CEN/SS F20 - Quality assurance

ISO 9004:2018 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.
ISO 9004:2018 provides a self-assessment tool to review the extent to which the organization has adopted the concepts in this document.
ISO 9004:2018 is applicable to any organization, regardless of its size, type and activity.

ISO 15378:2017 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.
In addition to ISO 9001, this document specifies Good Manufacturing Practice (GMP) requirements applicable to primary packaging materials for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards.
In ISO 15378:2017 the term "if appropriate" is used several times. When a requirement is qualified by this phrase, it is deemed to be "appropriate" unless the organization can document a justification otherwise.
ISO 15378:2017 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products.

ISO 9001:2015 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 ISO 9001:2015 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.

ISO 9000:2015 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 their 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.
ISO 9000:2015 specifies the terms and definitions that apply to all quality management and quality management system standards developed by ISO/TC 176.

ISO 10012:2003 specifies generic requirements and provides guidance for the management of measurement processes and metrological confirmation of measuring equipment used to support and demonstrate compliance with metrological requirements. It specifies quality management requirements of a measurement management system that can be used by an organization performing measurements as part of the overall management system, and to ensure metrological requirements are met.
ISO 10012:2003 is not intended to be used as a requisite for demonstrating conformance with ISO 9001, ISO 14001 or any other standard. Interested parties can agree to use ISO 10012:2003 as an input for satisfying measurement management system requirements in certification activities. Other standards and guides exist for particular elements affecting measurement results, for example, details of measurement methods, competence of personnel, interlaboratory comparisons.
ISO 10012:2003 is not intended as a substitute for, or as an addition to, the requirements of ISO/IEC 17025.

ISO 10012:2003 specifies generic requirements and provides guidance for the management of measurement processes and metrological confirmation of measuring equipment used to support and demonstrate compliance with metrological requirements. It specifies quality management requirements of a measurement management system that can be used by an organization performing measurements as part of the overall management system, and to ensure metrological requirements are met.
ISO 10012:2003 is not intended to be used as a requisite for demonstrating conformance with ISO 9001, ISO 14001 or any other standard. Interested parties can agree to use ISO 10012:2003 as an input for satisfying measurement management system requirements in certification activities. Other standards and guides exist for particular elements affecting measurement results, for example, details of measurement methods, competence of personnel, interlaboratory comparisons.
ISO 10012:2003 is not intended as a substitute for, or as an addition to, the requirements of ISO/IEC 17025.

Migrated from Progress Sheet (TC Comment) (2000-07-10): Revision of EN ISO 9004-1, incorporating 9004-2,-3,-4 and -8 (CC/981112)

Migrated from Progress Sheet (TC Comment) (2000-07-10): Revision of ISO 8402:1994, incorporating ISO 9000-1, -2, -3 and -4 (CC/981112)

ISO 19011:2011 provides guidance on auditing management systems, including the principles of auditing, managing an audit programme and conducting management system audits, as well as guidance on the evaluation of competence of individuals involved in the audit process, including the person managing the audit programme, auditors and audit teams.
ISO 19011:2011 is applicable to all organizations that need to conduct internal or external audits of management systems or manage an audit programme.
The application of ISO 19011:2011 to other types of audits is possible, provided that special consideration is given to the specific competence needed.

ISO 9004:2009 provides guidance to organizations to support the achievement of sustained success by a quality management approach. It is applicable to any organization, regardless of size, type and activity.
ISO 9004:2009 is not intended for certification, regulatory or contractual use.

ISO 15378:2015 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials.

ISO 15378:2011 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials.
ISO 15378:2011 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes.

ISO - Taking over of an ISO Technical Corrigendum

ISO 9001:2008 specifies requirements for a quality management system where an organization
needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
All requirements of ISO 9001:2008 are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
Where any requirement(s) of ISO 9001:2008 cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.
Where exclusions are made, claims of conformity to ISO 9001:2008 are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.

ISO 9000:2005 describes fundamentals of quality management systems, which form the subject of the ISO 9000 family, and defines related terms.
It is applicable to the following:
a) organizations seeking advantage through the implementation of a quality management system;
b) organizations seeking confidence from their suppliers that their product requirements will be satisfied;
c) users of the products;
d) those concerned with a mutual understanding of the terminology used in quality management (e.g. suppliers, customers, regulators);
e) those internal or external to the organization who assess the quality management system or audit it for conformity with the requirements of ISO 9001 (e.g. auditors, regulators, certification/registration bodies);
f) those internal or external to the organization who give advice or training on the quality management system appropriate to that organization;
g) developers of related standards.

ISO 19011:2002 provides guidance on the principles of auditing, managing audit programmes, conducting quality management system audits and environmental management system audits, as well as guidance on the competence of quality and environmental management system auditors.
It is applicable to all organizations needing to conduct internal or external audits of quality and/or environmental management systems or to manage an audit programme.
The application of ISO 19011 to other types of audits is possible in principle provided that special consideration is paid to identifying the competence needed by the audit team members in such cases.

ISO 15378:2006 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials.
ISO 15378:2006 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes.

Migrated from Progress Sheet (TC Comment) (2000-07-10): Revision of EN ISO 9001:1994, incorporating EN ISO 9002 and EN ISO 9003 ++ (CC/981112) ++ Resolution BT 59/1999 : · the relationship between EN ISO 9001: 2000 and modules ++ H, D and E - as defined in Council decision 93/465/EEC - shall be described in a ++ European foreword (an option preferred to an informative annex), in line with ++ the request of the mandate. This foreword is to be drafted by BT/WG 107, and is ++ to be circulated for comments to CEN member bodies in parallel with the enquiry on prEN ISO 9001:2000. (MCH 2000-01-20)

Migrated from Progress Sheet (TC Comment) (2000-07-10): Created after request of P. Pieters (961220) VA/ISO.

RESOLUTION BT C03/2003: EN ISO 10007:1996 WILL BE WITHDRAWN AND WILL NOT BE SUPERSEDED ONCE THE NEW EDITION OF ISO 10007 (WI CSF20043) BECOMES AVAILABLE (NT/030321).