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ISO/IEC 17025 Training

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dean balboa

on 12 December 2014

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Transcript of ISO/IEC 17025 Training

ISO/IEC 17025 Training
ISO/IEC 17000
Simplified Structure of
Laboratory QMS Documentation

Changes in Work Place
Do not use correction fluid nd erasers in correcting records !
5.10 Reporting the results
Format of reports and certificates
accomodate each type of test or calibration
- minimize misunderstanding
Amendments to Test/Calibration certificates
- No amendments in the form of:
- Amendments in the form of:
- supplements and referenced to old certificate
- new uniquely identified certificate and referenced to old certificate
- meet requirement of ISO/IEC 17025

ISO/IEC 17025:2005
Course Objective:
On completion of this seminar, participants will be able to:

1. Know the importance of laboratory quality
management system.
2. Understand the elements of ISO/IEC
3. Know the importance, benifits and
procedures in laboratory accreditation.
Course Outline:
Laboratory Quality management System
Overview of ISO/IEC 17025
Understanding the Clauses of ISO/IEC17025:2005
Normative Reference
Terms and Definition
Management Requirements
Technical Requirements
Laboratory Accreditation
Benefits of laboratory Accreditation
Internalnational Scene of Laboratory Accreditation
PAB Criteria for Accreditation
PAB Application and Requirements
What is expected of a Laboratory?
reaility of test result!
How about other Customer's Requirements?
low cost
agreed terms and condition
exceed expectations
degree to which a set of inherent characteristics fulfills requirements
(ISO 9000:2008)
Characteristics may be:
physical (mechanical, electrical, chemical,
sensory (related to smell, touch, taste, sight,
behavioral (e.g courtesy, honesty, veracity)
temporal (e.g punctuality, reliability, availability)
ergomic (e.g related to human safet)
functional (e.g maximum speed of aircraft)
Quality in the laboratory should aim to provide
Customer satisfaction!
Quality Management Systems (QMS)
can assist organizations in enhancing customer satisfaction
What is a Quality Management Systems?
a management system to direct and control an organization with regard to quality
(ISO 9000/2008)
Laboratory Qality Management System
QMS in the lab !
and more. . .
Quality Management System
Why implement a
Laboratory Quality Management System
Satisfy customer requirements
Improve accuracy and reliable of data
Improve efficiency through documented policy/procedures
Consistency through documented pilicy/procedures
Improve reputation of organization
Required by regulation
Required by customer's management system
supplier laboratories for ISO/TS 16949 require accreditation
Why use ISO/IEC 17025?
1. Specific o testing and calibration laboratories.
2. An internationally recognized general requirement
(harmonized accreditation criteria) for laboratories.
3. Basis for laboratories accreditation.
4. Basis for Mutual Recogtion Arrangements (MRA)
among laboratory accreditationbodies worldwide.
NOTE: for medical laboratories, use
ISO/IEC 15189:2003 Medical Laboratories- Particular requirements for quality and competence
Evolution of ISO/IEC 17025
ISO/IEC Guide 25-1978
"Guidelines for assesing the technical competence of testing laboratories"

technical only
ISO/IEC Guide 25-1982
"General requirements for the competence of testing laboratories"

