EN 13980:2002

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system
  4.1 General requirements
  4.2 Documentation requirements
      4.2.1 General
      4.2.2 Quality manual
      4.2.3 Control of documents
      4.2.4 Control of quality records
5 Management responsibility
  5.1 Management commitment
  5.2 Customer focus
  5.3 Quality policy
  5.4 Planning
      5.4.1 Quality objectives
      5.4.2 Quality management system planning
  5.5 Responsibility, authority and communication
      5.5.1 Responsibility and authority
      5.5.2 Management representative
      5.5.3 Internal communication
  5.6 Management review
      5.6.1 General
      5.6.2 Review input
      5.6.3 Review output
6 Resource management
  6.1 Provision of resources
  6.2 Human resources
      6.2.1 General
      6.2.2 Competence, awareness and training
  6.3 Infrastructure
  6.4 Work environment
7 Product realisation
  7.1 Planning of product realisation
  7.2 Customer-related processes
      7.2.1 Determination of requirements related to the
            product
      7.2.2 Review of requirements related to the product
      7.2.3 Customer communication
  7.3 Design and development
  7.4 Purchasing
      7.4.1 Purchasing process
      7.4.2 Purchasing information
      7.4.3 Verification of purchased product
  7.5 Production and service provision
      7.5.1 Control of production and service provision
      7.5.2 Validation of processes for production and
            service provision
      7.5.3 Identification and traceability
      7.5.4 Customer property
      7.5.5 Preservation of product
  7.6 Control of monitoring and measuring devices
8 Measurement, analysis and improvement
  8.1 General
  8.2 Monitoring and measurement
      8.2.1 Customer satisfaction
      8.2.2 Internal audit
      8.2.3 Monitoring and measurement of processes
      8.2.4 Monitoring and measurement of product
  8.3 Control of non-conforming product
  8.4 Analysis of date
  8.5 Improvement
      8.5.1 Continual improvement
      8.5.2 Corrective action
      8.5.3 Preventive action
Annex A (informative) Information relevant to particular
         types pf protection
Annex B (informative) Verification criteria for sintered
         components used as an integral part of a type of
         protection
Annex ZA (informative) Clauses of this European standard
         addressing essential requirements or other provisions
         of EU Directives
Bibliography

1.1GeneralThis European Standard specifies particular requirements and information for establishing and maintaining a quality system in accordance with the requirements of Annex IV and Annex VII of Directive 94/9/EC.It is intended for use by manufacturers, notified bodies and regulatory authorities.Therefore, when notified bodies assess the quality systems of manufacturers this document is intended to be the basis of the initial assessment and subsequent visits.1.2ApplicationOnly those requirements in clause 7 of this European Standard pertaining to the difference between Annex IV and VII of the Directive may be excluded, provided that conformity of the product can still be demonstrated.Permissible exclusions with respect to Annex VII of Directive 94/9/EC are as follows:7.1Planning of product realisation;7.2.3Customer communication;7.4Purchasing;7.5.1Control of production and service provision;7.5.2Validation of processes for production and service provision;7.5.3Identification and traceability.No explicit requirements in Annex IV and VII relate to the concept of "continuous improvement". As a consequence, references in this European Standard to the requirements of EN¬ ISO¬ 9001:2000 exclude this concept.