A C D E F G I M O P Q S U V W
Qm Qu

QM handbook (QMH)

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

A qua­li­ty ma­nage­ment ma­nu­al (QM ma­nu­al) is a cen­tral do­cu­ment that de­scri­bes a company’s qua­li­ty ma­nage­ment sys­tem (QMS). It ser­ves as a gui­de­line for the im­ple­men­ta­ti­on and main­ten­an­ce of qua­li­ty ma­nage­ment and en­su­res that all re­le­vant pro­ces­ses, re­spon­si­bi­li­ties and pro­ce­du­res are cle­ar­ly de­fi­ned. The hand­book also re­flects the management’s at­ti­tu­de to qua­li­ty and de­scri­bes the re­sul­ting me­a­su­res to en­su­re pro­duct or ser­vice qua­li­ty. It also acts as an im­portant point of re­fe­rence for em­ployees and au­di­tors, pro­vi­ding a quick and com­pre­hen­si­ve over­view of the qua­li­ty ma­nage­ment system.

Why is a QM manual needed?

The main idea of a QM hand­book is to pro­vi­de a com­pact sum­ma­ry of the ma­nage­ment sys­tem in a cle­ar­ly de­fi­ned place wi­thin the com­pa­ny. It should be made available to every em­ployee in the same way as ap­pli­ca­ble do­cu­ments, such as pro­ce­du­ral and work in­s­truc­tions. It is also re­qui­red for the in­tro­duc­tion of par­ti­ci­pa­ting em­ployees and au­di­tors in or­der to be able to con­vey in­for­ma­ti­on and con­tent of the QM sys­tem in a bund­led form at short notice.

Is a QM handbook mandatory?

While the QM ma­nu­al was still es­sen­ti­al in EN ISO 9001, it is no lon­ger man­da­to­ry sin­ce the ISO 9001:2015 re­vi­si­on. This was pre­vious­ly the main tool used by com­pa­nies to map the QM sys­tem and thus the struc­tures and pro­ces­ses wi­thin the com­pa­ny. Com­pa­nies now de­ci­de for them­sel­ves which work­flows and pro­ces­ses are do­cu­men­ted in­tern­al­ly and how they break down and de­scri­be procedures.

Thus, the new ISO 9001:2015 al­lows a more mo­dern (most­ly IT-ba­sed), dy­na­mic and free do­cu­men­ta­ti­on of the QM sys­tem. Ho­we­ver, the exis­ting QM hand­book can be ad­apt­ed to the re­qui­re­ments of ISO 9001:2015 and con­ti­nue to func­tion as a mo­ti­va­tio­nal and in­for­ma­ti­on tool.

What does a QM handbook contain? 

In ad­di­ti­on to in­for­ma­ti­on on the qua­li­ty po­li­cy and qua­li­ty ob­jec­ti­ves, a QM hand­book also con­ta­ins an over­view of:

  • Struc­tu­re of the com­pa­ny organisation
  • As­si­gned ro­les wi­thin the QM system
  • Do­cu­ment ar­ran­ge­ment of the QM system
  • Pro­cess instructions
  • In­s­truc­tions on work, safe­ty and testing
  • Qua­li­ty records

What are the advantages of a QM handbook?

  • It ser­ves to pre­sent the company’s own QM sys­tem to the out­side world in terms of cer­ti­fi­ca­ti­on and sa­les promotion
  • It is a ve­hic­le for con­ti­nuous qua­li­ty im­pro­ve­ment, which is con­stant­ly be­ing de­ve­lo­ped th­rough the ex­pli­cit ana­ly­sis and de­scrip­ti­on of all qua­li­ty-re­la­ted processes.
  • It ser­ves as pro­of of the ef­fec­ti­ve­ness of me­a­su­res by me­ans of a 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

Your path to digitisation — Discover our software

Our di­gi­ti­sa­ti­on so­lu­ti­ons pri­ma­ri­ly ad­dress do­cu­ment-ba­sed pro­ces­ses in ma­nu­fac­tu­ring, pro­duc­tion, and qua­li­ty ma­nage­ment. The ba­sis of the dls | eQMS is a ho­li­stic ECM/DMS sys­tem. The ECM/DMS sys­tem can be con­nec­ted to your exis­ting ERP sys­tem (e.g. SAP) and, thus, map al­most all do­cu­ment-ba­sed pro­ces­ses in the company.

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

What is an electronic quality management handbook?

As di­gi­ta­li­sa­ti­on pro­gres­ses, more and more com­pa­nies are tur­ning to elec­tro­nic qua­li­ty ma­nage­ment hand­books. The­se of­fer the ad­van­ta­ge of easy up­dating, bet­ter ac­ces­si­bi­li­ty, and in­te­gra­ti­on into exis­ting IT sys­tems such as ERP or DMS. An elec­tro­nic QMH makes it pos­si­ble to track ch­an­ges in real time and en­su­re that all em­ployees al­ways have ac­cess to the la­test information.

Best practices for an effective quality management handbook

  • Cla­ri­ty and com­pre­hen­si­bi­li­ty: The hand­book should be writ­ten in a clear and com­pre­hen­si­ble lan­guage to avo­id misunderstandings.
  • Re­gu­lar up­dates: A QMH must be re­gu­lar­ly re­view­ed and up­dated in or­der to com­ply with cur­rent stan­dards and com­pa­ny processes.
  • Em­ployee par­ti­ci­pa­ti­on: In­vol­ving em­ployees in the crea­ti­on and main­ten­an­ce of the QMH pro­mo­tes qua­li­ty awa­re­ness and ac­cep­tance wi­thin the company.
  • Au­dit and mo­ni­to­ring me­cha­nisms: Re­gu­lar au­dits and mo­ni­to­ring en­su­re that the qua­li­ty ma­nage­ment hand­book (QM hand­book) is im­ple­men­ted and used effectively.

