A quality certificate communicates responsibility

A quality management system is a tool for the management and development of a company’s operations. The world’s best-known quality standard, ISO 9001, is a good match for hospitals, pharmacies and health tech companies like NewIcon – organisations that share a development-oriented and quality-conscious mindset. Anticipation and risk management are the key considerations in designing quality management processes for the health care and pharmacy industries.

According to Product Manager and Lead Auditor Reija Poikonen of Kiwa Inspecta, the ISO 9001 quality management system is a voluntary but useful management and development tool for companies. The harmonisation of practices and adherence to the principles of the quality management system make daily work easier.

“The ISO 9001 quality management system has been constantly growing in popularity in pharmacies and hospitals. When the end customer is someone in need of treatment, patient and user safety are especially important in quality management processes”, Poikonen says.

A quality certificate communicates responsibility and improves cost-efficiency as risk management reduces errors.

“Without a doubt, following a quality management system broadcasts a certain corporate image. It helps to meet customer expectations, improve competitiveness and ensure the continuous improvement of practices”, says Poikonen, listing the benefits of quality management.

When it comes to quality, a positive attitude to development will get you far

Quality management certificates are granted by independent certification bodies. Kiwa Inspecta is an international certification body that evaluates and audits corporate management systems and business operations and certifies them if they meet the requirements. Kiwa Inspecta audited NewIcon in the spring of 2018, when the company updated its quality management system from ISO 9001:2008 to ISO 9001:2015.

“The certification of a quality management system can sound like a daunting project, but help and support is available. A certification project has two phases. The first phase consists of a review of the requirements for the quality system and the company’s current status, with the actual audit conducted in the second phase. The level of quality management in companies that apply for the certificate can vary quite a bit”, Poikonen says.

The audit examines the company’s management system and the related materials, such as indicators, risks and opportunities, and changes in operations. The auditor reviews the company’s processes, tours the premises and observes day-to-day activities, and interviews personnel. At the closing meeting, the auditor give the company a written report on his or her findings.

“A quality management certificate indicates that a company is quality-conscious and responsible and strives for continuous improvement. Quality is measured by the ability to fulfil customer and stakeholder needs and minimise variation in products and services”, Poikonen concludes.

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Improving quality – tips from the expert

  • Start by comparing the current operations of your pharmacy or hospital to the quality management system’s requirements
  • Analyse the risks and opportunities involved in your operations and think about measures to address them
  • Focus on the customer, be open and listen to their wishes and needs regarding your products and services
  • Don’t forget the importance of a positive attitude to change!

Did you know this about quality management systems?

  • The International Organization for Standardization (ISO) has designed the ISO 9000 series of certificates setting official standards for the management of organisations and companies from the perspectives of quality management and quality assurance.
  • A quality management system provides a framework for designing the company’s operations and processes
  • The development areas covered by ISO 9001 are management responsibility, resource management, process management, measurement, analysis and improvement.
  • An external certification body can award the ISO quality management system certificate to an organisation as proof of compliance with quality management principles.

The article was originally published in the Icon News magazine in 2018.


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