ISO IEC 17025 2017 Lab Competence Handout

The standard for laboratory competence
Awareness Seminar on
PNS ISO /IEC 17025:2017
March 24, 2021
Philippine Trade Training Center
Roxas Blvd., Pasay City
OBJECTIVES OF THE SEMINAR

• Participants to have a better understanding of the requirements
of PNS ISO/IEC 17025:2017 and be able to implement a system
in their organization which meet the requirements of the new
standard
• To provide awareness on the laboratory accreditation process
and activities of the accreditation body
1
COURSE OUTLINE
MODULE 1: INTRODUCTION
MODULE 2: UNDERSTANDING THE REQUIREMENTS OF

PNS/ISO/IEC 17025:2017
MODULE 3: THE PAB ACCREDITATION PROCESS
INTRODUCTION
MODULE 1
2
CONFORMITY ASSESSMENT,
ACCREDITATION AND MRA
• CONFORMITY ASSESSMENT
Any procedure used, directly or indirectly, to determine
that relevant requirements in technical regulations or
standards are fulfilled.
Processes that your product, service or system meets

the requirements of a standard
• CONFORMITY ASSESSMENT
Main forms of Conformity Assessment
Testing/calibration, certification and
inspection
Benefits
Provides consumers and stakeholders with added
confidence
Gives competitive edge to the company
Helps regulators ensure that health, safety or environmental
conditions are met
3
• Conformity assessment body (CAB)

Body that performs conformity assessment services and that
can be the object of accreditation
 Competence, impartiality and performance capability
CABs
 Laboratories (Testing and calibration)
 Certification bodies (QMS, EMS, HACCP, product certification, etc)
 Inspection bodies
Accreditation
The independent evaluation of conformity assessment bodies
against recognized standards to ensure their impartiality and
competence to specific tasks.
Key words: “Competence”

“Specific tasks”
4
• Mutual Recognition Arrangement
Uniform approach allows countries to establish agreements among themselves,
Based on mutual evaluation and acceptance of each other’s accreditation
systems.
Crucial in enabling test and calibration data to be accepted between these
countries.
Partner recognizes the other partner’s accredited laboratories as if they
themselves had undertaken the accreditation of the other partner’s laboratories.
World trade organization and agreement on technical barriers to trade (tbt)
“Once tested accepted everywhere”
ACCREDITATION BODY AND MRA
Accreditation Bodies
Accreditation Service
Conformity assessment bodies

Certification Inspection Test Cal
Body Body Lab Lab
Conformity Assessment Service
Market
Demands for
Conforming Purchasers competent
Product/ product/service
Regulators conformity
service Requirements assessment
Trade
Suppliers Organization and Demands for
Authorities facilitating
trade
5
Conformity Assessment Accreditation Hierarchy
Cooperation Government and Industry Cooperation
ILAC MRA Acceptance IAF MLA
Mutual Recognitions Mutual Recognitions

EA, APAC, IAAC EA, APAC, IAAC
ISO/IEC 17040 ISO/IEC 17040
Accreditation Bodies Accreditation Bodies

Accredit labs and Accredit labs and inspection
inspection bodies bodies
ISO/IEC 17011 ISO/IEC 17011
Laboratories Inspection Bodies Certification Bodies Certification Bodies

test, inspect certify certify
products, materials products, items, structures products management systems
ISO/IEC 17025 ISO/IEC 17020 ISO/IEC 17065 ISO/IEC 17021
Second
Suppliers
Confidence regarding Parties
ISO/IEC 17050 compliance with requirements
ACCREDITATION BODY AND MRA
PEER EVALUATION PROCESS (ISO/IEC 17040)
Accreditation Body Accreditation Body

in country A Recognition in country B
(ISO/IEC 17011) (ISO/IEC 17011)
Laboratory in country A Laboratory in Country B

