In this presentation, you would get knowledge about ISO17025. It's an updated version, terms and definitions. Which documents are required for certification.

1. INTRODUCTION TO ISO/IEC 17025:2017
Engr. Abdul Rahman
Cast Metals and Foundry Technology Centre Daska

2. GENERAL REQUIREMENTS FOR THE COMPETENCE
OF TESTING AND CALIBRATION LABORATORIES

3. UPDATED VERSION 2017
• International standard Organization/ International Electrochemical
Commission (ISO/IEC)
• ISO 17025, updated in 2017
• Risk based assessment and thinking
• Performance based requirements
• Flexibility in processes, procedures, documented information, and organizational
changes
• Laboratory’s definition is updated
• the usage of recent and updated IT technology

4. ISO/IEC 17025:2005 vs ISO/IEC 17025:2017
Begin with, the 2005 version of ISO/IEC 17025
included the following:
• Scope
• Normative references
• Terms and definitions
• Management requirements
• Technical requirements
The 2017 version of ISO/IEC 17025 includes the
following:
• General requirements
• Structural requirements
• Resource requirements
• Process requirements
• Management system requirements
Laboratory’s
definition is
updated

5. THINGS TO KEEP IN MIND
• For Accreditation
• “shall” indicates a requirement;
“should” indicates a recommendation;
“may” indicates a permission;
“can” indicates a possibility or a capability.
• There are 15 Management Requirement
And
10 Technical Requirements

6. Messages form ISO 17025:2017
Message in 5 lines
• Say what you do
• Do what you say
• Record what you do
• Check the differences
• Act on the differences
Message in 1 line
 do right thing, first time, every time to
Achieve Consistent Quality
 Continual improvement in the way of life

7. Three Critical Thoughts
1. Does the laboratory “say” what they do?
• Are there written documents (policies, procedures,
arrangements) that meet the requirements of ISO
17025?
2. Does the laboratory “do” what they say?
• Are they in compliance with their own quality system,
test methods and ISO 17025?
1. Can they “prove” it with their records?
• Including everything from training records to standards
preparation records to work books to client reports to
audit reports and everything in between?

8. CONTENTS
• 1 SCOPE
• 2 NORMATIVE REFERENCES
• 3 TERMS AND DEFINITIONS
• 4 GENERAL REQUIREMENTS
• 5 STRUCTURAL REQUIREMENTS
• 6 RESOURCE REQUIREMENTS
• 7 PROCESS REQUIREMENTS
• 8 MANAGEMENT SYSTEM REQUIREMENT

9. 1 SCOPE

10. 1 SCOPE
ospecifies the general requirements
• Competence
• impartiality
• Consistent operation
o applicable to all organizations, performing laboratory activities, regardless of
the number of personnel.
o Documents would be used by
• Customers
• regulatory authorities
• organizations and schemes using peer-assessment
• accreditation bodies
• others
No. of
elements to
be accredited
MANAGEME
NT
TECHNICAL
TEAM

11. Accreditation Bodies
ILAC
EA APLAC
IAAC
SADCA
EA European co-operation for Accreditation
APLAC Asia Pacific Laboratory Accreditation Cooperation
IAAC Inter-American Accreditation Cooperation
SADCA Southern African Accreditation Cooperation
ILAC International Laboratory Accreditation Cooperation
(www.ilac.org)

12. 2 NORMATIVE REFERENCES

13. 2 NORMATIVE REFERENCES
• ISO/IEC Guide 99, International vocabulary of metrology — Basic and general
concepts and associated terms (VIM)1)
• ISO/IEC 17000, Conformity assessment —Vocabulary and general principles
• ISO Online browsing platform: available at https://www.iso.org/obp
• IEC Electropedia: available at http://www.electropedia.org/
• Eurachemp

14. 3 TERMS & DEFINITIONS

15. 3 Terms and Definitions
Definitions
• Impartiality
• Complaint
• Interlaboratory comparison (ILC)
• Intralaboratory comparison
• Proficiency testing (PT)
• Laboratory
• Decision rule
• Verification
• Validation
References
• ISO Online browsing platform: available at
https://www.iso.org/obp
• IEC Electropedia: available at
http://www.electropedia.org/

16. 4 GENERAL REQUIREMENTS

17. 4 General Requirements
Impartiality
• Labs activities under impartiality
undertaking
• No Commercial, Financial or other
pressure to impeach Impartiality
• risks in the impartiality on an on-going
basis
• How to eliminate the Risk, If identified
Management would implement the
impartiality
Confidentiality
• Responsible for all information obtained,
Inform the customer about Public and
Private information
• Inform the customer, if Some Authorities
required confidential information.
• Information obtained other than customers
are also confidential
• Complaints, Feedback, Others
Competitors
• All personnel in activities shall keep the
information confidential

