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Betalink Instrumentation & Calibration Services LLC

Quality Management System Manual

QUALITY MANAGEMENT SYSTEM MANUAL


(BLICS-QSM-01)

Ref. Norm: ISO 17025:2005

Prepared By:

Name:
Design:
Sign:
Date:

Reviewed By:

Name:
Design:
Sign:
Date:

Approved By:

Name:
Design:
Sign:
Date:

COPYRIGHT
No part of this document may be reproduced in any form by print, photocopy, microfilm or any other
means wholly or partially, or disclosed to any person outside BLICS without a written permission.

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AMENDMENT RECORD
Page Revision Authorized
Sr. No. Summary of Change
No. No. / Date By

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Quality Management System Manual

TABLE OF CONTENTS

Number Section Page No.


1.0. General
1.1. Index and revision status
1.2. Purpose & Scope
2.0. Background of the laboratory
2.1. Activities
2.2. Profile of Betalink Lab
3.0. Definitions and conventions
3.1. Definitions and terminology
4.0. Management Requirements
4.1. Organization
4.2. Quality System
4.3. Do Document control
4.4. Review of Requests, tenders and contracts
4.5. Subcontracting of tests and calibrations
4.6. Purchasing services and supplies
4.7. Service to the Client
4.8. Complaints to the laboratory
4.9. Control of non-conforming testing work
4.10. Improvement
4.11 Corrective Action
4.12. Preventive actions
4.13. Control of records
4.14. Internal audits
4.15. Management review
5.0. Technical requirements
5.1. General
5.2. Laboratory Personnel
5.3. Accommodation & Environmental conditions
5.4. Test & Calibration methods and method validation
5.5. Equipment
5.6. Measurement traceability
5.7. Sampling
5.8. Handling of Test items
5.9. Assuring the quality of test results
5.10. Reporting the results
5.11. Occupational health & safety

1. GENERAL

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1.1 Index and Revision Status

The numbering of this manual corresponds directly to the numbering of ISO


17025:2005 standards.

Updates to this manual will be made by re-issuing the entire manual. The manual shall
take the next revision level.

1.2 Purpose and Scope

This manual documents the Laboratory's Quality, Administrative and Technical


management system and demonstrates the laboratory's ability to execute tests and/or
calibrations as per the technical standards, Customer's requirements and in
accordance with applicable regulatory requirements.

This manual establishes compliance with ISO 17025:2005. The scope of this
management system established, implemented and maintained at Betalink Lab is:

"To provide Testing and Calibration services for Temperature, Pressure and Digital
MultiMeters.

2. BACKGROUND OF THE LABORATORY

2.1Activities

The tests and calibration services provided by the laboratory are for Temperature,
Pressure and Digital Multimeters.

2.2 Profile of Betalink Laboratory

Betalink Instrumentation & Calibration Services LLC (BLICS) has been operating in the
UAE with the purpose of providing reliable and high quality cost effective Testing and
calibration services to the oil, gas, petrochemical, construction and heavy fabrication
sectors.

From the start, BLICS has pursued a policy of sustainable growth always ensuring that
it has the capacity to undertake new and varied work without jeopardizing existing
contracts. This policy has resulted in an enviable reputation for reliability and
performance.

With customer satisfaction as the driving force, BLICS has sought to stamp its authority
on those activities for which it has gained a reputation for quality and reliability among
its clients. Any diversification or expansion has been carefully measured against

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customer requirements and further trends. This has resulted in the proper and effective
utilization of available resources.

Betalink has two separate divisions who are taking care of Inspection and Calibration
works. They are independent from each other. This manual is of Testing/Calibration
division only.

3. DEFINITIONS AND CONVENTIONS

Fundamentals and vocabulary related to quality are given in ISO 9000. ISO/ IEC 17000
gives vocabulary and general principles related to ISO 17025:2005.

4. MANAGEMENT REQUIREMENTS

4.1 Organisation

4.1.1 Name and Location of the Organisation/Legal Identification

Betalink is a legal entity and legally responsible for all its Testing and
Calibration activities.

Company Name: Betalink Instrumentation & Calibration Services LLC

Address: Mussafah, Abu Dhabi, U.A.E.

TEL: +971 2 5508556

FAX: + 971 2 5508551

Email: info@blcontrol.com

Betalink Laboratory Management holds legal responsibility for its operation


and is organised to operate in accordance with the requirements of ISO/IEC
17025, whether carrying out work in its permanent facilities or on location, at
customer sites.

Ref: Betalink Trade License

4.1.2 Compliance

Betalink Laboratory is committed to carry out its testing and/or calibration


activities in such a way as to satisfy the needs of the client and regulatory
authorities and to satisfy the requirements of International standard ISO 17025.

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4.1.3 Scope of Laboratory Quality Management System

Betalink Laboratory quality management system covers activities in the


laboratorys permanent facility. The field of activities include:

Temperature Gauges
Pressure Gauges
Digital MultiMeters

4.1.4 Independence of Betalink Lab

The Betalink Laboratory provides testing and calibration services. No other


services are provided by our Laboratory that could place the lab in a position
where conflicting interest could be a concern. The staff of the laboratory reports
to the Lab Manager. This ensures the independence of the laboratory from the
other areas of the organisation. Responsibilities of key personal of the
laboratory that are involved and have influence on the testing and calibration
activities are defined in the Job Descriptions.

Some major responsibilities of the Lab Manager include:

Ensuring that suitable management systems and quality control


procedures are introduced in the laboratory.
Liaise directly with Quality/Technical In charges to ensure quality
procedures are in place, internal and external auditing is undertaken on
regular basis and our facilities at all times comply with local legislations
and defined rules, policies and procedures.

4.1.5 Organisation

4.1.5(a) Integrity

Betalink Laboratory Management provides managerial and technical personnel


with the authority and resources needed to carry out their duties. The authority
vested in the Technical In charge/ Quality In charge is described in their
respective Job Descriptions.

4.1.5(b) Undue Pressure

Betalink Management and personnel are free from any undue internal and
external commercial, financial and other pressures that may adversely affect
the quality of their work. The integrity of test results is the responsibility of all
personnel. Betalink Laboratory Quality Management ensures that employees
are never instructed or forced to alter of falsify data. Employees are free to
express concerns through the chain of command up to and including the
Laboratory Manager of Betalink.

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Employees report any instances where they feel they are subject to any undue
influence or conflict of interest arising from relations with suppliers, customers
or any other position or section of the organization.

All inquiries regarding the integrity of laboratory data are referred to the
Managing Director, Laboratory Manager and/or the Quality/Technical In
charges.

4.1.5(c) Clients confidential information and proprietary rights

It is the policy of our laboratory to protect the confidential information and


proprietary rights of our clients including the electronic storage and
transmission of results.

All employees accept in writing, by signature, confidentiality agreement, The


copy of signed agreement is retained in each employees personnel file.

Test / Calibration results are released only to the client. Release to someone
other than the client requires the express permission of the client, and the
results must be provided to the appropriate agency with clients letter of
permission. The release of the test results to anyone other than the client
requires the permission of Betalink Management. Laboratory reports and
documents are reviewed for accuracy prior to release.

4.1.5(d) Independence of Judgement and integrity

The company has policies and guidelines in place to avoid involvement in any
activities that would diminish confidence in its competence, impartiality,
judgment, or operational integrity. Technical competence is ensured through
check sample programs. Judgement is ensured through the hiring of qualified
personnel and by continuously refining, upgrading and improving his or her
knowledge and skills. Operational integrity is reviewed by management on a
regular basis at management review meetings to ensure continued suitability
and effectiveness of laboratory policies and procedures. Any problems are
acted on immediately through corrective action procedures.

4.1.5(e) Organisation and Management Structure

The organization and management structure is defined in the Organization


Chart. The organization chart is considered the official record on the date it is
marked. Betalink Laboratory management keeps the most current
organisational chart within the organisation and on a file.

4.1.5(f) Responsibility, authority and interrelation of personnel

The responsibility and authority of all personnel within the laboratory for
implementing, maintaining and improving the Management System has been
prepared and kept on a file in the form of Job Description. The Laboratory

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Manager with the coordination of Admin/HR and Quality Department of Betalink
is responsible for creating and maintaining Job Descriptions for each member
of staff within the laboratory. Job Descriptions of employees are reviewed and
updated as required.

4.1.5(g) Laboratory Supervision

Adequate supervision is ensured through designated Technical In charge and


through lab technician. For details of the education, experience and training of
the Technical In charge and Lab technician, please refer their personnel files.

