Documentation system

Q-Policy
statement

Q-manual

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

personel
Master list identifying current revision status and
distribution
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
purpose
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

17025
Independent or included in Manual
Including the managements 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
defined
 Quality manual contents -1
Title
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
interactions)
Structure of QMS documentation
Written procedures or references to them
References
Annexes
 SOPS 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
Archiving
 External documentation
Pharmacopoeias
Legislation
Standards
Guidelines
Reference material certificates
User Manuals equipment
Software
External calibration reports
 Forms
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
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

checks)
Review of documents and approval
Review:
By competent personel to check clarity, accuracy, adequacy of
content and structure

By users to verify information, practical use

Approval:

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 systems documentaion shall be communicated to,
understood by, available to and implemented by the
appropriated personnel

Controlled distribution
Paper:
Distributed where needed
Obsolete original archived and copies retrieved

Electronic:
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 (SOPs)
 Experience of participants
Choice of author
Review of documents: period and
procedure
Changes in documents
Content: How detailed is a description of a
procedure
Procedure to inform workers about new
changed documents
Choice to refer or repeat information