QMS Internal Auditor Training Course

based on ISO 17025:2005

Pre-Course Reading

QMS Internal Auditor Training course

ISO 17025:2005
Pre-Course Reading Material

Section 1: Course Introduction

1. INTRODUCTION
This course is designed and developed with the aim to provide students with the knowledge and skills
required to perform internal audits, in accordance with ISO 17025.
1.1)
1.2)
1.3)

Auditor certification: Students who successfully complete this QMS internal Auditor training
course will satisfy the training requirements for becoming IRCA approved QMS Internal
Auditor.
Pre-requisite: It is recommended that the students have basic knowledge and understanding
of the requirements of ISO 17025 before they start this course or at-least go through ISO
17025 standard and this pre-course reading material before arriving on course.
Pre-Course Reading: At the end of this document there is a Quiz based on Pre-course
reading material and Standard. It is important to complete this Quiz as it will become part of
Continuous Assessment program.
Duration: It is a 2-day full time class room based course.

1.4)

2. COURSE OBJECTIVES
2.1 Knowledge:

With reference to the Plan, Do, Check, Act cycle, explain the process-based quality
management system model for ISO 17025, and the role of internal audit in the
maintenance and improvement of quality management systems.

Explain the role and responsibilities of an auditor to plan, conduct, report and follow up
an internal quality management system audit based on 17025, in accordance with ISO
19011.

2.2 Skills:

Plan, conduct, report and follow up an internal audit of part of a quality management system
based on ISO 17025, and in accordance with ISO 19011.

3. Course Contents:

Introduction to ISO 17025

Auditing Management Requirements
Auditing Technical Requirements
Audit Definitions Principles and Types
Pre-Audit Activities
During Audit activities
Post Audit Activities
IRCA Certification Schemes and Auditor Competence

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ISO 17025:2005
Pre-Course Reading Material
4. Training methodology
Classroom based training with innovative, interactive learning techniques.

5. Continuous assessment
Students will be continuously assessed during the training session, In order to check the knowledge
and skills of the students with reference to auditing 17025.
6. Student assessment & Result
For successful completion of the course each student must:
Complete/attend all elements of the course.
Pass the continuous assessment.
On completion of the training, students will be awarded;
o Certificate of successful completion (on passing the examination)
o Certificate of attendance (In case of not passing continuous assessment)

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QMS Internal Auditor Training course

ISO 17025:2005
Pre-Course Reading Material

Section 2: Introduction & Overview of ISO 17025

1. Introduction

ISO/IEC 17025:2005 (General requirements for the competence of testing and calibration
laboratories) is the internationally recognised standard relating to the competence of testing
and calibration laboratories. It specifies criteria for the development and assessment of
management systems and laboratory technical controls that provide confidence in the results
obtained. The standard can be applied to a wide range of laboratory activities including
analytical, clinical, forensic, destructive/non-destructive testing and instrument/equipment
calibration.
2. Purpose

Main purpose of using ISO 17025 is to develop and implement a quality system which is focused on
improving the ability of organization to produce valid results.

ISO/IEC 17025 standard specifically addresses factors relevant to a laboratory's ability to

produce precise, accurate test and calibration data, including:

Technical Competency of Staff

Validity and Appropriateness of Measurement Methods
Traceability of Measurement and Calibration to National Standards
Appropriate Application and Measurement Uncertainty
Suitability, Calibration, and Maintenance of Test Equipment
The Testing Environment
Sampling, Handling, and Transportation of Test Items
Quality Assurance of Test, Inspection, or Calibration Data

3. Structure of ISO 17025

The ISO/IEC 17025 standard itself comprises five elements that are Scope, Normative References,
Terms and Definitions, Management Requirements and Technical Requirements. The two main
sections in ISO/IEC 17025 are Management Requirements and Technical Requirements.

3.1 Management requirements (Clause 4.0)

These requirements are primarily related to the operation and effectiveness of the quality
management system within the laboratory. Most of the requirements mentioned in Clause 4 of the
standard are almost similar to ISO 9001 QMS standard. If a company has already developed their
quality management system based on ISO 9001 it becomes easy to cover this part of the standard.
Management Requirements clause is further divided into 15 sub clauses which are as follows:
4.1 Organization
4.2 Management System
4.3 Document Control
4.4 Review of requests, tenders and contracts
4.5 Sub-contracting of tests and calibrations
4.6 Purchasing services and supplies
4.7 Service to the customer
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4.8 Complaints
4.9 Control of nonconforming testing and / or calibration work
4.10 Improvement
4.11 Corrective action
4.12 Preventive action
4.13 Control of records
4.14 Internal Audits
4.15 Management reviews

3.2 Technical requirements (Clause 5.0)

Technical Requirements include factors which determine the correctness and reliability of the tests
and calibrations performed in laboratory. Factors include human factors, accommodation and
environmental conditions, test and calibration methods and method validation, equipment,
measurement traceability, sampling and handling of test and calibration items.
Technical Requirements clause is further divided into 10 sub clauses which are as follows:
5.1 General
5.2 Personnel
5.3 Accommodation and environmental conditions
5.4 Test and calibration methods and method validation
5.5 Equipment
5.6 Measurement traceability
5.7 Sampling
5.8 handling of test and calibration items
5.9 Assuring the quality of test and calibration results
5.10 Reporting the results
Note: for Details about sub-clauses refer to ISO 17025.

