This document explains each clause of ISO in plain English to help you better understand the requirements of the standard. The document provides guidelines on what needs to be done to meet each requirement of the standard. It also gives insight into how to apply a process approach within the organization, helping you to understand how to establish and maintain the ISO based Laboratory Management System.
This white paper is intended for companies that need to perform an internal audit as part of their ISO management system. Learn how ISO can help you, and read about principles of auditing, auditor characteristics, and steps for internal auditing according to this standard.
This helpful document gives an overview of mandatory ISO documents and records, along with most commonly used non-mandatory documents. Template MS Word. Therefore, the final use of the record should determine the choice of enhancement; d All instances of electronic enhancement of records shall be recorded; e Details of the processes used in enhancement must be recorded.
This should include all the steps performed in the enhancement operation and the level to which these enhancements were applied. The level of detail required is such as to enable another operator to validate the original enhancement process if required.
Where electronic means are used to approve an inspection report, access to the electronic storage medium must be controlled. Additional reporting requirements may be imposed by the context of the inspection. The text below identifies the source of the element.
As required, other unique organisation identification may be used. Use of NATA Endorsement Reports on results covered by the scope of accreditation must include the name in which accreditation is held and the accreditation number.
Where client report forms are used, the issuing NATA-accredited facility must be clearly identified on the report. Where such forms do not require the information detailed above, the facility must retain information sufficient to provide that information if requested. A note to the effect that the client specified the use of these forms must be retained. Reports may be handwritten and presented at the inspection site, or typed, checked and formally presented.
Site reports and associated work covered by the Scope of Accreditation must meet all the criteria for accreditation. An appeals resolution system is not required unless the inspection is carried out under legally delegated authority, e.
Records See 8. Option B does not require that the inspection body's management system is certified to ISO Where the ISO management system is established for an entity that includes activities other than inspection, for Option B to be applicable the system shall appropriately cover the activities of the inspection body.
The required extent of verification will depend on the evidence provided. If the management system is certified by an accredited certification body, NATA will still need to verify compliance with 8. When the verification results in the identification of nonconformities, these will be reported against clause 8.
Quality documentation must include or reference the scope of accreditation and the policy on the use of the NATA endorsement. In particular, field notebook computers must be up- dated regularly and included in the internal audit program for content review.
Statutory and contractual obligations may specify longer record retention periods. The inspection body should also be aware of any client requirements regarding records storage. Audits should be appropriate to the scale, activities and risks of the inspection body.
As appropriate a sampling or risk-biased approach may be applied. These linkages are acceptable if persons involved do not have the possibility to influence the outcome of an inspection. In particular there exists a possibility to influence the outcome of an inspection if the person has the ability to: influence the selection of inspectors for specific assignments or customers; or influence decisions on conformity in specific inspection assignments; or influence remuneration for individual inspectors; or influence remuneration for specific assignments or customers; or initiate the use of alternative work practices for specific assignments.
Annex A2 Requirements for inspection bodies Type B A Type B inspection body may form part of a user organisation or a supplier organisation. Annex A3 Requirements for inspection bodies Type C Type C inspection bodies are distinct from Type B inspection bodies because they are not required to be a separate but identifiable part of the parent organisation. They may also offer their inspection services on the open market. Often Australian regulations do not identify independence requirements for inspection activities.
In situations where the same person may inspect and be asked to put right, make safe or oversee the rectification of any deficiencies that are identified, the client should be advised of and accept the proposed arrangements. The inspection body must have in place safeguards to protect against possible future charges of bias or over-servicing. Such safeguards could include photographic records, client acceptance of findings, retention of replacement items etc.
Modelling data may be used to characterise systems of interest, to resolve management problems associated with the object, system or environment, or to predict behaviour under variant conditions. The modelling process involves the selection of suitable media, then the selection, validation and combination of parameters, to establish a predicted performance. Modelling has application in many fields, including engineering design, design verification, construction and in-service asset management.
Parameters that may be addressed in modelling can include load, deflection, fluid flow, signal dissemination, fire propagation, remaining asset life, weather patterns etc. Where a clause is not included please refer to the general comments above.
Process background It is assumed that the process flow in modelling an activity may be detailed as in the following table. Models may vary from purpose-built structures to electronic configurations and software. In many instances standard modelling tools are modified to suit case-specific applications.
Where physical analogues of input parameters are required in the model e. Where the analogous performance of the model is determined by environmental considerations e. Computers 6. Where software is open to modification by the inspection body at all levels from the algorithm used, the input parameters selected and the match of data to inputs i.
Inspection methods and procedures 7. Worst-case models are to be applied unless reasonable justification is available for not doing so. The inspection body shall perform validation of the model chosen. Validation is understood here to entail the steps necessary to establish that the assumptions and governing equations of the model are relevant to the problem as outlined by the client. The standard includes all activities performed by an inspection body including examining products, installations, plants, processes, procedures, services and determining their conformity and the reporting of results.
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