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QUALITY MANAGEMENT SYSTEM

MANUAL

ISO 9001:2015
REV DATE REASON FOR REVISION REQUESTED BY
4 30/10/2013 Annual Revision of Manual KV
5 13/11/2017 Document transition to ISO 9001:2015 Standard MvD
6 05/08/2019 Update combined Logo to include ISO 45001:2018 KV
7 07/01/2020 Annual Review MvD

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OUR MISSION, QUALITY POLICY, AND VALUES & BELIEFS

1. MISSION STATEMENT

1.1. Quality Policy

The Managing Director of Iritron, whose principal operating company is Iritron, has committed the company to the
establishment and maintenance of a Quality Management System. Attention is drawn to the possibility that some
of the elements of this document may be the subject of patent rights.

o The Iritron Quality Policy statement is designed to provide the following:

“Get it right first time every time.”

o The Quality objectives are the following:

To meet and exceed customer expectations.

To achieve the objectives stated, it is the policy of Iritron to establish and maintain a comprehensive Quality
Management System, which is planned, developed and continuously improved in conjunction with other
management functions to meet the requirements of DIN EN ISO 9001:2015. The policies, systems, responsibilities
and authorities as defined in this quality policy manual, will be effective and binding from the date of approval by
the Managing Director.

The design and implementation of the Iritron quality management system is influenced by Iritron’s environment
changes and the risks associated with that environment, related to:

External issues, such as:

o Political stability in the countries in which activities are performed, and where products and services
are supplied.
o Cultural and religious issues related to countries abroad.
o Legal requirements in the countries in which activities are performed, and where products and services
are supplied.
o Political stability in South Africa, determined in terms of legislative requirements, related to local,
municipal, provincial and national structures.
o Economic stability, both in South Africa, and in countries abroad, linked to risks associated to
fluctuating financial markets, and rates of exchange.
o Changes in the personnel of clients.
o Changes in product and service requirements, as defined by clients.
o Risks related to the performance of service providers, suppliers and contracted processes.
o The performance of the opposition, in terms of financial and performance considerations.

Internal issues, such as:

o the competence of employees
o lack of specific skills, or competence, related to products, or the specific client working environment
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o The availability of resources, in terms of personnel and their availability.

o The ability of personnel to interact with clients, on a level which supports business co-operation.
o Appropriate financial management in terms of business stability, sustainability and future growth,
monitoring of processes, and the performance of individuals.
o Iritron’s varying needs.
o Iritron’s particular objectives.
o The products we provide.
o The processes that we employ.
o Our size and the organizational structure.
o The risks associated to the supply of products and services by Iritron, are managed by top
management, on a project related basis, with regular review of potential impacts, and actions taken to
address and minimise their effect, undertaken by the top management structure of Iritron, and the
applicable project management teams.

It is not the intent of this International Standard to imply uniformity in the structure of our quality
management system or uniformity of documentation.

1.2. Our Values and Beliefs

o Maintain complete Integrity in all our actions.

o Work in partnership with our customers to enhance their respect and loyalty, by determining,
understanding and acting upon, their specific needs and expectations. Customers is important to
the organization, but there are also other interested parties, affected by the performance, and
sustainability of Iritron, these being:

Customers and end users -

▪ Who require a product or service to be delivered in terms of their stated requirements.
▪ Who require the performance of products and services, to a stated period, or level of
performance, or both supplying insight into their future developments, and the adapting of
existing technology to meet new requirements, by offering the following services to clients:
o by applying a suite of tools and technologies to optimally address the customer’s specific
requirements
o by offering a wide range of project services delivery models, including turnkey, EPCM and
single-phase project segments
o electrical, instrumentation and control system engineering, design and consulting services,
including tendering and contract preparation, preliminary design, engineering and detailed
design, programming, manufacturing, acceptance testing, installation, commissioning, hand-
over and optimization, through the emphasis on adequate and appropriate project
management, design reviews, quality control and configuration management
o structured project execution as per the International Society of Automation (ISA) and SABS
ISO 9001:2015 methodologies
o plant automation audits

o process simulation, enabling rapid implementation and faster return on investments
o after sales service and support contracts
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o shareholders / top management of the organization

o financial performance of the organization
o high level of reputation of the organization
o operational performance of the organization
o sustainability of the organization
o confidence in the competence of employees
o adherence to statutory and regulatory requirements
o employees of the organization
o sustainability of the organization
o career growth and increasing levels of competence and exposure
o career and job satisfaction

o working environment, conducive to mental and emotional well-being, void off any form of
prejudice and harassment
o family members of employees
o sustainability of the organization, with a stable income
o work and employment stability
o working environment, conducive to mental and emotional well-being, void of any form of
prejudice and harassment
o Maintain a participatory environment; rely on the innate excellence of our People and provide a system
in which they can excel.
o Help our People achieve their full potential through continuous education, training and recognition of
exemplary performance.
o Make data-driven decisions that will maximize our opportunities for success.
o Recognize our responsibility as good citizens and good neighbors of the communities in which we
operate.
o Maintain beneficial supplier partnerships to assure that our needs and expectations for products and
services are met.
o Maintain a passion for Continuous Improvement and continuously improve our processes, products
and services.

2. SCOPE

2.1 General

Iritron specialises in the Engineering Design, Manufacturing, Supply, Installation, Commissioning and
Maintenance of Electrical, Instrumentation, Control and simulation Systems, as defined on the scope of
certification, referenced on the ISO 9001:2015 certificate, issued by TUV Rheinland. The Head Office is
situated in Pretoria.

The boundaries of the scope of the quality management system, and of certification, is defined by a
number of factors, such as:

• The fields of expertise of employees in the organisation, in terms of:

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o design and engineering

o electrical systems
o MV (Medium voltage up to 22kV)
o LV (Low voltage up to 1 kV)
o Instrumentation systems
o Control systems
o Management Information Systems (MIS)
o Manufacturing Execution Systems (MES)
o software development and systems integration
o DCS systems
o PLC systems
o SCADA systems
o Information and data historian systems
o simulation
o Factory Acceptance Test (FAT) simulation
o I/O and sequence control
o Dynamic simulation, rule-based simulation
o Event-based simulation
o Engineering and training simulators
o design based tools
o Electrical and instrumentation
o 1Des
o DAD
o AutoCAD
o INtools
o Microstation 3D

• Historical experience with the following equipment and processes:

o Air compressors
o Belt filters / filter presses
o Beneficiation plants
o Cable / wire plants
o Centrifugal compressors
o Chemical and flocculent dosage plants
o Clarifier control systems
o Crushers
o Control of density, temperature, pressure, flow, etc.
o Dewatering plants
o Distillery plants
o Dust suppression plants
o Filter presses
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o Flotation processes
o Furnaces and kilns
o Leaching, roaster, acid and evaporation processes
o Load out stations
o Material handling equipment (conveyors, etc.)
o Mills
o Power factor correction systems
o Power optimisation
o Power reticulation
o Power utility project management
o Protection and control
o Pumps and motors
o Sampling / batching systems
o Stackers / reclaimers / stock piling systems
o Thickener plants
o Weigh bridges / mass measurement
o Wet screening plants.

2.2 Permissible Exclusions

There are no clauses of the ISO 9001:2015 International Standard, which are deemed not to be
applicable to the scope of the implemented quality management system of Iritron.

3. NORMATIVE REFERENCES
The following document is indispensable for the application of this document. For dated references,
only the edition cited applies. For undated references, the latest edition of the reference document
(including any amendments) applies. ISO 9001:2015, Quality Management Systems – Fundamentals and
Vocabulary

4. IRITRON & OUR PRODUCTS

Terms and Definitions
For the purpose of this document, the terms and definitions given in ISO 9001 apply. Throughout the
text of this QMS, wherever the term “product occurs, it can also mean “service”.

Our ISO 9001:2015 based Quality Management System (QMS) has been developed in complete
alignment with both our Continuous Improvement philosophy and our Management System. The QMS
is that part of the overall management system which implements our Quality Policy, establishes
procedures by which we meet or exceed customer expectations, and satisfies international system
requirements for ISO registration.

Iritron’s modern facilities are situated at:

HEAD OFFICE:
Units 2, 3, 5a, 5b and 6 Persequor Close
49 de Havilland Crescent
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Persequor Techno Park

Meiring Naude Road
Lynnwood
0040
Pretoria
Gauteng
Republic of South Africa

Iritron has an extensive track record of successes in the fields of Plant Automation, Simulation,
Optimization and Information Systems and has more than 200 years of combined engineering
experience in these fields, focusing mainly on mineral processing and related industries. We have
proven our ability to manage projects efficiently and to produce high quality results.

Iritron is capable of handling projects that span all layers of the automation hierarchy and applies a
suite of tools and technologies to optimally address the Customer’s specific requirements. Extensive
practical experience linked to a sound fundamental understanding of processes, mathematics, neural
networks and integrated hardware and software applications ensure viable and valid solutions.
Iritron offers its customers either a complete turnkey project service on Automation, Simulation,
Optimization and Information Systems for industrial plants or implementation of only a single segment
of a project:
o Tendering and Contract Preparation,
o Preliminary Design,
o Engineering and Detail Design,
o Programming,
o Manufacturing of Instrumentation Panels, Control System Panels and Electrical Switchgear.
o Factory Acceptance Testing,
o Installation,
o Commissioning,
o Hand-over.

During the phases Iritron takes responsibility for the Project Management, Quality Control and
Configuration Management on its portion of the project.

