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Lumiform / Templates / ISO 17025 Laboratory Assessment Worksheet

ISO 17025 Laboratory Assessment Worksheet

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ISO 17025 Laboratory Assessment Worksheet

Audit

4. MANAGEMENT REQUIREMENTS

4.1 Organisation

4.1.3 Scope of Management System

ensure management system covers activities in the laboratory’s permanent facility, sites away from its permanent facilities, temporary or mobile facilities
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4.1.4 Conflict of Interest

when part of an organisation, ensure the laboratory defines the responsibilities of key personnel to identify potential conflicts of interest
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4.1.5a Managerial and Technical Personal

ensure managerial and technical personnel have the authority and resources needed to carry out duties and to identify and initiate actions to prevent or minimise departures from the management system or testing/calibration procedures
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4.1.5b Undue Pressure

ensure arrangements are in place so that management and personnel are free from internal and external commercial, financial and other pressures that might adversely affect the quality of their work
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4.1.5c Customer Confidentiality

ensure there are policies and procedures related to customer confidentiality, including electronic storage and transmission of results
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4.1.5d Operational Integrity

ensure the laboratory has policies and procedures to avoid involvement in activities that compromise the confidence in its competence, impartiality, judgement or operational integrity
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4.1.5e Organisation Chart

the organisation and management structure needs to be defined, including relationships between quality management, technical operations, support services and parent organisation (if applicable)
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4.1.5f Responsibility and Authority

specify the responsibility and authority of all personnel who manage, perform or verify work affecting the quality of the tests and/or calibrations
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4.1.5g Laboratory Supervision

ensure adequate supervision by appropriate personnel of all staff involved in calibration and testing activities
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4.1.5h Technical Management

identify technical management that has overall responsibility for technical operations and resources
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4.1.5i Quality Manager

appoint a member of staff, with direct access to senior management, as quality manager who has defined responsibility and authority for implementing and maintaining the management system
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4.1.5j Managerial Deputies

where practical, appoint deputies for key managerial personnel
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4.1.5k Importance of Roles

ensure personnel aware of relevance and importance of their activities and how they contribute to the objectives of the management system
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4.1.6 Appropriate Communication

appropriate communication processes must be established and include the effectiveness of the management system
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4.2 Management System

4.2.1 Policies and Procedures

document policies and procedures as a management system to ensure quality of all work and that they are communicated, available, understood and implemented
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4.2.2 Quality Policy Statement

ensure the quality policy statement is issued under the authority of top management and includes:
the laboratory management’s commitment to compliance with the Standard and to continually improve the management system
a statement of the laboratory’s standard of service
the purpose of the management system
a requirement for all personnel to be familiar with and implement the quality documentation
the laboratory management’s commitment to good professional practice and quality of its service
these overall objectives are to be reviewed as part of management review
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4.2.2, 4.2.5, 4.2.6 Quality Manual

maintain a quality manual that:
defines management system policies and objectives
includes or makes reference to supporting procedures, including technical procedures and outlines structure of the documentation in the management system
defines the roles and responsibilities of technical management and the quality manager
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4.2.3 Commitment to Management System

evidence of commitment to development, implementation and continual improvement of the management system must be available
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4.2.4 Customer Requirements

importance of meeting customer, statutory and regulatory requirements must be communicated
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4.2.7 Changes to Management System

integrity of the management system must be maintained when changes are made
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4.3 Document Control

4.3.1 Procedures

ensure procedures to control all documentation included in the management system are established and maintained
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4.3.2.1 Approval and Issue

ensure documents are reviewed and approved by authorised personnel prior to issue, and are included on a master list which identifies the revision status and distribution
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4.3.2.2 Availability

ensure all necessary quality documentation is available where required, reviewed and revised to maintain suitability
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4.3.2.2 Obsolete Documents

ensure documents are removed when obsolete and suitably marked if retained for either legal or knowledge preservation purposes
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4.3.2.3 Identification

all management system documents must be uniquely identified and include date of issue and/or revision identification, page numbering, total number of pages or a mark to signify the end of the document, and the issuing authority(ies)
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4.3.3.1 Document Changes

ensure changes to documents are reviewed and approved by the same function that performed the original review, or a designate
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4.3.3.2 Altered or New Text

ensure where practical, the altered or new text is identified in the document or the appropriate attachments
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4.3.3.3 Handwritten Amendments

ensure if hand written amendments are allowed, defined procedures are available, which include authorities, clear marking, initialling, dating, and formal re-issue
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4.3.3.4 Electronic Documents

establish procedures to describe how changes in documents maintained electronically are made and controlled
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4.4 Review of Requests, Tenders, and Contracts

