4.

General requirements
4.1 Impartiality
One reason to have honesty and integrity to laboratory results is to have an unbiased,
and of course, accurate results. This can be achieved through the implementation of
Impartiality, integrated into our laboratory activities and to be part of our work ethic. To be
impartial to the laboratory’s activities is being free to exercise your professional judgment
and competency as per the actual data results that you have gathered using the established
procedures.

After the new revision of ISO 17025 has been released, impartiality has become one of
the major requirements to be implemented or even integrated into all laboratory activities.
This means it is a mandatory process that must be implemented.

General Requirements for Impartiality

As per clause 4 of ISO 17025,2017 Standard, below are the General Requirements for
Impartiality

1. Laboratory activities shall be taken impartially structured and manage to safeguard

impartiality
2. The management shall be committed to impartiality
3. The laboratory shall ensure impartiality in all its activities and not allow commercial,
financial, or other pressures to compromise impartiality.
4. The laboratory shall Identify risk to impartiality on an on-going basis.
5. Once a risk to impartiality is identified, the lab should demonstrate how to minimize
or eliminate such risk.

4.2 Confidentiality
The lab is responsible for the management of all information obtained or created during
laboratory activities and is held responsible by legal enforcement. The standard requires that
the lab must inform its customer in advance of what information it intends to share with the
public. Furthermore, it addresses actions it will take if confidential information is released
into the public. Confidentially, requirement also encompasses laboratory personnel. In
general, the laboratory and its personnel are responsible for the information obtained or
created during the performance of laboratory activities, and all information is considered
proprietary information and shall be regarded as confidential, with exception to what is
required by law.

5. Structural requirements

A laboratory is part of a legal entity or a specific part of a legal and responsible entity
Legally for all his activities. The laboratory has a management department that is fully
responsible for it. The Laboratory identifies and documents its field of activities which are in
accordance with this document. This document complies with this area of its activities only,
which excludes laboratory activities that are continuously provided by external parties.

The laboratory activities are carried out to meet the requirements of this document, the
laboratory's clients, the legislative authorities, and the recognition-granting bodies. And it
must include all laboratory activities provided in all its permanent facilities, locations far
from its permanent facilities, temporary facilities, mobile facilities, or customer facilities.