4.1.5(h) Lab In charge / Manager

Betalink Laboratory Management and Quality System identifies and provides


adequate resources including the assignment of trained personnel for
management, performance of work and verification duties, infrastructure, and
equipment. Resources are ensured by the use of contract reviews,
management reviews, internal quality audits, and follow-up
corrective/preventative actions.

The technical management may be designated Lab Manager and Supervisor


who is responsible for testing and calibration area and technical operations.
The Lab In charge has the resources needed to ensure the required quality of
laboratory operations. In the absence of the Laboratory Manager, the Technical
Supervisor / Quality In charge will assume his/her responsibilities.

4.1.5(i) Quality In charge / MR

Quality In charge has responsibility for the quality system and its
implementation. The Quality In charge has access to the highest level of
management at which decisions are taken on lab policy and resources.

4.1.5(j) Deputies

When feasible, depending on availability of personnel, deputies are appointed


for key personnel.

In addition to the above statement, during the absence of Lab Manager, Lab
Supervisor or Quality In charge will assume his/her responsibilities. During the
absence of Quality In charge, Lab Manager will assume his/her responsibilities.
In the absence of the Laboratory Manager, the Lab Supervisor will assume
his/her responsibilities.

Management is responsible for ensuring that current and / or increased


workload requirements are met. This includes making adjustments as a result
of employee absence. Only fully trained employees are utilized to fulfil the
duties of personnel who are absent.

If sufficient human resources are not available, management will identify the

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best possible solution to meet operational requirements.

4.1.6(K) All the staff of Betalink is well aware of their responsibilities and management
objectives which are set by the management in order to fulfil the requirements
of ISO 17025:2005 standard.

Top Management of Betalink is committed to the communication process which


is established in the form of email, direct face to face communication with the
staff in case of any issue to resolve ,information displayed on notice board ,etc
and make sure the laboratories common objectives of customer satisfaction
and continual improvement are achieved

Ref:
Quality Policy,
Organization Chart,
Job Descriptions,
IIIC Policy,
Confidentiality Agreements.

4.2 Management System

4.2.1 Documentation of the System


.
4.2.1.1 Betalink Laboratory has established and maintains a quality system as
described in this manual. The system implements and maintains the
requirements of ISO/IEC 17025:2005, and other industry specific requirements
as required by our clients. Lab Management is committed to maintain a quality
system that meets the requirements of these standards and our customers.
The Quality Manual is the principal document that defines the quality system at
Betalink Laboratory.

4.2.1.2 Quality System Procedures are documented to establish and maintain


continuity of each activity or function affecting quality. Quality procedures are
readily available to personnel for reference and implementation. The quality
document structure contains this Quality Manual, Quality Procedures,
Calibration Methods and Quality Records.

The effectiveness of the Quality System is assessed in several ways:

By a program of planned internal audits, covering all aspects of the


operation of the quality system.
By regular management reviews of the suitability and effectiveness of
the quality system.
By analysis of potential and actual problems as shown by client
complaints and supplier and subcontractor assessments.
By other methods approved from time to time by the Quality
Management.

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This quality manual and associated document including procedures and
records serves as the quality plan for the laboratory. Other documents and
records include:

Standard operating procedures


Calibration methods
Organisational chart
Proposals
Work Instructions etc.

4.2.2 Quality Policy Statement

Betalink has established and maintained a quality policy which is


communicated, and reviewed at regular intervals.

Ref: Quality Policy

4.2.2 a) Laboratory testing and other services to client are always carried out in
accordance with stated standardised / validated methods and clients
requirements. Requests to perform tests that may jeopardise an objective
result or have a low validity are rejected.

4.2.2 b) Standards of service include:

Client Satisfaction
Accuracy
Timely

Excellence in the workplace is promoted by providing all employees with the


knowledge, training and tools necessary to allow for the completion of accurate
and timely work.

4.2.2 c) Objectives of Quality Management System

Achieve maximum customer satisfaction


Achieve maximum employee satisfaction Levels
Achieve greater expansion of local client base
Achieve expansion of local facilities and capabilities in line with
company plan and local needs.
Finance performance in accordance with budgetary requirements
Injury/accident rate superior to industry standard performance
100% of workforce trained as required by job function and in ethics
compliance
Compliance to appropriate International Standards at all designated
locations of Betalink laboratory activities. (e.g. ISO 17025 QMS)

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Ref: Quality Objectives

4.2.2 d) Personnel

Familiarise themselves with quality and technical documentation and


implement the policies and procedures in their work.

4.2.2 e) Management is committed to complying with ISO 17025 International


Standards

The objective of this Quality Manual is to document policies and associated


procedures that are integrated into our daily activities.

Additional objectives include:

To establish the level of the laboratorys performance


To update calibration methods to improve performance
To participate in proficiency testing or quality evaluation programs with
other laboratories
To ensure that all personnel are trained to a level of familiarity with the
quality system appropriate to the individuals degree of responsibility
To validate calibration methods to confirm that they are fit for indented
use
To establish and report on quality savings.

4.2.3 A list is maintained of the procedures, instructions and records for this
management system.

4.2.4 The Lab Manager communicate customer, statutory and regulatory


requirements to all lab Staff, some of the means being the use of this quality
manual, procedures, memos, e mails and training courses.

4.2.5 STRUCTURE OF DOCUMENTATION

Betalink Laboratorys Quality system is structured in different levels of


documentation. The different levels are illustrated below:

Level 1 Quality Policy Policy defined by top


management of Betalink.
Level 2 Quality Objectives Objectives defined by each
level in the Laboratory.
Level 3 Quality Manual Outline of Quality System in
accordance to ISO 17025
Standards.
Level 4 Procedures, Process Business Systems to define
Maps and control operations.

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Level 5 Technical Procedures, Defining how the specific
Process Map, Work activities are carried out.
Instruction, Bulletins,
Specifications, Job
descriptions
Level 6 Evidence that activities
Forms / Records specified in the higher level
documents are carried out.

For most clients, this Quality Manual and the associated documents form a
general Quality Plan. If necessary, specific Quality Plans will be prepared
on a per-client basis. These Quality Plans will modify the general
requirements stated in the Manual and associated documents.

All the above documents are controlled documents.

4.2.6 Roles and responsibilities

The roles and responsibilities of Laboratory Manager, Technical Supervisor


and Quality In charge are outlined in the individual Job Descriptions.

Technical management ensures that section 5 of this manual is


implemented and maintained. The Quality In charge ensures that section 4
of this manual is implemented and maintained.

Top management of Betalink also committed to ensure continual


improvement in its management system via various methods like customer
satisfaction analysis, Complaint handling, MRM, result of Internal and
external audits and importance of meeting customer statutory and
regulatory requirements are well explained to all its staff members.

The top management has measure responsibility to ensure integrity of


QMS throughout the laboratory activities and shall also ensure it even if
any changes in Quality planning are take place.

4.2.7 The Lab Manager shall ensure that changes to this management system
do not interfere with the goals and objectives established by the laboratory.
Concerned Staff shall be involved during discussions relating to changes
to this management system. The Lab Manager is responsible for ensuring
that corresponding changes are made to other areas of the system.

4.3 Document Control

4.3.1 General

Documents that are required by the Laboratory Quality Management


system shall be controlled. Control documents could be policy statement,
procedures, specifications, calibration tables, charts, text books, posters,

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notices, memoranda, software, drawings, plans, etc. Betalink is in the
process of making the transition from paper to electronic documentation.
As this transition progresses, documents are being transferred from paper
to an electronic document control system. Both systems are currently in
use, until such time as the transition to electronic media is complete.

To preclude the use of invalid or obsolete information, Lab personnel only


use controlled documents and data when performing tasks affecting
quality.

4.3.2 Document approval and issue

4.3.2.1 Review/Approval/Master list

Personnel at all levels are encouraged to review the procedures and work
instructions they use and to identify the need for revisions or new
documents/data systems. Any one may submit a draft of the proposed
changes or additions to the appropriate level authority for review and
approval.

All control documents shall be continuously reviewed for effectiveness by


the actual users, by means of suggestions for improvement made by
Management Review activities. Changes in industry standards or
regulations, customer requirements, etc., may require that the current
Laboratory Quality Management system be reviewed and amended
accordingly. This may result in revision of pertinent documents.

A master list of documents is maintained by the QA/QC and/or Laboratory


Management with current revision status of each document, this may
preclude the usage of obsolete documents.

