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 records-2

(ISO 17025:2005,4.13)
    

Retention time established Archived in suitable environment Held secure and in confidence Electronic records: backback-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 QMSQMS-documents 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 QAQA-manager has write access  Retrieval of obsolete file and access to new file

Distribution of QMSQMS-documents documents-2

Non-controlled copies: Non Clearly identified as nonnon-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