technical and quality system
Evolution of ISO/IEC 17025
ISO/IEC Guide 25:1990
"General requirements for the competence of calibration and testing laboratories"
technical and quality system
ISO/IEC 17025:1999
"General requirements for the competence of testing and calibrationlaboratories"
technical and quality system
Evolution if ISO/IEC 17025
ISO/IEC 17025:2005
"General requirements for the competence of testing and calibration laboratories"
technical and management system approved only on May 12, 2005 cancels and replaces ISO/IEC 17025:1999
General changes in
ISO/IEC 17025/2005
ISO/IEC 17025
General Requirements for the Competence of Testing and Calibration Laboratories
ISO/IEC 17025 Structure
Normative Reference
Terms and Definitions
Management Requirements
Technical Requirements
- Cross reference to ISO 9001:2000
- Guidelines for establishing applications for specific fields
Specifies the general equirements for the competence to carry out tests and calibration, including sampling.
Covers tests and calibration performed using standard, non standard and laboratory-developed methods
Applicable to all laboratories performing testing and/or calibration.
For use by laboratory customers, regulatory authorities and accreditation bodies to confirm or recognized competence.
Complience to requirements of this standards will operate a QMS that also meets the principles of ISO 9001.
2. Normative Reference
Conformity Assesment - Vocabulary and general principles.
International vocabulary of basic and general terms in metrology
the latest edition, including any amendments, applies !
3. Terms and Definitions
Use ISO/IEC 17000 and VIM (preferred)
otherwise, use ISO 9000:2000
ISO 9000:2000 Quality Management Systems - fundamentals and Vocabulary.
4. Management Requirements
4.1 Organization
4.2 Management system
4.3 Document Control
4.4 Review of request, tenders and contracts
4.5 Subcontracting of test and calibrations
4.6 Purchasing services and supplies
4.7 Service to the Customer
4.8 Compliants
4. Management Requirements
4.9 Control of Nonconforming testing an/or calibration
4.10 Improvement
4.11 Corrective action
4.12 Preventive action
4.13 Control of records
4.14 Internal audits
4.15 Management reviews
5. Technical Requirements
5.1 General
5.2 Personnel
5.3 Accomodition and environmental condition
5.4 Test and calibration methods and method validation
5.5 Equipment
5.6 Measuring traceability
5.7 Sampling
5.8 Handling of test and calibration items
5.9 Assuring the quality of test and calibration result
5.10 Reporting the result
Overview of:
ISO/IEC 17025
Management Requirements
4.1 Organization
Legally responsible entity
Meet requirements of ISO/IEC 17025
Satisfy needs of:
- customers
- regulatory authorities
- accrediting bodies
Scope of laboratory management system
- permanent facilities
- sites away from permanent facilities
- temporary or mobile facilities
4.1 Organization
Conflict of interest
- defined responsibilities of key personnel
Managerial and technical personnel
- authority and resources to:
- carry out duties, including implementation, maintenance and improvement of the management systems;
- identify occurence of departures from the management systems or from test / calibration poceedures;
- initiate actions to prevent or minimize such departures
- these are irrespective of other responsibilities !
Undue pressure and influence
- arrangements for management and personnel
4.1 Organization
Protection of customer's confidential information
- policies and procedures
- includes protection of electronic storage and transmission
of result
Competence, impartiality, judgement, or operational integrity
- policies and procedures
Laboratory organizational and management structure
- relationship of quality management, technical operations
and support services
Responsibility, authority and interrelationships
- all personnel affecting quality of test / calibration
1. Scope
4.1 Organization
Laboratory supervision
- done by those filiar with methods, proceedures,
- include trainee
Technical management
- overall responsibility for technical operations
- provision of resources to ensure required quality
Quality manager
- responsible and authorized to implement and
maintain the management system
- direct access to top management
4.1 Organization
- appointed for key managerial personnel
Personnel Awareness
- relevance and importance of thier activities
- how to contribute to achieve the management
system objectives
Appropriate Communication Processes
- established within the laboratory
- effectiveness of the management system
4.2 Management System
Management system
- established, implemented, and maintained
- appropriate to scope of activities
Policies, systems, programmes, procedures, instructions
- documented to ensure quality of tests/
- communicated to, understood by, available
to, and implemented by appropriate personel
4.2 Management System
Quality policy statement
- issued under the authority of top management
- content include should at least:

- commitment to good proffesional practice and quality
of service
- laboratory's standards of service
- purpose of management system related to quality
- requiring all personnel to be familiar with quality
documentation and implement policies and
procedures in their work
- management commitment to compliance with ISO/IEC
- continually improve effectiveness of the management
4.2 Management System
Top Management Commitment
- development and implementation of the management system
- continually improving effectiveness
Top Management Communication
- importance of meeting custumer requirements
- meeting statutory and regulatory requirements
Quality Manual
- include or refer to supporting procedures including technical
- outline the structure of the documentation
4.2 Management System
Roles and responsibilities defined in quality manual

Management System Integrity
- technical management
- quality manager

- maintained when changes are planned and
Changes in Work Place
What may be expected
Resistance to change
grudging compliance
if this happens, implement appropriate seminars/workshops to remedy situation
4.3 Document Control
- control all manaement system documents
- includes internally genereted and externally sourced
Approval and issue
- reviewed and approved prior to issue
- revision status and distribution identified ( through a masterlist or equivalent)
- authorizededitions at location required
Continuing suitability
- periodically reviewed and revised when necessary
4.3 Document Control
Document changes