(ISO/IEC 17025) (ISO/IEC 17025)
Recognition of
Test/Calibration
Results Test /Calibration Results
Equivalence
6
OBJECTIVES OF PNS/ISO/IEC 17025:2017?
• “General requirements for the competence of testing and

calibration laboratories”
• Developed with the objective of promoting confidence in the

operation of laboratories
• Requirements for laboratories to enable them to demonstrate

they operate competently, and are able to generate valid results
OBJECTIVES OF PNS/ISO/IEC 17025:2017?
• Facilitates acceptance of results between countries if conforming

laboratories obtain accreditation from bodies which have entered
into mutual recognition agreements with equivalent bodies in
other countries
7
BENEFITS OF PNS/ISO/IEC 17025:2017
ACCREDITATION
• National and international mutual recognition
• Reduced costs of re-testing
• Better control over laboratory operation
• Increased confidence in testing/calibration
• Increased profits
• Validity of test methods and provision of reliable data
Understanding the
Requirements of
PNS/ISO/IEC 17025: 2017
MODULE 3
8
GENERAL REQUIREMENTS FOR THE COMPETENCE

OF TESTING AND CALIBRATION LABORATORIES
Structure
Foreword
Introduction
Scope
Normative references
Terms and definitions
General requirements
Structural requirements
Resource requirements
Process requirements
Management system requirements
Annex A Metrological traceability
Annex B Management system options
Bibliography
9
Scope
Emphasis on “impartiality”
General requirements for competence, impartiality and
consistent operation of the laboratories
Applicable to all organizations performing laboratory
activities, regardless of the number of personnel
- First party
- second party
- third party
Scope
• Scope statements
Laboratory activities
Testing, calibration, sampling associated with subsequent testing
 Defined range of activities for laboratory

Excludes externally provided laboratory activities on an ongoing
basis
Basis for confirming or recognizing the competence of labs by its

customers, regulatory bodies, organizations and schemes using peer-
assessment, accreditation bodies and others
10
• Adopted Principles of ISO 9001:2015
ISO/IEC 17025:2017 adopted the quality management

principles of ISO 9001:2015 with modifications for
laboratories
Testing and calibration laboratories complying with the

standard also operate in accordance with the quality
management principles of ISO 9001:2015
Principles of ISO 9001:2015
 Quality management principles

1. Customer focus
2. Leadership
3. Engagement of people
4. Process approach
5. Improvement
6. Evidence-based decision making
7. Relationship management
11
PROCESS ORIENTATION
 ISO/IEC 17025:2017 adopted the “process approach
 Process is a set of interrelated or interacting activities

that use inputs to deliver an intended output or result
Sources Receiver of
INPUTS ACTIVITIES OUTPUTS Outputs
of Inputs
Risk-based Approach
Application of the concept of risk-based thinking thus
prescriptive requirements of ISO/IEC 17025 are replaced
by performance-based requirements;
Greater flexibility in the requirements for processes,

procedures, documented information and organizational
responsibilities;
A definition of “laboratory” and “decision rule” has been

added.
12
Focus on Information Technology:
 Modern-day laboratories work increasingly with

information and communication technologies
 Recognizes and incorporates the use of computer
systems, electronic records and production of
electronic results and reports
 Considers risks, data integrity, confidentiality,
validation of software in electronic documents
Laboratory and Decision Rule
A definition of “laboratory” and “decision rule” has been

added.
Laboratory: Body that performs one or more of the
following activities: testing, calibration, sampling
associated with subsequent testing or calibration
Decision Rule: Rule that describes how measurement

uncertainty is accounted for when stating conformity with a
specified requirement
13
PNS ISO/IEC 17025:2017 REQUIREMENTS
• General requirements
• Structural requirements
• Resource requirements
• Process requirements
• Management system requirements
4 GENERAL REQUIREMENTS
Impartiality
Well structured, impartial and managed organization
Commitment to impartiality
Impartiality of laboratory activities not influenced by commercial,
financial or other pressures
Identify risks to impartiality on an on-going basis

