July, 2018 Newsletter Articles

Risks and Opportunities

Jul 1, 2018 in Newsletter | Comments Off on Risks and Opportunities

ISO 9001:2015, clause 6, describes these planning requirements: 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes This article is about: ISO 9001:2015, 6.1, Actions to address risks and opportunities 6.1.1 When planning for the quality management system (QMS), the organization must consider the issues referred to in 4.1 (relevant to its purpose and strategic direction), and the requirements referred to in 4.2 (regarding interested parties), and determine the risks and...

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IATF 16949 Risk Additions

Jul 1, 2018 in Newsletter | Comments Off on IATF 16949 Risk Additions

The automotive quality standard, IATF 16949:2016, expands on the ISO 9001:2015 risk requirements in 6.1.2 with these sub-clauses: 6.1.2.1 Risk Analysis Include in the risk analysis, at a minimum, lessons learned from: product recalls and product audits; field returns and repairs; complaints, scrap, and rework. Retain documented information as evidence of the results of risk analysis. 6.1.2.2 Preventive Action Determine and implement actions to eliminate causes of potential nonconformities to prevent their occurrence. Preventive actions...

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Establishing Objectives

Jul 1, 2018 in Newsletter | Comments Off on Establishing Objectives

A “quality objective” is defined by ISO 9000:2015 as a quality result to be achieved. It can be a strategic, tactical, or operational target. Quality objectives are set to be consistent with the quality policy and specified for the relevant functions, levels, and processes within an organization (to ensure the effective deployment of the strategic direction and quality policy). This article addresses the requirements to “establish” quality objectives. A later article in this newsletter covers the requirements for...

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Achieving Objectives

Jul 1, 2018 in Newsletter | Comments Off on Achieving Objectives

An earlier article in this newsletter addressed the requirements to “establish” quality objectives. This article covers the requirements for planning how to “achieve” quality objectives. ISO 9001:2015, 6.2.2, states that when planning how to achieve quality objectives, the organization must determine: a) what will be done; According to ISO/TS 9002:2016, this simply means to determine the actions that need to be implemented to achieve the quality objectives. b) what resources will be required; Ensure that sufficient...

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Sample Objectives

Jul 1, 2018 in Newsletter | Comments Off on Sample Objectives

As auditors, we are called upon to assess conformity and effectiveness. To assess process effectiveness, we need to evaluate to what extent the planned activities are being realized and the planned results are being achieved. We may need to venture outside the defined scope of a specific process audit to fully judge its effectiveness (results). To assess how well the process is meeting the needs of its internal customers, interview those internal customers. They may have a different view of the process outputs than the process supplying...

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