- reviwed and approved by same function that performed original review or a designate
Altered or new text
- identified where practicable
Handwritten amendments
- procedure and authorities defined
- clearly mark, initialed and dated
- formally re-issued as soon as prcticable
Elecetronic documents
- procedures on changes control
4.3 Document Control
Obsolete documents
- removed from points of issue
- suitability marked if retained for legal or knowledge preservation
Unique identification
- internally generated documents
- indentification includes:

- date of issue
rivisin identification page number
total page number (or marked to end document)
- issuing authority
Document Structure
Quality Manual
Procedures Manual
Work Instructions Manual
- Each manual may not have the same content due
to different distribution coverage of Work
Document Structure
Test/Calibration Methods
- not combined in a manual
- best to file into specific methods and
make available to locations where
Forms Manua
- if Forms are not appended in each
Procedure, Work Instruction, or Test/
Calibration Method.
Document Structure
Level 3
Level 2
Level 1
Seperate Documents in accordance to level !
Work Instruction
Test and Calibration Methods
Form, Logbooks, Worksheets, Records
Hierarchy of Laboratory Quality
Management System Documentation

Level 1
Level 2
Level 3
Level 4
4.4 Review of request, tenders and contracts
Policies and procedures
- customer requirements, including methods,
are defined, documented and understood
- laboratory has capability and resources
- appropriate method selection
Request or Tender vs. Contract
- resolve before work starts
- contract acceptable to both parties
Records of review
- maintained
- include significant discussions, changes and
results of work
4.4 Review of request, tenders and contracts
Subcontracted work
- include in review
Notify customer
- any deviation from the contract
Changes to contract
- follow some review process
- communicate changes to all personel
4.5 Subtracting of tests and calibrations
- use cpetent subcontractor
(e.g laboratory complying to ISO/IEC 17025)
Customer Approval
- advise custumer in writing
- customer approval, preferably in writing
- subcontractor's work
(unless specified by customer or regulatory body)
Register of subcontractors
- records of subcontractors used with evidence on
compliance with ISO/IEC 17025
4.6 Purchasing service and supplies
Policy and procedures
- selection and purchasing of services/supplies that affect quality
- purchase, reception, storage of laboraory
reagents and consumables relevant to test
- inspect or verify reagents/consumables that
affect quality of test/calibration before use
- compliance to specified requirements
- maintain records
4.6 Purchasing services and supplies
Purchasing documents
- reviewed and approved for
technical content
Approved suppliers
- maintain list of suppliers
- records of evaluation of approved
4.7 Service to the customer
Willing to Cooperate
- clarification of customer's request
- monitor laboratory's performance of work
- confidentiality to other customers not
Customer feedback
- positive and negative
- analyzed to improve management system,
testing and calibration activities and
customer service
4.8 Compliants
Policy and procedures
- resollution of compliants froom customers and other parties
- maintain records on:
- compliants
- investigations
- corrective action
4.9 Control of nonconforming testing and/or calibration work
Policies and procedures
- for test/calibration work, or results not conforming
- procedures
- agreed requirements with customer
- responsibilities and authorities designated
- actions defined and taken
- evaluation of significance
- immedite corrective actions, with decision on
- notify customer and recall work, where necessary
- responsibility for authority to sume work
4.9 Control of nonconforming testing and/or calibration work
Corrective action procedure
- for non conforming work that:
- would recur
- there is doubt on compliance of laboratory's operations
4.10 Improvement
Contiually improve the effectiveness of the management system through:
- quality policy
- quality objectives
- audit results
- analysis of data
- corrective actions
- preventive actions
- management review
4.11 Corrective action
Policy, procedure and authority
- for implementing corrective actions on:
- nonconforming work
- departure from policies and procedures
Cause anaysis
- determine root cause(s) of problem
election and implemention
- identify the potential corrective actions
- select action most likely to eliminate problem
- action selected appropriate to magnitude and risk
of problem
- document and implement required changes
4.11 Corrective action
- to ensure effectiveness

