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.
Global Manager Group provides ISO/IEC 17025 training presentation to learn requirements of revised ISO/IEC 17025 standard which helps in ISO/IEC 17025:2017 accreditation and to establish good system in laboratories.
ISO 17025 certification gives testing and calibration laboratories the same type of accreditation that ISO 9001 gives to manufacturing and service organizations. Learn more at http://www.CEBOS.com
ISO 17025 Accreditation Detail Review Abdul Rahman
In this presentation, you would get knowledge about ISO17025. It's an updated version, terms and definitions. Which documents are required for certification.
This Presentation provide the understanding about importance of following standards and comply with regulatory requirements. This PPT Prepared to provide Awareness Training on Quality Management System as per ISO 17025:2017 with case studies and Questionnaires
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.
Global Manager Group provides ISO/IEC 17025 training presentation to learn requirements of revised ISO/IEC 17025 standard which helps in ISO/IEC 17025:2017 accreditation and to establish good system in laboratories.
ISO 17025 certification gives testing and calibration laboratories the same type of accreditation that ISO 9001 gives to manufacturing and service organizations. Learn more at http://www.CEBOS.com
ISO 17025 Accreditation Detail Review Abdul Rahman
In this presentation, you would get knowledge about ISO17025. It's an updated version, terms and definitions. Which documents are required for certification.
This Presentation provide the understanding about importance of following standards and comply with regulatory requirements. This PPT Prepared to provide Awareness Training on Quality Management System as per ISO 17025:2017 with case studies and Questionnaires
What Documentation Required for ISO 17025:2017 Accreditation?Global Manager Group
Global Manager Group has prepared presentation to provide information about Calibration and Testing Laboratory Accreditation Standard - ISO 17025 and about Documentation Requirements. All the documents like quality manual, procedures, audit checklist, etc that required for the ISO 17025:2017 Accreditation process are described in details in this presentation.
This publication is about ISO 17025 Certification for Laboratory Accreditation. ISO/IEC 17025 accreditation provides the assurance that calibration and testing laboratories are delivering good services, and consistent data.
PECB Webinar: Understanding the basics of laboratory management with ISO/IEC ...PECB
We will cover:
• Components and implementation of Laboratory Management System based on ISO 17025
• Principal process of Laboratory management system
• Quality, administrative and technical systems/requirements that govern the operations of a laboratory
Presenter:
This webinar will be presented by Dotun Bolade. He is a Certified PECB ISO/IEC 17025 Lead Assessor and Trainer.
A quality management system is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction
,
quality management systems
,
what’s iso?
,
getting to know iso
,
benefits of iso registration
,
requirements
,
requirements activity
,
quality management system (qms)
,
resource management
,
product realization
,
measure
,
analyze and improve
,
documentation activity
,
internal audits
,
how to do an internal audit
,
audit activity
,
registration process
,
two ways to be iso certified
The PPT explain about the NABL and accreditation process according to the ISO 17025. And how you will get benefited with the NABL/ISO 17025 accreditation for your Lab.
Estimation of Measurement Uncertainty in Labs: a requirement for ISO 17025 Ac...PECB
Knowledge of the uncertainty of measurement of testing and calibration results is fundamentally important for laboratories, their clients and all institutions using these results for comparative purposes. Uncertainty of measurement is a very important metric of the quality of a result or a testing method.
Main points covered:
• To introduce the basic concepts related to measurement results and measurement uncertainty
• Explain the relevance of these concepts to chemical analysis data
• Introduce mathematical concepts, uncertainty sources and important approaches for estimation of measurement uncertainty
Presenter:
This webinar was presented by Dotun Bolade, who is an Analytical Chemist/Environmental Scientist by training and practice with years of experience in laboratory instrumentation and automation. For him, ISO management systems have become second nature having worked in environments where ISO 9001, 14001, 18001 and 17025 have been fully implemented. He is a Certified PECB ISO/IEC 17025 Lead Assessor.
Link of the recorded session published on YouTube: https://youtu.be/AOpFou7_FVI
What Documentation Required for ISO 17025:2017 Accreditation?Global Manager Group
Global Manager Group has prepared presentation to provide information about Calibration and Testing Laboratory Accreditation Standard - ISO 17025 and about Documentation Requirements. All the documents like quality manual, procedures, audit checklist, etc that required for the ISO 17025:2017 Accreditation process are described in details in this presentation.
This publication is about ISO 17025 Certification for Laboratory Accreditation. ISO/IEC 17025 accreditation provides the assurance that calibration and testing laboratories are delivering good services, and consistent data.
