SS ISO 9000:2015 — Quality management systems — Fundamentals and vocabulary
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.
SS ISO 9001:2015 — Quality management systems — Requirements
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.
SS ISO 9004:2018 — Quality management — Quality of an organization — Guidance to achieve sustained success
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.
SS ISO 45001:2018 — Occupational health and safety management systems — Requirements with guidance for use
This document specifies requirements for an occupational health and safety (OH&S) management system, and gives guidance for its use, to enable organizations to provide safe and healthy workplaces by preventing work-related injury and ill health, as well as by proactively improving its OH&S performance.
This document is applicable to any organization that wishes to establish, implement and maintain an OH&S management system to improve occupational health and safety, eliminate hazards and minimize OH&S risks (including system deficiencies), take advantage of OH&S opportunities, and address OH&S management system nonconformities associated with its activities.
This document helps an organization to achieve the intended outcomes of its OH&S management system.
Consistent with the organization’s OH&S policy, the intended outcomes of an OH&S management system include:
- a) continual improvement of OH&S performance;
- b) fulfilment of legal requirements and other requirements;
- c) achievement of OH&S objectives.
This document is applicable to any organization regardless of its size, type and activities. It is applicable to the OH&S risks under the organization’s control, taking into account factors such as the context in which the organization operates and the needs and expectations of its workers and other interested parties.
This document does not state specific criteria for OH&S performance, nor is it prescriptive about the design of an OH&S management system.
This document enables an organization, through its OH&S management system, to integrate other aspects of health and safety, such as worker wellness/wellbeing.
This document does not address issues such as product safety, property damage or environmental impacts, beyond the risks to workers and other relevant interested parties.
This document can be used in whole or in part to systematically improve occupational health and safety management. However, claims of conformity to this document are not acceptable unless all its requirements are incorporated into an organization’s OH&S management system and fulfilled without exclusion.
SS ISO/IEC 17021-1:2015 — Conformity assessment — Requirements for bodies providing audit and certification of management systems —
Part 1: Requirements
This part of ISO/IEC 17021 contains principles and requirements for the competence, consistency and impartiality of bodies providing audit and certification of all types of management systems.
Certification bodies operating to this part of ISO/IEC 17021 do not need to offer all types of management system certification.
Certification of management systems is a third-party conformity assessment activity (see ISO/IEC 17000:2004, 5.5) and bodies performing this activity are therefore third-party conformity assessment bodies.
NOTE 1 Examples of management systems include environmental management systems, quality management systems and information security management systems.
NOTE 2 In this part of ISO/IEC 17021, certification of management systems is referred to as “certification” and third-party conformity assessment bodies are referred to as “certification bodies”.
NOTE 3 A certification body can be non-governmental or governmental, with or without regulatory authority.
NOTE 4 This part of ISO/IEC 17021 can be used as a criteria document for accreditation, peer assessment or other audit processes.
SS ISO/IEC 17025:2017 — General requirements for the competence of testing and calibration laboratories
This document specifies the general requirements for the competence, impartiality and consistent operation of laboratories.
This document 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.