Quality Manual

This Quality Manual complies with the Requirements of ISO 9001:2015 and
EN ISO/IEC 80079-34, ATEX Directive 2014/34/EU, IECEx Scheme

Prepared By: Phyllis Olsen Release Date: 07/08/2024

Rev. -8- July 08, 2024

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Alabama Specialty Products, Inc. ISO9001:2015 Quality Manual

Table of Contents Quality Management System Manual

Clause Content Description Page
Table of Contents 1-3
Approvals 4
Quality System Manual Revision Index 5-6
Manual Distribution – Hard Copy 7
Introduction 8
Quality Management Principles 8
Process Approach 8
Risk-Based Thinking 8
1 Scope 9
2 Normative Reference 10
3 Terms and Definitions 10-11
4 Context of the Organization 12
4.1 Understanding the Organization and Its Context 13
4.2 Understanding the Needs and Expectation of Interested Parties 13
4.3 Determining the Scope of the Quality Management System 13
4.4 Quality Management System and Its Process 14
5 Leadership 15
5.1 Leadership and Commitment 15
5.1.1 General 15
5.1.2 Customer Focus 15
5.2 Policy 16
5.2.1 Developing the Quality Policy 17
5.2.2 Communicating the Quality Policy 17
5.3 Organizational Roles, Responsibilities and Authorities 17
Organization Chart 18
Management Representative 19
Ex Representative 19
5.4 Quality Management System Planning 19
6 Planning 20
6.1 Actions to Address Risks and Opportunities 20
6.2 Quality Objectives and Planning to Achieve Them 20
6.3 Planning Changes 20
7 Support 21
7.1 Resources 21

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Table of Contents Quality Management System Manual

Clause Content Description Page
7.1.1 General 21
7.1.2 People 21
7.1.3 Infrastructure 21
7.1.4 Environment for the Operation of Processes 21
7.1.5 Monitoring and Measurement Resources 22
7.1.5.1 General 22
7.1.5.2 Measurement Traceability 22
7.1.6 Organization Knowledge 22-23
7.2 Competence 23-24
7.3 Awareness 24
7.4 Communication 24-25
7.5 Documented Information 25
7.5.1 General 25
7.5.2 Creating and Updating 25-26
7.5.3 Control of Documented Information 26
8 Operation 27
8.1 Operational Planning and Control 27
8.2 Requirements for Products and Services 27
8.2.1 Customer Communication 27
8.2.2 Determination of Requirements Related to Products and Service 27
8.2.3 Review of Requirements Related to Products and Services 28
8.2.4 Changes to Requirements For Products and Services 28
8.3 Design and Development of Products and Services 28
8.3.1 General 28
8.3.2 Design and Development Planning 28
8.3.3 Design and Development Inputs 29
8.3.4 Design and Development Controls 29
8.3.5 Design and Development Outputs 29
8.3.6 Design and Development changes 30
8.4 Control of Externally Provided Processes, Products and Services 30
8.4.1 General 30-31
8.4.2 Type and Extent of Control 31-32
8.4.3 Information for External Providers 33
8.5 Production and Service Provision 33

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Table of Contents Quality Management System Manual

Clause Content Description Page

8.5.1 Control of Productions and Service Provision 34
8.5.2 Identification and Traceability 34
8.5.3 Property Belonging to Customers or External Providers 34
8.5.4 Preservation 34
8.5.5 Post-Delivery Activities 35
8.5.6 Control of Changes 35
8.6 Release of Products and Services 35
8.7 Control of Nonconforming Outputs 36
9 Performance Evaluation 37
9.1 Monitoring, Measurement, Analysis and Evaluation 37
9.1.1 General 37
9.1.2 Customer Satisfaction 37
9.1.3 Analysis and Evaluation 37
9.2 Internal Audit 38
9.3 Management Review 38
9.3.1 General 38
9.3.2 Management Review Inputs 38-39
9.3.3 Management Review Outputs 39
10 Improvement 40
10.1 General 40
10.2 Nonconformity and Corrective Action 40
10.3 Continual Improvement 40

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Approvals
Executive Management is ultimately responsible for making balanced judgements, assessing the significance of
variations in our processes, and making decisions. In arriving at such decisions, the quality and personal integrity
of staff are of fundamental importance. In this context, every effort is made to ensure that each person in the
company understands that quality assurance is important to their future, that they know how they can assist in
the achievement of adequate quality and that they are encouraged to do so.

This quality manual and the quality policy are approved by the undersigned and are supported by all levels of
management within the company.

Signature on File 09/13/17 Signature on File 09/08/17

Tim Johnson Date James P. Gray Date

Chief Executive Officer /President President Metal Samples

Signature on File 09/08/17 Signature on File 09/08/17

Sai Mudiam Date Sam Patterson Date

Vice-President ALSPI Compliance Director

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Quality System Manual Revision Index

PAGE REVISION DETAILS OF CHANGE DATE APPROVED BY

1-38 - NEW- INITIAL RELEASE 01/25/18 Don Johnson

Moved the Ex-Representative from under
16-38 -1- Division VP to VP of ALSPI. 11/26/18 Don Johnson
Added “The person identified in clause 5.3
shall approve any changes that could
26 -2- compromise Ex compliance.” 12/18/18 Don Johnson
Added: “The person identified in clause 5.3
shall be involved any changes that could
28 -2- affect Ex compliance.” 12/18/18 Don Johnson
Added latest requirements of 80079-34,
Annex C to Clause 8.4.2 Type & Extent of
29 -2- Control. 12/18/18 Don Johnson
Referenced timescale between audits and
audits to be performed on both
ISO9001:2015 and EN/ISO80079-34, ATEX
36 -2- Directive 2014/34/EU and IECEx Scheme 12/18/18 Don Johnson

16 -3- Updated the Organizational Chart. 01/16/2020 Don Johnson

16 -4- Updated the Organizational Chart. 05/12/2021 Tim Johnson

16 -5- Updated the Organizational Chart. 06/10/2021 Tim Johnson

Updated Ex ISO/IEC 80079-34, ATEX
Entire Directive 2014/34/Eu to include IECEx Tim Johnson
Manual -6- Scheme 03/04/2022
Add additional requirements to Ex- Tim Johnson
17 -6- Representative responsibilities. 03/04/2022
Moved the requirements regarding Ex
32-33 -6- Product from clause 8.6 to the applicable 03/04/2022 Tim Johnson
clause 8.4.2, pages 29-30.
Made changes to Normative References 08/31/2023 Tim Johnson
9 -7-
Added Ex terms to Terms & Definitions 08/31/2023 Tim Johnson
9-10 -7-
Added Note to the end of clause 4.1 08/31/2023 Tim Johnson
12 -7-
Added “unless permitted by issuer of the Tim Johnson
certificate.” to Clause 7.5.2, paragraph “c” 08/31/2023
24-25 -7- and added CML to paragraph “f.”
Added missing Ex requirements to Clause 08/312023 Tim Johnson
34 -7- 8.6, Release of Products & Services.

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Quality System Manual Revision Index

PAGE REVISION DETAILS OF CHANGE DATE APPROVED BY

13 8 Added requirement details of ISO 07/08/2024 Tim Johnson

Amendment 1:2024

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MANUAL DISTRIBUTION

ISSUE NAME ISSUE DATE ISSUED TO

ELECTRONIC HARD COPY 01/25/18 Adobe Acrobat

ELECTRONIC HARD COPY 08/15/18 www.alspi.com

ELECTRONIC HARD COPY 11/26/18 Adobe Acrobat

ELECTRONIC HARD COPY 11/26/18 www.alspi.com

ELECTRONIC HARD COPY 12/18/18 www.alspi.com

ELECTRONIC HARD COPY 01/16/2020 www.alspi.com

ELECTRONIC HARD COPY 05/12/2021 Adobe Acrobat

ELECTRONIC HARD COPY 06/10/2021 Adobe Acrobat

ELECTRONIC HARD COPY 03/15/2022 Adobe Acrobat

ELECTRONIC HARD COPY 09/13/2023 Adobe Acrobat

ELECTRONIC HARD COPY 07/08/2024 Adobe Acrobat

Paper Copy 07/09/2024 Sai Mudiam

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Alabama Specialty Products, Inc. ISO9001:2015 Quality Manual

Introduction

Alabama Specialty Products, Inc. (ALSPI) is a materials processing firm that meets the needs of its customers
around the world. Combining the resources of its company divisions: Metal Samples Company, Alabama
Research and Development, Alabama Laser Technologies, and Alabama Laser. ALSPI offers a wide variety of
products and services.

