Documentation system

1. 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: 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

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 Review: • By competent personel to check clarity, accuracy, adequacy of content and structure • By users to verify information, practical useApproval: • 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