ISO 9001:2015 pdf free.Quality management systems – Requirements.
ISO 9001 specifics requirements for a quality management system when an organization:
a) needs to demonstrate its ability to consistently provide product or service that meets customer and applicable statutory and regulatory requirements. and
b) aims to enhance customer satisfaiion 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 requirements of this International Standard are generic and are intended to be applicable to all organizations. regardless of type. size and product and service provided.
NOTE I In this International Standard, the terms ‘product” or service” only apply to products and services intended for, or required by. a customer.
NOTE 2 Stacutor and regulator> requirements can be expressed as legal requirenienis.
2 ormative references
The following documents, in whole or in part. are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 9000:2015, Quality nlunai,’enu’nI wssern.s — ha,,4an,rnzats and ivcabulan
3 Terms and definitions
For the purposes of this document, the tcnns and dclinitions given in ISO 9000:20l5 apply.
4 Context of the organization
4.1 Understanding the organization and its context
The organhzalion shall detennine external and internal issues that are relevant to its purpose and uts strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.
The organization ha1l nioniror and review information about these external and internal issues.
4.2 Understanding the needs and expectations of interested parties
Due to their effect or potential effect on the organizations ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements. the organization shall determine:
a) the interested parties that are relevant to the quality management system;
b) the requirements of these interested parties that are relevant to the quality management system.
The organization shall monitor and review information about these interested panics and their relevant requirements.
4.3 Determining the scope of the quality management system
The organization shall determine the boundaries and applicability of the quality management system to establish its scope.
When determining this scope. the organization shall consider:
a) the external and internal issues referred to in 4.1;
b) the requirements of relevant interested parties referred to in 4.2;
c) the products and services of the organization.
The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system.
The scope of the organization’s quality management system shall be available and be maintained as dwumented information.
The scope shall state the types of products and services covered,and provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system.
Conformity to this International Standard may only be claimed if the requirements determined as not being applicable do not affect the organization’s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction.ISO 9001 pdf download.