1. Transmille Training
17025 Quality System

2. Overview: Quality Systems
For an organisation to be accredited it must be seen and be proven by independent assessment to be working to a system.
The international standard for this system is
ISO
ISO covers all the individual topics, section by sections for the complete operation of a laboratory. The standard is split into two parts
1: covering Management Requirements
2: covering Technical Requirements

3. Key Elements For Accredited Laboratories
Quality manual to ISO17025
Environmentally Controlled Laboratory
Head of Laboratory responsible for the operation of the laboratory with a good understanding of measurement procedures, the operation of the equipment and the quality system.
Quality Manager must be assigned
Traceable Reference standards with calibration history.
Measurement procedures with uncertainty budgets.

4. Quality Manual to ISO17025
Must address all aspects of Management Requirements required by standard.
Organisation (4.1)
Quality system (4.2)
Document control (4.3)
Review of requests, tenders and contracts (4.4)
Sub-contracting of tests and calibrations (4.5)
Purchasing services and supplies (4.6)
Service to the client (4.7)
Complaints (4.8)
Control of non-conforming testing and/or calibration work (4.9)
Corrective Action (4.10)
Preventive action (4.11)
Control of records (4.12)
Internal audits (4.13)
Management review (4.14)

5. Name of laboratory or organisation which is legally responsible
Quality Manual to ISO17025:- Management Requirements Organisation : Topics to be covered
Name of laboratory or organisation which is legally responsible
Activities conforming to relevant standards and guidelines
Permanent or mobile facilities
Organisation membership

6. Scope of quality system
Quality Manual to ISO17025:- Management Requirements Quality System : Topics to be covered
Scope of quality system
Activities conforming to relevant standards and guidelines
Reference to quality policy statement
Supporting systems such as procedure and software
Title responsible for ISO17025 conformance

7. Approval and review of documentation
Quality Manual to ISO17025:- Management Requirements Document Control : Topics to be covered
Approval and review of documentation
Activities conforming to relevant standards and guidelines
Location of documentation
Review / update / obsolescence policies
Access control & backup of documentation
RECOMMENDATION : USE MASTER DOCUMENT LIST

8. Quality Manual to ISO17025 – Example Controlled Documents List
INTERNAL DOCUMENTS
Laboratory Procedure Manual
Laboratory Quality Manual
Apparatus Inventor
Approved Sub Contractor
Approved Supplier
Calibration Request Form
UKAS Complaints Form
ProCal Software Manual  
ProCal-Track Software Manual
Skills Matrix
Training Log
Approved Signatory List
Schedule Of Accreditation
Accreditation Certificate
EXTERNAL DOCUMENTS
UKAS M4
ISO17025
UKAS M3003
URN 98/887
UKAS Lab 1
UKAS Lab 3
UKAS Lab 5

9. Procedure for the review of requests, tenders and contracts
Quality Manual to ISO17025:- Management Requirements Review of Contracts : Topics to be covered
Procedure for the review of requests, tenders and contracts
Defining and documenting methods to be used
Capability and resources to meet the requirements.
The appropriate test and/or calibration method is selected and capable of meeting the clients’ requirements
Maintaining records of reviews and any significant changes .  
Reviews on sub-contracted by the Laboratory
Informing clients of any deviation from their contracts.
Procedure if contract needs amending after work has commenced

10. Laboratory policy on sub contracting work
Quality Manual to ISO17025:- Management Requirements Sub-contracting work - 4.5: Topics to be covered
Laboratory policy on sub contracting work
Informing customer of sub contracted work
Responsibility for sub contracted work
Register of approved sub contractors

11. Laboratory policy on purchasing
Quality Manual to ISO17025:- Management Requirements Purchasing - 4.6: Topics to be covered
Laboratory policy on purchasing
Checking of supplies critical to calibration work
Checking / reviewing of purchasing documents
Approved suppliers list

12. Quality Manual to ISO17025:- Management Requirements Service to the Client - 4.7: Topics to be covered
Policy of the laboratory to cooperate with customers and to verify the work performed and ensure confidentiality

13. Policy for the resolution of complaints and the maintenance of records
Quality Manual to ISO17025:- Management Requirements Complaints - 4.8: Topics to be covered
Policy for the resolution of complaints and the maintenance of records
RECOMMENDATION : USE TEMPLATE COMPLAINTS FORM TO RECORD BOTH COMPLAINT AND ACTION TAKEN

14. Quality Manual to ISO17025:- Management Requirements Non Conforming Work - 4.9: Topics to be covered
Actions taken by the laboratory in the event of non conforming work, including informing the customer, evaluating the significance and halting work.