From activities
From its relationships
Relationships of personnel
Laboratory to demonstrate how it eliminates or minimizes
identified risks (mitigated risks)
14
Confidentiality
Responsibility, through legally enforceable
commitments, for the management of all information
obtained/created during the performance of
laboratory activities
 Customer information from laboratory
 Information from customer
 Information as agreed between customer and
the laboratory
 All other information considered proprietary
information be regarded as confidential
Confidentiality
Notification to customer/individual concerned of
confidential information released
Information about customer

obtained from other sources be kept confidential
Provider confidential to the customer
15
Confidentiality
Confidential information shall be kept by
Personnel
Any committee members
Contractors
Personnel of external bodies or
Individuals acting on the laboratory’s
behalf except as required by law
5 STRUCTURAL REQUIREMENTS
Laboratory must be a legal entity
Definition and documentation of the range of laboratory
activities
Restricts claims of conformity to standard for the
defined range
Excludes externally provided laboratory activities
on an on-going basis
16
Range of laboratory activities performed meet
requirements of the standard at:
Permanent facility, sites away from permanent
facility, mobile facility, customer’s facility
Organization and management structure of the

laboratory and its relationship with
Management, technical operations and support
services
Identification of any management that has overall
responsibility for the laboratory
Documentation of procedures to the

extent necessary
to ensure the consistent application of

its laboratory activities and the validity of
the results.”
 The extend of detail in that
documentation is up to the laboratory
17
6 RESOURCE REQUIREMENTS
General
“The laboratory shall have available the personnel, facilities,
equipment, systems and support services necessary to manage
perform its laboratory activities.”
Available personnel for implementation, maintenance and
improvement of management system
Authority and resources

Implementation, maintenance and improvement of
management system
Identification of deviations, initiation of actions,

reporting performance of management system and any
need for improvement, ensuring effectiveness of
laboratory activities
18
Internal and external communication related to effectiveness of

the management system
Maintenance of the integrity of the management system
Personnel
Internal or external personnel who has influence to results
of laboratory activities act impartially, competent and work
within the laboratory’s management system
Document competence requirements for each function

Personnel competent for the assigned tasks and to
evaluate the significance of deviations
Management to communicate to personnel duties,

responsibilities and authorities
19
Personnel
Documented procedures and retain records of
the following:
• Competence requirements
• Selection of personnel
• Training of personnel
• Supervision of personnel
• Authorization of personnel
• Monitoring competence of personnel
Personnel
Personnel authorization to perform specific
activities such as:
 Development, modification, verification and
validation
 Analysis of results, giving statements of
conformity or opinions and interpretations
 Report, review and authorizations of results
20
Facilities and environmental conditions
Suitable for the laboratory activities and not adversely
affect the validity of results
Documented requirements for necessary facilities and

environmental conditions for performance of laboratory
activities
Facilities and environmental conditions
Implement, monitor and periodically review measures
to control facilities covering:
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
Requirements implemented at sites or facilities outside

the laboratory’s permanent control
21
Equipment
Access to equipment required for the correct
performance of laboratory activities
Use of equipment outside the laboratory’s permanent

control
Procedure for handling, transport, storage, use and

planned maintenance of equipment
Equipment verification prior to use or returned into

service
EQUIPMENT
Criteria that determine when calibration of equipment is
required
–measurement accuracy or measurement uncertainty
affects the validity of the reported results, or
–to establish the metrological traceability of the
reported result.
22
Equipment
Equipment calibration program established, reviewed
and adjusted as necessary
Equipment labelled, coded or identified

Out-of-service equipment taken out of service
Equipment
Procedure for intermediate checks when necessary
Reference values and correction factors updated and
implemented
Measures to prevent unintended adjustments of

equipment invalidating results
23
Equipment
Equipment records retained to include:
Identity of equipment, its software and firmware
version
Manufacturer’s name, type identification and serial
number or other unique identification
Equipment verification of conformity to specified
requirements
Current location
Calibration dates, calibration results, adjustments,
acceptance criteria and calibration due date or
calibration interval
Equipment
Equipment records to include:
Documentation of reference materials, results,
acceptance criteria, relevant dates and period of
validity
Maintenance plan and maintenance carried out to

