ISO 13485 Implementation Training / Workshop

Title:	ISO 13485 Implementation Training / Workshop
Category:	Medical Devices
Duration:	1 day
Location:	This course is presented as an In-house course only
Course fee:	Please ring or use the enquiry button for details

An ISO 13485 implementation course providing the basics for achieving registration by a UKAS accredited certification body.

Course objectives

We provide guidance on designing your health and safety management system, showing examples from our experience of assisting over 3,500 organisations to gain registration to the ISO Standards.

Our ISO 13485 implementation advice is in two parts, firstly designing a system which adds real value to your organisation and secondly, ensuring that you satisfy the requirements of ISO 13485.

Who should attend?

This course is ideal for anyone that is planning an ISO 13485 Management System.

What will you learn?

	ISO 13485 and auditing terminology		Implementation tasks
	Interpreting the requirements of ISO 13485		Reviewing the management system - continual improvement
	ISO 13485 management systems – structures		The internal audit process
	Defining your Medical Devices policy and objectives		The certification/registration process
	Defining your processes		Key do's and don'ts
	Determining the documentation requirements

Delegates receive a manual and examples of documentation which can be used in designing and maintaining the environmental management system.

Registration to ISO 13485

Batalas recommends that you choose a United Kingdom Accreditation Service (UKAS) approved certification body to assess and register your quality management system. A list of certification bodies can be found on the UKAS website. Certificates awarded by organisations which are not accredited by UKAS (or other member of the IAF) may not be acceptable to your customers. (See FAQ)

In-company training courses

This course is only available as an in-company event. Our tutors can use your examples to demonstrate the most effective approach to design and implementation. Our training advisors can provide more details on the options available to your organisation.

More information

• Training course description in pdf format
• Make an enquiry for more information
• Book your place on an ISO 13485 Implementation training course
• Read articles relating to ISO 13485 and auditing
• Frequently asked questions (FAQ)

Associated courses

The following training courses are closely associated with this ISO 13485 Implementation training course.

• ISO 13485 Internal Auditor – For internal audit team members
• ISO 13485 Lead Auditor – For managers and audit team leaders
• ISO 9001 Awareness / Foundation – For those new to auditing and/or ISO 9001: 2008
• ISO 9001 Internal Auditor – For internal audit team members
• ISO 9001 Lead Auditor – For quality managers and audit team leaders
• ISO 9001 Advanced Auditor – Auditing to improve the quality management system
• Supplier Auditing - Evaluating and re-evaluating supplier performance