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Shared Success Through Quality

ISO 42001 Expertise for Small and Medium Size Businesses

Fast, practical consulting to simplify ISO 9001, 13485, 14001, 42001 & 45001 certification

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Sustainable support guaranteed

Expert for quality management

Fast implementation in your company

Jonathan Sternberg

Sternberg Consulting — Your Partner in Quality Excellence

I’m Jonathan Sternberg, a certified internal auditor and external QMR with hands-on experience across a wide range of industries — including automotive, semiconductors, laser optics, and medical devices. I support companies in meeting ISO 9001, ISO 14001, ISO 45001, and ISO 13485 standards — helping them confidently navigate certification and compliance.

With Sternberg Consulting, I combine deep regulatory expertise with a practical business mindset. My goal: to deliver tailored solutions that create real improvements and lasting success for your organization.

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Services

Tailored Quality Management Solutions for Your Business

Whether you’re starting from scratch or improving an existing system, we deliver expert consulting that makes ISO certification practical, efficient, and valuable.

ISO 9001 Quality Management Consulting

We perform a thorough gap analysis of your current processes and develop a tailored Quality Management System (QMS), guiding you through implementation and certification audits.

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ISO 13485 Medical Device Consulting

We translate complex regulatory requirements into practical QMS procedures—from design controls and risk management to technical documentation. This hands-on approach prepares you for audits 

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ISO 14001 Environmental Management Consulting

We identify your environmental aspects, legal obligations, and performance goals, then design and implement an ISO 14001-compliant Environmental Management System (EMS).

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ISO 42001 Artificial Intelligence Management System Consulting

We guide organizations in responsible AI governance—defining ethics frameworks, lifecycle processes, and accountability structures for emerging AI applications. This ensures effective management.

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ISO 45001 Occupational Health & Safety Consulting

We establish a risk-based Occupational Health & Safety Management System—from hazard identification through policy implementation—to protect employees and reduce workplace incidents.

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Internal Audits & External QMR Services

As certified auditors and Quality Management Representatives (QMRs), we perform impartial internal audits, document nonconformities, and develop corrective action plans. 

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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.

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ISO 9001 Guide

Discover The Secrets of Success of ISO 9001 — Certification

Your comprehensive guide to mastering quality management and achieving excellence.

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  • 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.
Simple Process

Your ISO Certification— In 3 Clear Steps

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1. Defining the Scope of Services

Clarify your goals and determine whether to build a new quality management system or enhance an existing one. We also support you in preparing and submitting BAFA funding applications where applicable.

2. Capture Scope of Services & Current State

We analyze your current processes and documentation to establish a clear baseline. This helps us tailor the scope of services precisely to your needs before we begin implementation.

3. Identify Measures & Ensure Compliance

We develop tailored measures and strategies to ensure your processes comply with applicable standards — and remain compliant over time.

4. Documentation & Certification Preparation

We help you create structured documentation and gather objective evidence — including quality objectives and management reviews — to ensure you’re well-prepared for certification audits.

5. Conducting Internal Audits

We conduct internal audits to evaluate the effectiveness of your system and identify improvement potential — always aligned with your business goals and compliance needs.

Find Question & Answers.

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1. 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.

Benefits include improved product quality, increased customer satisfaction, enhanced market access, compliance with regulatory requirements, and reduced risk of product failures.

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.

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.

Benefits include improved efficiency, increased customer satisfaction, enhanced reputation, better decision-making, and access to new markets.

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.

The timeline for certification varies, typically taking between 6 months to a year depending on the organization’s size, complexity, and existing processes.

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