The approval of appropriate documents and/or data systems for use is the
responsibility of the QA/QC or Laboratory Manager. QA/QC or Laboratory
Manager review and approve all documents prior to issue to the laboratory
personnel.

4.3.2.2 Availability of Documents

The master list of documents shows the current status of all controlled
documents. The master list document is organised with the following
information:

Document #
Document Name
Revision #
Date of Issue
Revision Status with date

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Controlled documents are approved before issue. All type of
correspondences, reports, original observations, derived data, and other
documents shall be retained for a period of 3 years or as specified in
master list of records.

The standard operating procedures (SOP) for document control ensures


that:

Authorized editions of appropriate documents are available at all


locations where operations essential to the effective functioning of
the laboratory are performed.
Documents are periodically reviewed and where necessary revised
to ensure continuing suitability and compliance with applicable
requirements.
Invalid or obsolete documents are promptly removed from all points
of issue or use to assure against unintended use.
Obsolete documents retained for either legal or knowledge
preservation purposes are suitably marked (i.e.; stamped
OBSOLETE and dated).

4.3.2.3 Identification

All quality system documentation is identified by:

Date of issue and/or revision number


Page numbering
Total number of pages (e.g. Page 2 of 2)
Issuing authority (i.e.; approval and signature)

4.3.3 Document Changes

4.3.3.1 Review/Approval

To maintain a current and progressive Lab QMS system, documents and


databases may be revised on an as needed basis. All revisions are
reviewed and approved by the Managing Director.

The Quality Manual is reviewed annually by the Quality In charge. Records


are kept for review.

Calibration methods and SOPs (Standard Operating Procedures) are


reviewed on a regular basis.

If, however, copies are left in bound manuals, they should be marked
through, labelled as obsolete, and signed and dated. Invalid documents
kept for legal and/or knowledge-preservation purposes should be suitably
identified as such to prevent unintended use.

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4.3.3.2 Identification of Changes

Where practical, the nature of the change shall be identified in the


document or the appropriate attachments. Revision number refers to
revision of a section of the Manual, starting from 0 and numerically
increasing by 1 for each time a section is revised.

4.3.3.3 Amendments by Hand

The Labs documentation control system does not allow for amendments of
Quality documents by hand pending the re-issues of the documents.
However, handwritten amendments to documents are permitted only by
those personnel authorized to do so. Amendments are clearly marked,
initialled, and dated. A revised document is formally re-issued at the time of
next review or at the earliest opportunity.

4.3.3.4 Computerized Documents

Laboratory Procedure for document control details how changes in


documents maintained in computerized systems are made and controlled.

Ref: Control of Documents and Data Procedure


Master List of Documents

4.4 Review of Requests, Tenders and Contracts

4.4.1 Policies and Procedures

Contract/order review is an integral part of the quality system at Betalink


Laboratory. All contracts/orders are reviewed and accepted only if the
requirements are clear and understood, and the laboratory has the
capability and capacity to assure full customer expectations. When
reviewing requests, tenders and contracts, Betalink Laboratory
management should be aware that clients might not always understand
their own needs. As far as practicable, Betalink Laboratory management
should give advice to clients and help them to determine the suitability of
test/analysis needs.

The contract review ensures that each clients requirements are


adequately defined and documented before the service or product is
ordered or dispatched. This should ensure that any order, once accepted,
can be completed without delay, and that the clients requirements
including delivery date, technical specification, and cost can be met.

If the contract review highlights any ambiguities or uncertainties then the


client will be contacted and the problem resolved before the order is
accepted.

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Typical types of contracts include:

Approved service quotations


Non-disclosure agreements
Sample submission requests
Memorandum of agreement
Memorandum of understanding
Research proposals and contracts
Verbal order (Oral agreements)
Activity plans

4.4.2 Records of Review

All records related to client contract reviews, including any significant


changes to contract are maintained. For review of routine and other simple
tasks, the date and the identification (e.g.; initials) of the person in the
laboratory responsible for carrying out the contracted work are considered
adequate.

For repetitive routine tasks, the review need be made only at the initial
enquiry stage or on grant of the contract for ongoing routine work
performed under a general agreement with the client, provided that the
clients requirements remain unchanged. For new, complex or advanced
testing task, a more comprehensive record is maintained.

4.4.3 Review of Subcontracted Work

The review activity ensures and addresses any testing/calibration to be


subcontracted.

4.4.4 Notification of Client

If the Betalink Laboratory is unable to comply with customer requirements,


the customer must be contacted before proceeding, and any comments
noted in the job file. This is typically communicated to the client prior to
performing the deviation.

4.4.5 Contract Amendment

If a contract needs to be amended after work has commenced, the same


contract review process is repeated and any amendments are
communicated to all affected personnel. The process for contract review is
further defined in the relevant Procedure.

Ref: Contract Review Procedure


Customer Supplied Products Procedure

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4.5 Subcontracting of tests and calibrations

4.5.1 Subcontractor Competence

Betalink Laboratory has documented the policies and procedures for


engaging subcontractors. It is the responsibility of Laboratory that clients
are ensuring the subcontracting laboratory has a satisfactory quality
system and is competent to perform the required test/calibration. Uses of
ENAS, DAC, Abu Dhabi Municipality or Dubai Municipality accredited
laboratories are sufficient to ensure competence. All results reported by
the subcontractor shall be covered by an endorsed report.

When a subcontractor is not accredited by ENAS, Abu Dhabi/Dubai


Municipality or another organisation recognised as equivalent, the
laboratory shall record its assessment of that laboratorys capability to
meet International Standard requirements. As an example, the laboratory
should require the following subcontractor records to demonstrate the
compliance with International Standard for the work in question, prior to
the subcontracting:

A copy of the subcontractors record of evidence to compliance with


International Standard.
A format of a test report or calibration certificate for the testing
intended to be subcontracted.

The accreditation status of subcontractors should be regularly reviewed to


ensure compliance.

4.5.2 Client Approval

Betalink Laboratory will advise the customer in advance of any intention to


subcontract testing/calibration in writing. Betalink Laboratory will gain the
approval of the client in writing, when possible.

4.5.3 Assurance of Subcontractor Competence

Betalink Laboratory considers itself responsible to the client for the


subcontractors work, except in the case where the client specifies which
subcontractor is to be used. It is the responsibility of Betalink Laboratory to
evaluate the competency of its subcontractor prior to the release of any
work to the subcontractor.

Records of subcontractor competence include, but are not limited to, the
following:

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Accreditation certificates or documentation
Registration certificates
Technical Documents
Audit results (if mutually agreed)

4.5.4 Subcontractor Register

A register of all subcontractors performing tests and calibration is


maintained. The QA/QC or Laboratory Manager maintains the list of
approved subcontractors.

Ref: Subcontracting Procedure

4.6 Purchasing Services and Supplies

4.6.1 Policies and Procedures

The lab has procedures for the selection and purchasing of supplies and
services it uses that affect the quality of the tests and calibrations
performed. Consumable materials are stored according to the appropriate
calibration method, SOP (Standard Operating Procedure), or work
instruction. Procedures are implemented to make effective
purchase/receipt of materials.

4.6.2 Quality

The Lab uses only such services and supplies that are of the quality
needed to ensure confidence in its testing. Services and supplies comply
with specified requirements. Records of the actions taken to assure
compliance are maintained.

Where no independent assurance of the quality of procured goods or


services are available or the suppliers evidence is insufficient, the
laboratory ensures that purchased goods and services comply with
specified requirements. Where possible and practical the laboratory
ensures that goods are inspected, calibrated, or otherwise in compliance
with any standard specification relevant to the calibration or test
concerned.

4.6.3 Technical Content

The description in the purchasing document may include type, class,


grade, precise identification, specification, drawings, inspection
instructions, other technical data including approval of test results, quality
required and quality system standard under which they were produced.

Purchasing documents for items affecting the quality of laboratory output

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shall contain data describing the services and supplies ordered. These
purchasing documents shall be reviewed and maintained

The completion of the Purchase Requisition is the responsibility of the


originator/Admin/Laboratory Manager. The review of the PR form for
accuracy is done by the technical In charge to approve the technical
content & by the Laboratory Manager or his deputy prior to release with
their signature and the date. (Signature is not required if the PR generating
electronically).

4.6.4 Evaluation of Approved Suppliers

Laboratory shall maintain records on all pertinent supplier/subcontractors;


these records are kept on file for a particular period of time, and shall be
verified as part of the Internal Laboratory Audit process.