The purpose of the Quality Manual is to document the quality system and policies and to inform ALSPI’s
customers of the controls implemented to ensure product quality. The Quality Manual provides for a quality
management system to:
 Consistently provide products and services that meet customer and applicable regulatory requirements.
 Address risks and opportunities associated with its context and objectives.
 Enhance customer satisfaction through effective application of the quality system, including processes
for continual improvement of the system and assurance of conformity to customer and applicable
regulatory requirements.

The Quality Management System of ALSPI meets the requirements of the ISO 9001:2015 and EN ISO/IEC
80079-34, ATEX Directive 2014/34/EU and IECEx Scheme, employs the process approach, which
incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking. Quality Management principles
described in the ISO9001 Standard are applied. This system addresses the design and production of the
company’s products and services.

The manual describes the Quality Management System, defines authorities, interrelationships and
Responsibilities of the personnel responsible for performing within the system. The manual also
provides procedures or references for all activities.

Internally the manual is used to guide the company’s employees through the various requirements of
the ISO 9001:2015 and EN ISO/IEC 80079-34, ATEX Directive 2014/34/EU, and IECEx Scheme that must be
met and maintained to ensure customer satisfaction and continuous improvement.

Externally the manual is used to introduce our Quality Management System to our customers and other
external organizations or individuals. The manual is also used to familiarize them with the controls that
have been implemented and to assure them that the integrity of the QMS is maintained; thus
demonstrating that the company is focused on customer satisfaction and continuous improvement.

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1 SCOPE
Scope and Exclusions

Alabama Specialty Products, Inc. is comprised of Metal Samples Co., Alabama Research and Development,
Alabama Laser Technologies, and Alabama Laser, located in Munford, Alabama, USA.

The success and reputation of the company may be measured by the high standing maintained with our
customers. A policy of continuous self-appraisal and carefulness has ensured the expansion of our customer
base.

This Quality Manual establishes compliance with ISO9001:2015 and EN ISO/IEC 80079-34, ATEX Directive
2014/34/EU and IECEx Scheme. It applies to all our business activities including research and development
where applicable, production, sales, marketing, and service activities.

The company has implemented a quality management system to demonstrate its ability to provide consistent
products that meet customer and applicable statutory and regulatory requirements. This enables the company
to address and achieve customer satisfaction through the effective application of the system, including
processes for continual improvement and the prevention of nonconformity.

The quality management system applies to:

 A complete line of corrosion monitoring equipment and supplies
 Medical laboratory equipment, and engineering, research, and development services
 Industrial laser cutting and welding equipment.
 Complete custom product manufacturing/fabrication capabilities.

In addition, Alabama Specialty Products, Inc. provides product to the following EU Directive:

 Equipment intended for use in Potentially Explosive Atmospheres (ATEX) Directive 2014/34/EU and
(IECEx) Scheme.

Currently, ALSPI has no non-applicable requirements to the ISO 9001:2015 Standard.

*NOTE: Italicized words and statements in this document pertain to the EN ISO/IEC 80079-34, ATEX
Directive 2014/34/EU and IECEx Scheme.

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2 NORMATIVE REFERENCE

This Quality Manual defines the policies and principles applied against each of the requirements of ISO
9001:2015 and EN ISO/IEC 80079-34, ATEX Directive 2014/34/EU and IECEx Scheme, as it relates to all
activities conducted in the company that determine quality. The QM defines guidelines within which the
company can operate.

Each section of the manual is related to an identified element of ISO 9001:2015 and EN ISO/IEC 80079-34,
ATEX Directive 2014/34/EU and IECEx Scheme.
Distribution

The ISO 9001 Management Representative (Management Representative) is responsible for the controlled
internal distribution of this manual, and changes thereto. Outside organizations and personnel have access to
the latest revision of our Quality Manual through the company website: www.alspi.com.

Uncontrolled Manuals

Any uncontrolled hard copy manuals are up to date at issue and are only issued to outside organizations,
customers, etc. Such uncontrolled manuals will be clearly marked “For information only, not subject to automatic
update.”

3 TERMS AND DEFINITIONS

The following terms and definitions are provided to assure a uniform understanding of selected terms as they
are used in these requirements.

Company Alabama Specialty Products, Inc., and its Divisions.

Supplier The party to whom an order has been placed by the company for the purchase of raw.
materials, equipment, supplies, or the performance of outside services for a particular order.

Customer Firm or person having a contractual agreement with, or the recipient of a product or service
from the company.

Product The result of a process, or series of processes, which is the combination of some, or all the
four generic product categories, hardware, software, services, and processed materials.

Ex Product Ex Equipment, protective system, safety device, Ex Component, and their combination, as
well as software and services.

Service Product installation and prove-out, or maintenance/repair other than routine preventive
maintenance, routine replacement of consumables, or replacement of out of warranty broken
and/or worn components of our products.

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Certificate Document that conveys the assurance of the conformity of a product, process, system,
person, or organization with specified requirements.
3 TERMS AND DEFINITIONS

Schedule Drawing Drawing or document listed in the certificate or test report.

Related Drawing Drawing or document not listed in the certificate but linked to the schedule drawing, and
used for example, for detailed manufacture or purchase of components parts.

ATEX The European certification given to equipment tested and approved to be intrinsically
safe.

IECEx International certification accepted in several countries to help build confidence in the
safety of Ex equipment.

Body Responsible
For Verification Body which conducts documentation review and periodical audits as appropriate.

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4 CONTEXT OF THE ORGANIZATION

4.1 Understanding the Organization and Its Context

Alabama Specialty Products, Inc. (ALSPI) is a materials processing company that meets the needs of its
customers around the world. Combining the resources of its company divisions, Metal Samples, Alabama Laser
Technologies, Alabama Laser and Alabama Research and Development, ALSPI offers a wide variety of products
and services. The supply of products and services include but are not limited to manufacturing of corrosion
monitoring and materials evaluation products, coupons, probes, instrumentation, high pressure access fittings,
injection systems, reference assortment kits and electrodes. The company designs and develops tissue slicer
products, such as tissue slicers, thickness gauges, coring presses, and tools, embedding and incubation units.
In addition, Alabama Specialty Products offers services, including laser cutting, welding, tube cutting, etching,
cladding, heat- treating, metal disposition and precision machining, bending, and forming, punching, wire EDM,
CNC milling, water jet and plasma cutting, material folding, CNC screw machining, powder coating, wet paint,
and grinding.

Further, the company provides services such as CAD and engineering, prototype fabrication, custom laser
system services, laser research and new product development. It serves aerospace, auto racing, transportation,
industrial equipment, medical, defense/government, construction equipment, furniture, agricultural, lawn/garden
equipment, automotive, oil and gas, water treating, chemical, and recreational vehicle industries. The company
is committed to superior quality, quick delivery, fair pricing, and excellent service. With a rapidly expanding
physical plant, state-of-the-art equipment, ever broadening product lines, dedicated research, and a highly skilled
work force, it stands ready to meet customer’s specific manufacturing needs.

