CHEMPRO

ISO/IEC 17025
Awareness
 ISO
CHEMPRO

INTERNATIONAL ORGANIZATION ON
STANDARDIZATION

IEC
INTERNATIONAL
ELECTROTECHNICAL COMMISSION

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CHEMPRO

“ISOS [EYE-SOH]”
EQUAL

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 Structure of Accreditation and
CHEMPRO
Certification systems
International Organization on Standardization, ISO
National Standards Formulating Body
International Electrotechnical Commission, IEC

QMS, EMS
International Accreditation

Compliance to Compliance to
ISO/IEC 17021 Certifying Body ISO 9001 14001

ISO 22000
Forim, IAF

Compliance to Compliance to
[HACCP] Certifying
ISO/IEC 17021 ISO 22000
Body
National Accreditation Body

Compliance to
Compliance to Product Certifying
Product
Recognized ISO/IEC 65 Body
as Standards
compliance
to ISO/IEC Compliance to Data Protection Compliance to
17011 ISO/IEC 17021 Certifying Body ISO 27006
International Accreditation

Compliance to Testing/Calibration
Conference, ILAC

ISO/IEC 17025 Laboratory Good Practices

Raw Materials
Compliance to and products
Inspection Bodies
ISO/IEC 17020

4
Compliance to Medical Testing
ISO/IEC 15189 Laboratory
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International Bureau of Weights and Measures, BIPM National Methodology Institute, NMI
 Why become an accredited laboratory?
CHEMPRO

o Recognition of competence
Quality oriented organization

o Benchmark for performance

Manufacturing organization uses laboratory
accreditation to ensure testing of their product is done
correctly.
o Marketing strategy
• Effective tool for testing, calibration, and
measurement.
• Recognition of technical competence at national
and international levels.
• Promotion, publication in directories
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 Management Requirements
CHEMPRO

4.1 Organization 4.9 Control of Non-

Conforming Testing
4.2 Management System 4.10 Improvement

4.3 Document Control

4.11 Corrective Action
4.4 Review of Request,
Tenders, and Contracts 4.12 Preventive Action

4.5 Subcontracting of 4.13 Control of Records

Tests and Calibrations

4.6 Purchasing Services 4.14 Internal Audits

and Supplies
4.15 Management Reviews
4.7 Service to Clients

4.8 Complaints
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 4.1 Organization
CHEMPRO

 Legally responsible

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 4.1 Organization
CHEMPRO

 Meet the requirements of the standard, regulatory authorities or

organization providing recognition and need of customer

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 4.1 Organization
CHEMPRO

 define organization and management structure

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 4.2 Management System
CHEMPRO

The term “management system” in this

International Standard means the quality,
administrative and technical system that govern
the operation of a laboratory

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 4.2 Management System
CHEMPRO

 Establish, implement and maintain appropriate

to scope and must assure quality of results

 Policies, systems, programs, procedures and

instructions
- appropriate to the scope
- documented
- communicated
- understood
- available
- implemented
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 4.2 Management System
CHEMPRO

 Quality Policy Statement

Purpose of the
management system
related quality

Commitment to good
professional practice
and quality service
to customers

Commitment to
compliance w/
ISO/IEC 17025

Issued under the

authority of the
top management

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 4.3 Document Control
CHEMPRO

QM
General
Procedure

Work Instructions

Instrument Procedure

Records
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 4.3 Document Control
CHEMPRO

Unique identification of
documents

Review, approve and

issue by authorized
personnel

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 4.4 Review of Requests, Tenders and
CHEMPRO Contracts

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 4.5 Subcontracting of Tests
CHEMPRO

 Unforeseen reasons: workload, further expertise

or temporary incapacity

 Continuing basis: permanent subcontracting,

agency or franchising arrangement

 Competent subcontractor

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 4.6 Purchasing Services and
CHEMPRO Supplies

 Selection of services and supplies

 Purchase and reception of services and supplies

 Storage of reagents and consumables materials

 Records
- verification or compliance to specification

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 4.7 Service to Client
CHEMPRO
Satisfaction

Criticism

Confidentiality
Clarify requests
Advice
Inform delays

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 4.8 Complaint
CHEMPRO

Policy and procedure

for the resolution of complaints received from
clients or other parties.
records of all complaints, investigations and
corrective actions

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 4.9 Control of Nonconforming Test
CHEMPRO

Policy and procedures to be implemented

when any aspect of its testing or the results
of this work, do not conform to its own
procedures or the agreed requirements of the
client.