Suppliers are evaluated and selected from a business perspective as well


as for quality of service and maintain records of evaluation.

Ref: Purchase and Store Procedure

4.7 Service to the client

4.7.1 General/Policies and Procedures

The laboratory provides cooperation to their clients/representatives to


monitor the performance of work undertaken by the laboratory and to
ensure confidentiality of other clients.

Other Services to the client include;

The Lab encourages dialog with the client to ensure proper


understanding of technical matters and correct interpretation of
results. Contact with the client, especially in large assignments,
should be maintained throughout the work. The laboratory should
inform the client of any delays or major deviations in the
performance of the test.

4.7.2 Client Feedback

Obtaining feedback from the client. Positive and negative feedback


can be obtained passively through ongoing communications with
the client or actively through client feedback form. The feedback is
used to improve the quality system, testing/calibration activities, and
client service.

Preparing, packaging and dispatching of test/calibrated items

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needed by the client for verification purposes.

Clients are given reasonable access to relevant areas of the lab to


witness their tests/calibrations being performed

4.8 Complaints to the Laboratory

4.8.1 Policies and Procedures

Laboratory has documented procedure to show how customer complaints


are recorded and resolved.

Betalink Laboratory resolves complaints received from clients or other


parties concerning the work of the Lab or the performance of its personnel.

When a complaint is received from a customer, the QA/QC or Laboratory


Manager or his appointed deputy/or any other employee within the
laboratory address the issue and follow through until resolution with the
client is reached. Details shall be noted in the relevant job file.

Records of complaints include the following information:

Details of the complaint


Investigation
Corrective action
Follow-up verification

If applicable, analysis for root cause should be conducted and corrective


action shall be taken.

All personnel are responsible for recording and responding to complaints.

Ref: Complaints and Feedback Procedure

4.9 Control of nonconforming testing and/or Calibration work

4.9.1 Procedures to Control Nonconforming Work

Betalink Laboratory has established and maintains a policy and


procedures that are implemented when any aspect of its calibration/testing
work, or the results of this work, do not conform to its own procedures or
the agreed requirements of the client.

4.9.1 a) The Responsibilities and authorities for handling of Non-Conforming


work/corrective actions are detailed in the Control of Nonconforming

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Procedure. QA/QC and/or Laboratory Manager/or his deputy is
responsible for handling of Non-Conforming work.

4.9.1 b) The policy and procedures shall ensure that all results/products that found
to be non-conforming shall be identified, documented, evaluated, and
prevented from unintended use. This procedure ensures that non-
conforming work or problems are corrected, where applicable, and subject
to verification after correction to demonstrate conformity.

4.9.1 c) Corrective actions shall be taken further to the occurrence of


nonconforming work or problems with the quality system or with
testing/Calibration activities. Further decision shall be taken accordingly.

4.9.1 d) Further to the identification of Non Confirming work, the client has to be
notified and work shall be recalled if necessary.

4.9.2 Root Cause Analysis

Where the evaluation of the situation casts serious doubt on the Betalink
compliance to its own policies and procedures, or that the nonconforming
situation could recur, corrective action is required. The corrective actions
procedure shall be followed to identify the root cause(s) of the problem
and to eliminate the cause(s).

All records relevant to the control of nonconforming occurrences will be


retained as records for legal, ethical and normal corrective action review
purposes.

The process for nonconforming testing work is further detailed in the


Control of Nonconforming Procedure.

4.10 IMPROVEMENTS

Periodic reviews shall be carried out of Betalink Lab's existing


management system and action taken to continually improve the
effectiveness of the established system.

Some of the tools that may be used for continual improvement are the
quality policy, quality objectives, audit results, analysis of data, corrective
and preventive actions and management review.

Ref: Control of Nonconformity Procedure

4.11 CORRECTIVE ACTION

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4.11.1 General

Betalink Laboratory Management has established and implements a


procedure for implementing Corrective Action within the laboratory.

Corrective action is retroactive after the fact. Problems with the quality
system or technical operations of the laboratory may be identified through
a variety of activities, such as control of nonconforming work, internal or
external audits, management reviews, feed-back from clients, or staff
observations.

Corrective action, including the elimination of recurrence of a problem, is


one of the main cornerstones of our Lab Quality Management System
improvement process. Betalink Laboratorys goal is to eliminate recurrence
of problems once they have been corrected, and at all times, to look for
better ways to perform our jobs so that the potential for problems is
minimized.

Anyone within the Laboratory may initiate a Corrective Action Request


when a failure to conform to requirements, whether internal or external, is
identified. The CAR form is an important tool in our quest for conformance
to requirements and to maintaining customer satisfaction.

Records of all CARs shall be maintained. CAR forms and problem-solving


tools are provided for the use of all employees. Use of these items will
provide documented evidence that the problem was properly investigated
and analysed, effectively corrected and the potential for recurrence has
been eliminated.

Action taken should include proper analysis of the problem, using


appropriate problem-solving tools, and should be appropriate to both the
magnitude of the problem as well as the element of risk involved. The
identified significance of the problem will assist in evaluating the
appropriate action to be taken for any nonconformity.

4.11.2 Cause Analysis

Corrective action always begins with an investigation to determine root


cause(s) of the problem.

Potential causes of the problem could include client requirements,


samples, sample specifications, methods and procedures, personnel skills
and training, consumable materials, or equipment and its calibration.

4.11.3 Selection and implementation of corrective actions

Where the investigation justifies corrective action, the Lab selects actions
most likely to eliminate the problem and prevent its recurrence. Corrective

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actions chosen are appropriate to the magnitude and risk of the problem
encountered. (Note- in plain language, this means determine whether the
benefit outweighs the cost). The Lab documents and implements any
required changes resulting from corrective action investigations. Controls
are applied to prevent recurrence. The laboratory documents and
implements the required changes resulting from corrective action
investigations.

4.11.4 Monitoring of Corrective Action

The Lab monitors implemented changes to ensure their effectiveness.


Monitoring is assigned to an appropriate individual such as the originator
of the CAR or the QA/QC or Laboratory Manager. Ensure that corrective
actions taken are effective. Changes resulting from corrective action are
documented.

4.11.5 Additional audits

Special audits follow the implementation of corrective actions to confirm


their effectiveness. A special audit is only necessary when a serious issue
or risk to the business is identified. Special audits are carried out by
trained and qualified personnel who are (whenever resources permit)
independent of the activity to be audited.

4.12 PREVENTIVE ACTION

4.12.1 Preventive Action Identification

Preventive action is proactive - before the fact. When the potential problem
is identified, steps are taken to prevent the problem from occurring in the
first place. The action taken is monitored to ensure it has been effective.
Additionally, any steps taken to prevent errors from occurring or to improve
operations are classified as preventive action.

Total quality management tools such as brainstorming, flowcharting,


Pareto charts etc; may assist this process. Consideration should also be
given to provide staff with a formal mechanism of contributing suggestions
for improvement.

Records of preventive action include the following information:

Details of potential non-conformances


Investigation
Preventive action
Follow-up verification.

4.12.2 Preventive Action Plans

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Action Required, plans shall be developed implemented and maintained to
reduce the likelihood of occurrence. Preventive action may result from the
review of operational procedures and analysis of data. Analysis of data
includes trend analysis, analysis of proficiency testing results, and risk
analysis.

Ref: Corrective and Preventive Action Procedure

4.l3 CONTROL OF RECORDS

4.13.1 General

4.13.1.1 Procedures

Quality Management records are established, identified, and indexed to


facilitate their retrieval, and are stored in a suitable environment to prevent
deterioration. Records are retained for designated period of time as stated
in their respective procedures, as applicable, and are suitably disposed of
at the completion of the retention period.

Records for each test and personnel responsible for the each calibration,
test, samplings, checking or results etc. shall be maintained.

The master list of records is organised with the following information:

Record No & Record Name


Responsibility
Storage Location
Retention Period

4.13.1.2 Record Integrity

Records are established to retain the raw data that is evidence of non-
conformance to customer requirements, industry standards and
regulations, ethical practices, and the Quality Management System
requirements.

In order to demonstrate conformance to specified requirements in the


Quality Management System, to industry/regulatory standards, and to
customer requirements, all pertinent records will be collected and retained.

Established records should be retained as per their respective procedures


to ensure prevention of loss of data due to unforeseen circumstances.
They should be organised in such a way as to facilitate retrieval, if

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necessary.

As a future plan, Records may be in any media, such as hard copy or


electronic media.

