Overview of Our References

Customer requirement regarding the company’s certification.

A small, international team with diverse cultural backgrounds and a start-up atmosphere. QMH impressed with its pragmatic approach, strong focus on substance and process, and effective collaboration model.

Extension of the existing management system to comply with ISO 9001 and the additional implementation of ISO 14001

A desire to achieve ISO 9001 certification, coupled with the need for a long-term transformation of the organisational structure. QMH stood out thanks to its expertise in both ISO 9001 and strategic consultancy regarding business development.

Strategic positioning through ISO 9001 certification

Adapting ISO 9001 to the specific organisation to ensure sufficient flexibility whilst meeting the required standardisation

Urgent vacancy in a senior management role

A very last-minute enquiry regarding the market launch phase of a new product. QMH stood out thanks to its in-depth knowledge of the client, a long-standing, positive relationship with the client and flexible resource management.

Supplier evaluation using the Assessment Standard, predominantly in Asia.

Planned by the customer at fairly short notice.

New customer requirements: TISAX assessment and IATF 16949

Implementation of two comprehensive standards in a relatively small SME

At the start of the coronavirus pandemic, a manufacturer of medical surgical masks was under considerable time pressure, as demand was rising rapidly and immediate certification was required. A standards-compliant quality management system, as well as evidence of compliance with ISO 9001 and ISO 13485, were absolutely essential for production and delivery to healthcare facilities. However, a formal QMS was only in its infancy; processes were not documented and responsibilities were not clearly defined.

The greatest challenge lay in the extremely short implementation timeframe, the need for process stability at the same time, and the strict regulatory requirements for medical devices. The organisation had to ramp up production, meet regulatory requirements, prepare documentation and train staff all at the same time. Furthermore, there were no established QMS structures in place, meaning that a complete system had to be set up whilst operations continued as normal.

A leading medical technology manufacturer commissioned an audit of an external logistics service provider after external reports of potential regulatory risks, particularly in relation to labelling processes, came to light. The logistics service provider assumes no regulatory responsibility in this context, meaning that the manufacturer remains fully responsible for compliance with regulatory requirements (e.g. ISO 13485, FDA requirements). There were organisational and documentation-related weaknesses that needed to be assessed at short notice.

The challenge was to gain a comprehensive overview of the process and compliance situation whilst under significant time pressure. Varying levels of maturity in the areas of labelling, risk assessment, document control, order management and the handling of instructions for use made a complete assessment difficult. In addition, the manufacturer needed to minimise regulatory risks, as deviations in the labelling process could have a direct impact on audit and regulatory requirements.

A manufacturing company based in Hamburg had an established ISO 9001 quality management system, the processes of which had become ‘well-established’ over the years and varied significantly from one department to another. Management had only limited insight into how the QMS was actually being implemented and wanted a comprehensive, reliable understanding of the system’s current maturity, efficiency and effectiveness, as well as its implementation across the various departments.

One challenge was the lack of consistent system transparency across departmental boundaries. Workflows that were, in some cases, unknown or interpreted differently, a lack of coordination between processes and responsibilities, and divergent implementation practices made it difficult to establish a consistent understanding of quality. At the same time, management wanted clear, transparent assessment criteria and recommendations for action.

The client has identified significant discrepancies and would like the company to be ISO 9001 certified.

A discrepancy between customer expectations on the one hand (a large multinational company) and only a moderate willingness to change on the other. QMH scored highly thanks to its specialist expertise regarding the interpretation of ISO 9001 and its intensive stakeholder management on both sides.

A long-established Swabian company.
Project (tuner module, car multimedia).
Delay in the project. RGA not implemented.
VDA 6.3 implemented only in part.
FMEA incomplete.

A long-established Swabian company with entrenched organisational structures.
Poor or non-existent communication with customers.
Challenge: To foster an understanding of the customer’s expectations.

Implementation of the IATF 16949 standard at an existing (industrial) site

Implementation of IATF within a (9001) industrial environment

No stable, functioning processes – weaknesses in the QMS.
In addition, highly specific problems in supplier- and customer-specific project and series production.

Improving and supplementing the processes of an existing QMS, whilst taking the company’s identity into account.
Handling escalations with very limited information regarding the exact nature of the activity.
Potential for strained supplier/customer relations.

Highly complex development and manufacturing processes; global engineering teams; stringent documentation and traceability requirements

Aviation projects require robust and systematic risk analyses. FMEA processes had been applied inconsistently, in some cases having developed over time. The client was seeking methodological expertise, experience with safety-critical and complex systems, and professional facilitation in a demanding and critical team environment.

Different RD departments without a standardised methodology; specific characteristics were not consistently identified; no professional FMEA software was in use

A lack of standardisation led to significant variation in the way FMEA was carried out. The client was seeking methodological expertise, process design know-how and experience in selecting and implementing professional FMEA software. Furthermore, coaching for the facilitators was crucial to ensuring the sustainable application of FMEA.

Development projects running in parallel; different teams specialising in mechanics, electronics, software and production; FMEA methods not applied consistently, particularly at the interface with FTA and FMEDA

There was a significant need for coordination between interdisciplinary teams; the lack of a structured facilitation approach led to long lead times and a lack of transparency in risk assessment. The client was seeking a facilitator with a sound grasp of methodology and a comprehensive understanding of systems, design, processes and medical technology.

Several global production sites; a process landscape that has evolved over time with inconsistent RM; validation documentation (IQ, Installation, OQ, Operational, PQ, Performance) not consistently harmonised; FDA audits are becoming increasingly critical, highlighting non-conformities

Complex regulatory requirements (FDA, ISO 14971, MDR). A lack of consistent PFMEA structures across critical – and, in particular, innovative – manufacturing processes such as vacuum brazing, assembly and testing. The client required a partner with an in-depth understanding of medical technology processes, regulatory compliance and the practical implementation of PFMEA.

Various engineering sites worldwide, diverse FMEA methods; a documentation landscape that has evolved over time; a lack of harmonisation between product families

High complexity due to multiple product lines and global development sites. A lack of consistency led to quality risks. The client was seeking a partner with a deep methodological understanding of DFMEA, basic and family FMEA, and automotive best practices.

Processes are heavily tied to work instructions. Process orientation is limited to the second process level, and there are no flowcharts.

The challenge was that, whilst there were well-documented high-level processes (Turtles) specified by head office, these were not being implemented at a local level as intended.

Maintenance staff at various production sites used problem-solving tools such as Ishikawa, 5Why and fault analysis to varying degrees and with varying levels of quality when compiling an 8D report. There was a lack of uniform standards for structured root cause analysis, as well as clear guidelines for the documentation and application of these methods in the event of a fault.

The challenge lay in the wide variation in the maintenance staff’s methodological knowledge, as well as the intense time pressure when plant malfunctions occurred. As a result, problem-solving tools were often applied incompletely or inconsistently. Furthermore, the diversity of plant types and fault patterns made it difficult to adopt a consistently standardised approach.

IATF 16949 and CSR are not covered by the company’s QMS. The QMS is not sufficient to meet customer requirements.

Risk-based thinking must be integrated into the QMS. A customer-focused approach must be demonstrated in the QMS.
Customer requirements and VDA must be taken into account in the QMS.

No processes described

Adapting standard processes to a craft business whilst ensuring the <strong>greatest possible flexibility</strong> in process design. QMH has stood out thanks to its experience across various fields of application and sectors, as well as its <strong>on-site presence</strong>.