Additional audits
- affected areas audited when in doubt
of compliance to:
- policies and procedures
- ISO/IEC 17025
4.12 Preventive action
- Needed improvements
- Potential sources of noncomformities
Action plans
- developed
- implemented
- monitored
- shall include:
- initiation of action
- application of controls to ensure
4.13 Control of records
Procedures for control of quality and technical records.
- identification
- collection
- indexing
- access
- filling
- storage
- maintain
- disposal
4.13 Control of records
Record intergrety
- legible
- readily retrievable
- protected from damaged, deterioration and loss
- establish rentention time
- secured and in confidence
Procedures for electronically-stored records
- protection and back-up
- prevention of un authorized access or
4.13 Control of records
Technical records
- ratain records of:
- original observations
- derived data
- information to establish audit
- staff records
- copy of test/calibration certificate
4.13 Control of records
Technical records
- sufficient information to:
- identify factors affecting uncertainty
- allow repeat of tests under identical
- identity of personnel responsible in:
- sampling
- performance of test/calibration
checking of results
4.13 Control of records
- observations, data, calculations recorder at
the time they are made
- identifiable to specific tasks
Correction to records
- erasure, deletion or obscuring records not
- mistake is crossed out, and correct value
entered alongside.
- alterations signed/initialed by person
making correction
- equivalent measures for electronically
stored records
4.14 Internal Audits
- Conducted in accordance with:
- predetermined schedule
- procedure
- conducted to verify operations comply with:
- management system
- ISO/IEC 17025
- Address all elements of the management
- Responsility of the Quality Manager
- Conducted by:
- trained and qualified personnel
- personnel independent of activity to be
4.14 Internal Audits
Timely corrective action
- doubt on effectiveness of operations
- doubt on correctness or validity of results
Notify customers
- if laboratory result may have been affecyed
- area audited
- audit findings
- corrective actions
Follow-up audits
- verify and record
- implementation of corrective action
- effectiveness of corrective action
Effects of Nonconformities
Cause a breakdon of the Quality System
May invalidate results of test and calibration
No breakdown of systems nor invalidation of test and calibration result
Isolated lapses in implementation
Nonconformities - Examples
Accomodation is such that serious cross contamination of samples cannote be prevented
Laboratory cannot ascertain which items are being used as reference standards
Internal audit and and management review was not conducted within the last 12 months
Laboratory identified a serious error in calibration record but did not notify client of erroneous results
Reciept of a significant number of compliants which are not being acted upon
Minor Nonconformities - Examples
An obsolete procedure is found on an analyst's table. Documented is not marked "Controlled Copy" nor marked "OBSELETE"
Two pages of a distributed proceedure were not signed by approving authority
One entry in the Job logbook indicated only the month and year sample was recieved, but not the day
Corrections to a record in testing used a correcction fluid
A Red Tag attached to the mass balance did not bear the end-users signature
4.15 Management review
- conducted in accordance with:
- predetermined schedule
- procedure
- Conducted to:
- ensure continuing suitability
- ensure effectiveness
- introduced necessary changes or improvements
- Review :
- laboratory's management system
- testing/calibrationactivities
- Conducted by :
- laboratory's top management
4.15 Management review
Review takes account of:
- suitability of policies and procedures
- reports from the managerial and supervisory
- outcome of recent internal audit
- corrective and preventive actions
- assessments of external bodies
- results of interlaboratory comparisons
proficiency testing
- changes in volume and type of work
- customer feedback
- complaints
- reccomendations for improvement
- other relevant
4.15 Management review
Findings and actions
- recorded
- actions carried out within the appropriate
and agreed timeframe
Overview of :
ISO/IEC 17025
Technical Requirement

5.1 General
Factors affecting correctnes and reliability
- human factors
- accomodation and environmental
- test and calibration methods and methods
of validation
- equipment
- measurement trace ability
- sampling
- handling of test and calibration items
Account these factors in the:
- development of test and calibration
- training and qualification of personel
- selection of equipment to be used
- calibration of equipment
5.2 Personnel
Ensure competence of personnel
- Operate specific equipment
- Perform test/calibration
- Evaluate results
- Sign test/calibration certificates
Qalification to perform specific tasks
- Education
- Training
- Expirience and/or demonstrated skills
5.2 Personnel
Training policy and procedure
- identify training needs
- provide training
- relevant to present and future task of laboratory
- evaluate effectiveness of training actions
- Personnel employed or under contract
- contracted personnel:
- supervised
- competent
- work in accordance with the management system
5.2 Personnel
Job Description
- managerial
- technical
- key support personnel
Authorized personnel
- perform sampling
- perform test/calibration activities
- issue test/calibration certificates
- give opinions and interpretations
- operate particular types of equipment
5.2 Personnel
Personnel Record
- contains:
- authorization/s (include date confirmed)
- competence (include date confirmed)
- educational and professional qualification
- training, skills and experience (technical
- include contracted personnel
- readily available
5.3 Accomodation and Environmental conditions
- facilitate correct performance of test/calibration
- ensure environmental conditions do not nvalidate
- document technical requirements for accomodation
and environmental conditions that can affect results
Environmental Conditions
- monitored, controlled and recorded if:
- specifications
- methods and procedures
- have influence on quality of results
- test/calibration stopped when these jeopardize
5.3 Accomodation and Environmental condition
Incompatible activities
- effective separation of areas

