COMPANY XXX

LOGO HERE

INTEGRATED

MANAGEMENT SYSTEM

MANUAL

ISO 9001:2015
ISO 14001:2015
ISO 45001:2018

Revision: 0

XXXXXXX
President/CEO

XXX
1234 Anywhere Street
North Las Vegas, NV 89081
TEL XXX-XXX-XXXX FAX XXX-XXX-XXXX
[Link]

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 Revision History

Date:
Version Describe Change Highlight(s) (mm/dd/yy)
Changed By: Name/Title
A Updated to ISO 9001:2015, ISO 14001:2015 version 05/26/2017 Gay Morgan

E Updated to comply with ISO 45001:2018 05/24/19 Mike Edar

Quality Manager

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 TABLE OF CONTENTS
Sec. # Title Page
Table of Contents
1.0 Company introduction 4
2.0 Scope 5
3.0 Non-applicability of requirements (exclusions) 5
4.0 Context of the organization 5
4.1 Understanding the organization and its context 5
4.2 Understanding the needs and expectations of interested parties 6
4.3 Determining the scope of the Integrated management system 6
4.4 Integrated management system and its processes 7
5.0 Leadership 7
5.1 Leadership and commitment 7-8
5.2 Policy 8-9
5.3 Organizational roles, responsibilities and authorities 9-10
5.4 Participation and consultation 10
6.0 Planning 10
6.1 Actions to address risks and opportunities 10
6.2 Quality objectives and planning 12 -13
6.3 Planning of changes 13
7.0 Support 13
7.1 Resources 14
7.2 Competence 15
7.3 Awareness 15
7.4 Communication 16
7.5 Documented information 16
8.0 Operation 16
8.1 Operational planning and control 17-18
8.2 Requirements for products and services 18-19
8.3 Design and development of products and services 20-23
8.4 Control of externally provided processes, products and services 24
8.5 Production and service provision 25
8.6 Release of products and services 25
8.7 Control of nonconforming outputs 26
9.0 Performance evaluation 26
9.1 Monitoring, measurement, analysis and evaluation 26-28
9.2 Internal audit 28
9.3 Management review 29
10 Improvement 30
10.1 General 30
10.2 Nonconformity and corrective action 30
10.3 Continual Improvement 31
Appendix Sequence of Interaction of Processes, 32-42
Quality and EHS Objectives, Sales Flow, Shipping Flow, & Operations Flow

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1.0 Company introduction

XXX was established in XXXXXXXXXXXXXXXXXX now houses complete Marketing, Engineering,

Procurement, Assembly, Inspection and Test capabilities.

XXX is located at XXXXXXXXXXXXXXXXXXXXXXXXXX on a 4.54-acre site containing a 27,000 sq.

ft. (0.6 acres) pump test facility, and 3 buildings totaling 25,000 sq. ft. of administrative, Safety, Health,
Environmental, Quality, Engineering, Operations, Project Management, Logistics, Aftermarket and
warehousing. The production facility houses equipment necessary to handle, disassemble, assemble,
test and package XXXXX of various sizes.

Another administrative building site is located at: XXXXXXXXXXXXXXXXXXXXXXXX involve:

Executive Management, Finance Purchasing, Sales, Human Resources and warehousing.

Performance data generated at the XXXX facility is collected by a state of the art data acquisition
system located in the administrative/customer building. XXX is committed to providing performance
testing services that conform to customer contractual requirements and are appropriate for their
intended end use. Quality in every aspect of an employee’s job performance is a mandatory
requirement. XXX’s procedures and practices are specifically designed and controlled to assure the
acceptable quality of its products and services.

Company XXXX’s origins go back to the XXXXXXXXXXXXXXXXXXXXXX

Over the next two decades the COMPANY XXX group expanded to include many cutting-edge
technologies, such as dialysis machines, digital computers and control systems for process control,
particle size analyzers, water analyzers, and carbon fiber composite materials, all the while continuing
to acquire technologies and building partnerships to increase their original pump business.
X

The structure of this manual includes an overview of various activities implemented through
Company’s quality system, followed by Process Flow Chart (Appendix 1) that contribute to an
effectively controlled management system.

The overall purpose of this manual:

• Describe continual improvement methods at XXX.
• Discuss company’s focus on customer satisfaction
• Provide and Integrated outline for Quality, Environmental, and Safety Management Systems
conformant to ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018
.

2.0 Scope of implementation ISO 9001:2015 § 4.3

ISO 14001:2015 § 4.3
ISO 45001:2018 § 4.1

The scope of this quality system includes - the policies, procedures, and requirements of the
Integrated Management Systems – Requirements (ISO 9001:2015, ISO 14001:2015 and ISO
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 45001:2018). Consideration was given to all interested parties within the context of the organization
in section 4.1 and 4.2 of this manual. The scope is made available on the Company XXXCryo Inc.
website. This manual applies to the activities located at:

1234 Anywhere St
North Las Vegas, NV 80000 and

1234 Dam near here Street

Las Vegas, NV 000000

The services, processes and activities will involve the quality, environmental and safety
management systems for the:

The XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX

3.0 Exclusions ISO 9001:2015 § 4.3

ISO 14001:2015 § 4.3
ISO 45001:2018 § 4.3

XXX has determined that there are no exclusions to the ISO 9001:2015, ISO 14001:2015 and ISO
45001:2018 standards.

IF YOU HAVE EXCLUSIONS STATE THEM HERE – You can leave the Clause Number as a place
holder and state (Excluded)

4.0 Context of the organization

4.1 Understanding the organization and its context

ISO 9001:2015 § 4.2
ISO 14001:2015 § 4.2
ISO 45001:2018 § 4.2

XXX has determined external and internal issues that are relevant to its purpose and its strategic
direction and that affect its ability to achieve intended results of the integrated management system.
These external and internal issues are communicated by top management and are referenced in
the External and Internal Issues Matrix maintained by XXXXXX (CEO, QA, etc). The periodic review
of these issues is conducted during the Management Review consist of:

• Achievement of SHE objectives

• Improved SHE performance
• Fulfilment of compliance obligations
• Ability to meet or exceed product statutory and regulatory requirements for customers
• Ability to enhance customer satisfaction

XXX understand the market place and strategic requirements to maintain business viability. We have
conducted a SWOT analysis and our website information has a basic description of our customers,
mission, and strategic focus.

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4.2 Understanding the needs and expectations of interested parties ISO 9001:2015 § 4.2
ISO 14001:2015 § 4.2
ISO 45001:2018 § 4.2

XXX has determined the needs and expectations of interested parties, so as to determine their
effect or potential effect on the company’s ability to provide products and services that meet
customer and applicable statutory and regulatory requirements.

XXX has determined the following information:

a) interested parties that are relevant to the IMS;
b) the requirements of these interested parties that are relevant to the IMS are referenced in the
Interested Parties Matrix maintained by XXXXXX (CEO, QA, etc).
c) External and Internal issues matrix
d) below are the needs and expectations considered as compliance obligations.

NOTE: If small business- can reference the landlord lease agreements – if they handle energy, trash, waste
and recycling programs onsite.

Other than the example below…

Documented information in Context of organization and needs of interested parties form describes
the process of determining context of the company and needs of interested parties. XXX monitors
and reviews and updates, as necessary, the Context of the Organization information.

4.3 Determining the scope of the Integrated Management System ISO 9001:2015 § 4.3
ISO 14001:2015 § 4.3
ISO 45001:2018 § 4.3

Consideration were given to sections 4.1 and 4.2 when developing the scope and conformance with
the Context of the Organization. The formal scope documented information is noted in Sections 2
and 3 above.

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 The procurement, assembly and testing of XXXX within the boundaries of the XXXX Street
property.

Reference Appendix 5 for Anywhere St. (other sites) property boundaries (if required)

4.4 Integrated management system and its processes ISO 9001:2015 § 4.4
ISO 14001:2015 § 4.4
ISO 45001:2018 § 4.4
4.4.1 XXX has established and documented an Integrated Management System (IMS), which provides
mechanisms for continual improvement of the IMS and systematic methodology for ensuring,
monitoring and measuring customer satisfaction, limiting impacts to the environmental and minimizing
injuries.

For implementation of the system, the Sequence and Interaction Process Flow is outlined in
Appendix A.

