• Gain an appreciation for the origins of ISO13485
• Understand the use of ISO13485 as the basis for a Quality Management System for Medical Device organisations
•  Awareness of the key differences to the ISO9001:2015 standard

• Develop a strategy for regulatory compliance as stipulated by IVDR
• Recognise the roles and responsibilities of Economic Operators (legal manufacturer, Authorised representative, Importer and Distributor) and other Key Players (Notified Body, Competent Authority, significant subcontractors) under the IVDR

• Define risk management terminology
• Explain how risk management relates to the product lifecycle
• Outline the stages of the risk management process

• Communicate the key requirements and concepts within the Regulation
• Reference the necessary aspects to evaluate if and how your company is affected by MDR and to what extent
• Define the vocabulary used within the MDR

• Understand the obligations of the MDR, and what that actually means for the economic operators
• Appreciate what an economic operator means as per the MDR

• Establish the requirements of Risk Classification as per the MDR Annex VIII
• Understand the medical device risk classification rules

• Establish the requirements detailed in Annex VII of the MDR
• Appreciate the Notified Body prospective and approach when assessing against the MDR

• What is the Industrial Health and Safety Management System (OH&SMS)
• Why and why OH&SMS is important to your organization
• ISO 45001 Background and Planned Performance

• Describe the roles and responsibilities of top management for the successful deployment and maintenance of OH&SMS.
• It is possible to describe how leadership requirements apply to all parts of the PDCA cycle and to other provisions of the standard.

• Gain an understanding of the key principles of what GHG emissions are
• Better define the GHG emission boundaries for your organization to support in mitigating them
• Enhance the integrity of your GHG quantification within your organizations environmental reporting

• What an Environmental Management System (EMS) is
• Why an EMS is important to an organization and what the benefits of an EMS are
• The background of ISO 14001:2015

• Define the key terms associated with the Road to Net Zero
• Identify the relevant legal, regulatory, and supply chain drivers to achieve Net Zero and their relevance to organizations
•  Identify the steps an organization will take to achieve Net Zero

• Understand and explain the importance and benefits of having an effective energy management system in place
• Develop and implement an EnMS that allows your organization to continually improve how it uses energy

• Understand why information security is important
• Describe what we mean by information security
• Identify the benefits of good information security in your organization

•  Gain an understanding of ISO/SAE 21434
• Identify the work products required to be conformant with ISO/SAE 21434
• Prepare your organization to implement ISO/SAE 21434

• Define the changes to ISO/IEC 27001:2022
• Determine how to use ISO/IEC 27002 in the management of ISO/IEC 27001 control sets
• Demonstrate how to audit changes to ISO/IEC 27001:2022

•  Identify the key requirements and benefits of ISO/IEC 27001:2022
• Manage information security in your organisation
• Take steps to ensure that information security is at the heart of your business

• Define the specific control areas of the CCM and differentiate between them
• Apply the maturity model when auditing a provider’s security controls
• Calculate a maturity score for each CCM control area

• Apply the maturity model when auditing a provider’s security controls
• Calculate a maturity score for each CCM control area
• Derive a provider’s maturity level from the maturity scores

• Understand the importance and benefits of having an effective BCMS in place
• Understand the content of ISO 22301:2019 and how it will improve your business
• Identify and manage risks to business continuity

• The basic principles of BIM
• Explain the terms “BIM according to ISO 19650” and “”UK BIM Implementation””
• Explain the value of information in all phases of a project and asset lifecycle

• Explain why allergens are a major concern
• Define the cause of allergic reactions
• Describe symptoms of allergic reactions and food intolerances

• HACCP – what it is and why it was developed
• Benefits of implementing a HACCP system
• Different types of hazards in food production

• Explain the risks associated with pests
• Identify signs of pest activity
• Take the correct actions to prevent pest activity

• Foodborne illnesses and food safety hazards
• The responsibilities of food handlers
• Temperature control
• Food facility design and construction

• Describe the key concepts of root cause analysis
• Explain the intent and benefits of root cause analysis
• Understand the root cause analysis process

• Describe what emergency planning involves in the context of an OH&SMS.
• List the events that typically occur during an emergency.
• Ask key questions that check if an effective emergency plan is in place.

• Describe what emergency planning involves in the context of an OH&SMS.
• List the events that typically occur during an emergency.
• Ask key questions that check if an effective emergency plan is in place.

•  Know about the various types of [specific hazard] be found in workplaces and sectors of particular prevalence
• Understand why [specific hazard] is a workplace hazard
• Be familiar with the types of harm that [specific hazard] can cause

• Describe what emergency planning involves in the context of an OH&SMS.
• List the events that typically occur during an emergency.
• Ask key questions that check if an effective emergency plan is in place.

• Describe what emergency planning involves in the context of an OH&SMS.
• List the events that typically occur during an emergency.
• Ask key questions that check if an effective emergency plan is in place.

• Define the steps involved in conducting a risk assessment.
• Explain the complexities inherent in assessing risks associated with human error.
• Describe a selection of tools and methodologies used in risk assessment.

•  Importance and benefits of an ISO 9001:2015 QMS
• Key requirements, terms and definitions of ISO 9001:2015
• Structure of ISO 9001:2015, which incorporates the Annex SL common framework for management system standards

• Gain a deeper appreciation and awareness of collaboration;
• Discover that ‘how you do it is as important as why you do it;
• Understand how collaboration offers a different, more productive way of working with like-minded organisations;

• Explain the guidelines of auditing, according to ISO 19011:2018
• Describe the application of these guidelines to auditing and therefore understand further how to:
• Initiate the audit

• Define and describe the main components of a management system
• Briefly describe and give an example of a management system standard

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