 Define Roles and Responsibility for Lab Operation and management.

 Testing to be performed as per Defined standard

 Essential documents development and maintenance for quality assurance.
 All the samples must be organized and documented.
 Written procedures must be followed for all the tasks.
 The quality of the results should be checked and monitored frequently.
 Test reports should be created for test results and the estimation of the
measurements.
 Data integrity must be ensured and maintained.
 Analytical processes must be validated for sampling and testing.
 Results that are non-conforming must be documented, analyzed and controlled.
 Employees must be qualified for their assigned jobs.
 Environmental conditions must be taken into account and monitored throughout.
 All the inquiries and complaints from clients should be formally addressed.

Internal Advantages

 Increased confidence in the testing and calibration reports due to increased

accuracy, validation, and right documentation.
 Improved control over laboratory operations due to detailed documentation, ISO
17025 standard regulations, and other effective guidelines.
 Improved testing competency and quality of the testing competencies and results.
 Improved feedback from clients for the improved accuracy of the results.
 Acquired measurable growth in business as a result of the improvement in
processes and results as well as improved efficiency.
 Streamlined internal management and consistency in operations and hence,
efficiency in the internal operations.
 Improved performance of the employees due to increased motivation.

External Advantages

 Recognition in the national and international markets as a result of exceptional

performance.
 Enhanced customer trust and confidence because of accurate test reports and
results.
 Reduction in multiple assessments hence increased client trust and saved time.
 Recognition in the industry for extraordinary performance.
  Cost and time saving as a result of increased efficiency.

Clause 4: Management System Requirements

4.1 Organization:
This clause guides on the roles responsibility of the laboratory, permanent facilities, responsibilities
of key personnel and policies and procedures about confidential information and proprietary rights ,
relationship between quality management , technical operations and support services and
organization and management structure of the laboratory, its place in any parent organization.

4.2 Quality System:

This clause guides on the establishing, implementing and maintaining of a quality system
appropriate to the scope of its activities.

4.3 Document control:

This clause guides on establish & maintain procedures to control all documents that form part of its
Quality system ( internally generated or from external sources) , such as regulations standards,
other normative documents , test and/or calibration methods , as well as drawings, software,
specifications, instructions and manuals.

4.4 Review of requests, tenders and contracts:

This clause describes the requirement to establish and maintain Policies and procedures for the
review of requests, tenders and contracts.
4.5 Subcontracting of tests and calibrations:
This clause tells about establish and maintain the policies and procedures for the subcontracts of
work whether because of unforeseen reasons or on a continuing basis.

4.5 Subcontracting of tests and calibrations:

This clause tells about establish and maintain the policies and procedures for the subcontracts of
work whether because of unforeseen reasons or on a continuing basis.

4.6 Purchasing services and supplies:

This clause describes the requirements of establish and maintain policy and procedures for the
selection and purchasing of services and supplies it uses that affect the quality of the tests and/or
calibrations.

4.7 Service to the client:

This clause guides on clients’ value the maintenance of good communication, advice and guidance
in technical matters and opinions and interpretations based on results, communication with the
client, especially in large assignments.

4.8 Complaints:
This clause guides on policy and procedure for the resolution of complaints received from clients or
other parties

4.9 Control of Non-conforming testing and/or calibration work:

This clause guides on policy and procedures on identification of nonconforming work or problems
with the quality system or with testing and/or with testing and/or calibration activities can occur at
various places within the quality system and technical operations.

4.10 Improvements:
This clause tells how to ensure the effectiveness of the management system continually improved.

4.11 Corrective actions:

This clause guides on policy and procedure of implementation of corrective action when non-
conforming work or departures in the quality system or technical operations have been identified
through a variety of activities , such as control of nonconforming work , internal or external audits ,
management reviews , feedback from clients or staff observations.

4.12 Preventive action:

This clause guides on preventive action is a pro-active process to identify opportunities for
improvement rather than reaction to identification of problems or complaints.
4.13 Control of records:
This clause tells about establish and maintain procedures to control of records through identification,
collection, indexing, access, filling, storage, maintenance and disposal of quality and technical
records.

4.14 Internal audits:

This clause guides on policy and procedure of internal Quality audit and implementation and
effectiveness.

4.15 Management reviews:

This clause describes the procedures and consideration of related subjects at regular management
meetings.

Clause 5: Technical requirements

Clause 5.1: General
This clause tells about factors contribute to the correctness and reliability of the tests and/or
calibrations performed by laboratory.

Clause 5.2 Personnel:

This clause guides on how to ensure that all laboratory personnel who can impact tests and
calibration results are adequately qualified.
Clause 5.3 Accommodation and environmental conditions:
This clause describes the policy and procedure on accommodation and environmental conditions,
such as to facilitate correct performance of the tests and/or calibrations.

Clause 5.4 Test and calibration methods and method validation:

This clause guides on policy and procedure of selection of methods, Laboratory developed methods,
No-standard methods, validation of methods, estimation of uncertainty of measurement, control of
data.

Clause 5.5 Equipment:

This clause describes the policy and procedure on sampling, measurement and test equipment
required for correct performance of the tests and/or calibrations. The intention to make sure that the
instruments are suitable for performing selected tests and/or calibrations and are well characterized,
calibrated and maintained.

