Documente Academic
Documente Profesional
Documente Cultură
The 6" ' ISO/CASCO WG 44 meeting was held on July 10-12, 2017 in ISO Central Secretariat,
Geneva. The deliverable of this meeting was the FDIS version of the new ISO/IEC 17025
version. The ISO/IEC 17025-2017 standard was released in end November 2017
2.0 Overview to the 1S0/IEC 17025 standards
Laboratory accreditation is a procedure by which an authoritative body gives fonnal recognition
of technical competence for specific tests/ measurements, based on third party assessment
and following international standard.
In the current global scenario an essential pre-requisrte of trade is that any product or seivice
is accepted fom1ally in one economy, must also be free to circulate in other economies without
having to undergo extensive re-testing. WTO recognises that non acceptance of test results
and measurement data is a Technical Barrier to Trade. Global sourcing of components calls
for equivalence of measurement, which can be facilrtated by a chain of accredited calibration
laboratories. Accreditation is considered as the first essential step for facilrtating mutual
acceptance of test results and measurement data.
Confidence in accredrtation is obtained by a transparent system of control over the accredrted
laboratories and an assurance given by the accreditation body that the accredited laboratory
constantly fuKils the accreditation criteria.
Accredrted laboratories can objectively state confom1ance of product or seivice to specified
requirements. It is important for the purchaser, regulator, government, and the public to be
able to identify accredited testing and calibration laboratories.
The accreditation body maintains its linkages with the international bodies like International
Laboratory Accreditation C0--0peration (ILAC) and Asia Pacific Laboratory Accreditation Co-
operation (APLAC). The accreditation body is a full member of both ILAC & APLAC and
regularly takes part in the Technical Committee Meetings of both ILAC & APLAC, engaged
upon development and updating of guidelines connected with accreditation activities.
For the ultimate goal of being mutually recognized by foreign accreditation bodies and to
overcome Technical Barriers to Trade for free trade of goods, the accreditation body became a
signatory to ILAC as well as APLAC Mutual Recognrtion Arrangements (MRA). The MRA is
I,ased on mutual evaluation and acceptance of other MRA partner laboratory accreditation
systems. Such international arrangements facilitate acceptance of tesU calibration results
between countries to which MRA partners represent.
In order to achieve the objective of the acceptance of tesV calibration data across the national
borders, the accreditation body operates and is commrtted to update its laboratory
accredrtation system as per international norms. For laboratories and users of laboratory
services, occasionally there is misunderstanding and confusion about the objectives and
function of "accreditation" based on ISO/IEC 17025:2017 General requirements for
competence of testing and calibration Laboratory
It is designed to made image and integrity of conforrnrty assessment to clarify the key
distinctions between the two different types of recognition of laboratories by erther accreditation
bodies or certification bodies.
At present many laboratories are not having very accurate masters, facilities or competent
person. They operate from residence or part of some other factory. In such environment you
as a customer will always like to visrt and see their facility or demand for accredrtation /
certification to enhance qualrty of your products.
ISO/IEC 17025:2017 has five major clauses, namely General requirements, Structural
requirements, Resource requirements, Process requirements and Management system
requirements. The management system requirements are written in language relevant to
lal,oratory operation but were developed to meet the systems requirements of ISO 9001.
Chapter: 1 Overview to ISO/IEC 17025:2017 Standards
For accreditation against ISO/IEC 17025 the emphasis is to establish the technical
competence of laboratory for defined set tests, measurements or calibrations. In doing so
however compliance with the standard's management requirements is also assessed.
However, accreditation against ISO/IEC 17025 should not be interpreted to be the same as
certification against ISO 9001.
1. Quality Manual {Optional\:- It states the Quality Policy and describes the macro level
Management system including details for how the standard requirements shall be fulfilled in
the company. It also includes Quality policy and ol>jectives as well as organizational chart and
optional for the laboratory to maintain it.
2. Quality Procedures: - It is normally called as middle management hand book and describes
requirement related activity for a system approach to supply consistent Quality in testing and/or
calibration services. They are considered to be the core of the system documentation and
confidential documents. They describe how the tasks and functions of the various departments
should be performed to meet the requirements of the ISO/IEC 17025:2017 standard and the
Quality Policy of the company.
3. Work Instructions/ Operating Procedure: - These documents are required for the Testing
and or calibration purpose otherwise affects Quality of testing and or calibration
4. Quality Records. Forms:- Forms, records etc. are supporting documents used by the
company to record infom1ation for different procedures followed.
JI
Acknowledgement & Scrutiny of
Application (by the Accreditation Member .
Body Secretariat)
Jl Feedback
Adequacy of Quality Manual
to
(by lead Assessor)
Laboratory
Jl and
Pre-Assessment of laboratory Necessary
(by lead Assessor) . Corrective
Jl Action
Final Assessment of Laboratory by
(by Assessment Tearn)
Laboratory
Jl
Scrutiny of Assessment Report
(by the Accreditation Member Body
Secretariat)
Jl
Recommendations for Accreditation
(by Accredttation Committee)
Jl
Approval for Accreditation
(by Chaim1an, the accreditation member
body)
.H
Issue of Accreditation Certificate
(by the accreditation member body
Secretaliat)
Chapter: 1 Overview to ISO/IEC 17025:2017 Standards
Accreditation Procedure
The lead assessor shall submit a pre-assessment report to the accreditation body
Secretariat wtth a copy to the laboratory wtthin 1Odays of completion of pre-assessment. The
laboratory shall comply with the inadequacies of the documented management system and its
implementation and sulimn a corrective action report to the accred tion body Secretariat.
