ISO/IEC
17025:2017
REQUIREMENTS
To learn the principles and
requirements of ISO/IEC
17025:2017
Objectives
To understand the roles of the
laboratory personnel in
planning and implementing
ISO/IEC 17025
Introduction to ISO /IEC
17025:2017
• International Organization for
ISO stands for:
Standardization
IEC Stands for: • International Electrotechnical Commission
ISO/IEC 17025 is an • General requirements for the competence
international standard
of testing and calibration laboratories
for:
Introduction to ISO /IEC
17025:2017
Risk based Engagement
thinking of People
Relationship Customer
management Focus
ISO 9001
Operates generally in Evidence
accordance with the based
decision
making
Leadership
principles of ISO 9001
Process
Improvement
Approach
Introduction to ISO /IEC
17025:2017
Basic requirements for accreditation:
Laboratory management system that is:
ESTABLISHED
DOCUMENTED
IMPLEMENTED
MAINTAINED
Technical Competence of Personnel
Commitment of the Management and Staff
Introduction to ISO /IEC 17025:2017
Management
General Structural Resource Process
System
Requirements Requirements Requirements Requirements
Requirements
(2) (7) (6) (11)
(9)
Elements of
ISO/IEC
17025:201
7
1. SCOPE OF ISO/IEC 17025
Competence
Specifies
requirements Impartiality
for
Consistent operation
Applicable to All organization with laboratory activities
regardless of the number of personnel
2. NORMATIVE REFERENCES
ISO/IEC Guide 99
ISO/IEC 17000,
International vocabulary
Conformity Assessment
of metrology – Basic and
– Vocabulary and general
general concepts and
principles
associated terms (VIM)
3. Terms and Definition
3.1 Impartiality – presence of objectivity
3.2 Complaint – expression of dissatisfaction by any person or organization to a laboratory,
relating to the activities or results of that laboratory, where a response is expected
3.3 Interlaboratory comparison – organization , performance and evaluation of measurements
or tests in the same or similar items by two or more laboratories in accordance with
predetermined conditions
3.4 Intralaboratory comparison – organization, performance and evaluation of measurements or
tests on the same or similar items within the laboratory in accordance with predetermined
conditions
3.5 Proficiency testing – evaluation of participant performance against pre-established criteria
by means of interlaboratory comparisons
3. Terms and Definition
3.6 Laboratory – body that performs one or more of the following activities: testing; calibration;
sampling, associated with subsequent testing or calibration
3.7 Decision Rule – rule that describes how measurement uncertainty is accounted for when
stating conformity with a specified requirement
3.8 Verification – Provision of objective evidence that a given items fulfills specified
requirements
3.9 Validation – verification where the specified requirements are adequate for an intended use
4. GENERAL REQUIREMENTS
4.1 Impartiality
All lab activities shall be impartial
Structured and managed to safeguard impartiality
Management commitment to impartiality
Identify risks to impartiality on an on-going basis
Demonstrate how it eliminates or minimizes such risk
4.1 Impartiality
Organizational structure
Commitment to Impartiality:
Policy Statement
Code of Ethics
NDAs
Updated Risk Registry concerning Impartiality
4.2 Confidentiality
Shall be responsible, through legally enforceable commitments, for the management of all
information obtained or created during the performance of laboratory activities
Shall inform the customer in advance, of the information it intends to place in the public
domain.
When the lab is required by law or authorized by contractual arrangements to release
confidential information, the customer or individual concerned shall, unless prohibited by law,
be notified of the information provided
Information about the customer obtained from sources other than the customer shall be
confidential between the customer and the laboratory
Personnel, including any committee members, contractors, personnel of external bosies, or
individuals acting on the lab’s behalf shall keep confidential all information obtained or created
during the performance of lab activities, except required by law
4.2 Confidentiality
Protection of information – to ensure information is provided only to authorized personnel
Commitment to Confidentiality:
Policy statement
Code of ethics
Policy on Restricted access to the laboratory
Policy on Surveillance system
5. STRUCTURAL
REQUIREMENTS
5.1 Shall be a legal identity
Proof of ownership e.g. SEC registration, BIR registration, Business permits
5. STRUCTURAL
REQUIREMENTS
Identify who has the Define and document
Shall be a legal identity:
overall responsibility of range of activities
- proof of ownership
the lab: e.g. test capabilities
e.g. SEC reg, BIR reg,
e.g. Lab Manager, included in the scope of
business permits
Division Chief accreditation
5. STRUCTURAL
REQUIREMENTS
Conduct activities to meet Define the organization Document procedures to
the requirements of the and Management the extent necessary to
