Integrating FMEA into the product life cycle. As a reliable means of identifying potential failures before they happen, failure mode and effects analysis (FMEA) deserves a place in every product life cycle.

Quality management systems (QMS) that conform to ISO 9001:2008 can take advantage of the requirements relating to constancy of purpose that are built into the standard.

Time management is one of the main challenges any auditor faces during an audit. When time is limited, knowing what questions to ask and evidence to seek is crucial for an effective and efficient audit. Careful planning and preparation will ensure the audit schedule is completed in a timely manner.

Internal Quality Audits are a requirement of ISO 9001 that rarely bring value to an organization past simply maintaining compliance to the standard. Despite their best efforts, even well-trained internal auditors may not be as effective as they could be.