Criteria and methods for effective operation and control of Integrated Management system processes
are established through documented process descriptions (procedures) for each process. Process
descriptions also indicate appropriate monitoring methods and responsibilities. General methods to
measure where applicable, monitor, analyze and evaluate IMS processes, and to implement actions
to achieve intended results and continual improvement are described in section 9.1 of this manual.
These processes address risks and opportunities as determined by the risk methodology outlined in
Sec. 6.1 of this manual.

4.4.2 XXX has created, and it maintains documented information necessary for the support and operation
of its processes. XXX also retains documented information as the necessary evidence to ensure
planned operations of its processes.

5. Leadership ISO 9001:2015 § 5

ISO 14001:2015 § 5
ISO 45001:2018 § 5
5.1 Leadership and commitment

5.1.1 General

Top management at XXX demonstrates its leadership and commitment with respect to the QMS by
taking accountability for the effectiveness of the QMS.

The statement of commitment of the management has been made in the Quality Policy and
Environmental Health and Safety (EHS) Policy (see section 5.3).
The top management actively participates in the development & improvement of the IMS through
the following:

Description
a. Establishing quality and EHS policy and objectives so that they are compatible with
context and strategic direction of XXX
b. Ensuring the integration of the IMS requirements into Company XXX’s business
processes
c. Promoting the use of a process approach and risk-based thinking throughout the
organization
d. Ensuring availability of resources for effective functioning of the IMS
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 f. Communication regarding importance of effective IMS management and
conforming to IMS requirements
g. Ensuring that IMS achieves its intended results and outcomes
h. Engaging, directing and supporting personnel to contribute to the effectiveness of
IMS
i. Promoting continual improvement
j. Providing necessary support to other management roles to demonstrate their
leadership as it applies to their area of responsibility

5.1.2 Customer focus and EHS Guiding Principals

Top management continually works on customer focus by addressing customer needs and
expectations. Top management demonstrates its commitment to customer focus by ensuring that all
the requirements (customer, statutory, regulatory) requirements are determined, understood and
met; risks and opportunities affecting conformity of products and services and ability to enhance
customer satisfaction are determined and addressed and customer satisfaction is maintained.

Customer needs and expectations are determined by XXX through:

• Customer related processes as described in section 7.2.1 of the manual.
• Customer feedback as described in section 7.2.3 of the manual.
XXX ensures that customer requirements are determined and adequately met through contract
review and established processes for customer feedback. One of the agenda items for
management reviews is the analysis of customer feedback to evaluate how customer needs and
expectations can be converted to organizational objectives that are aimed towards continual
improvement and enhancing customer satisfaction.

XXX Guiding Priincples for EHS

• XXX protects the environment and conserves natural resources, by striving to be a leader
in reducing, reusing, and recycling as well as ensuring that all wastes are properly
handled in a safe and environmentally approved manner.
• XXX controls its Occupational Health and Safety hazards to eliminate and minimize risk to
employees and other interested parties who may be exposed to OH&S risks associated
with its activities.
• XXX establishes and maintains appropriate controls, including periodic reviews, audits,
and timely corrective actions to ensure that the policy, objectives, and targets are
appropriate to current operations.

XXX makes available and/or communicate the EHS policy to our employees and interested parties.
XXX CEO Safety Health Environment commitment to safety statement can be reference on our
website. [Link]

5.2 Policy ISO 9001:2015 § 5.2

ISO 14001:2015 § 5.2
ISO 45001:2018 § 5.2

5.2.1 Top Management ensures that the quality and EHS policy is:
• Is appropriate to the purpose and context of the organization and supports its strategic direction
• Provides a framework for setting quality objectives

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 • Includes a commitment to comply with requirements and continually improve the Integrated
management system

The Quality Policy

“To meet or exceed customer expectations by providing superior services and continuously improve
them through the Quality Management System.”

The Environmental Health and Safety Policy

The health and safety of our employees, contractors and all users of our facilities shall be of primary
importance at all times, during which we shall operate to minimize any impact our operations may
have on the environment.

In addition:

XXX will strive to protect the environmental and prevent safety incidents by proactively addressing
safety into our daily operations and by the active participation of all employees.

We Will:
• Ensure that we comply with all applicable federal, state, and local regulatory requirements in
order to safeguard our workplace in order to prevent injuries to our employees and prevent
pollution.
• Where feasible, our operations will strive to reduce, reuse and recycle. Conduct business in
a socially responsible manner and strive to have minimal environmental impacts on our
community.
• Work to continually improve our management system, devote resources and technology to
create superior products and services while conserving natural resources in an
environmentally healthy and safe manner; thereby contributing to a sustainable global
society.
• Hold reviews and assessments of our management system in order to set goals and
measure improvements in our management system.

Company XXX is committed to ensuring that this policy communicated to our employees and is
available to the public. At XXX, our core values include safety and environmental performance as
key factor in doing business.

5.2.2 This Quality policy and EHS policy is available and maintained as documented information. A formal
training on quality policy and the EHS Policy is provided to company employees to ensure that it is
understood and applied within the company.

5.3 Organizational roles, responsibilities and authorities ISO 9001:2015 § 5.3

ISO 14001:2015 § 5.3
ISO 45001:2018 § 5.3

The top management has ensured that responsibilities and authorities within the organization are
assigned communicated and understood through the Organization Chart (Appendix C) and one-to
one correspondence and/or internal meetings. The chart includes those functions that contribute
directly to the quality of the company product and services.

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 Responsibilities & authorities of personnel are also described through methods such as job
descriptions, contracts and respective procedures/work instructions. It is the responsibility of Top
Management to ensure that when a new position is identified (new hire), the organization chart is
updated.

Top management also assigns responsibilities and authorities, as appropriate for:

a) ensuring that the IMS conforms to the requirements of ISO 9001:2015, ISO 14001:2015, and
ISO 45001:2018 standards;
b) ensuring that the IMS processes are delivering their intended quality, environmental and safety
outputs;
c) reporting on the performance of the IMS and on opportunities for improvement (see 10.0), in
particular to top management;
d) ensuring the promotion of customer focus throughout the organization;
e) ensuring that the integrity of the IMS is maintained when changes to the IMS are planned and
implemented.

5.4 Participation and consultation ISO 45001:2018 § 5.4

XXX encourages the participation of employees and contractors to increase their knowledge and
participation in EHS practices. All employees may participate in the system by sending a safety
suggestion to the EHS department or becoming a member of the Safety Committee or Process
Safety Committee (EHS permit requirements). The company promotes the participation of non-
managerial roles within the EHS system requirements, including incident investigations, risk
assessments, control and monitoring (FATs, new production equipment, inspections, and
Management of Change (MOC) processes) activities including internal auditing.

Incident investigations are performed with employees, supervisors and the Director of
Environmental, Health & Safety. The Director of Environmental, Health & Safety primarily provides
oversight on the incident investigation process.

6 Planning

6.1 Actions to address risks and opportunities ISO 9001:2015 § 6.1

ISO 14001:2015 § 6.1
ISO 45001:2018 § 6.1

Ref.: Risk Management Matrix (List of CapEx and other projects / action plans)

6.1.1 When planning for the IMS, XXX considers the issues referred to in 4.1 and requirements in 4.2
within the Context of Organization, and the Scope of the IMS. The cultural, market, and internal
and external interest parties can influence the IMS. Actions involving the risks and opportunities
analysis could previously be called “Preventive Actions.”

XXX determines risks and opportunities based on the context and needs and expectations
of interested parties. Such risks and opportunities are determined for the following
purposes:

a) provide assurance that IMS can achieve its intended result(s) and intended outcomes;
b) enhancement of desirable effects;
c) preventing, or reducing, undesired effects; and
d) to achieve improvement.

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 These risk and opportunities are assessed from our Processes and Interaction flows and the
Environmental Aspects process and documented the Risk Management Procedure EHS-P-027-01
in Controlled Documents.

6.1.2 Based on the risk and opportunities assessment in 6.1.1 above, IMS determines the actions and
the methods to address them. It also works to integrate and implement the actions into its IMS
processes and evaluates the effectiveness of these actions. It also ensures that the actions taken to
address risks and opportunities are proportionate to the potential impact on the conformity of
products and services.

6.1.3 Environmental Aspects and Hazard Identification, Risk Assessment, and Determining Controls

Ref: Environmental Aspect Procedure Environmental

Aspects Matrix
Hazard Identification, Risk Assessment and Controls Matrix

XXX has developed procedures for the ongoing identification of hazards, the assessment of risks,
and the implementation of necessary control measures (See Hazard Identification, Risk
Assessment, and Risk Control).

