deliverable of this meeting was the FDIS version of the new ISO/IEC The Standard introduces its main requirements throughout the clauses 4 to 8. ISO INTERNATIONAL. STANDARD. ISO/IEC. Second edition Details of the software products used to create this PDF file can be found in the. The concept of risk has always been implicit in ISO –the . Validate non –standard methods, . clauses 4 to 7 of ISO/IEC
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A new version of the standard was published by ISOand the International Electrotechnical Commission (IEC) in. to update its content and better serve the. PDF | Basic information on the ISO standard. Why it could be useful for a lab to apply to this standard. What exactly the standard entails. INTERNATIONAL. STANDARD. ISO/IEC. Second edition Details of the software products used to create this PDF file can be found in.
You must log in or register to reply here. The link to SI units shall be achieved by comparison or reference to national or international measurement standards or certified reference materials with stated metrological traceability to the SI. Table 1. In this case, the influence of such changes should be documented, and if appropriate, a new validation should be carried out. Nonconforming test results should be documented and controlled.
Management System Requirements are those steps taken by the organization to give itself quality management system tools to support the work of its people in the production of technically valid results.
Some national systems e. Additionally, the laboratory will be expected to keep abreast of scientific and technological advances in relevant areas. In common with other accreditation standards of the ISO series and unlike most ISO standards for management systems , third party auditing assessment of the laboratory is normally carried out by the national organization responsible for accreditation.
ISO series. In short, accreditation differs from certification by adding the concept of a third party Accreditation Body AB attesting to technical competence within a laboratory in addition to its adherence and operation under a documented quality system, specific to a Scope of Accreditation. Around the world, geo-political regions such as the European Community , and Asia-Pacific, the Americas and others, established regional cooperations to manage the work needed for such mutual recognition.
In the U. These bodies accredit testing and calibration labs, reference material producers, PT providers, product certifiers, inspection bodies, forensic institutions and others to a multitude of standards and programs. It does not matter which AB is utilized for accreditation. The MRA arrangement was designed with equal weight across all economies.
ABs include:. The CLAS program provides quality system and technical assessment services and certification of specific measurement capabilities of calibration laboratories in support of the Canadian National Measurement System.
In other countries there is often only one Accreditation Body. Typically these bodies encompass accreditation programs for management systems, product certification, laboratory, inspection, personnel and others:. From Wikipedia, the free encyclopedia. It also aligned more closely with the version of ISO  The version of the standard comprises five elements; Normative References, Terms and Definitions, Management Requirements, and Technical Requirements. Retrieved 27 March McIntyre Practical Benefits of Implementing a Quality System".
Retrieved 28 February Retrieved It shall be isolated to prevent its use or clearly labelled or marked as being out of service until it has been repaired and shown to perform correctly. NOTE Particular attention should be paid to measurement reference standards. NOTE Types of equipment having an effect on the accuracy of the measurement may include: The records shall include at least the following: Records shall be maintained for equipment significant to the laboratory activities.
The laboratory shall verify that equipment complies with specified requirements before being placed into service and when equipment has been outside the direct control of the laboratory. Equipment that has been subjected to overloading or mishandling. The laboratory shall identify equipment used for measurements and capable of achieving the accuracy required and complying with the specifications relevant to the laboratory activities concerned.
All equipment requiring calibration shall be labelled. When intermediate checks are needed to maintain confidence in the performance of the equipment. The laboratory shall have documented processes for appropriate handling.
It shall establish a documented calibration program for such equipment to ensure metrological traceability of the measurement results.
Services can include. The laboratory shall select and use reference materials that are fit for the specific purpose in the measurement process. NOTE 3 Reference materials can be used for a number of purposes in the measurement process including calibration.
NOTE 2 A multitude of names exist for reference materials and certified reference materials. When calibration and reference material data include reference values or correction factors.
ISO Guide 33 gives guidance on the selection and use of reference materials. For the use in the measurement process only. NOTE Products can include. Equipment shall be safeguarded from adjustments which would invalidate the test and calibration results.
Where metrological traceability to the SI units is not technically possible. The laboratory shall establish and maintain metrological traceability of its measurement results by means of a documented unbroken chain of calibrations or comparisons each contributing to the measurement uncertainty.
The link to SI units shall be achieved by comparison or reference to national or international measurement standards or certified reference materials with stated metrological traceability to the SI. For example. NOTE 1 Metrological traceability is often referred to as measurement traceability.
ISO describes metrological traceability chains in the field of laboratory medicine including those in which the top level stated reference is a certified reference material.
The technical requirements to be met for such reference materials. Where it is technically possible. The laboratory shall have a procedure for evaluating external providers on their ability to provide products and services in accordance with the laboratory established requirements including: The laboratory shall retain records of the verification processes to ensure products and service conform to the laboratory established requirements and any necessary actions arising. NOTE 2 Reference materials can differ with respect to their position in the metrological traceability chain primary.
Each contract shall be acceptable both to the laboratory and the customer. NOTE 2 Where a contract covers on-going work or a series of activities. NOTE Calibration laboratories fulfilling the requirements of this International Standard are considered to be competent. The important aspect for their applicability is. NOTE 1 For internal or routine customers. The procedures for these reviews leading to a contract for laboratory activities shall ensure that: Metrological traceability of measurement results shall be assured through calibrations by laboratories that can demonstrate competence.
Deviations requested by the customer shall not jeopardize the integrity of the laboratory or the results. All instructions. NOTE It is recognized that externally provided laboratory activities can occur: The laboratory should inform the customer of any delays in the performance of the laboratory activities. These include procedures for sampling. Records shall also be maintained of pertinent discussions with a customer relating to the customer's requirements or the results of the work.
The laboratory shall. NOTE For calibration laboratories. NOTE 2 Customers value the maintenance of good communication. Communication with the customer. NOTE 1 Such cooperation can include: Any change in requirements requiring modifications to the development plan shall be approved and authorized. When necessary. NOTE 1 Validation can include procedures for sampling. The validation shall be as extensive as is necessary to meet the needs of the given application or field of application.
NOTE International. Methods published either in international. As method-development proceeds. The customer shall be informed as to the method chosen. It can be necessary to provide additional documentation for optional steps in the method or additional details. The laboratory shall ensure that it uses the latest valid edition of a standard unless it is not appropriate or possible to do so. Records of the communications shall be kept. Laboratory-developed or modified methods or methods adapted by the laboratory may also be used if they are appropriate for the intended use and if they are validated see 7.
Records of the verification shall be maintained. The laboratory shall record the results obtained. If the method is revised. NOTE 2 The techniques used for the determination of the performance of a method can be one of. These records shall include: If the laboratory has conducted or directed the sampling stage.
Once received into the laboratory. The sampling plan and procedures shall be available at the site where sampling is undertaken.
Sampling plans shall. The laboratory shall have a sampling plan and procedures for sampling when it carries out sampling of substances.
All alterations to records shall be traceable. When the customer requires the deviating item to be tested or calibrated the laboratory shall include a disclaimer in the report or certificate indicating that the results may be compromised. The records shall include the identity of personnel responsible for each laboratory activity and checking of results.
The identification shall be retained while the item is under the responsibility of the laboratory. NOTE In certain fields it can be impossible or impractical to retain records of all original observations. Special care shall be taken to avoid deterioration. The system shall. The system shall be designed and operated so as to ensure that items cannot be confused physically or when referred to in records or other documents.
Original observations. When there is doubt about the suitability of an item for test or calibration. Handling instructions provided with the item shall be followed.
The laboratory shall document the basis upon which the opinions and interpretations have been made. The resulting data shall be recorded in such a way that trends are detectable and. In certain cases. Reasonable estimation shall be based on knowledge of the performance of the method and on the measurement scope and shall make use of.
ISO Guide 33 provides guidance on the selection and use of reference materials.
NOTE 1 In those cases where a well-recognized test method specifies limits to the values of the major sources of uncertainty of measurement and specifies the form of presentation of calculated results.
