Your company as already achieved ISO certification to a standard, but now, in order to add markets you need to conform to additional standards.
Will a new certification work with my current certificate?
Congratulations! You are already certified and that puts you in an elite group. Typically new certifications will add requirements but we haven’t run into one yet that is a conflicts with what you already have.
What will be the impact on the management review?
The requirements of all the standards for the management review are similar. There are some differences and a consultant can help you to identify them so you prevent a finding. Adding a second certification should not significantly increase the time to prepare and hold the management review.
Will I have to change my documentation system?
There will be additions in documentation and or documentation methods. ISO 9001 requires documented information while most other standards require documents and records. All the standards accept electronic media, including videos when used for documentation and training.
Adding ISO 9001
This is the most commonly first time implemented standards, however if your business is grounded in the medical device industry and you are branching into non-medical areas customers can have “tunnel vision” and insist on ISO 9001 certification. There are some additions to the management review and addressing internal, external issues and interested parties will require some revisions to the current system.
Adding ISO 13485
Assuming you already have ISO 9001 or IATF 16949 there will be significant work to comply with the medical device standard. There are no conflicting requirements but there are additional requirements.
Adding ISO 14001
This is one of the most commonly added standards and works well with both ISO 9001 and ISO 13485. There is no conflict. The requirements for the management review work with the other standards.
Do I need a consultant?
Yes. To get through implementing a new standard you need someone well versed in both systems and capable to guide you through the changes efficiently.
How to get started
Call a knowledgeable consultant company like, Technacon Company, Inc. We will guide you on the documents you need to purchase and help you establish an implementation plan. We start by looking to see what you already have in place and how you can utilize your systems to create an effective management system that should be certified to first time you call to be registered.
Contact us at: email@example.com or call (708) 814-3685
Technacon Company – Experts in ISO Implementation
- Full-Service International Standards Implementation
- Customized Training/Documentation
- 20+ Years of Experience
- ISO 9001
- ISO 13485
- ISO 14001
- ISO 17100