XXX has developed procedures to:

a) Identify the environmental aspects of its activities, products, and services that it can control and
those that it can influence. This includes changes, planned and new developments, and new or
modified activities, products and services.
b) Abnormal conditions and reasonable foreseeable emergency conditions.
c) Determine those aspects that have or can have significant impact(s) on the environment (i.e.
significant environmental aspects.) (See: Environmental Aspect and Impact Assessment
Procedure)
d) XXX considers the assessment results and effects of controls when setting Environmental and
Safety objectives and when establishing, implementing, and maintaining its IMS.
e) XXX has determined that the Hazard Identification, Risk Assessment, and Risk Control process
shall take place in a proactive manner, prior to incidents, rather than reactively in response to
iXXXdents.
f) For the management of change, XXX identifies the OH&S hazards, risks, and environmental
aspects associated with changes in the organization, the Environmental Health and Safety
Management System, or its activities prior to the introduction of such changes (see Hazard
Identification, Risk Assessment, and Risk Control; Environmental Aspect and Impact
Assessment Procedure; regulatory permit requirements; Safety Committee Structure and
Guidelines.)
g) Risks are classified as low, medium, or high, with low and medium risk jobs classified as
tolerable. Medium risk operations will be evaluated for the possibility of reducing risk through
additional controls. High risk operations are considered intolerable, requiring additional facility
installations, training, or other operational controls.
h) The Hazard Identification, Risk Assessment and Risk Control process is completed by
department supervisors or others with adequate knowledge of the operations.
i) Director of Environmental, Health & Safety shall monitor and document environmental and
safety compliance with required additional controls within the IMS.

6.1.4 Compliance Obligations: Environmental and Safety

XXX uses services and or miscellaneous periodicals which provide, either in published or electronic
form, applicable EHS laws, rules, and regulations of the Federal, State and Local government. When

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 reviewing legal and other requirements, a determination is made of how the legal and other
requirements apply to the environmental aspects and OH&S hazards.

a) International requirements for example, the European Union and or CE marks, are reviewed at
least annually for updates. XXX’s compliance obligations are linked or hyperlinked to other
requirements, therefore, any changes are made to the compliance requirements are tracked and
revised within the Environmental Aspects or Hazard Identification matrices.
b) At least annually or when there is a major rule change; EHS reviews the matrices and linked
compliance obligations. The Compliance Obligations Procedure list general requirements.
c) Other requirements are standards or best practices followed by XXX that are not necessarily
required by law. For example, NFPA, ASTM, CE, UL, ATEX, Bureau Veritas, DNV and ANSI.

Ref: Legal and Other / Compliance Obligations Procedure (or Matrix file)

6.1.5 Planning Action (risk and opportunities)

XXX has developed action plans to address improvements in the IMS. These plans can include:
a) Significant environmental aspects.
b) Risk to injuries that are considered “High Risk” and identified as needed improvement. c)
Compliance obligations.
d) Improvement activities identified in the risk and opportunities analysis.

These action plans will consider technological options, financial, operational and business
requirements.

6.2 IMS objectives and planning to achieve them ISO 9001:2015 § 6.2
ISO 14001:2015 § 6.2
ISO 45001:2018 § 6.2
6.2.1

The Top Management has ensured that Key Performance Indicators (KPIs), also known as quality,
environmental or safety objectives, are established at all relevant levels and functions based on key
processes identified at XXX. The objectives include those needed to meet requirements for product
and for the improvement of IMS processes. Such objectives are measurable and consistent with the
Quality and EHS Policy and take into consideration applicable requirements.

KPIs are monitored, communicated to the appropriate teams and updated as appropriate, based on
past results and applicable data.

The Business Objectives Matrix which includes the EHS Objectives is maintained by Quality
Assurance. Periodic review of the Business Objectives typically occurs during Management Review
and are determined to be as follows:

a) Consistent with the Quality and EHS Policies

b) Measurable
c) Monitored
d) Communicated
e) Updated as appropriate

6.2.2 Planning actions to achieve IMS objectives

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 When planning the KPIs, the company determines the necessary actions, the resources needed,
responsibilities for the KPIs, due dates, and the method of evaluating KPI results.

Planning actions to achieve objectives requires Top

Management interaction to determine the following:
a) What objectives will be put in place that have value.
b) What resources will be required, i.e. tooling, personnel, training, & infrastructure
c) Top management is responsible for the planning actions in order achieve objectives.
d) Objectives will be completed once the set criteria or requirements have been met.
e) During the annual Management Review, the results will be evaluated, including indicators for
monitoring progress toward achievement of the objectives.

XXX will consider how action to achieve its objectives can be integrated into other XXX business
processes.

6.3 Planning of changes ISO 9001:2015 § 6.3

Any changes to the IMS are carried out in a planned manner. In order to make changes, the
following factors are taken into consideration.
a) purpose of the changes and their potential consequences on the IMS
b) impact on the integrity of the IMS;
c) availability of resources;
d) changes in responsibilities and authorities, as necessary
e) Change management is handled by the CAR process, Engineering change process, and Quality
Document Release.

7 Support ISO 9001:2015 § 7

ISO 14001:2015 § 7
ISO 45001:2018 § 7

7.1.1 General

Ref: XXX training database

XXX ensures provision of necessary resources to implement, maintain and continually improve its
IMS, and/or to address customer satisfaction. Through organizational evaluations, XXX determines
capabilities of and constraints on existing internal resources and the need to obtain resources from
external providers.

7.1.2 People

Ref: XXX training database

XXX Organization Chart (latest revision)

XXX determines and provides personnel necessary for the effective implementation of its IMS and
the operation and control of its processes. A documented procedure is implemented in order to
determine the minimum level of competence required for assigning responsibilities to personnel at
different levels.

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 7.1.3 Infrastructure

The company determines, provides and maintains the infrastructure needed for the operation of its
processes and to achieve conformity of its product and services including:

a) Buildings, and associated facilities

b) Equipment which includes hardware and software
c) Transportation resources
d) Information and communication technology

7.1.4 Environment for the operation of processes

Ref: Operational Environmental and Safety and Fire Inspections

Facilities Inspections / Checklist

IMS determines and manages the work environment needed for the operation of its processes and to
achieve conformity of products and services. Social, psychological and physical factors are taken into
consideration in determining the suitable work environment. As appropriate, factors such as noise,
temperature, humidity, heat, lighting, airflow, hygiene and weather protection are managed as part of
the system.
Note: If you lease your facilities – the landlord may be responsible – state what are the landlord’s
obligations, ie. HVAC, trash, recycling, fire system (alarms, sprinklers)

7.1.5 Monitoring and measuring resources Note: If your company has no calibrated equipment –
you can exclude this clause requirement in ISO 9001:2016

Ref: QP-A-076-01 Measurement Traceability – Calibration Log (Test and QA)

The procedure for Measurement Traceability, which describes responsibility and method of
calibration, includes the following activities:

• List(s) of monitoring and measuring devices requiring control and records related to calibration •
Calibration schedule
• Each applicable device will have related:
• Identification
• Calibration schedule (ref. Calibration records)
• Reference Standard (National or international) or the basis used for calibration/ verification in
absence of any existing Standard
• Equipment is subject to periodic maintenance and is safeguarded from adjustments which can
invalidate the calibration. Such equipment will be properly handled by authorized employees to
prevent damage/deterioration.
• Take appropriate action for any delivered product found to be nonconforming due to a lack of
equipment calibration/maintenance through a corrective action.
• Maintenance of records of calibration and verification to ensure fitness of purpose

7.1.6 Organizational knowledge

XXX has determined the organizational knowledge necessary for the operation of its processes and
to ensure conformity of products and services. This knowledge is maintained as documented
information in various forms such as a spreadsheet detailing the knowledge base within the

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 company, in various documented procedures and forms. This knowledge is made to the extent
necessary. ….. by IT data bases: ERP system, SharePoint, etc, etc,

XXX examines its current knowledge base and determines how to access or acquire additional
knowledge when addressing changing needs of the business, entering new product lines or when
addressing new trends in the marketplace.

