Training

What is Scope?
 Scope is the Summary of what the standard is actually going to
tell us. As a good practice, the first thing to be read in any
Standard must be the scope.

 Summarizing the summary of scope of ISO 17025 for quick

review.
“This standards provide the general requirement for the
competence to carry out Calibration and/or Testing by providing
guidelines for Management System of Lab which includes
Quality & Administration requirements and Technical as well.
This standard is used by First, Second & Third party
Laboratories for management setup and by the accreditation
bodies to check competency requirements of Labs.
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.
What ahead?
 From scope we realized. That our
standard is categorized into two main
parts.

 Management Requirements
 Technical Requirements
Breaking down
 All type of manuals ask for these basic
things.
 Policies
 Procedures
 Forms
 Record
 Where needed or where not, is clearly
mentioned in all clauses and in some
clauses it is put upto organization to
develop these requirements as an optional.
Clause 4 (What it is going to
cover ?)
 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)
Management Requirements
Organisation - 4.1 : Summarizing

 Name of laboratory or organisation

which is legally responsible. Legality
proof.
 Activities conforming to relevant
standards and guidelines. Accreditation
certificates
 Permanent or mobile facilities
 Organisation membership. Either part of
larger organization or independent .
Preventing lack of impartiality
Management System - 4.2
 Scope of management system to be
developed , implemented and maintained.
 Activities conforming to relevant standards and
guidelines
 Reference to quality policy statement
 Supporting systems such as procedure and
software
 Title responsible for ISO17025 conformance
 From 4.2.3 to 4.2.7 tells us how the
management should be and how the qualitu
maual should be written and how the
reffernces should me made in it.
Document Control - 4.3 : Topics to be covered

 Approval and review of documentation

 Activities conforming to relevant standards
and guidelines
 Location of documentation
 Review / update / obsolescence policies
 Access control & backup of documentation
 Formats,Developing,Tracing,
Reviewing, Modifying, Distributing. All
these should be clearly defined
Quality Manual to ISO17025:- Management Requirements
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
Quality Manual to ISO17025:- Management Requirements
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

Manual is clearly referring to policy that our organization should

have. We should have a procedure of how we do subcontracting.
Approved list of subcontractors as a record. And forms for
evaluation.
Quality Manual to ISO17025:- Management Requirements
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
Quality Manual to ISO17025:- Management Requirements
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
Quality Manual to ISO17025:- Management Requirements
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
Quality Manual to ISO17025:- Management Requirements
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
Quality Manual to ISO17025:- Management Requirements
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.
Quality Manual to ISO17025:- Management Requirements
Improvement- 4.10: Topics to be covered

 Policy on improvement via management

review process.
 Improvement through teaching quality
objectives, analysing audit results.
Quality Manual to ISO17025:- Management Requirements
Corrective Action- 4.11: Topics to be covered

 Cause analysis
 Selection and implementation of corrective
action
 Monitoring of corrective action
Quality Manual to ISO17025:- Management Requirements
Control of records - 4.13: 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
Quality Manual to ISO17025:- Management Requirements
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
Quality Manual to ISO17025:- Management Requirements
Management Review - 4.15: 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
Quality Manual to ISO17025
 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;
2. Accommodation and environmental conditions;
3. Calibration methods and method validation;
4. Equipment;
5. Measurement traceability
6. The handling of calibration items.

 These factors have been taken into

account at all levels in the operation of the
laboratory
Quality Manual to ISO17025:- Technical Requirements
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 log’s

Quality Manual to ISO17025:- Technical Requirements
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 laboratory’s 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.
 Quality Manual to ISO17025:- Technical Requirements
Methods & Validation – 5.4: Topics to be covered
 The use of standard methods and procedure’s 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.
Quality Manual to ISO17025:- Technical Requirements
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 calculation’s here, all that is
required is to state the policy to use
M3003.
 Also ISO 5725 is there for guidlines on
incertanities.
Quality Manual to ISO17025:- Technical Requirements
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
 Quality Manual to ISO17025:- Technical Requirements
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 who’s work may have been effected.
Quality Manual to ISO17025:- Technical Requirements
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
Quality Manual to ISO17025:- Technical Requirements
Handling Equipment – 5.8: Topics to be covered
 Describe the goods in/despatch system

 How 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
Quality Manual to ISO17025:- Technical Requirements
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.

Quality Manual to ISO17025:- Technical Requirements
Reporting Results – 5.10: 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:-
 Quality Manual to ISO17025:- Technical Requirements
Reporting Results – 5.10: Topics to be covered

A calibration certificate must detail

1. A title (e.g. ‘Test Report’ or ‘Calibration Certificate’);
2. Name and address of the Laboratory:
3. Unique identification of the certificate (such as the serial number), and on
each page an identification:
4. The name and address of the client;
5. Identification of the method used;
6. An unambiguous identification of the item :
7. Date of receipt of the item and the date of the test or calibration;
8. Reference to the sampling plan and procedures used by the Laboratory:
9. Calibration results with, where appropriate, the units of measurement;
10. Name, function and signature of person authorising the certificate:
11. Where relevant a statement to the effect that the results relate only to the
items tested or calibrated.
12. The conditions ( environment )
13. Uncertainty of measurement
14. The source of Traceability of the measurements made
Tips on Developing Manual
 If you have a soft copy of manual , then
search for “Procedures” or “Documented
Procedures” to figure out that which
clause is going to require it .
 It will save your time as well.
 Also its better to write manual “clause by
clause” . It will help in complete
understanding.
 Making checklist from all clauses, which
will help in internal audit as well.
Good practises
 In manual referring to a procedure , form
or record clearly is a good writing
practice.
 We should wite procedures in
acceptable formats;
 Forms should represent a good asthetic
format .
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.
Where to Get More Information

 BSI or other National Standards Institutions

 UKAS
 Internet
 NPL web site