4.4.1, 4.4.3 Policies and Procedures

ensure policies and procedures related to review of requests, tenders and contracts are established, maintained and include:
defining, documenting and understanding customer requirements before commencing work
laboratory’s capability and resources
appropriate method selection
work that is subcontracted by the laboratory
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4.4.2 Records of Review

maintain records of reviews, including any significant discussions and/or changes throughout the contract
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4.4.4 Notification of Customer

ensure customer is informed of any deviation from the contract
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4.4.5 Changes to Contracts

ensure same contract review process is repeated if a contract has to be amended after work has commenced and that all affected staff are advised of the amendment
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4.5 Subcontracting of Tests and Calibrations

4.5.1, 4.5.4 Competency

ensure that subcontractors are competent (eg accredited laboratory) and records are maintained of subcontractors used and their competency (eg scope of accreditation)
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4.5.2 Customer Approval

ensure customer is advised in writing and approval gained where appropriate
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4.5.3 Responsibilty

unless customer or regulatory authority specifies subcontractor, laboratory is responsible for subcontractors’ work
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4.6 Purchasing

4.6.1 Policies and Procedures

document policies and procedures for selection, purchasing, reception and storage of relevant services and supplies
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4.6.2 Verification

ensure all purchased supplies that affect the quality are not used until verified as complying with defined specifications, and records of the actions taken to demonstrate compliance are maintained
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4.6.3 Purchasing Documents

ensure purchasing documents for items affecting the quality of work are reviewed and approved for technical content prior to release
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4.6.4 Approves Suppliers

maintain a list and records of the evaluations of all approved suppliers
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4.7 Service to the Customer

4.7.1 Cooperation

cooperate with customers to clarify requests and monitor laboratory's performance whilst ensuring confidentiality to other customers
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4.7.2 Feedback

feedback must be sought and used to improve the laboratory’s activities
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4.8 Complaints

4.8 Policy, Procedure and Records

document policy and procedure for the resolution of complaints from customers or other parties and ensure records of the complaints, investigations and corrective actions (4.11) are maintained
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4.9 Control of Nonconforming Testing and/or Calibration Work

4.9.1 Policies and Procedures

ensure policy and procedures are implemented when work or results do not conform to own procedures or customer requirements and include:
defined responsibilities, authorities and actions
an evaluation of the significance of the non conforming work
corrective actions and decision about the acceptability of the nonconforming work to be taken immediately
notification of the customer and work recall, if necessary
defined responsibility for authorising the resumption of work
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4.9.2 Recurrence

corrective action procedures (4.11) must be implemented when evaluation indicates recurrence could occur or there is doubt regarding compliance of laboratory's operations with own policies and procedures
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4.10 Improvement

4.10 Effectiveness

continually improve the effectiveness of the management system
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4.11 Corrective Action

4.11 Policies and Procedures

establish policy and procedures, and designate appropriate authorities for implementing corrective actions which include:
cause analysis to determine the root cause (4.11.2)
selection, implementation and documentation of corrective actions (4.11.3)
monitoring results to ensure effectiveness of corrective actions (4.11.4)
areas affected are to be audited (4.14) if nonconformities indicate laboratory not complying with own management system (4.11.5)
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4.12 Preventive Action

4.12 Identification and Action

ensure needed improvements and potential sources of nonconformities are identified and action plans developed, implemented and monitored, using controls to ensure they are effective
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4.13 Control of Records

