Overview
The 5-day Lead Auditor training course aims to provide participants with the knowledge, and develop the skills and expertise necessary to:
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Audit a Quality Management System (QMS) based on ISO 9001:2015
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Ensure that the organization is competent in maintaining and continually improving its QMS
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Perform third party audits by applying widely recognized audit principles, procedures and techniques
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Proficiently plan and perform internal and external audits in compliance with ISO 19011 and the certification process according to ISO 17021.
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Manage audit teams and audit programmes, communicate with customers, resolve conflicts, etc.
Based on practical exercises, the participants will master the audit tools and techniques.

ISO 13485: 2016
Lead Auditor


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We serve corporate clients investing in peoples' knowledge, skills, and competencies, to improve business performance, enhance process, product and service quality, and achieve sustained growth and profitability.
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We understand the meaning of the business terms "Voice of the Customer" and what constitutes "value" from the customer's point of view.
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We also understand the difference between "value" and "waste" from the business and individual learner point of view.
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We care about the people, the knowledge enhancement of which is entrusted to us by their organisation or themselves.
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We focus on learning (not just on training, and issuing certificates) and providing post-training advice and support through workshops and consulting services.
Stratos Lazaridis
CEO The Marvel Academy
Corporate Training Solutions
Mob: +44 (0)749 114 7156
Project Management - Business MS Transition Due to Revision of ISO MS Standard
Introduction
Review & Revision of ISO MSS
All ISO standards are reviewed every five years to establish if a revision is required to keep it current and relevant for the marketplace. This helps ensure they remain useful tools for the marketplace.
New ISO Directives - Annex SL
In April 2012, the ISO organisation updated its directives. Of particular importance is the “Annex SL”, in which Appendix 3 defines the “High Level Structure” and “Identical Core Text” for all new and revised management system standards. The concept is that some requirements, e.g. management review, are common to all management system standards and therefore ought to be identically worded.
This will ensure consistency among future and revised management system standards and make integrated use simpler. It will also make the standards easier to read and, in so doing, be understood by users. More information ...
Transition of Implemented MS
Organisations having their MS certified to an ISO standard, such as ISO 9001: 2008, are granted a three-year transition period after the revision of the subject standard has been published, to migrate their MS to the new edition of the standard.
Example: in September 2015, ISO published the revised version of ISO 9001. The new version, ISO 9001: 2015, replaced the previous one, ISO 9001: 2008. Organisation having their QMS certified to ISO 9001: 2008 have a three (3) year grace period, until September 2018, to migrate their QMS to the 2015 edition of the standard.
Our Services
The Current State
This type of service is provided when:
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An organisation has its MS certified to an ISO MSS, e.g. ISO 9001: 2008 and a new revision of the standard is published by ISO (in the above example ISO 9001: 2015 was published in September 2015)
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Project management (PM) may already be practised in the organisation adopting the MSS, using a recognised PM methodology, such as PRINCE2
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The end-to-end project for implementing the above MS will be managed using external resources, including the Project Manager and necessary Project Management Office (PMO) support
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An assessment of the current MS status, against the requirements of the revised MSS, has already been conducted, and a status assessment report and proposed action plan have been produced
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The above report and action plan have been reviewed by the business Management concerned
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A mandate for starting up the MS transition, to meet the requirements of the revised MSS, has been prepared and the Project Executive, Senior User, and Senior Supplier selected (see note below).
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The “starting up the project” phase has been approved
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The client’s organisation is prepared to provide the resources, including business SMEs, required for the successful MS transition.
Note: The Project Board roles of the Executive, Senior User, and Senior Supplier:
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Are mandatory in the PRINCE2 project management methodology
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Have clearly defined responsibilities and accountabilities
Service Offering
We can provide the following services:
Executive Briefing
This covers the following:
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Requirements of the revised MSS, and significant changes from the previous version
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Project management stages for transitioning the existing MS to the revised version of the MSS
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Project outputs (deliverables), outcomes, and benefits to the business
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The role of, and required support from, senior management to achieve the project objectives.
We recommend the 1-day “Executive Briefing to the MSS”, which covers all the above-mentioned topics. This can be customised and reduced to a half-day session.
Training of the Business SMEs and Other Stakeholders
This 2-day classroom training and learning is recommended for those SMEs who will be involved in the MS transition project, including other stakeholders.
The above Foundation-level training, covers the same topics as the Executive Briefing in more detail.
Review and Revision of MS Documentation
This service includes assistance and support with the review and, where necessary, revision of the mandatory MS documentation, including:
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Policy
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Processes
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Procedures
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Working instructions
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Lower-level documents, such as templates, forms, and reports.
E2E Project Management
Project Manager and Project Support (PMO): This service includes the sourcing, availability, and engagement of the Project Manager and PMO Support for the duration of the MS transition project.
The above resources will provide project management and project administration services, including the production of the projects “management products”:
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Project management documents required as part of setting up and managing the project, and establishing and maintaining quality.
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Three types of such products: baselines, records and reports.
Client Resources
The client will:
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Prepare the project mandate for starting up the MS transition project
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Select and appoint the Project Board Members i.e. the Executive, Senior User, and Senior Supplier (see note below).
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Select and appoint individuals who will assume the roles of Change Authority, Project Assurance, and Quality Control.
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Authorise the “Starting Up the project” phase
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Provide the resources, including Team Managers and SMEs, required for the production and delivery of the technical (specialist) products during the life cycle of the project.
Note: The roles of the Project Board members are mandatory in the PRINCE2 project management methodology, and each has clearly defined responsibilities and accountability.
The following diagram shows the Project Management Team structure:
