Bring out the best. Quality management that benefits the entire company.

Sjoerd Boomsma. Nice to meet you

I am a seasoned quality professional and I bring out the best in my customers, their employees and their suppliers. How do I do that? By going to the hole at each problem. Sprucing up and fine-tuning until the whole process gets better. I do not work just with standard checklists, but always come up with a good, tailored structural solution.

EXPERTISE: QUALITY MANAGEMENT, SYSTEM VALIDATION, GMP, AUDIT AND AUDIT PREP TO ISO 9001, 13485 AND 27001

Advice, support and coaching in quality management in the broadest sense of the word is the specialty of Bring out the Best. From an internal or supplier audit, support for audit readiness, an on-site workshop internal auditor, setup, implementation and reporting of validation to GMP life cycle management, GMP training and quality awareness. And everything in between. I work alone and in flexible teams of like-minded professionals. No assignment is too small or too large.

MY SPECIALTY: PHARMA AND HEALTH CARE

Healthcare and pharmaceutical technology is developing rapidly. There are many challenges in patient safety and the protection of their data. In recent years I have conducted dozens of successful audits and inspections of quality systems in this crucial industry. The practicality of these quality systems for the organization and its employees is always paramount at Bring out the Best. We aim to assure that processes run smoothly and everyone benefits. Interested? Please reach out.

My way of workinG

At Bring out the Best, every process and every project starts with an extensive introduction. Only when I am convinced that I can make a contribution that will benefit your organization, I will get started. Because it always concerns complex issues, I offer clarity in advance about approach, content, rates, time schedule and phasing. So that we start together in confidence. Not as a customer and supplier, but as colleagues. After all, we both want the best for your organization.

About me

I am convinced that quality management serves and supports the company and its employees. A system, process or procedure based on best practices is many times more effective than a system based solely on theories, rules and regulations. Rules and regulations will especially be observed, if the basis of the action is practical. I have experienced many successful audits and inspections of quality systems with a highly pragmatical approach.

The usability of the quality systems or the organization and its employees, including but not limited to the quality documents for validation, for the organization and its employees is always a priority to me.

What i DO

Services

Audit

We can take care of your internal and supplier audits, we can help you prepare for certification audits and of course support you in your efforts to raise quality awareness in your organization and at your suppliers.

ISO 9001

With an ISO 9001 certification you show that your company meets the international requirements in the field of quality management (KMS). Now a certificate is beautiful on the wall, ultimately the goal is to reduce business risk and improve operations. Quality should pay and not cost.

ISO 27001

ISO 27001 is the globally recognized standard for information security. This standard describes how you can deal with the security of information in a process-based manner

ISO 13485 / MDSAP

There are new European regulations for medical devices (MDR). ISO 13485 is an international standard that medical device manufacturers, suppliers and distributors can meet to demonstrate compliance with regulatory requirements related to medical devices. The Medical Device Single Audit Program (MDSAP) allows a single audit of a medical device manufacturer’s Quality Management System (QMS), which satisfies the requirements of multiple regulatory jurisdictions.

GMP

Good manufacturing practices (GMP) are the practices required to conform to the guidelines recommended by agencies that control the authorization and licensing. Like any quality regime, my goal is to set it up so that the system works for the people and the company and not the other way around. Quality must pay is my starting point.

Can I help you?