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17025 Quality System
Overview: Quality Systems
For an organisation to be accredited it must be seen and be

proven by independent assessment to be working to a system.
The international standard for this system is
ISO 17025.
ISO 17025 covers all the individual topics, section by

sections for the complete operation of a laboratory. The
standard is split into two parts
1: covering Management Requirements

2: covering Technical Requirements
Key Elements For

Accredited
Laboratories
Quality manual to ISO17025
Environmentally
Controlled Laboratory
Head of Laboratory responsible for the operation
of the laboratory with a good understanding of
measurement procedures, the operation of the
equipment and the quality system.
Quality Manager must be assigned
Traceable Reference standards with calibration
history.
Measurement procedures with uncertainty
budgets.
Quality Manual to ISO17025

Must
address all aspects of Management Requirements

required by 17025 standard.
Organisation (4.1)
Quality system (4.2)
Document control (4.3)
Review of requests, tenders and contracts (4.4)
Sub-contracting of tests and calibrations (4.5)
Purchasing services and supplies (4.6)
Service to the client (4.7)
Complaints (4.8)
Control of non-conforming testing and/or calibration work (4.9)
Corrective Action (4.10)
Preventive action (4.11)
Control of records (4.12)
Internal audits (4.13)
Management review (4.14)
Quality Manual to ISO17025:- Management Requirements
Organisation - 4.1 : Topics to be covered

Name
of laboratory or organisation which

is legally responsible
Activities conforming to relevant standards
and guidelines
Permanent or mobile facilities
Organisation membership
Quality System - 4.2 : Topics to be covered

Scope
of quality system
and guidelines
Reference to quality policy statement
Supporting systems such as procedure and
software
Title responsible for ISO17025
conformance
Document Control - 4.3 : Topics to be covered

Approval
and review of documentation

and guidelines
Location of documentation
Review / update / obsolescence policies
Access control & backup of
documentation
RECOMMENDATION : USE MASTER DOCUMENT
LIST

Example Controlled Documents List
INTERNAL DOCUMENTS
Laboratory Procedure Manual
Laboratory Quality Manual
Apparatus Inventor
Approved Sub Contractor
Approved Supplier
Calibration Request Form
UKAS Complaints Form
ProCal Software Manual
ProCal-Track Software Manual
Skills Matrix
Training Log
Approved Signatory List
Schedule Of Accreditation
Accreditation Certificate
EXTERNAL DOCUMENTS
UKAS M4
ISO17025
UKAS M3003
URN 98/887
UKAS Lab 1
UKAS Lab 3
UKAS Lab 5
Review of Contracts - 4.4 : Topics to be covered
Procedure for the review of requests, tenders and contracts

Defining and documenting methods to be used
Capability and resources to meet the requirements.
The appropriate test and/or calibration method is selected
and capable of meeting the clients requirements
Maintaining records of reviews and any significant
changes .
Reviews on sub-contracted by the Laboratory
Informing clients of any deviation from their contracts.
Procedure if contract needs amending after work has
commenced
Sub-contracting work - 4.5: Topics to be covered

Laboratory
policy on sub contracting work

Informing customer of sub contracted work
Responsibility for sub contracted work
Register of approved sub contractors
Purchasing - 4.6: Topics to be covered

Laboratory
policy on purchasing
Checking of supplies critical to calibration work
Checking / reviewing of purchasing documents
Approved suppliers list
Service to the Client - 4.7: Topics to be covered

Policy
of the laboratory to cooperate with

customers and to verify the work performed and
ensure confidentiality
Complaints - 4.8: Topics to be covered

Policy
for the resolution of complaints and the

maintenance of records
RECOMMENDATION : USE TEMPLATE

COMPLAINTS FORM TO RECORD BOTH
COMPLAINT AND ACTION TAKEN
Non Conforming Work - 4.9: Topics to be covered

Actions
taken by the laboratory in the event of

non conforming work, including informing the
customer, evaluating the significance and halting
work.
Corrective Action - 4.10: Topics to be covered

Cause
analysis
Selection and implementation of corrective
action
Monitoring of corrective action
Preventative Action - 4.11: Topics to be covered

Policy
on improvement via management review

process
Action plan to implement and monitor
preventative actions
Control of records - 4.12: Topics to be covered

Policy
on storage and accessibility of records

Technical data storage, including original
observations, derived data and sufficient
information to establish an audit trail, calibration
records, staff records and a copy of each
Calibration Certificate issued for six years.
Updating / correction of records
Internal Audits - 4.13: Topics to be covered