External factors exist outside the boundaries of the company and have significant influences on our growth and
survival. We have little or no control over these issues, but constantly monitor and adapt to any necessary
changes. Not all elements impact the day-to-day operations and thus are weighted differently. Common
external factors that influence the company include Related Industries - when developing business
philosophies and products we use our strength in quality, production, customer service and/or operational
efficiencies to build competitive advantages that benefit our customers. Customer Preferences - economic
factors relate to the values, attitudes and concerns of our target customers and their economic abilities to
afford our products. Technology - we continually embrace the science and technology required for production,
the Internet, social networks, and advances in communication technologies have revolutionized how we
operate. New Laws and Regulations - are constantly added due to political or social changes. Compliance -
can result in additional costs, development of modern technology, additional taxes, or legal fees. Finances -
provide operational support, which may include savings or available cash, and credit lines to fund new
ventures. Raw Materials - ALSPI uses a large number of raw materials. A sizeable variety of alloys is stored
on the premises, but any disruption in supply and/or changes in cost of materials could have an adverse effect.

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4 CONTEXT OF THE ORGANIZATION

4.1 Understanding the Organization and Its Context

Skilled Employees - the availability of adequately skilled employees at various levels is challenging. Formal and
in-plant training for critical skills exists. Progression of the trainee is based on specified levels of demonstrated
performance on the job. New trainees are phased into the work force where skill shortages occur. Demographics
- play a crucial role in the success of businesses, as learning consumer characteristics helps to determine what
products and services to create and how to market them. Future shifts in demographics also determine what
necessary adjustments we must make to our strategies. Due to the increasingly broad world economy the Global
context is becoming more important to observe by means of assessing the business environment in other
countries, including economic, financial, structure, business practices, and regulatory systems.

Climate Action Change (1:2024) The organization shall determine whether climate change is a relevant issue.
The company has determined that climate change is not relevant to our quality management system. The
company takes into account customer and regulatory requirements.

NOTE: ISO 9001:2015 applies with the following addition: In regard to this document, the context of the
organization is to ensure that any Ex-Product is in accordance with its certificate and technical documentation.

4.2 Understanding the needs and expectations of interested parties

Interested parties are individuals and other entities that add value to the organization. Meeting the needs and
expectations of interested parties contributes to the achievement of sustained success by the company. The
needs and expectations of interested parties can take a wide variety of forms, including collaboration,
cooperation, negotiation, and outsourcing or terminating an activity.

NOTE: “Relevant interested parties can have requirements related to climate change.”

a. Interested Party b. Needs and Expectations

Customers Quality, Price & Delivery of Products and Services
Owners/Share Holders Sustained Profitability and Transparency

Employees Good Work Environment, Job security, Recognition and Reward

Suppliers & partners Mutual Benefit and Continuity
Environmental Protection, Ethical Behavior, Compliance with
Community Statutory and Regulatory Requirements.

4. 3 Determining the Scope of the Quality Management System

This Quality Manual has been prepared to describe Alabama Specialty Products, Inc. The scope and permissible
exclusions of the QMS are expressed in section one of this manual.

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4.4 Quality Management System and Its Processes

Alabama Specialty Products, Inc., has established, documented, and implemented a Quality Management
System (QMS) in accordance with the requirements of the ISO 9001:2015 Standard. It is not a stand-alone
system but is integrated within ALSPI’s operating discipline which encompasses the policies, requirements, and
work processes of Environment, Health, Safety, Manufacturing, Human Resources and Quality.

It is recognized that defining, implementing, and documenting our quality management system is only the first
step towards fully implementing its requirements. The effectiveness of each process and its subsequent output
is measured and evaluated through regular internal audits, quality inspections and data analysis. Performance
indicators are linked to our objectives to control and monitor our processes, as well as assessments to determine
the risks and opportunities inherent to each process. We use trends and indicators relating to nonconformities,
objectives, and corrective action, as well as monitoring and measurement results, audit results and customer
satisfaction data, process performance and the conformity of our products.

Process Flow Chart, FC 4.4-1, provides a description of the interaction between the processes of the QMS
system.

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5 LEADERSHIP

5.1 Leadership and Commitment

Executive Management takes a visible and leading role in creating and sustaining core values, policies,
strategies, directions, performance expectations and customer focus. Executive Management approves and
leads the implementation of the quality management system that promotes excellence. Leadership from all levels
of the company plays an active role in verifying the effectiveness and efficiency of the QMS and ensuring that
resulting actions lead to continuous improvement.

5.1.1 General

Executive Management of ALSPI clearly demonstrates its commitment by:

 QMS effectiveness is measured, and management is involved in assessing this.

 The Quality Policy and objectives are in place per management direction, communicated in the
organization, and tracked for progress.
 The QMS is part of the business processes, not a side project.
 Resource needs are reviewed and addressed by management.
 Continual improvement is promoted and supported by management.
 There is a way to ensure customer, statutory and regulatory requirements are understood and met, and
people understand why this is important.
 There is a management focus on customer satisfaction.
 Organizational roles, responsibilities, and authorities are assigned, understood by the person who is
assigned, and known to those employees who need to assess a person in a certain role.

Management review is the significant method of feedback to top management on the maintenance of the
Quality Management System. This process continues to have a significant role in demonstrating top
management’s commitment to the QMS.

5.1.2 Customer Focus

ALSPI views its product and service quality as being defined by its customers. We continually look for ways to
interact directly with our customers to ensure that we focus on their unique needs and expectations. This close
working relationship helps ALSPI better meet its customers’ expectations today and to anticipate and meet their
needs in the future.

Executive Management ensures that not only are customer requirements understood, but they are determined
and met with the aim of enhancing customer satisfaction. Customer requirements are determined, converted into
internal requirements, and communicated to the appropriate people within the organization through documented
processes and work instructions.

Customer complaints and other customer feedback are continually monitored to identify opportunities for
improvement.

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5 LEADERSHIP

5.2 Policy

The quality policy of Alabama Specialty Products, Inc.’s is to achieve sustained, profitable growth by providing
products and services which consistently satisfy the needs and expectations of its customers.

This level of quality is achieved through implementation of a system of documented procedures that provide
guidance to our employees and reflect the competence of the Company to existing customers, potential
customers, and independent auditing authorities.

Achievement of this policy involves all staff, who are individually responsible for the quality of their work, resulting
in a continually improving working environment for all. This policy is provided and explained to each employee
by the Quality Assurance Department.

To achieve and maintain the required level of assurance the Management Representative retains responsibility
for the Quality Management System with routine operations controlled by the Quality Managers.

The objectives of the Quality Management System are:

• To maintain an effective Quality Management System complying with International

Standard ISO 9001 and EN ISO/IEC 80079-34, ATEX Directive 2014/34/EU and IECEx Scheme.
.
• To achieve and maintain a level of quality which enhances the Company’s reputation
with customers.

• To ensure compliance with relevant statutory and regulatory requirements.

• To endeavor, at all times to maximize customer satisfaction with the products and
services provided by Alabama Specialty Products, Inc.

NOTE: Executive Management is ultimately responsible for making balanced judgements, assessing the significance of variations in our
processes, and making decisions. In arriving at such decisions, the quality and personal integrity of staff are of fundamental importance.
In this context, every effort is made to ensure that each person in the company understands that quality assurance is important to their
future, that they know how they can assist in the achievement of adequate quality and that they are encouraged to do so.

Excerpt from Quality Manual Dated 03/19/09.

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5 LEADERSHIP

5.2.1 Developing the Quality Policy

Executive Management ensures that the Quality Policy:

 Is appropriate to the purpose of ALSPI.

 Includes a commitment to comply with requirements and continually improve the effectiveness of the
QMS.
 Provides the framework for establishing and reviewing quality objectives.
 Is communicated, understood, and promoted throughout the organization, and
 Is reviewed during the annual QMS review for continuing suitability.

5.2.2 Communicating the Quality Policy

Executive Management ensures that the quality policy is communicated internally to all employees. It is
included in the new employee orientation and training, day-to-day operations, and general awareness. It is
conveyed and reinforced during employee performance reviews. Externally it is provided on our website for
review by interested parties.

5.3 Organizational Roles, Responsibilities and Authorities

An organizational chart has been established to show the interrelation of personnel in the organization. Job
descriptions define the responsibilities and authorities of each of the positions on the organizational chart. Job
descriptions and the organizational chart are reviewed and approved by executive management for adequacy.
These documents are available in Human Resources. Organizational Chart on page (18).

