The amount of time required to achieve ISO 13485 certification varies widely by company. In our experience working with hundreds of medical device and IVD companies over the years, many companies are able to implement ISO 13485 in 4-7 months if utilizing outside consultants. Many people ask why the process takes so long. The primary reason is that once your ISO 13485 quality system has been implemented, you need to generate official records using implemented procedures that will be referenced during your subsequent registration audit by a Certification Body. It is possible to implement an ISO 13485:2003 quality management system in just a few months, but without auditable records it would be extremely difficult to achieve certification.
Commitment of senior management – Delays in achieving certification often occur when senior management views the implementation of ISO 13485 as just another regulatory hurdle put in place by government. Companies that achieve certification more quickly have the complete support of upper management who recognize ISO 13485 as a tool for meeting customer requirements, reducing risk and maintaining effective processes. Invariably, management support is key in pushing through the changes often demanded by ISO 13485 implementation.
Dedication of resources – The moral support of senior management is not enough to make ISO implementation happen. The company must allocate sufficient in-house resources. Hiring an outside consultant such as Emergo Group certainly helps the process move more quickly, but without a dedicated management representative who has the full support of senior management, change will happen slowly. Ultimately, the decision of whether to bring in outside consultants depends on how much revenue your company could generate by achieving compliance sooner. See our page on ISO 13485 costs. For instance, if “time to market” is important to you and every month your product is not on the market means thousands in lost sales, hiring a consultant to speed the process makes financial sense. In our experience, companies that complete ISO 13485 quality system implementation in 4-7 months have a management representative that dedicates 25-50% of their time to the implementation process.
Size of the company, complexity of manufacturing – If your company has 50 employees and one location, it often takes less time to implement ISO 13485 than if you have 500 employees and three locations or you have complex manufacturing processes (example: sterilization). With larger and more complex companies, more procedures must be written and more people are involved. Paradoxically, this is not always the case. Mid-size to larger companies sometimes have more resources dedicated to achieving ISO 13485 certification and can sometimes push through changes more quickly if there is support from all levels of senior management. We consider it our responsibility to help you achieve ISO 13485:2003 certification as soon as possible, maintain compliance over the long term and do so in a way that has minimal impact on your business.
We have been implementing ISO 13485 quality management systems for medical device companies since 1997. Most of our clients are small to mid-size medical device manufacturers. Thus, the 5-6 month timeline below reflects the average amount of time our clients take to achieve ISO certification. Companies that already have a quality management system in place such as ISO 9001:2000 or FDA Good Manufacturing Practice (GMP) can expect shorter implementation times. Here are the stages of the ISO 13485:2003 certification process:
Typically, you will schedule your certification audit 4+ weeks after we have conducted your final readiness review to allow for final changes to your system. Certification Bodies normally issue ISO 13485 certificates about 6-8 weeks after a favorable recommendation for certification.
