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Mandatory documents ISO 9001:2015

Since the publication of the new revision of ISO 9001 last month, many people have been
wondering what documents are mandatory in this new 2015 revision !ow many
documents are re"uired#So, here is the list $ below you will see not only mandatory
documents, but also the most commonly used documents for ISO 9001 implementation
Mandatory documents and records required by ISO 9001:2015
!ere are the documents you need to produce if you want to be compliant with ISO
9001%2015 &'lease note that some of the documents will not be mandatory if the
company does not perform relevant processes(%

Scope of the QMS c!ause "#$%

Qua!ity po!icy c!ause 5#2%

Qua!ity ob&ecti'es c!ause (#2%

)riteria for e'a!uation and se!ection of supp!iers c!ause *#"#1%


)nd, here are the
mandatory records
&note that records mar*ed with + are only mandatory in cases whenthe relevant clause
is not ecluded(%

-onitoring and measuring e"uipment calibration records+ &clause . 1 5 1(

/ecords of training, s*ills, eperience and "ualifications &clause . 2(

'roductservice re"uirements review records &clause 2


2(

/ecord about design and development outputs review+ &clause


2(

/ecords about design and development inputs+ &clause


(

/ecords of design and development controls+ &clause


3(

/ecords of design and development outputs +&clause


5(

4esign and development changes records+ &clause


(

6haracteristics of product to be produced and service to be provided &clause 5 1(

/ecords about customer property &clause 5(

'roductionservice provision change control records &clause 5(

/ecord of conformity of productservice with acceptance criteria &clause (

/ecord of nonconforming outputs &clause .2(

-onitoring and measurement results &clause 911(

Internal audit program &clause 92(

/esults of internal audits &clause 92(

/esults of the management review &clause 9(

/esults of corrective actions &clause 101(


+on,mandatory documents

7here are numerous non8mandatory documents that can be used for ISO 9001
implementation !owever, I find these non8mandatory documents to be most commonly
used%

'rocedure for determining contet of the organiation and interested parties &clauses
31 and 32(

'rocedure for addressing ris*s and opportunities &clause 1(

'rocedure for competence, training and awareness &clauses .12, . 2 and . (

'rocedure for e"uipment maintenance and measuring e"uipment &clause . 1 5(

'rocedure for document and record control &clause .5(

Sales procedure &clause 2(

'rocedure for design and development &clause (

'rocedure for production and service provision &clause 5(

:arehousing procedure &clause 53(

'rocedure for management of nonconformities and corrective actions &clauses . and


102(

'rocedure for monitoring customer satisfaction &clause 912(

'rocedure for internal audit &clause 92(

'rocedure for management review &clause 9(So, this is it $ what do you thin*# Is this
too much to write# 4o these documents cover all aspects of "uality management#
To learn more about changes in the new version of ISO 9001, see the How useful is ISO
9001? survey results.
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!ow to comply with new leadership re"uirements in ISO 9001%2015