ISO 9001:2015 – Questions and Answers

How expensive is a ISO-9001 certification?

The costs for ISO 9001 certification vary widely and mainly depend on the size of the organization. But the number of locations and the complexity of processes, products, and services also have a significant impact on the costs. Product safety and regulatory relevance can also increase the effort required for certification. So, depending on the case, the costs for certification can range from a low four-digit to a mid five-digit amount in euros.

Are companies required to get certified according to ISO 9001?

Only organizations in a few sectors are required to get ISO 9001 certified. The obligation is rarely due to regulations, but it is the case, for example, for car manufacturers (one of the requirements for general type approval). Usually, companies feel obliged to get ISO 9001 certification when their customers demand it.

Does ISO 9001 require the implementation of a risk management system?

No, ISO 9001 doesn’t require a risk management system, but only the identification of risks and opportunities, as well as conscious decisions and action planning to deal with the identified risks and opportunities. Also, the effectiveness of the implemented measures has to be reflected in the management review.

Common issues when preparing for an ISO 9001 certification

The challenges in preparing for an ISO 9001 certification are varied, even though the standard itself isn’t as complex as, for example, IATF 16949, EN 9100, ISO 13485, or ISO/IEC 17025. The effort with ISO 9001 mainly lies in clearly defining the scope of the QMS and the quality-relevant processes within the organization according to its context and then establishing (documenting) them. Additionally, depending on the circumstances, it can be challenging to foster a positive culture of failure and the mindset for continuous and sustainable improvement, as well as to create and retain audit-proof evidence for this.

What are the most common audit findings in ISO 9001?

The most common audit findings in ISO 9001 are found in areas like PDCA (for example, effective corrective actions for nonconformities including customer complaints), resources for monitoring and measuring (measurement and testing equipment management), compliance with customer requirements, and personnel resources (defining, ensuring, and continually maintaining the necessary competencies).