In such cases the laboratory shall at least attempt to identify all the contributions to the uncertainty of measurement and make a reasonable estimation of their magnitude. This monitoring shall be planned and reviewed and shall include. NOTE 7. Analysis of the results Statements of conformity When statement of conformity to a specification or standard for test or calibration is requested.
NOTE 2 The test reports or calibration certificates may be issued hard copy or by electronic provided that the requirements of this International Standard are met. If the results of the analyses are found to be outside pre-defined criteria.
All issued test reports or calibration certificates shall be maintained as technical records. NOTE 1 For the purpose of this International Standard test reports and calibration certificates are sometimes called test certificates and calibration reports. Any information listed in 7.
NOTE It is recommended that laboratories include a statement specifying that the test report or calibration certificate shall not be reproduced except in full. When data is provided by the customer there shall be clear identification of it. In addition. If a statement of conformity with a specification is made.
When statements of conformity are made. NOTE According to ISO Guide 99 a measurement result is generally expressed as a single measured quantity value including unit of measurement and a measurement uncertainty. Information on measurement uncertainty is needed in test reports when it is relevant to the validity or application of the test results.
When a statement of conformity with a specification is made omitting the measurement results and associated uncertainties.
Upon receipt of a complaint. NOTE This requirement can be superseded by legal regulations. Such amendments shall meet all the requirements of this International Standard.. The laboratory shall be responsible for all levels of the handling process for complaints. NOTE In many cases it can be appropriate to communicate the opinions and interpretations by direct dialogue with the customer.
Such dialogue can be written down. NOTE Commercial off-the-shelf software in general use within its designed application range can be considered to be sufficiently validated. Whenever there are any changes. The procedures shall ensure that: Management requirements 8. Some of the requirements can be more applicable to computerized systems than to non-computerized systems. In addition to meeting the requirements of clauses 4 to 7 the laboratory shall implement a management system in accordance with option A or option B.
These may be on various media. The control of records is covered in 8. NOTE Documents. Control of documents is covered in 8. The control of data related to the laboratory activities is covered in 7. Actions to address risks and opportunities Option A 8. NOTE 1 Options to address risks can include identifying and avoiding threats. NOTE Examples of the types of feedback include customer satisfaction surveys and review of reports with customers.
NOTE 8. NOTE Opportunities for improvement can be identified through the review of the operational procedures. The feedback shall be analyzed and used to improve the management system.
Access to these records shall be consistent with the confidentiality arrangements and records shall be readily available.
The laboratory shall retain records for a period consistent with its contractual and legal obligations. NOTE 2 Opportunities can lead to expanding the scope of the laboratory activities. The laboratory shall identify and manage non-conformities in its operations.
The laboratory a determine the causes of non-conformity. Metrological traceability. Metrological traceability Informative With regards to the Annex A. Appropriate references include. The reported measurement uncertainty alone does not define the measurement accuracy. Annex A. The measurement accuracy is defined either as the corrected error together with the reported measurement uncertainty.
Individual calibration certificates issued by the BIPM are also listed.
International vocabulary of metrology — basic and general concepts and associated terms VIM as the property of a measurement result whereby the result can be related to a reference through a documented unbroken chain of calibrations. In practice primary measurement standards sit at the top of the traceability chain. National measurement standards are not necessarily primary standards.
ILAC and ISO Declaration on Metrological Traceability provides specific guidance when there is a need to demonstrate international acceptability of the metrological traceability chain. At the highest level. Both of these options may be taken as evidence of traceability. The National Metrology Institutes NMIs establish and maintain national measurement standards and disseminate metrological traceability via calibration and measurement services and certified reference materials.
These may be realized directly through a mise en pratique or established though a primary reference measurement procedure. Care has been taken to incorporate all those requirements of ISO that are relevant to the scope of laboratory activities that are covered by the laboratory's management system. Laboratories that implement option B of clause 8 will therefore also operate in accordance with ISO As a result.