standard, customers, structure, responsibilities, ensure consistent
regulatory authorities, authorities, application of its
etc. interrelationships laboratory activities
5. STRUCTURAL
REQUIREMENTS
Available personnel,
Communication and
who have authorities
integrity of the
and resources to
management system
carry out their duties
6. RESOURCE
REQUIREMENTS
6.1 General
- Personnel
- Facilities
Shall have available - Equipment
- Systems
- Support services
6. RESOURCE
REQUIREMENTS
6.2 Personnel
Act impartially, be
competent and work in
Document competence Communicate duties
accordance with the
requirements and responsibilities
laboratory’s
management system
6.2 Personnel
Shall have procedure and records for:
Determining competence
6. Selection
RESOURCE Training
REQUIREM Supervision
ENTS Authorization
Monitoring of competence
6. RESOURCE
REQUIREMENTS
6.2 Personnel
Development,
modification,
verification, and
validation of methods
Authorized personnel to
perform the following Analysis of results
tasks:
Reports, reviews, and
authorization of
results
6. RESOURCE
REQUIREMENTS
6.3 Facilities and environmental condition
- Suitable
Laboratory conditions shall - Not adversely
be:
affect validity of
results
6. RESOURCE
REQUIREMENTS
6.3 Facilities and environmental condition
Shall monitor, control, and record environmental conditions in accordance with relevant
specifications, methods or procedures or where they influence the validity of the results
Measures to control facilities shall be implemented, monitored and periodically reviewed
When the laboratory performs lab activities at sites outside its permanent control – shall
ensure that requirements are met
6. RESOURCE
REQUIREMENTS
6.4 Equipment
- Access to the equipment
- Documented procedures
- Equipment verification
- Accuracy and measurement
Shall have: uncertainty
- Requirements if outside
permanent control
- Defective or “outside specs”
- Retain all records
6. RESOURCE
REQUIREMENTS
6.4 Equipment
Reference values
Calibration
of correction
Program
factors
Intermediate Unintended
Checks adjustments
6. RESOURCE
REQUIREMENTS
6.5 Metrological Traceability
Documented
unbroken chain of Traceable to SI Units
calibrations, each
contributing to MU,
linking to If not technically
appropriate possible, ensure to
reference demonstrate
traceability
6. RESOURCE
REQUIREMENTS
6.6 Externally provided-products and services
Supplies
Select Suitable
External Services Control supplier /
Verify
Service provider
Subcontractors
7. PROCESS REQUIREMENTS
7.1 Review of requests, tenders, and contracts - Requirements are
adequately defined,
documented, and
understood
- Has the capability and
resources to meet the
requirements
Shall have Review of requests, - When external providers are
Procedure shall
documented tenders, and contracts used, the requirements are
ensure that:
procedure for: applied, and customers are
advised
- Appropriate methods or
procedures are selected and
are capable of meeting the
customer’s requirements
7. PROCESS REQUIREMENTS
7.2 Selection, verification and validation of methods
7.2.1 Selection and verification of methods
Published
internationally Fit for use in the
Select
Appropriate laboratory and
Nationally Latest version agreed with
Verify customer
Reputable organization
7. PROCESS REQUIREMENTS
7.2 Selection, verification and validation of methods
7.2.2 Validation of methods
Non-standard methods
Fit for use in the
Standard methods Validated laboratory and
outside of intended Procedure agreed with
Recors
scope customer
Developed methods
7. PROCESS REQUIREMENTS
7.3 Sampling
Sampling plan and method
Retain records
7. PROCESS REQUIREMENTS
7.4 Handling of test items
Procedure for:
Transportation
Receipt Records:
Handling Deviation
Protection Special
Storage environmental
conditions
Storage
Retention
Disposal
7. PROCESS REQUIREMENTS
7.4 Handling of test items
Procedure for:
Transportation
Receipt Records:
Handling Deviation
Protection Special
Storage environmental
conditions
Storage
Retention
Disposal
Unique identification
7. PROCESS REQUIREMENTS
7.5 Technical Records
Lab Records Identity of personnel for each activity
Worksheet Date
Data Sheet Original observations and calculations
Logbooks Results, reports or any sufficient information
Etc. Amendments
7. PROCESS REQUIREMENTS
7.6 Evaluation of measurement uncertainty
Identify contributions
Evaluate
7. PROCESS REQUIREMENTS
7.7 Ensuring validity of results
Procedure for
Resulting data shall Monitoring shall be
monitoring the
be recorded planned and reviewed
validity of results
7.7 Use of reference materials or quality
Ensuring control materials
validity
of Use of alternative instrumentation that has
been calibrated to provide traceable results
results
7. Functional check(s) of measuring and
PROCESS testing equipment
REQUIREM Use check or working standards with
ENTS control charts, if applicable
Intermediate checks on measuring
equipment
Replicate tests or calibrations using the
same or different methods
7.7 Restesting or recalibration of
Ensuring retained items, if applicable
validity
of Correlation of results for different
results
characteristics of an item
7.