Conclusion

A qua­li­ty ma­nage­ment hand­book (QMH) is an in­dis­pensable tool for any com­pa­ny that wants to main­tain and con­ti­nuous­ly im­pro­ve its qua­li­ty stan­dards. It ser­ves as a com­pre­hen­si­ve re­sour­ce for all qua­li­ty-re­le­vant pro­ces­ses and me­a­su­res. The in­tro­duc­tion of an elec­tro­nic QMH of­fers ad­di­tio­nal ad­van­ta­ges such as simp­le up­dates and bet­ter ac­ces­si­bi­li­ty. Th­rough re­gu­lar re­views and em­ployee in­vol­vement, the QMH en­su­res that qua­li­ty tar­gets are met and stan­dards are ad­he­red to, which ul­ti­m­ate­ly helps to streng­then com­pe­ti­ti­ve­ness and cus­to­mer confidence. 

Start your digital transformation with our powerful, modular software solutions

Frequently Asked Questions (FAQs)

What are the ba­sic ele­ments of a QM manual?

The QM ma­nu­al com­pri­ses se­ve­ral ba­sic ele­ments of qua­li­ty ma­nage­ment. The­se include:

  • QM po­li­cy and objectives
  • De­scrip­ti­on of the main pro­ces­ses and their interactions
  • Ro­les and responsibilities
  • Pro­ce­du­re for do­cu­ment control
  • Me­thods for mo­ni­to­ring and me­a­su­ring qua­li­ty performance

What is the aim of a qua­li­ty ma­nage­ment handbook?

  • The aim of a qua­li­ty ma­nage­ment hand­book is to pro­vi­de a cen­tral re­fe­rence for all aspects of qua­li­ty ma­nage­ment wi­thin an or­ga­niza­ti­on. It ser­ves to en­su­re con­sis­ten­cy and trans­pa­ren­cy by pro­vi­ding clear in­s­truc­tions for qua­li­ty con­trol and improvement.

What is the struc­tu­re of a qua­li­ty ma­nage­ment manual?

The struc­tu­re of a qua­li­ty ma­nage­ment ma­nu­al can vary, but it ty­pi­cal­ly con­sists of the fol­lo­wing sections:

  1. In­tro­duc­tion and scope of application
  2. Mis­si­on state­ment and qua­li­ty objectives
  3. Over­view of core pro­ces­ses and procedures
  4. Re­spon­si­bi­li­ties and competencies
  5. Do­cu­ment con­trol and records
  6. Cor­rec­ti­ve and pre­ven­ti­ve ac­tions (CAPA)
  7. Mo­ni­to­ring, me­a­su­re­ment and analysis

What is the dif­fe­rence bet­ween a QM ma­nu­al and a QM ma­nage­ment manual?

  • The terms QM ma­nu­al and QM ma­nage­ment ma­nu­al are of­ten used in­ter­ch­an­ge­ab­ly. Both re­fer to the cen­tral do­cu­ment that de­scri­bes the gui­de­lines and pro­ce­du­res of the qua­li­ty ma­nage­ment sys­tem. Ho­we­ver, the term “QM ma­nage­ment ma­nu­al” em­pha­si­zes the ma­nage­ment aspects and the stra­te­gic si­gni­fi­can­ce of the QMS wi­thin the organization.

Why is a qua­li­ty ma­nage­ment hand­book important?

  • A qua­li­ty ma­nage­ment hand­book is im­portant be­cau­se it forms the ba­sis for a company’s qua­li­ty ma­nage­ment sys­tem. It helps to set and main­tain uni­form qua­li­ty stan­dards, en­su­re com­pli­ance with le­gal and re­gu­la­to­ry re­qui­re­ments and pro­mo­te con­ti­nuous improvement.

What does the QM do­cu­men­ta­ti­on contain?

  • The QM do­cu­men­ta­ti­on de­fi­ni­ti­on re­fers to all do­cu­men­ted in­for­ma­ti­on that is ne­ces­sa­ry to sup­port and ve­ri­fy the qua­li­ty ma­nage­ment sys­tem. This in­cludes the QM ma­nu­al, pro­cess de­scrip­ti­ons, pro­ce­du­ral in­s­truc­tions, work in­s­truc­tions, forms and records.

What are the be­ne­fits of a well-struc­tu­red QM ma­nage­ment ma­nu­al for companies?

A well-struc­tu­red QM ma­nage­ment ma­nu­al of­fers num­e­rous advantages:

  • In­creased ef­fi­ci­en­cy th­rough clear and stan­dar­di­zed processes
  • Im­pro­ving pro­duct qua­li­ty and safety
  • Fa­ci­li­ta­te the trai­ning of new employees
  • Sup­port with in­ter­nal and ex­ter­nal audits
  • Com­pli­ance with le­gal and re­gu­la­to­ry requirements

Share now!

Subscribe to the newsletter

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

You are currently viewing a placeholder content from Brevo. To access the actual content, click the button below. Please note that doing so will share data with third-party providers.

More Information

Device Master Record (DMR)

De­fi­ni­ti­on of the term (“What is a De­vice Mas­ter Re­cord?”) A De­vice Mas­ter Re­cord is a tech­ni­cal pro­duct file with a com­pi­la­ti­on of do­cu­ments and

Glossary contribution on the topic of document management

Document management

De­fi­ni­ti­on of the term (“What is do­cu­ment ma­nage­ment?”) Do­cu­ment ma­nage­ment re­fers to the pro­cess of crea­ting, or­ga­ni­s­ing, sto­ring and ma­na­ging do­cu­ments in di­gi­tal or physical