This document has been created by EUROLAB as a tool to help the laboratories

when creating their own Transition Plan to the new Standard ISO/IEC
17025:2017.

This document includes different tabs for each main chapter of the new
Standard, a detailed study on the news, and a comparison with the 2005
standard. Also, some useful tools to plan the transition in your own lab.

This document is not protected so you can customize it and adapt it at your own
convenience

For further details on the news of the Standard it is recommended to read the
Handbook of ISO/IEC 17025:2017, as well as the revised CookBooks of EUROLAB
SECTION 4 / GENERAL REQUIREMENTS

ISO 17025 Documented ISO 17025 If Change or new:

New? Or Change? Source in own
Main content Information? Main content (Y/N) Management System
2017-11 (Y/N) 2005-08
Main Aspect of Change
Clause Clause
Clarifiying / Risks and
4.1 Impartialitiy NO 4.1.4 / 4.1.5 Organization YES opportunities are now
implemented

4.2 Confidentiality NO 4.1.5 c) Organization YES Clarifying

Actual Version Neccessary Work/Corrective Action Monitoring (Date Related EUROLAB CookBook
Priority Responsible Deadline
suficient? (Y/N) and actions)

Identify risk to impartiality, Impartiality policy High QA/QC/Dept Hea 25 Dec 2018 5 Jan 2019 No. 19 "Impartiality and Confidentiality"
to be made

Procedure to be streamlined to new standard High QA/QC 25 Dec 2018 5 Jan 2019 No. 19 "Impartiality and Confidentiality"
SECTION 5 / STRUCTURAL REQUIREMENTS

ISO 17025 Documented ISO 17025 If Change or new:

New? Or
Main content Information? Main content Change? (Y/N)
2017-11 (Y/N) 2005-08
Main Aspect of Change
Clause Clause

5.1 legal form NO 4.1.1 legal form NO No significant change

5.2 management NO 4.1.5.a/h technical management YES more comprehensive term for
management is used

more comprehensive
5.3 range of activities YES 4.2.2 b qualitiy Manual YES
requirements

4.2.2 e more comprehensive

5.4 accordance with standard NO qualitiy Manual YES
4.2.6 requirements

5.5 internal organsiation YES 4.1.5 d/e/f organisational requirements NO No significant change

personnel and other No substitutes are required

5.6 NO 4.1.5 a/i organisational requirements NO
ressources anymore

5.7 communication / changes NO 4.1.6 4.2.7 communication / changes NO No significant change

 Monitoring
Actual Version
Source in own Management System suficient? (Y/N) Neccessary Work/Corrective Action Priority Responsible Deadline (Date and
actions)

Already in place (Trade license) - - - -

Already in place(organizatrion chart+Quality

system procedure avaialble to meet this - - - -
clause
scope of Activity to be included in Quality Normal QA/QC 25-Dec-18 5-Jan-19
Manual in detail

commitment to be given in the manual and Normal QA/QC 25-Dec-18 5-Jan-19

quality policy

- - - -

- - - -

- - - -
Related EUROLAB CookBook
SECTION 6 / RESOURCE REQUIREMENTS

ISO 17025 Documented ISO 17025 If Change or new:

New? Or
Main content Information? Main content Change? (Y/N)
2017-11 (Y/N) 2005-08
Main Aspect of Change
Clause Clause

Ressource requirements - Technical Requirements -

6.1 NO (5.1) NEW Summarising of several aspects
General General

4.1.5 f.h) Monitoring of personnel is new /

6.2 Personnel YES Organization / Personnel YES
5.2 Evaluation of effectivness is withdrawn

Laboratory facilities and Accomodation and Now this clause is also valid for use of
6.3 YES 5.3 YES
environmental conditions environmental conditions external facilities (6.3.5)

but reference to ISO/IEC 17034 is

6.4 Equipment YES 5.5 Equipment NO included

All equipment used quantified

6.5 Metrological traceability NO 5.6 Measurment traceability YES measurement results has to be
calibrated but annx A is just informativ

Externally provided products Purchasing services and Upgrading of terms/defintion and of

6.6 YES 4.5 / 4.6 YES
and services supplies / Subcontracting requirements
 Actual Version
Source in own Management System suficient? Neccessary Work/Corrective Action Priority Responsible
(Y/N)
 Monitoring
Deadline (Date and Related EUROLAB CookBook
actions)

No. 6 "How to assess the competence of

staff" No.
11 "Induction of new staff members"

No. 12 "Use of Excel"

No. 13 "Technical Records"
SECTION 7 / PROCESS REQUIREMENTS

ISO 17025 ISO 17025

Documented New? Or
Main content Main content
Information? (Y/N) Change? (Y/N)
2017-11 2005-08
Clause Clause
7.1 Review of requests, tenders, YES 4.4 Review of requests, tenders YES
contracts and subcontracts and contracts

7.2.1 Selection, verification and YES 5.4.1. / 5.4.2 Test and calibration methods NO
validation of methods and method validation -
General / Selection of
methods

