Professional Documents
Culture Documents
Standards of length were once represented by the distance between two marks on a solid metal bar. Copies of these standards were displayed in public places so that people could check the accuracy of the rules they were using.
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Kenneth Woolner of the University of Waterloo perpetuated a hoax in the April 1978 issue of CHEM 13 News
Woolner created the fictional character of Claude mile Jean-Baptiste Litre with a distinguished scientific career where he purportedly proposed a unit of volume measurement.
since no such person existed for "L", it seemed reasonable that one should be invented. Reg suggested that I should write a "biography" for the April issue of CHEM 13 NEWS, and over the course of an evening (which included, I think I recall, most of a bottle of scotch) we generated much of the substance of an 18th century life, full of drama, revolution and romance. Dr. Woolner , 1988
www.iso.org
ISO
International Organization for Standardization
Shouldn't the acronym be " IOS " ?
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ISO's name
"ISO" is a word, derived from the Greek isos, meaning "equal "
What is ISO ?
worldwide federation of national standards bodies from some 100 countries MISSION: to promote the development of standardization and related activities in the world to facilitating the international exchange of goods and services, and to developing cooperation in the spheres of intellectual, scientific, technological and economic activity
ISO's work results in international agreements which are published as International Standards.
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Main Products: International Standards. Other Publications: Technical Reports, Technical Specifications, Publicly Available Specifications, Technical Corrigenda, and Guides.[
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By default, the ISO Standards listing presents the complete listing of Published standards AND Standards under development..
The user chooses whether to access the listing By ICS (classified by subject in accordance with the International Classification for Standards) or By TC (sorted according to the ISO Technical Committee responsible for the preparation and/or maintenance of the standards
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Reference number
ISO[/IEC][/ASTM] [IS] nnnnn[:yyyy] Title, Where nnnnn is the number of the standard, yyyy is the year published, and Title describes the subject.
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ISO/IEC
ISO/IEC denotes a joint ISO and IEC (International Electrotechnical Commission) publication 1976 Agreement: the IEC covers the field of electrical and electronic engineering, all other subject areas being attributed to ISO When necessary, attribution of responsibility for work programmes to ISO or IEC is made by mutual agreement. In specific cases of mutual interest, joint technical bodies or working groups are set up.
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ISO/ASTM joint ISO and ASTM (American Society of Testing and Materials) International Standard
ISO/CIE: joint ISO and CIE (International Commission on Illumination) International Standard
ISO/HL7 joint ISO and HL7 (Health Level Seven) International Standard ISO/IEEE: joint ISO and IEEE (Institute of Electrical and Electronics Engineers) International Standard
ISO/OECD joint ISO and OECD (Organisation for Economic Cooperation and Development) International Standard
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2. Interpenetration of sectors
3. Worldwide communications systems 4. Global standards needs for emerging technologies
5. Developing countries
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organizing so that a concerted view of the country's interests is presented during international negotiations leading to standards agreements,
ensuring that a secretariat is provided for those ISO technical committees and subcommittees in which the country has an interest, providing their country's share of financial support for the central operations of ISO, through payment of membership dues.
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Consensus The views of all interests are taken into account Industry-wide Global solutions to satisfy industries and customers worldwide.
Voluntary International standardization is market-driven and therefore based on voluntary involvement of all interests in the market-place. .
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QUALITY
Quality is fitness for use. Juran [1988]
ISO 9001:2008 Quality management systems Requirements ISO 14001:2004 Environmental management systems - Requirements with guidance for use
ISO/IEC 27001:2005 Information technology - Security techniques Information security management systems Requirements
ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
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Laboratory Quality Management System: The operations or processes of the laboratory which define its policies and objectives and the manner in which they are implemented to ensure that the objectives are met. eg: ISO 9001:2000. www.iso.org Quality: The ability of the qualitative (analyte identification) and quantitative (accuracy, precision) data to satisfy the requirements of their purpose. The QA/QC(/QA) programme: The part of the laboratory management system that focuses on the quality of the data generated by the laboratory
Quality Assurance: Documented procedures in place within an analytical laboratory that define how the laboratorys work is to be conducted so as to be confident that the obtained data are of the required quality. QA consists of quality control and quality assessment activities. Quality Control: The practices and procedures that lead to the achievement of quality analytical data (suitable facilities, staff competence and training, good laboratory practices, standard operating and reporting procedures). Quality Assessment: The practices and the data generated by them that illustrate that the QC activities have been effected and that the data generated are of the quality required (SRMs, spiking, replicates, inter-laboratory comparisons, control charts, auditing, statistical analyses).