4.13.1.1 Procedures

establish and maintain procedures covering aspects listed below for control of quality and technical records:
Identification
Collection
Indexing
Access
Filing
Storage
Maintenance
Disposal
protect, back-up and prevent unauthorised access to or amendment of records stored electronically (4.13.1.4)
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4.13.1.2 Record Integrity

ensure all records are:
legible
readily retrievable
maintained in a suitable environment
retained for established time
held secure and in confidence (4.13.1.3)
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4.13.2.1 Technical Records

ensure laboratory retains records of:
original observations
derived data
sufficient information to establish an audit trail
calibration records
staff records
copy of each test report or calibration certificate issued
identity of personnel responsible for the sampling
identity of personnel responsible for test/calibration
identity of personnel responsible for checking results
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and that retained records of each test or calibration contain sufficient information to:
identify factors affecting the uncertainty
enable the test or calibration to be repeated using original conditions
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4.13.2.2 Recording

ensure observations, data and calculations are recorded at the time they are made and are identifiable to the specific task
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4.13.2.3 Correction to Records

ensure any changes to the original records (including electronic) are made so that:
original record is not obscured
correct value entered alongside
alterations signed or initialled by the person making the correction
equivalent measures must be taken for records stored electronically
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4.14 Internal Audits

4.14.1 Requirements

internal audits shall be conducted periodically and in accordance with a predetermined schedule and procedure to verify continuing compliance with the requirements of the management system and NAR
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quality manager is responsible for planning and organising audits to be carried out by trained and qualified personnel independent of activity being audited (where resources permit)
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4.14.2 Corrective Action and Notification of Customers

where validity of results has been questioned, timely corrective action must be taken and customers notified in writing if it is shown that laboratory results have been affected
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4.14.3 Records

records of area audited, audit findings and corrective actions must be retained
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4.14.4 Follow-up Audits

follow-up audits shall verify and record implementation and effectiveness of corrective action
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4.15 Management Reviews

4.15.1 Objectives

ensure the laboratory’s management conducts a review yearly of the management system and testing/calibration activities, based on a predetermined schedule and procedure to ensure continuing suitability and effectiveness and to introduce necessary changes or improvements

4.15.1 Contents

ensure the review includes:
suitability of policies and procedures
Reports from managerial and supervisory personnel
outcome of recent internal audits
corrective and preventive actions
assessments by external bodies
results of interlaboratory comparisons or proficiency tests
changes in the volume and type of the work
customer feedback
complaints
recommendations for improvement
other relevant factors (eg quality control activities, resources and staff training)
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4.15.2 Actions and Records

ensure findings and actions are recorded and carried out within an appropriate and agreed timescale
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5. TECHNICAL REQUIREMENTS

5.2 Personnel

5.2.1 Competence

ensure personnel performing specific tasks are qualified on the basis of education, training, experience and/or demonstrated skills and that when staff are being trained appropriate supervision is provided
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5.2.2 Training Policy

policy and procedures must be implemented for identifying training needs, providing training and evaluating its effectiveness
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5.2.3 Employees

ensure personnel are employed or contracted by the laboratory, and ensure contracted personnel are supervised, competent and work in accordance with the management system
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5.2.4 Job Descriptions

maintain current job descriptions for managerial, technical and key support staff
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5.2.5 Authorised Personnel

ensure management has authorised specific personnel to:
perform specific sampling, testing and/or calibration activities
issue test reports and/or calibration certificates and that NATA signatory approval has been taken into consideration
give opinions and interpretations (these are only permitted on test reports in the fields of Medical, Veterinary and Forensic testing)
operate particular types of equipment
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and that records for all technical personnel (including contracted personnel) are maintained for:
relevant authorisation(s) including date on which authorisation and/or competence is confirmed
competence
educational and professional qualifications
training, skills and experience
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5.3 Accommodation and Environmental Conditions

5.3.1 Facility

ensure the laboratory or off-site facility(ies) and environmental conditions do not compromise the quality of results and that the technical requirements for critical accommodation and environmental conditions are documented
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5.3.2 Monitoring

ensure the laboratory monitors, controls and records environmental conditions, where applicable and that tests and/or calibrations are stopped when results are jeopardised by the environmental conditions
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5.3.3 Incompatible Activities

ensure there is effective separation between areas of incompatible activity
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5.3.4 Access

ensure access to office and laboratory areas is controlled
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5.3.5 Housekeeping

ensure housekeeping measures are adequate
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5.4 Test and Calibration Methods and Method Validation

