Wir führen eine gründliche Gap-Analyse Ihrer aktuellen Prozesse durch und entwickeln ein maßgeschneidertes Qualitätsmanagementsystem (QMS), wobei wir Sie durch die Implementierung und Zertifizierungsaudits begleiten.
ISO Consulting for Small & Medium Businesses – Practical Systems That Work
Fast, practical consulting to simplify ISO 9001, 13485, 14001, 42001 & 45001 certification
Sustainable support guaranteed
Fast implementation in your company
Expert for quality management
Certified Internal Auditor & External QMR with Multi-Industry Expertise
With extensive experience as a certified internal auditor and external Quality Management Representative (QMR), I support organizations across multiple industries, including manufacturing, medical devices, construction, IT, and service sectors.
At Sternberg Consulting, the focus is on practical, results-driven ISO systems. The goal is not just certification, but building management systems that improve efficiency, ensure compliance, and create long-term value for your organization.
ISO Consulting Services for Quality Management
Whether you are implementing a new management system or improving an existing one, we provide expert ISO consulting that makes certification practical, efficient, and sustainable.
ISO 13485 Medical Device Consulting
Wir übersetzen komplexe gesetzliche Anforderungen in praxisnahe QMS-Prozesse von Designkontrollen und Risikomanagement bis hin zur technischen Dokumentation. Dieser praxisorientierte Ansatz bereitet Sie optimal auf Audits vor.
ISO 14001 Environmental Management Consulting
Wir identifizieren Ihre Umweltaspekte, rechtlichen Verpflichtungen und Leistungsziele und entwickeln anschließend ein ISO 14001-konformes Umweltmanagementsystem (UMS), das wir implementieren.
ISO 42001 Artificial Intelligence Management System Consulting
We support organizations in establishing responsible AI governance — from defining ethical frameworks and lifecycle processes to setting up accountability structures for new AI applications. This ensures effective management.
ISO 45001 Occupational Health & Safety Consulting
We establish a risk-based occupational health and safety management system, from hazard identification through to the implementation of policies, to protect employees and reduce workplace accidents.
Internal Audits & External QMR
As certified auditors and Quality Management Representatives (QMR), we conduct objective internal audits, document nonconformities, and develop action plans for corrective measures.
Quality Management Training
We offer targeted workshops and on-site training to build your team’s capabilities in system implementation, auditing, and continual improvement. By equipping staff with practical tools and methodologies.
Discover the Secrets of Success of ISO 9001 — Certification
A comprehensive guide to building an effective quality management system and achieving ISO 9001 certification with confidence.
- Clear explanation of ISO 9001 requirements
- Practical implementation guidance
- Preparation for successful certification audits
Your ISO Certification — In 5 Clear Steps
1. Defining the Scope of Services
We begin by clearly defining the scope of your management system. This includes identifying relevant processes, departments, locations, products, and services that fall under the ISO standard. A well-defined scope ensures clarity, avoids unnecessary complexity, and forms the foundation for successful certification.
2. Capture Scope & Current State
In this phase, we analyze your current processes, workflows, and documentation to understand how your organization operates today. Gaps between existing practices and ISO requirements are identified, allowing us to determine what needs to be improved, added, or adjusted.
3. Identify Measures & Ensure Compliance
Based on the gap analysis, we define and implement the necessary measures to meet ISO requirements. This includes establishing controls, procedures, risk assessments, and responsibilities to ensure compliance while keeping the system practical and aligned with your business operations.
4. Documentation & Certification Preparation
We develop and refine all required documentation, including policies, procedures, records, and manuals. Internal audits and management reviews are conducted to verify readiness, ensure effectiveness, and prepare your organization confidently for the certification audit.
5. Conduct Internal Audit & Certification
Before certification, internal audits are finalized to confirm conformity and system effectiveness. We support you throughout the certification audit process and provide guidance on corrective actions and continuous improvement to ensure long-term success beyond certification.
1. Who needs ISO 13485 certification?
Any organization involved in the design, production, installation, or servicing of medical devices can benefit from ISO 13485 certification.
2. What are the benefits of ISO 13485 certification?
Improved product safety, regulatory compliance, and access to global markets.
3. How does ISO 13485 differ from ISO 9001?
ISO 13485 is specific to medical devices and includes stricter regulatory requirements.
4. How long does it take to get ISO 13485 certified?
Typically between 3 to 6 months, depending on company size and readiness.
5. What are the benefits of ISO 9001 certification?
Improved process efficiency, higher customer satisfaction, and stronger credibility.
6. What is the structure of ISO 9001?
It follows a process-based approach focused on risk management and continuous improvement.
7. How long does it take to become ISO 9001 certified?
Usually 2 to 4 months with proper preparation.