date
Details of any damage, malfunction, modification

to or repair of the equipment
24
Metrological traceability
Establish and maintain metrological traceability of
measurement results by means of unbroken chain of
calibrations linked to an appropriate reference
Measurement traceable to SI units of measurement

through:
Competent calibration laboratory
Certified values of CRM’s by competent producer
Direct realization of SI units by comparison, directly
or indirectly with national or international standards
Metrological traceability
When metrological traceability to SI units not
technically possible
Traceability through certified values of CRM’s by

competent producer
Results of reference measurement procedures,
specified methods or consensus standards ensured
by suitable comparison
 Clearly described and accepted as
measurements fit for their intended use
25
Externally provided products and services
Supplies
• Select
External services • Control Competent
• Verify Supplier
“Subcontracting”
Only suitable externally provided products and
services are used:
Intended for incorporation into laboratory’s own
activities
Provided in part or full, directly to customer by the
laboratory, as received from external provider
Used to support the operation of the laboratory
26
Available procedure and retain records for:
Defining, reviewing and approving laboratory’s
requirements for externally provided products and
services
Defining criteria for evaluation, selection,

monitoring of performance and re-evaluation of
external providers
Available procedure and retain records:
that externally provided products and services
conform to laboratory’s requirements
any actions taken after evaluations, monitoring

performance and re-evaluation of the external
providers
27
Communicate requirements to external providers for:
Products and services to be provided
Acceptance criteria
Competence, including any required qualification of
personnel
Activities that the laboratory or its customer, intends
to perform at the external provider’s premises
7 PROCESS REQUIREMENTS
Review of request, tenders and contracts
Procedure for review of requests, tenders and contracts
to address that:
Requirements are adequately defined, documented
and understood
 Capability and resources to meet the requirements
 Requirements of externally provided products and
services applies
 Appropriate methods or procedures are selected
and meets customer requirements
28
Inform customer when method is considered
inappropriate or out of date
When customer requests statement of conformity to a
specification or standard, the specification or standard
and the decision rule is clearly defined
 Resolve any difference between request or tender and
the contract before laboratory activities commence
 Inform customer of any deviation from the contract.
Repeat contract review if contract is amended after
work has commenced
 Communicate any amendments to all affected
personnel
 Cooperate with customers on customer’s request
and in monitoring the laboratory’s performance
29
Retain records of:
Reviews and its changes
Pertinent discussions with customer on customer
requirements or results of laboratory activities
Selection, verification and validation of methods
All methods, procedures and supporting documentation
kept up to date and readily available to personnel
 Based on latest valid version
Standard supplemented with additional details

Inform customer of method chosen (if not specified)
30
Method verification done prior to introducing
them and records retained
When required, method development is

Planned
Assigned to competent personnel
Periodically reviewed, approved and
authorized
Method deviations for all laboratory activities
Documented
Technically justified
Authorized
Accepted by customer
31
 Validation of methods
Non-standard methods
Laboratory-designed/developed methods
Standard methods used outside their intended scope
Amplifications and modification of standard method
Perform new validation method when changes to a validated
method affect the original validation
 Validation of methods
Performance characteristics of validated methods
relevant to the customers’ needs and consistent with
specified requirements
Retention of validation records includes :
 Validation procedure used
 Specification of the requirements
32
• Selection, verification and validation of methods
Validation of methods
Retention of validation records includes :
 Determination of the performance
characteristics of the method
 Results obtained
 Statement on the validity of the method,
detailing its fitness for the intended use
Sampling
 Plans and procedures
- Available at the location
- Based on appropriate statistical methods
- Control factors to ensure validity of results
 Sampling method describes
 Selection of samples or sites
 Sampling plan
 Sample preparation and treatment
33
• Sampling
Records include
 Reference to sampling method used
 Date and time of sampling and sampling data
 Identification of sample and personnel

performing sampling
 Identification of the equipment used
 Environmental or transport conditions
 Diagram to identify sampling locations
 Deviations, additions to or exclusions from the