Assessment
After the laboratory confirms removal of inadequacies, the accreditation body shall propose
constnution of an assessment team. The team shall include the lead assessor (already
appointed), the assessor(s)/ technical expert(s) in order to cover valious disciplines within the
scope of accreditation sought. Thereafter the accred tion body shall fix up dates for on ne
Chapter: 1 Overview to 1S0/IEC 17025:2017 Standards
assessment of the laboratory in consultation with the laboratory, the lead assessor and
assessor(s).
The assessment team reviews the laboratory's documented management system and vefifies
i1s compliance with the requirements of ISO/IEC 17025:2017 and specific criteria. The
documented management system, SOPs, wor1< instructions, test methods etc. are assessed
for its implementation and effectiveness. The laboratory's technical competence to perform
specific tests / calibrations is also adjudged. The non-compliances, ii identified are reported in
the assessment report.
The assessment report shall contain the evaluation of technical manpower, all relevant material
examined, test wi1nessed; compliance to ISO/IEC 17025:2017 and relevant specific criteria and
the non-conformances, if any.
It shall also provide a recommendation towards grant of accredi1ation or otherwise. The
assessment report is prepared by the lead assessor, in the formats prescribed in published
document. The details of the non-conformances observed during the assessment, is handed
over to the laboratory by the Lead Assessor and the detailed assessment report is sent to the
accredi1ation body.
Scrutiny of assessment report
The assessment report shall be examined by the accredi1ation body, which shall communicate
the outcome of the assessment to the laboratory and shall ensure that the non-conformances
raised by the assessment team, which were not closed during the assessment, are well
understood by the laboratory.
Laboratory shall take necessary corrective action on the remaining non-conformance(s)/ other
concerns and shall submit a report lo the accreditation body Secretariat within a maximum
period of 3 months. The accreditation body shall moni1or the progress of closing of non-
conformances. When there are significant noo-confom1ance(s) identified during the on-si1e
assessment, the accreditation body may arrange for a verification visit for the closure of the
non-conformance(s).
Accreditation committee
After satisfactory corrective action by the laboratory, the Accredi1ation Committee examines
the assessment report, additional information received from the laboratory and the consequent
verifications.
In case the Accredi1ation Committee finds deficiencies in the assessment report to arrive at the
decision, the Secretariat obtains clarification from the Lead Assessor / Assessor/ Laboratory
concerned. In case everything is in order, the Accreditation Committee shall make appropriate
recommendations regarding accreditation of a laboratory to the Chaim1an, the accreditation
body.
Issue of accreditation certificate
When the recommendation results in the grant of accredi1ation, the accreditation body shall
issue an accredi1ation certificate which shall have unique number, discipline, and date of
validity alongwi1h the scope of accredi1ation.
The accredi1ation certificate on testing laboratories shall define field of test, materials/ products
tested, specific tests pertormed, specification/ standard method or technique used, range of
testing/ limit of detection and accuracy.
The accreditation certificate on calibration laboratories shall define the calibration field,
producV item calibrated, range of measurement, calibration measurement capability and
measuremenV calibration equipment used.
Chapter: 1 Overview to 1S0/IEC 17025:2017 Standards
The applicant laboratory must make all payments due to the accreditation body, before the
certificate(s) is/ are issued to the laboratory.
All decisions taken by the accreditation body regarding grant of accreditation shall be open to
appeal by the laboratory, to chairman the accredrtation body.
Surveillance and re-assessment
Accreditation to a laboratory shall be valid for a period of two or three years. The accreditation
body shall conduct and annual surveillance of the accredited laboratories. The laboratories
may enhance and reduce the scope of accreditation during Surveillance.
The laboratories may apply for renewal of accredrtation, atleast six months before the expiry of
validity of accreditation for which a Re-assessment shall be conducted.
Chapter: 2 1S0/IEC 17025:2017 Requirements
The details of ISO/IEC 17025:2017 requirements are given in the published copy of the
standard and all users are advised to purchase the copy of standards from ISO web site and
review applicability of requirements to their organization. For ready reference summary of
changes in ISO/IEC 17025:2017 is given IJelow. This chapter is prepared for training purpose
for our participants to understand the requirements
Changes in the structure of standard, as earlier there were only 2 main clauses were there,
such as 4.0 Management requirements and 5.0 Technical requirements. Now in this new
standard the structure is modttied as below to align it wrth all management system standard as
below;
4.0 General requirements, includes the sub clause of impartiality and confidentiality,
5.0 Structural requirements, as per the earlier requirements of clause no. 4.1.5,
6.0 Resource requirements, includes the sub clause of Personnel, Facilities and
environmental conditions, Equipment, Metrological traceability (Earlier it was
measurement traceability), Externally provided products and services (Earlier it was
purchasing),
7.0 Process requirements, includes the sub clause of Review of requests, tenders and
contracts, Selection, verification
i
and validation of methods, Sampling, Handling of test
or calibration rtems, Techn cal records (Separated as specific requirements under this
clause), Evaluation of measurement uncertainty (Separated as specific requirements
under this clause), Ensuring the validrty of resutts (Changed the title from quality of
results to validity of results), Reporting of resutts, Complaints, Nonconfonning work,
Control of data-lnfonnation management (introduction of some new requirements
alongwith the earlier requirements of control of data).
