D-119

Sales - Laboratory Sample Submission

Section D — Laboratory Operations and Specifications Revision 0 10 pages

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1.0 Purpose

1.1 The objective of the Sales-Laboratory Sample Submission process is to ensure
requirements of customers, regulatory authorities, and accreditation organizations are

met. Another objective is to ensure information provided to customers regarding Ion
Labs’ capability and testing requirements are accurate and communicated clearly.

1.2 The purpose of this procedure is to describe the process requirements including
responsibilities and controls for ensuring all test activities are completed per customer
requests. This procedure describes the requirements for communicating the scope of

accreditation to potential customers. This procedure also describes the process for
collecting, reviewing, and responding to customer feedback.

2.0 Scope

2.1 This procedure is applicable to all ISO 17025 accredited test activities performed by Ion

Labs.

3.0 Responsibility

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Management is responsible for ensuring tests are performed as requested by customers.
Management includes the Lab Director and Analytical Development Manager.

3.2 Management is responsible for reacting and responding to customer feedback regarding

lab activities including complaints and notifications of suspected nonconforming test
activities. Management is also responsible for determining the customers’ level of
satisfaction and their perception of Ion Lab’s laboratory performance. When complaints
are received, Management will be responsible for all decisions at all levels of the handling
process for complaints in accordance with the QS-112 Core Quality Systems and Quality
Events.

3.3 All personnel participating is Sales-Laboratory Sample Submission activities are
responsible for ensuring that information communicated to customers or potential
customers, correctly identifies the test services accredited to ISO 17025.

3.4 Sales personnel are responsible for communicating with customers to determine their

requirements and ensuring they are documented on Ion Lab’s quotes and Sales Orders.

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The completed quote documents Ion Lab’s understanding of customer’s requirements.

3.3 The Sales Manager and Lab Director are responsible for ensuring that this procedure is
accurate, understood and implemented effectively. No changes may be made to this
procedure without the authorization of the Sales Manager and Lab Director.

4.0 Definition

4.1 Customer — A person or organization that could or does receive a product or a service
that is intended for or required by this person or organization. A customer can be internal
or external to the organization.

4.1.1 Examples include but are not limited to customer, client, end-user, retailer,

receiver of product or service from an internal process beneficiary and purchaser.

5.0 References

5.1 D-201, SOP, QC Laboratory Sample Log Book Recording

5.2 D-201-F1, Form, QC Laboratory Sample Log

5.3 C-502, SOP, Record Storage, Retention, and Destruction

5.4 QS-108, SOP, Corrective and Preventive Action

5.5 E-601, SOP, Vendor Qualification

5.6 D-117, SOP, Laboratory Purchasing and Receiving

5.7 D-103, SOP, Analytical Method Validation

6.0 Procedure

6.1 Inputs to the Sales-Laboratory Sample Submission process include, but are not limited
to:

® Customer requests for test services,

6 Test deviation requests,

@ Accreditation policies,

@ Customer feedback, including complaints.

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6.2 General

6.2.1 Customers may be internal customers of Ion Labs and the same process applies.

6.2.2 If Ion Labs subcontracts testing, whether planned or due to unforeseen
circumstances, this work is awarded to a competent subcontractor that is
accredited to ISO 17025 for the required test. Customers are advised in writing

of the proposed use of subcontractors, and written approval of the customers is
required before proceeding with the tests. The written communications occur via
email.

6.2.2.1 Ion Labs remains responsible to the customer for any subcontracted
work, except in cases where the customer or regulatory authorities

specify the use of subcontractors.

6.2.2.2. A list of approved subcontractors and the subcontracted work is
maintained in accordance with the E-601 Vendor Qualification and D-
117 Laboratory Purchasing and Receiving procedure.

6.2.3 Ion Labs utilizes laboratory-developed methods which modify established test
methods to accommodate the purpose and intent of the published established test
methods. Deviations to established test methods will be identified and
documented as described in section 6.3.10 below. Test methods selected will be
established methods published either in international, regional, or national
standards, or by reputable technical organizations, in relevant scientific texts or

journals, or by the original equipment manufacturer. Lab-developed methods will
be based on published methods in accordance with the D-103 Analytical Method
Validation.

6.2.4 Confidentiality

6.2.4.1 Ion Lab’s legally enforceable responsibilities for the management of

information obtained or created during the performance of test activities
is documented within a Customers Purchase Order executed with each
customer.

6.2.4.2 Ion Labs does not typically place information obtained or created during
the performance of test activities into the public domain. In the event

Ion Labs intends to place information into the public domain, affected
customers will be notified in advance in writing of this intention,
including details regarding the information to be disclosed, and the
methods of disclosure. Information placed in the public domain will not
violate the legally enforceable responsibilities documented in

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Customers Purchase Order established with affected customers.

6.2.4.3 As documented on the Customers Purchase Order and the Sales Order,
all information (including materials and results) will be considered
proprietary information and will be regarded as confidential between the
customer and Ion Labs. Where agreed by the customer and Ion Labs,

customers may place information generated during test activities into
the public domain within the limits established in the Purchase Order.