Controlled access and use
- areas that affect quality of test/calibration

- adequate measures
- special procedures where necessary
5.4 Test and calibration methods and method validation
Method and procedures
- appropriate to test/calibration within scope
- includes:
- sampling
- handling
- transport
- storage
- preparation of test/calibration items
- estimation of uncertainty of measurement (where
- statistical techniques in analysis (where
- all instructions, standards, manuals, reference, data
- kept up to date
- readily available to personnel
5.4 Test and calibration methods
Method deviations
- documented
- technically justified
- authorized
- accepted by customer
5.4 Test and calibration methods and method validation
Method selection
- meet needs of customer
- appropriate for the test/calibration
- prefer use of international, regional or national
- use latest edition unless not appreciate or possible
- to ensure consistency, supplement standard methods
when necessary
- confirmed capability to use standard method
- inform customer
- of method selected if he does not spefy
- if his proposed method is inappropriate or
5.4 Test and calibration methods and method validation
Laboratory-developed methods
- planned activity
- plans updated
- effective communication among involved personnel
- assigned to qualified personnel
- adequate resources
Non-standard methods
- subject to agreement with customer
- clear specification of customer's requirement
- identify purpose of test/calibration
- appropriately validated before use
5.4 Test and calibration methods and method validation
Method validation
- validate to confirm fitness for intended use:
- non-standard methods
- laboratory-designed/developed methods
- standard methods used outside intended scope
- amplifications/modifications of standard
- record:
- results obtained
- procedure used
- statement whether fit for intended use
- range and accuracy of values relevant to
customer's needs
5.4 Test and calibration methods and method validation
Uncertainty of measurement
- calibration laboratories or testing laboratories
performing own calibration:
- procedure to estimate uncertainty of
measurement for all calibration activities
- testing laboratories
- document and implement procedure to
estimate uncertainty of measurement
- clear reporting of uncertainty of measurement
- account important components in the estimate
using appropriate methods of analysis
5.4 Test and calibration methods and method validation
Calculations and data transfer
- subject to systematic checks
Computers and automated equipment
- document and validate er-developed softwae
- established and implemment procedures to
protect data integrity and confidentiality in:
- data entry or collection
- data storage
- data transmission
- data processing
- maintain to ensure proper functioning
- provide appropriate environmental
5.5 Equipment
Sampling, Measurement and Test Equipment (including software)
- available
- capable of achieving required accuracy
- comply with specifications required of test/calibrations
- calibration programs established for key quantities
- calibrated or checked before placed in service
- operated by authorized personnel
- available updated operation and maintenance manual
- uniquely identified, when practicable
Equipment outside permanent control
- comply with ISO/IEC 17025 requirement
5.5 Equipment
Records maintained
- identity of equipment and software
- manufacturer's name, type identification, serial no.
- checks that equipment complies with specification
- current location, where appropriate
- manufacturer's instruction (manual), if available
- calibration history (dates, calibration certificates,
adjustments, acceptance criteria, due date of next
- maintenance plan where appropriate, maintenance
records carried to date
- damage, malfunction, modification or repair
5.5 Equipment
- safe handling
- transport
- storage
- use
- planned maintenance
Equipment taken out of service
- Equipment that:
- subjected to overloading or mishandling
- give suspect result
- shown to be defective
- outside specified limits
- isolated and clearly labeled to prevent use
- examine effect of defect/departure
- institute "control of nonconforming work"
Use a Red Tag to signify unfit for use.
ISO/IEC 17025

