Bring out the Best. Quality that improves 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, a solution that will improve the entire company. Bring out the Best is a promise, but also an appeal to my customers to bring out the best in themselves and in the company.

EXPERTISE: QUALITY MANAGEMENT, SYSTEM VALIDATION, GMP, AUDIT, WORKSHOP AND AUDIT PREP TO ISO 9001, 27001, 27017, 13485 / MDSAP

Advice, support and coaching in management of quality and information security in the broadest sense of the word is the speciality 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 (CSV/CSA) to GMP life cycle management, GMP workshops and quality and risk 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: Quality and information security

Technology is evolving rapidly. There are many challenges in terms of the security of users and customers and the protection of their data. In recent years I have carried out dozens of successful audits and quality systems in the life sciences as well as passed inspections. Practical usability of these management systems for the organization and its employees are always paramount at Bring out the Best. Quality and safety take shape in the workplace, this is where the real management starts so that processes run smoothly and everyone benefits.

“Delivering quality costs money, not delivering quality costs capitals”. I claim that the smart and pragmatic design and maintenance of a quality system even generates money. Interested? Please contact us.

My way of working

At Bring out the Best, every process and every project starts with a thorough introduction. Only when I am convinced that I can contribute to your organization, I will get started. If not, I try to think with you and will look for an alternative. 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. As an internal auditor we will join you in identifying the weak spots in your QMS and/or ISMS. We can also do your supplier audits to ensure your supplier brings out his best for you.

Quality management

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

Information Security management

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 27017 is an information security framework for organisations using (or considering) cloud services. Cloud service providers need to comply with this standard because it keeps their cloud service customers (and others) safer by providing a consistent and comprehensive approach to information security.

Medical devices

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?