Outsourcing is historically one of the most misunderstood concepts in quality management system (QMS) implementation and operation. Prior to ISO 9001:2015, the requirement for outsourced processes was limited to a few sentences in the standard’s clause 4.1. This article will present, through a case study, how understanding the implications that outsourcing, according to ISO 9001, is of key importance for a company.

Some history

ISO 9001:2008 clause 4.1 was so vague that a guidance document was needed. It was the subject of so many interpretations that Technical Committee (TC) 176 of the International Organization for Standardization (ISO) published guidance document ISO TC/176 SC 2/N 630R2—“Guidance on outsourced processes.”

The most impactful guidance from that publication was the definition that an outsourced process is one that the organization may conduct internally but has chosen to subcontract the work to an outside organization. It also states that the company must exhibit the same level of control over outsourced processes as it would over processes within its own QMS.

 …