5.4.1 Methods and Procedures

ensure laboratory uses appropriate methods and procedures for all calibration and test activities covered by scope of accreditation and that all instructions, standards, manuals, and reference data are current and available to personnel
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5.4.1 Method Deviations

ensure that deviations from the test and calibration methods are:
documented
technically justified
authorised
accepted by customer
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5.4.2 Method Selection

ensure laboratory selects and uses test and/or calibration methods that:
meet the needs of the customer; and
are appropriate for the test and/or calibration
the customer has been informed of the method chosen (if not specified)
where appropriate, are based on latest international, regional or national standards and where necessary the standard be supplemented with additional details to ensure consistent approach
have been verified for use in the laboratory, if a standard method
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5.4.2 Inappropriate Methods

ensure laboratory informs the customer if the method proposed by the customer is inappropriate or out of date
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5.4.3, 5.4.4 Laboratory-developed and Non-standard Methods

ensure introduction of these methods is planned, and assigned to qualified personnel with adequate resources and that plans are updated as development proceeds and communicated as necessary
when methods are used that are not covered by standard methods, then:
purpose of the test and/or calibration must be identified
method developed must be validated before use
customer agreement must be obtained and include specification of customer requirements
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5.4.5.2 Method Validation

laboratory must validate:
non-standard methods
laboratory-designed/developed methods
standard methods used outside their intended scope
amplifications and modifications of standard methods
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records for method validation must include
results obtained
procedure used
statement as to whether the method is fit for the intended use
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5.4.5.3 Range and Accuracy

ensure the range and accuracy of the values obtainable from validated methods are relevant to the customers’ needs
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5.4.6.1, 5.4.6.2, 5.4.6.3 Uncertainty of Measurement

calibration laboratories or testing laboratories performing their own calibrations must have and implement procedures for estimating the uncertainty of measurement for all calibrations
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testing laboratories must document and implement procedures for estimating uncertainty of measurement (refer to FAD for application of this clause)
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all uncertainty components which are of importance in the given situation must be taken into account using appropriate methods of analysis when estimating the uncertainty of measurement
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5.4.7.1 Calculations and Data Transfers

ensure calculations and data transfers are checked in a systematic manner
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5.4.7 Computers and Automated Equipment

ensure when computers or automated equipment are used for acquisition, processing, recording, reporting, storage or retrieval of test/calibration data that:
laboratory developed software is sufficiently documented and suitably validated
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procedures are established and implemented for protecting the data and include:
integrity and confidentiality of data entry or collection
data storage
data transfer
data processing
computers and automated equipment are maintained to ensure proper functioning
appropriate environmental and operating conditions are provided
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5.5 Equipment

5.5.1 to 5.5.4 Operation

ensure all equipment and its software (including that outside the laboratory’s permanent control) required for all testing and/or calibration activities:
is available and functioning properly (5.5.1)
is capable of achieving required accuracy (5.5.2)
complies with relevant specifications (5.5.2)
has calibration programs established for key quantities or values (5.5.2)
is calibrated or checked before being placed into service (5.5.2)
is checked and/or calibrated before use (see 5.6 also) (5.5.2)
is operated by authorised personnel (5.5.3)
has current instructions on use and maintenance available (5.5.3)
is uniquely identified, where practicable (5.5.4)
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5.5.5 Records

ensure records of equipment and its software are maintained and include:
identity of the equipment and its software
manufacturer’s name, model, and serial number or other unique identification
evidence that the equipment complies with the accuracy requirements and with specifications relevant to the tests or calibrations
current location, where appropriate
the manufacturer’s instructions, if available, or reference to their location
calibration history and due date of next calibration
the maintenance plan, where appropriate, and maintenance carried out to date
any damage, malfunction, modification or repair to the equipment
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5.5.6, 5.5.11 Procedures

ensure procedures for measuring equipment are documented and include:
safe handling
transport
storage
use
planned maintenance
where applicable, that copies of correction factors are correctly updated
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5.5.7 Out-of-service

ensure equipment subjected to overloading or mishandling, giving suspect results, or shown to be defective or outside specified limits is taken out of service, and is:
isolated or clearly labelled or marked as being out of service
examined for the effect of the defect or departure from specified limits on previous tests and/or calibrations
addressed under the “Control of nonconforming work” procedure (4.9)
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5.5.8, 5.5.10 Calibration Status

ensure equipment calibration status is identified, where practicable and where intermediate checks are needed to maintain confidence in the calibration status that a procedure is documented to carry out these checks
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5.5.9 Return to Service

ensure when equipment goes outside the direct control of the laboratory, that the function and calibration status are checked before being returned to service
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5.5.12 Adjustments

ensure equipment, both hardware and software, is safeguarded from adjustments which could invalidate the test/calibration results
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5.6 Measurement Uncertainty