Schedule
of internal audits, including persons

responsible
Actions taken when audits cast doubt on
effective laboratory operation
Policy on recording results of audit, and
corrective actions
Follow up of effectiveness of corrective actions
RECOMMENDATION : USE SCHEDULE TO AUDIT
ALL SECTIONS OF LABORATORY OVER A ONE
YEAR PERIOD TO SPREAD WORKLOAD
THROUGHOUT THE YEAR.
Management Review - 4.14: Topics to be covered

Meeting
of upper management to review key

aspects of the quality system and calibration
activities
Record of management review meetings and
actions that arise

Must
address all aspects of Technical

Requirements required by 17025 standard.
General (5.1)
Personnel (5.2)
Accommodation and environmental (5.3) conditions
Test and calibration methods and method validation (5.4)
Equipment (5.5)
Measurement traceability (5.6)
Sampling (5.7)
Handling of test calibration items (5.8)
Assuring the quality of test and calibration results (5.9)
Reporting the results (5.10)
Quality Manual to ISO17025:- Technical Requirements
General 5.1: Topics to be covered
Relevant factors effecting the reliability of

calibrations including
1.
Human factors;
Accommodation and environmental conditions;
Calibration methods and method validation;
Equipment;
Measurement traceability
The handling of calibration items.
2.
3.
4.
5.
6.
These factors have been taken into account at all

levels in the operation of the laboratory
Personnel 5.2: Topics to be covered

Management
to ensure competence of staff to

perform the work in the laboratory, and also to
ensure supervision of training.
Only
senior members of the organisation who are

directly employed to work in laboratory
Job
descriptions for both Laboratory staff and
key support staff.
Skill
matrix and Training logs
Accommodation 5.3: Topics to be covered
General description of the laboratory, including size, lighting &

ventilation, work areas etc.
Work is carried out in the laboratorys under strict environmental

control. Temperature, humidity, mains voltage and frequency are
monitored and recorded. It must also be stated that work in the
laboratory will be ceased in the event of a failure in environmental
control.
The separation of the Laboratory from the rest of the company is

adequate to provide a stable environment
Access to the laboratory only to approved staff.
A General statement about the tidiness of the laboratory and the location
of standards used.
Methods & Validation 5.4: Topics to be covered
The use of standard methods and procedures which meet requirement of

UKAS, and relevant data needed is available and kept up to date
The Method used to select the calibration procedure is required to be in the

manual, the method must meet the needs of the customer, unless the
laboratory does not feel that the procedure required by the customer is
correct, then they should be informed. When the method is not specified the
procedure should follow International or National standards.
A method to cover the development of a non standard procedure subject to

the clients agreement must also be covered in the manual
The requirements for the validation of a procedure must also be covered.

This will include calibration using reference standards, comparison of
results achieved with other methods, inter-laboratory comparisons,
systematic assessment of the factors influencing the result & assessment of
the uncertainty of the results based on scientific understanding of the
theoretical principles of the method and practical experience.
Uncertanties 5.4.6: Topics to be covered
The use of the principles laid out in UKAS document

M3003 (always the latest edition) are used to estimate
both random and systematic uncertainties. The method
applies to all measurements, whether made internally or
taken from external measurements by an outside body
and added to internal measurements.
NOTE
it is not required to show uncertainties

calculations here, all that is required is to state
the policy to use M3003.
Control of Data 5.4.7: Topics to be covered

How Calculation's on data and data transfer to a certificate for
example is checked:
This is normally dealt with by appointing a second person to
double check unless the calculation is simple
If computers are used how validation, documentation &

protection of data are performed.
A: All programs are verified by comparing results obtained
against readings taken manually.
B: Version numbers of programs used are kept
C: Master copies of all data on CD are kept
Equipment 5.5: Topics to be covered
Equipment capable to support the scope of accreditation.
Calibration programme to providing traceability to National Standards. Before any

equipment is placed into service in the Laboratory it is checked and calibrated.
The staff allowed to use equipment
Identification of equipment.
Label all equipment using a laboratory asset number with full details
Storage of records, documents and certificates for equipment

Keep all records manuals etc in a storage file in laboratory office
Action if equipment is suspected faulty/damaged

Remove from use, inform any client whos work may have been effected.
Measurement Traceability 5.6: Topics to be covered
Calibration program in section 5.5 gives traceability to national and

international system of S.I. Units through the use of UKAS laboratories.
Reference standards used only for calibration.
Inter comparison between laboratories own equipment and also any other
laboratories: An internal schedule which supplements the external
program may be drawn up to verify correct performance of key
equipment, the frequency of inter comparisons can only be drawn
from experience and the usage of a instrument.
Arrangements for the transporting of reference standards for external cal:

for example carried by hand or correctly packaged to prevent
damage and protect their integrity
Handling Equipment 5.8: Topics to be covered