Equipment that has been subject to
overloading or mishandling, give suspect results, or has been shown to be defective or outside specified limits, shall be taken out of service.
5.5 Equipment
Calibration status
- identified, including
- date last calibrated
- date of expiration (calibration due)
- documented procedure to carry out
intermidiate checks
Return to service
- check function before ping back of service
- documented procedure to carry out checks
Correction factors
- procedures to ensure updating
- safeguard from adjustments, both hardware
and software
5.6 Measurement traceability
Calibration program and procedure
- all equipment having an effect on validity of
- all equipment before putting into service
Calibration laboratories
- calibration traceable to SI units
- if not possible, then traceability to
appropriate measurement standards, e.g.
1. Certified Reference Materials (CRM)
2. Agreed methods/consensus standards
- participation to suitable interlaboratory
5.6 Measurement traceability
Testing laboratories
- same requirements as calibration laboratories.
- unless calibration contributes little to
uncertainty of measurement needed.
Reference Standards
- program and procedure for calibration
- traceable calibration
- use for calibration purposes
- calibrated before and after any adjustments
Reference Materials
- traceable to SI unit or CRM
- internal reference materials checked, as
5.6 Measurement traceability
Intermediate checks
- defined procedures and schedules
- reference standards
- primary standards
- transfer or working standards
- reference materials
Prevent contamination/deterioration
Protection of integrity
Procedure for
- safe handling
- transport
- use
5.7 Sampling
Plan and procedures
- available at the location
- based on appropriate statistical methods
- control factors to ensure validity of results
Deviations to documented procedure
- recorded
- included in documents containing results
- communicated to appropriate personnel
5.7 Sampling
- procedure on recording of relevant data and operations
- sampling procedure
- identification of samples
- environmental conditions (if relevant)
- diagram to identify sampling locations
- statistical basis of procedures

5.8 Handling of test and calibration items
- transport
- reciept
- handling
- protection
- storage
- retention and/or disposal
- include provision for
- protection of integrity
- protection of customer and laboratory
5.8 Handling of test and calibration items
- consistent in both items and records
- accomodate subdivision of groups of items
- retained from receipt to disposal
- record abnormalities or deficiencies of items
- consult customer for further instruction when:
- in doubt to suitability of item
- item does not conform to description
- test/calibration requirement is not sufficient
- record discussions with customer
5.8 Handling of test and calibration items
- procedures and appropriate facilities to
- deterioration
- loss or damaged
- follow handling instructions
- arrangements for protection and
- maintain, monitor and record special
environmental conditions, as required
5.9 Assuring the quality test and calibration result
- monitor validity of tests and calibration

Records made
- enable to detect trends
- application of statistical techniques in
reviewing results
5.9 Assuring the quality of test and calibration results
Monitoring examples
-use of CRM or secondary reference material
- participation in interlaboratory comparison or
proficiency testing program
- replicate using same or different methods
- retesting or recalibration of retained items
- correlation of results
Quality Control Data
- analyzed and take appropriate action action when found
outside predefined criteria
- planned action
- correct the problem
- prevent reporting of incorrect result
5.10 Reporting the results
Test reports and calibration certiicates
- accurate, clear, unamigous anobjective
- in accordance with specific instructions in
- include information:
- requested by customer
- necessary for interpretation of results
- required by method used
- may be simplified
- for internal customers
- written agreement with customer (external)
- information not reported is readily available
5.10 Reporting the result
Required content of Test/Calibration Certificates
- title
- name and address of laboratory
- location, when conducted different from address
- unique identification of test/calibration certificate
- certificate ID (identification that page is part)
- page number (identification that page is part)
- number of pages (provide clear indication of end)
- name and address of customer
- method used

5.10 Reporting the results
Required content of Test/Caibration Certificates
- description, condition, identification of item
- date receipt, when critical and date of
- sampling plan and procedures, where relevant
- results with units of measurements, where
- authorized signatory (name, function, signature)
- statement "result relate only to items tested"
5.10 Reporting the
Content of Test Certificates - Additional
- include
- deviations, additions,exclusions in test methods
- specific test condition
- compliance to specification, where relevant
- estimated uncertainty of measurement, when
- relevant to validity of application
- required by customer
- it affects compliance to specificationds
- opinions and interpretations, where appropriate and
- additional information required by
- specific method
- customer or group of customers
5.10 Reporting the result

Content of Test Certificates - Additional for Sampling
- Sampling date
- identification of item sampled
- location of sampling including
- diagrams
- sketches
- photographs
- reference to sampling plan and procedures
- environmental conditions during sampling
- standard or specifications used including
- deviations
- additions
- exclusions

5.10 Reporting the result
Content of Calibration Certificates - Additional
- conditions during calibration
- uncertainty of measurement or statement of compliance
- traceability of measurements
- relate only to quantities/results of functional tests
- if reporting statement of compliance
- identify clause of specification
- retain measurement results
- consider uncertainty of measurement
- report result before and after adjustments/repair
- NO recommended calibration interval, unless
agreed with customer