5.6.1 Calibration Program

ensure all equipment used in testing and/or calibration activities is calibrated using a defined procedure before being put into service and is included in the equipment calibration program
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5.6.2.1 Calibration Laboratories

must ensure the program for calibration of equipment is designed and operated so that calibrations and measurements are traceable to SI units, however, where traceability cannot be strictly made to SI units, traceability can be established by use of:
certified reference materials
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specified methods and/or consensus standards that are clearly described and agreed by all parties concerned
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Participation in suitable interlaboratory comparisons is required where possible.
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5.6.2.2 Testing Laboratories

the requirements given in 5.6.2.1 apply for measuring and test equipment unless it can be established that the associated contribution from the calibration contributes little to the total uncertainty of the test result
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5.6.3.1 Reference Standards

program and procedure for calibration of reference standards must be implemented
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reference standards must include traceability as described in 5.6.2.1
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reference standards of measurement must be used for calibration only
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reference standards must be calibrated before and after adjustment
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5.6.3.2 Reference Materials

where possible, reference materials must be traceable to SI units or certified reference materials
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internal reference materials must be checked
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5.6.3.3 Intermediate Checks

procedures and schedules must be available to carry out intermediate checks on reference, primary, transfer or working standards and reference materials to maintain confidence in the calibration status
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5.6.3.4 Transport and Storage

procedures for safe handling, transport, storage and use of reference standards and materials must be available
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5.7 Sampling

5.7.1 Procedures and Plan

ensure procedures for sampling are available at the sampling location and include:
a sampling plan (based on appropriate statistical methods, wherever reasonable)
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factors to be controlled to ensure validity of the test/calibration results
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5.7.2 Deviations

ensure customer-requested deviations, additions or exclusions from the documented sampling procedures are recorded and communicated to the appropriate personnel
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5.7.3 Records

ensure laboratory has procedures for recording sampling data and operations and that the records include:
sampling procedure used
identification of the sampler
environmental conditions (if relevant)
diagrams (or equivalent) to identify sampling location
statistics that sampling procedure is based on, if appropriate
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5.8 Handling of Test and Calibration Items

5.8.1 Procedures

document procedures for test and/or calibration item management which ensure protection of integrity of the item and the interests of the laboratory and customer and cover:
transportation
receipt
handling
protection
storage
retention and/or disposal
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5.8.2 Identification

ensure laboratory has a system for identifying test and/or calibration items both physically and in the records and accommodate subdivision of groups of items, if applicable
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5.8.3 Deficiencies

ensure any abnormalities or deficiencies on item received are recorded
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if there is doubt about suitability of item, or it does not conform to description provided, or the test or calibration required is not specified, ensure that the customer is contacted and that the instructions are recorded
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5.8.4 Facilities

ensure laboratory has procedures and appropriate facilities to maintain item integrity, and the protection of secured items and when specified environmental conditions are required, that these are maintained, monitored and recorded
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5.9 Assuring the Quality of Test and Calibration Results

5.9.1 Quality Control

ensure laboratory has quality control procedures for monitoring validity of tests and calibrations; it must be a planned activity that is reviewed and includes:
regular use of certified reference materials and/or secondary reference materials
participation in interlaboratory comparison or proficiency-testing programs
replicates using the same or different methods
retesting or recalibration of retained items
correlation of results for different characteristics of an item
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resulting data must be recorded so as trends are detectable and statistical techniques must be applied to the reviewing of the results where practicable
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5.9.2 Action on Quality Control Data

analyse and take appropriate action on quality control data that falls outside pre-defined criteria
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5.10 Reporting the Results

