ISO 9001 Audits
ISO 9001 is the international standard for a quality management system (QMS) and requires internal audits to be performed on a regular basis as per clause 9.2 in the ISO 9001 standard. Auditors need to be trained and qualified to conduct these audits. The purpose of internal audits is to evaluate performance, assess process conformity and to identify the improvement areas.
Internal audits are the first line of defence for top management to ensure that business processes are performing in a satisfactory manner. If an internal audit is conducted by in-house members who also handle other full-time tasks, the audit may not get the desired result. For this reason, it is crucial that experts perform this important business function.
Depending upon the risk of the product or supplier history, it is good practice to audit suppliers. Best-in-class organizations regularly conduct audits of their supply base. Organizations need to set up supplier metrics for quality and delivery at a very minimum. Based on the risk and the metrics, PPAPandAudits.com will conduct a need improvement based assessment, to help improve supplier quality or delivery.
During the 1980’s, organizations sneered at the idea of having a 0 defect program, claiming they would never be met. It is PPAPandAudits.com’s experience that this is indeed possible. There is a set by set trajectory from 10,000 ppm or greater to 1,000 ppm – 100 ppm – 60 ppm – to under 10 ppm. Improving the supplier base improves the customer. To accomplish this, it is important to add defect prevention strategies such as FMEA, mistake proofing, and disciplined problem solving. Let our experts show you how.
It is imperative that internal audits need to be well designed, as they work best when standardized properly. There are certain criteria to be taken into account in order to have a smooth and trouble-free auditing experience. Appointing the appropriate auditors, standardising the assessment of the audits, making use of forms and checklists, conducting regular meetings with the auditees, and receiving their feedback are few of the key focus areas. Reporting on the audits and following-up for the issues or improvements would be other beneficial points to be noted.
Though PPAPs or FAI are not required by ISO 9001, top organizations adopt them to ensure defect-free product launches. PPAPandAudits.com can set up an entire program of PPAP or FAI reviews.