1. Instructions and forms
Documentation system
Q-Policy statement
Q-manual
Procedures (SOPS)
Instructions and forms

2. 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

3. 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

4. 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

5. 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

6. Quality manual (ISO 17025: )
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

7. 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

8. 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

9. 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

10. External documentation
Pharmacopoeias
Legislation
Standards
Guidelines
Reference material certificates
User Manuals equipment
Software
External calibration reports

11. 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

12. 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

13. 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

14. 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.

15. 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)

16. Review of documents and approval
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

17. 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

18. 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

19. 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)

20. 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