7.2 Competence ISO 9001:2015 § 7.2

ISO 14001:2015 § 7.2
ISO 45001:2018 § 7.2

Ref: QP-A-062-01 Training and awareness XXX

Training Database
Human Resources – Job Descriptions

To ensure employees are competent to perform respective tasks, XXX takes the following actions:
a) Identification of competence needs for personnel performing conformity to product quality
requirements, EHS compliance obligations for training employees. This can include Human
Resource succession planning and OJT.
b) Provide training or other actions to satisfy job needs. Training related to new additions to XXXs’
processes or any changes is provided to relevant employees. Such training is recorded through
a Training record form.
c) Provide training to personnel not employed by XXX. Records of this training is retained in the
EHS drive under visitor orientation records consisting of but no limited to customers,
contractors, and 2nd and 3rd party inspectors.
d) Evaluation of effectiveness of training is provided through performance reviews and/or other
actions taken by individual managers to ensure competence as required.
e) Awareness training, as applicable, is provided to employees regarding the relevance and
importance of their activities and their contribution towards achieving quality objectives.
f) Maintaining appropriate records of education, experience, training and skills.

7.3 Awareness ISO 9001:2015 § 7.3

ISO 14001:2015 § 7.3
ISO 45001:2018 § 7.3

Ref: QP-A-062-01 Training and awareness

Operations – OJT Competency Employee Checklist

XXX ensures that its employees and contractors who provide services to the company and who are
under its control are aware of the following:

a) Quality and EHS policy;

b) Relevant quality and EHS objectives as it applies to their job function
c) Their contribution to the effectiveness of the IMS, including the benefits of improved
performance;
d) Implications of not conforming to the IMS requirements.

7.4 Communication ISO 9001:2015 § 7.4

ISO 14001:2015 § 7.4
ISO 45001:2018 § 7.4

Ref: XXX Communications Boards, emails, OSHA recordable (countdown form last injury clock)

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 7.4.1 Flow of information and instructions related to the effective implementation of the IMS is in line with
the organization chart and process descriptions. General topics for internal communication may
include quality and EHS policies, objective and status of improvement actions taken, overall
effectiveness of the IMS, and requirements for corrective and preventive actions.

7.4.2 Internal XXX communication methods include Bulletin Boards, XXX Server folders,
committee meetings, postings, all hands meetings and others.

Any employee may communicate ideas / suggestions for IMS improvement to the management (e.g.
managers or supervisors) directly or through their management. Employee feedback is reviewed,
and necessary action is taken by management. If the feedback/suggestion is aimed at improving the
system or any process, it may be discussed during management meetings.

7.4.3 XXX also determines the responsibility and authority with appropriate methods of external
communication relevant to its IMS as necessary to reach the right audience. Document information
will be retained for both external and internal communications; as required.

7.5 Documented information ISO 9001:2015 § 7.5

ISO 14001:2015 § 7.5
ISO 45001:2018 § 7.5

Ref: QP-A-042-01 QMS Documentation

QP-A-042-02 Documented Information

XXX maintains documented information in the form of procedures and forms to meet the requirements
of the ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018 standards as well as the requirements
of the company’s IMS for its effective operation.

Referenced documented procedures (listed above) describe the process of creating, updating and
controlling of documented information such as procedures and work instructions which are used to
ensure effective operation of the XXX IMS.

Appropriate identification (such as using a title, date, author or reference number), format and media
as well as review and approval for suitability and adequacy is ensured when creating and updating
documentation.

The documented information maintained by the company is controlled to ensure that is available and
suitable for use, wherever it is needed and that it is adequately protected so to maintain it in a proper
form as needed.

8. Operation ISO 9001:2015 § 8

ISO 14001:2015 § 8
ISO 45001:2018 § 8

8.1 Operational planning and control ISO 9001:2015 § 8.1

ISO 14001:2015 § 8.1
ISO 45001:2018 § 8.1.1

Operations Procedures
a) OP-B-001-01 Pump shaft straightness measurement
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 b) OP-B-002-01 Shaft Quenching
c) OP-B-003-01 Balance drum assembly (XXX Engineering)
Can be software processes or functional services ----- depends on the business – flow charts, etc.
Test Procedures
EHS P-025 Chemical Accident Prevention Program (CAPP)
EHS Procedure List (EHS Training Requirements List)
EHS-P-024 Process Safety Management (PSM)
EHS-P-025 Risk Management Program (RPM)

XXX has planned and developed its IMS to carry out operations for ensuring products and services
are satisfactorily provided to its customers. A flow chart of major identified processes, including
product realization processes and their interrelation is provided in Appendix 1.

In planning product realization, the following issues are determined:

• IMS objectives and requirements of the product and services

• Establish criteria for:
• Processes
• Product and service acceptance
• Resources to be provided that are specific for the products and services
• Production process documentation including controls and monitoring methods
• Required verification, validation, monitoring activities specific to the product, and the criteria
for product acceptance
• Documented information to evaluate that the product realization processes and the final
deliverables meet the customer and quality requirements.

Planned changes are controlled through change control process and are reviewed for
consequences of unintended changes and if such changes exist, then action is taken to mitigate
any adverse effects.

The organization shall ensure that outsourced processes are controlled or influenced. The type and
extent of control or influence to be applied to the process(es) shall be defined within the IMS.

Note: If you deliver products and services that are not validated (i.e. tested by the customer - or in a
systems install / validation after delivery – this section of the standard can be excluded (8.5.1 f).
Service / Food / consumer products do this..

Environmental – Life Cycle Perspective

XXX has established controls to ensure that the design and development process for the products
and services address the life cycle of our products and services. This is done by:
a) When procurement of products and services are reviewed, considerations will be made
regarding cost, materials sustainability and recyclability, and when possible, this review will
be considered during the vendor evaluation process.
b) When possible, environmental requirements will be made with outside vendors, when
possible only UL, CSA, ATEX, or CE certified products will be purchased. CE marked
materials for electronics will already conform to the RoHS banned labelling requirements for
electronics and other electrical circuits.
c) The final disposition of any product will be placed into final Manufacture Data Book (MDB)
documents for the product. Specific product manuals will direct the customer to properly
recycle all metals and electronics when the pump and associated equipment is being
decommissioned. Document information will be retained.
For small businesses life cycle can be explained by a simple flow chart:

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Delivery of Office Supplies --- Use (Company’s EMS takes care of in-house environmental aspects) –
reduction in impacts ----- Electronic delivery of services or if in print – outsourcing print media product – this
will all depend on the business. Most small businesses have minimal life cycle impacts.

8.1.2 Hierarchy of Controls

XXX, when updating and designing production requirements or products will use the concept of
hierarchy of controls in order of preference with regard to risk management principles.

8.2 Requirements for products and services ISO 9001:2015 § 8.2

8.2.1 Customer communication - quality

The following arrangements have been established for communication with the customer:

# Activity Method
a. Product and services information Sales, Marketing and/or
project management with
associated materials
b. Handling of enquiries, and Order Fulfillment Procedure
orders changes
c. Customer feedback Low Customer Support
d. Customer complaints Action Procedure
Customer Scorecard

During the quoting and proposal process, the sales processes will be followed. After the project and
formal handover process is completed the primarily means of communications with the customer will
reside with the Project Manager and Project Engineer, other departments; Quality and EHS will
provide support to PM, until the project and MDBs, CE, Environmental and Safety Declarations are
completed.
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 Depending upon the complaints or customer feedback, this IMS has the provision to initiate
corrective actions and take other actions to ensure customer satisfaction and continual
improvement.

8.2.2 Determining the requirements related to products and services; including EHS Procurement
and Contractor

Ref: QP-A-072-01 Statement of Work; Request for Quote / Proposal Package Sales Process
EP-A-001-01 Product Realization – Engineering

XXX’s Sales and Applications Engineering (R&D) departments are responsible for administering
requirements to ensure orders are properly handled, during the initial quoting process; RFP / RFQ
processes; which can include:

a) Customer requirements that include technical specifications, delivery, services and

other information or amendments (Technical and Commercial Specifications, Specific
Customer Technical Specifications, etc.),
b) Requirements necessary for intended use but not specified by the customer, such as
any other additional requirement determined by the organization (e.g. packaging
requirements)
c) Statutory, regulatory or legal requirements related to the product (depends on customer
requirements; i.e. CE marking, Hazardous Materials declarations, etc.)
d) Safety and Environmental procurement will include the purchasing of equipment and
materials with the safe handling and risk being assessed within the processes and
interactions at XXX (See Appendix A).
e) When services are provided or outsourced products under the context of the
organization (See Context of the Organization form), vendor and contractor risk must be
effectively managed. Contractors and service providers working at XXX will
acknowledge the receipt of the Contractor Safety procedure and provide the required
documented information, prior to working onsite. Applicable hazards and risk will be
formally discussed, and any issues will be mitigated prior to the start of any work onsite.