15. Selection and implementation of corrective action
Quality Manual to ISO17025:- Management Requirements Corrective Action : Topics to be covered
Cause analysis
Selection and implementation of corrective action
Monitoring of corrective action

16. Policy on improvement via management review process
Quality Manual to ISO17025:- Management Requirements Preventative Action : Topics to be covered
Policy on improvement via management review process
Action plan to implement and monitor preventative actions

17. Policy on storage and accessibility of records
Quality Manual to ISO17025:- Management Requirements Control of records : Topics to be covered
Policy on storage and accessibility of records
Technical data storage, including original observations, derived data and sufficient information to establish an audit trail, calibration records, staff records and a copy of each Calibration Certificate issued for six years.
Updating / correction of records

18. Schedule of internal audits, including persons responsible
Quality Manual to ISO17025:- Management Requirements Internal Audits : Topics to be covered
Schedule of internal audits, including persons responsible
Actions taken when audits cast doubt on effective laboratory operation
Policy on recording results of audit, and corrective actions
Follow up of effectiveness of corrective actions
RECOMMENDATION : USE SCHEDULE TO AUDIT ALL SECTIONS OF LABORATORY OVER A ONE YEAR PERIOD TO SPREAD WORKLOAD THROUGHOUT THE YEAR.

19. Record of management review meetings and actions that arise
Quality Manual to ISO17025:- Management Requirements Management Review : Topics to be covered
Meeting of upper management to review key aspects of the quality system and calibration activities
Record of management review meetings and actions that arise

20. Quality Manual to ISO17025
Must address all aspects of Technical Requirements required by standard.
General (5.1)
Personnel (5.2)
Accommodation and environmental (5.3) conditions
Test and calibration methods and method validation (5.4)
Equipment (5.5)
Measurement traceability (5.6)
Sampling (5.7)
Handling of test calibration items (5.8)
Assuring the quality of test and calibration results (5.9)
Reporting the results (5.10)

21. Relevant factors effecting the reliability of calibrations including
Quality Manual to ISO17025:- Technical Requirements General – 5.1: Topics to be covered
Relevant factors effecting the reliability of calibrations including
Human factors;
Accommodation and environmental conditions;
Calibration methods and method validation;
Equipment;
Measurement traceability
The handling of calibration items.
These factors have been taken into account at all levels in the operation of the laboratory

22. Job descriptions for both Laboratory staff and key support staff.
Quality Manual to ISO17025:- Technical Requirements Personnel – 5.2: Topics to be covered
Management to ensure competence of staff to perform the work in the laboratory, and also to ensure supervision of training.
Only senior members of the organisation who are directly employed to work in laboratory
Job descriptions for both Laboratory staff and key support staff.
Skill matrix and Training log’s

23. Access to the laboratory only to approved staff.
Quality Manual to ISO17025:- Technical Requirements Accommodation – 5.3: Topics to be covered
General description of the laboratory, including size, lighting & ventilation, work areas etc.
Work is carried out in the laboratory’s under strict environmental control. Temperature, humidity, mains voltage and frequency are monitored and recorded. It must also be stated that work in the laboratory will be ceased in the event of a failure in environmental control.
The separation of the Laboratory from the rest of the company is adequate to provide a stable environment
Access to the laboratory only to approved staff.
A General statement about the tidiness of the laboratory and the location of standards used.

24. Quality Manual to ISO17025:- Technical Requirements Methods & Validation – 5.4: Topics to be covered
The use of standard methods and procedure’s which meet requirement of UKAS, and relevant data needed is available and kept up to date
The Method used to select the calibration procedure is required to be in the manual, the method must meet the needs of the customer, unless the laboratory does not feel that the procedure required by the customer is correct, then they should be informed. When the method is not specified the procedure should follow International or National standards.
A method to cover the development of a non standard procedure subject to the clients agreement must also be covered in the manual
The requirements for the validation of a procedure must also be covered. This will include calibration using reference standards, comparison of results achieved with other methods, inter-laboratory comparisons, systematic assessment of the factors influencing the result & assessment of the uncertainty of the results based on scientific understanding of the theoretical principles of the method and practical experience.