5.1 Management structure

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Job description

Finance
Administrator

Lab Technician

Human Resources
Officer
Director
Quality Assurance

IT Specialist

Safety Officer
 Job description
Job title Director
The direct boss Board of Directors
Completion of a bachelor's degree program at an accredited college
Qualifications or university with major course work in chemical, civil,
metallurgical, mechanical, or materials engineering.
Experience
Skill in:
 coordinating the activities of the laboratory with intra- and extra-
departmental agencies
Ability to:
 plan, organize and direct, through subordinate supervisors, a city-
wide program of materials testing
 direct the development of standards for inspections of vendor
Skills and abilities
facilities to assure the provision of quality products
 set standards to establish satisfactory levels of employee
performance.
 evaluate and formulate test procedures
 express ideas effectively, both orally and in writing
 establish and maintain effective working relationships with
associates, vendors, manufacturers, and departmental officials
1. Representing the company and speaking on its behalf.
2. Supervising the daily and routine business of the company.
3. Participate in setting the main objectives in the company.
4. Supervising recruitment processes and developing capabilities as
well.
Responsibilities 5. Attending board meetings and drafting issued decisions in
addition to developing plans based on these decisions.
6. Communicating with employees and discussing the strategies
that the company follows and its results.
7. Ensure that the services or goods provided by the
company reach the customers with the best quality
 Job description
Job title Finance Administrator
The direct boss Director
Qualifications  Bachelor's degree in accounting, finance, or a similar field.
Experience
Skill in:
 Strong problem-solving skills
 Excellent communication skills, both written and verbal
 Superb organizational and time management abilities
Skills and abilities  In-depth knowledge of financial controls and accounting
standards.
Ability to:
 recognize the connection between a firm’s fiscal behavior and
open market demands.
1. Create and update spreadsheets of daily transactions.
2. Manage accounts receivable and payable.
3. Review and process reimbursements.
4. Prepare budgets.
5. Maintain reports on financial metrics, including investments,
Responsibilities return on assets and growth rates.
6. Keep records of invoices and tax payments.
7. Manage company’s liabilities (e.g. insurance premium).
8. Identify and address account discrepancies.
9. Participate in payroll processes.
10. Report on financial projections (e.g. liquidity and cash flow).
 Job description
Job title Lab Technician
The direct boss Human Resources Officer
Completion of a bachelor's degree in laboratory sciences,
Qualifications Biomedical sciences, Chemistry, or any related field, from
accredited university.
Experience
 Independence
 Meticulous attention to detail
 Excellent written and oral communication skills
Skills and abilities
 Good teamworking skills
 Analytical skills
 Time management
1. Receive, label, and analyze samples (blood, toxic, tissue etc.).
2. Design and execute laboratory testing according standard
procedures, make observations and interpret findings.
3. Conduct experiments under defined conditions to verify/reject
various types of hypotheses using refined scientific methods.
4. Organize and store all chemicals substances, fluids, and
Responsibilities
compressed gases according to safety instructions.
5. Record all data and results in specified forms (paper and
electronic) with accuracy and responsibility.
6. Maintain equipment and assist in ordering laboratory supplies.
7. Ensure that all safety guidelines are always followed strictly and
maintain a clean and orderly environment.
 Job description
Job title Human Resources Officer
The direct boss Director
Completion of a bachelor's degree business administration, social
Qualifications
studies, or relevant field; further training will be a plus
Experience
 Proven experience as HR officer, administrator, or other HR
position
 Knowledge of HR functions (pay & benefits, recruitment, training
& development etc.)
 Understanding of labor laws and disciplinary procedures
Skills and abilities
 Proficient in MS Office; knowledge of HRMS is a plus
 Outstanding organizational and time-management abilities
 Excellent communication and interpersonal skills
 Problem-solving and decision-making aptitude
 Strong ethics and reliability
1. Support the development and implementation of HR initiatives
and systems
2. Provide counseling on policies and procedures
3. Be actively involved in recruitment by preparing job
descriptions, posting ads, and managing the hiring process
4. Create and implement effective onboarding plans
5. Develop training and development programs
6. Support the management of disciplinary and grievance issues
7. Maintain employee records (attendance, EEO data etc.)
according to policy and legal requirements
8. Review employment and working conditions to ensure legal
compliance.
9. Assist with day to day operations of the HR functions and duties
10. Provide clerical and administrative support to Human Resources
executives
Responsibilities 11. Compile and update employee records (hard and soft copies)
12. Process documentation and prepare reports relating to personnel
activities (staffing, recruitment, training, grievances,
performance evaluations etc.)
13. Coordinate HR projects (meetings, training, surveys etc.) and
take minutes
14. Deal with employee requests regarding human resources issues,
rules, and regulations
15. Assist in payroll preparation by providing relevant data
(absences, bonus, leaves, etc.)
16. Communicate with public services when necessary
17. Properly handle complaints and grievance procedures
18. Coordinate communication with candidates and schedule
interviews
19. Assist our recruiters to source candidates and update our
database
Job description
Job title Quality Assurance
The direct boss Human Resources Officer
A bachelor's degree is generally required for the position of a
quality assurance with high expectation for excellent verbal and
Qualifications
written communication skills. Experience in a quality assurance
department in the same industry is preferred
Experience
 attention to detail
 communication skills - verbal and written
 data collection, management, and analysis
 problem analysis and problem-solving
 planning and organizing
Skills and abilities
 sound judgment
 decision-making skills
 customer service orientation
 effective interaction with stakeholders
 teamwork
1. Create quality measurements to track improvement in products
2. Execute quality improvement testing and activities
3. Develop quality assurance standards and company processes
4. Adhere to industry quality and safety standards
Responsibilities 5. Ensure products meet customer expectations and demand
6. Create reports documenting errors and issues for fixing
7. Work closely with the development team to improve existing
products
8. Maintain standards for reliability and performance of production
 Job description
Job title IT specialist
The direct boss Director
Completion of a bachelor's degree in a technical discipline, such as
Qualifications computer science, information technology, or computer
engineering.
Experience
 Working knowledge of relevant operating systems, software, and
programming
 Excellent problem-solving and critical thinking skills
 Keen attention to detail
Skills and abilities  Good organization, time management and prioritization
 Efficient troubleshooting abilities
 Effective communication skills, including speaking, writing and
active listening
 Great customer service and interpersonal skills
1. Review diagnostics and assess the functionality and efficiency of
systems
2. Implement security measures
3. Monitor security certificates and company compliance of
requirements
Responsibilities
4. Offer technical support to company staff and troubleshoot
computer problems
5. Install and update company software and hardware as needed
6. Anticipate and report the cost of replacing or updating computer
items.
 Job description
Job title Safety Officer
The direct boss IT specialist
 Completion of a bachelor's degree safety management,
engineering or relevant field is preferred.
Qualifications
 Certificate in occupational health and safety.

