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ISO 9001:2015 is a widely used standard for quality certification and also one of the most stringent. This standard ensures that every aspect of a contract manufacturer’s business is well-run and continually improving, including key processes, management roles and responsibilities, documentation, customer satisfaction, employee training, vendor performance and internal audits.
Certification audits are used to evaluate the effectiveness of and assess conformity to documented Procedures and Work Instructions, and identify opportunities for improvement. During an audit, a manufacturer’s quality system is measured against the requirements of the standard. More than just a method of checking practice against procedure, audits are a powerful tool in manufacturing improvement processes. Below please find 3 tips to ensure a successful audit: