A - QM Employee Guide
Employee Guide Quality Management |
dev-threads GmbH, Lorenzer Platz 5a, 90402 Nürnberg |
Note
For reasons of better readability, the male spelling is used. We, therefore, expressly point out that the exclusive use of the masculine form should be explicitly understood as gender neutral.
Quality Policy
Our philosophy is a secure future for the company and thus also for our employees. We want to achieve this through sustainable economic activity and through appropriate growth. The people, as employees, as customers and as suppliers come first. Dealing with employees, customers and suppliers is always human and fair. Problems are solved in the spirit of partnership and fairness.
Through innovative, first-class services and above-average commitment we secure our future and gain a competitive advantage. From our employees we expect the willingness to perform and entrepreneurial thinking. The constant assurance of the satisfaction of our customers are among our top prioritized business principles. Therefore, the judgement of the customers about our quality is decisive.
All our services are of a consistent high quality. Every single employee is responsible for ensuring our quality standards through his personal performance. With risk-based thinking we keep our awareness about the importance of error detection and avoidance. Quality and safety-relevant activities are continuously monitored and planned, controlled and checked. In this way we ensure that in addition to the quality requirements of our customers, the applicable legal requirements and official regulations are observed.
Through a continuous improvement process, the commitment of all employees at all levels, the quality of our services can be permanently increased. Our quality policy is known throughout the company and is regularly checked for ongoing appropriateness as part of the management review. Finally, we make the quality policy available to relevant interested parties on request, as far as we consider this information appropriate.
Context of the organization
Company presentation
The dev-threads GmbH offers its customers support in Software development. Our focus lies clearly in the applied implementation of software projects. We advise and develop together with our customers in large projects or plan and implement small to medium-sized projects from scratch.
Context of the organization
Knowledge of the relevant topics that affect our organization is important for setting up and initiating necessary and appropriate measures. Only if we clearly recognize these we are able to determine targeted measures to master these topics.
We determined and evaluated our context factors using context analysis
(FB-4-1-01 Risk
Matrix
). This list is
available as proof and is reassessed and adjusted appropriately at least once a
year in the management review. Through the assessment, we determined the most
relevant factors for us and pay special attention to them. This does not mean
that other factors are not important to us - however, from the perspective of
capacities, relevance and consistency, we do not want too many factors to
influence our actions at once, but rather proceed in a focused and consistent
manner.
Interested parties
Relevant interested parties are our customers, employees, suppliers, cooperation
partners and the competition. We deal systematically and regularly with the
relevant interested parties, their requirements, changes in the influence and
interests, and where necessary, take appropriate measures to respond
accordingly. We document the specific requirements and expectations using the
FB-4-1-01 Risk
Matrix
form.
Scope and limits of the Quality Management System (QMS)
The regulations of the quality management system apply to all employees and services of dev-threads GmbH, Lorenzer Platz 5a, 90402 Nürnberg. The regulations also apply to all employees who do not work at the company location, but at the customer’s site or in the home/mobile office. All employees are hereby called upon to make their contribution to the implementation, maintenance and improvement of the quality management system.
Field of application
When defining the scope of application, both the context of the organization, and the requirements of relevant interested parties, as well as the above mentioned services have been taken into account. The scope of the QMS shall be
Customer-related support in software development in major projects as well as website development
The Quality Management System meets the requirements of DIN EN ISO 9001:2015 (hereinafter ISO 9001).
Property of customers and external providers is treated with care and controlled, so that the regulations of the QMS also include the property of customers and external providers.
Furthermore, externally provided processes and services that influence the conformity of the services with the requirements are also within the scope of this QMS.
Limits/Non-application
The limits of our Quality Management System are:
7.1.5 Monitoring and measurement resources: The requirement for metrological traceability is neither demanded by our customers nor by the legislator, or defined by us as a necessary measure for monitoring measurements. Furthermore, no measuring equipment is used.
8.3 Development: We do not carry out any development in the sense of the standard - we develop exclusively on the basis of customer requirements in the sense of a service.
This does not affect our ability or responsibility to provide services that meet customer requirements and applicable legal or regulatory requirements.
Quality Management System and its processes
This guide gives an overview of our Quality Management System.
The foundation of our QMS is customer orientation.
In order to ensure that our services meet the the demands of our customers, a process-oriented QMS was established, which fulfills all requirements of ISO 9001.