18. 5 STRUCTURAL REQUIREMENTS

19. 5 Structural Requirements
• Laboratory shall be a legal entity or part of legal entity
• The laboratory shall identify management that has overall responsibility for
the laboratory.
• define and document the range of laboratory activities for which it conforms
with this document.
• Labs activities should meet the requirements of this document.
• Irrelevant persons are not allowed in Lab/activity area
• Smooth Communication and Integrity of Laboratory

20. 6 RESOURCE REQUIREMENTS

21. 6 Resource requirements
6.1 General
The following things should be available in the Laboratory
Personnel
Facilities
Equipment
System and support necessary to manage and perform the Laboratory
activities

22. 6 Resource Requirements
6.2 Personnel
oAll personal shall be Impartial, Competent and work in accordance to the
Laboratory Management System.
oLaboratory shall document each and every activities of Personals
 Education , Training, Experience, Technical skill
oPersonal are competent for the assigned task
oManagement shall communicate the duties to the concerned personals
oLaboratory shall have procedures to retain the record
 Training, education, technical skill, supervision of personal
oAssign extra duties, Including but not limited to,
 Development, Modification, methods, Results review,

23. 6 Resource Requirements
6.3 Facilities and Environmental Conditions
• Facilities and environment, suitable for the Laboratory actives
• Documents the requirements necessary for the Laboratory activities
• Monitor, Control and Document the necessary condition for activities
• Measures to control facilities shall be implemented, Monitored and
Periodically reviewed
 access to and use of areas affecting laboratory activities
 prevention of contamination, interference or adverse influences on laboratory
activities
 effective separation between areas with incompatible laboratory activities
• In case of On-Site activities, Laboratory shall ensure the required conditions
for the activities

24. 6.4 Equipment
• Laboratory shall have the access to required
 Equipment, materials, software, hardware, standard and etc.
• In case of On-Site, Laboratory shall ensure the required condition for
equipment according to this document are met.
• Laboratory shall draw the procedures for Handling, storage,Transportation
and Planned Maintenance of Equipment
• The laboratory shall verify that equipment conforms to specified
requirements before being placed or returned into service
• Measuring equipments met standard of precision, accuracy and calibrated
6 Resource Requirements

25. • Laboratory shall establish the calibration program of the required instruments
• Label every instruments with detail calibration information.
• Label Instruments which are out of order/defective or required calibration.
• Implement Intermediate check, where necessary to maintain confidence in the performance
of the equipment
• calibration and reference material data or correction factors should be updated
• prevent unintended adjustments of equipment from invalidating results
• Records shall be retained for equipment which can influence laboratory activities
 identity of equipment
 Manufacturer name, SN, U-ID
 Metrological traceability
 Location
 Calibration date
 Reference materials

26. 6 Resource Requirements
6.5 Metrological traceability
• The laboratory shall establish and maintain metrological traceability
 documented unbroken chain of calibrations
• The laboratory shall ensure that measurement results are traceable to the
International System of Units (SI) through:
 calibration provided by a competent laboratory
 certified values of certified reference materials provided by a competent producer with
stated metrological traceability to the SI; or
 direct realization of the SI units ensured by comparison, directly or indirectly, with
national or international standards.
• Laboratory shall demonstrate metrological traceability to an appropriate
reference if SI traceability is not possible.

27. 6 Resource Requirements
6.6 Externally provided products and services
• The laboratory shall ensure that only suitable externally provided products and
services
 for incorporation into the laboratory’s own activities
 directly to the customer by the laboratory
 used to support the operation of the laboratory
• The laboratory shall have a procedure and retain records for
 defining, reviewing and approving the requirements for externally provided services
 defining the criteria for evaluation, reevaluation, selection and monitoring
• The laboratory shall communicate its requirements to external providers

28. 7 PROCESS REQUIREMENTS

29. 7 Process requirements
• 7.1 Review of Requests, Tenders, and Contracts.
• 7.2 Selection, Verification, and Validation of Methods.
• 7.3 Sampling.
• 7.4 Handling of Test and Calibration Items.
• 7.5 Technical Records.
• 7.6 Evaluation of Measurement Uncertainty.
• 7.7 Ensuring the Validity of Results.
• 7.8 Reporting of Results.

30. 8 MANAGEMENT SYSTEM REQUIREMENTS
(QMS)

31. 8 Management system requirements (QMS)
• The laboratory shall Establish, Document, Implement and Maintain a
management system that is capable of supporting and demonstrating the
consistent achievement of the requirements of this document and assuring the
quality of the laboratory results
Two Option
1. Option A
2. Option B

32. 8 Management system requirements(QMS)
• Option B
A laboratory that has established and maintains a management system, in accordance with the
requirements of ISO 9001, is exempted from this step.
• Option A
As a minimum, the management system of the laboratory shall address the following:
 management system documentation
 control of management system documents
 control of records
 actions to address risks and opportunities improvement
 corrective actions
 internal audits
 management reviews

