ISO 9001:2015

Definition of the term (“What is ISO 9001:2015?”)

ISO 9001:2015 is an in­ter­na­tio­nal stan­dard for qua­li­ty ma­nage­ment sys­tems. It spe­ci­fies the re­qui­re­ments that an or­ga­niza­ti­on must meet in or­der to im­ple­ment and main­tain an ef­fec­ti­ve qua­li­ty ma­nage­ment sys­temThis stan­dard ap­pli­es to or­ga­niza­ti­ons of all si­zes and in all in­dus­tries. It em­pha­si­zes the si­gni­fi­can­ce of cus­to­mer fo­cus, lea­der­ship, em­ployee en­ga­ge­ment, pro­cess ori­en­ta­ti­on, con­ti­nuous im­pro­ve­ment, and eva­lua­ti­on of risks and opportunities.

What requirements must organizations meet for ISO 9001:2015?

  • The spe­ci­fi­ca­ti­on of qua­li­ty ob­jec­ti­ves and the im­ple­men­ta­ti­on of me­a­su­res to achie­ve the­se objectives.
  • The im­ple­men­ta­ti­on of a do­cu­men­ted qua­li­ty ma­nage­ment sys­tem that de­fi­nes the pro­ces­ses and responsibilities.
  • Mo­ni­to­ring and me­a­su­ring pro­ces­ses to en­su­re they are effective.
  • Eva­lua­ting cus­to­mer re­qui­re­ments and en­su­ring cus­to­mer satisfaction.
  • The con­ti­nuous im­pro­ve­ment of pro­ces­ses and the qua­li­ty ma­nage­ment sys­tem as a whole.

What should be considered when implementing ISO 9001:2015?

  1. Lea­der­ship and en­ga­ge­ment: An  ef­fec­ti­ve lea­der­ship is the foun­da­ti­on of a suc­cessful QMS. 
  2. Plan­ning: Stra­te­gic plan­ning is cri­ti­cal to alig­ning your QMS with your organization’s goals. 
  3. Sup­port and re­sour­ces: To achie­ve qua­li­ty goals, you need the right re­sour­ces and support. 
  4. Ope­ra­ti­ons: Ef­fi­ci­ent ope­ra­tio­nal pro­ces­ses are the fo­cus of ISO 9001:2015. 
  5. Per­for­mance eva­lua­ti­on: Mo­ni­to­ring and me­a­su­ring per­for­mance is of cri­ti­cal significance. 
  6. Im­pro­ve­ment: Con­ti­nuous im­pro­ve­ment is key to main­tai­ning and im­pro­ving your QMS. 

Your path to digitization — Discover our software

Our di­gi­tiza­ti­on 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 are the benefits of an ISO 9001:2015 certification?

ISO 9001:2015 com­pli­ance can help com­pa­nies to im­pro­ve the qua­li­ty of their pro­ducts and ser­vices, re­du­ce cos­ts, build cus­to­mer trust, and in­crease their com­pe­ti­ti­ve­ness. It is im­portant to note that the stan­dard is up­dated re­gu­lar­ly, so or­ga­niza­ti­ons should en­su­re that they are al­ways using the la­test ver­si­on to meet the requirements.

What needs to be kept in mind with the latest revision of ISO 9001:2015?

The last re­vi­si­on of the stan­dard took place in 2015 (ISO 9001:2015). It is the fifth edi­ti­on of the ISO 9001 stan­dard, which spe­ci­fies the cri­te­ria for a qua­li­ty ma­nage­ment sys­tem (QMS). Among other things, this sta­tes that pro­ces­ses must be va­li­da­ted which can­not be mo­ni­to­red du­ring their crea­ti­on and whe­re the re­sult only be­co­mes evi­dent in the end. Ac­cor­din­gly, the com­pon­ents sup­port­ing this pro­cess, in­clu­ding the soft­ware, must also be va­li­da­ted. It is sta­ted here that do­cu­men­ted in­for­ma­ti­on in­clu­ding tho­se using soft­ware must be iden­ti­fia­ble and as­si­gnable, have an ade­qua­te for­mat and must be sub­ject to a re­spec­ti­ve va­li­da­ti­on and ap­pr­oval. The sub­ject of re­gu­lar con­trol of all data and do­cu­ments and their ma­nage­ment is also gi­ven ap­pro­pria­te con­side­ra­ti­on in this standard.

Conclusion

In sum­ma­ry, ISO 9001:2015 is not just a stan­dard; it is a com­mit­ment to ex­cel­lence. By ad­he­ring to its prin­ci­ples and im­ple­men­ting a strong QMS, or­ga­niza­ti­ons can in­crease cus­to­mer sa­tis­fac­tion, op­ti­mi­ze ope­ra­ti­ons and ul­ti­m­ate­ly achie­ve their busi­ness goals. If you want to es­tab­lish a cul­tu­re of qua­li­ty in your or­ga­niza­ti­on, ISO 9001:2015 is your gui­de to success.

Start your digital transformation with our powerful, modular software solutions

Frequently Asked Questions (FAQs)

What is ISO 9001:2015 and why is it im­portant?
ISO 9001:2015 is an in­ter­na­tio­nal stan­dard for qua­li­ty ma­nage­ment sys­tems. It is im­portant be­cau­se it helps or­ga­niza­ti­ons to im­pro­ve their pro­ces­ses, in­crease cus­to­mer sa­tis­fac­tion, and achie­ve ope­ra­tio­nal excellence.

How long does it take to im­ple­ment an ISO 9001:2015?
The time re­qui­red for im­ple­men­ta­ti­on va­ries de­pen­ding on the size and com­ple­xi­ty of the or­ga­niza­ti­on. On avera­ge, it can take se­ve­ral months to a year or longer.

Is the ISO 9001:2015 cer­ti­fi­ca­ti­on man­da­to­ry?
The ISO 9001:2015 cer­ti­fi­ca­ti­on is not man­da­to­ry, but many or­ga­niza­ti­ons choo­se to pur­sue it to de­mons­tra­te their com­mit­ment to quality.

What are the cos­ts as­so­cia­ted with an ISO 9001:2015 cer­ti­fi­ca­ti­on?
The cost of an ISO 9001:2015 cer­ti­fi­ca­ti­on can vary wi­de­ly de­pen­ding on fac­tors such as the size of the or­ga­niza­ti­on and the com­ple­xi­ty of its pro­ces­ses. They in­clude cos­ts for con­sul­ting, trai­ning and cer­ti­fi­ca­ti­on audits.

Can small busi­nesses be­ne­fit from ISO 9001:2015?
Yes, ISO 9001:2015 can be­ne­fit small busi­nesses by hel­ping them to im­pro­ve their pro­ces­ses, gain a com­pe­ti­ti­ve ad­van­ta­ge and build cus­to­mer trust.

Who car­ri­es out the ISO cer­ti­fi­ca­ti­on?
The cer­ti­fi­ca­ti­on of the stan­dards is car­ri­ed out by no­ti­fied bo­dies, such as TÜV. 

Share now!

Subscribe to the newsletter

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

FDA 21 CFR Part 11

De­fi­ni­ti­on of the term (“What is FDA 21 CFR Part 11?”) FDA 21 CFR Part 11 is a set of re­gu­la­ti­ons in­tro­du­ced by the US Food and

Document Management System (DMS)

De­fi­ni­ti­on of the term (“What is a Do­cu­ment ma­nage­ment sys­tem (DMS)?” A do­cu­ment ma­nage­ment sys­tem (DMS) can be un­ders­tood as the ma­nage­ment of elec­tro­nic documents