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Gain the confidence to effectively audit a QMS in accordance with internationally recognized best practice techniques. Demonstrate your commitment to quality by transforming existing auditor skills to ISO 9001:2015. Consolidate your expertise with the latest developments and contribute to the continual improvement of the organization. You’ll grasp the key principles and practices of effective QMS audits in line with ISO 9001:2015 and ISO 19011:2018 “Guidelines for auditing management systems”

In this five-day course our experienced tutors will teach you how to lead, plan, execute and report on an audit of an ISMS in an organization assessing its conformance with ISO/IEC 27001:2017. To attend this course, you should already have knowledge of the key Plan-Do-Check-Act (PDCA) cycle within management systems. You should also have knowledge of Information Security Management principles and requirements of the standard.

By attending this course, delegates will gain the necessary auditing skills through activity-based learning, and practical auditing experience with coaching, group workshops and open forum discussions. Experienced BSI tutors will guide delegates through the entire audit process; from initiation to conducting audit follow-up. Successful completion of this training course, by passing the relevant examination and skills assessment, will demonstrate knowledge to undertake and lead a management systems audit.

Our Business Continuity Management Systems Lead Auditor Training Course teaches the fundamental auditing principles and practices, in conformance with national and international accepted norms and regulations relating to BCMS requirements. By attending this course, you will also gain the necessary auditing skills through activity-based learning, and practical auditing experience with coaching, group workshops and open forum discussions.

Together with the usual cases of substitution in seafood, spices and herbs, through to diluted olive oil and honey, food fraud to optimize profit is here to stay. Increasing food prices and an ever more complex global food supply chain present an irresistible opportunity for fraudulent activity. Identify food fraud threats and vulnerabilities, putting VACCP and TACCP into practice alongside your food safety HACCP plans. The BRCGS Packaging Standard is the first packaging Standard in the world to be recognized by the Global Food Safety Initiative (GFSI).

The BRCGS is a Global Food Safety Initiative (GFSI) recognised scheme. The popular Standard is accepted as a benchmark for food safety worldwide and is often a core requirement of the supplier approval process for food retail and manufacturing. This BRCGS lead auditor course delivered by BSI is designed to help you gain a firm understanding of the standard, and learn how to undertake a BRC Global Standards audit. Auditing techniques will be practiced and developed, to include the auditor competency skills required of GFSI scheme auditors.

Hazard Analysis Critical Control Points (HACCP) is a risk management tool is primarily used to manage food safety risks. A HACCP system allows you to identify hazards and put in place controls to manage these throughout your supply chain during production. The HACCP scheme meets the requirements of the Codex Alimentarius Commission (CAC) – established by the WHO and the Food and Agriculture Organization of the United Nations to bring together international food standards, guidelines and codes of practice to ensure fair trade. 

The BRCGS Packaging Standard is the first packaging Standard in the world to be recognized by the Global Food Safety Initiative. By using a hazard and risk-based approach that addresses site cleanliness standards, printed packaging controls, product inspection and the control of foreign bodies, certified organizations and their customers can be confident in the resulting in the quality management system. The new BRCGS Packaging Materials – Issue 6 includes changes for the former standard.

This 5-day in-depth course will provide an understanding of the Standard in terms of the protocol, requirements and how to audit effectively. Delegates will gain an in-depth guide to the requirements of the Standard, and learn how to undertake a BRCGS audit, including effective planning, conducting and reporting of the audit.

This course will enable individuals to plan the process of identifying, measuring and improving their own organization’s culture of food safety. You’ll learn what culture is and how to implement plans to improve it, overlaying these with the FSMS to get best results. Food safety culture is defined by the Global Food Safety Initiative (GFSI) as ‘shared values, beliefs and norms that affect mind-set and behaviour toward food safety in, across and throughout an organization’

Explore the role of risk management during product development and in post market follow up. Develop an understanding of the interface and interaction with Notified Bodies, economic operators (importers, distributors, EU Representatives) and subcontractors/suppliers, according to their obligations under the IVDR. 

The Medical Device Single Audit Program (MDSAP) is a foundational international initiative led by Regulatory Authorities of the International Medical Device Regulatory Forum (IMDRF) to implement a certification program where recognized third party Auditing Organizations (AO) can conduct a single audit of a medical device manufacturer that will be accepted by multiple regulators to address various QMS/GMP requirements.

This one-day intensive course enables you to gain a detailed understanding of the clinical evaluation process for medical devices against the requirements of the Medical Device Regulation (MDR - EU 2017/745), MEDDEV 2.7/1 Revision 4 and relevant MDCG guidance documents. The course is designed to provide you with an understanding of the clinical evaluation process including details on the regulatory requirements, the principles of clinical evaluation, how they are performed and documented. 

Learn about the key requirements of the new In Vitro Diagnostic Regulation (IVDR EU 2017/746), published in Spring 2017 with a five year transition period. To CE mark an IVD in Europe it will soon be mandatory to conform to this Regulation. The Regulation will affect all In Vitro Diagnostic device manufacturers, importers, distributors and EU Representatives.

This one-day intensive course enables greater understanding of the key requirements for technical documentation for IVDs, in line with the European IVD Regulation (IVDR) requirements in Europe. A required part of conformity assessment and CE Marking is the need for Technical Documentation which includes the collation of supporting information about your IVD Device. 

Aby zapewnić zrozumienie oceny działania urządzeń do diagnostyki in vitro zgodnie z rozporządzeniem IVD, jak ocena działania wpisuje się w cykl rozwoju produktu oraz wymagania rozporządzenia IVD (IVDR) dotyczące dowodów klinicznych.

Jeśli są Państwo zaangażowani w planowanie, przeprowadzanie lub dokumentowanie oceny działania i badań klinicznych dla urządzeń IVD w Europie, ten intensywny, jednodniowy kurs umożliwi lepsze zrozumienie oceny działania urządzeń do diagnostyki in vitro zgodnie z rozporządzeniem IVD, jak działanie wpisuje się w cykl rozwoju produktu i wymagania rozporządzenia IVD (IVDR) dotyczące dowodów klinicznych.

This course aims to offer guidance on implementation of the requirements stipulated in the MDR. It focusses on enabling you to draw up a clear concept or project plan, and how to integrate the requirements into your business and your documentation. Moreover, you should gain confidence and expertise to evaluate and implement more specific requirements on your own. 

Learn about the key requirements, concepts, and the overall process for CE marking under the Medical Devices Regulation (MDR). The CE mark gives access to a market with 500+ million people. The course will give you an understanding of the key requirements, which will provide the knowledge to understand Regulatory Affairs of medical devices in EU.

Our one-day training course has been designed to introduce IVD manufacturers and other Economic Operators in the supply chain to the key changes to requirements for CE marking following the publication of the new IVD Regulation (IVDR).

This one-day intensive course enables greater understanding of the impact that ISO 14971:2019 has on the decision-making process when manufacturing medical devices. It helps medical device professionals understand how ISO 14971:2019 can improve their business and risk management efforts.

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