiencies in communication
prevent recurrence. A documented procedure - deficiencies in documentation
shall be established to define requirements for
- deficiencies in personnel training and
• reviewing nonconformities (including cus- motivation
tomer complaints)
- deficiencies in materials
• determining the causes of nonconformities
- deficiencies in tools and equipment
• evaluating the need for action to ensure that
- deficiencies in the operating environ-
nonconformities do not recur
ment
• determining and implementing action - deficiencies in calibration of test equip-
needed ment.
• records of the results of action taken (see
4.2.4) In pursuing corrective actions, the
• reviewing corrective action taken. organization identifies sources of information,
09/2002 01
and collects information to define the necessary 8.5.3 Preventive Action

corrective actions. The defined corrective
actions are focused on eliminating causes of The organization shall determine actions to
nonconformities in order to avoid recurrence. eliminate the causes of potential
Examples of sources of information for nonconformities in order to prevent their
corrective action consideration include: occurrence. A documented procedure shall be
- customer complaints established to define requirements for
- nonconformity reports - determining potential nonconformities
- internal audit reports and their causes
- outputs from management review - evaluating the need for action to prevent
- outputs from data analysis occurrence of nonconformities
- outputs from satisfaction measurements. - determining and implementing action
needed
- relevant quality management system
records - records of results of action taken (see
4.2.4)
- the organization’s people
- reviewing preventive action taken.
- process measurements
- results of self-assessment. Results of the evaluation of the
effectiveness and efficiency of the preventive
action should be an output from management
review, and should be used as an input for the
modification of plans and as an input to the
improvement processes.
09/2002 01
8. 6 RESPONSIBILITY IN GENERAL
Responsibility
Quality Tasks
c d e f
Planning of monitoring and measurement D I A E
Measurement and monitoring of customer satisfaction A A A A
Planning and conducting of audits A A E A
Monitoring and measurement of processes D E I E
Monitoring and measurement of product D I I E
Control of nonconforming product D E I E
Analysis of data D E I E
Corrective and preventive action D E I E
etc. ... ... ... ...

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The Quality Manual is property of company’s name

ITTC Sample Quality Manual System was changed to Quality Management

3 Terms and definitions

4 Quality management system

8 Measurement, analysis and improvement

Prepared, verified and approved

Application and ITTC–Recommended Procedures as

3 Glossary of terms 09/2002 01 5

4 Quality management system 09/2002 01 8

5 Management responsibility 09/2002 01 9

6 Resource management 09/2002 01 4

7 Product realization 09/2002 01 16

8 Measurement, analysis and improvement 09/2002 01 8

Prepared Verified Approved

Name Name Name

Compared to ISO 9001/9002:1994 the A primary concern of any organisation

Prepared Verified Approved

Name Name Name

2.1 QUALITY service, and hence affect the manner in which

Prepared Verified Approved

Name Name Name

Audit Systematic, independent and documented process for obtaining audit

Benchmarking A technique for measuring an organisation’s products, services, and

Capability Ability of an organization, system or process to realize a product that

Certification The authoritative act of documenting compliance with agreed

Competence Demonstrated ability to apply knowledge and skills.

Prepared Verified Approved

Name Name Name

listings) and also covers any associated specifications, inspection

Contract An agreement formally executed by both customer and organisation

Conformity The fulfilment of a specified requirement by quality characteristic of

Corrective action Action to eliminate the cause of a detected nonconformity or other

Customer Organisation or person that receives a product.

Customer satisfaction Customer’s perception of the degree to which the customer’s

Design A process of originating a conceptual solution to a requirement and

Design review A formal documented comprehensive and systematic examination of a

Evaluation To ascertain the relative goodness, quality, or usefulness of an entity

Inspection The inspection of an entity to determine whether it conforms to

Instruction The written and/or spoken direction given in regard to what is to be

ISO The International Standard Organisation. It is the specialised

Measuring equipment Measuring instrument, software, measurement standard, reference

Organisation Group of people and facilities with an arrangement of responsibilities,

Preventive action Action to eliminate the cause of a potential nonconformity or other

Procedure Specified way to carry out an activity or a process. A sequence of

Process Set of interrelated or interacting activities which transforms inputs

Process capability The ability of a process to maintain product characteristics within

Product Result of a process.

Quality Degree to which a set of inherent characteristics fulfils requirements.

Quality manual Document specifying the quality management system of an

Quality policy The overall quality intentions and direction of an organisation as

Quality records Objective evidence of the achieved features and characteristics of a

Quality system The organisation structure, responsibilities, activities, resources and

Requirement A need or expectation that is stated, generally implied or obligatory.

Review Activity undertaken to determine the suitability, adequacy and

Rework Action on a nonconforming product to make it conform to the

System Set of interrelated or interacting elements.

Traceability Ability to trace the history, application or location of that which is

Validation Confirmation, through the provision of objective evidence that the

Verification Confirmation, through the provision of objective evidence that

4 QUALITY MANAGEMENT SYSTEM

Prepared Verified Approved