Quality management handbook

Definition of the term („What is a quality management handbook?“)

The qua­li­ty ma­nage­ment ma­nu­al ser­ves as an in­ter­nal com­pi­la­ti­on and re­cord of the qua­li­ty ma­nage­ment sys­tem of a com­pa­ny. It de­scri­bes the ma­nage­ment po­li­cy on qua­li­ty im­ple­men­ted in the com­pa­ny as well as the re­sul­ting mea­su­res. Mo­reo­ver, it ope­ra­tes as an ent­ry point for em­ployees and au­di­tors to get a quick over­view of the QM system.

What is a QM handbook used for?

The ge­ne­ral idea of a QM hand­book is to brief­ly sum­ma­ri­ze the ma­nage­ment sys­tem at a cen­tral lo­ca­ti­on in the com­pa­ny. Thus, it should be pro­vi­ded to the en­t­i­re staff tog­e­ther with all fur­ther ap­p­li­ca­ble do­cu­ments and work in­st­ruc­tions. Mo­reo­ver, it is re­qui­red for the on­boar­ding of af­fec­ted em­ployees and au­di­tors al­lowing to quick­ly and con­cise­ly pro­vi­de in­for­ma­ti­on on and con­tents of the QM system.

Is a QM handbook mandatory?

While the QM hand­book was still in­dis­pensable on EN ISO 9001, it is no lon­ger ur­gent­ly re­qui­red sin­ce the re­vi­si­on ISO 9001:2015. Pre­vious­ly, it was the main in­stru­ment al­lowing com­pa­nies to il­lus­tra­te the struc­tures and pro­ce­du­res wi­t­hin the com­pa­ny. Now, com­pa­nies de­ci­de them­sel­ves, which pro­ce­du­res and pro­ces­ses are in­tern­al­ly do­cu­men­ted and how they struc­tu­re and de­scri­be pro­ce­du­res. The new ISO 9001:2015 thus al­lows for a more mo­dern (main­ly IT-ba­sed) dy­na­mic and fle­xi­ble re­cord­ing of the QM sys­tem. Howe­ver, the exis­ting QM hand­book can be ad­jus­ted to the re­qui­re­ments of the ISO 9001:2015 and still ser­ve as mo­ti­va­ti­on and information.

What does a QM handbook have to include?

Apart from the in­for­ma­ti­on on the qua­li­ty po­li­cy and the qua­li­ty goals, a QM hand­book con­tans an over­view of:

  • Struc­tu­re of the com­pa­ny organization
  • Ro­les as­si­gned wi­t­hin the QM system
  • Do­cu­ments as­si­gned in the QM system
  • pro­cess instructions
  • Work, safe­ty and test instructions
  • Qua­li­ty records

Benefits of a QM handbook

A QM hand­book is an es­sen­ti­al part of a pro­per do­cu­ment con­trol. Every step, from crea­ti­on to fi­nis­hing and pa­ck­a­ging, can be pre­sen­ted in a com­pre­hen­si­ble man­ner so that po­ten­ti­al sources of er­ror can be iden­ti­fied at an ear­ly sta­ge. The­re­fo­re, a com­pa­ny should have a qua­li­ty ma­nage­ment sys­tem (QMS) to po­si­ti­on its­elf as a com­pe­ti­ti­ve company.

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GxP

All gui­de­li­nes for good working prac­ti­ce, which are par­ti­cu­lar­ly im­portant in me­di­ci­ne, phar­ma­cy and phar­maceu­ti­cal che­mi­stry, are sum­ma­ri­sed by the ab­bre­via­ti­on GxP. The “G” stands for

Quality management handbook

De­fi­ni­ti­on of the term („What is a qua­li­ty ma­nage­ment hand­book?“) The qua­li­ty ma­nage­ment ma­nu­al ser­ves as an in­ter­nal com­pi­la­ti­on and re­cord of the qua­li­ty management