DQS MED information regarding the new ISO 13485
Medical Devices – Quality Management
1. Time limits
There exists a three-year transition period after the publication of the new standard. During this time, the previous standards remain valid. All certificates are going to expire in the third year, after the publication of the respective standard reference. The DQS MED will not issue certificates according to the old standards four months before the end of the respective transition period.
- Expiration date for SCC-accredited certificates according to ISO 13485 is February, 28th, 2019.
- Expiration date for DAkkS-accredited certificates according to ISO 13485 is March, 31st, 2019.
2. Procedure for change
At any time, the customer can decide to target the transition to the new standard, independently from regularly audits (surveillance or re-certification). However, the most cost-effective type of transition will be the conversion within the scope of a regular re-certification or surveillance audit. It the customer wishes to change to the new standard before or after the regular annual audit, this can take place within the scope of a special audit.
During the three-year transition period, the DQS MED will closely accompany their certified customers, to ensure that a secure transition to the new standard can take place before the expiry of the time limits. It should also be noted, that the case might be that corrective measures are necessary, which must be closed before a positive certification decision.
To determine the maturity and effectiveness of the current management system in relation to the new standard, the implementation of a Mock Audits (1-2 PT) can be very helpful. For this purpose a written commissioning from the customer must exist. As a result, of the audit, the rank of conformity with the new standard and the resulting changes on the managements system are shown by us. The Mock Audit can also be used, to identify a realistic resources and time scheduling. With an extra effort and expense it is possible to combine a Mock audit with a regular audit.
A successful mock audit can be accepted instead of a readiness examination, if it was implemented less than six months before the actual system assessment.
4. Transition audit
Before a certificate based on the new standard revision can be issued, an audit onsite has to be implemented by the DQS MED, to verify that the new requirements are implemented and applied in the organization. This audit is planned as a double-stage procedure. It consist out of a readiness examination and a system assessment. The audit can take place within the scope of a surveillance / re- or special audit.
The readiness examination is necessary to determine the changes on the management system as well as the status of the requirements regarding the new standard, so that the readiness for system assessment can be evaluated. The readiness examination can be performed onsite or in the form of a technical file review including different evidences, among others review, internal audits and trainings.
The audit period required for the system assessment is determined on the basis of the IAF MD 9, if necessary other regulatory requirements as CMDCAS, MDD or MDSAP (in preparation) and additional times (see chart) for the transition to the new standard. After a positive certification decision, the customer receives a certificate with reference to the new standard, which is issued after the following rules:
- In case of a transition for a re-certification audit – for three years
- In case of a transition at a surveillance / special audit – for the remaining time of the old certificate.
Can be replaced by a positively completed mock audit within the last six months
Transition in a regular surveillance / repeat audit
Transition in al sprecial audit
|1 - 15||0,5 bis 1,0 PT|
|16 - 25||0,5 bis 1,0 PT||min. 1,0 PT|
|26 - 100||min. 1,0 PT|
|101 - 500||min. 1,0 PT||min. 2,0 PT|
5. Negative audit result for the transition
If a customer does not meet the requirements for the transition of the certification from the old to the new standard, the DQS MED can issue a certificate on the basis of the old standard under the following conditions:
- The audit evidences submitted by the auditor for examination confirm, that the management system of the customer meets the requirements of the old standard
- The customer was informed about the shortened duration (see time limits) of the certificate according to the old standard and is aware of this
6. Consideration of regulatory certification programs
The following regulatory certification programs are used by the DQS MED: Canadian Medical Device Conformity Assessment System (CMDCAS), Directive 93/42 / ECC (MDD), Medical Device Single Audit Program (MDSAP, in preparation) The above-described procedures also apply to the transition from the old to the new standard in these regulatory certification programs.
However, when using CMDCAS and / or MDSAP the ISO 13485:2016 revisions from Health Canada GD 210, the MDSAP audit model and the MDSAP accompanying document must be considered, once these are available.