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Navigating the Certification Process for ISO 9001, AS9100, and ISO 13485

Introduction to the Certification Process

Navigating the maze of certifications in contract manufacturing can feel overwhelming. However, these certifications aren’t just hoops to jump through; they are crucial for establishing credibility, quality, and trustworthiness in the industry. This blog post aims to demystify the certification process for ISO 9001, AS9100, and ISO 13485, offering you a clear roadmap for success.

Why Certify?

Before diving into the nitty-gritty, it’s essential to understand why these certifications are worth your time and investment. Simply put, certifications like ISO 9001, AS9100, and ISO 13485 are a testament to your commitment to quality, safety, and operational excellence, providing your clients peace of mind and giving your organization a significant reputational boost.

Common Elements Across Certification Processes

Regardless of the specific certification, some universal steps are involved, such as:

  • Conducting a gap analysis
  • Preparing documentation
  • Implementing necessary changes
  • Internal audits
  • External audits by an accredited certification body

Certification-Specific Requirements

ISO 9001

  • Steps to certification: Gap analysis, documentation of Quality Management System (QMS), internal audits, external audit.
  • Typical timelines: 3-6 months
  • Costs involved: Varies depending on company size, but generally ranges from a few thousand to tens of thousands of dollars.


  • Steps to certification: Similar to ISO 9001, with additional focus on areas like risk management and product traceability.
  • Typical timelines: 6-9 months
  • Costs involved: Slightly higher than ISO 9001 due to more specialized requirements.

ISO 13485

  • Steps to certification: Again, similar to ISO 9001 but with added elements like sterile manufacturing and regulatory compliance.
  • Typical timelines: 6-12 months
  • Costs involved: Can be expensive due to specialized healthcare requirements, often surpassing $20,000 for small businesses.

Preparing for Certification

  • Documentation: Every process must be documented comprehensively, following the certification guidelines.
  • Process Mapping: Understand how each department interacts and affects quality.
  • Training: Ensure your team understands the implications of the certification and is prepared for the audit.

Audit Process Explained

Audits can be intimidating, but preparation is key. An audit generally involves:

  1. Initial review: Preliminary check of your documentation and processes.
  2. Site Audit: A more in-depth, on-site examination.
  3. Final Review: A review of the audit findings and any necessary corrective actions.
  4. Certification: If all goes well, the certification body will issue the certificate.

Post-Certification: Maintaining Compliance

Earning the certificate is just the beginning. Annual or bi-annual re-audits and continuous improvement activities are essential for maintaining your certification status.

Case Study: Machining Concepts

At Machining Concepts, we pursued these certifications not as an end but as a means to continually improve our quality and customer satisfaction. From preparation to audit and beyond, each step offered an opportunity to streamline processes and enhance efficiency. The result has been a significant ROI in terms of client trust and market competitiveness.

Frequently Asked Questions

  • Is certification a one-time cost? No, maintaining certification will involve regular audits and possibly renewal fees.
  • Can one certification substitute for another? Generally no, as each certification serves a specific industry or need.
  • How long does it take to get certified? The time required varies depending on the certification and the readiness of your organization. It can range from a few months to a year or more.
  • Who conducts the certification audits? Audits are generally conducted by accredited certification bodies or third-party auditors that specialize in your industry.
  • Can multiple certifications be pursued simultaneously? While it’s possible, pursuing multiple certifications at the same time can be complex and resource-intensive. It’s often advisable to stagger the certification processes.
  • What are the penalties for non-compliance post-certification? Non-compliance can lead to warnings, corrective action requests, and in severe cases, revocation of the certification.
  • Do all team members need training for certification? While not every employee needs to be an expert, a general level of awareness and understanding across the team is essential for maintaining compliance.
  • Are certifications internationally recognized? Most certifications like ISO 9001, AS9100, and ISO 13485 are internationally recognized, but always check the scope of recognition for your specific needs.
  • What is the average cost of obtaining a certification? Costs can vary widely depending on the size of your organization and the certification in question. They can range from a few thousand dollars to tens of thousands or more.
  • How often do standards get updated? Standards can be updated every few years, and organizations may need to undergo re-certification or adjustments to comply with new versions.
  • Can a certification be fast-tracked? Some certification bodies offer accelerated programs, but these often come at a premium cost and may require additional resources.
  • Is a consultant necessary for the certification process? While not mandatory, consultants can provide valuable expertise and may streamline the certification process.


Understanding the certification process is crucial for both earning and maintaining ISO 9001, AS9100, and ISO 13485 certifications. While the process may seem daunting, the benefits far outweigh the initial investment in terms of time and resources.

Additional Resources

Equip yourself with the knowledge and resources you need to make an informed decision. Certifications are not just plaques on the wall; they are a testament to your commitment to excellence.

Call to Action

If you’re on the fence about pursuing these certifications, consider this: the long-term advantages of being a certified contract manufacturer far exceed the temporary challenges of the certification process. So, take the first step towards a more credible and competitive future.

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