When the designated retention period has ended, records must be


disposed of in an appropriate manner. This includes electronically stored
records as well as paper copies.

4.13.1.3 Record Security

Access to records is secured through authorization and filing cabinets.

4.13.1.4 Record Backup

Data is password protected.

Backups ensure integrity and availability of data/information in the event of


system/power failure.

4.13.2 Technical Records

4.13.2.1 Record Information

Technical records are accumulations of data and information that result


from carrying out tests and which indicate whether specified quality or
process parameters are achieved. They may include forms, contracts,
work sheets, work books, note books, instrument print outs, magnetic
media, check sheets, work notes control graphs, test reports, clients notes,
papers, and feedback, original observation, derived data, sufficient
information to establish an audit trail, calibration records, and test reports
to clients.

The laboratory shall retain records for the defined period.

The records for each test contain sufficient information to permit its
repetition. Records include:

Customer details
Date of receiving sample
Date of reporting
Job No. & Report No.
Test results
Calibration method and units
Authorised signature and stamp

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4.13.2.2 Recording

Handwritten records must be legible and made with indelible ink


immediately after an observation, after data is collected and/or after
calculations are made.

4.13.2.3 Corrections to Records

For database records, measures are taken to avoid loss or change of


original data. Mistakes are crossed out and the correct value entered
alongside. Mistakes are not erased, made illegible, or deleted. All
alterations to records are signed or initialled by the person making the
correction.

Ref: Control of Records Procedure

4.14 INTERNAL AUDITS

4.14.1 Internal Audit Program

Betalink Laboratory conducts routine internal audits on its laboratory at


least once every year in accordance with a predetermined schedule and
procedure to verify that its operations continue to comply with the quality
management systems to which it subscribes. Audits are carried out by
trained and qualified personnel who are (wherever resources permit)
independent of the activity to be audited. Personnel are not to audit their
own activities except when it can be demonstrated that an effective audit
will be carried out. Audits can be performed through the aid of a checklist
prepared in advance to minimize the possibility of overlooking any details
during the audit. Types of audits include: quality/technical management
system audit, processes and procedures, products, services and reports.
The audit should determine if:

Procedures described in the quality system are being followed;


Objectives (as defined in the quality system) are being achieved;
Designated duties are being carried out satisfactory and
There are opportunities for improvement.

Planning and execution of audits should coincide with planned


management review activities so that results of audits are available for
review.

4.14.2 Corrective Action

When audit findings cast doubt on the effectiveness of the Labs


operations or on the correctness or validity of the Labs test results, timely
corrective action is taken. When any audit findings cast doubt on results
submitted to a client the lab notifies the client in writing that results may

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have been affected.

Non-conformances that can be resolved easily are to be corrected


immediately, ideally during the audit. Records are made on the audit
checklist. Non-conformances that require a more involved resolution are
recorded on a CAR form and resolved as per this Quality Manual.

4.14.3 Records and Management

All audits, the associated findings and any resultant corrective actions are
recorded. A report is prepared by the auditors and distributed to those
audited and/or the Laboratory Manager within an appropriate and agreed
timeline. The audit report may include the following sections, as
appropriate:

Audit objective and scope


Area or section audited
Personnel involved auditors and auditees
Date of audit
Opening and closing meetings
Audit report distribution

The QA/QC and/or Laboratory Manager is responsible for ensuring that


CAR is sufficiently recorded. Follow-up is performed by the auditor and
recorded when CAR is complete and deemed effective. The audit records
are kept in the laboratory.

4.14.4 Follow-up Audits

Follow-up activities verify and record the implementation and effectiveness


of the action taken. The follow up audits are performed at a mutually
acceptable time between the area implementing corrective action and the
auditor. Follow-up time is determined when the CAR is issued.

Ref: Internal Audits Procedure

4.15 Management reviews

4.15.1 Review of Quality System and Testing

The review takes account of:

Suitability of policies and procedures


Reports from QA/QC, Laboratory Manager / technicians /
administrative staffs.
The outcome of recent internal audits
Corrective and preventive actions

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Assessments by external bodies
Results of inter-laboratory comparisons or proficiency tests
Change in the volume and type of work undertaken
Feedback from clients, including complaints and client satisfaction
surveys
Other relevant factors, such as quality control activities, resources
and personnel training.
Recommendation for improvement.

The effectiveness of the quality system shall be reviewed by the


laboratorys management at least once every twelve months. Results of
review are fed into the laboratory planning system and include goals,
objectives and action plans for the coming year.

All Management Review records are regarded as Business Management


Records and shall be maintained accordingly. Management reviews are
normally conducted in the form of Management meetings.

4.15.2 Findings, Action and Records

Findings from management reviews and the actions that arise are
recorded in the minutes of the meeting. Management will ensure that the
actions are discharged within an appropriate and agreed timescale.

Ref: Management Review Procedure

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5 TECHNICAL REQUIREMENTS

5.1 General

5.1.1 Correctness and Reliability

Correctness and reliability of the tests performed by Betalink have many


contributing factors. These factors include:

Human factors
Accommodation and environmental conditions
Calibration methods and method validation
Equipment
Measurement traceability
Sampling
Handling of test items

5.1.2 Measurement Uncertainty

The above factors have an effect on measurement uncertainty. Betalink


conscientiously takes these factors into account in executing/ developing
calibration methods and procedures, training programs, qualification of
personnel, the selection and calibration of the equipment we use.

This section discusses these factors and the programs that we have in place to
address them to ensure that the measurement uncertainty is acceptable to the
tests being performed.

Ref: Calibration and Testing Procedure

5.2 LABORATORY PERSONNEL (Competence, Awareness, Training)

5.2.1 Competence and Qualification

Betalink Management ensures the competency of all who operate specific


equipment, who perform tests, calibration and, evaluate results and sign
test/Calibration reports/Certificates. When using staff that is undergoing
training, adequate and appropriate supervision is provided. Personnel
performing specific tasks are qualified on the basis of appropriate education,
training, experience, and/or demonstrated skills, as required.

The evaluation of personnel is a major part of laboratory assessments. This


criterion is evaluated based on the range, complexity and frequency of

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performing of tests for which accreditation is sought.

Vision deficiencies may prevent some people from performing some work
satisfactorily. It is the responsibility of the laboratory management to ensure in
such cases that vision problems shall not affect validity of results.

Personnel responsible for giving opinions and interpretations shall have in-
depth knowledge of the relevant technical discipline. They should comply with
the additional aspects of the competence ISO/IEC 17025:2005.

5.2.2 Training Policies and Procedures

Laboratory Management shall formulate goals for the laboratory personnel with
respect to their skills, education and training. Laboratory Management shall
maintain current job descriptions for the laboratory manager, technical
supervisor, Quality in charge and key support personnel involved in
testing/calibration activities.

Betalink shall have proper procedures for training new technical personnel and
for developing the expertise of existing technical personnel in new or rarely
used techniques. The criteria used to assess the competence of trainees shall
form an integral part of the procedures. Records of training and assessments
of competence shall be kept. These shall include or refer to records of test
results performed during training and assessment of competence. The validity
of results produced by technical personnel, particularly in the early stages after
completion of training in new techniques shall be monitored.

Training in the laboratory must include all methods or parts of methods and
techniques that personnel are asked to perform. Minimally, the analyst must
demonstrate competency through observation by management and verification
using replicate and/or check samples.

Training is designed to be relevant to the current and anticipated work of the


Lab. Effectiveness of training shall evaluated by keeping records of training
certificates and analysis of the staff competence.

5.2.3 Employees

Testing must be either performed or supervised by experienced/competent


personnel.

5.2.4 Job Descriptions

Betalink maintains current job descriptions for all personnel (managerial,


technical, and support personnel) involved in tests and calibrations. These are
maintained centrally in the administration area of the laboratory.

Job descriptions are dated and signed to demonstrate that each employee has

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read it and is in agreement. They are maintained current.

5.2.5 Competency of Lab Personnel

The Lab qualifies personnel performing specific tasks through education,


training, experience or demonstrated skills, as appropriate. The Lab maintains
records of competency, educational qualifications, training, skills, and
experience for all lab personnel, as appropriate

The purpose of these records is to provide evidence that personnel have been
adequately trained and their competence to perform particular tests has been
assessed. In some cases it may be pertinent to state any particular limitations
to competence. The records are maintained in a registry of skills and include:

Academic and professional qualifications


External and internal courses attended
Relevant on-the-job training and retraining as necessary (i.e.;
demonstration of competence)
Skills and experience (i.e.; resume)
Relevant authorisations

Records are held centrally in the administration/HR or QA/QC area.