sampling method and sampling plan
Handling of test or calibration items
Procedures
Transportation, receipt, handling, protection,
storage, retention and disposal/return of
test/calibration items and all provisions for protection
of integrity of test and/or calibration items
Identification
System for identification of test and/or calibration
items
34
Handling of test or calibration items
 Deficiencies
 Record any deviations from specified conditions on item
received
 Consult customer and record results of consultation
 When the customer requires the item to be tested or calibrated
acknowledging a deviation from specified conditions, the
laboratory shall include a disclaimer in the report indicating
which results may be affected by the deviation.”
Environmental conditions maintained, monitored and recorded

during sample storage or conditioning
Technical records
Technical records contain:
Results, report and sufficient information
Date and identity of personnel responsible for
each laboratory activity, data check and results
Original observations, data and calculations

recorded at the time they are made
35
Technical records
 Amendments to technical records can be tracked to
previous versions or to original observations
 Original and amended data and files retained

including:
 Date of alteration
 Indication of altered aspects
 Personnel responsible for the alterations
Evaluation of measurement uncertainty

Identify contributions to measurement uncertainty
Evaluation of measurement uncertainty for all
calibrations, including “in-house” calibrations
Evaluation of measurement uncertainty for testing
laboratory
36
Evaluation of measurement uncertainty
A laboratory is not required to calculate a unique

uncertainty every time a test is performed provided the
stated conditions are met and the identified critical
influencing factors are under control
Ensuring the validity of results

Procedure
Monitoring validity of results
 Planned and reviewed
Records
 Data from internal activities
 Trends of resulting data are detectable
 Statistical techniques applied in reviewing results
37
Monitoring includes
 Use of RM or quality control materials
 Use of alternative instrumentation that
can be calibrated
 Functional checks of measuring and
testing equipment
 Use of check or working standards with
control charts
 Intermediate checks on measuring
equipment
Monitoring includes
 Replicate tests or calibration using the
same or different method
 Retesting or recalibration of retained items
 Correlation of results for different

characteristics of an item
 Review of reported results
 Intra-laboratory comparisons
 Testing of blind samples
38
Monitoring laboratory performance through:
 Participation in proficiency testing
 Participation in inter-laboratory comparisons other than
proficiency testing
Data from monitoring activities analyzed, used to control and
improve laboratory’s activities
Appropriate action taken to data found outside pre-defined
criteria
Reporting of results
Results reviewed and authorized prior to released
Report results
Accurately, clearly, unambiguously and objectively
Include all information
Agreed with the customer
Required by the method
Necessary for the interpretation results
Issued reports retained as technical records
39
Test reports and calibration certificates
For in-house labs
Report in a simplified way
Any information not reported to client, but is

normally required to be, must be readily
available
Common requirements for reports (test, calibration or
sampling)
Include the following information:
Title (test report or calibration certificate or
report of sampling)
Name, address of laboratory
Location of performance of laboratory activities
Unique ID (report number, page number and
number of pages ON EACH PAGE)
Name and contact information of the customer
Identification of method used
Test item or sample description and condition of
the item
40
sampling)
 Include the following information:
 Date of receipt and date of test or calibration
items and date of sampling
 Date of performance of the laboratory activity
 Date of issue of the report
 Reference to sampling plan and procedures,
where applicable
 Test or calibration results and units of
measurement
sampling)
 Include the following information:
 Additions to, deviations, or exclusions from the
method
 Signatory or person authorized to release work
 Clear identification when results are from
external providers or customers
 Statement to effect “results relate to items
tested, calibrated or sampled”
 “Shall not be reproduced except in full without
the approval of the laboratory”
41
Specific requirements for test reports:
Environmental conditions
Statement of conformity with requirement or
specification
Measurement uncertainty
• When it is relevant to the validity or application of
the test results
• A customer requirement
• When it affects conformity to a specified limit
Specific requirements for test reports:
Opinions and interpretations
Additional information required by the
specific method, authorities, customers or
groups of customers
Sampling data if the laboratory conducted
sampling
42
Specific requirements for calibration certificates:
In addition to the common requirements for reports:
Measurement uncertainty of the measurement result
Conditions under which the calibrations were made
A statement identifying how the measurements are
metrologically traceable
The results before and after adjustments or repair

