transmille training 17025 quality system. overview: quality systems for an organisation to be...

Transmille TrainingTransmille Training17025 Quality System

Overview: Quality SystemsOverview: 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 17025.

ISO 17025 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 Requirements2: covering Technical Requirements

Key Elements For Key Elements For Accredited LaboratoriesAccredited 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.

Quality Manual to ISO17025Quality Manual to ISO17025 Must address all aspects of Management Requirements

required by 17025 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)

Quality Manual to ISO17025:- Management RequirementsQuality Manual to ISO17025:- Management Requirements

Organisation - 4.1Organisation - 4.1 : : Topics to be coveredTopics to be covered

Name of laboratory or organisation which is legally responsible

Activities conforming to relevant standards and guidelines

Permanent or mobile facilitiesOrganisation membership


Quality System - 4.2Quality System - 4.2 : : Topics to be coveredTopics to be covered

Scope of quality systemActivities conforming to relevant

standards and guidelinesReference to quality policy statementSupporting systems such as procedure and

softwareTitle responsible for ISO17025

conformance


Document ControlDocument Control - 4.3- 4.3 : : Topics to be coveredTopics to be covered

Approval and review of documentationActivities conforming to relevant

standards and guidelinesLocation of documentationReview / update / obsolescence policiesAccess control & backup of

documentation

RECOMMENDATION : USE MASTER DOCUMENT LIST

Quality Manual to ISO17025 – Quality Manual to ISO17025 – Example Controlled Documents ListExample Controlled Documents List

INTERNAL DOCUMENTSLaboratory Procedure ManualLaboratory Quality ManualApparatus InventorApproved Sub ContractorApproved SupplierCalibration 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 DOCUMENTSUKAS M4 ISO17025 UKAS M3003 URN 98/887 UKAS Lab 1 UKAS Lab 3 UKAS Lab 5


Review of ContractsReview of Contracts - 4.4- 4.4 : : Topics to be coveredTopics 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


Sub-contracting workSub-contracting work - 4.5- 4.5: : Topics to be coveredTopics 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


Purchasing Purchasing - 4.6- 4.6: : Topics to be coveredTopics to be covered

Laboratory policy on purchasing Checking of supplies critical to calibration work Checking / reviewing of purchasing documents Approved suppliers list

Quality Manual to ISO17025:- Management Requirements Quality Manual to ISO17025:- Management Requirements

Service to the ClientService to the Client - 4.7 - 4.7: : Topics to be coveredTopics to be covered

Policy of the laboratory to cooperate with customers and to verify the work performed and ensure confidentiality


ComplaintsComplaints - 4.8: - 4.8: Topics to be coveredTopics 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


Non Conforming WorkNon Conforming Work - 4.9: - 4.9: Topics to be coveredTopics 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.


Corrective ActionCorrective Action - 4.10: - 4.10: Topics to be coveredTopics to be covered

Cause analysis Selection and implementation of corrective

action Monitoring of corrective action


Preventative ActionPreventative Action - 4.11:- 4.11: Topics to be coveredTopics to be covered

Policy on improvement via management review process

Action plan to implement and monitor preventative actions


Control of recordsControl of records - 4.12:- 4.12: Topics to be coveredTopics 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


Internal AuditsInternal Audits - 4.13:- 4.13: Topics to be coveredTopics 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.


Management ReviewManagement Review - 4.14:- 4.14: Topics to be coveredTopics 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

Quality Manual to ISO17025Quality Manual to ISO17025Must address all aspects of Technical

Requirements required by 17025 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)

Quality Manual to ISO17025:- Technical RequirementsQuality Manual to ISO17025:- Technical Requirements

GGeneraleneral – 5.1 – 5.1:: Topics to be coveredTopics to be covered

Relevant factors effecting the reliability of calibrations including

1. Human factors;2. Accommodation and environmental conditions;3. Calibration methods and method validation;4. Equipment;5. Measurement traceability 6. The handling of calibration items.

These factors have been taken into account at all levels in the operation of the laboratory


Personnel – 5.2Personnel – 5.2:: Topics to be coveredTopics 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


Accommodation – 5.3Accommodation – 5.3:: Topics to be coveredTopics 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.


Methods & Validation – 5.4Methods & Validation – 5.4:: Topics to be coveredTopics 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.


Uncertanties – 5.4.6Uncertanties – 5.4.6:: Topics to be coveredTopics 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.


Control of Data – 5.4.7Control of Data – 5.4.7:: Topics to be coveredTopics 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 keptC: Master copies of all data on CD are kept


Equipment – 5.5Equipment – 5.5:: Topics to be coveredTopics 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 equipmentKeep 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.


Measurement Traceability – 5.6Measurement Traceability – 5.6:: Topics to be coveredTopics 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


Handling Equipment – 5.8Handling Equipment – 5.8:: Topics to be coveredTopics 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


Assuring Quality – 5.9Assuring Quality – 5.9:: Topics to be coveredTopics 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.


Reporting Results – 5.9Reporting Results – 5.9:: Topics to be coveredTopics 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 17025 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:-


Reporting Results – 5.9Reporting Results – 5.9:: Topics to be coveredTopics to be covered

A calibration certificate must detail1. A title (e.g. ‘Test Report’ or ‘Calibration Certificate’); 2. Name and address of the Laboratory:3. Unique identification of the certificate (such as the serial number), and

on each page an identification:4. The name and address of the client; 5. Identification of the method used;6. An unambiguous identification of the item :7. Date of receipt of the item and the date of the test or calibration; 8. Reference to the sampling plan and procedures used by the Laboratory:9. Calibration results with, where appropriate, the units of measurement;10. Name, function and signature of person authorising the certificate:11. Where relevant a statement to the effect that the results relate only to

the items tested or calibrated. 12. The conditions ( environment ) 13. Uncertainty of measurement 14. The source of Traceability of the measurements made

SummarySummary 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

Where to Get More InformationWhere to Get More Information

BSI or other National Standards InstitutionsUKASInternetNPL web site