Medical Device ISO 13485 Auditing

ISO 13485 compliant QMS auditing is required of device manufacturers to ensure and support safety and efficacy while quality goals are achieved; this can be done internally, moreover, an auditing of QMS and processes by an external auditor is unbiased and objective.

Pepgra Healthcare performs completely QMS assessments independently via a notified body or a registrar for a) firms having ISO 13485 certification, and b) firms approaching initial ISO 13485 certification audit.

You can ascertain the status and condition of your quality framework with the help of an ISO 13485; this ensures that practices conform to Good Manufacturing Practices in addition to ISO 13485.

Implications of ISO 13485

Here is what the audit entails:

• 1. An off-site review of your current quality and regulatory documentation before your on-site ISO 13485 audit by a Notified Body or Registrar.
• 2. A systematic and independent process audit to determine conformity or nonconformity of your QMS to ISO 13485:2016 requirements.
• 3. Exhaustive documentation (internal/external) review to ensure requirements is in conformance.
• 4. Assessing the ISO 13485 audit requisites through an objective scrutiny of the evidence.
• 5. An in-person assessment of conformance through face-to-face interviews and fact-based observations to ensure if QMS requirements are met.
• 6. An evaluation of current special controls and validated processes. Pepgra CRO consultants are knowledgeable in various processes such as sterilization, clean rooms, or software systems.

Apart from the aforementioned ISO 13485 audit services, Pepgra CRO experts perform specific ISO 13485 process audits to hone in on specific zones of non-compliances; moreover, our experts review areas that cannot be audited internally because of conflict of interest. Pepgra provides on the premise and trial-site ISO 13485 development programs for auditors to assist customers learn to efficiently self-audit their quality frameworks. A classroom-based training methodology that teaches employees to measure conformity to ISO 13485. Our QMS training modules cover the following:

• The ISO 13485 related performance issues.
• The actual need for quality audits.
• The need for an internal audit program planning.

Some of the topics we address about phasing into ISO 13485:2016 include 1) Deadline for transitioning to ISO 13485:2016, 2) Transitioning to ISO 13485:2016, and 3) Time to finish an ISO 13485 audit.

Pepgra experts respond to the above topic

Notified Bodies will not issue ISO 13485:2003 certificates after March 2018. Therefore, companies that obtain ISO 13485:2003 by January 1, 2017, for example, will only have a valid certificate until March 2019. Companies must obtain certification to ISO 13485:2016 after this date,

There will be a high demand for the service of notified bodies because of many audit requests; moreover, EU regulators will pressure notified bodies to perform stringent, detailed, and lengthy audits that display control of device maker’s suppliers cum processes. The number of notified bodies available for audits will get smaller as new requirements lead some to shut down business; hence, don’t delay or else you will have a lot of catching up to do.

The bigger the firm and more complex the processes are and more time is required to complete the audit. Pepgra suggests that companies allow a minimum of three and half days to finish the assessment process in addition to an extra 2 days on site.

Contact Pepgra experts to get through audits of notified bodies and international quality assessments.

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