 Senior Electrical Engineer serves as the Ex-Representative and is responsible for the activities associated
with products intended for use in explosive atmospheres, and is under the direction of the President of Metal
Samples and Chief Technical Officer.
 These activities include interfacing with the approval organization for Ex certificates when changes in
design requires changes in the schedule drawings.
 The appointed Management Representative is responsible for interfacing with the approval organization for
changes in the Quality system.
 The Senior Electrical Engineer and Chief Technical Officer are responsible for initial approval and changes
to schedule drawings where appropriate.
 The Senior Electrical Engineer and Chief Technical Officer are responsible for any necessary concessions.
For changes that impact the explosion proof design there are no concessions.
 The Senior Electrical Engineer is responsible for informing customers of any applicable special conditions
for safe use and any limitations. lf the sign "X" is placed after the certification number; it indicates that the
equipment or protective system is subject to special conditions for safe use specified in the schedule to this
certificate.
 The Electronics Lab Supervisor is responsible for receiving inspection of Ex product/services, reviewing Ex
certificates and technical documentation and identifying any changes that effect product compliance with the
certificate. The Ex-Representative is responsible for annually checking the validity of all Ex related
certificates, standards, regulations, and other external specifications.

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5 LEADERSHIP

Management Representative

The CEO has appointed a Management Representative. As management representative, he or she has the
following responsibilities and authority:

 Ensure that processes needed for the quality management system are established and implemented.
 Report to executive management on the performance of the quality management system and note any
needed improvements.
 Promote awareness of customer requirements throughout the organization.
 Act as a liaison with external parties such as customers or auditors on matters relating to the QMS.

Ex Representative

Authorized person to deal with products manufactured to the requirements of an “Ex” type directive (e.g., ATEX
or IECEx). The Ex-Representative has the following responsibilities and authority:

 Ensure the implementation of approved (by Notified Body) documents, verifies validity of Ex certifications,
standards, and regulations (ATEX/IECEx), etc., annually.
 Maintain approved documents.
 Verify and approve Purchase Orders for Ex product.
 Verify the product according to the requirements called out on the Purchase Order and the Ex-certificate.
 Shall be involved in any changes that could affect Ex product compliance.
 Influence training activities.
 Evaluate non-conformances.
 Perform audits regarding Explosive Atmospheres procedures.

5.4 Quality Management System Planning

The quality system has been planned and implemented to meet our quality objectives and the requirements of
4.1 of the ISO 9001:2015 standard. The CEO and executive management have identified, planned, and provided
the resources needed to achieve the quality objectives and ensure the continual improvement of the system.
Process Flow Chart, FC 4.4-1 represents an overview of the ALSPI Quality Plan.

The company also applies quality planning to all work resources and considers the implementation of the
contents of this quality manual to meet ISO 9001:2015 requirements and to be their primary quality plan. Quality
Plans for individual jobs are documented through individual job routings and Inspection and Test Reports, QF
8.6-1-A.

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Alabama Specialty Products, Inc. ISO9001:2015 Quality Manual

6 PLANNING

6.1 Action to Address Risk and Opportunities

While planning the QMS, ALSPI considers the context of the organization, needs and expectations of
interested parties, and the scope of the QMS. The CEO and executive management determine risks and
opportunities related to the ability to give assurance that the QMS can achieve intended results, enhance desirable
results, prevent, or reduce undesired effects, is compatible with the context of the organization, and can achieve
continual improvement.

Executive management is responsible for incorporating risk-based thinking into our organization’s culture. Risk and
opportunity management is undertaken as part of ALSPI’s day-to-day operations and is captured in the following
categories: Budgets and profitability (Strategic level), Performance and efficiency (Programmer level), Resources
and targets (Department Level), and Evaluation and assurance (Process level). This ensures that each category for
capturing risk and opportunity is managed at the most appropriate level.

ALSPI has planned actions to address the risks and opportunities and has initiated appropriate procedures to
integrate and implement appropriate actions into our QMS including the evaluation of the effectiveness of our QMS
processes. The company also applies quality planning to all work resources and considers the implementation of the
contents of this quality manual to meet ISO 9001:2015 requirements. (Quality Plans for individual jobs are
documented through individual job routings and Inspection and Test Reports).

6.2 Quality Objectives and Planning to Achieve Them

Executive management at ALSPI ensures that quality objectives are established throughout the quality management
system at relevant functions, levels, and processes. The quality objectives meet the following requirements:

 Consistent with the Quality Policy.

 Measurable.
 Take into consideration the applicable requirements.
 Relevant to conformity of products and services and enhancement of customer satisfaction.
 Monitored.
 Communicated.
 Updated as appropriate.

The objective results are regularly reviewed by the management to monitor

realization and to include new or modified situations during regular production and management review meetings.

6.3 Planning of Changes

When the organization determines a need for changes to the Quality Management System, the Management
Representative takes responsibility to carry them out in a planned manner. Executive management plans changes to
the QMS considering the purpose of the changes & potential consequences, integrity of the QMS and allocation or
relocation of responsibilities & authorities.

The quality system ensures that the product conforms to the type described in the Ex-certificate. All the elements,
requirements and provisions adopted by ALSPI are documented in a systematic and orderly manner in the form of
written policies, procedures, and instructions. The quality system documentation permits a consistent interpretation of
quality programs, plans, manual and records.
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7.1 Resources

ALSPI determines and provides resources needed for establishment, implementation, maintenance, and
continual improvement of the Quality Management System. We are committed to preserving and
communicating organizational knowledge.

7.1.1 General
Resources include:
 People.
 Machines and materials.
 Software and hardware.
 Tools.
 Environment.
 Monitoring and measuring instruments.
 Safety equipment.
7.1.2 People

ALSPI provides the necessary staff with the needed knowledge and skills, organization infrastructure, and
financial resources for establishing, implementing, maintaining and improving the QMS.

7.1.3 Infrastructure
Executive Management is committed to providing and maintaining suitable facilities that are necessary to
implement the Quality Management System that will achieve conformity of product. The required infrastructure
and resources are identified, this includes building facilities, necessary workspace, associated facilities,
process equipment, information systems, communication media and transportation.

An electronic maintenance program specifies the type and the frequency of needed maintenance, the methods
for maintenance and the verification of its completion.
Executive Management ensures the timely availability of identified and approved resources.

7.1.4 Environment for the Operation of Processes

Executive Management ensures that the appropriate human and physical factors for the work environment are
considered and provided, including such factors as noise, temperature, lighting, etc. ALSPI is committed to
maintaining its facilities in a safe and healthy manner and establish and provide an infrastructure that is needed
to comply with product requirements.

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7.1.5 Monitoring and Measuring Resources

The monitoring and measurement to be undertaken is identified and the monitoring and measuring equipment
needed to provide evidence of conformity of product to specified requirements is determined.

Measuring and monitoring equipment is used and controlled to ensure that measurement capability is consistent
with monitoring and measurement requirements.

In addition, Quality Control reviews and records the validity of the previous measuring results when the
equipment is found not to conform to requirements. ALSPI takes appropriate action on the equipment and any
product affected.

7.1.5.1 General

Suitable equipment is used. Monitoring and measuring activities are implemented. Product release, delivery, and
post - delivery activities are implemented.

ALSPI provides procedures, production equipment, working environments and inspection/testing facilities that
together provide assurance with respect to the compliance of the product with the type described in the Ex-
certificates.

7.1.5.2 Measuring Traceability

Records of the results of calibration and verification are maintained. Ref: PC 7.1.5, Control of Measuring and
Monitoring Devices.

The capability of computer software to satisfy the intended application is established prior to initial use and
reconfirmed as necessary, when used in the monitoring and measurement of specified requirements.