Experience
 Experience in writing reports and policies for health and safety
 Familiarity with conducting data analysis and reporting statistics
 Proficient in MS Office; Working knowledge of safety
management information systems is a plus
Skills and abilities
 Outstanding organizational skills
 Diligent with great attention to detail
 Excellent communication skills with the ability to present and
explain health and safety topics
1. Support the development of OHS policies and programs
2. Advise and instruct on various safety-related topics (noise levels,
use of machinery etc.)
3. Conduct risk assessment and enforce preventative measures
4. Review existing policies and measures and update according to
legislation
5. Initiate and organize OHS training of employees and executives
Responsibilities 6. Oversee installations, maintenance, disposal of substances etc.
7. Stop any unsafe acts or processes that seem dangerous or
unhealthy
8.
9. Record and investigate incidents to determine causes and handle
worker’s compensation claims.
10. Preparing reports on the facts and providing statistical
information to senior management.
 6. Resource Requirements
6.1 General
The laboratory has the personnel, facilities, equipment, systems, and support services
necessary to carry out its activities.

6.2 Personnel
1. All laboratory personnel who can have an influence on the laboratory activities, also the
internal or external personnel perform their work with integrity and efficiency in
accordance with the laboratory management system.
2. The laboratory documents the competency requirements for each business that
influences its activity outcomes, including education requirements, Qualification,
training, technical knowledge, skills, and experiences.
3. The laboratory ensures that the personnel have the competence to carry out the
laboratory activities for which they are responsible, and they appreciate the importance
of deviation and its consequences.
4. The laboratory management informs each employee of his duties, responsibilities, and
powers, based on the pre-defined job structure.
5. The laboratory should have a procedure (s) and keep records of:

6.2.1 Determine Necessary Competence:

The organization decides what specific competencies are needed for a person to
perform his job effectively. To determine employee requirements for a specific job, by
asking the following questions:

1. What areas of job-specific knowledge should a person in this position understand well?
2. What manual, mental, or interpersonal skills should an employee possess to do the job
well?
3. What natural abilities or talents would a person have to be effective in this field?

A properly defined job description can help with guiding this process. The description
should at least give a basic understanding of what is required and how the employee qualifies
for the job. After you have collected the answer to those questions, the hiring process and
training and development plans can be created. Also, the selection of the right person will be
a lot easier when these requirements are clearly defined.

6.2.1.1 Ensure Competence:

The requirements mandate that everyone who affects the KIT (i.e., everyone in the
organization) must be competent. by separating four different variables relating to
competence:

 Education
 Training
 Skills
 Experience

Of course, it is pretty much up to the organization what they define as competent, but it
should be in line with the job description. Also be cautious for inconsistencies. When
someone is hired that does not really fit the profile, make sure the appropriate training is
giving.