PECB Webinar: Understanding the basics of laboratory management with ISO/IEC ...PECB
We will cover:
• Components and implementation of Laboratory Management System based on ISO 17025
• Principal process of Laboratory management system
• Quality, administrative and technical systems/requirements that govern the operations of a laboratory
Presenter:
This webinar will be presented by Dotun Bolade. He is a Certified PECB ISO/IEC 17025 Lead Assessor and Trainer.
A quality management system is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction
,
quality management systems
,
what’s iso?
,
getting to know iso
,
benefits of iso registration
,
requirements
,
requirements activity
,
quality management system (qms)
,
resource management
,
product realization
,
measure
,
analyze and improve
,
documentation activity
,
internal audits
,
how to do an internal audit
,
audit activity
,
registration process
,
two ways to be iso certified
The PPT explain about the NABL and accreditation process according to the ISO 17025. And how you will get benefited with the NABL/ISO 17025 accreditation for your Lab.
Estimation of Measurement Uncertainty in Labs: a requirement for ISO 17025 Ac...PECB
Knowledge of the uncertainty of measurement of testing and calibration results is fundamentally important for laboratories, their clients and all institutions using these results for comparative purposes. Uncertainty of measurement is a very important metric of the quality of a result or a testing method.
Main points covered:
• To introduce the basic concepts related to measurement results and measurement uncertainty
• Explain the relevance of these concepts to chemical analysis data
• Introduce mathematical concepts, uncertainty sources and important approaches for estimation of measurement uncertainty
Presenter:
This webinar was presented by Dotun Bolade, who is an Analytical Chemist/Environmental Scientist by training and practice with years of experience in laboratory instrumentation and automation. For him, ISO management systems have become second nature having worked in environments where ISO 9001, 14001, 18001 and 17025 have been fully implemented. He is a Certified PECB ISO/IEC 17025 Lead Assessor.
Link of the recorded session published on YouTube: https://youtu.be/AOpFou7_FVI
Accreditation of Research Laboratories: An Awareness CreationSolomon Abate
This presentation is prepared for the awareness creation of EIAR center directors, quality management representatives, laboratory heads and custodians. The training is given starting November 30, 2015 for five days.
Introduction of conformity assessment principles for facilitating cross border trades and harmonizes the understanding of businesses in order to overcome Technical Trade barrier (TBT).
It is intended to ensure certification bodies operate certification schemes in a competent, consistent and impartial manner, thereby facilitating the recognition of such bodies and the acceptance of certification at the national and international level.
It also facilitates authorities to enforce their regulatory activities of certain particular high risk products.
U.S.F.D.A. was the pioneer in the concept of process validation.
Validation had proven to be an important tool for quality management of pharmaceutical according to ISO 9000:2000.
U.S.F.D.A. was the pioneer in the concept of process validation.
Validation had proven to be an important tool for quality management of pharmaceutical according to ISO 9000:2000.
What is NABL ?
The National Accreditation Board for Testing and Calibration Laboratories (NABL) is an autonomous body under the guidance of the Dept. Of Science & Technology, Govt. of India.
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is the main ISO/IEC standard used by testing and calibration laboratories. In most countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent. In many cases, suppliers and regulatory authorities will not accept test or calibration results from a lab that is not accredited. Originally known as ISO/IEC Guide 25, ISO/IEC 17025 was initially issued by ISO/IEC in 1999. There are many commonalities with the ISO 9000 standard, but ISO/IEC 17025 is more specific in requirements for competence and applies directly to those organizations that produce testing and calibration results and is based on somewhat more technical principles. Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results. It is also the basis for accreditation from an accreditation body.
There have been three releases; in 1999, 2005 and 2017. The most significant changes between the 1999 and 2005 release were a greater emphasis on the responsibilities of senior management, explicit requirements for continual improvement of the management system itself, and communication with the customer. It also aligned more closely with the 2000 version of ISO 9001
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is the main ISO/IEC standard used by testing and calibration laboratories. In most countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent. In many cases, suppliers and regulatory authorities will not accept test or calibration results from a lab that is not accredited. Originally known as ISO/IEC Guide 25, ISO/IEC 17025 was initially issued by ISO/IEC in 1999. There are many commonalities with the ISO 9000 standard, but ISO/IEC 17025 is more specific in requirements for competence and applies directly to those organizations that produce testing and calibration results and is based on somewhat more technical principles. Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results. It is also the basis for accreditation from an accreditation body.