Ref: Training Procedure,


Organization Chart,
Job Descriptions.

5.3 ACCOMODATION AND ENVIRONMENTAL CONDITIONS


(INFRASTRUCTURE)

5.3.1 Facility

Laboratory management shall ensure that the facility is designed well and
environmental conditions shall not invalidate the results of the analysis or
adversely affect the required quality of any measurement.

It is important that the working environment of the laboratory is free from


excessive draughts. The temperature should be reasonably stable and uniform
and any temperature gradients measured vertically, horizontally should be
small.

5.3.2 Monitoring

Apart form above, due attention shall be paid, for example, dust,
electromagnetic disturbances, radiation, humidity, electrical supply, and sound
and vibration levels, as appropriate to the technical activities concerned. Tests

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shall be stopped when the environmental conditions jeopardize the results of
the test activities.

5.3.3 Separation of Incompatible Activities

Any areas considered as incompatible activities are effectively separated. This


can include also a proper sanitation facility to exclude the possibility of cross-
contamination. Segregation of activities is achieved through time and space
allocations.

5.3.4 Controlled Access

Access to and use of areas affecting quality of testing is adequately defined


and controlled.

Access to the laboratory is restricted to authorized personnel. The authorised


personnel are made aware of the following items;

The intended use of the area


The restrictions imposed on working within such areas
The reasons for imposing the restrictions.

5.3.5 Good House Keeping

The Lab ensures good housekeeping. Special procedures are prepared when
necessary.

Controlled use of cleaning and housekeeping is exercised. The laboratory


complies with the local health and safety requirements.

5.4 Test and Calibration methods and method validation

5.4.1 Policy for testing methods

A formalised system shall be in operation for issuing, reviewing and updating of


methods and specifications. The system shall enable the laboratory to be
aware of any new editions of published standards. Methods shall be reviewed
regularly with respect to the publications of new editions of standards,
development in the testing / calibration technology and other relevant
information.

Methods and procedures used for all tests are appropriate as per:

Sampling, handling, transport, storage, and preparation of items to be


tested / calibrated.

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An estimation of the measurement of uncertainty as well as statistical
techniques for analysis of test data where appropriate.

Instructions on the use and operations of all relevant equipment and on the
handling and preparation of items for testing are available. All Instructions,
Standards, Manuals and reference data relevant to the work of the laboratory
are maintained current and readily available to personnel. Deviation from
calibration methods must be documented, technically justified, authorized, and
accepted by the customer.

5.4.2 Selection of methods

Betalink selects and establish calibration methods that meet the needs of the
customer and are appropriate to the test being performed.

The lab ensures the latest valid edition of the calibration method unless it is not
appropriate or possible, or when the customer requests a certain earlier
revision level to be executed.

Methods that have been published either in International, National or Regional


Standards or by reputable technical organisation, or in relevant scientific texts
or journals, or as specified by the manufacturer are selected when the
customer does not specify the method to be used.

The ability of the laboratory to achieve satisfactory performance against


documented performance characteristics is verified before samples are
analysed.

Laboratory-developed methods or methods adopted by the laboratory may also


be used if they are appropriate for the intended use and if they are validated.
The customer is informed as to the method chosen. The laboratory confirms
that it can properly operate Standardized Methods before introducing the tests.
If the standardized method changes, the confirmation is repeated.

The customer is informed when the method proposed by the customer is


considered to be inappropriate or out of date.

5.4.3 Laboratory-developed methods

Laboratory developed calibration methods are planned and assigned to


qualified personnel equipped with adequate resources. As the development of
the calibration methods proceeds, plans are updated and technical changes
are duly communicated to all affected personnel.

Methods developed in-house are validated and authorised before use where
available. Determination of uncertainty must be part of this validation process,
and is essential for ongoing quality control.

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5.4.4 Non-Standard methods

Discussion and agreement for the use of non-standard methods is recorded as


part of contract review procedures.

When it is necessary for the Lab to select non-standardized calibration


methods, the methods are subject to agreement with the customer per the
customers documented requirements and specifications, and are validated
before use. Qualitative calibration methods must be validated to demonstrate
estimated sensitivity and specificity, relative accuracy to official methods (If
appropriate) positive and negative deviation, limit of detection, matrix effect,
repeatability, and reproducibility.

Quantitative calibration methods are validated to demonstrate specificity,


sensitivity, and relative accuracy, positive and negative deviation, repeatability,
reproducibility, and limit of determination.

5.4.5 Validation of methods

5.4.5.1 Performance Characteristics

Validation of methodology is a value judgement in which the performance


parameters of the methods are compared with the requirements for the test
data. A prerequisite for a valid method is that data produced by the method
must attain a state of statistical control. Interlaboratory Comparison or
proficiency testing must be carried out as required with an approved laboratory
by Abu Dhabi / Dubai Municipality to find out the accuracy of data and reports.

5.4.5.2 Fit for Use

All modified/extended/amplified standard methods as well as laboratory


designed calibration methods and non-standard calibration methods and
procedures are validated to ensure that such methods and procedures are fit
for their intended use and are relevant to the requirements of ISO/IEC 17025
as well as the customer.

All type of calibration methods, for example non-standard methods, laboratory-


designed methods or standard methods used outside their intended scope, and
amplifications and modifications of standard methods shall be examined in
regular intervals to meet the given application or field of application.

Developments in methodology and techniques require methods to be changed


from time to time. The difference in performance between revised and obsolete
methods is established so that it is possible to compare old and new data.

Where a change in method involves only minor adjustments such as sample


size etc, the amended method is validated and the changes brought to the
attention of accreditation body at the time of next accreditation audit.

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Records are kept on all validation activities. The Laboratory Manager or his
deputy shall be responsible for the validation and adoption of new calibration
methods and amendments of existing calibration methods.

5.4.5.3 Customers Needs

Validation includes the specification of the requirements, determination of the


characteristics of the methods, the comparison of the requirements with the
values of the characteristics of the method, and a statement on the validity.

As method development proceeds, regular review is required to verify that the


needs to the customer are still being fulfilled. Changing requirements requiring
modifications to the development plan are approved and authorized.

Validation is always a balance between costs, risks, and technical possibilities.

Ref: Calibration Methods.

5.4.6 Estimation of Measurement Uncertainty

5.4.6.1 Calibration

Betalink shall develop procedures for estimating uncertainty of measurement


when deemed necessary.

The uncertainty of test and calibration results are calculated and documented
in accordance with the requirements of ISO/IEC 17025.

Repeatability and reproducibility data are the components of measurement


uncertainty and are determined as a first step towards producing estimates of
this parameter.

5.4.6.2 Documented procedures detail the methods used for estimating uncertainty of
measurement and include all uncertainty components, which are of importance
in the given situation.

5.4.6.3 The data relevant to a particular test is presented on the test certificate or the
test report. A detail of measurement uncertainty is shown in Figure 1.1 below.

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FLOW DIAGRAM OF UNCERTAINTY ESTIMATION

Set Specification (If relevant)

Identify Uncertainty Sources

Quantify Uncertainty Sources

Estimate Standard Uncertainty by


Converting to Standard Deviations

Calculate Combined Uncertainty

NO Do Significant YES
Re-evaluate the
Prepare Components Significant
Report Need Components
Re-
evaluation?

Figure: 1.1
5.4.7 Control of data

5.4.7.1 Calculations and Data Transfers

Calculations and data transfers are subject to appropriate checks in a


systematic manner. The Laboratory Manager validates test data through the
following arrangements prior to release the final report / certificate to any
external parties:

Checks to determine accuracy of calculations.

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Checks for transcription errors, omissions and mistakes.
Checks to determine consistency with normal or expected values.

For those analyses where normal data calculation is required, it is performed


according to the instructions provided in the calibration method.

5.4.7.2 Computers and Automated Equipment

Data generated using computer software programs that are interfaced directly
to instruments incorporates all dilutions and calculations, thereby eliminating
the need for manual data reduction.

Commercially developed software in general use within its designed application


range may be considered sufficiently validated.

Electronic records, electronic signatures, and handwritten signatures executed


to electronic records must be equivalent to proper records and handwritten
signatures to paper.

5.5 Equipment

5.5.1 Required Equipment

Betalink is furnished with the necessary infrastructure, measurement, and test


equipment required for the correct performance of its testing. All equipments
are used in an environment appropriate to its proper performance. All
equipments required by a test is described in each method, including the
equipments tolerance.