For a more in-depth profile please visit Iritron’s website at www.iritron.co.za

5. CONTEXT OF THE ORGANISATION - ISO 9001: 2015 Paragraph 4.0

5.1 Understanding the organization and its context ISO 9001: 2015 Paragraph 4.1
Iritron has established, documented, implemented and are maintaining a Quality Management System, and
are continually improving the effectiveness of the quality management system, to be consistent with the
requirements and stipulations of the ISO 9001: 2015 international standard. In implementing the quality
management system, Iritron has:

o identified the processes needed for the quality management system and has applied this to all

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functional activities of Iritron

o determined the sequence and interactions of these processes
o determined the criteria and methods needed to ensure that both the operation and control of these
processes are effective
o determined the sequence and interactions of these processes
o ensured the availability of resources and information necessary to support the operation, control
and monitoring of these processes
o monitored, measured, analysed and evaluated these processes
o implemented actions that are necessary to achieve planned results, and to ensure continual
improvement of these processes.
o identified risks and opportunities for improvement and implemented corrections.
o monitor and review information about external and internal issues
o processes evaluated and changes implemented to ensure that the processes achieve the intended
results

Any product / service / function that affects product conformity with requirements that are outsourced by
Iritron, will be subject to the exercising of control, at a relevant level, by Iritron. The extent of this control will
be identified within the quality management system and control over outsourced external providers form.

5.2 Understanding the needs and expectations of interested parties - ISO 9001: 2015 Paragraph 4.2
Due to their effect or potential effect on Iritron’s ability to consistently provide products and
services that meet customer and applicable statutory and regulatory requirements, Iritron
determines the following:
o interested parties that are relevant to the quality management system;
o requirements of these interested parties that are relevant to the quality management system.
.
5.3 Determining the scope of the quality management system ISO 9001: 2015 Paragraph 4.3
Iritron have established, and are maintaining, a Quality Policy Manual, which is a controlled
document that includes provision for the following:
o the scope of the quality management system of Iritron, as defined in paragraph 1 and 3 of this
document
o details and justifications of any requirements of the ISO 9001: 2015 international standard, as per
paragraph 1.0 of this document, deemed not to be applicable to the quality management system,
should there be any
o the documented procedures, in flow chart format, established for the quality management system.

The scope of the processes of the quality management system, is supported by the creation, and
maintenance, of applicable versions of documented information, defined in terms of a formal index.

5.4 Quality management system and it’s processes - ISO 9001: 2015 Paragraph 4.4
5.4.1 Iritron have established, documented, implemented and are maintaining a quality management system, and
are continually improving the effectiveness of the quality management system, to be consistent with the
requirements and stipulations of the ISO 9001: 2015 international standard. In implementing the quality
management system, Iritron have:
o identified the processes needed for the quality management system and has applied this to all
functional activities of Iritron
o determined the sequence and interactions of these processes
o defined the inputs and outputs expected from these processes, these being:
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o top management
o input
o investment in the creation, and sustainability of the organization
o strategic vision and future for the organization
o output
o employment opportunities for personnel
o a global market player in the supply of products and services, as defined in the
scope of the quality management system
o sales and marketing
o input
o requirements of clients, and other interested parties
o requirements related to business growth
o output
o exposure of the organization in the marketplace
o catalyst to business growth and expansion
o design and development and project management
o input
o client requirements related to:
o concept which needs to be put into practice
o client and product requirements
o upgrade requirements related to existing products, plant and
methodologies
o improvement of internal processes, competence and methodologies
o output
o tangible representation of the conversion of concept requirements, to
simulation models
o improvement of products and processes as well as process optimisation
o customer satisfaction
o purchasing
o input
o requirements for obtaining products or services from external providers
o assurance of the ability of external providers to supply products and services to
acceptable levels of quality
o output
o purchase orders
o information to be supplied to external providers
o list of approved external providers
o monitoring and measurement data related to the performance of external
providers
o stores and warehousing
o input
o management of raw materials (equipment) final products
o logistics management
o stock control and management, including product preservation
o output
o stock management criteria and improvement of cash flow processes
o dispatch and delivery
o operational processes
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o input
o client requirement for the supply of products and services
o product requirements defined in terms of design and development outputs
o quality assurance and quality control requirements
o output
o product which meets client requirements
o product which meets quality management system requirements
o human resources
o input
o statutory and regulatory requirements
o need to employee new personnel, based on organisational requirements
o improved competence of existing employees

o output
o recruitment and employment, related to:
o professional competence
o technical competence
o client products and / or requirements
o specialised knowledge related to the strategic objectives of the
organization
o training and skills development of employees
o professional competence
o technical competence
o client products and / or requirements
o specialised knowledge related to the strategic objectives of
the organization
o statutory training
o management system related training and awareness
o information technology
o input
o software licensing requirements
o need for retention of electronic data and documented information
o maintenance of the electronic infrastructure
o output
o maintaining legal software, and ensuring the use of only licensed software
packages
o maintaining back-up information, which can be effectively utilised for
restoration purposes
o maintaining the functionality of equipment, and the resolution of issues
arising from the use of electronic equipment, and their interfaces
o quality assurance and quality control
o input
o client requirements which need to form part of product characteristics
o monitoring and measuring interaction required by the organisation, and in
terms of quality management system requirements
o documented information required for the control and management of
operational processes, both internally and externally
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o output
o quality control plans
o inspection and release requirements
o information to be submitted to external providers
o confidence in the meeting of technical requirements by products and
services
o determined the criteria and methods needed to ensure that both the
operation and control of these processes are effective
o ensured the availability of resources and information necessary to support the
operation, control and monitoring of these processes
o monitored, measured, analysed and evaluated these processes
o implemented actions that are necessary to achieve planned results, and to
ensure continual improvement of these processes.
o identified risks and opportunities for improvement and implemented
corrections.
o monitor and review information about external and internal issues
o processes evaluated and changes implemented to ensure that the
processes achieve the intended results.