7.1.6 Organization Knowledge

The Organization shall determine the knowledge necessary for the operation of its processes and to
achieve conformity of products and services. Organizational knowledge is the specific knowledge that the
company has gained by experience, which is used and shared to achieve the objectives of the company. This
comes from internally, such as intellectual property, lessons learned from failure and successes, or the results
of improvements, or externally from conferences, customer knowledge, or supplier knowledge. Knowledge is a
resource needed for the company to support the quality management system processes and to ensure
conformity of its products and services.

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ALSPI captures necessary knowledge in a number of ways including but not limited to:

 Work Instructions
 Processes
 Product Knowledge
 Work Experience
 Technologies and Infrastructures
 Checklist
 Training Classes, Seminars etc.
 On-The-Job-Training
 Conferences and Networking
 Knowledge Databases
 Legal Requirements and Limitations
 Logistics Requirements
 Customer Requirements and Expectations
 Business & Market Knowledge
Documents for maintaining knowledge and providing evidence of compliance include but not limited to:

 Contract Reviews – clause 8.2.3.2

 Operations of processes – clause 4.4.2
 Monitoring & measuring resources, fitness for use – clause 7.1.5.1
 Planning & control processes – clause 8.1
 Design & Development records – clauses 8.3.3. – 8.3.6
 Change control records – clause 8.5.6
 Supplier evaluations – clause 8.4.1
 Personnel competency records – clause 7.2
 Product non-conformity records – 8.7.2
 Corrective action records – 10.2.2

ALSPI’s Organizational Knowledge is continually improved through company practices, behaviors, decisions,
and performance. Our focus is on knowledge processes, creation, acquisition, refinement, storage, transfer,
sharing and utilization. These processes support organizational innovation, individual learning, collective
learning, and collaborative decision making. The outcomes are improved organizational behaviors, decisions,
products, services, processes, and relationships that enable the company to improve its overall performance.

7.2 Competence
To ensure the competence of personnel, job descriptions have been prepared identifying the qualifications
required for each position that affects conformity to product requirements. Qualifications include requirements
for education, skills, and experience.

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Appropriate qualifications, along with required training, provide the competencies required for each position.
Human Resources maintains appropriate records of education, training, skills, and experience.

ALSPI ensures that all personnel having an impact on Ex compliance receive appropriate training.

Qualifications are reviewed upon hire, when an employee changes positions or the requirements for a position
change. Human Resources maintains records of employee qualifications. If any differences between the
employee’s qualification and the requirements for the job are found, training or other action is taken to provide
the employee with the necessary competence for the job. The results are then evaluated to determine if they
were effective.

ALSPI ensures that all personnel having an impact on Ex compliance receive appropriate training.

7.3 Awareness

All employees are trained in the relevance and importance of their activities and how they contribute to the
achievement of the quality objectives.

7.4 Communication

Executive management shall ensure that appropriate internal and external communication processes are
established within the organization and that communication takes place. Executive management can
communicate within the organization at all levels. Communication is one of our support processes
necessary to make the QMS work and to stimulate continuous improvement. It is the link between
requirements and the people who must fulfill them. The methods and nature of ALSPI communications
include, but are not limited to the following:

 Changes in work instructions

 Revisions to customer specifications
 Project status
 Training
 Process deviations
 Segregation of material
 Signatures
 E-mails
 Meetings
 ECN’s
 Internal audits
 Memos
 Bulletin Boards
 Computer terminals
 Records

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Internal and external communications relating to Ex product shall be controlled. These communications
may include but not limited to, manufacturer documentation, technical documentation, Ex certificates, and non-
conform products placed on the market. External communication could be communicated to clients,
certification body, providers, distributors, authorities etc.
7.5 Documented Information

7.5.1 General

The QMS documentation includes:

 The documented Quality Policy and Quality Objectives.

 The Quality Procedures were established to meet quality, customer, and regulatory requirements. The
documented processes and workflows are implemented and maintained.
 All such documents (including work instructions and forms) that ALSPI needs to ensure the effective
planning, operation, and control of its processes.
 All records that are required by quality, customer, and regulatory requirements to provide objective
evidence of policy, product and/or process compliance.
 All documentation required by the ISO 9001:2015 and EN ISO/IEC 80079-34, ATEX Directive
2014/34/EU and IECEx Scheme.

7.5.2 Creating and Updating

ALSPI has established, documented, implemented, and maintains a Quality Procedure for the control of
documents and records. This procedure defines how all documents and records that are required by the QMS
are controlled. (Ref: QP 7.5.3)
They provide evidence of conformity to requirements and the effective operation of our Quality Management
System.
All such records are kept legible, readily identifiable, and retrievable.
Records are considered a type of document; records are controlled according to the requirements of QP 7.5.3.

a) The company maintains quality records in order to provide evidence of conformance to requirements as well
as to provide evidence of effective operation of the QMS. (Ref: QP 7.5.3, Control of Documents and
Quality Records.)
b) ALSPI’s procedures ensure that information contained within ALSPI’s documentations is compatible with
the technical documentation. ALSPI shall not initially approve or subsequently amend related drawings
unless they are in compliance with the schedule drawings.

c) ALSPI’s quality system ensures that no factor (type, characteristic, etc.) defined within the Ex
Certificate and technical documentation (e.g., schedule drawings) is modified unless permitted by the issuer
of the certificate.

d) ALSPI has a documented system that refers all related drawings to the relevant schedule drawings,
Where there are common schedule drawings associated with more than one Ex certificate,
ALSPI has a documented system to ensure simultaneous supplementary action in the event of
an amendment to such drawings.
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e) Where ALSPI also has drawings for equipment not intended for use in explosive atmospheres, ALSPI
has a system that enables both the related drawings and schedule drawings to be clearly identified,

f) Intertek or CML are the notified bodies responsible for the quality system of each Ex-certificate.

g) Ethical business practices are applied. We believe it would not be in the company’s best interest to send
technical documents that were misleading.

h) ALSPI has a documented procedure to annually check the validity of all Ex related certificates,
standards, regulations, and other external specifications. (Ref: QP 7.5.3, Control of Documented
Information and EXDOC-000011, EX Standards Compliance Checklist.)

7.5.3 Control of Documented Information

REF: QP 7.5.3, Control of Documented Information.

As a minimum, the list of documents requiring control and retention, as far as applicable, shall be:
those arising from regulatory requirements, all documents regulated by external certifying bodies, customer
orders, contract review, training records, part specifications, drawings, bill of materials and inspection and test
data (per batch), calibration data, sub-contractor evaluations, delivery data (customer, delivery date and
quantity, including serial numbers where available).

Documented information is retained indefinitely in the company business management software to provide
evidence of conformity to the requirements specified by ISO standard 9001:2015, ATEX/IECEX, and customer
requirements and of the effective operations of our management system. All management system documents
are controlled according to QP 7.5.3, Control of Documented Information.

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8 OPERATION

8.1 Operational Planning and Control

Quality planning is required before new products or processes are implemented. Quality plans for product
realization have been prepared in the form of collaborative processes involving many functions and departments.
These are outlined in Process Flow Chart FC 4.4-1 which addresses the requirements and interactive needs.
These are further delineated in each of the appropriate paragraphs of Section 8.

The quality planning elements specifically determine quality objectives for products; the need for processes,
facilities, documentation, and resources specific to product realization; product verification and validation,
monitoring, inspection, and test activities; criteria for product acceptability and the records to demonstrate
product and process conformance.

8.2 Requirements for Products and Services

Alabama Specialty Products, Inc. has documented procedures that provide for the determination/identification
of customer requirements, to include those that are not specified, but are necessary for intended use or
compliance with statutory and regulatory requirements applicable to the product.

Reviews of customer specifications are performed when received and any requirements documented for
implementation as applicable. These may take the form of quality assurance instructions, standard comments
for specific customer orders, instructions for design implementation or the use of industry standards for design,
product fabrication, validation and/or verification processes.

8.2.1 Customer Communication

ALSPI recognizes the necessity for customer communication and feedback as a major contributing element of
customer satisfaction and has implemented an effective process for communicating with customers.

