This International Standard has been drawn up with the objective of promoting confidence in bodies performing inspection.
Inspection bodies carry out assessments on behalf of private clients, their parent organizations, or authorities, with the objective of providing information about the conformity of inspected items with regulations, standards, specifications, inspection schemes or contracts. Inspection parameters include matters of quantity, quality, safety, fitness for purpose, and continued safety compliance of installations or systems in operation. The general requirements with which these bodies are required to comply in order that their services are accepted by clients and by supervisory authorities are harmonized in this International Standard.
This International Standard covers the activities of inspection bodies whose work can include the examination of materials, products, installations, plants, processes, work procedures or services, and the determination of their conformity with requirements and the subsequent reporting of results of these activities to clients and, when required, to authorities. Inspection can concern all stages during the lifetime of these items, including the design stage. Such work normally requires the exercise of professional judgement in performing inspection, in particular when assessing conformity with general requirements.
Testing and calibration laboratories ISO/IEC 17025 enables laboratories to demonstrate that they operate competently and generate valid results, thereby promoting confidence in their work both nationally and around the world.
It also helps facilitate cooperation between laboratories and other bodies by generating wider acceptance of results between countries. Test reports and certificates can be accepted from one country to another without the need for further testing, which, in turn, improves international trade.
Conformity assessment — General requirements for bodies operating certification of persons This International Standard has been developed with the objective of achieving and promoting a globally accepted benchmark for organizations operating certification of persons. Certification for persons is one means of providing assurance that the certified person meets the requirements of the certification scheme. Confidence in the respective certification schemes for persons is achieved by means of a globally accepted process of assessment and periodic re-assessments of the competence of certified persons.
However, it is necessary to distinguish between situations where certification schemes for persons are justified and situations where other forms of qualification are more appropriate. The development of certification schemes for persons, in response to the ever increasing velocity of technological innovation and growing specialization of personnel, can compensate for variations in education and training and thus facilitate the global job market. Alternatives to certification can still be necessary in positions where public services, official or governmental operations are concerned.
Safety and quality are non-negotiable in the medical devices industry
Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery. Increasingly, organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do
ISO 31000, Risk management – Guidelines, provides principles, a framework and a process for managing risk. It can be used by any organization regardless of its size, activity or sector.
Using ISO 31000 can help organizations increase the likelihood of achieving objectives, improve the identification of opportunities and threats and effectively allocate and use resources for risk treatment.
ISO 41001:2018 specifies the requirements for a facility management (FM) system when an organization:
The requirements specified in ISO 41001:2018 are non-sector specific and intended to be applicable to all organizations, or parts thereof, whether public or private sector, and regardless of the type, size and nature of the organization or geographical location.
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