Information concerning DIN EN ISO 9001

The aims of DIN EN ISO 9001 are:

  • continual improvement of quality management (QM) systems and thus of products and services in order to increase customer satisfaction;
  • QM systems based on organisations' processes; and
  • QM system design based on the following eight management principles:
    • Customer focus
    • Leadership
    • Involvement of people
    • Process approach
    • System approach to management
    • Continual improvement
    • Factual approach to decision-making
    • Mutually beneficial supplier relationships

General structure

The standard is divided into the following four areas:

  • Management responsibility
  • Resource management
  • Product realisation
  • Measurement, analysis and improvement

Key points

The key points specified in the standard are set out below. (The numbers in brackets refer to the relevant clauses in the standard):

Requirements relating to the QM system (4.1)

  • The business processes and the interaction between them must be described
  • Processes and their results must be measured, monitored and analysed

    This can be done, for example, by means of a matrix in which the documented procedures are assigned to the processes. The procedures must be monitored using, for example, indicators.

Customer focus (5.2, 7.2.1, 5.5.2)

  • Customer needs must be determined and translated into internal requirements
    Goal: Customer satisfaction
  • The following requirements must be taken into account:
    • Customer requirements relating to the product, availability, delivery and support
    • Other requirements necessary for the product's purpose
    • Statutory and other requirements The "Management representative" must promote awareness of the customer requirements within the organisation.

Quality policy and objectives (5.5.3, 5.4.1)

  • The quality policy must be reviewed to ensure continuing suitability and the documents required for this purpose must be controlled.
  • Measurable quality objectives, aimed at continual improvement, must be specified.

Quality planning (5.4.2)

  • There is a requirement to determine the processes and the resources needed and to plan and document them and the continual improvement of the quality management system in order to achieve the quality objectives.

Internal communication (5.5.3, 4.2.3)

  • Communication with regard to the processes must be ensured between the various levels and functions. The output from the preceding process is the input for the following process.

Reviewing the QM system (5.6)

  • The review should cover the following:
    • Results of audits and customer feedback
    • Process performance and product conformity
    • Preventive and corrective actions
    • Follow-up actions from previous reviews
    • Changes that could affect the QM system

Resource management (6.1, 6.2)

  • The resources needed to implement and improve the processes and to ensure customer satisfaction must be determined and provided.
  • The effectiveness of training must be reviewed.
  • It must be ensured that the employees are aware of the relevance of their activities.

Customer requirements (7.2)

  • These include both requirements stated and not stated by the customer with regard to the product plus regulatory or statutory requirements and
  • arrangements for communicating with customers (product information, order handling and customer complaints).

Design and development (7.3)

  • Where design and development changes are made, the effects on products already delivered must also be evaluated.

Purchasing (7.4)

  • Supplier evaluation must be carried out in accordance with specified criteria.

Measurement, analysis and improvement (8)

  • Measurement and monitoring of processes
  • Measurement of customer satisfaction
  • Analysis of data
  • Continual improvement by means of audits, analysis of data, corrective and preventive actions and management reviews.

Creating a new QM system

Once the business processes have been identified and described, they should be checked against the individual requirements set out in the standard. Valuable information on possibilities for implementation can be found in ISO 9004 "Managing for the sustained success of an organization".

Using an existing QM system to set up a QM system conforming to ISO 9001

Organisations that already have a QM system also have to identify and describe their business processes. This can be done using a flow chart, for instance. The existing documented procedures should then be assigned to the processes, any missing ones added and process reviews introduced. Once the processes have been checked against the individual requirements specified in the standard, additions also need to be made to the quality manual. The new standard requirements can be compared with those in the existing documentation by means, for example, of a matrix. Any forms, work instructions, inspection instructions, etc. already introduced can usually remain in use.

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