Audits at Aqua free - Insights

Interview with the Head of Quality Management

Interviewer: Thank you for taking the time to talk to us today about certifications and audits at Aqua free. 
Martin Langer: It is my pleasure. I am delighted to share my experiences. 

Interviewer: Let us start with a fundamental question. Can you explain the significance of the ISO 9001, ISO 13485 and ISO 14001 certifications for Aqua free? 
Martin Langer: Certainly. ISO 9001 certification represents comprehensive quality throughout our company. It is an internationally recognised standard for quality management systems. 

ISO 13485 is particularly relevant for us as a medical equipment manufacturer and focuses on the safety and quality of our medical equipment. 

In contrast, ISO 14001 relates to our sustainability efforts and challenges us to manufacture our products in a more environmentally friendly manner, thereby making our production processes more sustainable. 

Interviewer: How exactly does an audit as part of these standards work? 
Martin Langer: An audit is basically the same as a TÜV inspection. It assesses whether a company operates in compliance with established standards as well as legal requirements and objectives. 

Audits take place annually, with random checks performed over a period of two years and re-certification with full monitoring every third year. 

An audit confirms and documents that we adhere to established quality standards, comply with them fully and manufacture our products accordingly. For each audit, the inspection body assigns certified auditors who objectively and impartially assess our system against the respective standard. 

Interviewer: What does a new certification process look like? 
Martin Langer: A new certification process is carried out in two steps. Step 1 involves checking all the system-relevant documents. This includes, for instance, the management manual and the related procedural instructions. 

In step 2, these and other system-relevant documents (such as work instructions and forms) are examined on-site by an auditor over several days. 

A certificate for the corresponding certification is issued only after all identified deviations have been addressed and a suitable solution has been found. 

Interviewer: And what is specifically demanded by ISO 9001? 
Martin Langer: Just like other certifications, ISO 9001 is structured according to various chapters. The chapters describe the individual areas of the company. 

For example, there is a chapter on management, which describes the company's objectives, the management's guidelines and its responsibilities. It is also where risks are analysed and opportunities for the company explored. 

Other chapters, for instance, focus on production, development, skills and training as well as many other areas that are essential for a company. 

Interviewer: Why are these certificates so important for Aqua free, especially in the medical sector? 
Martin Langer: Medical products are subject to strict rules and standards. Certification provides our customers with transparency and integrity. 

It monitors production, maintains traceability and includes the monitoring of our suppliers. These are all issues that ensure the customer receives the best quality. 

Interviewer: Can you tell us something about how you prepare for an audit? 
Martin Langer: An effective system should always be available. When preparing for an audit, I compare key figures and check whether we have achieved our targets. 

Roughly four months before the external audit, I go through all the key documents and standard specifications together with an external auditor. We refer to this process as an internal audit, which can always be carried out by an in-house member of staff trained to do so. 

Interviewer: Finally, could you tell us something about CAPA and the importance of ISO 9001 within the context of opportunities and risks at the company? 
Martin Langer: CAPA defines how our company develops, how it addresses problems to resolve them effectively while also ensuring that they cannot recur in the future across various areas and developments. 

As part of the ISO 9001 certification process, I analyse opportunities and risks to optimise our company, enhance the quality of our products and processes and to position ourselves as an even more attractive business in the market, which is renowned for its quality and performance. This is a key ingredient of our internal audits. 

Interviewer: Thank you for this insightful information. 
Martin Langer: You are welcome. It was my pleasure.