6.2.4.4 In the event Ion Labs is compelled to release information by court order,
information will be provided as required. Unless prohibited by law or
court order, the customer or individual concerned will be notified of the

information provided in association with the release of information.

6.2.4.5 In the event external sources provide information regarding customers
(for example, in the event of complaints or investigations overseen by
regulators), this information will remain confidential between the

customer and Ion Labs. The source of this information will be
confidential to Ion Labs, and will not be disclosed to the customer,
unless agreed by the source in writing.

6.2.4.6 Personnel acting on Ion Labs’ behalf (including contractors, and other
personnel of external bodies) will keep confidential all information
obtained or created during the performance of laboratory activities,

except where required by law to disclose such information.
Communication of these requirements to affected parties will occur as
described in E-601 Vendor Qualification and D-117 Laboratory
Purchasing and Receiving procedure.

6.2.5 Decision Rule

6.2.5.1 The decision rule is the rule that describes how measurement uncertainty
is accounted for when stating conformity with a specified requirement.

6.2.5.2 As stated on the Customer’s Purchase Order, the decision rule for the
test’s conformity or nonconformity does not consider the measurement
uncertainty for the test activities performed. The decision is based on

the actual results. The statement on the form serves as the
communication to the customer.

625.3 However, if the customer requests another specification or standard, the

decision rule will be selected and agreed to by the customer. The agreed
upon decision rule will be noted on a revised or a new Customer

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Purchase Order.

6.2.6 Accreditation References

6.2.6.1 Management will ensure the accreditation body’s policy concerning
their requirements when making reference to the accredited status will
be strictly adhered to. ANAB Accreditation Requirement AR2201,

“Control and Use of Accreditation Symbol provides detailed
explanations of the requirements generalized below (see the policy
located in the Documents of External Origin folder for all requirements).
In general, as part of ensuring compliance to the policy, Management

will ensure the following during communications with potential
customers:

e lon Labs may refer to its ANAB accreditation on test reports, on
its website, in its general literature and promotional materials, and
in business solicitations, under the following provisions:

lon Labs may only use the accreditation symbol or reference
O
to ANAB accreditation if the accreditation status is current and
remains in good standing.
The accreditation symbol or reference to ANAB accreditation
shall not be placed on products or items that Ion Labs has

tested.

Ion Labs shall not use the accreditation symbol or refer the
accreditation in any way that may be misleading or
misrepresent the accreditation status.

Ion Labs shall ensure claims of accreditation are related only
to activities within their scope of accreditation and not

associated with other activities in which Ion Labs may be
involved.

[on Labs shall ensure that the use of the accreditation symbol
or reference to the accreditation status is not affixed to a
product (or part of it) or used in any way to imply that a product

has been certified.

Ion Labs shall not use the accreditation symbol or refer to the
accreditation in any manner that gives the impression that
ANAB accepts responsibility for the results, or for any opinion

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or interpretation derived from those results, or that ANAB
approves of those results.

o Itis lon Labs’ responsibility to use the accreditation symbol or
any materials representing our accreditation in such a way as
to enhance the reputation and value of accreditation for all

stakeholders.

o The ANAB accreditation symbol always shall be used in its
original, designed proportions and shall not be modified,
distorted, compressed, or stretched in any way. It will not be

sized in a way that renders it unreadable.

o lon Labs will use the accreditation symbol as provided by
ANAB, at Ion Labs discretion.

o lon Labs shall not imply or mislead the scope of its accredited
activities using certificates or reports, enclosures, stationery,
or other materials. Ion Labs shall not lead any user of the

results or interested party to believe that the work is covered
by the scope of accreditation when it is not.

6.2.6.2 All records associated with this process, including accepted Customer
Purchase Orders, communications regarding the customers’
requirements, approved deviations, and feedback indicating customer

satisfaction and responses are retained per SOP C-502 Record Storage,
Retention, and Destruction.

6.3 Sales Order Establishment and Review

6.3.1 Laboratory activities will be performed based on documented quotes and
purchase orders established with customers describing the tests to be performed

and the services to be provided. Sales personnel may initiate quotes with
customers. Lab personnel review and approve the quotes to ensure customer
requirements have been adequately defined, documented, understood, and Ion
Labs has the capability and resources to meet customer requirements. Special
requirements beyond those documented in the quote may be documented in

emails or other correspondence with the Sales personnel and/or Lab personnel
and retained with the orders’ records.

6.3.2 Requests for quotes will be reviewed to identify risks to impartiality.
Management may be contacted prior to processing the request to determine if
risks to impartiality potentially exist based on the customer or the service

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requested. If no risks to impartiality are determined by Management, the request

may be processed as described below, and the quote will document no risk to
impartiality was determined. Ifa risk to impartiality exists, the Lab Director will
take steps to address the risk and communicate with the customer as appropriate.
Risks to impartiality may arise from Jon Labs’ activities, from Ion Labs’

relationships with other organizations, or from the relationships of Ion Labs’
personnel. If ongoing actions will be required to address the risks, these actions
will be documented on the Risks and Opportunities worksheet of the LMS
Planning Tool.