6.2.1.2 Take Action to Achieve Competence:

Once competency has been determined for all personnel affecting product conformity,
the organization must compare individuals to its competency needs and identify where gaps
exist. Options for dealing with a gap between actual performance and required performance
include:

 On-the-job training
 Coaching and counseling
 Independent study (traditional, audio, video, and internet-based)

6.2.1.3 Keep Evidence:

The organization stresses the need to keep records as evidence of competence. This can
be accomplished on one or multiple records. The fewer odd records, the better - especially if
the records are kept on paper.

Examples of evidence include:

1. Job descriptions/postings (evidence of determination of competency).

2. Employee resume and certifications (evidence that competency was met).
3. Training attendance and agendas (evidence that competency was met).
 4. Test results, certifications, performance evaluations (evidence that actions were
effective).

6.2.2 Delegate employees:

The laboratory should authorize personnel to carry out specific laboratory activities
like:

1. Development, modification, verification and validation of methods.

2. Analyze results, including a statement of compliance or expressions of opinions and
interpretations.
3. Record, review and approve the release of results

6.2.3 Monitor (control) the efficiency of employees:

 Maintain current and accurate records associated with the evaluation and maintenance of
competencies. Before undertaking any accreditation activities, personnel shall be
evaluated to demonstrate that they possess the appropriate knowledge and skills based on
the established competence criteria. The evaluation shall be conducted using a
combination of two or more of these methods: examinations (oral or written), review of
records (employment, training, etc.), feedback (surveys, personal references, complaints,
peer review), interviews and observations (practical tests, witnessing of activity, etc.).
 Developed procedures for periodically monitoring the performance of all categories of
personnel involved in the performing and managing accreditation activities.
 The Quality Manager is responsible for maintaining updated records of competence for
all personnel involved in the management and performance of accreditation activities.

6.3 Facilities and environmental conditions

Environmental requirements for calibration laboratories. All test equipment and
reference standards used in calibration laboratories are affected by environmental changes in
temperature, relative humidity, barometric pressure, vibration, and several other
environmental conditions. The laboratory needs to monitor, control, and record those
environmental conditions that influence the measurement results. There should be a
continuous monitoring system that records those environmental conditions at specified time
intervals. The monitoring and control must also extend to encompass the storage and
handling of equipment within the laboratory.

6.3.1 Temperature Stability

The stability of the temperature during the time it takes to make a measurement is an
important aspect for calibration laboratories, and limits should be established and maintained.

6.3.2 Relative Humidity

Relative Humidity greater than 60% can lead to rust or corrosion effects in certain
instruments such as Gage Blocks, where below 20%, electrostatic discharge issues can cause
problems with electrical measurements or the handling of sensitive electrical components.
Most calibration laboratories should maintain a Relative Humidity Environment of between
30% to 50% Relative Humidity to achieve the best balance.

6.3.3 Vibration
Vibrations that are present in the laboratory should not compromise the validity of the
measurement results or affect the life of standards and associated equipment. Specific
standards such as analytical balances and surface plates should be isolated from vibration as
much as possible by using isolated pads or special vibration tables. Those items should also
be located away from laboratory foot traffic.

6.3.4 Barometric Pressure

The barometric pressure can influence some mass and force measurements. Weather
fluctuations make it difficult to control the barometric pressure in a laboratory environment.
Accurate barometric pressure measurements are required to apply any necessary corrections
to the measurement results.

6.3.5 Electromagnetic Interference

Some electronic measurement equipment, especially used for RF and high resistance
measurements, are susceptible to interference from electrical and magnetic fields. Sufficient
shielding precautions, use of proper cables and filtering should be observed to keep the
interference to a level that will not impact the measurement results.

6.3.6 Air Cleanliness and Airflow

A positive air-pressure differential between the inside of the laboratory and the outside
areas is an important factor to reduce the influx of dust into the calibration laboratory.  Air
cleanliness limits can be critical for some calibration laboratories, especially within the
medical field. Tack mats located within the entryway can also assist in reducing particles
entering the laboratory.