We ensure that all business processes that have an impact on quality are consistently planned, controlled and monitored. We also consider the context of the organization, relevant interested parties, as well as risks/opportunities and take these into account in the planning and control of the QMS and its processes.
A fundamental method for planning, controlling and monitoring the entire QMS and the individual processes is the so-called PDCA cycle. We have internalized this method, combined with risk-based thinking, and have it applied to the entire QMS and its processes.
In addition to meeting the customer requirements, the continuous improvement of the Quality Management System is a central component of the company’s goals.
To meet these requirements:
the required processes, inputs into the processes, expected results and their sequence and interaction were specified,
the criteria and methods, e.g. defined performance indicators and measurements for the implementation and control of the processes were defined,
the necessary resources and information were ensured,
responsibilities and authorities for the respective process were assigned,
consideration of opportunities and risks and, if necessary, measures for risk management were defined,
the monitoring, measurement and analysis were regulated,
all necessary measures to achieve the planned results and to continuously improve them were taken,
documentation necessary for processes identified was created.
Structure of the Quality Management System
The structure of the documentation of the entire Quality Management System is divided into five levels, which are realized via the company’s IT infrastructure:
Level A - QM employee guide (this chapter)
This employee guide to quality management describes aspects of the QMS and gives an overview of the installed QMS. It demonstrates our commitment to quality management and customer orientation. The guide or extracts thereof may also be made available to interested, external parties, provided the management authorizes the transfer. The process landscape gives an overview of the processes of the QMS. In addition, interfaces and interactions can be seen. The process landscape is displayed on level A.
Level B - QM process descriptions (found here)
With the help of the detailed process descriptions, the implementation of all the elements of the QMS in the company is ensured. This level is deliberately not part of the employee guide, but is made available to all employees internally as part of the documentation of the QMS. The process descriptions are structured analogously to the chapter numbers of the basic standard ISO 9001 and are also numbered consecutively. Additional process descriptions of the specific standard are thematically assigned to the basic structure.
Level C - QM work instructions
The 3rd level C reflects the highest level of detail in the documentation. Work instructions are created especially if individual process steps need to be further specified in a meaningful way, if written regulations are appropriate, prescribed or necessary (e.g. test instructions). Currently there are no work instructions defined yet.
Level D - QM checklists and forms
Checklists and forms are stored as templates in this area. These are tools that help us to meet the requirements of the QMS. Forms and checklists are available via our QMS Gitlab.
Level N - QM proofs
As part of the verification, records required by the standard or other sensible records are documented. Proofs show that e.g. specific exams have been carried out or specific competencies have been acquired.
Interaction of the processes
The Quality Management System of our company is process-oriented. The processes described are subdivided as follows:
Management processes: They contribute to the definition of the corporate policy and goals.
Core processes: They contribute directly to product realization, from the identification of customer needs to their satisfaction.
Supporting processes: They contribute to the smooth running of the processes by providing them with the necessary resources and supply.
The representation of the process landscape shows the interaction of the processes.
Regulation of the distribution and modification service
The distribution of quality management documentation or individual chapters are distributed via the companies QMS Documentation by the Quality Management Officer (QMO). This also ensures that employees have access to the parts of the documentation that are relevant to them.
If there is no access to the documentation, paper versions can also be distributed. However, printouts from the QMS Documentation are only working copies that are not subject to revision service. Only the documentation found here is the valid version.
The QMO is responsible for updating the quality management contents and for making it known. The Quality Management System and its entire documentation are checked and updated by the QMO at regular intervals. The changes are marked with a revision index.
The QMS Documentation is owned by dev-threads GmbH. Information copies or parts thereof can be given out to external parties with the approval of the management. These information copies are not subjected to the revision service. The QMO makes a note who is the recipient of such a copy of information.
Leadership and commitment
Commitment of the management, role model function and customer orientation
The management is responsible for the effectiveness of the Quality Management System.
The management sets a good example, transports the importance of the QMS and supports the employees in the implementation, maintenance and improvement of the QMS, by providing the necessary framework and resources.
It defines the quality policy and ensures that quality goals are derived that fit the company’s strategy and context, which are known in the organization and to which every employee can contribute within the scope of his possibilities.
The management also uses suitable measures to ensure that customer requirements, legal requirements as well as opportunities and risks with regard to the conformity of the services are determined and integrated into the business processes and are taken into account for the improvement of customer satisfaction.