A statement of conformity with requirements or
specifications
Specific requirements for calibration certificates:
In addition to the common requirements for
reports:
Opinions and interpretations, where appropriate
When sampling activity is done, reporting
follows the requirements for reporting sampling in
calibration certificates
Calibration certificate or sticker shall not contain

any recommendation on the calibration interval
except where this has been agreed with the
customer.
43
Reporting sampling – specific requirements
In addition to the common requirements for
reports:
Date of sampling
Unique identification of the sample
Location of sampling
Reporting sampling – specific requirements
In addition to the common requirements for reports:
Reference to sampling plan and method
Environmental conditions during sampling
Information required to evaluate measurement
uncertainty for subsequent testing
44
Reporting statements of conformity
Document the decision rule employed taking into
account the level of risk associated with the decision
rule employed and apply the decision rule
Report statement of conformity identifying:

To which the results of the statement of
conformity applies
Which specifications, standards or parts thereof
are met or not met the decision rule applied
Reporting opinions and interpretations
Only personnel authorized for the expression of
opinions and interpretations release the respective
statement
Opinions and interpretations expressed in reports
are based on the results obtained and clearly
identified
Retain records of opinions and interpretations
directly communicated with the customer
45
Amendments to report
Any change in information clearly defined in the report including
reason for the change
Reported in another document which include the statements

(amendment to report, serial number or equivalent form of wording)
Amendments meet the requirements of the standard

When issuing a complete new report, it must be uniquely identified
and contain reference to the original
Complaints
Documented process to receive, evaluate and make
decisions on complaints
Available description of the handling process for

complaints to any interested party on request
Responsibility for all decisions at all levels of the

handling process for complaints
46
Complaints
Process for handling complaints include the
following:
Description of the process for receiving,
validating, investigating the complaint and
deciding what actions to be taken
Tracking and recording complaints including
actions taken
Any appropriate action is taken
Complaints
Laboratory responsibility for gathering and verifying all necessary
information to validate the complaint
Acknowledge receipt of complaint and provide progress reports and

outcome to the complainant
Outcome to be communicated to the complainant and to be

reviewed and approved by individuals not involved in the original
laboratory activities in question
Provision of formal notice at the end of complaint handling to the

complainant
47
Nonconforming work
Procedure includes:
Designated responsibilities, authorities and actions
defined
Actions are based upon the risk levels established

by the laboratory
Evaluation of significance of nonconforming work

including impact analysis on the previous results
Nonconforming work
Procedure includes
Decision taken on the acceptability of the non
conforming work
Customer notification and work recall
Responsibility for authorizing resumption of work
Records of non-conforming work and actions retained
Recurrence
Implement corrective action procedures
48
Control of data and information management
Laboratory access to data and information needed to
perform laboratory activities
Laboratory information management system

Used for collection, processing, recording, reporting,
storage or retrieval of data
 Validated for functionality
Any changes, laboratory software configuration or

modifications to commercial off-the-shelf software are
authorized, documented and validated prior to implementation
Laboratory information management system:
Protected from unauthorized access
Safeguarded against tampering and loss
Operated in an environment that complies with
provider or laboratory specifications
49
Laboratory information management system:
Maintained in a manner that ensures the
integrity of data and information
Include recording system failures and the
appropriate immediate and corrective actions
LIMS managed and maintained off-site or
through an external provider must also comply
with applicable requirements of this standard
Instruction manuals and reference data related to
LIMS are readily available to personnel
Calculations and data transfers checked in

appropriate and systematic manner.
50
8 MANAGEMENT SYSTEM REQUIREMENTS
Options
The revision now provides two distinct options (A or
B) for establishing management system
Option A: laboratory shall address the
requirements in clauses 8.2 to 8.9
Option B: establish and maintain a management

