ISO Internal Auditor - Baltimore, United States - QCS International LLC

QCS International LLC Baltimore, United States

3 weeks ago

Description

"Excellent course, Alistair did well to make the course interesting and supplemented the slides/prepared content with interesting examples from his auditing experiences to demonstrate his points."
ISO 13485 Internal Auditor Delegate
Training courses for ISO Quality Management Systems

We provide IRCA and CQI certified ISO 13485 training courses that will help you on your journey towards certification and ensure your auditors deliver positive change to your organisation.

We also offer ISO 13485 training for lead auditor grade, which contributes directly towards achieving the status of a third-party approved body auditor.

Our ISO 13485 courses are led by highly trained and qualified experts who teach in an interactive and engaging manner, making your journey to recognition as easy and rewarding as possible.

Our available courses can be viewed on these pages:

ISO 13485:2016 is the internationally recognised standard for a quality management system applied to the manufacture of medical devices (MD-QMS).

Organisations can be certified to this standard to showcase that their products have been subject to rigorous and detailed processes.

The standard covers all aspects of a medical device's lifecycle, including design, development, production, storage, installation, use, servicing, and decommissioning.

Compliance with ISO 13485 is a crucial part of the medical device industry and demonstrated to regulatory bodies that a company has a fully effective QMS in place.

Benefits of ISO 13485 Training

Like other ISO standards, certification may not be compulsory.

However, c ertification to ISO 13485 demonstrates regulatory compliance and provides potential customers, clients, regulators, and other professionals within the supply chain with the level of assurance that they seek before deciding to authorise, purchase, or use your product.

One of the key components of ISO 13485 is the necessity to demonstrate that staff within the organisation are competent to perform the tasks that they are required to do.

Having highly competent staff minimises risk to the organisation, the manufacturing process, and the end user.

Personnel responsible for the application of ISO 13485 requirements have a particular relevance to the company as they will deliver processes, procedures and advice that will be relied upon to fulfil certification ambitions quickly and successfully.

As the standard places particular emphasis on risk management, having competent staff is one of the key actions to take to address any risks that are identified.

Our courses provide guidance on understanding the requirements of the standard and ensuring your internal auditors are competent and deliver results that drive improvement - a key element of ISO 13485.

"This course was amongst one of the hardest courses I have ever completed. However, the instructors were of an exceptional standard, passing on actual experiences giving "real life" experiences of issues we may expect/experience whilst auditing. I have enjoyed my course and will recommend it to my peers"
"Very well conducted, learned loads. Enjoyed the learning, would defiantly recommend to my work colleagues"
Internal Auditor Delegate

"Course was very well given with the course material spaced out very well and not overwhelming. Breaks & Lunch enjoyable. Real life anecdotes from trainer added to learning and course enjoyment"
ISO 13485 Internal Auditor Delegate

"The course was very informative and really did help me understand the standard, how it fits with my company and how to complete internal audits. Along with this, the group and the trainer made it worthwhile and informative'"
ISO 9001 Internal Auditor Delegate

"Really enjoyed the course and appreciated the extensive & experience that the tutor had. I found the assignments to be of more interesting part but totally appreciated the details of the course content"
ISO 9001 Delegate

"The course was great, really enjoyed it. David was very thorough in teaching the course also very helpful in areas where I was struggling. Thank you, guys, very much, felt very welcomed and comfortable at QCS and hoping to return for some more training at some point Keep up the good work"
"Ian done really well to keep it interesting, he was well spoken and was great help when needed. The course was very well presented, and I will definitely be recommending it to anyone looking to do this in the future."
ISO 14001 Internal Auditor Delegate

"This course was amongst one of the hardest courses I have ever completed. However, the instructors were of an exceptional standard, passing on actual experiences giving "real life" experiences of issues we may expect/experience whilst auditing. I have enjoyed my course and will recommend it to my peers"
"Very well conducted, learned loads. Enjoyed the learning, would defiantly recommend to my work colleagues"
Internal Auditor Delegate

"Course was very well given with the course material spaced out very well and not overwhelming. Breaks & Lunch enjoyable. Real life anecdotes from trainer added to learning and course enjoyment"
ISO 13485 Internal Auditor Delegate

"The course was very informative and really did help me understand the standard, how it fits with my company and how to complete internal audits. Along with this, the group and the trainer made it worthwhile and informative'"
ISO 9001 Internal Auditor Delegate

"Really enjoyed the course and appreciated the extensive & experience that the tutor had. I found the assignments to be of more interesting part but totally appreciated the details of the course content"
ISO 9001 Delegate

"The course was great, really enjoyed it. David was very thorough in teaching the course also very helpful in areas where I was struggling. Thank you, guys, very much, felt very welcomed and comfortable at QCS and hoping to return for some more training at some point Keep up the good work"
"Ian done really well to keep it interesting, he was well spoken and was great help when needed. The course was very well presented, and I will definitely be recommending it to anyone looking to do this in the future."
ISO 14001 Internal Auditor Delegate

"This course was amongst one of the hardest courses I have ever completed. However, the instructors were of an exceptional standard, passing on actual experiences giving "real life" experiences of issues we may expect/experience whilst auditing. I have enjoyed my course and will recommend it to my peers"
How to get ISO 13485 Certification

The standard stipulates many and varied requirements that must be all be fulfilled in order to achieve certification. It is likely that an organisation will already be fulfilling some of these (e.g. mechanisms for maintaining the competency of staff, record keeping of customer requirements/orders, and controls that allow you to deliver the goods/services you provide of the correct type and on time).

However, there are some requirements that organisations will find harder to achieve if they are unfamiliar with quality management or the manufacture of medical device products.

Gaining certification requires you to self-examine and to commit to improvement in your organisation's processes. We can help you with this and train your staff to be able to take your certification forward.
We've outlined the steps to ISO 13485 certification below.

The first stage will be to review your current arrangements against the clauses of the standard, highlighting any gaps and what you have to do to gain certification.

We can complete this gap analysis for you and supply you with the training and support to deliver the identified actions.

QCS only works with companies that are seeking a certificate awarded by a UKAS accredited body.

The United Kingdom Accreditation Service (UKAS) is the only body based in this country that authorises organisations to award fully recognised certification to ISO Non-UKAS bodies exist but some organisations shall not recognise their certificates (be careful who you get your certificate from and for how long you are tied into a contract).

If you are unsure what is best for you, then do get in touch.
Need some help?
Speak to one of our training experts today.

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