2. INTRODUCTION
ISO/IEC 17025 is the international standard
used by laboratories in developing their
quality, administrative and technical systems
that govern their operations.
3. ISO/IEC 17025
The two main clauses are:
o Clause No. 4.0 Management Requirements
o Clause No. 5.0 Technical Requirements
4. Organization (Cl. No. 4.1)
Legally Identifiable
Meet the needs of Client, ISO/IEC-17025, regulatory
authorities
Scope
• permanent facilities/mobile facility
• Sites away from permanent
facility/temporary facility
Defined Authority / Responsibility
• Part of large organization
• Key personnel :- potential conflict of interest
• Nominated managers for Quality and Technical
Function
• Nominated deputies
Cont’d
5. Organization (Cl. No. 4.1)
Free from commercial , financial pressure.
Clients confidential information, proprietary
rights.
Competence, Impartiality, judgment and Integrity
Organization chart indicating relationship
between Quality Manager, Technical operations
and support services
Inter-personnel relationship
6. Quality System (Cl. No. 4.2)
Quality system documentation shall be
communicated to ,understood by,available to,
and implemented by the appropriate personnel.
7. The Quality Manual (Cl. No. 4.2)
“a document stating the quality policy and
describing the quality system of an
organisation”
ISO 10013
8. Structure of Documentation
(Cl. No. 4.2)
Quality
Manual
Quality
Procedures
Instructions
Blank Tags, Forms, Labels,
Cards, Worksheets etc.
Data
9. Document Control
(Cl. No. 4.3)
- It is to ensure that each person
working in laboratory has with
him/her, the current version of
document, to perform his/her work.
10. Documentation Control
(Cl. No. 4.3)
Review and approval of documents
Master List of procedure
• availability
• Review, revision & amendment
• Externally-generated Documents
• removal of obsolete documents
• identification of obsolete documents
retained for other reasons
Cont’d
11. Documentation Control
(Cl. No. 4.3)
Identification of Document
• Title
• date of issue
• revision status
• page numbering to signify end of
document
• authority for issue
12. Review of Requests, Tenders
and Contracts (Cl. No. 4.4)
The laboratory must have a format procedure
for the planned and systematic evaluation of its
capability to undertake each new request to
provide a testing or measuring service.
The procedure will also apply to undertaking
or accepting a significant increase in the
volume of testing work currently performed.
13. Subcontracting of tests or
calibrations
(Cl. No. 4.5)
Approval from client, preferably in writing,
when the lab intends to subcontract.
Ensure and demonstrate subcontractors
competence and compliance with 17025.
Laboratory maintains responsibility.
Maintain a register of all subcontracting work.
14. Purchasing Services and
Supplies
(Cl. No. 4.6)
Procedures for selection and purchasing of
service and supplies that affect the quality of
tests
Procedures for handling consumable materials
Purchasing document contains description
Inspected or otherwise verified as complying
Record of evaluation of suppliers of critical
service
15. Service to the client
(Cl. No. 4.7)
Clients allowed to clarify requirements and
monitor performance of laboratory.
Laboratory to ensure confidentiality to other
clients.
16. Complaints
(Cl. No. 4.8)
Policy and procedure for resolution of
complaints
Records of complaints, including all
investigations and corrective actions
17. Control of Non-Conforming Testing
and/or Calibration Work (Cl. No. 4.9)
Policy and procedures for nonconformance in
testing. Procedure shall include:
• responsibilities and authorities are defined
• evaluation of significance
• remedial actions
• recall of nonconforming work released to
clients
• responsibility for resumption of work
18. Corrective Action
(Cl. No. 4.10)
Corrective actions focuses on fixing problems
that already exist.
Corrective action must be implemented when
departures from acceptable practices are
identified.
Cause analysis - root cause.
Eliminate the problem, prevent recurrence.
Cont’d
19. Corrective Action Loop
(Cl. No. 4.10)Problem
Identified
Records &
Document
Updated
Corrective
Action
Affective?
Likely
Cause
Identified
Corrective
Action
Identified
Corrective
Action Taken
No
Yes
20. Preventive Action
(Cl. No. 4.11)
Identify potential sources for nonconformance,
technical or relating to quality system.
Procedures
• initiation of action , implementation
• controls to ensure effectiveness
21. Records
(Cl. No. 4.12)
Procedure for identification, collection,
indexing, access, storage, maintenance,
disposal of quality and technical records.
Records legible, readily retrievable, stored in a
suitable environment.