system in accordance with the requirements of ISO
9001

Options
Both options require that the management system is
capable of supporting and demonstrating the consistent
achievement of the
Requirements of ISO/IEC 17025 clauses 4 to 7
Assuring the quality of the laboratory results.
Laboratories need only conform to one of the options (not

both)
51
General
Establish, document, implement and maintain
a management system
Implement a management system in

accordance with Option A or Option B

• Option A
Management system documentation
Control of management system documents
Control of records
Actions to address risks and opportunities
 Improvements
 Corrective actions
 Internal audits
 Management reviews
52
Option B
A laboratory that has established and maintains a
management system in accordance with ISO 9001
and fulfills clauses 4 to 7 also fulfils the management
system requirements specified in clauses 8.2 to 8.9

Management system documentation (option A)
Establish, document and maintain policies and
objectives for the fulfillment of the purposes of the
standard
Policies and objectives

Acknowledged and implemented at all levels of
the laboratory organization
Address the competence, impartiality and

consistent operation of the laboratory
53
Management system documentation (Option A)
Evidence of commitment to development,
implementation and continual improvement of the
management system from management
Documentation, processes, systems, records are

included in, referenced from or linked to the management
system
Access of all personnel to the parts of the management

system documentation and related information applicable
to their responsibilities

Control of management system documents (Option A)
Management system documents are:
Controlled (internal and external documents)
Approved for adequacy prior to issue by authorized
personnel
Periodically reviewed and updated
Uniquely identified
Changes and current revision status are identified
Available at points of use and distribution is controlled
Unintended use of obsolete documents is prevented
54
Control of records (option A)
Establish and retain legible records
Retain records for a period consistent with its
contractual obligations
Access to records consistent with confidentiality

commitments
Records readily available

Control of records (Option A)
Implement controls for
Identification
Storage
Protection
Back-up
Archive
Retrieval
Retention time
Disposal
55
Actions to address risks and opportunities (Option A)
Consider risks and opportunities associated with
laboratory activities in order to:
Give assurance that management system achieves its

intended results
Enhance opportunities to achieve the purpose and
objectives of the laboratory
Prevent, reduce, undesired impacts and potential
failures in laboratory activities
Achieve improvement
MAJOR CHANGES
 Risk-based thinking
Risk can be found in the requirements for:
Impartiality and confidentiality
Corrective actions
Improvement
Management review
Decision rule on conformity assessment
Actions taken on non-conforming work and
Assurance of the validity of results
56
• Actions to address risks and opportunities (Option A)
Plan:
actions to address risks and opportunities
integration and implementation of these actions
into its management system
to evaluate effectiveness of these actions

actions taken to address risks and opportunities

 Improvements (Option A)
Identify and select opportunities for improvement
Implement necessary actions
Seek feedback (positive and negative) from customers
Analyze feedback
Use feedback for improvement of management system,
laboratory activities and customer service
57
Corrective actions (Option A)
When a nonconformity occurs:
React to nonconformity and take action to control
and correct NC
Address the consequences

Evaluate the need for action to eliminate the cause of
NC through:
Review and analysis of NC
Determination of cause of NC
Determination if similar NC exist or could potentially
occur
Implement action needed
Review effectiveness of CA
Update risks and opportunities determined during
planning
Make changes to the management system
58

When a nonconformity occurs:
CA appropriate to the effects of NC
Retain records of
NC, causes and ca
Results of CA

Internal audits (Option A)
Conduct internal audits at planned intervals to evaluate
if management system conforms to:
The requirements of the standard
The laboratory’s own requirements for its
management system including laboratory activities
Is effectively implemented and maintained
59
• Internal audits (Option A)
Plan, establish, implement and maintain an audit
program (frequency methods, responsibilities, planning
requirements, reporting, changes affecting the laboratory
and results of previous audits)
Define the audit criteria and scope for each audit

Results of audit reported to relevant management
Implement appropriate correction and corrective action
without delay
Retain records of implementation of internal audit

