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 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
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
 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
 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 system’s 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 (SOP’s)
 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