Any product/service/function that affects product conformity with requirements that are outsourced by
Iritron, will be subject to the exercising of control, at a relevant level, by Iritron. The extent of this control will
be identified within the quality management system and control over outsourced external providers
requirements.

5.4.2 Iritron maintains the necessary documented information to support the operation of all of it’s processes.
Iritron also retains documented information to have confidence that the processes are being carried out as
planned.

6.0 LEADERSHIP ISO 9001: 2015 Paragraph 5.0

6.1 LEADERSHIP AND COMMITMENT ISO 9001: 2015 Paragraph 5.1

6.1.1 General
Top management demonstrates leadership and commitment with respect to the quality
management system by;
o taking accountability for the effectiveness of the quality management system
o ensuring that the quality policy and quality objectives are established for the quality management
system and are compatible with the context and strategic direction of the organization as per clause 2.1
o ensuring the integration of the quality management system requirements into Iritron’s business
processes
o promoting the use of the process approach and risk-based thinking
o ensuring that adequate resources needed for the quality management system are available.
o communicating the importance of effective quality management and of conforming to the quality
management system requirements through the quality policy
o ensuring that the quality management system achieves its intended results
o engaging, directing and supporting Iritron personnel to contribute to the effectiveness of the quality
management system
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o promoting improvement
o supporting other relevant management roles to demonstrate their leadership as it applies to their
areas of responsibility

6.1.2 Customer Focus ISO 9001: 2015 Paragraph 5.1.2

Top management demonstrates leadership and commitment with respect to customer focus by
ensuring that:
o customer and applicable statutory and regulatory requirements are determined, understood and
consistently met.
o risks and opportunities that can affect conformity of products and services and the ability to
enhance customer satisfaction are determined and addressed as per the PFC for customer
satisfaction.
o focus on enhancing customer satisfaction is maintained

6.2 Quality Policy ISO 9001: 2015 Paragraph 5.2

6.2.1 Developing the quality policy
The Quality Policy Statement of Iritron is a controlled document, which has been defined as per paragraph
1.1 of this document which address the following:
o is appropriate to the purpose and context of the organization and supports its strategic
direction
o provides a framework for setting quality objectives
o includes a commitment to satisfy applicable requirements
o includes a commitment to continual improvement of the quality management system

6.2.2 Communicating the quality policy

The Quality Policy Statement of Iritron is a controlled document which has been defined as per paragraph 1.1
of this document which address the following:
o is communicated and applied in Iritron and available on notice boards and points of interest
o is available to all interested parties, as appropriate.

6.3 Organizational roles, responsibilities and authorities ISO 9001: 2008 Paragraph 5.3
Top management ensures that responsibilities and authorities for relevant roles are assigned,
communicated and understood within the organization through organogram’s and job descriptions.

Top management assigned the responsibility and authority for:

o ensuring that the quality management system conforms to the requirements of this International
Standard
o ensuring that all processes are delivering their intended outputs
o reporting on the performance of the quality management system and opportunities for
improvement
o ensuring promotion of customer focus throughout the organization
o ensuring that the integrity of the quality management system is maintained when changes to the
quality management system are planned and implemented.

7.0 PLANNING ISO 9001: 2015 Paragraph 6.0

7.1 Actions to address risks and opportunities
7.1.1 When planning for the quality management system, Iritron consider the issues
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referred to in section 5.1 of the manual and the requirements referred to in 5.2 of the manual and
determines the risks and opportunities that need to be addressed to:
o give assurance that the quality management system can achieve its intended result(s)
o enhance desirable effects
o prevent, or reduce, undesired effects
o achieve improvement.

7.1.2 Iritron will plan

o actions to address risks and opportunities
o how to;
o integrate and implement actions into its quality management system processes
o evaluate the effectiveness of these actions

Actions taken to address risks and opportunities are proportionate to the potential impact on the conformity of
products and services.

7.2 Quality objectives and planning to achieve them ISO 9001: 2015 Paragraph 6.2
7.2.1 Iritron ensures that quality objectives and goals, including those needed to meet requirements for
products/services, are established at relevant functions, levels and processes at Iritron
The quality objectives will be:
o consistent with the quality policy
o measurable
o taken into account applicable requirements
o relevant to conformity of products and services and to enhancement of customer satisfaction
o monitored
o communicated
o updated as appropriate

Iritron will maintain documented information on the quality objectives.

