Standards

This document specifies the general requirements for the competence, impartiality and consistent operation of laboratories. It is applicable to all organizations performing laboratory activities, regardless of the number of personnel.

Laboratory customers, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others use this document in confirming or recognizing the competence of laboratories.

This regional standard specifies requirements for a management system where a micros small and medium-sized enterprise needs to demonstrate its ability to consistently meet applicable requirements for quality, environmental and occupational safety and health; and aims to enhance its performance, through the process of continual improvement, assurance of conformity to applicable quality, environmental and occupational safety and health requirements, and the prevention of non-conformity by the application of this system.

 This standard specifies the general requirements for a laboratory safety management system, which will enable a laboratory to formulate a policy and objectives. It takes into account legislative requirements and information about significant risks, that the laboratory can control and over which  it can be expected to have an influence, to protect its employees and others, whose health and safety may be affected by the activities of the laboratory. 

This standard specifies the general requirements for a laboratory safety management system, which will enable a laboratory to formulate a policy and objectives, taking into account legislative requirements and information about significant risks, which the laboratory can control and over which it can be expected to have an influence, to protect its employees and others, whose health and safety may be affected by the activities of the laboratory. In addition this standard specifies specific requirements for medical laboratories. This standard is applicable to any laboratory that wishes to: (a) implement, maintain and improve an Occupational Safety and Health Management System; (b) assure itself of its conformance with its stated safety policy; and (c) make s self-determination and self –declaration of conformance with this standard.

This International Standard describes the fundamental concepts and principles of quality management which are universally applicable to the following: — organizations seeking sustained success through the implementation of a quality management system; — customers seeking confidence in an organization’s ability to consistently provide products and services conforming to their requirements; — organizations seeking confidence in their supply chain that product and service requirements will be met; — organizations and interested parties seeking to improve communication through a common understanding of the vocabulary used in quality management; — organizations performing conformity assessments against the requirements of ISO 9001; — providers of training, assessment or advice in quality management; — developers of related standards. This International Standard specifies the terms and definitions that apply to all quality management and quality management system standards developed by ISO/TC 176.

This International Standard specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. All the requirements of this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides. NOTE 1 In this International Standard, the terms “product” or “service” only apply to products and services intended for, or required by, a customer. NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements

This document gives guidelines for enhancing an organization’s ability to achieve sustained success. This guidance is consistent with the quality management principles given in ISO 9000:2015.

This document provides a self-assessment tool to review the extent to which the organization has adopted the concepts in this document. 

This document is applicable to any organization, regardless of its size, type and activity.

This International Standard provides guidelines beyond the requirements given in ISO 9001 in order to consider both the effectiveness and efficiency of a quality management system, and consequently the potential for improvement of the performance of an organization. When compared to ISO 9001, the objectives of customer satisfaction and product quality are extended to include the satisfaction of interested parties and the performance of the organization.

This International Standard is applicable to the processes of the organization and consequently the quality management principles on which it is based can be deployed throughout the organization. The focus of this International Standard is the achievement of ongoing improvement, measured through the satisfaction of customers and other interested parties.

This International Standard consists of guidance and recommendations and is not intended for certification, regulatory or contractual use, nor as a guide to the implementation of ISO 9001.

This Technical report provides guidelines for the development and maintenance of the documentation necessary to ensure an effective quality management system, tailored to the specific needs of the organization.  The use of these guidelines will aid in establishing a documented system as required by the applicable quality management system standard. This system as required by the applicable quality management system standard.  This Technical Report may be used to document management systems other than that of the ISO 9000 family, for example environmental management systems and safety management systems.

This International Standard gives guideline on the design and use of environmental performance evaluation within an organization . Its applicable to all organization, regardless of type , size, location and complexity. This international Standard does not establish environmental performance levels . It is not intended for use as a specification standard for certification or registration purposes or for the establishment of any other environmental management system conformance requirements.