8.0 Management system requirements, includes the sub clause of Options having Option
A and Option B, in this case the;
• Option A is having specific management system requirements to be implemented by
laboratory to comply with the requirements of this revised standard. The requirements are
Management system documentation, Control of management system documents, Control of
records, Actions to address risks and opportunities (New requirements introduced for better
improvement and establishing control on the risks), Improvement, Corrective action, Internal
audrts, and Management reviews.
• Option B can be optioned by laboratory, in this case the laboratory has to establish and
maintain a management system, in accordance with the requirements of ISO 9001 and need to
certified as per ISO 9001 through certifying body app.-oved by IAF, and that is capable of
supporting and demonstrating the consistent fu ilment of the requirements of clauses 4 to 7 of
ISO/IEC 17025 also fulfils at least the intent of the management system section requirements
(clauses 8.2 - 8.9).
Apart from the above major changes, there are few functional as well as implementation
requirements, Which are improvement for the laboratory.
Chapter: 2 1S0/IEC 17025:2017 Requirements
The revised ISO/lEC 17025 standard focuses on the lisk based approach and continual
performance improvement in the laboratory activities. Hence by this the major focus area of
the laboratory will be improved and will get more benefit out of the implementation.
This requires in-<lepth involvement of the people in each and every activity for better
improvement and benefit out of the activities.
The format of the new standard has been significantly changed to be more in line with new ISO
formatting guidelines. The basic format is similar to other new standards such as ISO/IEC
17020 and ISO/IEC 17065.
The new standard is now structured as follows:
1. Scope
2. Normative references
3. Terms and definitions
4. General requirements
5. Structural requirements
6. Resource requirements
7. Process requirements
8. Management requirements
Annex A - Metrological Traceability (Informative)
Annex B - Management System (Informative)
Bibliography
General Information
According to International Accredrtation Forum (IAF) and the International Laboratory
Accreditation Cooperation (ILAC), accreditation is defined as "the independent evaluation of
conformity assessment bodies against recognized standards to ensure their impartiality and
competence.'
This standard was developed wrth the objective of promoting confidence in the operation of
laboratolies and contains requirements for laboratolies to enable them to demonstrate that
they operate in a competent and impartial way and that they are able to provide valid results.
During rts development phase rt has been tlied to align the standard wrth the plinciples of ISO
9001, although this was not alwa','S practically possible. Still rt is a fair statement to make that
the laboratories complying with the standard will also, in general, comply wtth the principles of
ISO9001.
The standard can be used for accreditation purposes, for self-assessment of the laboratories
and for second party assessments by laboratory customers, regulatory authorities,
organizations and schemes using peer-assessment.
Its requirements are applicable to any organization that performs the activities of testing and/or
calibration and/or sampling associated wtth subsequent testing or calibration. Therefore,
accredrtation to the new standard can be also achieved by organizations offering sampling
associated with subsequent testing or calibration. When the standard uses the term
"laboratory" is referring to any of the 3 options mentioned above (testing, calibration, and
sampling).
Chapter: 2ISO/IEC 17025:2017 Requirements
The potential of perfom1ing only sampling activities is a new element in the standard. 11, for
example, a laboratory is performing tests and takes samples by its own capacity, it should
meet all requirements related to both: sampling and testing. On the other hand, if any
organization performs only sampling and then the samples are forwarded to a laboratory for
testing, then this organization should comply with new standard requirements regarding
sampling and rts management system should ensure that the sampling activity doesn1 affect
negatively on test results. Requirements for sampling organizations are similar to testing and
calibration laboratories: personnel shall be competent, equipment has to be maintained and
calibrated, sampling procedure has to be validated, quality of sampling has to be assured etc.
Confirmation of competence of organization to provide sampling can be provided through
accredrtation against the new ISO/IEC 17025.
Guide 99 ISO/IEC, International vocabulary of metrology - basic and general concepts and
associated tem1s (VIM), is referenced in the standard as a normative reference. The definitions
also given in ISO/IEC 17000 are applicable. In addrtion, the standard provides the detailed
definitions of the terms impartiality, complaint, interlaboratory comparison, intralaboratory
comparison, proficiency testing, laboratory, decision rule.
30 Comoarison of 1S0/IEC 17025·2005 and 1S0/IEC 17025·2017
Performance asked by revised IS0/IEC 17025:2017 and comparison of standard
As we all of know that the ISO/IEC 17025 has been revised in the year 2017, and all laboratories
(CAB - Conlom1ity Assessment Bodies) have to amend the present accreditation (ISO/IEC
17025:2005) to ISO/IEC 17025:2017. The previous standard and rts requirements were talking
aliout the conformance to the standard, which have been replaced by the perfom1ance
improvement during the entire process with conformance. Total restructuring of the ISO/IEC 17025
is done and new requirements are introduced. Please find below the changes/ introduction etc. in
the comparison ol lSO/IEC 17025:2017 to ISO/IEC 17025:2005.
IS0/IEC
1S0/IEC 17025:2017 Requirements with title of clause Modification /
17025:2005.
introduction
clause no.
General requirements Introduction with
4.1 Impartiality the incorporation
4.0 of some of
4.2 Confidentiality requirements of
clause no. 4.1
Modification with
5.0 Structural requirements 4.1
introduction.
