PECB Webinar: Overview of ISO 13485 - Medical DevicesPECB
The webinar covers:
• The key section of ISO 13485
• The benefits of ISO 13485
• In brief how ISO 13485 & ISO 9001 correlate
Presenter:
This webinar was presented by Raza Shah, Chief Editor and Owner of Bitehqeeq.
Link of the recorded session published on YouTube: https://youtu.be/gZlhUlqgo1g
Specific Detailed Changes to the New ISO 13485:2016Greenlight Guru
Today's medical device regulatory environment is changing faster than ever. Keeping up can be daunting. The new quality management standard ISO 13485:2016 was published in Q1 of 2016.
greenlight.guru has partnered with special guest and consultant, Mark Swanson, to keep you ahead of these changes.
Mark spent the last 4 years on the working group that revised the new ISO 13485.
Mark has all the exclusive insider knowledge on the changes you want. And he's going to be sharing it with you for free.
(You can view the full webinar here: http://www.greenlight.guru/webinar/iso-13485-2016-changes)
In this webinar you'll learn specifically:
-How to prepare for the coming regulatory changes with ISO 13485:2016
-How to apply risk based thinking to your quality processes to ensure compliance
-What you need to know about the design control updates
-How to incorporate ISO 9001:2015 and 13485:2016 to your supplier controls
-A general overview of the standard and its most significant changes (before anyone else)
The Business Case for Integrated Design ControlsGreenlight Guru
How leveraging these 4 approaches to FDA design controls will allow you to use them as a competitive advantage to reduce risk and get devices to market faster.
Read the full post: http://blog.greenlight.guru/business-case-design-controls
The webinar covers:
• Misconceptions about management reviews
• Evaluating performance of the organization
• How performance reviews affects the bottom line
• How to improvement management ownership of the review process
Presenter:
This webinar was presented by Sheryl Anderson, Managing Director for Quality Systems Solutions & Initiatives (QSSI) and certified trainer for HACCP ISO 9001 & ISO 22000.
Link of the recorded session published on YouTube: https://youtu.be/dGdxT5fyUoc
PECB Webinar: Overview of ISO 13485 - Medical DevicesPECB
The webinar covers:
• The key section of ISO 13485
• The benefits of ISO 13485
• In brief how ISO 13485 & ISO 9001 correlate
Presenter:
This webinar was presented by Raza Shah, Chief Editor and Owner of Bitehqeeq.
Link of the recorded session published on YouTube: https://youtu.be/gZlhUlqgo1g
Specific Detailed Changes to the New ISO 13485:2016Greenlight Guru
Today's medical device regulatory environment is changing faster than ever. Keeping up can be daunting. The new quality management standard ISO 13485:2016 was published in Q1 of 2016.
greenlight.guru has partnered with special guest and consultant, Mark Swanson, to keep you ahead of these changes.
Mark spent the last 4 years on the working group that revised the new ISO 13485.
Mark has all the exclusive insider knowledge on the changes you want. And he's going to be sharing it with you for free.
(You can view the full webinar here: http://www.greenlight.guru/webinar/iso-13485-2016-changes)
In this webinar you'll learn specifically:
-How to prepare for the coming regulatory changes with ISO 13485:2016
-How to apply risk based thinking to your quality processes to ensure compliance
-What you need to know about the design control updates
-How to incorporate ISO 9001:2015 and 13485:2016 to your supplier controls
-A general overview of the standard and its most significant changes (before anyone else)
The Business Case for Integrated Design ControlsGreenlight Guru
How leveraging these 4 approaches to FDA design controls will allow you to use them as a competitive advantage to reduce risk and get devices to market faster.
Read the full post: http://blog.greenlight.guru/business-case-design-controls
The webinar covers:
• Misconceptions about management reviews
• Evaluating performance of the organization
• How performance reviews affects the bottom line
• How to improvement management ownership of the review process
Presenter:
This webinar was presented by Sheryl Anderson, Managing Director for Quality Systems Solutions & Initiatives (QSSI) and certified trainer for HACCP ISO 9001 & ISO 22000.
Link of the recorded session published on YouTube: https://youtu.be/dGdxT5fyUoc
Significant changes are underway that impact the quality and regulatory systems of medical device companies and their suppliers. ISO 13485:2016 adds new requirements to address risk management and to better align the standard with global regulatory requirements (FDA, MDD, JPAL, etc.). With the release of ISO 9001:2015, the ISO 9001 and ISO 13485 standards are no longer integrated. A new single audit MDSAP program will be in effect beginning 2017 that incorporates applicable FDA, Canadian, Brazilian, Australian and Japanese quality system requirements into the annual ISO 13485 audit cycle. The presentation will provide an overview of these changes and the steps required to incorporate these changes into existing quality management systems.
How To Manage and Mitigate Risk in Medical Device New Product DevelopmentGreenlight Guru
A company’s ability to understand and manage risk can mean the difference between financial success and disaster.
(You can view the full webinar here: http://www.greenlight.guru/risk-in-medical-device-new-product-development-webinar)
In this webinar you'll learn:
- How to understand the true nature and impact of project and product risk
- How to effectively measure risk quantitatively
- How to use risk management as a tool to accelerate NPD
- What you need to know about the upcoming risk-based changes to ISO 13485 to ensure compliance
Design controls are not an easy subject to address during and after the design of medical devices and manufacturing processes. Design controls should drive the device design process, not be an afterthought. This session focuses on treating design as a separate entity within the quality management system, user needs vs. design inputs, continuation of design controls after the transfer process, design review and more.
