Governance, Risk and Compliance Blog

Join us at the Quality Context Training Conference in Sheffield

Posted by Emily Hill on Thu, Sep 24, 2015

Join us on the 20th October at the Showroom Cinema in Sheffield for the first ever annual Quality Context training conference.

Organised by Quality Context, a key Qualsys partner, the conference will bring together thought-leaders in the pharmaceutical and healthcare industry to discuss the future of GMP, GDP, GCP and GPvP.

Here are a few of industry experts who will be speaking at the event:

 

Alexis Krachai, Director of Counter Context, advises some of the world’s largest healthcare companies on strategic positioning, stakeholder consultation and staff engagement. Alex will give a presentation on Communicating the Importance of Quality.

 

Victoria Cavendish, Director of Orca Solutions Ltd, has over 14 years’ experience across academia, health service, Clinical Research Organisations (CRO’s), and the private medical device sector. Victoria will be delving into the details on Delivering Quality in the Medical Device Industry.

 

Derek Woodcock, Associate of Quality Context, is a PV expert, with over 30 years’ regulatory and pharmacovigilance experience in R&D and commercial environments. Derek will give a presenting Developments in ADR Reporting: A Limitation or an Opportunity for GVP Audits.

 

Peter Miles, Consultant and Facilitator at Catalyze, uses software models to help groups with collective sense-making. Peter will be providing us insight into Collaborative Decision-Making: Managing Complexity, Uncertainty & Diverse Perspectives.

 

Ian Birch, Director of BECO Integrated Services Ltd, has a wealth of experience in commercial and clinical roles with technical, quality and auditing experience. Ian will be presenting Mergers, Acquisitons and Sales: The Impact On The Pharmaceutical Quality System.

 

Iain Moore, Global Head of Quality Assurance at Croda International Plc, has helped define and implement GMPs for cosmetic and pharmaceutical ingredients. Ian will discuss Why the Guidelines for Ascertaining GMP for Excipients Are The Best Thing Since ICH Q7.

 

All proceeds for the event will be donated to Children’s Hospital Charity. The event starts at 9am and ends at 6pm. 

To sign up, email enquiries@qualitycontext.com, we look forward to seeing you there.

 

Tags: Events, Pharmaceutical Regulation, ISO 15189

Qualsys User Group 2015 - Hosted at the CQI and IRCA Headquarters

Posted by Callum Hornigold on Thu, Apr 30, 2015

EQMS users from across the world came together for Qualsys’ 2015 EQMS User Group to discuss the current state of the Quality industry, upcoming EQMS functionality and the future of the Quality professional.

Hosted at the CQI and IRCA headquarters in London, representatives from EQMS customers such as BT, Diageo and Sodexo engaged in a comprehensive agenda with presentations from the Qualsys team. The event also boasted a range of thought leaders and guest speakers, including:

  • Richard Green, Head of Technical Services for the CQI, covering major developments towards ISO 9001:2015.
  • Aaron Schmick, Quality Systems Manager at MonoSol LLC, on implementing a multi-location EQMS.
  • Mark Davy, Quality Manager at Specialist Laboratory Medicine and Leeds Teaching Hospital Trust.

"The EQMS User Group 2015 provided a forum for EQMS users to gain essential insight into product developments and deliver valuable feedback regarding their experience as a Qualsys customer," said Rob Needham, Qualsys IT Director. "It was great to see a lot of satisfied customers, hear exciting suggestions for future developments and share the stage with some of the greatest opinion leaders within the Quality industry. We are now currently using the feedback to project our software and services forward for the future." 

 

 

 

The State of the Quality Industry

The day began with introductions from CQI and IRCA, before Qualsys’ Business Development Manager, Ben Saxton, took the stage to provide an overview of last year’s successful performance for Qualsys, reflecting on the growing team, evolving technology and expanding user base.

Qualsys’ Business Development Manager, Michael Ord, then analysed the results of Qualsys’ Global Quality Survey which revealed exciting, controversial and thought-provoking statistics about the state of the Quality industry.


Mike_Screen_shot



EQMS Version 6.5 and Implementing a Multi-location EQMS

After delegates discussed the increasing importance of software and technology in their role, Qualsys’ Technical Director, Rob Needham, demonstrated EQMS Version 6.5 and revealed the product roadmap for the next 12 months. EQMS is shaped and improved based on the feedback from its users, and the User Group demonstration brought exciting developments as well as new suggestions.

Following a break, guest speaker Aaron Schmick, the Quality Systems Manager at MonoSol LLC, presented on the lessons learned from implementing a multi-location EQMS. Expressing MonoSol’s focus on quality, Aaron described the process and importance of selecting the optimum electronic quality management system for a world-leading manufacturing company. Having travelled over from Chicago for the User Group, Aaron’s hands-on experience and practical advice were well received by the audience.