Resource requirements
6.1 General 5.1 Modification
6.2 Personnel 5.2 Modification
6.0 6.3 Facilities and environmental conditions 5.3 Modification
6.4 Equipment 5.5 Modification
6.5 Metrological traceability 5.6 Modification
6.6 Externally provided products and services 4.6 Modification
Process requirements
7.1 Review of requests, tenders and contracts 4.4 Modification
7.0 Modification with
7.2 Selection, verification and validation of 5.4 changes in the
methods
words
7.3 Sampling 5.7 Modification
Chapter: 2 1S0/IEC 17025:2017 Requirements
7.4 Handling of test or calibration items 5.8 Modification
Modification with
7.5 Technical records 4.13.2 introduction
7.6 Evaluation of measurement uncertainty 5.4.6 Modification
Modification with
7.7 Ensuring the validity of results 5.9 changes in the
words
7.8 Reporting of results 5.10 Modification
7.9 Complaints 4.8 Modification
1SO/IEC
Modification/
1SO/IEC 17025:2017 Requirements with title of clause 17025:2005,
introduction
clause no.
7.10 Nonconforming work 4.9 Modification
Modification with
changes in the
7.11 Control of data-Information management 5.4.7 word and
introduction of new
requirements
Management system requirements --------·-- ----·------
8.1 Options -----·----- New introduction
Management system documentation (Option Modification with
8.2 4.2 introduction.
A)
8.3 Control of management system documents
(Option A) 4.3 Modification with
introduction.
Control of records (Option A) 4.13 Modification with
8.4 introduction.
8.0 8.5
Actions to address risks and opportunities
(Option A)
--·-----·--- New introduction
Modification with
8.6 Improvement (Option A) 4.10 introduction.
4.11 Modification with
8.7 Corrective action (Option A) introduction.
Modification with
8.8 Internal audits (Option A) 4.14 introduction.
Modification with
8.9 Management reviews (Option A) 4.15
introduction.
The changes are done to align the clause numbers with the other management system
standard also. In majority of the cases, new requirements are introduced.
One more option given in this revised standard is that, if laboratory wishes to go for ISO 9001
certification then they may not have to implement the requirements given in the clause no. 8.0.
In this situation, laboratory can have 2 certificates. One is ISO 9001 management system
certification certificate and other is ISO/lEC 17025:2017 accreditation certificate.
Chapter: 2 ISO/IEC 17025:2017 Requirements
4.0 General requirements
Impartiality and Confidentiality requirements are discussed in clause 4. The risk-based thinking
is evident throughout the standard. It should l>e noted Iha! lhe new standard expects from the
laboratory to plan and implemenl actions to address risks and opportunities. Although
addressing risks and opportunities is laboratory's responsibility, the standard sets specific
requirements. The firs! requirement of such risks and opportunities that is needed to be
addressed is menlioned in clause 4, where the laboratory is required to identify and eliminate
or minimize risks related lo impartiality, on an on1ioing basis.
The confidentiality requirements indude, among others, the responsibility of the laboratory to
inform its customer in advance, of the information it intends to place in the public domain. It is
also discussing how to handle the release of confidential infom1ation required by law or
authorized by contractual arrangements. The confidentially requirement is also extended to
laboratory personnel, including any committee members, contractors, personnel of external
bodies, or individuals acting on the laboratory's behalf, even in the case that information is
obtained from sources other than the customer (e.g. complainant, regulators).
4.1 Impartiality
Safeguarding impartiality and undertake laboratory activities (structured, managed and
impartial way)
Management commitment for impartiality
Responsible for impartiality and not allow commercial, financial or other pressures.
Identify risk on an ongoing basis to impartiality (Include risk arises from activities,
relationships and personnel)
If risk is identified then demonstrate to eliminate or minimize risk to impartiality
4.2 Confidentiality
Proprietary information to be kept confidential as per legally enforced commitment like
contract terms
Inform customer/ concerned individual to release confidential information, if required by
law or authorized by contractual arrangement
All personnel including contractors and individual acting on the laboratory's behalf to
keep infom1ation confidential for laboratory activities except by law
5.0 Structural requirements
In clause 5, main requirements are defined, including: Legal status of the laboratory,
organization and management structure, identification of management, range of lal,oratory
activities, documenting its procedures, availability of personnel responsil>le for the
implementation and maintaining the integrity of the management system.
It should be noted that the new standard clearly requires (see clause 5.3) that the laboratory
shall only claim conformity with this document for this range of laboratory activities, which
excludes externally provided lal,oratory activities on an ongoing basis. This means that the
lal,oratory is expected to be accredited, and include in the scope of accreditation only
testing/calibration/sampling activities that is providing by utilizing its own resources.
In its 2005 version the standard allowed to sulicontract tests and calibrations in the case that
the laboratory was not in position to perform them. According to the new standard the
lal,oratory can be accredited only for those laboratory activities, for which it is competent.
Chapter: 2ISO/IEC 17025:2017 Requirements
Subcontracting is allowed only for outstanding situations, like ove oad of wor1(, sickness of
personnel, maintenance of equipment or other similar cases.