7.2.2 Validation of methods YES 5.4.3 / 5.4.4 / Laboratory-developed NO

5.4.5 methods / Non-standards
methods / Validation of
methods

7.3 Sampling YES 5.7 Sampling NO

7.4 Handling of items YES 5.8 Handling of items NO
7.5 Technical records YES 4.13.2 Technical records YES

7.6 Evaluation of measurement NO 5.4.6 Estimation of uncertainty of YES

uncertainty measurments

7.7 Assuring the validity of results YES 5.9 Assuring the quality of results YES
7.8.1 Reporting of results - General YES 5.10.1 Reporting of results - General NO

7.8.2 Reports - common YES 5.10.2 Test reports and calibration NO

requirements certificates
7.8.3 Test reports NO 5.10.3 Test reports NO
7.8.4 Calibration certificates NO 5.10.4 Calibration certificates NO
7.8.5 Sampling reports NO 5.10.2 Test reports and calibration NEW
certificates
7.8.6 Reporting statements of YES NEW
conformity

7.8.7 Reporting opinions and YES 5.10.5 Opinions and interpretations NO

interpretations
7.8.8 Amendments to reports YES 5.10.9 Amendments to test reports NO
and calibration certificates
7.9 Complaints YES 4.8 Complaints YES

7.10 Nonconforming work YES 4.9 Control of nonconforming test YES

and/or calibration work

7.11 Control of Data / YES 4.13 Control of records YES

Informationmanagement
If Change or new: Actual Version
Source in own Management System suficient? Neccessary Work/Corrective Action Priority
(Y/N)
Main Aspect of Change

Specification concerning conformity

reporting has to be clearified

More precisely

More precisely

No significant change
No significant change
No explicit statement on error correction is
necessary anymore
measurement uncertainty has to be
evaluated if possible (before: just estimated)
and sampling has to be included

List of requirements has been extended /

further this list does not content choices but
must-haves
No significant change

No significant change

No significant change
Reduction of text
Requirements for sampling reports are
described in a separate clause
Passage concerning statements of conformity
is new (decision rule)

More precisely

No significant change

More extensive description / Procedure has

to be available for interested parties und has
to content certain requirements (for example
2nd person) / Ongoing has to be reported

More precisely and consideration of risks

More extensive description and more

additional requirements for electronical
datas incl. Authorization of updates
 Monitoring
Responsible Deadline (Date and Related EUROLAB CookBook
actions)

No. 1 "Validation of test and calibration methods"

No. 15 "The assessment of the trueness of a measurement procedure by use of a reference
material"

No. 1 "Validation of test and calibration methods" No.

4 "Use of interlaboratory comparison data by laboratories"

No. 3 "Handling of untestable / deviating samples"

No. 13 "Technical Records"

No. 15 "The assessment of the trueness of a measurement procedure by use of a reference
material"

No. 20 "Planning of activities to ensure the validity of test results" No. 2

"Criteria for the selection of a proficiency testing scheme" No. 4.2 "Use
of interlaboratory comparison data by laboratories" No. 15 "The
assessment of the trueness of a measurement procedure by use of a reference material"
No. 17 "Interlaboratory
comparison - the views of laboratories "
No. 8 "Determination of conformance with specifications or limit values with particular
reference to measurement uncertainties - possible strategies" Technical Report
"Decision rules applied to conformity assessment"

No. 12 "Use of Excel"

No. 13 "Technical records"
SECTION 8 / MANGEMENT REQUIREMENTS

ISO 17025 Documented ISO 17025 If Change or new:

New? Or
Main content Information? Main content Change? (Y/N)
2017-11 (Y/N) 2005-08
Main Aspect of Change
Clause Clause
8.1.1 Options YES NEW In the past there have not
been a selection between 2
options
8.1.2 Option A NO NEW Option A was described in the
past in section 4
8.1.3 Option B NO NEW In the past no consideration
of ISO 9001 was possible

8.2 Management system YES 4.2 Management system YES Organization, quality manual
documentation and qualitiy politic were
withdrawn in this clause

8.3 Control of management NO 4.3 Document control YES Reduction of text

system documents
8.4 Control of records NO 4.13.1 Control of records - General NO

8.5 Action to address risks and NO NEW Risks and opportunities are
opportunities new requirements
8.6 Improvement NO 4.7.2 / 4.12 Service to the customer / YES Requirements concerning
Preventive action preventive actions are
reduced
8.7 Corrective action YES 4.11 Corrective action YES More precisely and
consideration of risks and
opportunities
8.8 Internal audits YES 4.14 Internal audits NO More precisely

8.9 Management reviews YES 4.15 Management reviews YES Changes concerning external
and internal aspects and
consideration of risks and
opportunities
 Actual Version Monitoring
Source in own Management System suficient? Neccessary Work/Corrective Action Priority Responsible Deadline (Date and
(Y/N) actions)
Related EUROLAB CookBook

No. 18 "Risk Consideration / Risk based

approach"
No. 16 "Corrective and preventive
action"

No. 9 "Internal audits"

No. 10 "Internal audits - the auditor"
No. 14
"Internal audits - audit report"

No. 7 "Management reviews for

laboratories"