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Top ISO 9001 Failures

ISO 9001:2015 is the international standard that outlines what requirements a quality management system (QMS) must meet in order for an organization to be ISO 9001 certified. Adopting QMS is a strategic decision for an organization because it can help to improve its overall performance and provide a sound basis for sustainable development initiatives. Certification is used to demonstrate the ability of the organization to consistently provide products and services that meet specific customer and regulatory requirements. Read on to learn more about ISO 9001 and ISO 9001 failures.Top ISO 9001 Failures IQS

What are its benefits?

In order to thrive, businesses need to identify what risks they face and how they can be affected by them. Once a company implements a QMS based on ISO standards, it should be able to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, facilitate opportunities to enhance customer satisfaction, address risks and opportunities associated with company goals and objectives, and, perhaps most importantly, demonstrate conformity to specific QMS requirements.

Not meeting these requirements and falling into the trap of ISO 9001 failures can raise the cost of compliance. To mitigate costs, manufacturers must leverage IT resources and solutions, as we will see below.

ISO 9001 failures

It can be very costly, not to mention time-consuming, to obtain all requisite compliance certifications that your company requires. However, the benefits of meeting compliance requirements far outweigh the costs of obtaining them. To lower the cost of achieving compliance, manufacturers should avoid these common ISO 9001 failures and pitfalls that many companies fall prey to when trying to obtain certification.


Inadequate documentation remains one of the top reasons manufacturers do not pass regulatory audits after the first inspection. In fact, documentation is one of the most emphasized components of ISO 9001. By deploying an integrated document control software module, companies can steer clear of failing audits and inspections because of a lack of documentation.

Employee competency

Companies need to inculcate a culture of awareness of quality management to make sure certification is not missed due to a lack of employee competency. An effective training program, ideally one that is delivered online and across the entire organization with evaluation and measurement tools, is also needed to ensure a positive feedback loop of competent employees teaching and training future employees to ensure the cycle of standards compliance continues within the organization.

Risk mitigation

A significant part of the updates in 9001:2015 over the 2008 version involves discussions on risk management. ISO 9001:2015 asks organizations to establish end-to-end risk management processes and to execute those processes consistently. However, because risk applies to so many different situations in so many different ways, organizations need to answer questions such as:

  • How will potential threats be identified?
  • How can undesirable effects be prevented or reduced?
  • How can success or attainment of intended outcomes be measured?
  • Who will be held responsible for ensuring that risk management processes work correctly?
  • Where are threats expected to arise from?
  • Who are the players who can help identify and deal with risks?
  • How can risk management systems be evaluated, tested and updated to ensure that they will work as and when needed?

Every company needs to answer these questions for themselves. However, beyond answering risk-related questions, risk management needs to be performed across the board in all of the following ways as well:

  • Leadership must promote risk-based thinking.
  • Risks that impact customers need to be identified and addressed.
  • Remedial actions and responses need to be outlined along with execution steps and procedures.
  • Risk mitigation steps need to be evaluated for efficacy.

Doing all of the above requires leveraging IT resources and infrastructure to enable companies to measure, track and respond to risks whenever they arise. It also enables them to know what remedial steps work and which ones do not as well as create a company-wide risk mitigation culture. Proper IT resources and infrastructure for risk management also allows companies to efficiently document and implement processes and procedures for all business functions and ensure that employees receive adequate training in identifying, managing and responding to all of the above.

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