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GOOD HOSPITAL PRACTICE

GOOD HOSPITAL PRACTICE

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QM according to DIN EN 15224 / ISO 9001

3.7.02 QM manual - document control

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Goal and purpose

The hospital's procedural instructions and work instructions must be continuously maintained. Standardised formats must be defined for the creation and management of documents. The documents must be checked for compatibility with existing rules before they come into force. It must be ensured that all QM manuals issued participate in the amendment service.

When managing in a content management system (CMS), the following must be ensured - * Proof of validity

  • Findability
  • Retention periods
  • Archiving and protection against loss and tampering
  • Readability, dating, revision data, identifiability
  • Authorisation status
  • Control of authorisation, issue, distribution, revision, collection of the previous version
  • Release, availability
  • The documents should be understood and acceptable
  • Procedure for the revision
  • Removal of obsolete documents

The manual is preceded by an explanation of the scope of application and the exemption provisions

Area of application

Management of the QM manual in paper form and as a CMS.

Description of the

Resources

conSense GmbH

iqs Software GmbH

QM practices

QM Pilot

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