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.