Government RFQ and proposal process differ – your company will have to define this.
Documented information as evidence of the review and any subsequent actions are maintained. If
the customer does not provide their requirements in writing, the requirements must be confirmed
prior to acceptance. Where product requirements are changed, all documents are amended, and
personnel made aware of the changes.

8.2.3 Emergency preparedness and response ISO 45001:2018 § 8.2

Ref: Emergency Action Plan (EAP), Emergency Response Plan and Fire Prevention Plan

XXX maintains an Emergency Action Plan (EAP), which identifies the potential for incidents,
accidents and emergency situations that can impact the environment or workplace health and
safety and how XXX will respond to them. The EAP is located on the server, paper copies are
available in the Director of Environmental, Health & Safety’s office. XXX reviews and revises this
plan, if necessary after an EHS incident, accident or emergency, and annually as required.

Emergency drills are completed, and documented information is saved electronically within the SHE
and Facilities server drives.

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 8.2.4 Management of Change

XXX has established a process for the implementation and control of planned changes that
influence it health and safety performance such as:
a) New products, processes or services
b) Changes to work processes, procedures, equipment, or XXX’s organizational structure
c) Changes to applicable compliance obligations
d) Changes to knowledge or information concerning hazards and associated risks
e) Developments in knowledge and technology

XXX will control all risk to injuries weather a process is temporary in nature of permanent, to review
the consequences of unintended changes, and where applicable, to take action to mitigate any
adverse effect that might arise as a result of the occurrence of change. This can result in changes
in:
a) Technology
b) Plant and equipment
c) Facilities
d) Work practices and procedures
e) Design specifications
f) Raw materials
g) Employees
h) Compliance obligation (Legal and other)

8.3 Design and development of products and services (or Exclude) ISO 9001:2015 § 8.3
(NOTE – IF this section is excluded – just state it is excluded and move on. If the site does have
part of the Design – ie. Engineering Design and install of equipment for production (food processes)
you can not except this clause in total. If there are corporate procedures addressing commissioning
and decommissioning equipment and product validation runs – reference them here.)
Ref: Sales Flow Process – Appendix 4
EP-A-001-F-01 - Engineering Design and Development process
EP-A-001-01 Product Realization and Design
EP-A-001-F-02 - Engineering Change Order process
EP-A-001-F-03 - Engineering Functional Testing process

8.3.1 General

XXX has established, implemented and maintained documented design and development
processes as referenced above. These documented procedures ensure that provision of products
and services is per planned arrangements.

8.3.2 Design and development planning

XXX plans and controls the design and development of their products through procedures for
hardware and software designs. These procedures provide information for design and development
planning, communication links and associated responsibilities.

Specific requirements for design and development planning include the following: a)
design and development stages, activities
b) review, verification and validation that are appropriate to each design and development stage
c) responsibilities and authorities for design and development
d) internal and external resources
e) communication links and interfaces between personnel involved in the process
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 f) involvement of customers and users in the design and development process, such as user
acceptance tests, beta testing of hardware and software etc.
g) requirement for providing products and services
h) levels of control over the process as specified by customers and other relevant parties

Planning output is updated and communicated as appropriate, as the design and development
progresses.

Evidence that design and development requirements have been met are maintained as documented
information.

8.3.3 Design and development inputs

Ref: Sales and Applications Engineering – Handover Documents

EP-A-001-F-01 - Engineering Design and Development process

Inputs relating to product requirements are determined by various means. These inputs include:
a) Sales and Applications Engineering – Handover Documents
b) General Arrangement Drawings
b) Functional and performance requirements (Handover Documents and Pump Technical Data
Sheets)
c) Applicable statutory and regulatory requirements
d) Where applicable, information derived from previous similar designs
e) Other requirements essential for design and development including potential consequences
of failure depending on product and service type

These inputs are reviewed for adequacy. Requirements are complete, unambiguous and not in
conflict with each other. Documented information of inputs and review of inputs are maintained per
procedural requirements.

8.3.4 Design and development controls

Ref: EP-A-001-F-01 - Engineering Design and Development process

XXX design and development processes have built in controls to ensure that:
a) The resulting output of the design and development process is well defined
b) Design reviews are conducted as necessary to ensure that results meet the requirements
c) Verification of activities are conducted to match inputs with outputs
d) Validation activities are conducted to the extent necessary to ensure that resulting products
and services meet the intended application and use
e) If there are any issues identified during design reviews, verification or validation stages then
necessary actions are taken to resolve these issues
Documented evidence pertaining to the information in (a) through (e) above is retained.

8.3.5 Design and development outputs

Ref: EP-A-001-F-01 - Engineering Design and Development process

EP-A-001-F-02 - Engineering Change Order process

The outputs of design and development are provided in a form that enables verification against the
design and development input and are approved prior to release. Such outputs include the design.
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 Engineering, Project Management / Quality Assurance ensures that design and development
outputs:

a) Meet the input requirements for design and development

b) Provide appropriate information for purchasing, production and for service provision
c) Contain or reference monitoring and measuring requirements as well product acceptance
criteria
d) Specify the characteristics of the product and services that are essential for their intended
purpose and their safe and proper use

Documented information from design and development outputs is retained in appropriate form.

8.3.6 Design and development changes

Ref: EP-A-001-F-02 - Engineering Change Order process

In case of changes in design and development, authorized Engineering personnel evaluate the
changes. All changes to design and development are reviewed, verified and validated, as
appropriate, and approved (including customer acceptance) before implementation. This is to
ensure that there is no adverse impact on conformity to requirements.

The reviews of design and development changes include evaluation of the effect of the changes on
product and services already delivered.

Ruckus Wireless maintains documented information as records on changes, results of reviews,

authorization for change and actions taken to prevent any adverse effect.

8.4 Control of externally provided processes, products and services ISO 9001:2015 § 8.4

8.4.1 General

Ref: QP-A-074-01 Purchasing

Approved Supplier List (ASL)
Vendor Selection and Approval Process, Appendix 5

XXX ensures that externally provided processes, products and services conform to specified
requirements.

a) XXX has a documented procedure for vendor selection and approval providing information on
methods to control purchasing, implement vendor qualification and evaluate processes in order
to ensure that the purchased product and service conform to the purchase requirements.
b) Completed qualification and subsequent evaluation along with any follow-up carried out for
approved vendors are maintained as records.
c) In addition, vendor control is also established through monitoring of vendor performance with
regards non-conforming materials, on-time delivery and quality of the products delivered.

XXX maintains documented information as evidence on the activities above and any action items
resulting thereof.

8.4.2 Type and extent of control

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 Ref: QP-A-074-01 Purchasing
QP-C-002-01 Receiving

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

As a result, the company ensures the following:

a) Externally provided processes remain within the control of its MIS
b) Definition of both the controls for an external provider and the products and services provided by
the external provider
c) Consideration of the following:
• The potential impact of outsourced processes, products and services on the company’s
ability to consistently meet customer and applicable statutory and regulatory
requirements;
• The effectiveness of the controls applied by the external provider to the products and
services being provided to XXX.

d) Verification, or other activities, necessary to ensure that the externally provided processes,
products and services meet requirements.

The QP-C-002-01 Receiving Procedure the necessary requirements for verification of purchased
product to ensure that purchased product meets purchase requirements.

8.4.3 Information for external providers

Ref: QP-A-074-01 Purchasing

QP-C-002-01 Receiving

XXX has a documented procedure to describe the purchasing process and the requirements for
providing purchase order information to external providers on the following:

a) Processes, products and services to be provided. This will include all facets of quality, safety and
environmental requirements.
b) Approval of products and services; methods, process and equipment; release of products and
services
c) Any required competence criteria for personnel
d) Methods of interaction with XXX and points of contact (described in P.O.s and service contracts)
e) Control and monitoring of vendor performance as determined by the company, such as through
Material Review Boards (MRBs) or Performance Review Boards.
f) Any verification or validation activities which the company or its customers might intend to
perform at vendor’s premises

8.5 Production and service provision ISO 9001:2015 § 8.5

8.5.1 Control of production and service provision

Ref: EP-A-001-F-02 - Engineering Change Order process

Operations – Assembly processes:
Ex-tank Flowchart,
Hydrostatic Testing Flowchart
In tank Flowchart
Pump Assembly Flowchart
Pump Component Flowchart
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 Final Assembly Flowchart – Appendix 7
Shipping process – Appendix 6
Testing – processes and procedures

Production and provision at XXX is planned and controlled through the following ways, as
applicable:

• The Incoming Material (QP-C-002-01 Receiving) and Outgoing Shipment (Logistics

procedures and/or an Inspection and Test Plan (ITP) shipment requirement)
• Availability of information that describes the key characteristics of the product/service
• Work instructions (if necessary) required
• The use of suitable equipment for production and service operations
• Availability and use of monitoring and measuring devices equipment
• Ensuring qualification of employees that are performing specific tasks (internal resources and
vendors).
• Ensuring use of monitoring and measurement practices and implementing adequate
monitoring and measuring methods.
• The implementation of defined operations for labeling and packaging
• Implementing release, delivery and post-delivery activities per agreement with customers.