Management reviews (Option A)
Review management system at planned intervals to
check:
Its continuing suitability, adequacy and
effectiveness
Review stated policies and objectives
60
Record inputs to management review which include:
Changes in internal and external issues that are
relevant to the laboratory
Fulfillment of objectives
Suitability of policies and procedures
Status of actions from previous management
reviews
Outcome of recent internal audits
Corrective actions
Assessment by external bodies

Record inputs to management review which include:
Changes in the volume and type of the work in the
range of laboratory activities
Customer and personnel feedback
Complaints
Effectiveness of any implemented improvements
Adequacy of resources
Results of risk identification
Outcomes of the assurance of the validity of results
Other relevant factors such as monitoring activities
and training
61
Outputs from management review recorded related to actions
and decisions on:
Effectiveness of the management system and its

processes
Improvement of laboratory activities

Provision of required resources
Any need for change
The PAB Accreditation

Process
MODULE 5
62
Inquiry
Acquire forms, relevant

documents/requirements
Pre-assessment
(if necessary)
Submit application documents,

copy of quality/procedure manual, other relevant
documents
Document review
Flowchart for Selection of assessment team

Accreditation On site assessment
Report of
assessment
and corrective
actions
Granting of accreditation/certification
First SV (after 12 months);

2nd SV (after 24 months)
Full reassessment (after five years)
THANK YOU
Ms Helen P. Subradil
Management System Consultant
Contact Number: 09157042632
Email add: zeedira@gmail.com
END
63

ISO IEC 17025 2017 Lab Competence Handout

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The standard for laboratory competence

OBJECTIVES OF THE SEMINAR

MODULE 2: UNDERSTANDING THE REQUIREMENTS OF

MODULE 3: THE PAB ACCREDITATION PROCESS

Processes that your product, service or system meets

• Conformity assessment body (CAB)

Key words: “Competence”

Conformity assessment bodies

Conformity Assessment Service

Mutual Recognitions Mutual Recognitions

Accreditation Bodies Accreditation Bodies

Laboratories Inspection Bodies Certification Bodies Certification Bodies

Accreditation Body Accreditation Body

Laboratory in country A Laboratory in Country B

• “General requirements for the competence of testing and

• Developed with the objective of promoting confidence in the

• Requirements for laboratories to enable them to demonstrate

OBJECTIVES OF PNS/ISO/IEC 17025:2017?

• Facilitates acceptance of results between countries if conforming

GENERAL REQUIREMENTS FOR THE COMPETENCE

 Defined range of activities for laboratory

Basis for confirming or recognizing the competence of labs by its

ISO/IEC 17025:2017 adopted the quality management

Testing and calibration laboratories complying with the

Principles of ISO 9001:2015

 Quality management principles

 ISO/IEC 17025:2017 adopted the “process approach

 Process is a set of interrelated or interacting activities

Greater flexibility in the requirements for processes,

A definition of “laboratory” and “decision rule” has been

 Modern-day laboratories work increasingly with

Laboratory and Decision Rule

A definition of “laboratory” and “decision rule” has been

Decision Rule: Rule that describes how measurement

Identify risks to impartiality on an on-going basis

Information about customer

Organization and management structure of the

Documentation of procedures to the

to ensure the consistent application of

Authority and resources

Identification of deviations, initiation of actions,

Internal and external communication related to effectiveness of

Maintenance of the integrity of the management system

Document competence requirements for each function

Management to communicate to personnel duties,

Documented requirements for necessary facilities and

Requirements implemented at sites or facilities outside

Use of equipment outside the laboratory’s permanent

Procedure for handling, transport, storage, use and

Equipment verification prior to use or returned into

Equipment labelled, coded or identified

Measures to prevent unintended adjustments of

Maintenance plan and maintenance carried out to

Details of any damage, malfunction, modification

Measurement traceable to SI units of measurement

Traceability through certified values of CRM’s by

Externally provided products and services

Defining criteria for evaluation, selection,

any actions taken after evaluations, monitoring

Standard supplemented with additional details

When required, method development is

 Identification of sample and personnel

 Environmental or transport conditions

 Diagram to identify sampling locations