33. 8 Management system requirements(QMS)
8.2 Management System Documentation
• Establish the policies and objectives which fulfilled the requirement of this document.
• Fulfill the criteria of impartiality, competency and consistent operation
• Document every thing as a proof and provide evidence
• Documentation shall be referenced from, or linked to the management system
• All personnel involved in laboratory activities shall have access to the parts of the management
system documentation and related information that are applicable to their responsibilities
8.3 Control Of Management System Documents
The laboratory shall control the documents (internal and external) that relate to the fulfilment of
this document
o Approved
o Periodically reviewed
o Updated versions

34. 8 Management system requirements(QMS)
8.4 Control of Records
• The laboratory shall establish and retain legible records to demonstrate fulfilment of the
requirements in this document
8.5 Actions to Address Risks and Opportunities
• consider the risks and opportunities associated with the laboratory activities
• The laboratory shall plan
a. actions to address these risks and opportunities
b. how to implement plans
• Actions taken to address risks and opportunities shall be proportional to the potential impact

35. RISK AND OPPORTUNITY
RISK ANALYSIS
• Intended user Identification
• Area wise risk identification
• Risk estimation
RISK EVALUATION
• Risk acceptability decisions
RISK MONITORING AND
CONTROL
• OPTION analysis
• Implementation of measures
• RESIDUAL RISK evaluation
• Overall RISK acceptance Post
test operation information
POSTTEST OPERATION
INFORMATION
• Post-Production experience
• Review of Risk management
experience – customer use

36. Quality Manual
Quality Policy
Procedures
Work Instruction
Quality Strategy
Additional detail on how specific
jobs are carried out.
How policy implemented.
QP + QS + description of quality
system, how standards are
applied.
Mission Statement
Describe how processes which
affect quality are carried out.
Developing a Quality System
In a Quality System, work activities are described in written procedures and carried out in a planned
way. The structure of a Quality System conforms to the relevant standards.

37. Mandatory Document for ISO 17025:2017
Documents and Record
Control Procedure
Quality Procedures Competence Training and
Awareness Procedures
Facilities and Environment
Procedures
Customer Service
Procedure
Externally Provided
Products and Services
Procedures
Equipment and
Calibration Procedures
Test and Calibration
Method Procedure
Quality Assurance
Procedures
Sampling Procedures
Handling of Laboratory
Test or Calibration Items
Procedures
Testing and Reporting
Procedure
Complaints,
Nonconformity and
Corrective actions
procedure
Calibration Report and
Certificate Procedure
Requirements

38. LABORATORY UNDER ISO 17025:2017
ISO/IEC
17025
ISO/IEC
9001

39. requests,
tenders and
contracts
7.1
Measurement
Uncertainty
7.6
Technical
Records
7.5
7.4
7.2
Sampling
7.3
Reporting of
results
7.8
Ensuring the
validity of
results
7.7
Selection,
verification
and
validation of
methods
Handling of
test or
calibration
items
6.2 6.3 6.5 6.6
6.4
CUSTOMERS
7.9 complaints
7.10 Non
Conforming work
CUSTOMERS
8.8 Internal
Audit
Feedback
ISO/IEC 17025-2017

40. 7.1 Review of
requests, tenders
and contracts
7.2 Selection,
verification and
validation of
methods
7.3 Sampling
7.4 Handling of test
or calibration items
7.5 Technical
records
7.6 Evaluation of
measurement
uncertainty
7.7 Ensuring the
validity of results
7.8 Reporting of
results
7.9 Complaints
7.10
Nonconforming
work
6.1
General
6.2
Personnel
6.3 Facilities
and
environmental
conditions
6.4
Equipment
6.5
Metrologica
l
traceability
6.6
Externally
provided
products and
services
8.1 Options
8.2 Management
system documentation
(Option A)
8.3 Control of
management system
documents (Option A)
8.4 Control of records
(Option A)
8.5 Actions to address
risks and
opportunities (Option
A)
8.6 Improvement
(Option A)
8.7 Corrective actions
(Option A)
8.8 Internal audits
(Option A)
8.9 Management
reviews (Option A)
Managerial
Requirements
Technical
Requirements
8.0 QMS
5.0 Structural
Requirements
4.0 General
Requirements
6.0 Resource
Requirements
7.0 Process
Requirements
4.2
Confidentiality
4.1
Impartiality
ISO 17025 Requirements

41. What is Needed to Start?
• Application
• Quality Manual
• Quality and Technical SOPs & Wis
• Completed ISO 17025 Assessor Checklist
• Equipment List & Technical Staff Matrix
• Scope: Test names w/corresponding method IDs
• PT (General): Enrollment & Successful PT
Commercially available and relevant PT data for all tests and/or methods
(if available) for which accreditation is sought (such as ASTM PT
programs).

42. • Corrective and preventive actions, method approval plans, and management
review attach timelines to improvement processes ensuring completion.
• Issues with methods, personnel, and equipment are identified and resolved
more quickly.
• System is continually maturing and improving.
• Customer satisfaction is improved.
• Specialized, customer quality requirements are met.
• Business opportunities may increase.
Overall Benefits of Accreditation

43. THANK YOU