ISO 9001 certification have seen a decline in the past two years per data from ISO. Some say that 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 QMII’s clients had considered letting their certification lapse as conformity to the new standard was perceived as too complex.
To certify or not
Let us begin by looking at the purpose of ISO 9001. ISO 9001 provides a framework for organizations looking to put in place a system that will enable them to consistently deliver products/services to customers that meet their requirements and enhance customer satisfaction. ISO 9001 certification is external validation that the system meets the requirements of ISO 9001. However, ISO 9001 allows organizations to use the standard and self-declare conformity without incurring the cost of certification. Many argue that there is no value in doing this. This is probably correct if you are implementing a system to meet a contractual or customer requirement. In these cases, certification is a requirement.
Waning trust in the system
Organizations that implement ISO 9001 for the benefits it will deliver in improved productivity, reduction in process waste and management of risks have seen the bottom line improve with time . If implementing the standard enables consistent quality, why then the reluctance? Perhaps the trust in the ISO 9001 certification process has declined over time. Often have we heard from quality managers of the challenges faced when they raise non-conformities in internal audits. These are often viewed as “finger pointing” exercises since the certification body has already audited and “cleared” (certified) the system.
We have also heard from clients of certification bodies and auditors wanting to view documented evidence of organizational context, stakeholder needs and risks. The standard however does not require these to be documented and leaves it up to the organization to determine the risk of not doing so. Some auditors, however, struggle with auditing undocumented systems and auditing to the new standard . As a result, organizations start documenting their system for the auditors and certification bodies resulting in a system tailored for auditors and forced down on the organization by auditors. The auditors were to provide inputs to TM (top management) to make better decisions, instead now the auditors and audits have become the product. The system must be designed for the employees not for the auditors. The intent of the standard to act as a preventive tool gets lost in this compliance process.
Over the past two decades there have been several mergers and acquisitions leading to larger multi-site organizations and perhaps as a result a reduction in certifications. As these organizations have grown, and maybe in part owing to the declining trust in the certification system, they have decided to conduct their own supplier audits. As such suppliers have chosen to let their certification lapse since they are nevertheless being audited by the customer and that is the audit that really counts for them.
Supplier audits are more focused on the customer contractual requirements. Organizations who perceive ISO 9001 as a documentation burden will then only document the parts of the system to meet contractual requirements rather than document the system to meet the organization’s requirements based on ISO 9001. They fail to see that ISO 9001 leaves the extent of system documentation up to the organization and often perceive it as everything needs to be documented.
While quality does matter and customers are still looking to receive a quality product, oft incorrect interpretation of the standard leads many to choose against ISO 9001 certification. At times other certification requirements like CE marking may be more desired and certification to two standards be burdensome. Also methodologies like Six Sigma and Lean have gained prominence. So, ISO 9001 certification gets the boot.
Those looking to gain the benefits of a quality management system need not re-invent the wheel. ISO 9001 provides the framework that essentially reflects business 101. If you do not need ISO 9001 certification then you can self-declare and let the doubters come and assess for themselves. In the meantime, you will still gain from a well implemented management system. Remember, you already have a system that has brought you thus far, align ISO 9001 to your system and not your system to ISO 9001.
 Guasch, Luis J.; Racine, Jean-Louis; Sanchez, Isabel; Diop, Makhtar. 2007. Quality systems and standards for a competitive edge (English)
Quality Progress October 2017, Article: The results are in…