8.5.2 Identification and traceability

Ref: EP-A-001-F-02 - Engineering Change Order process

EP-A-002-02 - Item Numbering - Component Sub-Assembly Assembly

Where appropriate, XXX identifies its outputs (products and services) by suitable means.
Identification and traceability related to incoming products is described, maintained and
implemented in the ECO process.

As applicable, products are identified by P/N, S/N, and board revision numbers. Nonconforming
products are clearly marked per the control of non-conforming products procedure.

For small business – contract numbers, project numbers, customer names are normally used for ID
and traceability – especially any formal written reports or products requested. If your company does
not require this – exclude it. Applies to Human Resources / services with no formal report
requirement, i.e. hotels.

8.5.3 Property belonging to customers or external providers (Note: if you have no customer
property – exclude this clause)

Ref: QP-A-075-04 Customer Property

XXX has established a procedure to document the process for handling customer property or the
property belonging to external providers.

XXX will exercise care to maintain, protect and safeguard all customer supplied equipment
(including intellectual property, as applicable) as well as property belonging to external providers. If
any such property is lost, damaged, or otherwise found to be unsuitable for use, it is recorded as
documented information and reported to the affected party as outlined in the procedure.

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 8.5.4 Preservation (Note: if you are a service provider – no products involved – exclude this clause)

Ref: Shipping process – Appendix 6

QP-D-002-02 Export Compliance Procedure

Preservation of outputs during production and service provision includes conformity to requirements
for identification, handling, packaging, storage and protection of incoming and finished products and
during delivery process.

8.5.5 Post-delivery activities

XXX has determined and requirements for post-delivery activities for its products and services by
considering:
• applicable statutory and regulatory requirements
• potential undesired consequences
• nature, use and intended lifetime of its products and services
• customer requirements
• customer feedback

XXX Project Management is responsible for administering requirements to ensure orders are
properly finalized after the FAT and the Logistics department is responsible for final delivery
requirements. Support for final packaging and shipment may be given by the Operations
department.

8.5.6 Control of changes

XXX reviews and controls changes for production or service provision, to the extent necessary to
ensure continuing conformity with requirements. XXX 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.

8.6 Release of products and services ISO 9001:2015 § 8.6

Ref: Shipping process – Appendix 6

XXX monitors and measures the required characteristics of the product to verify that product and
service requirements have been met. This is carried out at appropriate stages of the manufacturing
processes in accordance with the product quality requirements. All products are monitored and
measured to determine how well they comply with pump specs and quality requirements.

Evidence of conformity with the acceptance criteria is maintained through inspection and monitoring
and measuring records; primarily the Pump FAT report. The records include Management employees
authorized to release final product. Product release will not proceed until all the required processes
have been satisfactorily completed, unless otherwise approved by management and, where
applicable, by the customer.

Note: Small business deliverables – if you are in people resources – the approval of the require
employee skill set. The client may determine termination….for not being the right fit. Instead of a
product --- it’s the final employee skill set that is determined by the customer. In the section above –
you can find “Product” and replace that with “Associate / Employee Skillset” need to define it for
your company.
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8.7 Control of nonconforming outputs ISO 9001:2015 § 8.7

Ref: QP-A-083-01 Control of Nonconforming Outputs

Procedures have been established at various levels of the company for control of non-conforming
products, both hardware and any pump accessories. These procedures describe:

• Identification & control of non-conforming product

• Responsibility and authority for controls
• Methods of initiating and completing corrective actions
• Acceptance under concession by relevant authority of the customer when applicable
• Taking action on material precluding its original intended application
• Methods of maintaining records of the nature of non-conformities and subsequent actions
taken
• Re-verification of the corrected product for conformity to the requirements (e.g. rework or
repair).
• Review customer’s complaints for non-conformity detected after delivery,
• Corrective action taken appropriate to the effect or potential effect of the non-conformity.

XXX tracks all Non-conforming Product in the XXX CAR database. The database is used to
provide feedback on vendor performance and for documenting non-conformities in the IMS.

All the above processes generate documented evidence which is retained by the company as
evidence of control of nonconforming outputs.

9 Performance evaluation ISO 9001:2015 § 9

ISO 14001:2015 § 9

9.1 Monitoring, measurement, analysis and evaluation ISO 9001:2015 § 9.1

ISO 14001:2015 § 9.1
ISO 45001:2018 § 9.1

9.1.1 General

The following methods have been developed to plan and implement the processes such as
monitoring, measurement, analysis and evaluation. These help in evaluating performance and
effectiveness of the IMS. As needed, documented information is retained as evidence. XXX monitors,
and measures the key characteristics of their activities, which may have an impact on the environment
or workplace health and safety. EHS equipment that needs calibration is tracked by the Quality
Assurance Department through the calibration program, or directly by EHS through agreements with
equipment vendors and service providers. A summary of equipment that requires calibration is
maintained by the Quality department.

XXX collects a variety of data relevant to our potentially significant impacts that include:

• Chemical purchases, usage and chemical characteristics

• Periodic safety inspection reports from onsite safety inspectors (API 5-year inspection, monthly and
annual Test Stand inspections).

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 The performance of the IMS is monitored annually through the internal management system audits,
and annually through the external management system assessments. Results from the IMS audits
are communicated to appropriate management.

Processes Monitoring and Analysis Evaluation

Requirement
Measurement

Conformity of Through testing Test and Inspection 1. Analysis of customer complaint

product provided and inspections records and 2. Corrective action to reduce customer
with respect to nonconformance complaints
customer reports (if generated) 3. Feasibility of adapting improved
requirement(s) technology and/or hiring expertise

Conformity of Internal audit for Internal Audit results 1. Identification of root cause for
QMS with ISO QMS and completion of nonconformance
9001:2015, ISO corrective and 2. Prompt preventive and corrective
14001:2015 and preventive action action
ISO 45001 3. Conducting regular audits and
standards management reviews

Ensuring the Internal audits Management Reviews1. Ensuring employees/contractors

effectiveness and and understand their role in effective
continual management implementation of IMS
improvement of review 2. Setting objectives to improve quality
the IMS safety and environmental
performance of the services and
product(s)
3. Review of objective fulfillment and
planned arrangements of IMS
For service businesses – the conformity to services will need to explained – monitoring is done through an complaints
– analysis is measured and can be a QMS Goal (Zero Complaints/year or 90% retention of customers/year etc.

9.1.2 Customer satisfaction - Quality

XXX monitors customer satisfaction for key customers on a regular basis. Customer satisfaction is
determined by a number of data set points tracked in the section below (9.1.3 Analysis and
Evaluation). This data may be compiled by Project Management, Sales and The Director of Quality
on a periodic basis for further analysis with a focus on continual improvement and customer
satisfaction. Such data is analyzed per section 9.1.3 of this manual.

9.1.2a Evaluation of Compliance – Environmental and Safety

XXX evaluates compliance with applicable EHS compliance obligations through internal audits, and
third-party compliance audits annually. If the compliance audits are conducted under attorney client
privilege, then XXX respects that privilege and maintains strict confidentiality on report visibility and
distribution. Reports are not shared with other 3rd parties.

The auditors must be determined to be competent in accordance with EHS requirements.

Competence is demonstrated through a resume or similar documentation of experience that is
relevant to the topic that is being audited.

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 Periodically, but at least annually, EHS reviews the laws, rules and regulations contained in the
legal and other matrices within the Environmental Aspects and Hazard ID matrices.

Records of audits, facility tours, and risk assessments are located on the EHS drive. Incident
reports are located on the Incident Database or EHS drive.