7.2.2 Iritron plans to achieve its quality objectives by determining the following:
o what will be done
o resources that will be required
o who will be responsible
o when it will be completed
o how the results will be evaluated
o

7.3 Planning of changes ISO 9001: 2015 Paragraph 6.3

Iritron determines the need for changes to the quality management system and changes
will be carried out in a planned manner.
Iritron considers the following:
o purpose of the changes and their potential consequences
o integrity of the quality management system
o availability of resources
o allocation or reallocation of responsibilities and authorities

8.0 SUPPORT ISO 9001: 2015 Paragraph 7.0

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8.1 Resources
8.1.1 General
Iritron determines and provides the resources required for the establishment, implementation, maintenance
and continual improvement of the quality management system
Iritron considers the following:
o the capabilities of, and constraints on, existing internal resources
o what needs to be obtained from external providers.
8.1.2 People
Iritron determines and provides the person/s necessary for the effective implementation of the quality
management system and for the operation and control of its processes.

8.1.3 Infrastructure
Iritron determines, provides and maintains the infrastructure necessary for the operation of their processes and
to achieve conformity of products and services
o Infrastructure include the following:
o buildings and associated utilities
o equipment, including hardware and software
o transportation resources
o information and communication technology.

8.1.4 Environment for the operation of processes

Iritron determines, provides and maintains the environment necessary for the operation of its processes and to
achieve conformity of products and services.
A suitable environment can be a combination of human and physical factors, such as:
o social (e.g. non-discriminatory, calm, non-confrontational)
o psychological (e.g. stress-reducing, burnout prevention, emotionally protective)
o physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise)

These factors can differ substantially depending on the products and services provided.

8.1.5 Monitoring and measuring resources

8.1.5.1 General
Iritron determines and provides the resources needed to ensure valid and reliable results, when monitoring or
measuring is used to verify the conformity of products and services to requirements.
Iritron ensures that the resources provided:
o are suitable for the specific type of monitoring and measurement activities being undertaken.
o are maintained to ensure their continuing fitness for their purpose.
Iritron retains appropriate documented information as evidence of fitness for purpose of the monitoring and
measurement resources.

8.1.5.2 Measurement traceability

When measurement traceability is a requirement, or is considered by Iritron to be an essential
part of providing confidence in the validity of measurement results, measuring equipment will be:
o calibrated or verified (against calibrated units), or both, at specified intervals, or prior to use, against
measurement standards traceable to international or national measurement standards; when no
such standards exist, the basis used for calibration or verification shall be retained as documented
information
o identified in order to determine their status
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o safeguarded from adjustments, damage or deterioration that would invalidate the calibration status
and subsequent measurement results.

Iritron determines if the validity of previous measurement results has been adversely affected when measuring
equipment is found to be unfit for its intended purpose and will take appropriate action as required.

8.1.6 Organizational knowledge

Iritron determines the knowledge necessary for the operation of its processes and to achieve conformity of
products and services.
This knowledge will be maintained and be made available to the extent necessary.
When addressing changing needs and trends, Iritron considers its current knowledge and determine how to
acquire or access any necessary additional knowledge and required updates.

8.2 Competence ISO 9001: 2015 Paragraph 7.2

Iritron:
o determines the necessary competence of person(s) doing work under its control that affects the
performance and effectiveness of the quality management system
o ensure that these persons are competent on the basis of appropriate education, training, or
experience
o where applicable, take actions to acquire the necessary competence, and evaluate the
effectiveness of the actions taken; retain appropriate documented information as evidence of
competence.
8.3 Awareness ISO 9001: 2015 Paragraph 7.3
Iritron ensures that persons doing work under Iritron control are aware of:
o the quality policy
o relevant quality objectives
o their contribution to the effectiveness of the quality management system, including the benefits of
improved performance
o the implications of not conforming with the quality management system requirements.

8.4 Communication ISO 9001: 2015 Paragraph 7.4

Iritron determines the internal and external communications relevant to the quality management system,
including:
o on what it will communicate
o when to communicate
o with whom to communicate
o how to communicate
o who communicates.

8.5 Documented information ISO 9001: 2015 Paragraph 7.5

8.5.1 General
Iritron’s quality management system includes:
o documented information required by this International Standard
o documented information determined by Iritron as being necessary for the effectiveness of the
quality management system.

8.5.2 Creating and updating

When creating and updating documented information, Iritron ensures appropriate:
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o identification and description (e.g. a title, date, author, or reference number)

o format (e.g. language, software version, graphics) and media (e.g. paper, electronic)
o review and approval for suitability and adequacy.

8.5.3 Control of documented information

8.5.3.1 Documented information required by the quality management system and by this International
Standard is controlled to ensure:
o it is available and suitable for use, where and when it is needed
o it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).

8.5.3.2 For the control of documented information, Iritron address the following
activities, as applicable:
o distribution, access, retrieval and use
o storage and preservation, including preservation of legibility
o control of changes (e.g. version control)
o retention and disposition

Documented information of external origin determined by Iritron to be necessary for the planning and
operation of the quality management system is identified as appropriate and controlled.
Documented information retained as evidence of conformity is protected from unintended alterations.