Laboratory to be legal entity or part of legal entity
Identification of Laboratory management with overall responsibility
Defining and documenting range and scope of laboratory activities. Exclude external
provided activities
Identifying wor1( (calibration and or testing) at pem1anent facilrties and at other site or
mobile facilities or at a customer's facility
Define the organization and management structure, Managerial and technical
personnel having authorities and resources to implement, maintain and improve the
management system. Specify the responsibility, authority and
Ensure communication for effectiveness of system and the importance of meeting
customers' and other requirements
Change management and maintain integrity of system
6.0 Resource requirements
Resource requirements are considered to include personnel, facilrties, equipment, systems and
support services necessary to manage and perform the laboratory activrties. It is expected that
all internal or external personnel of the laboratory shall be competent and act impartially. The
standard doesn't refer at this clause to All personnel, but only to personnel who could influence
on the results of laboratory activities. This is not only personnel who is directly involved in
testing/calibration/sampling activities, but also personnel who is indirectly involved, like
technical personnel. For example, it can be personnel that perfom1 maintenance of the
equipment, or management system personnel, who evaluate suppliers and/or maintain the
management system including internal auditing activities.
This clause sets requirements for the laboratory infonnation management system(s) used for
the collection, processing, recording, reporting, storage or retrieval of data.
• Sets requirements for the laboratory infonnation management system(s) used for the:
• 1-Collection, 2-Processing, 3-Recording, 4-Reporting, 5--Storage, Retrieval of data.
Give access to the data and infonnation needed to perfonn laboratory activities
• lnfonnation used for the collection, processing, recording, reporting, storage or retrieval
of is validated for functionality and interface. For any changes in software, implement
the change management including authorization, documentation and configuration
management IJefore implementation
Estabush controls like protection, data tempering, accuracy, integrity, immediate actions
for business continuity in case of failure etc. to implement laboratory infonnation
management system
• If the laboratory information management system is managed by external provider then
he also has to follow the requirements
• Ensure that instructions, manuals and reference data relevant to the laboratory
information management system are made readily available to personnel
Calculations and data transfers shall be checked in an appropriate and systematic
manner.
8.0 Management system requirements
The laboratory can choose between implementing a management system in accordance with
option A or option B. Option A lists the minimum requirements for implementation of a
management system in a lalioratory. care has been taken to incorporate all those
requirements of ISO 9001 that are relevant to the scope of laboratory activities that are
covered by the management system. Option B allows laboratories to establish and maintain a
management system in accordance with the requirements of ISO 9001. Laboratories that
implement option B will therefore also operate in accordance with ISO 9001. Conformity of a
laboratory to the requirements of ISO 9001 does NOT, by itseK, demonstrate the competence
of the laboratory to produce technically valid data and results. This is accomplished only
through compliance to ISO/IEC 17025.
Chapter: 2 1S0/IEC 17025:2017 Requirements
The requirements for documentation have been significantly reduced in clause 8. The
documentation requirements related to the operation of the management system per clause 8
are:
Management System poficies and olijectives (8.2.1)
• Analysis of Customer feedback (8.6.2)
Corrective actions, non-conformities related records (8.7.3)
Internal aud and results records (8.8.2)
• Management review input and output record (8.9.2)
It should be noted that there are no requirements any more for documented procedures related
to management system activities referred in clause 8. There is also no requirement for Oual y
Manual.
1.0 INTRODUCTION: -
ISO/IEC 17025:2017 is a generic document and it does not specify "hovl' to do, but only states
"What" to do. As per the standard, the Management system should be documented and be
demonstrable in the manner consistent with the requirements of ISO/IEC 17025:2017. The
total demonstration in the Management system consists of four tiers of documents.
1. Laboratory Quality Manual (optional)
2. Procedure Manual
3. Work Instruction / Operating Procedure Manual
4. Fonns, Records
The amount of documentation should support and efficient quality assurance system without
creating a paper bureaucracy. The detail for documenting above four tiers of documents is
described in this paper. The total documentation needed for ISO/IEC 17025:2017 comprises of
four tiers as shown in Annexure-1. The pyramid shows documents required for a management
system.
2.0 NEED FOR DOCUMENT CONTROL: -
The Management system consists of a number of documents. Some system should be
provided for safe keeping of complex records. It is important to clear1y define as to where they
should be kept and for how long, and who is responsible for them. Each written procedure
should be checked and signed by an authorised person, with issue number and issue date.
Quality Manager should have a list of all completed procedures, applicalile to the individual
departmental activities. Against each listed document tile number should be shown together
with the date of the latest change. It is also called a "Master Copy". It is a yardstick against
which any other controlled copy can be judged.
From time to time tile Committee for Management Review and Corrective Action may put
forward recommendations for change in the procedure. The Quality Manager should be
responsilile for implementing tile change. For making a change, the new page should be
circulated to the keeper of the controlled copy of the document with an instruction to insert tile
new page in order and return tile replaced page to the Quality manager. Thus outdated
documents will be removed from circulation. The change, which has been made, should be
known to the staff and everyone should implement tile new procedure. When a number of
major changes have been made, a complete new manual has to be issued. The retention
period for these records can be decided either contractually or by the policy and it is to be
mentioned in tile Quality Manual.
3.0 QUALITY MANUAL (1 s t tier of documentation) This is optional and not cornulsory
3.1 WHAT IS QUALITY MANUAL: -
Quality Manual states the Quality Policy and describes tile Management system of an
organisation. It may relate to an organisation's total activities or to a selected part of it, e.g.
spec ied requirements depending upon the nature of services, processes, contractual
requirements, governing regulations etc. Quality Manual is a typical fom1 of main document
used in drawing up and implementing a management system. It is expected to provide an
adequate description of tile Management intention to fulfil system requirement while serving as
a permanent reference for implementation and maintenance of the system.
This question may arise in the mind of readers especially when detailed infom1atioo is given in
other tiers of documentation like procedures and work instructions.