The management also fulfills its self-commitment by carrying out an annual assessment of the QMS, the so-called management assessment.
Finally the management commits itself to the necessary resources for the realization and maintenance of the QMS.
Planning of the Quality Management System
The planning of the Quality Management System considers the context of the organization, the requirements of the interested parties and the resulting opportunities and risks, so that opportunities can be exploited, risks minimized and the effectiveness of the QMS can be continuously improved.
True to the motto “only those who know their destination will find their way”, we plan, document and monitor our goals at least once a year. The achievement of objectives is assessed as part of the annual management review.
We also integrate any changes into the planning of the Quality Management System in order to systematically take their effects on the QMS into account. Changes that have an impact on the QMS can arise in all areas of the company. It is therefore necessary that all employees communicate necessary changes to the QMO. We do that by using our QMS Gitlab repository. Issues help us to keep track of required changes and adjustments. Merge requests will make sure that all employees got notified on relevant changes.
Necessary changes are also systematically identified, assessed and, if necessary, taken with measures in the course of audits and management reviews. The implementation is tracked with responsibilities and deadlines using our QMS Issue Tracker. This can also mean the redefinition of responsibilities and authorities as well as the provision of resources.
Support
Ressources
In order to implement, maintain and continuously improve the Quality Management System, we determine the necessary resources (people, infrastructure, working environment, resources for monitoring and measurement, knowledge of the organization) in suitable ways and ensure that they are checked and maintained.
Knowledge, competence, awareness, communication
We also ensure that the necessary knowledge and skills are available in the company. The employee is made aware of the quality management by regular training and also internal and external communication channels are defined.
Documented Information
We create documented information when they
Are required by the standard (see PD-7-5-1 Documented Information).
Are essential for the Quality Management System.
Are useful for the successful execution of our processes.
Are necessary for the proof of achieved results.
The documented information is recorded in the QMS Gitlab which also includes necessary downloadable forms.
The QMO answers questions about the requirements of the standard for the creation, updating and control of the documented information.
Operation
Within the framework of the defined core processes, we ensure that provision of services and activities after the delivery take place under controlled conditions (see B - QM process descriptions/8 - Operation).
In addition to the systematic planning and control of operational processes, the requirements for services are known and the communication with the customer is defined and the feasibility ensured.
Development processes are planned, systematically controlled and development inputs are transformed into development results, systematically taking any changes into account.
Externally provided processes, products and services are checked for compliance with the requirements and the necessary information is sent to the external providers in advance.
During the provision of the services, we ensure that the status of the process results, property of customers or external providers, is traceable at all times by means of suitable labeling and that the process results and services are carefully treated and preserved.
Unplanned changes and the release of the services are also documented and traceable.
The verification and validation of our products/services takes place on the basis of evaluations of defined key figures, complaint analyzes, internal audits and customer feedback as well as defined test criteria in production.
Process results and services that do not meet the requirements (non-conformities/errors) are reduced as far as possible through systematic planning and control. Any errors that have occurred are also identified and documented in a comprehensible manner and measures are taken to eliminate the cause (see PD-8-7-1 Control of non-conformities).
Loss and damage of customer equipment are reported immediately to the CEO and to the customer representative who is responsible for handing out the equipment. (see: PD-7-2-1 Knowledge Competence Awareness Communication ) Those incidents will be documented by describing in detail:
what, when, to whom and how the incident happened
the improtance and security issues coming along
how to proceed to resolve the incident
a final protocol after the incident has been resolved
Evaluation of the performance
For the continuous improvement of the Quality Management System and in line with the PDCA cycle, we monitor, measure, analyze and evaluate various topics at regular intervals, such as customer satisfaction, suppliers and the QMS (see PD-9-1-1-assessment-performance). We compare the target and actual situation and if necessary, initiate corrective measures. By doing so, we initiate measures to help us achieve our goals and keep an eye on continuous improvement.
Declaration of commitment by the management
The management hereby puts the Quality Management System of dev-threads GmbH into effect.
The regulations documented therein are binding for all employees. However, these do not replace the personal responsibility of each individual for the quality of their performance.
The QMO has been given the responsibility and authority for planning, monitoring and correcting the QMS, as well as for creating, approving, distributing and maintaining the quality management documentation by the management.