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
Clearifiying / 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 Clearifying

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

No. 19 "Impartiality and Confidentiality"

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

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

5.4 accordance with standard NO 4.2.2 e qualitiy policy YES more comprehensive
4.2.6 requirements

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

5.6 personnel and other NO 4.1.5 a/i organisational requirements NO No substitutes are required
ressources anymore

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

 Actual Version Monitoring
Source in own Management System suficient? (Y/N) Neccessary Work/Corrective Action Priority Responsible Deadline (Date and
actions)
Related EUROLAB CookBook
SECTION 6 / RESOURCE REQUIREMENTS

ISO 17025 Documented ISO 17025 New? Or If Change or new:

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

Ressource requirements - Technical Requirements -

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

4.1.5 f.h) Monitoring of personnel is new /

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withdrawn

Laboratory facilities and Accomodation and Now this clause is also valid for use of
6.3 environmental conditions YES 5.3 environmental conditions YES 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 and services YES 4.5 / 4.6 supplies / Subcontracting YES 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 New? Or If Change or new:

Documented
Main content Information? (Y/N) Main content Change?
2017-11 2005-08 (Y/N)
Main Aspect of Change
Clause Clause
7.1 Review of requests, tenders, YES 4.4 Review of requests, tenders YES Specification concerning conformity
contracts and subcontracts and contracts reporting has to be clearified
7.2.1 Selection, verification and YES 5.4.1. / 5.4.2 Test and calibration methods NO More precisely
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 More precisely

5.4.5 methods / Non-standards
methods / Validation of
methods

7.3 Sampling YES 5.7 Sampling NO No significant change

7.4 Handling of items YES 5.8 Handling of items NO No significant change
7.5 Technical records YES 4.13.2 Technical records YES No explicit statement on error correction is
necessary anymore
7.6 Evaluation of measurement NO 5.4.6 Estimation of uncertainty of YES measurement uncertainty has to be
uncertainty measurments evaluated if possible (before: just estimated)
and sampling has to be included

7.7 Assuring the validity of results YES 5.9 Assuring the quality of results YES List of requirements has been extended /
further this list does not content choices but
must-haves

7.8.1 Reporting of results - General YES 5.10.1 Reporting of results - General NO No significant change
7.8.2 Reports - common YES 5.10.2 Test reports and calibration NO No significant change
requirements certificates
7.8.3 Test reports NO 5.10.3 Test reports NO No significant change
7.8.4 Calibration certificates NO 5.10.4 Calibration certificates NO Reduction of text
7.8.5 Sampling reports NO 5.10.2 Test reports and calibration NEW Requirements for sampling reports are
certificates described in a separate clause
7.8.6 Reporting statements of YES NEW Passage concerning statements of
conformity conformity is new (decision rule)

7.8.7 Reporting opinions and YES 5.10.5 Opinions and interpretations NO More precisely
interpretations
7.8.8 Amendments to reports YES 5.10.9 Amendments to test reports NO No significant change
and calibration certificates
7.9 Complaints YES 4.8 Complaints YES 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

7.10 Nonconforming work YES 4.9 Control of nonconforming YES More precisely and consideration of risks
test and/or calibration work

7.11 Control of Data / YES 4.13 Control of records YES More extensive description and more
Informationmanagement additional requirements for electronical
datas incl. Authorization of updates
 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. 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"