Quality Manual is needed for the followina reasons:
Chapter: 3ISO/IEC 17025:2017 Documentation
(1) It describes the objectives of top management for different clauses of ISO/IEC
17025:2017 standard applicable to all departments of the company and thus seives as
guideline for planning and documenting the procedures.
(2) Change is a perpetual process in an organisation. Unless there is a Wlitten description
of each task function, rt will be difficult to make any reasoned evaluation of any
proposed change or rt outcome.
(3) It is used as basic for adequacy audrt of Management system and thus is also used as
a basic for effective implementation of the management system.
(S) It is also used lo rationalise one's own management system.
The introductory pages of a qualrty manual should provide general information about the
organisation concerned and the quality manual itself.
The minimum information about the organization should be rts name, location and means of
communication. Additional infom1ation about the organization such as its line of business, a
brief description of its background, history, size, etc. may also be included.
(1) The current issue amendment number, date of issue or effectively and affected
contents,
Chapter: 3ISO/IEC 17025:2017 Documentation
(2) A brief description of how the quality manual is revised and maintained, Who reviews its
contents and how often, who is authorized to change the quality manual, and who is
authorized to approve it. This infom1ation may also be given under the system element
concerned. A method for determining procedure change history may be included,
appropriate.
(3) A brief description of the procedure used to status and controls the distribution of the
quality manual, Whether or not it contains confidential infom1alion, Whether it is used
only for the organization's internal purpose or Whether it can be availal>le externally,
(4) Approval signatures (or other means of approval) of the authorized people responsible
for implementation of the content of the quality manual.
The management system policies related to quality, including a quality policy statement, shall
be defined in a quality manual. The overall objectives shall be established, and reviewed
during management review. The quality policy statement shall be issued under the aUthority of
top management. It shall include at least the following:
The management's commitment to good professional practice and to the quality of its testing
and calibration in seivicing s customer. The management's statement of the standard of
seivice. The purpose of the management system related to quality. A requirement that all
personnel concerned with testing and calibration activities within the laboratory familiarise
themselves with the quality documentation and implement the policies and procedures in their
worl<; and the management's comm ment to comply with this International standard and to
continually improve the effectiveness of the management.
(E) Organization: -
This section of a quality manual should provide a high level description of the internal structure
of the organization. SUbsections within this section or in a system element procedure should
provide details of the responsil>ilities, authorities and hierarchy of those functions, Which
manage, perform and verify worl<-affecting quality.
This will form the most important section of the Quality Manual. It gives brief description of
broad activities for each clause. It also gives information on how the requirements stipulated in
the clauses of the standard are applicable and fulfil by the company. The description should be
divided into logical sections revealing a well aH>rdinated management system.
This international standard cannot be used to define a unique format for the description of
management system elements, which can be applied to all (or even most) products and
seivices. Requirements for elements of management system are provided by the ISO series
standards or the applicable standard used by the organization. It is recommended that
whenever applicable, these elements be used for the creation of the management system and
that the description of the elements of the management system l>e in a fom1at similar to their
sequencing in these standards.
Chapter: 3ISO/IEC 17025:2017 Documentation
(G) Definitions: -
Although ii is recommended when practical, to use standard definitions and terms which are
referenced in recognized quality tem1inology documents or in general dictionary usage, this
section of a quality manual should contain the definitions of terms and concepts that are
uniquety used within that quality manual. Special attention should be given to words that have
different meaning to different people or specific meaning to specific sectors of businesses. The
definitions should guarantee a complete, unijorm and unambiguous understanding of the
contents of the quality manual. The use of references to existing concepts, terminology,
definitions and standards (e.g. ISO: 8402) is highly recommended.
(1) A "Quality Policy" should be first evolved by the Chief Executive. He can take the help
of senior managers.
(2) A person from the steering committee who is from the top management should write
the Quality Manual. In most of the cases, the Quality Manager, himself writes the
manual.
(3) Based on the company's Quality Policy, the broad objectives and activities for each
department have to be decided and fitted into the relevant clauses. For this, the
department heads should give draft write-up of the activities in their department Then
ii should l>e meticulously scrutinised to ensure that the system is sufficient to achieve
the company's Quality Policy objectives or benchmarks. The clauses applicable to each
department of the company are identified.
(4) Organisation chart should be chalked out and the responsibility and authority of each
personnel mentioned in the organisation chart should be documented. Personnel
authorised to take decisions must be included in the organisation chart. Preparation of
the chart will help in identifying and documenting the responsibility for activities under
each clause.
(5) A suitable numbering system, department wise and Clausewise should be decided
which can be made applicable to the remaining tiers of documentation. This will help in
cross-referencing Quality Manual with other tiers of documentation like, procedures,
work instructions and records. It is very important that all the tiers should have cross
linkages with each other.
(7) After preparing the draft of Quality Manual it should be circulated to all department
heads lo ensure that there is no discrepancy or that no important activity ii left out.
(8) After their approval, tile final draft should be prepared. The final draft should have
company name and logo, issue number, issue date, controlled-copy identification on
each page, page number and signature of preparing and approving authority.
Chapter: 31S0/IEC 17025:2017 Documentation
3.5 THE PROCESS OF QUALITY MANUAL APPROVAL. ISSUE AND CONTROL: -
(1) Poor to issuing the manual, the document should be subjected to a final review by
responsible individuals to assure clarity, accuracy, suitability and proper structure. The
intended users may also have the opportunity to comment on the usability of the
document. The release authorization, by the level of management responsible for
complete implementation of the new quality manual or rts individual sections, should
then be granted and incorporated in all copies.