Use Non-Conformance Report Form

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 4.10 Improvement
CHEMPRO

• Continually improve the effectiveness of

management system through the use of
- Quality policy
- Quality objectives
- Audit results
- Analysis of data
- Corrective and preventive actions
- Management Review

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 4.11 Corrective Actions
CHEMPRO

 Cause analysis to determine root cause

 Selection, implementation of corrective action
 Monitoring effectiveness of corrective actions
 Additional audit, where needed

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 4.12 Preventive Actions
CHEMPRO

 Identify
- needed improvement and potential
sources of nonconformities
 Action plan developed, implemented and
monitored

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 4.13 Control of Records
CHEMPRO

• Procedures for control of quality and technical

records
- identification, collection, indexing, access,
filing, storage, maintenance, disposal

• Legible, readily retrievable, retained for

established time, secure and confidence

• Procedure to protect and back-up records

• Requirement for alterations - revisions w/

change request 24

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 4.14 Internal Quality Audit
CHEMPRO

• To verify continuing compliance with MS

requirements and ISO/IEC 17025

• Audit procedure

• Periodic internal audits in accordance with

predetermined schedule

• Audit program address all elements of MS

including testing activities
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 4.15 Management Review
CHEMPRO

A formal evaluation by top management of the

status and adequacy of the quality system in
relation to quality policy and objectives

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 Technical Requirements
CHEMPRO

5.1. General 5.6 Measurement Traceability

5.2. Personnel 5.7 Sampling

5.3. Accommodation 5.8 Handling of Test and

and Environment Calibration

5.4. Test Methods and 5.9 Assuring the Quality of

Method Evaluation Test and Calibration
Results
5.5 Equipment
5.10 Reporting the Results

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 5.1 General
CHEMPRO

 Account factors affecting the correctness and reliability

of tests

- development of test and calibration methods and

procedures

- training and qualification of personnel

- selection and calibration of equipment

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 5.2 Personnel
CHEMPRO

• Personnel Competence
- Qualified on the basis of
* education, training, experience and/or demonstrated
skill
* all personnel including trainees are appropriately
supervised
• Employees
- employed or contracted
- contracted personnel supervised

• Job Descriptions

• Continuous improvement thru trainings

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 5.3 Accommodation and Environmental
CHEMPRO Conditions
Accommodation is the premises where the laboratory function are
carried out.

• Considerations
 Design and construction materials
 Space including storage
 Services and facilities
 Access and facilities
 Area for administrative duties

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 5.3 Accommodation and Environmental
CHEMPRO Conditions
The environment is the set of conditions that may influence the
test and/or measurement of results.

• Considerations
 Temperature and humidity
 Dust, biological sterility, chemical cleanliness
 Ventilation and fume extraction
 Noise levels and acoustics and ergonomics
 Vibration and radiation

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 5.3 Accommodation and Environmental
CHEMPRO Conditions
o Monitoring
 Monitoring, control and record environmental conditions
(where applicable)

o Access
 Control in office and laboratory areas
 People access, security and safety issues

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 5.4 Test Methods and Method
CHEMPRO Validation
 Method Selection

 Standard Method
 verified for use if to be introduced for the first time

 Non-standard Method
 validated prior to use
o Laboratory-designed/developed methods
o Standard methods used outside their intended scope
o Amplification and modification of standards method
o Customer-supplied method

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 5.5 Equipment
CHEMPRO

 Operation

All equipment and software required for all testing activities

o Available and functioning properly

o Capable of achieving required accuracy
o Comply with relevant specifications
o Calibration programs established for key quantities or values
of instruments

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 5.5 Equipment
CHEMPRO

 Operation

o Checked and/or calibrated before use

o Operated by authorized personnel
o Available updated instructions on use and maintenance
o Uniquely identified, where practicable

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 5.6 Measurement Traceability
CHEMPRO

 General
o Calibration procedure and program
o All equipment (newly installed or repaired) are calibrated
before put in service

“ A calibration certificate bearing an accreditation body logo

from calibration laboratory accredited to this International
Standard, for the calibration concerned is sufficient evidence
of the calibration data reported.”

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 Usual Path for Traceability of
CHEMPRO
Measurement

International Bureau of Weights and Measurement

(BIPM, Paris)

National Measurement Laboratory

(ITDI, CSIRO, NIST, etc)

PAO Accredited Calibration Laboratories

Laboratory reference equipment or artifacts

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 5.7 Sampling
CHEMPRO

 Sampling Procedure
 Competent Sampler
 Environmental condition
 Description of the sampling location
 Statistic (if relevant)

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 5.8 Handling of Test and Calibration
CHEMPRO Items
 Procedures
Transportation, receipt, handling, protection,
storage, retention and/or disposal, and
provisions for protection of test items

 Identification
System for identification of test items and
subsample both physically and in records

 Deficiencies
Record any abnormalities or deficiencies on
items received
Consult customer and record instructions for
non-conforming samples

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 5.9 Assuring the quality of test and
CHEMPRO calibration results

 The need for quality control procedures for

monitoring the validity of test

• Use of certified reference material

• Inter laboratory/proficiency testing
• Replicate testing

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 5.10 Reporting of Results
CHEMPRO

 Describes reporting of test results

 Clear and accurate results

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CHEMPRO

~END~

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