ISO 9001:2015 Quality Management System: Preparing for a Successful Transition

Duration: 90 Minutes
In this webinar our speaker Lena Cordie will train on how to carry out a gap analysis against the requirements of ISO 9001:2015 to make the transition smooth and transparent. This exercise will provide your organization with structured assistance to highlight the extent to which existing systems and controls cover the requirements of ISO 9001:2015, or to identify an implementation action plan, where needed.
ISO 9001 2015 QMS
Instructor: Lena Cordie
Product ID: 503857
Delegates will gain a good understanding of the changes from ISO 9001:2008 to ISO 9001:2015 quality management system standards. The course will include some practical skills to enable you to implement and manage these changes within your company and for auditors to audit to the criteria of the new standard.

Objectives of the Presentation
On completion of this course attendees will be able to:
  • Explain the purpose and intent of the new series of management systems standards
  • Understand the application of the principles of quality management
  • Understand the new structure and terminology of ISO 9001:2015
  • Understand the differences between ISO 9001:2015 and ISO 9001:2008 standards
  • The timescale for the transition to ISO 9001:2015
Why Should you Attend
Is your organization ready for ISO 9001:2015? Have you begun preparing to transition or get certified to the new standard?

ISO 9001:2015 is one of the most significant updates in ISO standards affecting almost every industry and every supplier. This standard sets out the criteria for a quality management system and can be used in any organization. All companies must conform to the new standards by September 2018.

The new version of the standard as an integral part of an organization's efforts towards sustainable development and promotes it as a tool for improving overall performance. It encourages more internal and external stakeholder focus as part of the adoption of a risk-based approach to quality management and emphasizes the importance of adopting a Quality Management System (QMS) as a strategic decision for an organization.

Areas Covered
    Background to ISO 9001:2015
    • Evolution of ISO 9001
    • Reasons for change
    New Structure of ISO 9001:2015
    • Structure of ISO 9001:2015
    • Annex SL
    • Seven Quality Management Principals
    • Process Approach
    • Risk Based Thinking
    • Terms and Definitions
    Changes to Requirements of ISO 9001:2015
    • Context of the organisation
    • Leadership and commitment
    • Risks and opportunities
    • Documentation
    • Organisational Knowledge
    • Communication
    • Operation
    • Management review
    • Nonconformity and corrective action
    Transition Process
    • Timing
    • Auditing
    • Re-certification Requirements
Q&A - you'll be able to post your questions about any aspect of the transition post webinar for a live Q&A session.

Transition Readiness Checklist - You will also receive an ISO 9001:2015 - Transition Checklist which give you an indication of your readiness for audit against ISO 9001:2015.

Who will Benefit
This course is suited to anyone working with Quality Management System standards.
  • Quality Managers
  • Quality Engineers
  • Quality Auditors
  • Regulatory Managers
  • Design & Development Managers
  • Design Engineers
  • Production Managers
  • Production Supervisors
  • Manufacturing engineers
  • Members of your transition team
  • Internal and External Quality Assurance Auditors
  • Management Consultants
Topic Background
With over one million certified companies over the world, the international quality management systems standard ISO 9001 is among the most commonly used today. According to a Harvard Business School Study, adopters of the ISO 9001 standard are able to achieve higher sales, improve productivity, and reduce the Cost of Poor Quality. ISO 9001 recently received its latest revision with the release of ISO 9001:2015 to help businesses achieve greater gains in terms of quality, operational efficiency, and customer satisfaction.

Manufactures have yet to understand the changes involved to undertake a smooth transition of their QMS and maintain compliance.
$300
Recorded Session for one participant
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Lena Cordie has over 20 years of quality and project management experience including 10 years in project management at Target Financial Services and 11 years as director of operations at Key Surgical, a medical device company focused on sterile processing, personal protection, and OR products. In this position she was responsible for overseeing all quality and regulatory functions, production, product procurement, and order fulfillment.

As a consultant at Qualitas Professional Services, LLC, Ms. Cordie now focuses on helping companies implement quality management systems, UDI solutions for labeling and FDA GUDID submissions, and providing validation, documentation and project management resources to global medical device companies.

She is an active member of AAMI (Association for the Advancement of Medical Instrumentation) - serves as a voting member of many sterilization standards committees and co-chairs the terminology committee; ISO (International Organization for Standardization) - serves as a US representative and participates in ISO/TC 198 (ISO 17664 & ISO 11139) and ISO/TC 210 (ISO 13485 & ISO 15223) working groups; and RAPS (Regulatory Affairs Professionals Society) - serving as chairperson of the RAPS Twin Cities Chapter.


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