5.10 Reporting the
Opinions and interpretations
- document the basis
- clearly marked as such in certificates
Test/Calibration reports from subcontractors
- Test certificates
- may contain subcontractor results
- results are clearly identified as subcontractor's
- Calibration certificates
- issue subcontractor's certificate
Electronic transmission of reports
- meet requirements of ISO/IEC 17025
What is Accreditation?
"Procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks"
- ISO/IEC Guide 2:1996
Key words: "competent" "specific tasks"
"Third-party attestation related to a conformity assesment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks"
- ISO/IEC 17011:2004
Recognition of Competence
Laboratory accreditation provides formal recognition to competent laboratories, thus providing a ready means for customer to identify and select reliable testing measurement and calibration services
To maintain this recognition, laboratories are re0evaluated periodically by the accreditation body.
The laboratory is also required to participate in relevant proficiency testing program between reassessments, as a further demonstration of technical competence
Scope of Laboratory Accreditation
Usually expressed in various combinations of:
1. Products (e.g. specific electrical appliances)
2. Parameters (e.g. volts, ohms etc)
3. Ranges (e.g. -40 to 70 dergrees)
4. Accuracy (best measurement capability or uncertainty of measurement)
5. Type of test (electrical safety test)
6. Test specification (IEC .......)
Laboratory Accreditation System
The accreditation system involve:
1. A group of competent people operating the system
2. An organization with proper structure to ensure impartiality
3. A set of rules and regulation
4. Access to the expertise needed for conducting assessments
5. Linkage to the internationally recognized metrology standards
6. Access to Proficiency Testing programmes
Essence of Laborator Accreditation
To evaluate the technical competence of laboratory
- Competent personnel
- Adequate equipment and calibration/verification
- Sampling and control of testing items
- Validity of testing methods
- Environment and facilities
To evaluate the effectiveness of the quality management system
- Management commitment and clear quality objectives
- Documented Quality System to fulfill the quality objectives
- continous improvement mechanism
Benefits of Laboratory Accreditation
Formal recognition of competence that leads or may lead to international acceptance
Improve organizational effectiveness and efficiency
added assurance to customers, and the public, in terms of quality, reliability, credibility and consistency
Benefits of Laboratory Accreditation
Stratetigic support to ISO 9001-certified customers and other export oriented customers
Gain competitive advantage over unaccredited laboratories
Win customer's confidence
Obtain outside check of internal quality system
Laboratory Accreditation bodies in the world
International Partnership
in Laboratory Accreditation
Philippine Accreditation Office
formerly BPSLS

Bureau of Product Standards Laboratory Accreditation Scheme
Philippine Accreditation Office
Functions :
National Accreditation Body of the Philippines for Conformity Assesment and related bodies
To run accreditation schemes for conformity assesment bodies (e.g testing, inspection certification) in the Philippines
To achieve signatory status in regional/international Mutual or Multilateral Recognition Arrangements (MRA) to facilitate entry of Philippine goods and services into importing countries
Philippine Accreditation Office
Scope of Service :
Systems and Product Accreditation
- ISO 9001, ISO 14001, HACCP, Product Certification,
Personnel Certification, Information Security
Laboratory Accreditation
- Testing, Calibration, Medical Testing, Inspection
Bodies, Proficiency Testing, Reference Materials
Philippine Accreditation Office
- Laboratory Accreditation -
Existing scheme covers accreditation of:
testing and calibration laboratories

testing laboratories

calibration laboratories
Philippine Accreditation Office
- Laboratory Accreditation -
Fields of accreditation:
Biological testing
Chemical testing
Electrical testing
Mechanical testing
Philippine Accreditation Bureau
- Laboratory Accreditation -
Status of international membership:
Asia Pacific Laboratory Accreditation Cooperation
member since November 1996
signatory to APLAC-MRA since November 2005
International Laboratory Accreditation Cooperation
member since September 1996
signatory to ILAC-MRA since November 2005
PAB Authority
DTI DAO 13:1995.
"Revised Rules for BPS Scheme on Accreditation of Testing and Calibration Laboratories"

Republic Act No. 9236.
"National Metrology Act of 2003"

SEC 13.
Accrediting Body - The laboratory accrediting
body attached to the Department of Trade and
Industry (DTI) is hereby stregthened and
recognized under this Act as the national
accreditation body.
Change of BPSLAS
to PAB
DTI DAO04:2006.
"Transfer of the Accreditation Functions from the Bureau of Product Standards to the Office of the Undersecretary of the Consumer Welfare and Trade Regulation Group"
(11 April 2006)
- in conpliance with ISO/IEC 17011:2004 to maintain
signatory status with APLAC and ILAC Mutual
Recognation Arrangement (MRA).
Basis of Operation
ISO/IEC 17011:200
4 Conformity Assesment - General requirements for accreditation bodies accrediting conformity assessment bodies

Criteria for Accreditation
- PNS ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
- PAB Guidance Documents
- PAB Supplementary Requirements
PAB Guidance Documents
GD 01 "PAB Accreditation"
GD 02 "Guidelines for the use of Logo and Laboratory Reference
to PAB Accredited status"
GD 03 "Guideline on Traceability of Measurements"
GD 04 "Guidelines on Participation to Proficiency Program"
GD 05 "Guidelines on Measurements Uncertainty"
GD 06 "Guidelines on Grading of Non-conformities"
GD 07 "Guidelines for laboratory Staff and PAB Approved
GD 08 "Code of Ethical Standards"
GD 09 "Class of Test Structure - Chemical Testing"
GD 10 "Class of Test Structure - Biological Testing
PAO Guidance Documents
GD 11 "Class of Test of Structure - Mechanical Testing"
GD 12 "Class of Test of Structure - Construction Materials"
GD 13 "Class of Test of Structure - Electrical Testing"
GD 14 "Class of Test Of Structure - Metrology
GD 15 "Internal Audits for Laboratories"
GD 16 "Management Review for Laboratories"
GD 17 "Guidelines on Stating Tests Calibration Results and
Reporting of Compliance with Specification"
*Not yet available at this time
PAB Supplementary Requirement
SR 01 "Supplementary Requirements for Accreditation in
the field of Chemical Testing"
SR 02 "Supplementary Requirements for Accreditation in
the field of Biological Testing"
SR 03 "Supplementary Requirements for Accreditation in
the field of Electrical Teststing
SR 04 "Supplementary Requirements for Accreditation in
the field of Mechanical Testing"
SR 05*, SR 06*
SR 07 "Supplementary Requirements for Accreditation in
the field of Calibration"
*Not yet available at this time
PAB Accreditation Procedure
PAB Application Requirements
1. Application for Assessment (LASF 02)
2. Acceptance of Accreditation Conditions (LASF 34)
3. Laboratory Assessment Checklist (LASF 06-2)
4. Application for Signatory Approval (LAS 03)
5. Assessor's Briefing (LASF 04)
- laboratory staff organization chart
- equipment calibration certificates
- sample register page
- reports/certificates with associated workbook/sheet records
- inter laboratory comparison/proficiency testing result
- internal audit reports and corrective action records
- management review records
6. Quality Manual and related documentation
Application for Accreditation
Acceptance of Accreditation Condition
Laboratory Assessment Checklist
Application for Signatory Approval
Assessors Briefing
Key Players in the Application
Authorized Representative
- A person nominated by an applicant or accredited laboratory in all matters relating to the accreditation.
- This person is the official contact of the laboratory

Approved Signatory
- A laboratory personnel nominated by the laboratory competent to evaluate test test result critically and occupying a position involving responsibility for adequacy of test results.
PAO Grading of Nonconformity Findings for Corrective Action
Highly significant
: credibility of accreditation is seriously threatened resulting to suspension of accreditation.
: corrective action must be completed at a specified time frame before accreditation is granted
: isolated nonconformities not affecting result of test or calibration
: areas for improvement
Corrective Actions must be submitted within
1 month
from date of assessment
PAB Accreditation Logo
PAB Accreditation Fees
Application Fee
P 300
(non refundable)

- Assessment Fees

On-site assessment P 500 per man-hour
Document review P 4,000 per applicant

- Accreditation Fee
P 5,000 per field of accreditation

- Annual Accreditation Fee
P 3,000 per field of accreditation
Accreditation Criteria
Documented system based on PNS ISO/IEC 17025

Implement laboratory management system in accordance with PNS ISO/IEC 17025
Participates in proficiency testing.

Complies with conditions for accreditation; PAO supplementary requirements and guidance documents

Pays all fees
one standard,
one test,
accepted everywhere.
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