International

 

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ISO/IEC 17025:2017(E)

Annex B 

(informative) 

 

Management system options

B.1  Growth  in  the  use  of  management  systems  generally  has  increased  the  need  to  ensure  that 

laboratories can operate a management system that is seen as conforming to ISO 9001, as well as to 

this document. As a result, this document provides two options for the requirements related to the 

implementation of a management system.

B.2  Option A (see 

8.1.2

) lists the minimum requirements for implementation of a management system 

in a laboratory. Care has been taken to incorporate all those requirements of ISO 9001 that are relevant 

to  the  scope  of  laboratory  activities  that  are  covered  by  the  management  system.  Laboratories  that 

comply with 

Clauses 4

 to 

7

 and implement Option A of 

Clause 8

 will therefore also operate generally in 

accordance with the principles of ISO 9001.

B.3  Option B (see 

8.1.3

)  allows  laboratories  to  establish  and  maintain  a  management  system  in 

accordance with the requirements of ISO 9001, in a manner that supports and demonstrates the 

consistent fulfilment of 

Clauses 4

 to 

7

. Laboratories that implement Option B of 

Clause 8

 will therefore 

also  operate  in  accordance  with  ISO  9001.  Conformity  of  the  management  system  within  which  the 

laboratory operates to the requirements of ISO 9001 does not, in itself, demonstrate the competence of 

the laboratory to produce technically valid data and results. This is accomplished through compliance 

with 

Clauses 4

 to 

7

.

B.4  Both options are intended to achieve the same result in the performance of the management 

system and compliance with 

Clauses 4

 to 

7

.

NOTE 

Documents, data and records are components of documented information as used in ISO 9001 and 

other management system standards. Control of documents is covered in 

8.3

. The control of records is covered in 

8.4

 and 

7.5

. The control of data related to the laboratory activities is covered in 

7.11

.