Paper Presnetation on ISO/IEC 17025:2017 organized at Labtech2017 in Bahrain. The topics discussed in that presentation like what are the major changes, what is considered in revised ISO 17025:2017, requirements of ISO 17025:2017, etc. are explained in this ppt presentation.

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 International experts nominated by ISO/IEC member bodies
ISO/CASCO looked at a number of items for revision activities:
 An extensive web-based user survey,
 New quality concepts and ideas for inclusion in revised
ISO/IEC 17025 standard,
 Formal interpretations of ISO/IEC 17025,
 Support and guidance notes, and
 Common terminology and structure with other standards
What is being considered in revising the
standard?

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 ISO/CASCO
 CASCO develops policy and publishes standards related to conformity
assessment and they are ISO committee involved in revision of ISO/IEC
17025.
 ISO/IEC 17025 Revision Process
 Confirmation of the technical competency of a testing or calibration
laboratory by an independent third party (accreditation body).
ISO/IEC 17025 Change Process
Total time of the revision: Approx. 36 months
► Final ISO/IEC 17025:2017 is released on November 30, 2017
Approval
for revision
ISO/IEC
17025-2017
Publication-
End 2017
October
2014
Adoption Draft (DIS) FDIS released
May
2016
December
2016
July
2017
Committee
draft (CD1) and CD2

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 Structure of the standard and clause titles are changed
 Clauses 8 is aligned with ISO 9001:2015
Overview of Major Changes
Option -A
ISO 17025:2017 Clause 4
management requirements
Option -B
Laboratories, who are certified to ISO
9001:2015 are exempted from
clause no. 8.0 requirements
 Other changes
 Philosophical
 Definitions
 Structural
 Resources
 Processes

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4. General
Requirements
5. Structural
Requirements
6. Resource
Requirements
7. Process
Requirements
8. Management System
Requirements
4.1
Impartiality
4.2
Confidentiality
6.1 General
6.3 Facilities and
environmental
conditions
6.2 Personnel
6.4 Equipment
6.5 Metrological
traceability
6.6 Externally
provided products
and services
7.1 Review of
requests, tenders
and contracts
7.4 Handling of
test or calibration
items
7.3 Sampling
7.5 Technical
records
7.6 Evaluation of
measurement
uncertainty
7.7 Assuring the
validity of results
7.8 Reporting of
results
7.9 Complaints
7.11 Control of
data –
Information
management
7.10 Non
conforming work
8.1 Options7.2 Selection,
verification
and validation
of methods 8.2 Management
system
documentation
(Option A)
8.5 Actions to
address risks and
opportunities
(Option A)
8.4 Control of
records (Option A)
8.6 Improvement
(Option A)
8.7 Corrective
action (Option A)
8.9 Management
reviews (Option A)
8.3 Control of
management
system documents
(Option A)
8.8 Internal audits
(Option A)
ISO/IEC 17025: 2017 Requirements

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Below is the list of key changes and accordingly ISO/IEC 17025
Revision had implication to your laboratory management system
► Emphasis on the impartiality and confidentiality
► Risk based approach- Risk and opportunities identification and control
► Document range and scope of laboratory activities
► Word “quality manager” or “technical manager” is removed
► Periodically review measures and control for environmental
condition ( access and use of area, contamination, separation )
► Equipment include instruments, software, standards, reference
materials and data, reagents, consumables or auxiliary
apparatus
► Define and document competence of staff.
► The term ‘outsourcing’ is replaced by ‘external provision’
► Authorize personnel to develop, modify, validate and perform
methods as well as analyze and report results
► Verify capability to perform methods and maintain records
Summary of Key changes

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► IT: IMS to validate, data integrity, data security, data protection,
confidentiality, Immediate action on software failure, control on
external provider if externally managed
► "Decision rules" for passed/not passed {statement of conformity}. It
has to be communicated, documented and to be applied
► Reference materials ( recommendation for manufacturer must have
ISO 17034 for Metrological traceability )
► Process of complaint handling and information validation and
independent handling
► All methods, procedures and test standards are kept up to date and
available
► Include disclaimer for result compromised in case of deviation
► Track amendments
► Use of statistical Methods( Control charts, Uncertainty records)
► In test report the date of issue of the report is required
► Records for supervision, authorization and monitoring of personnel
► Management review to discuss risk, issues and monitoring activities
Summary of Key changes (Continue)

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Laboratory Process
Samples Preparation Analysis
Data
evaluation Report
Equipment
• Suitable
• Maintained
• Calibrated
Method
• Appropriate
• Validated
Quality
Control
Data
Management
Sample
Handling
Laboratory
Facilities
Chemicals /
Reagents
Calibration
Standards
(CRMs)
Competent
Staff

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 Procedure for personnel
 Laboratory environmental conditions
 Equipment control
 Intermediate checks
 Risk management process
 Results of reference measurement and
traceability
 External providers of products and
services
 Review of tenders and contracts
 Quality Assurance for Consistency and
the validity of the results
Procedures required by ISO/IEC 17025 : 2017
List of Procedures required to establish
Laboratory Management System
 Evaluation of the measurement
uncertainty and use of statistical
techniques
 Procedure for method validation
 Control on test or calibration items
 Monitoring the validity of results and
test reporting
 Customer complaint handling
 Procedure for Nonconforming work
 Control of management system
documents

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► Conduct awareness program for revision to ISO/IEC 17025:2017
► Review all documents to meet revised ISO/IEC 17025:2017 requirements and Identify changes.
► Promote the use of risk based thinking and determine risk and opportunities
► Review quality policy and establish quality objectives as well as prepare risk sheet
► Revise Quality Manual and prepare documents as per revised ISO/IEC 17025:2017.
► Train internal auditors for requirements of revised ISO/IEC 17025:2017 standard
► Assess the system through internal audit as per revised ISO/IEC 17025:2017 standard.
► Take corrective actions on identified non-conformities.
► Apply to revised existing certificate to ISO/IEC 17025:2017 standard to your existing accreditation
body.
► Final audit (Either in surveillance audit or special audit by accreditation body on ISO/IEC
17025:2017
Note: Also all accredited laboratories needs to update the system within 3 year of release of
standard.
 Steps to update existing ISO/IEC 17025:2005 system to revised ISO 17025:2017
laboratory management system (Existing accredited laboratories)
ISO/IEC 17025 : 2017 Accreditation Steps
The ISO/IEC 17025:2017 is released in Nov. 2017, the accredited laboratories may go for
Upgradation to ISO/IEC 17025:2017 before 2020

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► We provide industry specific documents based on ISO/IEC 17025 : 2017.
► The ready to use list of documents required as per ISO/IEC 17025 : 2017 is
available on our website. Visit @ www.Globalmanagergroup.com
Global Manager Group
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The ISO/IEC 17025:2017 is released on 29th Nov. 2017, the accredited laboratories may
go for Upgradation to ISO/IEC 17025:2017 before 2020
For further inquiry contact to :
Mr. Devang Jhaveri
sales@Globalmanagergroup.com