6.4 Laboratory Management

 Ensures laboratory facilities meet the required environmental conditions, including any
needed separation of work areas to ensure that analyses and calibrations will not be
adversely affected within resources provided.
 Ensures laboratory storage areas provide proper storage of samples, reagents,
microbiological media, chemicals, select agents, standards and reference materials, and
radioactive wastes and hazardous waste.
 Ensures any additional laboratory conditions needed for specialized analyses are met,
including structural, equipment needs and procedures for the handling and analysis of
extremely hazardous materials within resources provided.
 Ensures additional resources needed are identified and procured.
 Ensures scheduled cleaning and maintenance service of the laboratory facility is
accomplished.
 Ensures a pest control program is in place.
 Ensures modifications are made to the laboratory to accommodate new equipment, so
the equipment does not interfere with the environmental controls in the laboratory.
 Implements environmental control programs in the laboratory.
 Performs continual laboratory surveillance to ensure proper conditions are being met
and Recognizes when environmental conditions are not met and adversely affect test or
calibration results.

6.5 Staff
 Plans and conducts laboratory operations in designated areas.
 Monitors and records environmental conditions in their areas.
 Identifies and implements any environmental controls needed to complete sampling,
analysis, and calibration, and ensure these factors do not adversely affect the quality of
the work.
 Practices good housekeeping practices.
  Practices proper handling and storage of hazardous waste as defined in the Hazardous
Waste Plan, so as not to adversely affect laboratory operations.

6.6 Environment
 The laboratories are designed to provide space, engineering controls, and proper
environmental conditions for optimal sample storage, sample handling, analysis, and
calibrations, in accordance with general laboratory practices, safety, and applicable
Federal, State, and local regulations.
 Facilities consist of laboratories, office areas, storage rooms, and special purpose areas.
Laboratories are sectioned by testing compatibility and design capabilities. Floors in the
laboratories are constructed from a material that is resistant to most chemical spills and
easily disinfected. Floors are clean, dry, and in sound condition so there are no tripping
hazards.

6.7 Equipment
The purpose of this procedure is to describe the process of for handling, transport,
storage, use and planned maintenance of equipment to ensure proper functioning, to prevent
contamination or deterioration and to maintain metrological traceability.

This procedure applies to all equipment of every type and class that are used in the
laboratory. Users of this procedure are managers, supervisors and technicians working as
employers in the laboratory or other personnel associated with the laboratory.

6.7.1 General Equipment:

Equipment purchased by [KIT] can achieve the measurement accuracy and
measurement uncertainty required to provide valid results. Laboratory management ensures
that all equipment complies with specified requirements before being placed into service.

List of devices and Equipment

Serial Device Duration of Calibration
# Device Name Notes
No. location calibration port
 6.7.2 Handling procedure:
To keep track of items received for testing or calibration, along with their results,
[KIT] uses a Laboratory Information Management System so that test or calibration items are
secure and do not deteriorate, become damaged, or have a risk of loss or contamination
during handling, and to ensure that handling does not jeopardize the validity of results
provided to the customer.

HANDLING OF ITEMS RECEIVED FOR TESTING PROCEDURE

Code:
Version:
Created by:
Approved by:
Date of version:
Signature:

6.7.3 Test and Calibration Method Procedure

The purpose of this procedure is to ensure that the correct test and calibration methods
are chosen to meet customer requirements; that those methods are appropriate and the
organization meets all of the requirements of ISO/IEC 17025:2017; and to ensure that when
required, that verification and validation are applied to tests and calibrations.

The Quality Manual, based on ISO 17025, is used to document the Lab Quality
Management System of an organization. In addition to describing the organization’s
structure, the manual states the general requirements of impartiality and confidentiality and
other specific requirements for structure, resource, process, and management.

