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.

Your path to digitization — Discover our software

Our di­gi­ta­liza­ti­on so­lu­ti­ons pri­ma­ri­ly ad­dress do­cu­ment-ba­sed pro­ces­ses in ma­nu­fac­tu­ring, pro­duc­tion and qua­li­ty ma­nage­ment. The ba­sis of the dls | eQMS is an in­te­gra­ted ECM/DMS sys­tem. The ECM/DMS sys­tem can be lin­ked to your exis­ting ERP sys­tem (e.g. SAP), thus en­ab­ling you to im­ple­ment al­most all do­cu­ment-ba­sed pro­ces­ses in your company.

Live insight into the GxP-compliant document management system of Digital Life Sciences

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

  • It ser­ves for the ex­ter­nal pre­sen­ta­ti­on of the own QM sys­tem in the sen­se of the cer­ti­fi­ca­ti­on as well as the sa­les promotion.
  • It is used for con­ti­nuous qua­li­ty im­pro­ve­ment, which is con­ti­nuous­ly de­ve­lo­ped th­rough an ex­pli­cit ana­ly­sis and de­scrip­ti­on of all qua­li­ty-re­le­vant processes
  • It func­tions as pro­of of the ef­fec­ti­ve­ness of me­a­su­res by me­ans of target/actual comparison
  • It mo­ti­va­tes em­ployees, as they are ac­tively in­vol­ved in the crea­ti­on of a QM sys­tem and are thus mo­ti­va­ted to think and act in a qua­li­ty-con­scious manner.

Start your digital transformation with our powerful, modular software solutions

Share now!

Subscribe to the newsletter

You want to stay up to date? Then subscribe to our newsletter.

EU GMP Guidelines Chapter 4

De­fi­ni­ti­on of the term (“What is Chap­ter 4 of the EU GMP Gui­de?”) Chap­ter 4 of the EU GMP Gui­de fo­cu­ses on do­cu­men­ta­ti­on and re­cords in

Corrective action

De­fi­ni­ti­on of the term (“What is a cor­rec­ti­ve ac­tion?”) In ISO 9000, a cor­rec­ti­ve ac­tion is de­scri­bed as “ac­tion ta­ken to eli­mi­na­te the cau­se of