5.10.1, 5.10.8 Test Reports and Calibration Certificates

results of tests and calibrations must be reported accurately, clearly, unambiguously, objectively and in accordance with any specific instructions in the methods
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test reports and calibration certificates must include all information requested by the customer, required by the method and necessary for the interpretation of the test or calibration results
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results may be reported in a simplified way when performed for internal customers or in the case of a written agreement with customer, however, any information not reported to the customer, but is normally required to be, must be readily available in the laboratory
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test reports and calibration certificates must be designed to accommodate each type of test or calibration carried out and to minimise the possibility of misunderstanding or misuse
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for details on the use of the NATA endorsement refer to the Field Application Document and the NATA Rules
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5.10.2, 5.10.3 Test Reports

test reports must include the information listed in the Standard under 5.10.2 items (a) to (k) and the FAD:
title (a)
name and address of the laboratory, and the location where the testing/calibrations were carried out, if different from the address of the location (b)
unique identification of the test/calibration document, including on each page an identification to ensure the page is recognised as part of the document and a clear identification of the end of the document (c)
name and address of the customer (d)
identification of the method used (e)
description, condition and identification of the item tested or calibrated (f)
date of receipt of test/calibration item where applicable and the date the work was carried out (g)
reference to the sampling plan and procedures used by the laboratory or other bodies where applicable (h)
results with, where appropriate, the units of measurement (i)
name, function and signature or equivalent identification of person authorising the test/calibration document (j)
statement to the effect that the results relate only to the items tested or calibrated where applicable (k)
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where necessary for the interpretation of the test results the items included in 5.10.3 (a) to (e) must also be included in the test report with the exception of (d) which is not allowable under NATA's regulations except for Medical, Veterinary and Forensic testing
deviations, additions or exclusions from the test method, and specific test conditions, eg environmental conditions (a)
statement of compliance/non-compliance with requirements and/or specifications (b)
statement on the estimated uncertainty of measurement where applicable (information on uncertainty is needed in test reports when it is relevant to the validity or application of the results, when a customer's instruction requires or when the uncertainty affects compliance to a specification limit) (c)
opinions and interpretations where appropriate and needed (d)
additional information required by specific methods or customers (e)
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test reports containing the results of sampling must also include the additional requirements listed in 5.10.3.2 (a) to (f) as necessary for the interpretation of the test results
date of sampling (a)
unambiguous identification of the material sampled (b)
location of sampling including any diagrams, sketches or photographs (c)
reference to the sampling plan and procedures used (d)
details of environmental conditions during sampling (e)
any standard or specification for the sampling method or procedure and deviations, additions or exclusions from the specification (f)
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5.10.2, 5.10.4 Calibration Certificates

calibration certificates must include the information listed in the Standard under 5.10.2 items (a) to (k)
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where necessary for the interpretation of the calibration results, the requirements included in 5.10.4.1 (a) to (c) must also be included in the calibration certificate
conditions, eg environmental during calibration that have an influence on the measurement results (a)
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uncertainty of measurement and/or statement of compliance with an identified metrological specification(b)
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evidence that the measurements are traceable (c)
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if a statement of compliance with a specification is made, the clauses of the specification which are met or not met must be identified (5.10.4.2)
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where a statement of compliance is made omitting the measurement results and associated uncertainties, the laboratory must record and retain those results (5.10.4.2)
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the uncertainty of measurement must be taken into account when statements of compliance are made (5.10.4.2)
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calibration results before and after adjustment or repair, if available, must be reported (5.10.4.3)
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calibration certificates or labels must not contain any recommendation on the calibration interval except when requested by the customer (5.10.4.4)
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5.10.5 Opinions and Interpretations

Are not permitted on test reports unless written authority has been granted by NATA’s Chief Executive except for Medical, Veterinary and Forensic and R&D testing
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5.10.6 Testing and Calibration Results Obtained From Subcontractors

results of tests performed by subcontractors must be clearly identified
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where calibration work has been subcontracted, the laboratory performing the work must issue the calibration certificate to the contracting laboratory
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5.10.7 Electronic Transmission of Results

where results are transmitted electronically or electromagnetically the requirements set out in the Standard must be met
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5.10.9 Amendments to Test Reports and Calibration Certificates

amendments to a test report or calibration certificate after issue must be in the form of a further document or data transfer and include reference to the original as detailed in the Standard and meet the requirements of NAR
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when a complete new test report or calibration certificate is required, it must be uniquely identified and include a reference to the original it replaces
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