Annex B (Informative) Management System Options
This annex provides additional information on the management system options available to laboratories, ensuring conformity to ISO 9001 while fulfilling the requirements of this document.
B.1 General
Growth in the use of management systems has increased the need to ensure that laboratories can operate a management system that conforms to both ISO 9001 and 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
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 relevant ISO 9001 requirements that apply to the scope of laboratory activities.
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
Option B (see 8.1.3) allows laboratories to establish and maintain a management system in accordance with 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 Comparison of Options
Both options are intended to achieve the same result in the performance of the management system and compliance with Clauses 4 to 7.
B.5 Schematic Representation of Operational Processes
Figure B.1 illustrates an example of a possible schematic representation of the operational processes of a laboratory, as described in Clause 7.
