Management systems

Auditing, implementation and further development of certified management systems

Q methods

Selection, application and qualification for Q-methods

Qualification

Classic and digital training concepts tailored to our customers

ISO 9001 - Tier 1 supplier

 

Initial situation:

As part of the ISO 9001 certification, our customer relied on a management system made up of various document templates. Rapid growth meant that the management system and the real company structure, with its processes, differed more and more from each other. The result was that some discrepancies were found in the recertification audit.

After DECURA got involved, we first got an overview of the risks and problems at the customer with our own GAP audit. We were able to identify the customer's understanding of his QM system as the core cause. There was specific QM documentation that differed from the operational reports and documents. So a parallel structure was built for QM.

Solution:

The awareness of QM in the company was significantly increased through consultation appointments and training courses for employees and managers. Then, with the responsible contact person in the company, measures were determined that were able to close the gaps in compliance with the standards. The customer was qualified to implement the various measures himself in order to empower the company and the employees. The effectiveness was checked in a final audit by DECURA, whereby the readiness for the follow-up audit could be confirmed at the same time.

We succeeded in enabling the customer for the follow-up audit within just under 2 months. The second audit was completed without any further deviations. Even after the consulting project has ended, the customer is able to maintain the certification and to further improve the management system independently. The documentation effort and audit preparation time could be sustainably reduced, the release of this tied employee capacity allows the focus to be directed to more important topics in the future.

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IATF 16949

 

Initial situation:

Due to a legal change in China, our customer had to prove the certification of one of his production lines according to IATF 16949 within four months. At this point in time, the factory was exclusively certified to ISO 9001

Market approval for an entire product category was in danger.

Solution:

First of all, we informed the top management about the requirements of IATF 16949.

An internal audit was carried out as the basis for a GAP analysis in order to adopt a project plan with clear milestones and escalation mechanisms together with the managers.

The affected production line was specifically prepared for a conformity assessment according to IATF 16949. In order not to endanger the market approval of the product, we developed quick and pragmatic solutions that could be implemented in ongoing operations.

After attaining the proof of conformity, a robust QM system was set up in the long term, which, in contrast to the first step, was designed intensively by the employees.

This included the qualification of employees so that they understand the requirements and can implement them according to the circumstances on site.

The implementation took place parallel to regular internal audits in order to identify weak points at an early stage and to bring about the necessary management decisions.

The result was the successful IATF 16949 certification of the entire site. During the initial certification, only two minor non-conformities could be found, which could be closed in the week after the audit.

Two years after the certification, 90% of the plant's managers confirmed that the QM system is one of the most decisive factors for the company's economic success.

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ISO 17025

Initial situation:

A test laboratory for mainly thermal tests approached DECURA with the request for timely accreditation according to ISO 17025. Due to the restrictions caused by the corona situation at the time, it was not possible to work together on site.

Solution:

In order to enable a robust communication structure and the best possible preparation for certification, DECURA recommended using two collaboration tools that we have been using for years. The quick integration into the customer's Microsoft TEAMS environment enabled simple but intelligent communication.

Then, with the help of the maturity level software quiub®, framework conditions were created in order to carry out the accreditation preparation completely digitally.

The DECURA consultants fully support the customer in preparing for the accreditation audit by the German Accreditation Service (DAkkS), the quiub served as a knowledge repository and project management tool so that the complex processes of the test laboratory can be adequately mapped and implemented.

The tool remains in use even after the end of the project in order to prove the ongoing functionality of the management system.

The consulting services include the elaboration of processes and procedures, the creation of work and procedural instructions as well as review and revision of the existing documents, taking into account the security of accreditation.

 

ISO 50001

You will find more information here shortly!

 

ISO 45001 - Tier 1 supplier

Initial situation:

In order to maintain its supplier status, the customer had to prove certification according to ISO 45001 at short notice.

Solution:

At the beginning, a project plan with key milestones was drawn up.

