ISO Certification 101
Before we go into the details on whether you should consider getting an ISO certification, it is important to establish what ISO certification is. The International Organisation for Standardisation (ISO) is an independent body dedicated to publishing international standards. ISO certification is awarded to an organisation by a certifying body when the organisation has shown sufficient evidence that they have met all the requirements of the selected ISO standards through completing an assessment audit.
For laboratory quality management systems, the relevant ISO certification is typically ISO 9001. This ISO standard ensures that the organisation has a systematic approach to quality management, encompassing processes for continuous improvement, customer satisfaction, and adherence to regulatory requirements.
ISO-based Quality Management System
You can still develop a Quality Management System (QMS) without obtaining ISO certification. By developing a QMS tailored to your laboratory’s specific needs, you can achieve many of the same operational benefits associated with ISO certification. This includes establishing systematic procedures, improving process efficiency, and ensuring consistent quality in your lab’s output.
While you may not gain the external validation that ISO certification provides, a well-designed QMS can still enhance internal processes, facilitate regulatory compliance, and build a foundation for continuous improvement. Additionally, it can serve as a stepping stone, preparing your laboratory for future certification if you choose to pursue it.
Now let’s delve into the pros and cons of pursuing ISO certified.
Pros and Cons of ISO Certification
PROS:
Credibility and Competitive Edge
The process of ISO certification significantly enhances your laboratory’s credibility, by instilling trust in the quality of work your lab produces. Achieving ISO certification demonstrates that your QMS is comprehensive and effective, ensuring top-quality standards across various processes. This certification not only strengthens your lab’s reputation but also boosts client and stakeholder engagement, providing a clear competitive edge.
Improved Efficiency:
Achieving ISO certification involves a thorough and rigorous evaluation of every aspect of your lab’s operations. This process scrutinises your quality management systems, administrative practices, personnel training, and quality assurance protocols. By rigorously assessing these critical areas, ISO certification ensures that your lab possesses the necessary resources, effective communication channels, standardised procedures, as well as monitoring and checking processes. When these elements function cohesively, they significantly enhance the overall efficiency of the lab, streamlining operations and optimising performance across all dimensions. Top of Form Bottom of Form
Risk Management:
The process of ISO certification ensures that all risks associated with internal lab processes are managed. It also provides assurances that external compliances such as regulatory and legal compliances are covered.
CONS:
Expensive:
ISO certification can be a significant financial burden for the business. Each laboratory has unique offerings and processes, which often require substantial significant investment of resources to ensure requirements to meet and maintain certification requirements.
Time-consuming:
The process of obtaining ISO certification can take anywhere from 6 to 12 months. Furthermore, maintaining compliance with ISO standards requires ongoing commitment and oversight for as long as the lab operates. This means that the quality framework must be continuously managed and updated to ensure that the standards are adhered to and that the certification remains valid.
Suitability:
For newer labs, obtaining ISO certification may not be feasible due to the substantial resources required. The time, effort, and financial investment necessary to achieve and maintain certification can be challenging for labs with limited capabilities.
In summary, obtaining ISO certification is a rigorous process that requires careful consideration. Depending on your lab’s current goals, ISO certification can offer significant benefits. These include enhancing your lab’s reputation and credibility, improving efficiency across all operations, and reducing long-term risks.