25. Quality Manual to ISO17025:- Technical Requirements Uncertanties – 5.4.6: Topics to be covered
The use of the principles laid out in UKAS document M3003 (always the latest edition) are used to estimate both random and systematic uncertainties. The method applies to all measurements, whether made internally or taken from external measurements by an outside body and added to internal measurements.
NOTE it is not required to show uncertainties calculation’s here, all that is required is to state the policy to use M3003.

26. B: Version numbers of programs used are kept
Quality Manual to ISO17025:- Technical Requirements Control of Data – 5.4.7: Topics to be covered
How Calculation's on data and data transfer to a certificate for example is checked:
This is normally dealt with by appointing a second person to double check unless the calculation is simple
If computers are used how validation, documentation & protection of data are performed.
A: All programs are verified by comparing results obtained against readings taken manually.
B: Version numbers of programs used are kept
C: Master copies of all data on CD are kept

27. Quality Manual to ISO17025:- Technical Requirements Equipment – 5
Quality Manual to ISO17025:- Technical Requirements Equipment – 5.5: Topics to be covered
Equipment capable to support the scope of accreditation.
Calibration programme to providing traceability to National Standards. Before any equipment is placed into service in the Laboratory it is checked and calibrated.
The staff allowed to use equipment
Identification of equipment.
Label all equipment using a laboratory asset number with full details
Storage of records, documents and certificates for equipment
Keep all records manuals etc in a storage file in laboratory office
Action if equipment is suspected faulty/damaged
Remove from use, inform any client who’s work may have been effected.

28. Quality Manual to ISO17025:- Technical Requirements Measurement Traceability – 5.6: Topics to be covered
Calibration program in section 5.5 gives traceability to national and international system of S.I. Units through the use of UKAS laboratories.
Reference standards used only for calibration.
Inter comparison between laboratories own equipment and also any other laboratories: An internal schedule which supplements the external program may be drawn up to verify correct performance of key equipment, the frequency of inter comparisons can only be drawn from experience and the usage of a instrument.
Arrangements for the transporting of reference standards for external cal: for example carried by hand or correctly packaged to prevent damage and protect their integrity

29. Describe the goods in/despatch system
Quality Manual to ISO17025:- Technical Requirements Handling Equipment – 5.8: Topics to be covered
Describe the goods in/despatch system
How are customers instruments identified
Recording of condition upon receipt and informing customer of damage
Precautions taken to prevent deterioration or damage to the calibration or test item during storage

30. Quality Manual to ISO17025:- Technical Requirements Assuring Quality – 5.9: Topics to be covered
Random calibration checks on clients results will be made by independent measurement techniques
Results of the quality control checks and internal audits reviewed in the Management Review.
Participate in inter-laboratory comparison or proficiency testing programmes as required by UKAS.

31. Quality Manual to ISO17025:- Technical Requirements Reporting Results – 5.9: Topics to be covered
The laboratories policy on reporting results is to issue the client with an unambiguous and legible certificate that meets the requirements of UKAS and ISO and provides all of the data requested by the client.
How and when certificate and labels are printed, checked and signed, and how can sign.
Note: The details on a test report are different from a calibration certificate details which follow:-

32. A calibration certificate must detail
Quality Manual to ISO17025:- Technical Requirements Reporting Results – 5.9: Topics to be covered
A calibration certificate must detail
A title (e.g. ‘Test Report’ or ‘Calibration Certificate’);
Name and address of the Laboratory:
Unique identification of the certificate (such as the serial number), and on each page an identification:
The name and address of the client;
Identification of the method used;
An unambiguous identification of the item :
Date of receipt of the item and the date of the test or calibration;
Reference to the sampling plan and procedures used by the Laboratory:
Calibration results with, where appropriate, the units of measurement;
Name, function and signature of person authorising the certificate:
Where relevant a statement to the effect that the results relate only to the items tested or calibrated.
The conditions ( environment )
Uncertainty of measurement
The source of Traceability of the measurements made

33. Summary
This course has covered all topics in the ISO17025 quality system and shown the requirements to be meet in operating a laboratory.
To further develop an understanding the standard itself should be studied along with the template quality manual which can be customised to produce your own manual.
Please feedback to us any comments on this training session

34. Where to Get More Information
BSI or other National Standards Institutions
UKAS
Internet
NPL web site