(2) The internal distribution of the manual, Whether in total or by section, should assure that
all users have appropnate access. Proper distribution and control can be assured by
numencal numbering of copies for recipients. Management should assure individual
familiarity with manual content appropriate to each user within the organization.
(3) A method of providing for the development, control and incorporation of change to the
manual should be provided. This task should be assigned to an appropriate document
control function. The same rules and procedures used in developing the basic manual
should apply to the processing of changes.
nd
4.0 WHAT IS A QUALITY PROCEDURE MANUAL 12 tier of documentation)?: -
6.4.13
Documentation of reference materials, results, acceptance criteria, relevant dates and the
period of validity
6.5.1 Maintain metrological traceability of its measurement results
7.1.1 Contract review requirements
7.6 Decision rule to give statement of conformity to a specification or standard
7.8.7.1 Document the basis upon Which the opinions and interpretations have been made.
7.11 Any changes in data to be documented and authorized
8.1.1 Document the system to plan and implement
8.2.1 Document, and maintain policies and objectives
Chapter: 3ISO/IEC 17025:2017 Documentation
1.0 Risk
Risk is the possibility of loss. It is a function of both probability of occurring of an adverse event
and rts impact on the various related things; the impact can occur in a combination of factors
like as time delay, performance loss, financial loss, etc.
A risk is a pre-cursor to a problem, Wllich has a probability to occur at any given point of time
in the lalioratory, occurrence of which will impact the predicted objectives and goals for a
laboratory with the available resources.
Risk cannot be eliminated from the laboratory, but rt can lie managed wrth a proper risk
mrtigation plan. Risk management is critical to the success of any laboratory and rt is always a
strategic side of lalioratories.
A risk can be defined as any internal or external situation or event that has a potential to
impact upon organization, preventing the organization from successfully achieving rts
objectives, delivering rts services, caprtalizing on rts opportunities or carrying out rts events.
Risk management is simply the practice of systematically identifying and understanding risks
and the control mechanisms that are in place to manage them. Ultimately the process gels you
to a point of deciding Wllether, in the context of a particular strategy, activity or function, a risk
is acceptable or requires an action or not.
The risk management process does not encourage management team members / managers
to lie risk averse. In lac ii is designed to provide laboratory team members/ managers wrth a
degr'*! of confidence to be able to manage risk to an acceptable level and to take a level of
risk commensurate with the opportunity. The key element in managing risk is correctly
balancing risk and reward. An organization Wllich is risk averse will create inllexibilrty in the
business and erect barriers to the achievement of the organization's goals
Following are the fundamental risk management functions that are must be taken care to
effectively manage risks attached to a laboratory:
I Chapter:4Risk and Opportunity
a. ldentify:Laboratory Team/ Manager will analyze classification of potential risks and make
applicable list of risks specific to the lal>oratory.
b. Analyze:Laboratory Team/ Manager will update the impact of risks on cost. schedule, and
product testing, quality, and customer satisfaction, followed by a discussion for reaching on
a common consensus for each risk. This will include following tasks:
a. Analyzing Risks
b. Prioritizing Risks
c. Plan:Laboratory Team/ Manager will prepare a plan in order to detennine what steps and
actions to be taken against risks. This will include identification of mitigation/ contingency
ptan and implementation of mitigation/contingency plan.
d. Track:Laboratory Team / Manager / Leader will continuous monijor the risks in the
laboratory
e. Control:Lalloratory Team / Manager will execute and implement the appropriate risk
mitigation plan upon identification of risk reached to ijs threshold value.
f. Communicate: Provide visibility and feedback data internal and external key interest
parties members on current and emerging risk activiities.
Brainstonning: This process encourages a group of people meeting face to face to put
forward all their thoughts and ideas on a specific topic. During a brainstonning session all
input is encouraged without evaluation. Evaluation of ideas occurs at the completion of the
session when the ideas are analyzed. The diversity of participants will have an impact on the
nature of the ideas and perspectives, so some thought will need to be given to who will
participate in the process.
Focus groups: A focus group is made up of individuals Who are invited to attend one or more
meetings in order to focus their attention and provide information and feedback on a specific
topic or area of concern.
Analysis of systems: This involves studying the way a system or process functions and
interacts within an organization in order to find any weaknesses. System may refer to the
management processes as well as to the policies and procedures that support those
processes. It may also refer to an operational system of interlinking procedures or processes.
Audits: This is the name given to the process of anaJyzing a management system, checking
to see that the documented procedures and operational methods are the same.
Checklists: This involves using a list of ijems against which to check a situation, event,
scenario, process, etc.
Feedback and communication: This includes safety meetings, customer feedback fonns or
phone calls, complaints handling, etc.
Probability
# Category Rank Description
Business Impact on
Potential
Operations,
Legal and customer,
Regulatory reputation and Personal and
Business technical and human factor
Impact Obligations Loss of
Financial Health Goodwill
Little or no No Legal or Negligible No distress or
Disruption/ Regulatory obligation embarrassment Embarrassment
Very Low i
Financ al Loss within the caused
organization
Little or no Very small Legal or Minor and small distress or
Disruption/ Regulatory obligation limited Embarrassment
Low Financial Loss embarrassment caused
within the
organization
Detrimental to Technical breach of a Adversely affect Minor
business legal or regulatory relations with embarrassment or
Medium efficiency or obligation customers or distress to an
financial health shareholders individual
Process
Sub Risk Risks Associated l
i
k e
li
h ood Risk
Process (PO)
lll'f)>Ct
Value
Tech/ Customer Env. People Legal Others
Quality
10.1 Identify risks to its impartiality on an onijoing basis. Include those risks
• From its activities,
From its relationships with supplier, customer
• From the relationships of its personnel.