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ISO 17025 General Requirements for the competence of testing and calibration laboratories
1. Scope 1.1 applies to all laboratories (not just chemical) regardless of size. 1.4 this international standard is for use by laboratories in developing their quality, administrative and technical systems that govern their operations. Laboratory clients, regulatory authorities and accreditation bodies may also use it in confirming or recognizing the competence of laboratories.
2. Normative references
3. Terms and definitions Refer to ISO 9001:1994 , 9002:1994 and ISO/IEC Guide 2, These have now been incorporated into ISO 9000:2000, ISO 9001:2000.
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ISO 17025 General Requirements for the competence of testing and calibration laboratories (cont.)
4. Management requirements
4.1 Organization
The laboratory shall (amongst other things) be legally responsible; operate a management system covering work in the laboratories permanent facility and at sites away from its permanent facility (if relevant) have technical management with responsibility for the technical operations and the provision of resources have a quality manager with defined responsibility and authority for ensuring that the quality system is implemented and followed at all times
4.2 Quality System The laboratory shall (amongst other things) establish, implement and maintain a quality system (like ISO9001:2000) document its policies, systems, programmes, procedures and instructions the quality system policies, and objectives shall be defined in a quality manual include technical procedures.
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ISO 17025 General Requirements for the competence of testing and calibration laboratories (management requirements cont.)
4.10 Improvement
4.11 Corrective action 4.12 Preventative action 4.13 Control of records 4.14 Internal audits 4.15 Management reviews
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MANAGEMENT REQUIREMENTS
ISO 17025:2005
Related to the operation and effectiveness of the quality management system within the laboratory and has similar requirements to ISO 9001.
Divided into fifteen chapters
4.1 Organization
ISO 17025:2005
Ensures the roles and responsibilities of the laboratory and the management and key personnel are defined.
ISO 17025:2005
ISO 17025:2005
Ensure that all documents related to management system are uniquely identified and created, approved, issued and changed following documented procedures.
ISO 17025:2005
Ensure that requirements of requests, tenders and contracts are well defined, reviewed, understood and documented. Key points are:
1.4.1 The review by the laboratory supervisors should ensure that the laboratory has technical capability and the resources to meet the requirements. 1.4.2 Changes in contract should follow the same process as the initial contract.
ISO 17025:2005
Policies and procedures for situations when many aspect of work is problematic
4.10 Improvement
ISO 17025:2005
Continuous improvement of management systems -Quality Policy
-Quality Objectives
-Audit Results
-Analysis of Data
-Corrective and preventive actions
-Management Review
ISO 17025:2005
ISO 17025:2005
Key points
Procedures for identification, collection, indexing, storage, retrieval and disposal of records Storage of records such that its security, confidentiality, quality and integrity are ensured throughout the required retention time Technical records should be retained together with processing parameters
ISO 17025:2005
Ensure the continued suitability and effectiveness of the quality system, policies and testing and calibration procedures
ISO 17025:2005
Key points
Schedule and procedure for periodic management reviews Recommended review frequency is once a year Includes discussion on the outcome from recent internal audits and external assessments, corrective and preventive actions, results of proficiency testing, customer complaints and feedback and any recommendations for improvements Management should decide on follow-up activities
ISO 17025 General Requirements for the competence of testing and calibration laboratories (cont.) 5. Technical requirements 5.1 General 5.1.1 Many factors determine the correctness and reliability of the test and/or calibrations performed by a laboratory. These factors include contributions from: human factors,
ISO 17025 General Requirements for the competence of testing and calibration laboratories. (technical requirements cont.) 5.2 Personnel (competence, training, job descriptions, responsibilities) 5.3 Accommodation and environmental conditions (permanent and in the field, sterility , dust, temperature, vapors, access, ) 5.4 Test and calibration methods and method validation shall use appropriate methods and procedures including sampling, handling, transport, storage and preparation of items to be tested . shall use test and/or calibration methods, including methods of sampling, which meet the needs of the client and which are appropriate Methods published in international, regional or national standards shall preferably be used. shall confirm (verify) that it can properly operate standard methods before introducing the tests or calibrations.
ISO 17025 General Requirements for the competence of testing and calibration laboratories. (technical requirements cont.)
5.5 Equipment (scope, operation, maintenance, calibration) 5.6 Measurement traceability (calibrations to international standards; sample to result; reference standards and materials) 5.7 Sampling shall have a sampling plan and procedures for sampling sampling plans shall, whenever reasonable, be based on appropriate statistical methods. 5.8 Handling of test and calibration items (transportation, preservation, storage). 5.9 Assuring the quality of test and calibration results
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