6.7.3.1 CALIBRATION OF PRESSURE GAUGES, INSTRUMENTS

Inspection / calibration of pressure gauges is carried out with the equipment developed
and manufactured in L-plan. Calibration methods and equipment satisfy the following
requirements:
 1. EA-10/17 EA Guidelines on the calibration of electromechanical manometers, July
2002
2. DKD-R 6-1 Calibration of Pressure Gauges, 01/2003.
3. ISO / IEC 17025: 2005-General Requirements for the Competence of Testing and
Calibration Laboratories
4. Pressure gauges – Part 1: Bourdon tube pressure gauges – Dimensions, metrology,
Requirements and Testing
5. Pressure gauges – Part 3: Diaphragm and capsule pressure gauges – Dimensions,
metrology, Requirements and Testing.

6.7.3.2 Standard Thickness Gage Calibration

 Purpose

The purpose of this procedure is to provide general instructions for the calibration of
standard thickness gages.

 Scope
This general procedure shall be used in the absence of any specific calibration
procedure for standard thickness gages. To eliminate or minimize the effects of certain error
sources, coating thickness meters may need to be calibrated for proper measurement.

As accuracy of an ultrasonic thickness gauge is highly related to the material to be

measured and the speed of sound in this material, the calibration report must include the
information regarding the reference material and the speed of sound applied.

CALIBRATION REPORT AND CERTIFICATE REQUIREMENTS PROCEDURE

Code:

Version:

Created by:

Approved by:

Date of version:

Signature:
6.8 Metrological Traceability
Traceability of equipment to the same standard is a prerequisite for comparability of
test and calibration results. Ideally all measurements should be traceable to International
System of Units (SI). While this is typically possible for physical measurements such as
length (m) and weight (kg), this is more difficult in chemical measurements.

Key points for traceability of calibrations:

o Sampling should follow a documented sampling plan and sampling procedure.

o The sampling plan should be based on statistical methods.
o The sampling procedure should describe the selection and withdrawal of representative
samples.
o The sampling location and procedure, the person who took the sample, and any other
relevant information about the sampling process should be recorded.
 7. Process requirements

7.1 Review of requests, tenders, and contracts:

The laboratory has a procedure for reviewing requests, bids and contracts through a
committee composed of the Quality Department, the laboratory officer and the technician
concerned. However, this procedure considers the following:

o Study the bid, submit the quotation, and make contracts to be submitted for signature
by the administration.
o Requirements are defined, documented, and understood.
o The laboratory has the capacity and resources to fulfill the requirements.
o Appropriate methods or procedures are chosen and can meet the client's requirements.

The laboratory ensures good communication with the client, making sure that their
needs are well met, but the client must also be informed if their methods are inappropriate or
outdated, or if their request cannot be completed because it may jeopardize the safety of the
laboratory.

7.2 Selection, Verification and Validation of Methods

7.2.1 Selection and verification of methods:
The laboratory uses methods and procedures appropriate to the activities and, when
necessary, to assess uncertainty as well as statistical methods for data analysis. The
laboratory ensures that the methods, procedures and supporting documents are kept up to date
and made available to all employees.

Based on ISO 17025: 2017, the lab is kept up to date with methods as appropriate and
when customers do not specify a method, the lab selects the best and most recent valid
version. The laboratory should communicate the method they are using with the client.

The laboratory needs to keep verification records. Additionally, when style

development is required the development should be planned and assigned to competent
personnel. Periodic reviews of method development should be undertaken.

7.2.2 Selection and Validation of methods:

Method validation is the process used to confirm that the analytical procedure
employed for a specific test is suitable for its intended use. Results from method validation
can be used to judge the quality, reliability, and consistency of analytical results; it is an
integral part of any good analytical practice. Analytical methods need to be validated or
revalidated. laboratory shall use appropriate methods and procedures for all tests within its
scope.

Selection of methods

 Methods must meet customer requirements.

 Preference for standard methods (international/national standards).
 Laboratory shall confirm that it can properly operate standard methods before
introducing the tests.
 Laboratory-developed methods may be used if they are validated.

The laboratory retains the following records of validation:

 The validation of the procedure used.

 Specification of the requirements.
 Determination of the performance characteristics of the method.
 Results obtained.
 A statement on the validity of the method.

