Could you provide risks and opportunities examples or references for small companies?
Planning of changes (cl.6.3 in ISO 9001:2015) is carried out as part of the Management review by the Coordinating Council or an equivalent.
The First leader, area managers including Quality manager are part of the Council.
Decisions on changes are recorded in the Minutes as the Coordinating Council decisions (for minor changes), or implemented based on individual projects.
It is expedient to describe the planning of changes in sec. 6.1 of Quality Manual. Wherein it is necessary to pay attention to the following:
- Sec. 6.1.a. Objective and Rationale of changes are worded by the Initiator, usually a Quality manager. The potential consequences of changes are reviewed in the form of risks and opportunities assessment for examples in accordance with MM 6.1-01-01 Actions to address risks and opportunities in QMS processes. The examples of risks and opportunities for any company are given in Annex 2.
- Sec. 6.1.b. The integrity of the Quality management system is ensured by relating the inputs and outputs of the processes and providing compliance with all requirements of Sec. 4.4 with respect to Changes.
Sec. 6.1.c and sec. 6.1.d are carried out similarly to ISO 9001:2008.
A complete set of ISO 9001:2015 Quality System Procedures
Other ISO 9001:2015 Documents and Templates
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