Clause 5.6 Measurement traceability:

This clause describes the procedure on system for selecting , using , calibrating , checking ,
controlling and maintaining measurement standards, reference materials used as measurement
standards, and measuring and test equipment use perform tests and calibrations.
Clause 5.7 sampling:
This clause guides on selection, sampling plan, withdrawal and preparation of sample or samples
from substance, material or product to yield the required information.

Clause 5.8 Handling of test and calibration items: :

This clause describes how to ensure that sample integrity is maintained during transport, storage,
and retention and those samples are disposed of safely.

Clause 5.9 Assuring the Quality of test and calibration results:

This clause guides on procedures for monitoring the validity of tests and calibrations through
proficiency testing program or ILC , Measurement of uncertainty , regular use of certified reference
materials and/or internal quality control using secondary reference materials and/or replicate tests
and/or retesting and/or co-relation of results for different characteristics of an item.

Clause 5.10 reporting the results:

This clause guides on how results of each test, calibrations or series of tests or calibrations carried
out by the laboratory shall be reported accurately, clearly, unambiguously and objectively and in
accordance with any specific instructions in the test or calibration methods.
Documentation is important but it is critical to realise that it is not, in itself, the quality system.
Because the major obstacle that you see when you decide to adopt a formal quality system is the
production of the documentation, it is easy to fall into this trap. The key piece of quality
documentation is the quality manual, describing its policies, the structure of Quality system
documentation and compliance to ISO/IEC 17025:2017 & relevant accreditation specific criteria. .
The quality manual is, typically, prepared and checked by laboratory management, usually under the
overall co-ordination of the quality manager. It should, however, be formally authorised for issuing
from as high a point in the management hierarchy as possible; chief executive, director general,
chairman are typical points. This ensures that the manual has the strongest authority and also
shows, to the accreditation body, a commitment on the part of the senior management to the quality
system.

A policy documents the laboratory’s intent to implement ISO/IEC 17025. The Quality
Manual is the top tier of the document hierarchy. It describes the approaches to achieve
quality data. It also includes policy statements describing the laboratory’s intention to
conform to ISO/IEC 17025 requirements. For example, a policy statement could be: All
personnel involved in calibration and testing should be competent for the assigned task.

A process or generic procedure describes how various quality requirements can be

achieved. For example, it describes how the requirement ‘Personnel should be
competent for the assigned task’ can be implemented.

Standard operating procedures (SOPs) or Working Procedures are step-by-step

instructions for how to exactly perform a specific task, such as calibrating a specific
instrument. Records are generated on a day-by-day basis, such as analytical results
from product tests or calibration records of a balance.

All documents should be properly controlled. For example, each change should be
authorized and logged, and the updated document should get a new revision number or
code.

Policies and Quality Manual

Policies including the quality policy statement should be documented in the Quality Manual. Senior
management should write the quality policy statement, which should outline the laboratory’s
commitment to quality. The quality manual describes the quality system and documents the
laboratory’s goal and overall concept for how to conform to ISO/IEC 17025. It should also describe
how the remainder of the quality system documentation is organized. It should be developed by
working groups representing different departments.

Processes
Processes or standard procedures describe how various ISO/IEC 17025 requirements can be
achieved. For example, it describes how the requirement ‘All personnel involved in calibration and
testing should be competent for the assigned task’ can be implemented. Another example is the
laboratory’s approach to calibrating and checking different types of equipment. For a better
understanding, process flowcharts should be included in a process description.

Standard Operating Procedures (SOPs) and Work Instructions

Routine activities follow documented procedures. These are typically defined as standard operating
procedures (SOPs) or work instructions. While quality manuals and processes describe tasks and
approaches, procedures and work instructions give step-by-step instructions on performing tasks.
Examples of SOPs are procedures for checking and calibration of equipment. All laboratory SOPs
should use the same format, to make writing and reading easier. A good practice is to have an SOP
for how to author, review, approve, distribute, and update SOPs. Preferably senior members of
anticipated user groups should write SOPs. This helps ensure that SOPs have the right level of
information and are used and followed.

Records
Records to demonstrate conformity with ISO/IEC 17025 and as required by customers should be
retained for a specific amount of time. Examples are original laboratory observations, test results,
 supporting documents such as chromatograms, and training certificates and equipment calibration
protocols.

Checklists, forms, templates, and examples help implement quality work effectively and consistently.
Examples of these include checklists and worksheets for vendor assessment, handling
nonconforming test results, and for internal audits. These items help document specific tasks
consistently and effectively.

Records
Development and maintenance of documentation should be controlled through document control
and management procedures that are part of the management system. Documents include both
internal, such as SOPs, quality manuals, and training plans and external documents, such as
regulations, standards, test methods, and instrument operating manuals.

The procedure for document control should ensure that:

 Official documents are created or acquired, reviewed, and approved prior to use.

 Documents are uniquely identified with document and revision number, date of revision, and issuing
authority.

 A quality list with all controlled documents is maintained by QA. The list includes document and
revision number, title, date of issue, date of last review, and locations.

 Internal documents include page numbers and total number of pages on each page. Users of the
documents are adequately trained before the documents are released.

 Current authorized versions of documents are readily available at the user’s workspace