5.5.2 Required Accuracy

The equipment and related computer software are capable of achieving the
accuracy required and suitable for the test specifications. Testing and
verification programs are established for all items of equipment having a
significant effect on results. All Lab equipment is tested and calibrated or
checked to ensure it meets the equipment specification requirements and
complies with relevant standard specifications.
The procedures for checking newly received equipment are as determined by
manufacturers specification and /or those determined by the laboratory during
procurement.

5.5.3 Authorized Personnel

Access to laboratory equipment is controlled to ensure that only authorised


personnel use equipment. Instructions on the operation and maintenance of
equipment are readily available.

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Quality Management System Manual


5.5.4 Identification of Equipment

Each item of equipment and its software used for testing and measurement
significant to the quality of the testing results is uniquely identified through an
asset (Number/Identification).

Components that can be interchanged between various instruments are


tracked in equipment logbooks, but are not assigned individual asset
(Number/Identification).

5.5.5 Inventory and Maintenance Records

Records are maintained of each item of equipment and its software significant
to the calibrations performed. The information related to service and
maintenance is kept in individual equipment files/and or binders or stored
electronically. Other information kept in files can include;

Condition when received (e.g.; new, used, refurbished).


Dates and results of calibration and or verification and date of next
calibration and or verification.
Performance history when appropriate (e.g.; response time, drift, noise
level)
Identity of item
Manufacturers name, type identification and serial number or other
unique identification.
Checks that equipment complies with the specification.
Current location, where appropriate.
Manufacturers instructions, if available or reference to their location.
Dates, results and copies of reports and certificates of calibration,
adjustments, acceptance criteria, and due date of next calibration.
Maintenance plan, where appropriate, and maintenance carried out to
date.
Damage, malfunction, modification or repair to equipment.

5.5.6 Equipment Procedures

The Lab has a procedure for safe handling and storage of testing equipment to
ensure proper functioning to prevent contamination or deterioration. Test
equipment (both hardware and software) is safeguarded from adjustments that
would invalidate the test results. Procedures for each piece of measuring
equipment are located in the appropriate room where the equipment is located.

5.5.7 Out of Service Equipment

All Lab equipment subjected to overloading or mishandling, or shown to be


defective, outside of specified limits or giving suspect results is taken out of
service. Such equipment is isolated or clearly marked as out-of-service until it

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has been repaired and shown to perform correctly. The Lab examines the
effect of the equipment problem on previous calibrations and implements any
nonconforming procedures, as required.

Out of service equipments are clearly marked.


The laboratory examines the effect of the defect or departure from specified
limits on previous test/and or calibrations and institutes the Control of
Nonconforming procedure.

5.5.8 Calibration Status

Calibration labels have a write-on surface and a pressure sensitive adhesive


(or a piece of paper with company logo on it). The areas that are filled out
include the person who performed the calibration, the date it was performed,
the date it is due for re-calibration, and the equipments identification number.

CALIBRATION STATUS

By: Date:

Due: ID#:

Measuring equipment that has failed calibration or is deemed out of service is


labelled with one of the following labels;

CALIBRATION VOID OUT OF SERVICE

DO NOT USE DO NOT USE

A piece of equipment that is not calibrated or checked is labelled with the


following label;

FOR REFERENCE ONLY

5.5.9 Return to Service

All items of equipment that go outside the control of the laboratory for a period
is checked to ensure the function and calibration are satisfactory before being
returned to service.

5.5.10 Periodic Checks

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Periodic and in service checks for equipment are carried out in a defined
procedure to maintain confidence in calibration status.

5.5.11 Correction Factors

Calibrations that give rise to a set of correction factors are updated along with
all copies of this data as required.

5.5.12 Safeguards and Adjustments

Test and calibration equipment including hardware and software are


safeguarded from adjustments that invalidate test and/or calibration
results/status.

1) Safeguards against adjustment for laboratory equipment (Hardware) include;

Detailed Manufacturers manuals on the operation of the equipment.


Policies permitting only fully trained and competent personnel to operate
equipment.
Access to the laboratory is restricted to authorised personnel.

2) Safeguards against adjustment of software includes;

Password protection for important files and packages.


Access to laboratory is restricted to authorised personnel.

Ref: Maintenance & Calibration Procedure

5.6 Measurement Traceability

5.6.1 General

The laboratory has an established programme and procedure for calibration of


all equipment that are used for testing/calibration including equipment for
subsidiary measurements that has a significant effect on the accuracy of the
test result.

It is necessary to establish a program for the maintenance and calibration of


equipment. The program includes a system for selecting, using, calibrating,
checking, controlling and maintaining:

Measurement Standards
Reference standards used as measurement standards.

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Measuring and test equipment used to perform test and calibration.

Procedures are documented where appropriate. All measurements that


contribute a defining role in testing accuracy are based directly or indirectly on
reference standards, reference materials, certified reference materials or other
standards or materials having appropriate trace ability.

5.6.2 Specific requirements

5.6.2.1 Calibration

All calibration work performed by the laboratory will be in accordance with the
documented procedure using equipment traceable to National/International
Standards.

Traceability to SI units of measurement may be achieved by reference to an


appropriate primary standard or by reference to a natural constant, the value of
which in terms of the relevant SI unit is know.

The term Identified metrological specification means that it must be clear from
the calibration certificate against which specification the measurements have
been compared with, by including the specification or by giving an
unambiguous reference to the specification.

When the terms international standard or national standard are used in


connection with trace ability, it is assumed that these standards fulfil the
properties of primary standards for the realisation of SI units.

Maintain certificates of all reference standards measuring equipment, or


certified reference material used in ensuring trace ability. Where trace ability to
National Standards of measurement is not applicable, the laboratory provides
satisfactory evidence of correlation of results, for example by participation in a
suitable program of inter-laboratory comparisons or proficiency testing.

Reference standards, such as thermometers and weights are traceable to a


national or international standard (e.g.: NIST)

5.6.2.2 Testing

5.6.2.2.1 The extent to which the requirements are followed depends on the relative
contribution of calibration uncertainty. If calibration is dominant factor, the
requirements are strictly followed. If, however, calibration is not one of the
major contributors to the total uncertainty, other ways for providing confidence
may be used.

5.6.2.2.2 Where traceability of measurements to SI units is not possible or not relevant


the laboratory shall use certified reference material supplied by competent
supplier to give a reliable physical or chemical characterisation of a material or

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use specified methods that are clearly described and agreed by all concerned
parties.

The laboratory participates in proficiency testing and/or check sample


programs. The QA/QC or Laboratory Manager maintains the list of programs.

5.6.3 Reference standards and reference materials

5.6.3.1 Reference standards

The laboratory has programme and procedure for calibration of reference


standard. The reference standard shall be calibrated by approved bodies,
which can provide trace ability to the International Standard. These reference
standards are only used for calibration and not for regular testing purposes.
Reference standards shall be calibrated before and after any adjustment.

5.6.3.2 Reference materials

Reference materials, used in the laboratory are traceable as defined in the


relevant standards.

5.6.3.3 Intermediate checks

The laboratory has performed checks on calibration status of reference,


primary, transfer or working standards and reference materials in accordance
with defined procedures and schedules.

5.6.3.4 Transport and Storage

The Betalink uses a procedure for the safe handling, transport, storage and
use of reference standards and reference materials to prevent contamination
and in order to protect their integrity.

5.7 Sampling

5.7.1 Sampling Plan and Procedures

Sampling is a defined procedure whereby a part of substance, material or


product is taken to provide for testing as a representative sample of the whole.
Sampling can also be required by appropriate specification for which the
substance, material or product is to be tested / calibrated.

The sampling plan describes the allocation, withdrawal and preservation of a


sample or samples from a substance, matrix, material or product to yield the
required information.

5.7.2 Deviations, Additions or Exclusions

Any deviations as per customer specific instructions from the documented

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standard procedure shall be communicated to all lab personnel and recorded in
all test results.

5.7.3 Records

Adequate sample identification upon receipt in the laboratory includes;

Unique and unambiguous sample identification, usually a number or


alphanumeric identification, retained throughout the testing life of the
test item.
Sampler Identification
Sample source and date if available
Identification number or description (from customer) if any
Product description
Tests desired and/or methods requested
Date of receipt
Delivery carrier
Sample condition

5.8 Handling of Test and Calibration items

5.8.1 Procedures

The Lab has process for the transportation, receipt, handling, protection,
storage, retention and disposal of test and calibration items to assure the
integrity of the test/calibration and the interests of the laboratory and the
customer. Samples are stored so as to ensure their integrity by preventing
against deterioration, contamination, and loss of identity. It is recognized that
this is a general statement, but details shall be elaborated in the relevant
procedures/work instructions.