Nearly as well-received were the lunchtime sandwiches. At lunch, attendees had an informal chance to meet and network with each other and the Qualsys team and share thoughts on the future of the Quality industry. Following lunch were the breakout group sessions, where delegates divided into smaller groups and discussed ideas and suggestions raised by the morning sessions. 


ISO 9001:2015, Annex SL and ISO 15189

Guest speaker Mark Davy, the Quality Manager at Specialist Laboratory Medicine and Leeds Teaching Hospital Trust, presented on the challenges associated with ISO 15189 when managing quality at one of the country’s leading medical facilities. Always candid and humorous, Mark’s talk resonated with delegates from across the spectrum of industries.

CQI and IRCA’s Head of Technical Services, Richard Green, then cut to the core of the upcoming ISO 9001:2015 changes and the impact they will have on quality professionals. Dissecting the jargon, Richard explained the importance of Annex SL and challenged the audience by redefining the role of leadership, context and risk in quality management. 


Richard_Green

Auditing with the iPad and Future Technology

The Qualsys team then presented on the iEQMS Audit Manager mobile application, developed in response to the increasing significance of versatile mobile technology. With a live demonstration on an iPad, Simon Wells and Ben Saxton conveyed the powerful potential that the app delivers.

To round off the day, Qualsys’ Managing Director, Mike Pound, reflected on the company’s 20th anniversary and looked ahead to 2016 and the future of quality management.

"Thank you for everybody who made the day and thank you to our EQMS customers," said Mike Pound. "We've been doing this for 20 years but we wouldn't have done it for five minutes without them. The future holds many developments, all shaped by our customers needs so we can continue to deliver operational excellence."

As delegates made their way out to the post-event drinks reception, they left with more than just expert insight. CPD certificates were awarded to each attendee, and complimentary goody bags and quality Qualsys mugs were handed out to much smiles all round.

See All the Video Footage of the Event Now!

 

 EQMS_User_Group_CTA

 

Tags: iEQMS Auditor, Events, ISO 15189

5 Crucial ISO 15189 Resources for Laboratory Professionals

Posted by Alastair Atcheson on Tue, Feb 24, 2015

In October 2012, the final draft of ISO 15189 was approved. The transition from CPA to UKAS introduced new requirements designed to ensure that your laboratory consistently delivers technically valid results by complying with both technical competence and management system requirements.

The following collection of resources provides:

  • a comprehensive breakdown of the Standard
  • reasons for achieving accreditation
  • how to ensure compliance with the Standard

 

1. ISO 15189 Accreditation: Is It Worth It?



ISO 15189 Accreditation  

 

Are you new to ISO 15189, or perhaps unsure if it is worthwhile getting your business accredited? This introductory article aims to help you make that decision by:

  • providing an overview of the Standard, its purpose and its global presence
  • comparing ISO 15189 and CLIA
  • considering the advantages ISO 15189 can bring to your laboratory

 

2. A2LA FAQ

ISO 15189 Checklist

This FAQ from the American Association for Laboratory Accreditation works as a ISO 15189 checklist, offering great introduction to the essential points relating to ISO 15189. It talks you through:

  • details of a quality management system requirements necessary to comply with ISO 15189
  • requirements contained within ISO 15189
  • benefits of getting ‘peer evaluated’ accreditation and the process of accreditation itself

 

 

3. Everything You Wanted to Know – Presentation from POLQM


ISO 15189 Explained

 

Authored by Michael Noble from the University of British Columbia, this comprehensive presentation lives up to its ambitious title as it covers:

  • the history of ISO 15189 and the purpose of its development
  • a breakdown of the Standard and its contents
  • the significance of ISO 15189:2003 and its place in the future
  • options for applying ISO 15189 and the difference between accreditation and certification
     
     

4. ISO 15189 Gap Analysis – Qualsys

ISO 15189 Checklist

 

Performing a gap analysis is advised to help ensure that your laboratory meets the requirements for ISO 15189. This free tick-box spreadsheet is an ISO 15189 cheklist that allows you check your laboratory against each clause in the Standard and also includes a:

  • series of simple self-assessment tick boxes
  • summary of all additional requirements compared to the CPA Standard
  • gap analysis result (out of 100%) to identify areas of improvement

 

5. Whitepaper – Dark Daily

ISO 15189 Accreditation

 

This professional whitepaper is an excellent resource for those wanting to know more about the main components of a Quality Management System designed to oversee medical laboratories. It provides valuable insight into:

  • four main components of an ISO 15189 QMS – Management Responsibility, Resource Management, Service Realisation and Analysis & Improvement
  • the Deming Cycle, which your business can utilise for continual improvement
  • case studies that demonstrate successful application of much of the theory 



Want more?


ISO 15189 Software


Image credits.
http://laboratory-manager.advanceweb.com/

Tags: GRC Resources, ISO 15189