 ALSPI produces hard copy product and services catalogues and catalogues for its divisions.
 ALSPI maintains a comprehensive website.
 Customers can contact ALSPI via phone, e-mail, fax, and mail.
 Customer complaints are managed through the Sales Department.
 Customer Satisfaction Surveys are used to monitor customer satisfaction.

8.2.2 Determination of Requirements Related to Products and Services

Alabama Specialty Products, Inc. has documented procedures that provide for the determination/identification
of customer requirements, to include those that are not specified, but are necessary for intended use or
compliance with statutory and regulatory requirements.

Reviews of customer specifications are performed when received and any requirements documented for
implementation as applicable. These may take the form of quality assurance instructions, standard comments
for specific customer orders, instructions for design implementation or the use of industry standards for design,
product fabrication, validation and/or verification processes.

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8.2.3 Review of Requirements Related to Products and Services

In order to establish and maintain customer satisfaction, a formal system is in place and maintained to ensure
that each commitment to supply a product is formally reviewed and controlled. The review is conducted prior to
the commitment to supply a product and ensures that:

 The requirements are adequately defined and documented.

 Where the customer provides no written statement of requirements, the order requirements are confirmed
verbally before acceptance.
 ALSPI has the resources to meet the defined requirements.

The review ensures that any stated customer requirement is compatible with the Ex-certificate e.g., equipment
group, temperature class, type of protection, EPL and ambient temperature range.

Record requirements from these reviews are shown on the quote, e-mails, and/or the order acknowledgement.

8.2.4 Changes to Requirements for Products and Services

In cases in which product or service requirements are changed, ALSPI ensures that relevant documents are
amended, and relevant personnel are made aware of the changed requirements.

 Any differences between the contract and the tendered quotation are resolved to the mutual satisfaction
of the involved parties before formal acceptance of the contract.
 In the event of product/contract requirement amendments, appropriate notification is given to affected
departments within ALSPI and that relevant documentation is revised.
 The person identified in clause 5.3 shall approve any changes that could compromise Ex compliance.

8.3 Design and Development of Products and Services

Vice President of Engineering appoints persons responsible for planning, realization and management of
product design and development and project management according to QP 8.3.1 Design or Development
Project Creation.

8.3.1 General
The Design and Development procedures outline the processes for controlling the Design and Development
process.

8.3.2 Design and Development Planning

The company reviews and evaluates design requirements to ensure that the products it designs and/or
develops meet or exceed customer specifications. While addressing technical, logistical, and financial
concerns that impact the design process activities, ALSPI consistently exercises its organizational interfaces.
Planning is maintained to its most current status, as appropriate, as design activities progress.

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8.3.3 Design and Development Inputs

ALSPI identifies design and development inputs and any applicable statutory or regulatory requirements
during contract review and/or customer meetings. Ambiguous, conflicting, changing, and unclear/incomplete
requirements are clarified by reviews of the design at various stages of the designing process. Design
requirements are amended to accurately capture all pertinent design input information. Design and
development inputs, where applicable, are derived from previous similar designs and other
requirements essential for design and development.

Inputs are reviewed for adequacy, and ensures that all requirements are complete, unambiguous, and not in
conflict with each other. Records are maintained in compliance with section 7.5.3, Control of Documented
Information.

8.3.4 Design and Development Controls

ALSPI performs systematic reviews of design and development at suitable stages in accordance with our
design and development plan (Ref: 8.3.2). These reviews:

 evaluate if the results of design and development are able to meet requirements.
 identify any problems and propose necessary actions.

Representatives of those functions concerned with the design and development stage under review are
participants in the reviews.

Records of the results of the reviews and any necessary actions are maintained. (Ref: 7.5.3)

The design control procedure assures that at appropriate stages of design, design verification is conducted
in accordance with planned arrangements (Ref: 8.3.2) to assure the design stage output meets the design
stage input requirements. Records of design verification and any necessary actions are maintained.

The design control procedure assures that design validation is performed in accordance with planned
arrangements (Ref: 8.3.2) to ensure that the resulting product is capable of meeting the requirements for the
specified application or intended use, where known. Wherever practical, validation is completed prior to
the delivery of implementation of the product. Records of the results of validation and any necessary
actions are maintained.

8.3.5 Design and Development Outputs

ALSPI captures design and development outputs in design review minutes and customer reviews as needed.
The reviews are performed specifically to verify that design output meets or exceeds design input
requirements, contains or references acceptance criteria, and identifies characteristics of the design crucial
to the safe and proper functioning of the product. It also assures design outputs are reviewed and approved
prior to release. Design and development outputs provide appropriate information for purchasing,
production and for service provision. The design control procedure assures that all pertinent data required
for the product to be identified, manufactured, inspected, used, and maintained is defined.

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8.3.6 Design and Development Changes

All design changes either initiated by ALSPI or requested by the customer are reviewed and approved before
implementation. Changes that impact parts or product form, fit or function will have applicable verification
and/or validation performed.

The person identified in clause 5.3 shall be involved in any changes that could affect Ex product compliance.

8.4 Control of Externally provided Processes, Products and Services

8.4.1 General

Where ALSPI chooses to outsource any process that affects how our products meet requirements,
ALSPI ensures control over such processes and maintains responsibility for meeting customer
requirements. The QMS identified the type and extent of control over such outsourced processes.
While manufacture, testing and final inspection may be sub-contracted, the responsibility for ensuring
conformance with the Ex-certificate shall not be sub- contracted, suppliers that provide a product,
process or service that can affect the product's compliance with the Ex-certificate, shall only be
selected after an evaluation has demonstrated that they have the capability of ensuring compliance
with all specified requirements.

 documented objective evidence that the supplier can provide a product, process, or service
that is fit for its purpose shall be made by one or more of the following methods:

 the supplier has an acceptable Ex quality system,

 the supplier has a quality system certificate in accordance with the appropriate
standard and with an acceptable scope,
 a documented site assessment to ensure that all relevant controls are available,
documented, understood and effective.

 suppliers providing calibration services (including verification on measuring devices by comparisons with
calibrated equipment) shall be evaluated on their ability to meet stated requirements, in addition to 7.1.5.

 where the features affecting the type of protection cannot be verified at a later stage, e.g., encapsulated
intrinsically safe circuits, then the product, process or service shall only be accepted by one of the following
methods:

 ALSPI can demonstrate that the control process implemented by the subcontractor
ensures Ex compliance,
 the body responsible for the verification of the quality system performs periodic
audits at the sub-contractors.

 Suppliers not used for a period exceeding 1 year shall be re-evaluated in accordance with
FC 8.4.2. prior to the placing of a contract or a purchase order.

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8.4.1 General

 Where requirements b) and c) are not mandatory for products, processes, or services where
ALSPI verifies conformance in accordance with 8.4.2.

 The ongoing ability of the supplier to provide conforming product, process or service shall be
reviewed at periods not exceeding one year.

 ALSPI shall facilitate an arrangement whereby the body responsible for the verification of the Ex
quality system may also verify aspects of any supplier’s operation that affects the type of protection.

8.4.2 Type and Extent of Control

A documented process, FC 8.4.2, Purchasing, is followed to ensure that the purchased product conforms to
the specified purchase requirements. The process outlines the extent of control required for suppliers.
Suppliers are evaluated, selected, and re-evaluated based on their ability to supply products in accordance
with requirements as outlined in the process. Receipt or acceptance of a Declaration of Conformity according
to Annex C does not absolve the manufacturer from responsibility to ensure conformity. It shall be confirmed
that one of the following processes is used to verify the continued conformity of the materials critical to the
applied type of protection, used in the production of the Ex-equipment:

 Review of the Declaration of Conformity from the material supplier within the supply chain that may impact
the material characteristics; as applicable; to demonstrate that the material used in the production of the Ex
equipment is in accordance with schedule drawings.

 Review of the manufacturer’s confirmation that the material maintains the particular material property of
concern, e.g., flammability, CTI, RTI, or UV resistance, chemical composition, physical properties.

