ISO/CE Mark Audits Made Easy: Which Certification Bodies Offer Bundled & Remote Options
Introduction
New ventures are under immense strain to add value to the product within a short period of time and at the same time meet the legal compliance requirements across regions. Quality, safety, and regulatory acceptance in global markets necessitate ISO certification and CE Mark as a bare minimum.
Here is a problem: there are separate audits for ISO and CE Mark. They are time-consuming, expensive, and difficult. Startups do not have a lot of any of these in excess. This is the time when iso/CE Mark audits with remote options come in handy.
Instead of separate processes, businesses can use a streamlined, singular path.
Maxicert streamlines the certification process. This article will show you the certification bodies and bundled audits that are important for startups.
Why Startups Need ISO/CE Mark Audits.
Let’s explain with examples. Being a certified company means that you have a global market at your disposal and that you can sell freely without any restrictions.
It is legal to sell the ISO 9001-certified company’s products without any further restrictions because the ISO certification proves that the company meets global standards.
For new businesses developing innovative ideas, these recognitions enhance trustworthiness with potential consumers.
- Enhance the level of trustworthiness with potential consumers.
- Provide access to additional investors and new geographic markets.
- Lower the possibility of risks associated to regulations and compliance.
- Give a more favorable position than rivals who do not possess certifications.
Without them, even the best product can face roadblocks in entering global supply chains.
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Obstacles and Issues within Individual Audits from the Perspective of a Startup
Many startups approach ISO and CE certification separately, only to discover:
- Expensive: Paying for two audits means the travel expenses associated with each auditor, plus their fees, along with admin costs.
- Delays: The lengthy time for market entry for audits to be completed is attributable to each audit having a unique timeline.
- Redundant Work: Teams are now tasked with the situation where they must “defend” the same set of documents, not once, but twice.
Within a startup where time is of the essence, the aforementioned issues and challenges are not only capable of delaying a product’s release, but also increasing the burn rate.
What Is Included Within a Combined ISO/CE Mark Bundle Audit?
The evaluation and aided processes for ISO and CE Mark Bundle Audits are done within a set period for streamlined efficiency.
The benefits of this strategy within this context are
- Time saved due to the certification being required
- Expenses saved through fewer admin and audit visits
- Easy drainage of administrative workflows due to the simultaneous fulfillment of separate but related requirements
- Losing weeks or months from the launch schedule
This technique is ideal for startups within the following sectors:
- Medical Devices (ISO 13485 + CE Mark applicable for the EU)
- Electronics (ISO 9001 + CE Mark)
- Industrial manufacturing (ISO + CE product standards)
Certification Bodies That Offer Bundled & Remote Audits
Not all certification bodies provide bundled audits. Here are some that do:
Internationally Recognized Bodies
- TÜV SÜD – Trusted worldwide for CE and ISO audits, especially in medical and industrial sectors.
- SGS—Offers combined audits with strong support for startups.
- BSI (British Standards Institution)—Known for global credibility and remote auditing options.
- Intertek—Flexible in offering ISO + CE services, suitable for fast-moving startups.
These bodies are well accepted by regulators and customers worldwide, giving startups confidence that their certifications will hold weight.
Remote Audit Options
With digital tools, many certification bodies now provide remote audits, where much of the process is conducted online.
How it works:
- Video-based facility inspections.
- Digital submission of documentation.
- Virtual interviews with employees.
- Online management system reviews.
- Remote audits are accepted in industries like:
- Software and IT services
- Electronics manufacturing.
- MedTech and devices (in some cases).
This saves startups from travel costs, site preparation stress, and scheduling delays.
Evaluating Audit Bundles
In selecting a certification body for a startup, the following aspects should be considered:
- Scope: Will the body perform an assimilated audit for ISO and CE Mark?
- Remote Flexibility: Do they offer fully virtual audits?
- Timeline: Are they able to prioritize startups and complete the work faster?
- Cost: Is it cheaper to purchase the bundled option than to purchase individual audits?
Separate Audits vs. Bundled ISO/CE Mark Audits
| Factor & Separate Audits | Bundled ISO/CE Mark Audits |
|---|---|
| Cost: Pay twice for auditor visits, travel, and admin fees | Single combined fee, more affordable |
| Time: 2 separate audit schedules; longer certification timeline | Parallel audit process; faster certification |
| Documentation: Duplicate submission of similar documents | Shared requirements reviewed once |
| Team Effort: Staff must prepare and attend two audits | One streamlined process with less disruption |
| Market Entry: Delayed product launch due to longer certification | Faster market access with fewer delays |
| Best For: Large companies with dedicated compliance teams | Startups and SMEs needing efficiency |
How Maxicert Helps Startups with ISO/CE Mark Audits
The most stressful aspect of an audit is preparation; however, all the auditing work is done by the Maxicert team.
We help the startups by:
- Knowing what ISO standard + CE Mark you need
- Documenting what is needed
- Preparing teams for the audit.
- Providing access to certifying bodies with bundled and remote audit options.
- Controlling all communication to ensure there is no time lost.
Maxicert will help you streamline the process to ensure that you have the certifications with minimal complications.
Steps to Secure Bundled ISO/CE Mark Audits Efficiently
To all the people and businesses interested in speeding up the certification process, here are the steps to take:
- Identify Your Requirements – Determine what ISO standards and CE Mark categories apply to you.
- Contact Maxicert – Let us assist you in finding the most suitable certification authority for bundled audits.
- Prepare Documentation – Focus on the important elements of the quality management system, mitigation of risk, and ensure the technical documentation is complete.
- Schedule Remote/Hybrid Audit – Auditing done remotely will save you time and reduce costs.
- Get Certified – Get the ISO and the CE certifications in one process.
Conclusion
It is particularly important for startups to manage their time well, and so they need to keep in mind that every week can be valuable in their growth. Certification doesn’t have to be a bottleneck in the growth process, in fact, when done with precision it can aid in growth acceleration.
With Maxicert, we help the right certifying partners to the startups and manage the preparation of the necessary paperwork so that every part of the process is as easy as it can be.
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FAQ
Can ISO and CE Mark audits really be combined?
Yes. Many certification bodies allow bundled audits where overlapping requirements are reviewed together. This saves both time and cost.
Are remote audits accepted by regulators and customers?
Yes, especially after COVID-19, remote audits became widely accepted in many industries. However, some sectors may still require partial on-site visits.
How much time do startups save with bundled audits?
Depending on scope, startups can save 4–8 weeks compared to running audits separately.
Which industries benefit the most from bundled audits?
Medical device, electronics, and industrial manufacturing startups gain the most efficiency from combining ISO and CE Mark audits.