Transmille Training 17025 Quality System

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 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 Requirements 2: covering Technical Requirements

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.

Quality 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)

Name of laboratory or organisation which is legally responsible Quality Manual to ISO17025:- Management Requirements Organisation - 4.1 : 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

Scope of quality system Quality Manual to ISO17025:- Management Requirements Quality System - 4.2 : 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

Approval and review of documentation Quality Manual to ISO17025:- Management Requirements Document Control - 4.3 : 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

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

Procedure for the review of requests, tenders and contracts Quality Manual to ISO17025:- Management Requirements Review of Contracts - 4.4 : 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

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

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

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

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

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.

Selection and implementation of corrective action Quality Manual to ISO17025:- Management Requirements Corrective Action - 4.10: Topics to be covered Cause analysis Selection and implementation of corrective action Monitoring of corrective action

Policy on improvement via management review process Quality Manual to ISO17025:- Management Requirements Preventative Action - 4.11: Topics to be covered Policy on improvement via management review process Action plan to implement and monitor preventative actions

Policy on storage and accessibility of records Quality Manual to ISO17025:- Management Requirements Control of records - 4.12: 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

Schedule of internal audits, including persons responsible Quality Manual to ISO17025:- Management Requirements Internal Audits - 4.13: 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.

Record of management review meetings and actions that arise Quality Manual to ISO17025:- Management Requirements Management Review - 4.14: 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

Quality Manual to ISO17025 Must 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)

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

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

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.

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.

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.

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

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.

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

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

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.

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 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:-

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

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

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