PROCESS Review of reported results
REQUIREM
ENTS
Intralaboratory comparison
Testing of Blind items
7. PROCESS REQUIREMENTS
7.8 Reporting of results
Test Report
Common
Requirements:
Certificate of
16
Analysis
Title
Name and address of the laboratory Common
Location of performance of the lab activities, including when
Requireme
performed at a customer facility or sites away from the lab’s
permanent facilities
nts
Unique identification that all its components are recognized
as a portion of a complete report and clear identification of
the end
Name and contact info of the customer
Identification of the method used Common
Description, unambiguous identification, and when
Requireme
necessary, the condition of the item nts
Date of receipt of the test items, date of sampling, where
this is critical to the validity and application of results
Date of performance of the laboratory
activity
Date of issue of the report Common
Requireme
Reference to the sampling plan and nts
sampling method used by the lab
Statement to the effect that the results
relate only to the items tested
The results with units of measurement
Additions to, deviations, or exclusions
from the method Common
Requireme
Identification of the person(s) authorizing nts
the report
Clear identification when results are from
external providers
7. PROCESS REQUIREMENTS
7.8 Reporting of results
Specific Requirements:
- Data provided by customers
Test Report - Specific Test Conditions
- Statement of Conformity
- Calibration of certificates
Certificate of - Sampling
Analysis - Opinions and interpretations
- Amendments to reports
7. PROCESS REQUIREMENTS
7.9 Complaints
Documented process to receive, evaluate and make decisions on complaints
Progress report
Receive and validate of the
Investigate and investigation
evaluate
Decisions Outcome /
decisions
7. PROCESS REQUIREMENTS
7.10 Nonconforming work
Root cause Evaluate
Document Decision and
analysis and significance;
procedure and notify customer
corrective action; impact on
implement when necessary
Risk analysis previous results
7. PROCESS REQUIREMENTS
7.11 Control of data and information management
8. MANAGEMENT
SYSTEM
REQUIREMENTS
8.1 Options
Option A : Address Clause 8.2 to 8.9
Option B : ISO 9001 and Address Clause 4 to 7
8. MANAGEMENT SYSTEM
REQUIREMENTS
8.2 Management system documentation
Policies and
objectives
Management
Referencing or Commitment
linkage system
documentation
Access
8. MANAGEMENT SYSTEM
REQUIREMENTS
8.3 Control of management system documents
Policy Controlled
Uniquely identified
Manual
Approved for use
Procedures
Reviewed and updated
Identified changes
Work Available at points of use
Instructions Prevent use of obsolete docs
Records and Forms
8. MANAGEMENT SYSTEM
REQUIREMENTS
8.4 Control of records
Shall establish and retain legible records
Shall implement controls needed for the identification, storage, protection, back-up, archive,
retrieval, retention time, and disposal of records
Shall retain records for a period consistent with its contractual obligation
8. MANAGEMENT SYSTEM
REQUIREMENTS
8.5 Actions to address risks and opportunities
Assurance that the MS Enhance opportunities to
achieve its intended use achieve objectives
Prevent or reduce
undesired impacts / Achieve improvement
failures
8. MANAGEMENT SYSTEM
REQUIREMENTS
8.5 Actions to address risks and opportunities
Plan Actions:
Proportional to the potential
impact on validity of test
results
Integrate and implement
actions
Evaluate effectiveness
of actions
8. MANAGEMENT SYSTEM
REQUIREMENTS
8.5 Actions to address risks and opportunities
Step 1: Identify risks and opportunities
Step 2: Evaluate the risk NOTE: There is no requirement for formal
methods for risk management. Labs can
decide whether to develop a more extensive
Step 3: Rank the risks and opportunities methodology of other guidance or standard.
Step 4: Determine actions to be taken
Step 5: Implement, monitor, and follow-up
8. MANAGEMENT SYSTEM
REQUIREMENTS
8.6 Improvement
Review of operational procedures
Use of policies
Overall objectives
Audit results
Corrective actions
Management review
8. MANAGEMENT SYSTEM
REQUIREMENTS
8.6 Improvement
Shall seek feedback
both positive and
negative from
customers
This Photo by Unknown Author is licensed under CC BY-NC
Shall be analyzed
8. MANAGEMENT SYSTEM
REQUIREMENTS
8.7 Corrective Actions
A. React to nonconformity
B. Evaluate
C. Implement Actions
D. Review effectiveness of actions
8.8 Internal Audit
8.
Conduct internal audits
MANAGEM
ENT • Audit program
SYSTEM • Audit criteria and scope
REQUIREM • Reporting of audit results
ENTS • Implementation of corrective
actions
• Retention of records
8. MANAGEMENT SYSTEM
REQUIREMENTS
8.9Management Review:
B. Record inputs
A. Planned to MR (15 C. Record outputs
Interval minimum to MR
requirements)
8. MANAGEMENT SYSTEM
REQUIREMENTS
Changes in internal and external issues
Management Fulfillment of objectives
Review Suitability of policies and procedures
Inputs Status of actions from previous MR
Outcome of recent internal audits
Corrective actions
Assessments by external bodies
Changes in volume/type of worl
Customer and personnel feedback
Complaints
Effectiveness of implemented improvements
Adequacy of resources
Results of risk identification
Outcomes of the assurance of the validity of results
Other relevant factors (e.g. monitoring, training)