This served as a communication document to the OEM in order to prevent the supplier status from being downgraded.

An audit served as the basis for carrying out a GAP analysis. On this basis, those responsible for the new topic and the innovations in the integrated management system were determined. The primary objective was to describe the issue of the management system for occupational safety not just as an additional task for the QM department.

The personnel department was named as having overall responsibility for the topic and the QM department provided support exclusively with its know-how for management systems and process management.

Together with those involved, the requirements of ISO 45001 were consistently integrated into the existing processes, such as procurement, personnel development and management.

The representatives for the area of occupational safety were always included in order to prevent parallel organization.

After the description in the management system, all employees were initially qualified through training courses and workshops. For this purpose, a role and level-appropriate qualification concept was implemented.

The certification was successfully completed on schedule and the issue of occupational safety was implemented as a clear management task.

 

ISO 14001

You will find more information here shortly!

PMM - test equipment management

 

Initial situation:

Our internationally active customer has changed the system for managing test equipment for reasons of standardization in order to meet the normative requirements of ISO 9001 and, in some cases, IATF 16949. Due to the large number of employees and the complexity of the overall process, a target-oriented training concept had to be developed that takes all roles and committees of the overall process into account.

Solution:

In order to ensure internal expertise and maximum qualification benefits for employees, we worked together with decision-makers and software developers from the start. Due to the closely staggered adjustment of the software to the needs of the customer, the training concept also had to be continuously adapted and revised.

A training portfolio was developed and implemented through close cooperation that has continued to this day, which successfully ensured the qualification of employees.

As external consultants, we are an important point of contact for employees and can ensure that the implementation is permanently compliant with the standards in the various international locations of the customer.

IFS / IFS Broker

 

Initial situation:

A raw materials trading unit of a world-famous baby food manufacturer asked DECURA to participate in the expansion of an existing management system according to GMP + to a system that can be certified according to IFS criteria. The project started before the Corona restrictions and could be transferred to the lockdown phase without loss of time.

Solution:

The existing management system according to GMP + was analyzed in order to be able to use existing control modules for the expansion. The use of a shared SharePoint room enabled a smooth exchange of documents. As part of a GAP analysis, all essential aspects that are required for certification according to IFS Broker could be worked out together with the customer in a few workshops.

The documents available in SharePoint were then merged with the requirements of the IFS Broker as part of an initial filling of the quiub® maturity management system and aggregated into knowledge and evidence modules.

Due to the corona lockdown, the further finalization of all requirements could only be completed with digital contact. The management review and auditing were then migrated to the group system.

The services of DECURA included the status analysis of the existing management system, a GAP analysis based on it as well as the initial filling of the maturity level management system based on a shared document platform and support in locating systems in the group structure.

GDPR - General Data Protection Regulation

 

Initial situation:

When the GDPR came into force, our customers had to meet the requirements for the protection of personal data. The lack of best practice and judicial decisions on the interpretation of the law as well as the high risk due to the potential sanctions by data protection authorities caused great uncertainty among our customers.

Solution:

First, we had to get an overview of the current situation at the customer in an audit. Subsequently, concrete measures could be planned, the implementation of which could help improve data protection. In the first step, a list of processing activities was drawn up together with the customer. This should form the basis for the data protection management system. In the next step, the customer's employees were informed about the basic principles and requirements of data protection in a short training sequence. Creating awareness among employees ensures compliance with the GDPR in day-to-day operations.

Our customers now have a pragmatic system that covers the requirements of the GDPR. A certain degree of flexibility is always important here, as court rulings, best practices and requirements of the data protection authorities are increasingly changing the requirements for a data protection management system (or in some cases just specifying them more precisely).

We are still named and involved as the DPO of our customers, so we can keep you informed about news about data protection.

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DECURA Consulting Group GmbH

Leopoldstraße 244
80807 München

+49 (0)89 2080393-92

info@decura.de
 

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