Secure and in confidence.
Protection and backup of computer records.
22. Internal Audits
(Cl. No. 4.13)
Predetermined schedule.
Comply with requirements of Quality System
and ISO/IEC 17025.
All elements of Quality System.
Trained and qualified personnel,
independence & Conflict of Interest.
Records maintained of audits findings and
corrective actions.
23. Management Review
(Cl. No. 4.14)
Management with executive responsibility.
Predetermined schedule.
Suitability and effectiveness.
Changes for improvements.
Record the findings and also corrective actions.
Quality manager is responsible to prepare the
agenda.
Quality manager is responsible for action taking as
decided by Management Review.
25. The “People” Requirements of
Accreditation (Cl. No. 5.2)
Number required for workload
Qualifications and experience
Responsibilities and authorities
Job descriptions
Performance criteria and performance appraisal
Training needs identification
Training records
Continuing education
26. Approved Signatories
Approved signatory status is granted to those
staff members of a laboratory who are
sufficiently qualified and experienced and who
have been assessed by AB to be fully competent
in technical and quality management aspects of
the laboratory.
27. Criteria for the granting of
“Approved Signatory” status
Technical Competence including:
Relevant qualifications and/or experience.
Close involvement in the day-to-day operations.
Familiarity with test procedures including scientific basis
and technical limitations.
Ability to make critical evaluation of test results.
Knowledge of Quality Management system.
Knowledge of and commitment to AB and their criteria
and ISO/IEC 17025.
Sufficient time in the laboratory to become fully familiar
with the operating systems of the laboratory.
28. Accommodation and Environment
(Cl. No. 5.3)
A laboratory is any place, in a building or in the field
where measurements, tests, calibrations are carried
out.
ISO/IEC 17025
“The laboratory facilities for testing and/or calibration
shall be such as to facilitate correct performance of
tests and/or calibrations. The laboratory shall ensure
that the environment does not invalidate the results or
adversely affect the required quality of any
measurement.
29. Laboratory Environment (Cl. No. 5.3)
The environment is the set of conditions that may
influence the test and/or measurement results.
Considerations :
• Temperature and humidity
• Dust, biological sterility,chemical cleanliness
• Ventilation and fume extraction
• Noise levels and acoustics and ergonomics
• Vibration and radiation
• Cross contamination prevention
• Power Supply and electromagnetic compatibility
• Lighting
• People access and security issues
30. Test & Calibration Methods
(Cl. No. 5.4)
ISO/IEC 17025 :1999 - the laboratory shall have
instructions on the use of equipment, on the
handling, and preparation of items and for test and
calibration procedures and the calculation of
uncertainty of measurement.
• Meets Clients requirements
• Test methods from standard writing institution
• Laboratory developed test methods
• Non standard test methods
31. Test Method Selection (Cl. No. 5.4)
Consider:
Client’s wants and needs
Regulatory or standard requirements
Industry acceptance
Sampling and sample preparation
Environmental and accommodation requirements
Staff capability requirements
Repeatability, reproducibility and uncertainty
Recovery or matrix effects
Safety
Cost and time
32. Validation (Cl. No. 5.4)
Selectivity & specificity
Range
Linearity
Limit of detection
Limit of repeatability
Reproducibility
Ruggedness
Bias
Precision
33. Measurement Uncertainty
(Cl. No. 5.4)
ISO/IEC 17025 (5.4.6)
Calibration laboratory or testing laboratory
doing calibrations must formally estimate
uncertainty for all calibrations.
Testing laboratories must estimate uncertainty
but may be with less rigor:-
…..They must make a “reasonable estimation”
and “attempt to identify all components”.
34. Equipment (Cl. No. 5.5)
Sufficient and appropriate for workload
Fit for purpose
Instillation, Environment
Commissioning and Verification
In-use status to prevent other staff interfering
Maintenance schedules
Operational status - damaged?
Control and repair procedures
Calibrations and schedules
Records of all above items.
35. Traceability (Cl. No. 5.6)
Property of the result of a measurement or the
value of a standard whereby it can be related to
stated references, usually , national or international
standards , through an unbroken chain of
comparisons all having stated uncertainties
NOTES
1. The concept is often expressed by the adjective
Traceable
2. The unbroken chain of comparisons is called a
Traceability chain.
