ISO 9001 certifications have seen a decline during the past two years, per data from the International Organization for Standardization (ISO). Some say the standard has gotten too complicated with the introduction of organizational context, risk-based thinking, and the removal of mandatory documented procedures. Even a few of my company’s clients have considered letting their certification lapse because conformity to the new standard was perceived as too complex.
Almost all quality improvement comes via simplification of design, manufacturing... layout, processes, and procedure
https://www.theauditoronline.com/the-decline-in-iso-9001-certification-does-quality-matter-anymore/