Describe
How
the goods in/despatch system
are customers instruments identified
Recording
of condition upon receipt and

informing customer of damage
Precautions
taken to prevent deterioration or

damage to the calibration or test item during
storage
Assuring Quality 5.9: Topics to be covered

Random
calibration checks on clients results will

be made by independent measurement techniques
Results
of the quality control checks and internal

audits reviewed in the Management Review.
Participate
in inter-laboratory comparison or
proficiency testing programmes as required by
UKAS.
Reporting Results 5.9: Topics to be covered
The laboratories policy on reporting results is to issue the client

with an unambiguous and legible certificate that meets the
requirements of UKAS and ISO 17025 and provides all of the data
requested by the client.
How and when certificate and labels are printed, checked and
signed, and how can sign.
Note: The details on a test report are different from a calibration
certificate details which follow:-
Reporting Results 5.9: Topics to be covered

A calibration certificate must detail
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
A title (e.g. Test Report or Calibration Certificate);

Name and address of the Laboratory:
Unique identification of the certificate (such as the serial number), and
on each page an identification:
The name and address of the client;
Identification of the method used;
An unambiguous identification of the item :
Date of receipt of the item and the date of the test or calibration;
Reference to the sampling plan and procedures used by the Laboratory:
Calibration results with, where appropriate, the units of measurement;
Name, function and signature of person authorising the certificate:
Where relevant a statement to the effect that the results relate only to
the items tested or calibrated.
The conditions ( environment )
Uncertainty of measurement
Summary
This
course has covered all topics in the

ISO17025 quality system and shown the
requirements to be meet in operating a
laboratory.
To further
develop an understanding the standard

itself should be studied along with the template
quality manual which can be customised to
produce your own manual.
Please
feedback to us any comments on this

training session
Where to Get More Information

BSI
or other National Standards Institutions

UKAS
Internet
NPL web site

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17025 Quality System

Overview: Quality Systems

For an organisation to be accredited it must be seen and be

The international standard for this system is

ISO 17025 covers all the individual topics, section by

1: covering Management Requirements

Key Elements For

Quality Manual to ISO17025

address all aspects of Management Requirements

Quality Manual to ISO17025:- Management Requirements

Organisation - 4.1 : Topics to be covered

of laboratory or organisation which

Quality Manual to ISO17025:- Management Requirements

Quality System - 4.2 : Topics to be covered

Quality Manual to ISO17025:- Management Requirements

Document Control - 4.3 : Topics to be covered

and review of documentation

Quality Manual to ISO17025

Quality Manual to ISO17025:- Management Requirements

Review of Contracts - 4.4 : Topics to be covered

Procedure for the review of requests, tenders and contracts

Quality Manual to ISO17025:- Management Requirements

Sub-contracting work - 4.5: Topics to be covered

policy on sub contracting work

Quality Manual to ISO17025:- Management Requirements

Purchasing - 4.6: Topics to be covered

Quality Manual to ISO17025:- Management Requirements

Service to the Client - 4.7: Topics to be covered

of the laboratory to cooperate with

Quality Manual to ISO17025:- Management Requirements

Complaints - 4.8: Topics to be covered

for the resolution of complaints and the

RECOMMENDATION : USE TEMPLATE

Quality Manual to ISO17025:- Management Requirements

Non Conforming Work - 4.9: Topics to be covered

taken by the laboratory in the event of

Quality Manual to ISO17025:- Management Requirements

Corrective Action - 4.10: Topics to be covered

Quality Manual to ISO17025:- Management Requirements

Preventative Action - 4.11: Topics to be covered

on improvement via management review

Quality Manual to ISO17025:- Management Requirements

Control of records - 4.12: Topics to be covered

on storage and accessibility of records

Quality Manual to ISO17025:- Management Requirements

Internal Audits - 4.13: Topics to be covered

of internal audits, including persons

Quality Manual to ISO17025:- Management Requirements

Management Review - 4.14: Topics to be covered

of upper management to review key

Quality Manual to ISO17025

address all aspects of Technical

Quality Manual to ISO17025:- Technical Requirements

General 5.1: Topics to be covered

Relevant factors effecting the reliability of

These factors have been taken into account at all

Quality Manual to ISO17025:- Technical Requirements

Personnel 5.2: Topics to be covered