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6. Planning

Note: The organization slightly deviates from the approach towards risk and opportunity presented in ISO 9001. The organization views “uncertainty” as neutral, but defines “risk” as a negative effect of uncertainty, and “opportunity” as a positive effect of uncertainty. The organization has elected to manage risks and opportunities separately, except where they may overlap. Formal risk management may not be utilized in all instances; instead, the level of risk assessment, analysis, treatment and recordkeeping will be performed to the level deemed appropriate for each circumstance or application.

6.1 Actions to Address Risks & Opportunities

The organization considers risks and opportunities when taking actions within the quality management system. These actions are considered relative to products and services. Risks and opportunities are identified as part of the “Context of the Organization” SWOT Analysis located within section 4.1 (QualityManagementSystemComponent).

The organization also assesses risk during the initial production stages within the "Supporting Documentation" listed under 8.2.1 - "Determination of requirements related to products". This procedure defines how risks are managed in order to minimize their likelihood and impact, and how opportunities are managed to improve their likelihood and benefit. Risks and opportunities are managed in accordance with this procedure and documented in the related checklist document.

6.2 Quality Objectives and Planning to Achieve Them

As part of the adoption of the process approach, the organization utilizes its process objectives, as discussed in 4.4, as the main quality objectives for the QMS. These include overall product-related quality objectives; additional product-related quality objectives may be defined in work instructions or customer requirements.

The process objectives have been developed in consideration that they:

a) be consistent with the quality policy;

b) be measurable;

c) take into account applicable requirements;

d) be relevant to conformity of products and services and to enhancement of customer satisfaction;

e) be monitored;

f) be communicated;

g) be updated as appropriate.

Process quality objectives are defined in the minutes of management review per section 9.3 below.

The planning of process quality objectives is defined in section 4.4.

6.3 Planning of Changes

Changes to the quality management system and its processes are carried out in a planned manner per the procedure listed in ConfigurationManagement.

JohnKreis -- 07 Mar 2018

Topic revision: r4 - 20 Jun 2019 - JohnKreis
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