6.3.3 Sales personnel will ensure the quote includes information regarding appropriate

test service(s) to satisfy the customer’s requirements. All tests will be performed
using established test methods (Standard Test Procedures) relevant to the
customers' needs and consistent with requirements specified by the customer. For
ISO 17025 accredited tests, the quote must indicate if the customer wants the

accredited test or not.

6.3.3.1. Accredited tests will provide the customer with all required information
including the accreditation logo on the test report. Test Reports for
unaccredited tests provide traceability to a national or international
standard but may not disclose the measurement uncertainty and will not

include the accreditation logo or any reference to the accreditation status
of the Lab.

6.3.4 If the customer does not specify the established test method to be used, Lab
personnel will review information regarding the customer’s intended outcome for
the requested tests and if the Lab can satisfy the customer’s requirements, an

appropriate test method will be selected within the scope of Ion Labs’ tests. The
Lab Director or Analytical Development Manager indicates the method selected
by providing the information to Sales personnel to document it in the quote.

6.3.5 Ifat any time it is learned the method and/or laboratory activities requested by the
customer are found to be inappropriate, out of date, or outside the capability of

Ion Labs, the Lab Director or Analytical Development Manager will inform the
customer of Ion Labs’ capabilities and describe why the methods and/or
laboratory activities requested cannot be satisfied. This includes requests for
quotes indicating accreditation for tests that are not in Ion Labs’ scope of

accreditation.
6.3.6 As stated on the quote, the decision rule for the chosen test does not consider the

measurement uncertainty of the test performed. The decision is based on the
actual results. The statement on the form serves as the communication to the

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customer. However, if the customer requests another specification or standard,

the decision rule will be selected and agreed to by the customer. The agreed upon
decision rule will be recorded on the quote and Test Report.

6.3.7 The Lab Director or Sales personnel will ensure any differences between the
customer’s requirements and Ion Labs’ capabilities are resolved before the quote

is sent to the customer and is accepted or before any laboratory activities
commence. This will ensure the test activities will be acceptable to both the
customer and Ion Labs.

6.3.8 While reviewing, evaluating, and approving quotes with customers, Ion Labs staff
members will cooperate with customers (and their representatives as necessary)

to clarify the customer’s request and describe Ion Lab’s capabilities.

6.3.9 Where the customer has specified performance monitoring of laboratory activities
in relation to the work performed, Ion Labs will agree to the specified monitoring
unless the monitoring activities will cause deviation from the established test
method, pose a risk to personnel safety, or negatively affect the outcome of

laboratory activities.

6.3.10 If laboratory activities deviate from the accepted test method, customer
requirements, and/or the Sales Order, details regarding the deviation will be
documented on the test paperwork and the Test Report. The test paperwork will
document the deviated requirement, provide a technical justification for the

deviation, include a record of authorization for the deviation from Ion Labs’
Management, and include evidence of acceptance of the deviation by the
customer. The Lab Director will evaluate deviations requested by the customer
to ensure they will not impact the integrity of the laboratory or the validity of the

results. The customer will be informed of the decision.

6.3.11 Approval of Customer’s Purchase Orders will be indicated by the creation of the
Sales Order. The Quote and the Customer’s Purchase Orders will be retained as
records of the requirements review and Ion Lab’s capability of satisfying the
customer requirements.

6.3.12 If pertinent discussions (determined at the discretion of the Lab personnel based

on impact of test results or service delivery) were held relating to the customer’s
requirements or the results of the laboratory activities, records of these
discussions will be retained Sales Order.

6.3.13 Ifthe customer amends their Purchase Order or notifies the Lab for an amendment
after test activities have started, the process described above will be repeated to
ensure the change can be accommodated and all affected personnel have been

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notified.

6.4 Customer Feedback and Complaints

6.4.1 Management will seek feedback from customers, both positive and negative,
through information gathered during direct personal contact with customers
(including but not limited to in-person meetings, emails, and participation in

industry events). Customer feedback will be recorded on the Customer Feedback
Log as evidence of analyzing and using feedback to improve the management
system, laboratory activities, and customer service.

6.4.2 When the feedback received is determined to be a lab or testing complaint
regarding the performance or outcomes of laboratory activities, the QS-112 Core

Quality Systems and Quality Events process will be used.

6.4.3 Customer feedback which will be analyzed and used for improvement will be
based upon performance factors including (but not limited to) quality, timeliness
of reported results, and accuracy and clarity of results.

6.4.4 Information regarding customer feedback will be submitted to Management

during management review (see the Management procedure). Management will
also review customer feedback as it becomes available and will react
appropriately according to the information received, initiating corrective actions
as appropriate as described in the QS-108 Corrective and Preventive Action.

6.5 Record Management

6.5.1 Records are maintained per SOP C-502 Record Storage, Retention, and

Destruction.

6.6 Process Outputs

6.6.1 Outputs to the Sales -Laboratory Sample Submission process include, but are not
limited to:

® Accepted orders for test services,

® Approved deviations,

@ Positive and negative feedback received from customers and follow-up
actions, including corrective actions where necessary.

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8.0 Revision History

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 10/19/21 | New N/A J. Sassman | - | - |