Guidance to auditor(s)
This document is intended to provide structured assistance to conduct the audit. To fit that purpose it containskey questions related to each standard clause. It shall not to be part of the audit report.
1.2ApplicationAre any exclusions to requirements of ISO9001:limited to clause 7?not customer and/or regulatory requirements?4.2.2 a)defined and justified in the Quality Manual?4.2.1 b)Quality Manual4.2.2a)Does the Quality Manual define:the scope of the quality management system (products and processes)?b)documented QMS procedures, or reference to them?c)a description of the interaction between the processes of the quality managementsystem?4.1General requirementsIs the QMS:DOCUMENTED, implemented, and maintained?Is the Quality Management System’s effectiveness continually improved (see8.5.1)?4.1a)b)c)d)e)f)Has the organisation:Identified the processes needed?Determined the sequence and interaction of these processes?Determined criteria and methods for effective operation and control?Made supporting resources and information available?Measured, monitored and analysed these processes (see 8.2.3)?acted to achieve planned results and continual improvement of these processes(see 8.5.1)?4.1Are any outsourced processes controlled and identified within the QMS?4.2.1Documentation requirementsa)b)c)d)e)Does the quality management system documentation include:Policy and objectives?A quality manual?Required documented procedures?Process related documentation?Required quality records?NOTE 2Is the QMS documentation appropriate to:a)the organisation’s size and activities?b)its complexity?c)competency of personnel?5.1Management responsibility