ISO/IEC 17025 scope

Documentation system
Procedures (SOPS)
Instructions and forms
Document control -1
(ISO 17025: 2005,4.3)
 Laboratory
shall establish and maintain
procedures to control all documents of the
management system
 Internal documents; specifications,
instructions manuals etc.
 External documents; normative documents
regulations, standards etc.)
 Documents = Electronic or paper copies
Document control - 2
(ISO 17025: 2005,4.3)
All documents reviewed and approved by authorised
Master list identifying current revision status and
Documents should be available at all locations where
operations are performed
Periodically reviewed
Invalid or obsolete documents are promptly removed and
suitably marked if retained for knowledge preservation
Unique identified: date and /or revision, page numbering
including total pages and issuing authorithies
Document control - 3
(ISO 17025: 2005 4.3)
Document changes
Changes reviewed and approved by same function of
original review
Where practical altered/new text is identified
If amendment by hand is allowed define procedures and
authorities for amendments
Procedure describing changes in electronic documents
Quality policy statement
(ISO 17025: 2005, 4.2)
 Written
according to current version of ISO
 Independent or included in Manual
 Including the management’s commitment
to meet requirements and to continually
improve the QMS
 Communicated and understood by staff
 Reviewed for continous suitability
Quality manual
(ISO 17025: 2005 4.2)
QMS policies related to quality (including a
quality policy statement) shall be defined in a
quality manual
 Quality manual includes or make reference to
the procedures. Outline of structure of
documentation is given.
 Roles and responsibilities of technical
management and quality manager shall be
Quality manual contents -1
Table of contents
Proof of review
Revision number, issue date
Tracking of changes
Information related to organization (name,adress,
activities history,size etc)
Mention the standard on which QMS is based
Scope of QMS
Quality manual contents - 2
Quality Policy or reference
Responsibilities (organizational chart,
description of functions
Description of the QMS ( processes and their
Structure of QMS documentation
Written procedures or references to them
SOP’S and Workinstructions
Harmonized format
Uniquely identified
Proof of review
Tracking of changes
Defined structure: Name organization, title,
purpose, scope,responsabilities/authorities,
description activity (including resources needed)
Related documents and forms
External documentation
 Pharmacopoeias
 Legislation
 Standards
 Guidelines
 Reference
material certificates
 User Manuals equipment
 Software
 External calibration reports
 Adequate
to record data to prove
compliance with the QMS requirements
 Title, unique identification, revision index,
issue date
 Procedures / instructions should mention
the forms to be used related to the
described activity or be annexed to them
External documentation
Documents of external origin, which are part of
the QMS or can have a large influence on the
system should be controlled
 Review: updates of external docs are followed
by documentated evaluation of the impact on
internal QMS documents, if necessary internal
QMS docs are updated
 Also check by update of internal docs if referred
external docs are still valid
 Plans
apply to a specific situation
 Examples :sampling, testing, validation,
auditing training etc
 Define the purpose of the plan
 Unique identification
 Proof of approval
 For plans specific forms can be used
Registration of records -1
( ISO 17025:2005,4.13)
Procedure required for identification,
maintenance, storage
Legible and easy retrievable
Fully traceability of test circumstances (give
information to identify factors affecting the
uncertainity and to enable the test under the
same conditions, including identity of personel
acting in the tests.
Registration of records- 2
(ISO 17025:2005,4.13)
Retention time established
Archived in suitable environment
Held secure and in confidence
Electronic records: back-up and protection
against unauthorized access or amendments
Mistakes crossed out (original entry still visble)
and signed and dated
(ISO 17025:2005, 5.4.7)
Calculations and data transfer (appropriate
Review of documents and approval
By competent personel to check clarity, accuracy, adequacy of
content and structure
By users to verify information, practical use
By management responsible for application of the procedure
Controlled copies should show proof of approval
Proof of approval should be kept
Distribution of QMS-documents-1
The system’s documentaion shall be communicated to,
understood by, available to and implemented by the
appropriated personnel
Controlled distribution
 Distributed where needed
 Obsolete original archived and copies retrieved
 Only QA-manager has write –access
 Retrieval of obsolete file and access to new file
Distribution of QMS-documents-2
Non-controlled copies:
 Clearly identified as non-controlled copy
 Inform the receiver that no information of
updates will be given
Archiving of records
(ISO 17025:2005, 4.13)
 For
the chosen period follow national and
specific regulations according to the tests
carried out
 Normally minimal 5 years
 Related documents have to be also
available (SOP’s)
Experience of participants
 Choice
of author
 Review of documents: period and
 Changes in documents
 Content: How detailed is a description of a
 Procedure to inform workers about new
changed documents
 Choice to refer or repeat information