36. Path for Traceability of Measurement
INTERNATIONAL BUREAU OF WEIGHTS
AND MEASURES ( BIPM, PARIS)
NATIONAL METROLOGY
LABORATORY
(NML)
ACCREDITED LABORATORIES
USER TESTING/CALIBRATION LABORATOTRY
37. Voltage Traceability
JOSEPHSON VOLT
UNCERTAINTY +/- 0.001 ppm
ELECTRONIC STANDARD CELL
+/- 0.5 ppm
HIGH ACCURACY CALIBRATOR
+/- 1 ppm
MEDIUM ACCURACY CALIBRATOR
+/- 50 ppm
HAND HELD VOLTMETER
+/- 1000 ppm or 0.1 %
38. Certified Reference Material (CRM)
(Cl. No. 5.6)
Reference Material accompanied by, a
certificate, one or more of whose property value
are certified by a procedure which establishes its
traceability to an accurate realization of the unit
in which the property values are expressed and
for which each certified value is accompanied by
an uncertainty at a stated level of confidence.
ISO Guide 39 : 1992
39. Reference Material (Cl. No. 5.6)
Reference materials must be:
Characterized (certified value)
Homogeneous
Stable
Certified, traceable reference materials purchased from
reputable sources.
Certified traceable calibration standards traceable to
national or international measures.
Reference materials and items used for no other
purpose than calibration.
Check intermediate materials and items regularly
against reference standards.
Store reference items and materials carefully.
40. Sampling (Cl. No. 5.7)
The sampling process may be one of the most critical
aspects of the entire testing procedure, and may be a major
contributor to the overall uncertainty of measurement.
The laboratory must assure that the samples for testing
have been taken by a skilled person following approved
sampling procedures.
When laboratory is not directly responsible for sampling or
has no assurance that samples truly representative of the
bulk of product to be assessed, the laboratory must protect
itself thus:
Each test report shall carry a statement such as:
“Results relate only to the sample as received”
41. Handling of Test and Calibration Items
(Cl. No. 5.8)
ISO/IEC 17025:1999 “the laboratory shall have
procedure to protect the integrity of test/calibration
items ”
Identify test/calibration items & sub- samples
throughout.
Record abnormalities of items & consult client for
advice.
Prevent deterioration during storage & handing –
monitor and record conditions.
Security during storage.
In non-destructive testing, prevent damage/injury to
samples/people.
Sampling plan & handling procedures available to
sampling staff.
42. Quality Control (Cl. No. 5.9)
Quality Control – Operational activities aimed at
monitoring the quality of testing throughout the process
and at identifying unsatisfactory results.
• Checking calculations and data transcriptions
• Blanks, standards, reference items, retest of retained
items
• Replicate testing and statistical calculations
(confidence limits)
• Trends analysis and trend charts
• The laboratory Comparison Programmes ( Proficiency
testing)
Quality Control includes Proficiency Testing
43. Reporting the Results (Cl. No. 5.10)
ILAC Guidance to Clause 5.10 (G.5.10.1)
G.5.10.1 laboratories that are accredited by an
accreditation body which is a signatory of the ILAC
or regional multilateral agreement in the field of
testing or calibration, may state on certificates and
reports, in the appropriate language: xxxxx (full
name or acronym of accreditation body) is one of the
signatories to the yyyyy (full name or acronym of
the regional or international organization)
multilateral agreement / arrangement for the mutual
recognition of test reports and/or calibration
certificates (whichever is relevant).
Cont’d.
44. Reporting the Results (Cl. No. 5.10)
ILAC Guidance to Clause 5.10.4.2. (G.5.10.4.2.1.)
G.5.10.4.2.1 accreditation bodies should provide
rules for the way in which measurement uncertainty
has to be taken into account when statements of
compliance are made. Such rules should follow
ILAC G8 or EA5/01.
Clause 5.10.6 testing and calibration results
obtained from subcontractors.
ILAC Guidance to Clause 5.10.6. (G.5.10.6.1)
G.5.10.6.1 accreditation bodies should ensure that
when the laboratory does not take responsibility for
the subcontracted work, as provided for in ISO/IEC
17025 clause 4.5.3 this fact is clearly stated in the
report.
45. Opinions and Interpretations
(Cl. No. 5.10)
Laboratory clients want the solution to their
problem, not a list of numbers
Opinions and interpretations include
– Opinions on conformity of samples/items with
requirements
– Fulfillment of contractual requirements
– Recommendation on how to use test results
– Guidance on improvements
Special staff will be granted signatory approval for
opinions and interpretations.
They may have special technical qualifications.
Knowledge and experience assessed by the technical
assessor.
Example: Medical Pathologists verses