ISO 13485 – Medical Devices

Quality Management Systems – Requirements for Regulatory Purposes

ISO 13485 is a quality management system designed specifically for the Medical Devices industry.

The ISO 13485 standard follows the ISO 9001:2008 standard and adds additional requirements (such as compliance with statutory and regulatory requirements) for those companies involved in the medical and pharmaceutical  supply chain at any level/tier.

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The latest revision of ISO 13485:2016 was published in March 2016, find out what this means for you
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ISO 13485:2016 Transition Workshop

1 Day Workshop – £525

The Batalas ISO 13845:2016 Transition Workshop is designed for quality professionals who have an existing knowledge of the ISO 13485:2003/2012 standard and wish to learn the new requirements of the 2016 revision.

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ISO 13485 Internal Auditor Course

2 Day Course – £875

The Batalas ISO 13845 Internal Auditing training course is aimed at professionals wanting to conduct internal audits to the ISO 13845 standard. This very intensive 2 day course will help you to evaluate the effectiveness of your organisations management system.

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ISO 13485 Auditor / Lead Auditor Course

5 Day Course – £1595

The Batalas ISO 13845 Lead Auditing training course covers 2 main aspects of auditing

a) the requirements of the ISO 13485 including regulatory and legislative controls

b) using ISO 19011 we will teach you how to plan, conduct, lead and report audits within their own organisation and their suppliers for conformity to the ISO 13845 standard.

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Need help - get in touch now

Contact us for help with transitioning to the new standard – call one of our friendly team on 0333 700 9001

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ISO 13485 Implementation Workshop

We provide a series of workshops to guide your organisation through every stage of the implementation process. Implementation workshops are available as in-company events only.
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Implementing ISO 13485 and need some support?

If you are looking to implement ISO 13485 in your company and would like some help, Batalas offer support to companies of all shapes and sizes. We have assisted over 4,500 companies in the UK to achieve registration to a recognized management system.
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Frequently Asked Questions for Auditing Management Systems

Yes

Firstly, the ISO standard (ISO 13485) states that you must internally audit your organisation at planned intervals and that you must audit if it

  • meets the planned arrangements (with regards to product realization)
  • meets the requirements of the ISO standard
  • meets the requirements of your management system

But you will note that it does not directly say that you must audit every 12 months. Having said that, it is common sense that if you left it longer than 12 months (or even shorter) between audits then would you be able to prove that the system does everything above? Therefore the industry standard is every 12 months, although this can change:

The standard also states that when planning the audit programme you must take into account the “status and importance” of the processes and areas being audited, and very importantly the results of previous audits. In other words, if a process if critical to what you do, or previous audits have found problems, then that process must be audited more often.

One of the main reasons why internal audits raise trivial, and in some cases repeating, nonconformities is that audit reports are not ‘closed out’ correctly. It is important that actions taken to address nonconformities are corrective action (correcting the root cause of the issue) and not correction (purely a short term fix).
Managers are measured on results and therefore results orientated information is of prime concern to them. If the internal audit process includes the identification of process effectiveness and opportunities for improvement then you will grab their attention.

Technically yes.

The requirement in all standards is to conduct internal audits against

  • the appropriate ISO standard
  • any regulatory and legal requirements
  • your own management system requirements

Having said that, if you work in a larger organisation then the likelihood is that you have a team of auditors, some audit the entire system and others will conduct smaller process/procedure audits  – every situation is different, if in doubt give one of our friendly team a call for free advice

Yes. The advantage is that a good auditor may be able to use his/her experience to identify opportunities for improvement which would not have been possible by using your own staff. The downside is that the use of external auditors tends to lead to a lack of ownership of the management system.

Auditing can be seen as a fairly negative process, with the emphasis being on digging into the detail and raising what is seen to many as trivial issues.

Consequently, when selecting internal auditors it is normal to add more junior staff to complement the small team of quality, environmental and health & safety professionals.

Internal auditing should be focused on improving the management system, and hence business performance, and therefore more senior managers should be involved in internal auditing.

One of the ways to get them involved is to allocate to them the task of auditing for improvement, with more junior staff involved in the more time consuming tasks of conformance auditing.

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