Question 1…
Will we be able to retain our joint certification to ISO 9001 and ISO 13485?
Yes, however the way the certification bodies are certifying to the different criteria is not aligned.
One certification body has responded that they will need extra time on their audits to examine if the new requirements of ISO 9001:2015 have been fulfilled, another has responded that there will need to be an additional audit with different auditors to ensure the requirements of ISO 9001 are satisfied. Yet, another large certification body has indicated no additional time will be required.
ISO 13485:2016 is intended to facilitate global alignment of appropriate regulatory requirements for quality management systems applicable to organizations involved in one or more stages of the life-cycle of a medical device. It includes some particular requirements for organizations involved in the life-cycle of medical devices and excludes some of the requirements of ISO 9001:2015 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to ISO 13485:2016 cannot claim conformity to ISO 9001:2015 unless their quality management system meets all the requirements of ISO 9001:2015.
Concepts such as Leadership, meeting requirements of interested parties and ensuring opportunities (as well as risks) are identified and addressed are not requirements of ISO 13485:2016.
Question 2…
What are MDSAP ‘super audits’ and do I need to be certified to use this system?
The Medical Device Single Audit Program pilot (MDSAP) was conducted with the buy-in from the competent authorities in Australia, Brazil, Canada, Japan and the United States. The MDSAP Pilot is intended to allow MDSAP recognized auditing organizations to conduct a single audit of a medical device manufacturer that will satisfy the relevant requirements of the medical device regulatory authorities participating in the pilot program.
(The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme and the European Union (EU) are Official Observers.)
The audits are 20% to 30% longer to allowing for the QMS and products being audited to the different national regulatory requirements to be examined for compliance.
Health Canada, the competent authority for Canada, are leading the way and intend to implement MDSAP as the sole mechanism for manufacturers to demonstrate compliance with the QMS requirements of their medical device regulations. As of January 1st 2019, only MDSAP certificates will be accepted.
The other pilot scheme supporters have announced that, they too will accept the MDSAP audits as part of regulatory submissions subject to some qualifications and exclusions (see relevant competent authority web-sites for more information).
Question 3…
Will the changes to the European Device Regulations require a ‘Qualified Person’ within the organisation responsible to regulatory compliance?
The proposal is that manufacturers shall have available within their organisation at least one qualified person who possesses expert knowledge in the field of medical devices.
The expert knowledge shall be demonstrated by either of the following qualifications:
- A diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study, in natural sciences, medicine, pharmacy, engineering or another relevant discipline, and at least two years of professional experience in regulatory affairs or in quality management systems relating to medical devices;
- Five years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
The qualified person is required to at least be responsible for ensuring the following matters:
- The conformity of the devices is appropriately assessed before a batch is released;
- The technical documentation and the declaration of conformity are drawn up and kept up-to-date;
- The reporting obligations are fulfilled;
- In the case of investigational devices, that the devices used meet national regulatory requirements relating to clinical investigation.
- The qualified will suffer no disadvantage within the manufacturer’s organisation in relation to the proper fulfilment of his/her duties.
Question 4…
Can you explain the MDSAP audits 5 point grading scheme?
The Non-conformity grading system that applied to MDSAP audits is introduced in the guidance document GHTF/SG3/N19:2012. It includes a system for grading the severity of non-conformities in a consistent manner. Confusingly there are 6 different grades a non-conformity can have despite the 0 to 5 rating (grade 5 & 6 are treated as equivalent as they both equally as severe to require urgent action).
QMS Impact
Direct Impact
When the nonconformity has the potential to affect safety or performance, it should be written against the specific requirement in ISO 13485:2003 found in clauses 6.4 through 8.5, because it has direct QMS impact.
Indirect Impact
When the nonconformity is against the manufacturer’s quality manual, procedures or requirements, is not specifically required in ISO 13485:2003 or does not impact safety or performance, then the nonconformity should be assigned to clauses 4.1 through 6.3, because it has indirect QMS impact.
Occurrence
First
The first category addresses a nonconformity in a particular sub-clause (X.X.X)
Repeat
The second category is a nonconformity that has been identified within either of two previous QMS audits which evaluated the same sub-clause (X.X.X). Such a nonconformity poses an increased risk because it is an indicator that a corrective action has not been adequately taken or implemented.
Scoring and Escalation
This procedure described above allows a score of 1 to 4 to be assigned to the non-conformity. The score can be further escalated by the two following scenarios;
- The absence of a documented procedure or process (the score is escalated by 1)
- The release of a non-conforming medical device as a result of the non-conformity (the score is escalated by 1)
The system allows greater discrimination with regards to severity cf. the major/minor non conformity system that most auditors are used to applying.
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