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ISO 17025:2005
Pre-Course Reading Material
4.0 Benefits:
Some of the benefits of having a certified ISO 17025 Laboratory are as follows:

ISO 17025 certifications are recognized worldwide as stipulated in International

Laboratory Accreditation System (ILAC).
Better control of laboratory operations and feedback to laboratories as to whether they
have sound Quality Assurance System and are technically competent.
Enhanced Customer satisfaction.
It minimizes the risk of producing or supplying a non-conforming product or service.
Saves retesting time and costs by doing it right the first time.
Customers can search and identify the laboratories accredited by The Accreditation
Member Body for their specific requirements from their website or Directory of Accredited
Laboratories.
Increase in quality awareness.
Better communication.
Enhanced business strategy.
Users of accredited laboratories will enjoy greater access for their products, in both
domestic and international markets, when tested by accredited laboratories.
Savings in terms of time and money due to reduction or elimination of the need for retesting of products.
Improved national and global reputation and image of the laboratory.
Continually improving data quality and laboratory effectiveness.
Improved supplier-relationships.
Cutting back on costs of non-quality.
Controlled processes and activities throughout the organisation.
Increase of confidence in Testing/ Calibration data and of personnel performing work.
Potential increase in business due to enhanced customer confidence and satisfaction.

5.0 PLAN-DO-CHECK-ACT (PDCA) CYCLE

The PDCA cycle was first developed in the year 1920 by Walter Shewhart. W. Edward Deming
made the PDCA Cycle more popular. ISO 9001 Standard process model is actually based on the PlanDo-Check-Act cycle (PDCA) which can be applied to all kinds of processes.
Plan:
The objectives and processes needed to meet customer requirements, consistent with the
Organisations policies, need to be planned and established;
Do:
The processes are implemented;

Check:
The process and products are monitored and measured against the policies, objectives and
requirements for the product and the results are analysed and reported;
Act:
Actions are taken to continually improve process performance.

PDCA cycle can be combined with Process approach and it can be embedded in any process
throughout the organization to bring improvement.
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ISO 17025:2005
Pre-Course Reading Material

Section 3: Key Terms and definitions

Some of the key terms and definitions related to ISO 17025 are described below:

MANAGEMENT SYSTEM
It is a set of interrelated elements used to establish policy and objectives and to achieve those
objectives. A management system of an organization can include different management systems such
as a quality management system or environmental management system.
CONFORMITY ASSESSMENT
Demonstration that specified requirements relating to a product, process, system, person or body
are fulfilled

ACCREDITATION
Third party attestation related to a conformity assessment body conveying formal demonstration of
its competence to carry out specific conformity assessment tasks.
CERTIFICATION
Third-party attestation related to products, processes, systems or persons

AUDIT
Is defined as Systematic, independent and documented process for obtaining audit evidence and
evaluating it objectively to determine the extent to which audit criteria are fulfilled.

AUDIT EVIDENCE
Is defined as records, statements of fact or other information, which are relevant to the audit criteria
and verifiable.

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ISO 17025:2005
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Section 4: ISO 17025 Quiz

1. ISO 17025 is divided into two main sections which are?

A. ___________________________________, B. ___________________________________

2. A _______________ laboratory performing its own calibrations shall have a ______________ to estimate the
uncertainty of measurement for all calibrations and types of calibrations.
A. Calibration, record

B. Calibration, procedureC. Testing, Procedure

D. Calibration or Testing, Procedure

3. ISO 17025 requires laboratory to be held legally responsible.

A. Yes

B. No

4. Review of requests, tenders and contracts are not required to be performed as per IO 17025.
A. Yes

B. No

5. Authorities and responsibilities for personnel performing testing or calibration work and
equipment which they are authorized to operate are defined in ________________.
A. Organization chart

6. A first party audit is

A. an internal audit

B. Authorization Matrix

B. an audit by a customer or client

C. an audit by an independent organization

7. Information which can be proved true, based on facts obtained through Observation, measurements or
test results is called
A. objective evidence

B. a deficiency

C. a nonconformity report

D. observation report

8. Certified Reference materials (CRM) are used for

__________________________________________________________________________________________________________
__________________________________________________________________________________________________________

9. List two suitable programs in which Laboratories are required to participate to ensure their laboratory
and calibration results.
1)
2)

_____________________________________________________________________________________________________
_____________________________________________________________________________________________________

10. Samples should be protected during _________, _________ & ____________.

11. Checks needed to maintain confidence in the calibration status of reference, primary transfer or

working standards and reference materials are known as _______________________

A. Reference checks

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B. Intermediate Checks C. Supervisory checks

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D. Sampling

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