10.2 If a risk to impartiality is identified, then laboratory has to demonstrate how it eliminates or
minimizes such risk.
10.5 Actions to address risks and opportunities (OptionA){ldentify risk, plan action and
implement actions)
10.5.1 The laboratory has to consider the risks and opportuntties associated with the laboratory
activities in order to:
a) Give assurance that the management system achieves its intendedresutts;
b) Enhance opportuntties to achieve the purpose and ol>jectives of thelaboratory;
c) Prevent,orreduce,undesiredimpactsandpotentiattailuresinthelaboratoryactivities;and
d) Achieveimprovement.
10.5.2 The laboratory has to plan actions to address these risks andopportunities (Risk mttigation
plan) although the organization plans actions to address risks, there is no requirement for
formal methods for risk management (){ a documented risk management process
10.5.3 Actions taken to address risks and opportuntties are proportional to the potential impact on the
validity of laboratoryresutts. The Options to address risks can include identifying and avoiding
threats, taking risk in order to pursue an opportunity, eliminating the risk source, changing the
i
l kelihood or consequences, sharing the risk, or retaining risk by informed decision.
10.5.4 Improvement
Opportunities for improvement can be identified through the review riskassessment,analysis
of data,andproficiencytestingresutts
10.5.5 Corrective Action
Update risks and opportunities detem1ined during planning, ifnecessaryfor corrective action
10.5.6 Input to management review
Results of riskidentification to discuss in management review meeting;
Reference:
ISO 31000, Risk management- Principles andguidelines
Total 31 time risk word is used in the IS0/IEC 17025:2017 standard.
I Case: 1 Global INC Laboratory
Now malket is demanding more accuracy in resutts, precession in calibration or testing. Also
laboratory is engaged in calibration of instruments of Pham1aceutical Industries,
Pham1aceutical Machine Manufacturing industries, Food Industries, Government Organization
Like (Air force, ONGC, Global Railway Etc.) and many Mechanical Industries. All the industries
are asking very high accuracy in results and higher compatibility of personnel engaged in
calibration activities.
Dr. George the son of the Chairman who is currently the Managing Director is a very dynamic
person. As soon as he got the information about ISO/IEC 17025:2017 he has read available
literature on IS0/IEC 17025:2017 and brought the standard of IS0/IEC 17025:2017 and attend
seminars on the subject. Soon after the first seminar he called a meeting of staff of all discipline
and discusses the matter. Naresh Oberoi Technical Manager has been appointed as the
Management Representative. The company engaged Global Manager Group a leading
consultancy in ISO/IEC 17025:2017 and TOM to help them in all consultancy. They have
already had several sessions of this steering group. As a result the company has developed a
strategic plan, qualtty policy, vision, mission and goals. An awareness programme has also
been done for all staff. The Quality Manual has been produced. The laboratory has also
trained some staff in internal audit.
You are one of the laboratory's officials who have been trained in internal audit for ISO/IEC
17025:2017 and are now asked to carry our compliance audit of the Management System.
THE AUDIT:
•:• During your audit you find the following irregularities: Write dovm is ii Non-conformity and if yes
under what clause no. Of ISO/IEC 17025:2017
1. The laboratory is using ISO/IEC 17025 Accreditation body symbol for all the discipline
though he got accredttation only for Mechanical discipline. The scope of measurement
parameters under accredttation covering range of laboratory activity is not documented.
2. The decision rule is not defined and agreed with customer in reporting the statement of
conformtty. Also level of risk associated with the decision is not considered in applying
the decision rule.
3. Temperature records and humidity records of environment monitoring for standard room
is not maintained though same was the requirements as per test method.
5. No risk and opportunities associated with the laboratory activities are considered to
enhance opportunities to achieve the purpose and objectives of the laboratory.
Case: 2 ISOnEC 17025:2017 - R o l e play-Risk Identification, Impartiality and Decision rule
Divide the participants in various teams to understand the impartiality and risk and decision rule
and perfom1 Role play.
Workshop-1
ISO/IEC 17025:2017 Questionnaire
> Analyse the statement provided below and indicate in the box whether you consider the
statements is as per ISO/IEC 17025-2017 requirement or not? If you consider it is the
requirement then write "True" and if not part of the standard then write it as "False·.
> If you consider the statements to be "True", please indicate in the box the clause number
from ISO/IEC 17025:2017 which supports your decision.
The laboratory shall use procedures for all laboratory activities and,
3. where appropriate, for evaluation of the measurement uncertainty
as well as statistical techniques for analysis of data.
Workshop-2
ISO/IEC 17025:2017 Questionnaire
> Analyse the statement provided below and indicate in the box whether you consider the
statements is as per ISO/IEC 17025-2017 requirement or not? If you consider it is the
requirement then write "True· and if not part of the standard then write it as "False".
> If you consider the statements to be "True", please indicate in the box the clause number
from ISO/lEC 17025:2017 which supports your decision.
The laboratory must take feedback from the customer and analyze
2. the same for improvement in the management system.
8. Inter laboratory comparison plan is not required for next one year.