9.1.3 Analysis and evaluation

XXX determines, collects and analyzes appropriate data to demonstrate the suitability and
effectiveness of the quality management system and to evaluate where continual improvement of the
effectiveness of the quality management system can be made. This includes data generated as a
result of monitoring and measurement and from other relevant sources.

The analysis of data provides information relating to:

a) Customer satisfaction, which consist of:

• Customer Complaints / Year
• End-of-project surveys
• Customer Feedback (by any means)
• Customer aftermarket sales surveys
• Percentage of an increase in sales / year
• A percentage of repeat business / year, and
• Warranty Claims.
b) Conformity to product / service requirements.
c) Characteristics and trends of key processes and product performance, including Opportunities
for improvement.
d) Vendors.

Companywide Key Performance Indicators (KPIs) are monitored for data analysis.

Significant aspects of such data will be analyzed through management review meetings.

9.2 Internal audit ISO 9001:2015 § 9.2

ISO 14001:2015 § 9.2
ISO 45001:2018 § 9.2

Ref: QP-A-082-02 Internal audit

An internal audit procedure is maintained as documented information to ensure that the IMS is
effectively implemented, maintained and conforms to the requirements of the ISO 9001:2015, ISO
14001:2015 and the ISO 45001:2018 Standards and to the Integrated management system
requirements established by XXX.

This procedure describes requirements for the audit program including; audit interval/ frequency,
methods, responsibilities and authorities to conduct audits, report results and follow up activities.
Internal Audits are documented to ensure that the IMS conforms to the following and is being
effectively implemented and maintained:

a) Define the audit criteria

b) Select auditors and conduct audits to ensure objectively and impartiality of the audit process
c) Ensure that the results of the audits are reported to relevant management.

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9.3 Management Review
ISO9001:2015 § 9.3
ISO 14001:2015 § 9.3
ISO 45001:2018 § 9.3

9.3.1 General

Top management reviews the IMS at least once a year, and after each complete internal audit
cycle. Inputs to reviews include the following topics (as a minimum) to ensure continuing suitability,
adequacy and effectiveness of the system.

The following are discussed, at a minimum, in the management review meeting:

a) Status of actions from previous management reviews
b) Changes in external and internal issues that are relevant IMS
c) Information on the performance and effectiveness of the IMS, including trends in:
• The Needs and expectations of interested parties, including EHS compliance obligations
• Changes in Significant Environmental Aspects
• Changes in Risk and Opportunities (IMS)
• Customer satisfaction and feedback from relevant interested parties;
• The extent to which quality and EHS objectives have been met;
• Process performance and conformity of products and services;
• Nonconformities and corrective actions;
• Monitoring and measurement results;
• Fulfilment of Compliance Obligations;
• Audit results;
• The performance of external providers;
• Relevant communication(s) from interested parties (EHS communications and Customer
Complaints)
d) Adequacy of resources;
e) Effectiveness of actions taken to address risks and opportunities
f) Opportunities for improvement.

Market strategy, strategic direction and other internal/external issues influenced by the industry and relevant
to the organizations interests may also serve as discussion points.

Management review meeting minutes provide the output of reviews that includes decisions and
actions on:

a) Conclusions on the continuing suitability, adequacy and effectiveness of the IMS.

b) Decisions related to “Opportunities for improvement.”
c) Decisions related to Changes to the IMS.
d) Actions needed when IMS Objectives are not achieved/
e) Resource needs
f) Opportunities to improve integration of the IMS with other business processes, if needed.
g) Any implications for the strategic direction of XXX.

A documented management review meetings records, required agenda items and documented
information necessary to maintain as evidence will be retained.

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10 Improvement ISO 9001:2015 § 10
ISO 14001:2015 § 10
ISO 45001:2018 § 10

10.1 General ISO 9001:2015 § 10.1

ISO 14001:2015 § 10.1

XXX determines and selects opportunities for improvement and implement any necessary actions to
meet customer requirements and enhance customer satisfaction by doing the following:

a) Improvement in products and services

b) Correcting, preventing or reducing undesired effects
c) Improvement in the performance and effectiveness of the IMS

10.2 Nonconformity and corrective action ISO 9001:2015 § 10.2

ISO 14001:2015 § 10.2
ISO 45001:2018 § 10.2

10.2.1 Incident, nonconformity and corrective action

Ref: QP-A-085-02 Corrective Action

XXX has documented procedures to address product non-conformities as well non-conformities due
to systemic issues or those arising from complaints.

Documented information as procedures have been established at various levels of the company for
control of non-conforming products. These procedures describe:

• Identification & control of non-conforming product

• Responsibility and authority for controls
• Methods of initiating and completing corrective actions
• Acceptance under concession by relevant authority of the customer when applicable
• Taking action on material precluding its original intended application
• Methods of maintaining records of the nature of non-conformities and subsequent actions
taken
• Re-verification of the corrected product for conformity to the requirements (e.g. rework or
repair).
• Review customer’s complaints for non-conformity detected after delivery,
• Corrective action taken appropriate to the effect or potential effect of the non-conformity.

10.2.2 Incident Investigation

Ref: EHS P-005 Incident Investigations

Incident Investigation Form

Incidents are recorded in the appropriate database and managed per the EHS P-005 Incident
Investigations procedure.

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 Corrective actions generated by incident reporting and investigation are evaluated and managed per
the CAR database system. The incident investigation form will be used to document the root cause,
corrective action and effectiveness review for each injury or near miss investigation.

The principles as risk assessment and risk reduction will apply to incident investigations. Root cause
analysis is the key to progressive improvement and requires XXX to determine what caused or causes
have been identified for the incident or nonconformity, what can be actioned to address the cause,
review any risk assessments or establish a new assessment – as required before implementing an
action. Simply, once as an action plan is implemented, prior to the action to correct the incident is
made; the appropriate risk assessment is verified. This is to avoid causing more risk to injuries (i.e.
the fix would cause more risks to injury). This may include re-assessing the Hazard Identification
matrix.

10.3 Continual improvement ISO 9001:2015 § 10.3

ISO 14001:2015 § 10.3
ISO 45001:2018 § 10.3

XXX ensures continual improvement of the suitability, adequacy and effectiveness of its Integrated
management system through the use of:

1. Quality policy 2. IMS objectives

3. Audit results 4. Analysis and evaluation of data
5. Corrective actions 6. Management review

Needs and opportunities arising from the above are addressed as part of continual improvement
and to provide the intended quality product, expected outcomes for enhanced environmental and
safety performance.

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 Appendix 1 Sequence Of Interactions

Appendix 2
Sales Flow Chart

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 Appendix 3
Shipping Flow
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Integrated Management System Manual Page 34 of 38

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 Appendix 4
Operations Process Flows

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Integrated Management System Manual Page 36 of 38

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Integrated Management System Manual Page 37 of 38

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 Appendix 5
Facilities Boundaries

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COMPANY LOGO
HERE EHS-001-01
IMS PROCEDURE REV. A

Context of the Organization

1. Purpose:
The purpose of this procedure is to provide an analysis of Golden State Food’s (GSF) Context of the
Organization.

2. Scope
This procedure applies to all employees work for, or on behalf of GSF while on GSF facilities.

3. References:
ISO 14001:2015 Environmental Management Systems
Integrated Management System Manual (IMS Manual)

4. Definitions
Environment: Surroundings in which the company operates, including air, water, land, natural resources,
flora, fauna, humans and their interrelation (from ISO 14001 Section 3.2.1).
Interested party: Person or organization (3.1.4) that can affect, be affected by, or perceive itself to be
affected by a decision or activity.
EXAMPLE: Customers, communities, suppliers, regulators, non-governmental organizations, investors, and
employees. Note 1 to entry: To “perceive itself to be affected” means the perception has been made known
to the organization.

5. Procedure: Understanding the Organization and it’s Context ISO 14001:2015 § 4.1
ISO 45001:2018 § 4.1

XXXXX has determined external and internal issues that are relevant to its purpose and that affect its ability
to achieve the intended outcomes of its environmental management system. The intended outcomes of the
EMS include:

1) The enhancement of environmental and OSH performance

2) The fulfilment of compliance obligations (Legal and Other); and,
3) The achievement of environmental and OSH objectives.

This is done through the analysis of XXXXX ’s vision, values, objectives and policies as described on the
company’s website and within the EMS. Internal and external issues related to the environmental conditions
are listed in Section (7) of this procedure (in the second column – Interest partied – What they expect /
issues).