9.0 OPERATION ISO 9001: 2015 Paragraph 8.0

9.1 Operational planning and control
Iritron plan, implement and control the processes needed to meet the requirements for the provision of
products and services, and to implement the actions determined in
Chapter 7 of the manual, by:
o determining the requirements for the products and services
o establishing criteria for:
o the processes
o the acceptance of products and services
o determining the resources needed to achieve conformity to the product and service
requirements
o implementing control of the processes in accordance with the criteria
o determining and keeping documented information to the extent necessary:
o to have confidence that the processes have been carried out as planned
o to demonstrate the conformity of products and services to their requirements.
o Iritron controls planned changes and review the consequences of unintended
changes, taking action to mitigate any adverse effects, as necessary.

9.2 Requirements for products and services ISO 9001: 2015 Paragraph 8.2
9.2.1 Customer communication
Communication with customers includes:
o providing information relating to products and services
o handling enquiries, contracts or orders, including changes
o obtaining customer feedback relating to products and services, including customer
complaints
o handling or controlling customer property
o establishing specific requirements for contingency actions, when relevant.
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9.2.2 Determining the requirements related to products and services

Determining the requirements for the products and services to be offered to customers, Iritron ensures that:
o the requirements for the products and services are defined, including:
o any applicable statutory and regulatory requirements
o those considered necessary by the organization
o Iritron can meet the claims for the products and services it offers.

9.2.3 Review of requirements related to products and services

9.2.3.1 Iritron ensures that it has the ability to meet the requirements for products and services to be offered to
customers. Iritron performs a review before committing to supply products and services to a customer, to
include:
o requirements specified by the customer, including the requirements for delivery and
post-delivery activities
o requirements not stated by the customer, but necessary for the specified or intended
use, when known
o requirements specified by the organization
o statutory and regulatory requirements applicable to the products and services
o contract or order requirements differing from those previously expressed.
Iritron ensures that contract or order requirements differing from those previously defined are resolved.
The customer’s requirements shall be confirmed by Iritron before acceptance, when the customer does not
provide a documented statement of their requirements.

9.2.3.2 Iritron retains documented information, as applicable:

o on the results of the review
o on any new requirements for the products and services.

9.2.4 Changes to requirements for products and services

Iritron ensures that relevant documented information is amended, and that relevant persons are made aware
of the changed requirements, when the requirements for products and services are changed.

9.3 Design and development of products and services ISO 9001: 2015 Paragraph 8.3
9.3.1 General
Iritron establishes, implements and maintain a design and development process that is
appropriate to ensure the subsequent provision of products and services.

9.3.2 Design and development planning

In determining the stages and controls for design and development, Iritron considers:
o the nature, duration and complexity of the design and development activities
o the required process stages, including applicable design and development reviews
o the required design and development verification and validation activities
o the responsibilities and authorities involved in the design and development process
o the internal and external resource needs for the design and development of products and
services
o the need to control interfaces between persons involved in the design and development
process
o the need for involvement of customers and users in the design and development
process
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o the requirements for subsequent provision of products and services

o the level of control expected for the design and development process by customers and
other
o relevant interested parties
o the documented information needed to demonstrate that design and development
requirements
o have been met.

9.3.3 Design and development inputs

Iritron determines the requirements essential for the specific types of products and services to be designed and
developed. Iritron considers:
o functional and performance requirements
o information derived from previous similar design and development activities
o statutory and regulatory requirements
o standards or codes of practice that the organization has committed to implement
o potential consequences of failure due to the nature of the products and services.
Inputs are adequate for design and development purposes, complete and unambiguous. Conflicting design and
development inputs will be resolved. Iritron retains documented information on design and development
inputs.
9.3.4 Design and development controls
Iritron applies controls to the design and development process to ensure that:
o the results to be achieved are defined;
o reviews are conducted to evaluate the ability of the results of design and development to
meet requirements
o verification activities are conducted to ensure that the design and development outputs
meet the input requirements
o validation activities are conducted to ensure that the resulting products and services meet
the requirements for the specified application or intended use
o any necessary actions are taken on problems determined during the reviews, or verification
and validation activities
o documented information of these activities is retained.

9.3.5 Design and development outputs

Iritron ensures that design and development outputs:
o meet the input requirements
o are adequate for the subsequent processes for the provision of products and services
o include or reference monitoring and measuring requirements, as appropriate, and
acceptance criteria
o specify the characteristics of the products and services that are essential for their intended
purpose and their safe and proper provision.

Iritron retains documented information on design and development outputs.

9.3.6 Design and development changes

Iritron identifies, reviews and control changes made during, or subsequent to, the design and development of
products and services, to the extent necessary to ensure that there is no adverse impact on conformity to
requirements.
Iritron retains documented information on:
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o design and development changes

o the results of reviews
o the authorization of the changes
o the actions taken to prevent adverse impacts.

