ISO 9001 and inspection

ISO 9001:2015 does not require 100% inspection. Unless that is an explicit or contracted customer requirement it is not usual to perform 100% inspection.

First, analyze your current performance: What is the level of defects? Can you identify trends? Are there any defect-types more common than others? Are there any day of the week, line of production, type of product, shift, … more prone to defects? Does your organization follow statistical process control to monitor process performance?

If your organization cannot accept present level of defects it must engage in one or more quality improvement project(s).

Some organizations use sampling plans based on an ISO standard (ISO 2859-1) to conclude with a certain level of certainty the quality of a lot based on a sample. So, instead of 100% inspection, your organization will design a quality control and/or a process control plan(s) in order to monitor performance and act when needed.

Some organizations with very low defects level instead of inspection do what they call a product audit. For example, they go to the warehouse, pick a package ready to go and they start with the box, the labels, the way the product was put in the box, then analyze the product. Of course they inspect the product but if they find any non-conformity their main concern is with what is not working in their process that allows this to happen.

The following material will provide you more information about inspection:

- Article - Making the best out of ISO 9001 Quality Plan - https://advisera.com/9001academy/blog/2015/12/08/making-the-best-out-of-iso-9001-quality-plan/- Article - How to establish QMS Statistical Process Control according to IATF 16949 - https://advisera.com/16949academy/blog/2017/08/30/how-to-establish-qms-statistical-process-control-according-to-iatf-16949/- Article - How to use quality control tools to improve your QMS - https://advisera.com/9001academy/blog/2017/04/18/how-to-use-quality-control-tools-to-improve-your-qms/- Free webinar on demand - Measurement, analysis, and improvement according to ISO 9001:2015 - https://advisera.com/9001academy/webinar/measurement-analysis-and-improvement-according-to-iso-9001-2015-free-webinar/- Enroll for free course - ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/