 Confirmation that equipment testing necessary to confirm that the material is in accordance with the Ex
certificate or schedule drawings are repeated as required.

 Purchased products that can compromise the type of protection ALSPI shall determine and implement
verification arrangements which demonstrate the product’s compliance with the Ex-certificate,
considering the nature of the product and the nature of the supplier.

 When deciding what type of verification is required for a particular purchased product, ALSPI shall
consider the nature of the purchased product, the supplier and how critical it is to the type of protection.

 Where the supplier has been evaluated, and documented objective evidence has been obtained to
demonstrate that the supplier is fully capable of producing and verifying the product or service, no
further verification of the product or service is required, provided a declaration of conformity according
to ISO/IEC 17050-1 is supplied with each batch or product.

 Where the Ex-certificate specifies routine tests or inspections, these shall be carried out on each
product, unless specifically permitted by the Ex-certificate and the technical documentation, statistical
methods shall not be used. They may be carried out by either the supplier or ALSPI.

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8.4.2 Type and Extent of Control

 When carried out by the supplier, this shall be specified on the purchasing documents, e.g., by a quality
plan, and confirmed by the supplier, e.g., by a declaration of conformity according to ISO/IEC 17050-1
including test results, if required.

 Where verification of a purchased product cannot be carried out after manufacture, e.g., the internal
parts of encapsulated intrinsically safe circuits, then the product shall only be accepted if supplied with
a declaration of conformity according to ISO/IEC 17050-1. This shall specifically state compliance to
the purchase documents, e.g., a quality plan that lists the factors that together demonstrate conformity
of the product.

 Where sample inspections or tests are permitted, they shall be conducted in a manner which
demonstrates conformity of the entire batch.

 Where either the supplier or ALSPI requires training or specialist skills or knowledge to carry out a
verification, then the training material, specialist skill, knowledge or background shall be documented
and training records maintained.

 Where ALSPI chooses not to carry out inspections and tests on their own premises, then inspections
and tests shall be performed on the supplier’s premises under the responsibility of ALSPI.

 Where a supplier provides a product with evidence of conformity applicable to use in an explosive
atmosphere (e.g., Ex certificate), then further verification is not required unless ALSPI considers it
necessary.

 Where verification of a purchased product relates to the material (metals, alloys, nonmetallic parts,
resins and similar), a specific analysis certificate or declaration shall be supplied.

Alternative processes may be utilized if it can be demonstrated that they provide the same level of conformity.
Records of the evaluation and necessary actions are maintained as quality records.

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8.4.3 Information for External Providers

Purchasing information describes the product or the service to be purchased, including where appropriate:

 Requirements for approval of product, processes, procedures, services, and equipment.

 Purchasing documents shall clearly describe the specific requirements pertaining to subcontracted
products set out in the Ex-certificate and the equipment documents (e.g., for process control, testing or
inspection).
 for items where conformance cannot be verified after manufacture (e.g., encapsulated intrinsically safe
circuits), the purchasing information shall set out the specific quality procedures, resources and
sequence of activities relevant to the particular item.
 ALSPI shall define the method by which documents, e.g., technical specifications, stated in a particular
purchase order remains traceable to the order.
 Where ALSPI does not provide such documents with subsequent orders, then ALSPI shall have
procedures for ensuring that suppliers have current copies of documents and that their integrity is
maintained.
 Requirements for qualification of personnel.
 Quality management system requirements.
In cases where ALSPI intends to have verification and/or validation performed at the supplier’s premises,
arrangements and methods of product release are submitted in the purchase order information. This includes
materials used in the Ex-equipment is in accordance with scheduled drawings, material maintains the particular
material properties (CRT, RTI, or UV resistance), chemical composition, physical properties, and necessary
testing to confirm that the material is in accordance with the Ex-certificate or schedule drawings is repeated as
required.
Prior to communicating the purchase information to the supplier, ALSPI ensures that the purchase
requirements are adequate.

The verification of purchased product is performed in accordance with work instruction WI 8.4.2-1,
Receiving Inspection. Where the company or its customer proposes to perform verification activities at the
supplier’s premises, the intended verification arrangements and the methods of product or service release
are specified in the purchasing documentation. Verification by the customer neither releases the company
of responsibility to provide products or services, which are acceptable to the customer, nor does it preclude
subsequent rejection by the customer.
8.5 Production and Service Provision
ALSPI validates any processes for production and service provision where the resulting output cannot be
verified by subsequent monitoring or measurement. This includes any processes where deficiencies
become apparent only after the product is in use or the service has been delivered. Validation
demonstrates the ability of these processes to achieve planned results.

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8.5.1 Control of Production and Service Provision

ALSPI plans and carries out the production and service provision under controlled conditions according to
documented procedures, processes, and work instructions where applicable.

 Quality control checks are performed;

 Evidence of completed inspections;
 Detailed process work instructions and specifications for all products;
 Criterial for workmanship and competence;
 Defining qualification criteria and approval of special processes prior to use;
 Approval of equipment and qualification of personnel;
 Requirements for records;
 Revalidation

ALSPI provides procedures, production equipment, working environments and inspection/testing facilities that
together provide assurance with respect to the compliance of the product with type as described in the Ex-
certificate.

8.5.2 Identification and Traceability

ALSPI identifies the product throughout the product realization, identifying the product status with respect to
monitoring and measurement requirements. ALSPI controls and records the unique identification of the
product wherever traceability is a specified requirement. ALSPI establishes and maintains procedures for product
identification during all stages of production, testing, final inspection and placing on the market. Traceability is
required with respect to the final product and its significant parts. Traceability can be achieved using serial number,
batch, or other acceptable methods.

8.5.3 Property Belonging to Customers or External Providers

ALSPI exercises care with customer property while it is under the company’s control or being used. A work
instruction, WI 8.5.3-4, Processing Customer Supplied Material outlines the identification, verification,
protection and safeguarding of customer property provided for use. If any customer property is lost,
damaged or otherwise found to be unsuitable for use, this is reported to the customer and records are
maintained in ERP System.

No customer-supplied products/materials are used in the manufacturing of Ex products.

8.5.4 Preservation
The methods used for handling, storing, packaging, preserving and delivery of products to ensure they are
not damaged and that they are maintained in an acceptable condition are documented in various processes
and procedures These also apply to any constituent parts.
The manufacturer shall provide customers with instructions prepared in accordance with the relevant standards
or statutory and regulatory requirements.

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8 OPERATION

8.5.5 Post-Delivery Activities

Post-delivery support is usually contractual or regulatory, but not always, and may include but is not limited to:

 Engagement with customers to determine if the products or services were to their satisfaction.
 On-site installation of equipment.
 Contractual arrangements such as warranties or technical support.
 Frequently asked questions.
 Authentication of the products.

8.5.6 Control of Changes

ALSPI identifies any design and development changes and maintains records. Changes that impact parts or
product form, fit or function will have applicable verification and validation performed and approvals prior to
their implementation including, if applicable, approval by the customer, statutory or regulator authority. The
review of design and development changes includes an evaluation of the effect of the changes on constituent
parts and products already delivered. Ref: WI 8.5.6-1, Origination and Use of ECR/ECN.

8.6 Release of Products and Services

The verification of purchased product is performed in accordance with work instruction WI 8.4.2-1,
Receiving Inspection. Where the company or its customer proposes to perform verification activities at the
supplier’s premises, the intended verification arrangements and the methods of product or service release
are specified in the purchasing documentation. Verification by the customer neither releases the company
of responsibility to provide products or services, which are acceptable to the customer, nor does it preclude
subsequent rejection by the customer.

Documented procedures have been established and maintained to monitor and measure the characteristics
of the product to verify that requirements for the product are met.
This is conducted at appropriate stages of the product realization process in accordance with the planned
arrangements. Evidence of conformity with the acceptance criteria is maintained. Records indicate the
person(s) authorizing release of the product for delivery to the customer. Product release and service delivery
to the customer does not proceed until the planned arrangements have been satisfactorily completed, unless
otherwise approved by a relevant authority and where applicable by the customer.

Where routine tests are required by the certificate and technical documentation, these tests shall be performed
as specified. Unless specifically permitted by the certificate and the technical documentation, statistical
methods shall not be used.

Ex Products shall only be released after final inspection and testing have been satisfactorily completed. The
manufacturer shall provide customers with instructions prepared in accordance with the relevant standards or
statutory and regulatory requirements, including any Special Conditions of Use or particulars of possible
misuse. Ref: WI 8.5.4-6, Rev. 1, Final Packaging and Delivery.

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8.7 Control of Nonconforming Outputs

ALSPI ensures that products which do not conform to requirements are identified and controlled to prevent
unintended use for delivery. ALSPI takes actions appropriate to the effects or potential effects, of the
nonconformity when nonconforming product is detected after delivery or use has started. These activities
and responsibilities are defined in documented quality procedure QP 10.2, Non-Conformity and Corrective
Action. Records of the nonconformities and actions taken are kept in accordance with QP 7.5.3, Control
of Documents and Quality Records. Nonconforming products are corrected and subject to re-verification
after correction to exhibit conformity to product requirements.

The following applies to the control of nonconforming outputs regarding Ex products:

 ALSPI shall maintain a system such that in the event of the product not complying with the Ex
certificate, and having been supplied, then ALSPI’s customer can be identified.

 ALSPI shall take action, appropriate to the degree of risk, where a nonconforming product has
been supplied to a customer.

 Where an unsafe nonconforming product has been supplied to a customer, ALSPI shall inform the
customer in writing as well as the body responsible for the verification of the quality system, and the
issuer of the Ex-Certificate.
 Where it is not possible to trace the unsafe, nonconforming product (e.g., product supplied via a
distributor or for high volume products such as cable glands) then a notice shall be placed in
appropriate publications providing recommended action to be taken.

 For all nonconforming products that have been supplied to a customer, ALSPI shall maintain, for a
minimum period of 10 years, records of:

 Serial numbers or identification of products supplied.

 The customer who received the product
 Action taken to inform customers and the body responsible for the verification.
 The quality system in the case of unsafe nonconforming product
 Action taken to implement corrective action and update risk and opportunities.

Concessions for the product that takes it outside the design, as defined in the Ex-certificate and
technical documentation, are not permitted.

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9 Performance Evaluation

9.1 Monitoring, Measurement, Analysis and Evaluation

9.1.1 General
The company plans and implements suitable methods for determining which aspects of the quality
management system and its processes are to be monitored, measured, and evaluated. The frequency and
methods by which our processes are monitored, measured, and evaluated is determined and informed by:

 Statutory and regulatory requirements

 Customer specifications requirements and feedback
 Processes and QMS requirements
 Process performance and audit results
 Non-conformities and corrective actions
 Critical for service

All monitoring, measuring and evaluation outputs are documented and analyzed to determine process
effectiveness and to ensure their effectiveness in achieving in-tolerance results, and to identify opportunities for
improvement.

9.1.2 Customer Satisfaction

Customer satisfaction is one of the key indicators of the performance of our Quality Management System.
ALSPI, therefore, monitors information relating to our customers’ perception as to whether ASLPI has met
customer requirements.

ALSPI has determined and established the methods used to obtain and to use this information. These methods
include a review of Customer Return Reports, repeat customer order volume, and a customer satisfaction
survey that is posted on our website.

9.1.3 Analysis and Evaluation

ALSPI determines, collects, and analyzes appropriate data to determine the suitability and effectiveness of
the quality management system and to identify improvements that can be made using QP 9.1, Monitoring,
Measurement, Analysis, and Improvement. This includes data generated by monitoring and measurement
activities and other relevant sources.

 Customer satisfaction and perception data (Ref:8.2.1)

 Conformity to product, customer, and legal requirements (Ref: 8 6)
 The effectiveness of actions taken to address risks and opportunities.
 Suppliers and external providers (Ref 8.4)
 Improvement opportunities identified during internal audits and management review.

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9 Performance Evaluation

9.2 Internal Audit

ALSPI conducts two internal audits annually to determine whether the quality management system conforms to
the requirements of ISO 9001:2015 (1), EN ISO/IEC 80079-34, ATEX Directive 2014/34/EU and IECEx
Scheme (2) and company requirements and have been effectively implemented. The maximum period
between audits is normally 12 months and shall not exceed 14 months.
ALSPI develops the audit plans annually, taking into consideration the status and importance of the activities
and areas to be audited as well as the results of previous audits. The audit plan is revised after each audit
and updated if needed. The audits criteria, scope, frequency, methods and responsibilities are defined.
Audits are conducted by personnel other than those who perform the activity being audited.
The documented procedure includes the responsibilities and requirements for planning, conducting audits,
ensuring their independence, recording results, and reporting to management.

The management accountable for the area being audited is responsible for ensuring that actions are taken
without undue delay to eliminate detected nonconformities and their causes. Follow up activities include
the verification of the actions taken and the reporting of verification results.

9.3 Management Review

9.3.1 General
Executive Management reviews the QMS annually at management review meetings. This review assesses the
continuing QMS suitability, adequacy, and effectiveness, identifying opportunities for improvement and needed
changes. Records are maintained for each management review meeting.

 The maximum intervals between reviews should normally be 12 months and shall not exceed 14 months.
 Top management shall chair the review.
 Personnel responsible for the activities detailed in 5.3 shall participate in the review.

9.3.2 Management Review Input

Assessment of the QMS is based on a review of information inputs to management review. These inputs
include the following:
 Results of audits
 Customer feedback
 Process performance and product conformity
 Status of corrective and preventive actions
 Follow-up actions from previous management reviews
 Planned changes that could affect the QMS – External & Internal Issues
 Recommendations for improvement
 Quality Goals
 Risk & Opportunities for Improvement & Effectiveness of Actions Taken
 Monitoring & Measuring Results
 Ex Product (Explosive Atmospheres)
 Performance of External Providers

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9 Performance Evaluation

9.3.2 Management Review Input

The review includes the overall effectiveness of the quality management system with respect to products
intended for use in potentially explosive atmospheres.

9.3.3 Management Review Output

During these review meetings, management will identify appropriate actions to be taken regarding
the following issues:

 Improvement of the QMS and its processes

 Improvement of product related to customer requirements
 Resource needs

Responsibilities for required actions are assigned to members of the management review group.
Any decisions made during the meeting, assigned actions and their due dates are recorded in the minutes of
management review.

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10 Improvement
10.1 General
Identification of continual improvement needs are determined by analyzing customer satisfaction
information, product and process conformance data, supplier performance data, relevant interested parties, internal
audit results and other data and information relevant to quality performance. Management review considers all
pertinent information and defines priorities for improving the quality system. The corrective action and/or auditing
processes are used to formally identify, respond to, verify acceptability of actions, and track the corrective
action request or internal audit findings.

10.2 Nonconformity and Corrective Action

ALSPI manages nonconformities to control and correct them and deal with the consequences, according to
procedure QP 10.2-1, Control of Non-conforming Product and WI 10.2-1, Issue and Handling of Corrective Action
Request.

Concessions for the product that take it outside the design, as defined in the Ex-certificate and
technical documentation is not permitted.

10.3 Continual Improvement

ALSPI initiates actions to continually improve the suitability, adequacy, and effectiveness of the QMS.
Continual improvement techniques and processes are applied to areas of the business that have an impact on
the quality of our products and services. We analyze customer satisfaction information, product and process
conformance data, supplier performance data, internal audit results and other data and information relevant to
quality performance. We take necessary actions on the results of improvement projects as well as from the
Management Review, which considers all relevant information and defines priorities for improving the quality
system. The corrective action and/or auditing processes are used to formally identify, respond to, and verify
effectiveness of actions taken to address risks and opportunities for continual improvement.

The implementation of the “Process Approach” including the PDCA Cycle and Risks provides verifications that
our QMS is solid, and the achievement of effective process performance.

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