7.3 Sampling Procedure

The purpose of this procedure is to describe the process of regular sampling of a
smaller set of materials or fractions selected under controlled conditions using statistically
valid methods.

Main points of sampling

o Sampling should follow the sampling plan and documented sampling procedures.
o The sampling plan should be based on statistical methods.
o Must describe the check and withdrawal sampling procedure from representative
samples.
o The location and procedure for sampling, the person taking the sample, and any other
information relevant to the sampling process must be recorded.
When sampling, the laboratory must maintain appropriate records of the samples. These
records should include, where applicable:

 References to the sampling method.

 Date and time of sampling.
 Data for identifying and describing the sample.
 Individuals performing the sample.
 Environmental conditions or transportation conditions.
 Charts or other equivalent means for determining the sampling site.
 Deviations and additions or exceptions to the sampling method and the sampling plan.
7.4 Handling of test or calibration items
The laboratory carries out a procedure to transport, receive, handle, protect, store,
retain, dispose of, or return test or calibration items. This includes all provisions necessary to
protect the integrity of the test item or calibration, and to protect the integrity of the test or
calibration item, and in the interest of the laboratory and the customer, the laboratory takes
precautions to avoid deterioration, contamination, loss, or damage to the item during
handling, transportation, storage, preparation for testing or calibration.

Additionally, the laboratory:

1. Defines handling instructions.

2. It contains a system for unambiguous identification of test or calibration items.
3. Make sure not to confuse the items.
4. Score any deviations.

The laboratory consults with clients if there is any doubt about the suitability of an item
for titration testing, or if the item does not conform to the description provided. If requested
by the client, the laboratory must include a disclaimer in the report indicating results that may
be affected by the deviation.

7.5 Technical records

Ensure that the technical records of all laboratory activities contain the results, report
and information in order to facilitate and identify the components affecting the measurement
results and associated uncertainty in measurement, and to enable the repetition of laboratory
activities under conditions as close as possible to the original. When you keep records, you
must include the date and identify the personnel responsible for laboratory activities. Records
shall include original notes, statements, and accounts, and be recorded at the time of their
preparation. If changes are made, these modifications should be reverted to previous versions
or to the original notes. It maintains all files, including the original and the modifications,
including the date of change, amended aspects, and the personnel responsible for any
modifications.
7.6 Evaluation of measurement uncertainty
It is important to understand where the uncertainty comes from. Therefore, the
laboratory identifies contributions to the uncertainties. By looking at all important
contributions, even those arising from sampling. When performing a calibration, the
laboratory evaluates its equipment for uncertainty. When performing the test, the uncertainty
must be assessed. If the test method excludes the accurate assessment of measurement
uncertainty, laboratories should make estimates of uncertainty based on an understanding of
theoretical principles or from practical experience.

7.7 Ensuring the validity of result

7.7.1 The laboratory should have a procedure for monitoring the validity of the
results.
As an ISO / IEC 17025: 2017 certified tester, ensuring that the results are correct
should be a top priority. One of the goals of validity is the ability to identify trends using
statistical techniques. To fulfill the requirements, the laboratory must develop a procedure to
monitor the validity of its results. The main goal is to understand if a system or process is
ineffective so that you can take preventive action. Aptitude Test is now more important than
ever, and it's covered in 7.7.2.

The procedures required to monitor the validity of the results

1. Use of reference materials or quality control materials.

2. The use of alternative devices that have been calibrated to obtain sequential results.
3. Perform a functional check of the testing and measuring equipment.
4. Use of verification standards or work standards with quality control charts.
5. Repeat checks or titrations using the same or different methods.
6. Recheck or calibrate held materials.
7. Connect the results.
8. Review the results of the reports.

7.7.2 The laboratory should monitor its performance by comparing its results
with those of other laboratories, whenever available and appropriate.
This may be accomplished through:
  Participate in technical aptitude tests.
 Take part in cross-comparisons other than aptitude tests.

7.7.3 Data on monitoring activities should be analyzed and used to control and
improve laboratory activities whenever possible.

7.8 Reporting of results