Unlock Your Company’s Potential With Customized ISO Certification Consulting
From the initial analysis to successful certification, Sternberg Consulting supports your company with customized, efficient quality management solutions. Experience sustainable support and expert advice, even after the project has been completed.
- Sustainable support guaranteed
- Expert for quality management
- Fast implementation in your company
Expert Guidance, ISO Excellence
Sustainable Support Guaranteed
We are available to answer your questions 6 months after completion of the project. You can rely on our ongoing expert advice.
Expert for Quality Management
Expert in quality management and your partner for excellent QM. Benefit from our in-depth expertise in quality management.
Fast Implementation in your company
Rapid implementation is possible with good coordination and sufficient customer capacity. Your success is our goal.
Expert Solutions for Your Quality Needs
Discover tailored quality management solutions designed to elevate your business. From implementing new systems to adapting existing ones, we ensure compliance with industry standards through comprehensive audits, meticulous process documentation, and strategic planning. Trust our expertise to prepare your organization for successful certification and sustained excellence.
ISO 9001 Guide
Discover The Secrets of Success of ISO 9001 Certification
Your comprehensive guide to mastering quality management and achieving excellence.
- Gain A Comprehensive Understanding Of The ISO 9001 Certification Process.
- Discover Strategies For Implementing A Robust Quality Management System/
- Find out how to avoid common pitfalls and ensure the success of your company.
ISO 9001 Consulting
Achieve ISO 9001 quality management certification with us at your side. Our expertise in quality management processes ensures compliance with international standards – from the initial analysis to successful certification. Benefit from our advice to make your system efficient and reliable and to achieve certification smoothly.
ISO 13485 consulting
With our expertise in ISO 13485 consulting, you can navigate the medical device market with confidence. We simplify the complexity of certification and support compliance with essential quality and safety standards. Rely on our support to successfully master the demands of the market.
QM Training
Our ISO 9001 and ISO 13485 consultancy training programs transform your team into quality management experts. Theoretical principles and practical application merge into a deep understanding of standards and best practices. Increase product and service quality, minimize risks and secure competitive advantages.
Individual Steps of Our Consulting
Depending on the wishes and needs of our customers, we usually carry out the sqm consultation in the following steps.
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Defining the Scope of Services:
Define the scope and prepare funding applications: Decide whether to implement a new quality management system or adapt an existing one. Review and apply for potential BAFA funding.
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Capture Scope of Services & Current State
Before signing the contract, we clearly define the scope of our services. We then capture the current state of company processes and documentation to identify existing processes and the implementation of quality management measures.
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Identify Measures & Ensure Compliance
We determine the necessary measures, strategies, and processes to ensure compliance with standards on an ongoing basis.
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Process Documentation & Certification Preparation
Document the processes and relevant evidence, such as quality objectives and management review, to optimally prepare for certification.
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Interne Audits durchführen
We conduct internal audits to review and ensure compliance with established quality standards and processes.
Frequently Asked Questions
Is there still any questions from you? You can contact us for more advanced questions or answers
Who needs ISO 13485 certification?
Any organization involved in the design, production, installation, and servicing of medical devices can benefit from ISO 13485 certification. This includes manufacturers, suppliers, and service providers.
What are the benefits of ISO 13485 certification?
Benefits include improved product quality, increased customer satisfaction, enhanced market access, compliance with regulatory requirements, and reduced risk of product failures.
How does ISO 13485 differ from ISO 9001?
While both standards focus on quality management, ISO 13485 is specific to the medical devices industry and includes additional requirements related to regulatory compliance, risk management, and product traceability.
How long does it take to get ISO 13485 certified?
The time frame varies based on the size and complexity of the organization. It typically takes between 6 months to a year to implement the necessary changes and undergo the certification audit.
What are the benefits of ISO 9001 certification?
Benefits include improved efficiency, increased customer satisfaction, enhanced reputation, better decision-making, and access to new markets.
What is the structure of ISO 9001?
ISO 9001 is structured according to the High-Level Structure (HLS), which includes sections on context of the organization, leadership, planning, support, operation, performance evaluation, and improvement.
How long does it take to become ISO 9001 certified?
The timeline for certification varies, typically taking between 6 months to a year depending on the organization’s size, complexity, and existing processes.