6. Context of the Organization ISO 14001:2015 § 4.2

ISO 45001:2018 § 4.2

The process of understanding the context of the organization for the requirements of 4.1 and 4.2 of the ISO
14001:2015 standard involves the description of the company as noted within the website at:
[Link]

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COMPANY LOGO
HERE EHS-001-01
IMS PROCEDURE REV. A

Context of the Organization

The company does conduct Strategic Planning at the highest management levels. These are discussed in
management meetings, where management discusses variables that might affect the business, i.e. market
share, competitor performance, this may include a SWOT or Strategic Business Planning. These are
completed to meet the intended results and outcomes of EMS and provide enhanced quality, safety and
environmental performance within the scope of the products and services provided.

The interested parties, both internal and external are identified below. They include a 3-pillar approach to
summarize the needs and expectations of these parties inherent in the organizations they represent. They
include:

1. First Party entities. May be involved in day-to-day operations.

2. Second Party organizations / entities. Includes compliance organization, suppliers and professional
community organizations.
3. Third Party entities. These organizations include 3rd party Product Marks and Registration bodies.

1st Party 2nd Party 3rd Party

Employees Customers Intertek (Registrar)

Shareholders Key Industries / Consumers GMPs

GSF Owners Stakeholders Food Safety Standards

Process and Interactions – Owner Operators Distributor Quality

Inter-Department Functional Areas Management Process
Suppliers / Vendors (DQMP)
Corporate Requirements
Regulatory Agencies: International Featured
Suppliers / Vendors (onsite – Standards IFS Logistics
Working on Behalf of the NATIONAL Regulatory Bodies Version 2.2 (IFS)
organization) State of California
Fire Department Other Product or Process
Neighbors Permitting Certifications
Pandemic Response

Other applicable Government

Programs
(May be identified in the
Compliance Obligations Matrix)

City of Industry
Chamber of Commerce
Schools / Universities Temporary
Employee Agencies
Trade and Industry Associations
Freight Carriers
Insurance Carrier
Environmental Community
Programs / Golden State
Foundation

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COMPANY LOGO
HERE EHS-001-01
IMS PROCEDURE REV. A

Context of the Organization

7. Internal and External Interested Parties ISO 14001:2015 § 4.2

ISO 9001:2015 § 4.2
ISO 45001:2018 § 4.2

1. Identify the interest of the Organization, their degree of influence and interest groups.
2. Establish what is expected of them in the organization.
3. Describe the risks and opportunities that may affect the system.

What they expect /

issues (including Risks Opportunities
Interested parties
environmental / Safety (Site Does Not do this) (Site Addresses)
conditions)
Employees • Job security • Loss of work • More orders / work
Contractors/Vendors • Process – Interaction • Bad communications • Increase safety
• Better flow • Bad product • Less waste
Functional • Better communications • Waste in processes and • Better production
Departments
• Less Waste interactions. Env. • More communications
• Job Safety Impact
• Unsafe work
Corporate • EHS Support • Not enough • Training
Stakeholder • Internal audit communications • Sharing best practices
Site Owners • Leadership • Bad Perception of the • KPI tracking & goal
• KPI setting market / Brand setting and attainment
• Guidance Protection
• Lack of resources
Suppliers / Vendors • Partnership – more • Decrease use of out • Decrease cost –
(onsite) business sourcing outsourcing
• Long term contracts • No long-term • Increase productivity -
• Increase support relationship outsourcing
(Janitorial, Cleaning, Recycling)

Neighbors • No impacts to • Waste is being released • Community involvement

environment (Enclosed – public incident – i.e. Earth Day
buildings) • Impacts from company • Community Open Tours
• Good neighbors – no decrease property • City recognition and
NIMBY effect (Industrial values awards
Park)
Key Customers • Products that meet food • Bad food safety • Stable business
safety specifications performance relationships
(DQMP. IFS) • Consumer perceptions • Increase of sales
• Environmentally are not met. Loss of • Good perception and
sustainable packaging customer(s) Image
(Waste management, • Product safety not • Better communications
Sustainable Packaging) emphasized – marketing
• Good performance and involvement
perception • Certifications (Safety,
ISO, DQMP, IFS)

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COMPANY LOGO
HERE EHS-001-01
IMS PROCEDURE REV. A

Context of the Organization

What they expect /
issues (including Risks Opportunities
Interested parties
environmental / Safety (Site Does Not do this) (Site Addresses)
conditions)
Compliance • Comply with regulations • Complaints • Systematic process to
organizations • Permits to conduct • Compliance Citations / ensure Compliance
(Identified in business Fines (ISO)
Compliance • Good standing with • Bad Public Perception • Good public image
Obligations matrix) •
Regulators • Bad publicity Contribution to the
Regulators: EPA,
• Potential partnerships, • Sick employees Community &
OSHA, DTSC
i.e. OSHA Consultation – Environment
Voluntary inspections • No fines / NOVs
• Pandemic Response • Safety of Employees
Logistics • Manifest and correct • On-time delivery is • Accurate logistics
Freight Carriers paperwork slowed down handling
• Accurate counts in goods • Freight loads not • Good control of
• Timely response to managed – creates spills shipping and receiving
questions from customers and damaged food • Better control over
• Waste and Food Waste – • Requirements for materials
Handles properly shipment is not met • Accurate Manifests
• Maintaining the food
preservation (cold chain)
Schools / • Familiarity with GSF • No student or • Sharing best practices
Universities (Interns) needs (interns, professionals interested • Increase awareness of
employees) in working at GSF BOSE’s core values and
Trade and Industry • Understanding of best • Potential employees do mission
Associations practices not consider GSF a good • Increase positive
• Potential networking and place to work perceptions of GSF as a
Outreach
employee resource • No community good employer
associations
involvement
Insurance Carrier • GSF will reduce risk to • GSF facilities do not • Increase safe of work
employees and maintain the work environment for
environment environment employees
• Expect facilities to • Increases in spills and • Reduce risk of
maintain building and risk injuries to employees emergencies incidents
to fire and emergencies • Claims are filed for • No claims are filed
• Communicate new incidents the insurance • Reduction in insurance
construction and company will cover cost rates
modifications to facilities. (loss)

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Context of the Organization

8. Scope of the IMS ISO 14001:2015 § 4.3

ISO 45001:2018 § 4.3

The scope of the IMS covers the following addresses and activities (Ref: Quality, EHS Manual). The scope of
this management system includes - the policies, procedures, and requirements of the Quality, Environmental,
Safety Management System for the ISO 14001:2015, ISO 9001:2015, ISO 45001:2018 standard. Consideration
was given to all interested parties within the context of the organization in section 4.1 and 4.2 of this manual.
The scope is made available upon request. This manual applies to the physical boundaries at the fence line and
activities located at:

Andador XXXXXXXXXXXX
ADRESSSES

Additional Site: Cal. Valle de los Cirios, #12821, Modulo A y B,

Parque Industrial Valle Bonito, Col. El Realito
Tijuana,, Baja California, 22250, Mexico
The services, processes and activities will involve the environmental management system within the scope of
registration of the services provided for:

The manufacture and distribution of Household products, cleaners and air fresheners

Note: This scope applies to all XXXX employees and those working on XXXX’s behalf. It will be communicated to
interested parties upon request.

9. Integrated management system and its processes ISO 14001:2015 4.4

ISO 45001:2018 § 4.4

XXXXX has established and documented an Integrated Management System (AMS), which provides
mechanisms for continual improvement of the AMS and systematic methodology for ensuring, monitoring and
measuring customer satisfaction, limiting impacts to the environment.

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IMS PROCEDURE REV. A

Context of the Organization

DISTRIBUTION – LOGISTICS

Management
Polices / Mgt PLANNING
Review / KPIs
E ACT (Management Review / KPIs) E
X Support Resources X
T IT Cust.
T
Internal Corrective
E Action (CA) Feedback E
Audit
R R
Facilities / Improvement
N Maintenance N
A CHECKING A
L HR L

C Security C
Receiving
U Warehouse U
DOING
S S
T T
Operational Control
O O
(Logistics Service Delivery)
M GSF Order M
E Process (JDE) Receipt /Product ID E
R - Inventory R
Staging - Order
Completion
/ Dry Storage /
Labelling
S Customer Finished
S
U Order Cold Storage Goods U
P Management P
P (ROP) P
L Pick Process L
I Shipping I
E Packaging Prep. Load Truck E
R R
Print / Pallet

Revision History
Rev. Para. Description By Approved Date
A All Initial Release TC CV 20JUN2018

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