External Quality Assurance Officer

External quality assurance officer as a service according to ISO 9001 & ISO 13485

Quality Assurance Officer
for your QM system

An external quality assurance officer (QA officer) is an excellent solution for small and medium-sized enterprises (SMEs) that may not have the resources to employ their own QA officer for QM systems according to ISO 9001 & ISO 13485.

We will provide your company with an external Quality Assurance Officer for both planned and existing QM systems compliant with ISO 9001 or ISO 13485. Our external QA officers are proficient in the quality management standards of ISO 9001 and ISO 13485.

Our own company's quality management system is certified in accordance with these two standards. Our Quality Assurance Officers specialise in QM systems for SMEs, medical device manufacturers and pharmaceutical companies.

Does the standard require a Quality Assurance Officer? We will clarify this next.

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Does ISO 9001 or ISO 13485 explicitly require a QA officer?

Before the 2015 revision of ISO 9001, the role of a QA officer was explicitly required, as is still the case under ISO 13485:2016. However, since the revision of ISO 9001 came into force, this is no longer the case. Instead, the revised standard places even higher expectations on management to promote and guarantee the effectiveness of the quality management system (QMS).

The management is responsible for ensuring that the customer, legal and regulatory requirements for a quality management system are understood and met. An internal or external QA officer assists the management in fulfilling these duties. Although his role is no longer a strict requirement under ISO 9001, the tasks remain necessary and must be completed.

For small and medium-sized enterprises (SMEs), an external QA officer can be a highly beneficial option, as mentioned earlier. Now, let’s dive into the specifics of how an external QA officer service can benefit your company.

External Quality Assurance Officer as a service for small and medium-sized companies

Small and medium-sized companies often delegate the task of quality management representative to an external Quality Assurance Officer. His tasks vary and are often tailored to the specific needs of each company..

Here is an overview of the possible external Quality Assurance Officer as a service that SMEs can obtain from us.

Establish or further develop a QM system

An external QA officer is at your disposal if you want to set up or further develop a QM system:

Advice and support in setting up a QM system in accordance with ISO 9001 or 13485
Ensuring that the quality management system conforms to standards
Adaptation of the QM system to innovations and changes (standards, laws, customer requirements, etc.)
Consultancy and participation in the creation of quality policy and objectives
Maintaining and further developing the existing QM system
Identifying potential improvements and coordinating their implementation in the QM system
Introducing and supporting the supervision of effective risk management

Support with quality management documentation

We can help create and maintain essential quality management documentation, including:

Quality management manual
Process descriptions
Work instructions

Process Monitoring Support

We support the monitoring of company processes and report on the effectiveness of the QMS to management. Key tasks include:

Preparing management reviews and conducting them alongside management
Advising on error tracking, root cause analysis and error analysis
Reviewing and approving internal and external quality-related documents
Participation in the evaluation of test results
Supporting the documentation and verification of QM records

Internal and external audits

If internal or external audits are scheduled, our QA officer will be happy to advise and help you.

Consultancy, coordination and implementation of internal annual audits
Planning and support for external certification and re-certification audits
Assistance with the audit follow-ups

QM training for Employees

QM training for employees is important so that they understand the general requirements, how the quality management system works and the associated benefits.

Planning and implementation of QM training for employees and management personnel on all quality management issues
Communicating the quality principles to promote quality awareness within the company

Six Key Advantages of an External QA Officer for SMEs

Many SMEs delegate the task of quality management representative to an external Quality Assurance Officer. An external Quality Assurance Officer offers clear advantages for SMEs if the company and cost structure do not permit the provision of an in-house Quality Assurance Officer.

Cost-Effective

You only pay for the specific services you need, providing financial planning security.

Focus on QM Systems

An external QA officer can fully focus on the QMS, unlike internal employees who may be distracted by other tasks. This ensures the QM system is maintained properly, avoiding issues during certification or re-certification audits.

Optimize Internal Resources

Employees can remain focused on core business activities, as the he handles quality management tasks.

Experience and Expertise

SMEs benefit from the extensive experience of professional QA officers without the cost of training and educating internal staff.

Neutral Perspective

He brings a neutral perspective, which often gains higher acceptance from employees. This helps create the right conditions for implementing, applying, and further developing a successful QMS.

Solution-Oriented Approach

With exposure to various quality management systems, processes, and methods, he is often able to solve QM-related issues more quickly and efficiently.

Why a quality assurance officer is important

Even though ISO 9001 no longer mandates a QA officer, the role remains critical within a company. The QA officer is a central point of contact for internal staff, management, customers, and auditors regarding all aspects of quality management.

He is responsible for implementing, maintaining, and developing the QMS, while promoting quality awareness and improvement initiatives within the company. To fulfill these duties, a QA officer must be skilled in a range of methods and procedures related to quality management, as well as legal and regulatory requirements, and project management.

Weiterhin ist ein Qualitätsmanagementbeauftragter auch für die Implementierung, Betreuung und Weiterentwicklung des Qualitätsmanagementsystems verantwortlich. Dabei treibt er das Qualitätsbewusstsein und Verbesserungsprojekte aktiv voran.

Um all diesen Aufgaben gerecht zu werden, muss ein QMB umfassende Kompetenzen vorweisen. Dabei gehören die wichtigsten Methoden und Verfahrensweisen des Qualitätsmanagements genauso zum Wissensschatz des QMB, wie die Vertrautheit mit den gesetzlichen und behördlichen Anforderungen und Kenntnisse im Projektmanagement.

DO YOU NEED SUPPORT WITH AN EXTERNAL QUALITY ASSURANCE OFFICER?

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Rebecca Schelle
Unit Manager