CAW Consultancy have now launched another great system for ISO 17025 British Standard

1. ISO/IEC 17025:2005
Competence of testing and
calibration laboratories
Also available with integrated ISO 9001:2015, want to
stream line the system with a a digital paperless
management system app
Designed By CAW Consultancy

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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

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

12. 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

13. 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

14. 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

15. 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.

16. 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)

17. 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

18. 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

19. 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

20. 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)

21. 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

22. Biological Information

23. Calibration Information

24. Chemical Information

25. Construction Information

26. Electrical Information

27. Environmental Information

28. Forensic Information

29. Geotechnical Information

30. Renewable Energy Information

31. Fire And Textiles Information

32. Contents Of Our System Part 1

33. Contents Of Our System Part 2

34. Contents Of Our System Part 3