Additional requirements to EN ISO 9001

This page gives guidance on how to implement resolution BT 92/1994 (revised).

1 BACKGROUND

EN ISO 9001 is, by design, generic in nature and is intended to be used for all economic sectors. Some economic sectors, however, have considered it useful to develop additional requirements and/or specific guidance on the implementation of EN ISO 9001. Such documents have been developed and justified in different ways, and could undermine what the EN ISO 9000 series has achieved as the common denominator for quality assurance and as an instrument for global trade.
This could lead to problems for cooperation and dialogue, especially between economic sectors, and will not benefit industry and customers in the long run. Furthermore, it increases the complexity of the EN ISO quality requirements and because more quality audits are needed for companies working in different sectors, this also leads to added costs. It is clear that this proliferation of documents has to be addressed in order to ensure that the objectives of standardization are maintained and that the benefits of the quality systems are realised.

2 OBJECTIVES

• To maintain the integrity of the EN ISO 9001 clause and subclause structure; 
• To limit guidance or added requirements to specific sector objectives only; 
• To state the rules that have to be followed when preparing documents supplementary to or derived from EN ISO 9001.

3 APPLICATION

Resolution BT 92/1994 is applicable when the title, scope, content and/or subject of a new work item is related to the field of quality management systems.

4 IMPLEMENTATION

4.1 At definition stage

The Technical Committee (TC) and/or Working Group (WG) to which the work item has been assigned should:

• make sure that the proposed standard is in the field of quality management systems;
• clearly identify and justify the need for sector specific implementation guidance and/or supplementary requirements in the field of EN ISO 9001;

The inclusion within a quality management system of requirements for regulatory or safety systems should not be precluded.

• decide if the proposed standard will be: 
  o a guide to the implementation of EN ISO 9001; or 
  o a standard with supplementary requirements.

Supplementary requirements should be presented differently to guidance documents. The recommended titles are "Guidance on implementation of EN ISO 9001 for [sector xxx]" and "Supplementary requirements [and guidance] to EN ISO 9001 for [sector xxx]".

In the case of a guidance standard, the topics and related clauses on which guidance is needed should be identified. In the case of a standard with supplementary requirements to EN ISO 9001, these should be justified within the standard.

4.2 During the development stage

During the development stage it is recommended that:

• the new standard be related to a defined issue of EN ISO 9001; 
• as the final version of the guidance standard or the supplementary requirements standard will not include the full text of the original document, specific reference shall be made to the related (sub)clauses;
• the proposed standard will be reviewed regularly and at appropriate stages to ensure conformity to the resolution BT 92/1994.