5.8.2 Identification of Test and calibration Items

The Betalink has an established system for identifying test and calibration
items throughout the life of the item in the Lab to ensure items cannot be
confused physically. Sample labelling indicates the unique identification and
conforms to applicable legal requirements.

5.8.3 Receipt

The lab records abnormalities or departures of the test and calibration item
from the normal or specified condition required by the test/calibration method.
The Lab consults the customer for further instructions before proceeding and
records the discussion when there is doubt as to the suitability of a
test/calibration item or when an item does not conform to the description
provided, or when the test/calibration required is not specified in sufficient

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detail.

Arrangements are in place to ensure that elapsed time between sampling and
testing/calibration does not exceed test/calibration method specifications
(holding time).

5.8.4 Protection

The Lab has a procedure and information on storage and transport of samples,
includes all information that may influence the test / calibration result. This
procedure has provided to those responsible for taking and transporting the
samples.

The laboratory establishes whether the sample has received all necessary
preparation or whether the customer requires preparation to be undertaken or
arranged by the laboratory. Proper requirements for packaging, environmental
conditions, and separation from incompatible materials are observed. Where
samples have to be stored or conditioned under specific conditions, these
conditions are maintained, monitored and recorded, where necessary.

Where a sample, or portion of sample, is to be held secure (e.g.; for reasons of


record, due diligence or to enable re-check analysis), the laboratory has
storage and security arrangements that protect the condition and integrity of
the sample.

5.9 Assuring the quality of test and Calibration results

5.9.1 Betalink has quality control procedures for monitoring the validity of tests and
calibrations undertaken. The resulting data is recorded in such a way that
trends are detectable and, where practicable, statistical techniques shall be
applied to the reviewing of the results.

The validity of test and calibration results shall be monitored and reviewed by:

Regular use of certified reference materials and/or internal quality


control using secondary reference materials;
Participation in inter laboratory comparison or proficiency-testing
programmes
Replicate tests or calibrations using the same or different methods
Retesting / Re calibration of retained items
Correlation of results of different characteristics of an item (if relevant)

5.9.2 Quality control data shall be analysed and where its found outside the specific
limits planned action shall be taken to prevent recurrence.

5.10 Reporting the results

5.10.1 General

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Betalink provides test / calibration report to the customer accurately, clearly,
unambiguously, objectively and in accordance with any specific instructions in
the test / calibration methods.

The results are reported in a standard test report format and include all the
information requested by the customer and necessary for the interpretation of
the test / calibration results and required by the test / calibration method.

The test / calibration report or certificate is designed so that its format


minimizes the possibility of misunderstanding or misuse by the reader.

The test / calibration reports are issued as either hard copy or by electronic
data transfer.

5.10.2 Test Reports and Calibration Certificates

Signing authority for test reports / Calibration certificates is the responsibility of


Lab Manager / Technical Supervisor or to the person nominated during his
absence. Records of individuals with signing authority for Calibration or test
report are approved by the Managing Director / Lab Manager.

Hard copies of Calibration Certificates or test reports include the page number
and total number of pages.

Our Calibration Certificate or test reports include the following information:

A title - Test Report or Calibration Certificate


Name and address of our Calibration or testing laboratory
Unique identification of the calibration certificate or test report and on
each page an identification in order to ensure that the page is
recognized as part of the Calibration certificate / test report and a clear
identification of the end of the test report / Calibration Certificate.
The name and address of the customer
Identification of the method used
A description of, the condition of, and unambiguous identification of the
item(s) tested / calibrated
The date of receipt of the test or calibration item (s) where this is critical
to the validity and application of the results, and the date (s) of
performance of the test/calibration
Reference to the sampling plan and procedures used by the laboratory
or other bodies where these are relevant to the validity or application of
the results.
The test/calibration results with, where appropriate, the units of
measurements
The name (s), function (s) and signature (s) or equivalent identification
of person (s) authorizing the test report or calibration certificate.
Where relevant, a statement to the effect that the results relate only to
the items tested or calibrated.

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A statement is included specifying that the calibration certificate or test report is
not be reproduced except in full, without written approval of the Laboratory.
Data reported to the customer contains the appropriate significant digits for
each test/calibration method. Low-level data are identified as being below
specified limits.

5.10.3 Test Reports

5.10.3.1 Test reports include the following, where necessary for the interpretation of
results:

Deviations from, additions to, or exclusions from calibration method, and


information on specific test conditions, such as environmental
conditions.
Where relevant, a statement of compliance/non-compliance with
requirements and/or specifications.
Where applicable, a statement on the estimated uncertainty of
measurement of the test results; information on uncertainty is needed in
test reports when it is relevant to the validity or application of the test
results.
Where appropriate and needed opinions and interpretations.
Additional information required by specific methods, customers, or group
of customers.

5.10.3.2 Test reports containing the result of sampling include the following, where
necessary for the interpretation of results:

Date of sampling
Unambiguous identification of substances, material or product sampled
(including name of manufacturer, model or type of designation and serial
numbers as appropriate).
Location of sampling, including any diagrams, sketches or photographs.
Reference to sampling plan and procedures used.
Details of any environmental conditions during sampling that may affect
the interpretation of the test results
Any standard or other specification for the sampling method or
procedure, and deviations, additions to or exclusions from the
specification concerned.

5.10.4 Calibration Certificates

5.10.4.1 Betalink issue calibration certificates in accordance with the standards.

The conditions (e.g.; environment) under which the calibrations were


made that have an influence on the measurement results.
The uncertainty of measurement and/or a statement of compliance with
an identified metrological specification or clauses thereof
Evidence that the measurements are traceable. (See 5.6.2.1)

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5.10.4.2 The calibration certificate relates only to quantities and the results of functional
tests. If a statement of compliance with a specification is made,
this identifies which clauses of the specification are met or not
met.
When a statement of compliance with a specification is made omitting the
measurement results and associated uncertainties, BLICS
records those results and maintains them for possible future
reference.
When statements of compliance are made, the uncertainty of measurement is
taken into account.

5.10.4.3 When an instrument for calibration has been adjusted or repaired, the
calibration results before and after adjustment or repair, if
available, are reported

5.10.4.4 A calibration certificate or calibration label does not contain any


recommendation on the calibration interval except where this
has been agreed with the customer.

5.10.5 Opinions and Interpretations

Laboratory shall document the basis upon which the opinions and
interpretations have been made. It would be appropriate to
communicate the opinions and interpretations by direct dialogue
with the customer. Records for all such communications shall be
maintained.

Opinions and interpretations included in a calibration certificate or test report


may comprise, but not be limited to the following:

Opinion on conformity of the results with requirements


Fulfilment of contractual requirements
Recommendations on how to use the results
Guidance to be used for improvements

In many cases it is appropriate to communicate the opinions and


interpretations by direct dialogue with the customer. This
dialogue is written down.

5.10.6 Testing and Calibration results obtained from subcontractors

If subcontractors work is involved within the analysis report, It shall be clearly


identified in the final report by the Laboratory Manager/ Technical supervisor or
his deputy or whoever releasing the final report to the customer. The
subcontractor reports the results either in writing or electronically to our

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laboratory.

5.10.7 Electronic transmission of results

If the test or calibration results are transmitting to a customer via electronically


(either by fax, telex, e-mail or through any other means), the requirements of
ISO 17025 International standard shall be met. Reports to be protected before
transmitting.

5.10.8 Format of Reports

The layout of the test report or calibration certificate is such that the
presentation of the test/calibration data facilitates ease of assimilation by the
reader and minimizes the possibility of misunderstanding or misuse. The
headings are standardized as far as possible.

5.10.9 Amendments to test reports and calibration certificates

When it is necessary to issue a complete new test report or calibration


certificate, it is uniquely identified and contains a reference to the original that it
replaces.

5.11 Occupational Health and Safety.

The health and safety management system is independent from, but closely
aligned with the Laboratory Quality Management System. It is administrated by
the Safety Department and QA/QC. Procedures and Safety manual address
conditions and activities encountered in the work environment such as use of
personal protective equipment, and general safety. Betalink comply with Health
and Safety requirements as specified by the Abu Dhabi Municipality.

Ref: Safety Procedure

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