9.4 Control of externally provided processes, products and services ISO 9001:2015 Paragraph
9.4.1 General
Iritron ensures that externally provided processes, products and services conform to requirements.
Iritron determines the controls to be applied to externally provided processes, products and services when:
products and services from external providers are intended for incorporation into Iritron’s
own products and services
products and services are provided directly to the customer(s) by external providers on
behalf of Iritron
a process, or part of a process, is provided by an external provider as a result of a decision
by Iritron.

Iritron determines and applies criteria for the evaluation, selection, monitoring of performance, and re-
evaluation of external providers, based on their ability to provide processes or products and services in
accordance with requirements. Iritron retains documented information of these activities and any necessary
actions arising from the evaluations.

9.4.2 Type and extent of control

Iritron ensures that externally provided processes, products and services do not
adversely affect Iritron’s ability to consistently deliver conforming products and services to its customers.

Iritron will:
o ensure that externally provided processes remain within the control of its quality
management system;
o define both the controls that it intends to apply to an external provider and those it intends
to apply to the resulting output;
o take into consideration:
o the potential impact of the externally provided processes, products and services
on Iritron’s ability to consistently meet customer and applicable statutory and
regulatory requirements
o the effectiveness of the controls applied by the external provider;
o determine the verification, or other activities, necessary to ensure that the
externally provided processes, products and services meet requirements.

9.4.3 Information for external providers

Iritron ensures the adequacy of requirements prior to their communication to the external provider.
Iritron communicates to external providers its requirements for:
o the processes, products and services to be provided
o the approval of:
o products and services
o methods, processes and equipment
o the release of products and services
o competence, including any required qualification of persons
o the external providers’ interactions with the organization
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o control and monitoring of the external providers’ performance to be applied

by Iritron
o verification or validation activities that Iritron, or its customer, intends to
perform at the external providers’ premises.

9.5 Production and service provision ISO 9001:2015 Paragraph 8.5

9.5.1 Control of production and service provision
Iritron implements production and service provision under controlled conditions.
Controlled conditions include the following:
o the availability of documented information that defines:
o the characteristics of the products to be produced, the services to be provided, or the
activities to be performed
o the results to be achieved
o the availability and use of suitable monitoring and measuring resources
o the implementation of monitoring and measurement activities at appropriate stages to
verify that criteria for control of processes or outputs, and acceptance criteria for products
and services, have been met
o the use of suitable infrastructure and environment for the operation of processes
o the appointment of competent persons, including any required qualification
o the validation, and periodic revalidation, of the ability to achieve planned results of the
processes for production and service provision, where the resulting output cannot be
verified by subsequent monitoring or measurement
o the implementation of actions to prevent human error
o the implementation of release, delivery and post-delivery activities.

9.5.2 Identification and traceability

Iritron uses suitable means to identify outputs when it is necessary to ensure the conformity of products and
services.
Iritron identifies the status of outputs with respect to monitoring and measurement requirements throughout
production and service provision.
Iritron controls the unique identification of the outputs when traceability is a requirement, and retains the
documented information necessary to enable traceability

9.5.3 Property belonging to customers or external providers

Iritron exercises care with property belonging to customers or external providers while it is under Iritron’s
control or being used by Iritron.
Iritron identifies, verify, protect and safeguard customers’ or external providers’ property provided for use or
incorporation into the products and services.
When the property of a customer or external provider is lost, damaged or otherwise found to be unsuitable for
use, Iritron reports this to the customer or external provider and retain documented information on what has
occurred.
9.5.4 Preservation
Iritron preserves the outputs during production and service provision, to the extent necessary to ensure
conformity to requirements.

9.5.5 Post-delivery activities

Iritron meets requirements for post-delivery activities associated with the products and services.
In determining the extent of post-delivery activities that are required, Iritron considers:
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o statutory and regulatory requirements

o the potential undesired consequences associated with its products and services
o the nature, use and intended lifetime of its products and services
o customer requirements
o customer feedback.

9.5.6 Control of changes

Iritron reviews and control changes for production or service provision, to the extent necessary to ensure
continuing conformity with requirements.
Iritron retains documented information describing the results of the review of changes, the person(s)
authorizing the change, and any necessary actions arising from the review.

9.6 Release of products and services ISO 9001:2015 Paragraph 8.6

Iritron implements planned arrangements, at appropriate stages, to verify that the product and service
requirements have been met.
The release of products and services to the customer will not proceed until the planned arrangements have
been satisfactorily completed, unless otherwise approved by a relevant authority and, as applicable, by the
customer.
Iritron retains documented information on the release of products and services. The documented information
will include:
o evidence of conformity with the acceptance criteria
o traceability to the person(s) authorizing the release.

9.7 Control of nonconforming outputs ISO 9001:2015 Paragraph 8.7

9.7.1 Iritron ensures that outputs that do not conform to their requirements are identified and controlled to prevent
their unintended use or delivery.
Iritron takes appropriate action based on the nature of the nonconformity and its effect on the conformity of
products and services. This also applies to nonconforming products and services detected after delivery of
products, during or after the provision of services.
Iritron deals with nonconforming outputs in one or more of the following ways:
o correction
o segregation, containment, return or suspension of provision of products and services
o informing the customer
o obtaining authorization for acceptance under concession.

Conformity to the requirements will be verified when nonconforming outputs are corrected.

9.7.2 Iritron retains documented information that:

o describes the nonconformity
o describes the actions taken
o describes any concessions obtained
o identifies the authority deciding the action in respect of the nonconformity.

10.0 PERFORMANCE EVALUATION ISO 9001: 2015 Paragraph 9.0

10.1 Monitoring, measurement, analysis and evaluation
10.1.1 General
Iritron determines:
o what needs to be monitored and measured
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o the methods for monitoring, measurement, analysis and evaluation needed to

ensure valid results
o when the monitoring and measuring shall be performed
o when the results from monitoring and measurement shall be analysed and
evaluated.

Iritron evaluates the performance and the effectiveness of the quality management system.
Iritron retains appropriate documented information as evidence of the results.

10.1.2 Customer satisfaction

Iritron monitors customers’ perceptions of the degree to which their needs and expectations have been
fulfilled. Iritron determines the methods for obtaining, monitoring and reviewing this information.

10.1.3 Analysis and evaluation

Iritron analyses and evaluate appropriate data and information arising from monitoring and measurement.
The results of analysis will be used to evaluate:
o conformity of products and services
o the degree of customer satisfaction
o the performance and effectiveness of the quality management system
o if planning has been implemented effectively
o the effectiveness of actions taken to address risks and opportunities
o the performance of external providers
o the need for improvements to the quality management system.

10.2 Internal audit ISO 9001:2015 Paragraph 9.2

10.2.1 Iritron conducts internal audits at planned intervals to provide information on whether the quality
management system:
o conforms to:
o Iritron’s own requirements for its quality management system
o the requirements of this International Standard
o is effectively implemented and maintained.

10.2.2 Iritron will:

o plan, establish, implement and maintain an audit programme(s) including the
frequency, methods, responsibilities, planning requirements and reporting, which shall take
into consideration the importance of the processes concerned, changes affecting Iritron,
and the results of previous audits
o define the audit criteria and scope for each audit
o select auditors and conduct audits to ensure objectivity and the impartiality of the audit
process
o ensure that the results of the audits are reported to relevant management
o take appropriate correction and corrective actions without undue delay
o retain documented information as evidence of the implementation of the audit
program and the audit results.

10.3 Management review ISO 9001:2015 Paragraph 9.3

10.3.1 General
Top management reviews Iritron’s quality management system, at planned intervals, to ensure its continuing
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suitability, adequacy, effectiveness and alignment with the strategic direction of Iritron.

10.3.2 Management review inputs

The management review will be planned and carried out taking into consideration:
o the status of actions from previous management reviews
o changes in external and internal issues that are relevant to the quality management system

o information on the performance and effectiveness of the quality management system,

including
o trends in:
o customer satisfaction and feedback from relevant interested parties
o the extent to which quality objectives have been met
o process performance and conformity of products and services
o nonconformities and corrective actions
o monitoring and measurement results
o audit results
o the performance of external providers
o the adequacy of resources
o the effectiveness of actions taken to address risks and opportunities
o opportunities for improvement.

10.3.3 Management review outputs

The outputs of the management review will include decisions and actions related to:
o opportunities for improvement
o any need for changes to the quality management system
o resource needs.

Iritron retains documented information as evidence of the results of management reviews.

11.0 IMPROVEMENT ISO 9001: 2015 Paragraph 10.0

11.1 General
Iritron determines and selects opportunities for improvement and implement any necessary actions to meet
customer requirements and enhance customer satisfaction.
This will include the following:
o improving products and services to meet requirements as well as to address future needs
and expectations
o correcting, preventing or reducing undesired effects
o improving the performance and effectiveness of the quality management system.

11.2 Nonconformity and corrective action ISO 9001: 2015 Paragraph 10.2
11.2.1 When a nonconformity occurs, including any arising from complaints, Iritron:
o reacts to the nonconformity and, as applicable:
o take action to control and correct it
o deal with the consequences
o evaluates the need for action to eliminate the cause(s) of the nonconformity, in order that
it does not recur or occur elsewhere, by
o reviewing and analysing the nonconformity
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o determining the causes of the nonconformity

o determining if similar nonconformities exist, or could potentially occur
o implements any action needed
o reviews the effectiveness of any corrective action taken
o updates risk and opportunities determined during planning, if necessary
o makes changes to the quality management system, if necessary.

Corrective actions will be appropriate to the effects of the nonconformities encountered.

11.2.2 Iritron retains documented information as evidence of:

o the nature of the nonconformities and any subsequent actions taken
o the results of any corrective action.

11.3 Continual improvement ISO 9001:2015 Paragraph 10.3

Iritron continually improves the suitability, adequacy and effectiveness of the quality management system.
Iritron considers the results of analysis and evaluation, and the outputs from management review, to determine if
there are needs or opportunities that need to be addressed as part of continual improvement.

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