Integrated Management Systems ASQ Silicon Valley section 0613 april 2017_gr c...Govind Ramu
ASQ Publication: http://asq.org/quality-progress/2017/05/standard-issues/all-together-now.html
There are several benefits to having an integrated management system (IMS). In the long term, an IMS helps improve efficiency by removing redundancies of different management systems. Above all, an organization can benefit from having the ability to understand how all of its business process owners’ actions affect all management systems, opening minds to think more broadly about the life cycle of products and services.
PECB Webinar: ISO 13485:201X - Dis 2 - Proposed changesPECB
The webinar covers:
• Projected timeframe for issue quarter 1 2016
• Effect of ISO9001:2015 on ISO13485:201X
• Main proposed changes to ISO13485:201X
Presenter:
This webinar was presented by David Smart, PECB Certified Trainer and Managing Director of Smart ISO Systems / Smart Mentoring.
Link of the recorded session published on YouTube: https://youtu.be/l-24Q6F4vFg
Corrective Actions and Risk management for ISO 9001:2015sundaybizsys
The Quality Database is a simple, inexpensive ISO 9001 compliant program that allows small businesses to efficiency manage the Quality System. The database tracks corrective and preventive actions, internal audit tracking, safety improvement, supplier corrective actions, continual improvement projects and risk management. Compile and analyze Customer Survey results. Document QMS review meetings and results. The program is ideal for small businesses striving for ISO 9001 and AS9100 compliance.
The webinar covers:
• Analysis of the 6 step approach to process auditing
• How to define processes through Generic Processes Model
• Overview of the process affecters 8 M’s, business processes and processes types.
Presenter:
This webinar was hosted by David Smart, PECB Certified Trainer and Managing Director of Smart ISO Systems / Smart Mentoring.
Link of the recorded session published on YouTube: https://youtu.be/X5rUniMYV_U
An in-depth discussion on the new automotive Quality Mangement System Standard 16949: 2016 and the challenges in moving to this new version from the old ISO/TS 16949. From processes to procedures, work instructions to risks, Michael Wolfe and Jonathan Brun discuss the best practices to stay in complete compliance with the standard.
Overview of the proposed Photovoltaic Solar Quality Management System standardGovind Ramu
The goal of this Technical Specification (standard) is to provide a guideline for manufacturers of PV modules to produce modules that, once the design has proven to meet the quality and reliability requirements, replicate such design in an industrial scale without compromising its consistency with the requirements. Expected timeline for release is June 2015.
Bridging the gap between quality and finance may 2013John Cachat
Quality in your organization: Is it a competitive advantage, or just another cost of doing business?
Quality and finance may not always see eye to eye, but are they really that different? Great gains can be made by quality and accounting working together when the main focus is cause and effect analysis. John Cachat, an expert in quality management system software and design, will share insight on how to more effectively open communication to get your project funded.
• Quality professionals need a better understanding of financial terms and approaches
• Finance professionals need a better understanding of Quality terms and approaches
• Everyone needs to learn how to significantly improve situations over which they have control
People and process will drive the correct application of technology. Culture will eat technology for lunch.
Significant changes are underway that impact the quality and regulatory systems of medical device companies and their suppliers. ISO 13485:2016 adds new requirements to address risk management and to better align the standard with global regulatory requirements (FDA, MDD, JPAL, etc.). With the release of ISO 9001:2015, the ISO 9001 and ISO 13485 standards are no longer integrated. A new single audit MDSAP program will be in effect beginning 2017 that incorporates applicable FDA, Canadian, Brazilian, Australian and Japanese quality system requirements into the annual ISO 13485 audit cycle. The presentation will provide an overview of these changes and the steps required to incorporate these changes into existing quality management systems.
How To Manage and Mitigate Risk in Medical Device New Product DevelopmentGreenlight Guru
A company’s ability to understand and manage risk can mean the difference between financial success and disaster.
(You can view the full webinar here: http://www.greenlight.guru/risk-in-medical-device-new-product-development-webinar)
In this webinar you'll learn:
- How to understand the true nature and impact of project and product risk
- How to effectively measure risk quantitatively
- How to use risk management as a tool to accelerate NPD
- What you need to know about the upcoming risk-based changes to ISO 13485 to ensure compliance
Design controls are not an easy subject to address during and after the design of medical devices and manufacturing processes. Design controls should drive the device design process, not be an afterthought. This session focuses on treating design as a separate entity within the quality management system, user needs vs. design inputs, continuation of design controls after the transfer process, design review and more.
Integrated Management Systems ASQ Silicon Valley section 0613 april 2017_gr c...Govind Ramu
ASQ Publication: http://asq.org/quality-progress/2017/05/standard-issues/all-together-now.html
There are several benefits to having an integrated management system (IMS). In the long term, an IMS helps improve efficiency by removing redundancies of different management systems. Above all, an organization can benefit from having the ability to understand how all of its business process owners’ actions affect all management systems, opening minds to think more broadly about the life cycle of products and services.
PECB Webinar: ISO 13485:201X - Dis 2 - Proposed changesPECB
The webinar covers:
• Projected timeframe for issue quarter 1 2016
• Effect of ISO9001:2015 on ISO13485:201X
• Main proposed changes to ISO13485:201X
Presenter:
This webinar was presented by David Smart, PECB Certified Trainer and Managing Director of Smart ISO Systems / Smart Mentoring.
Link of the recorded session published on YouTube: https://youtu.be/l-24Q6F4vFg
Corrective Actions and Risk management for ISO 9001:2015sundaybizsys
The Quality Database is a simple, inexpensive ISO 9001 compliant program that allows small businesses to efficiency manage the Quality System. The database tracks corrective and preventive actions, internal audit tracking, safety improvement, supplier corrective actions, continual improvement projects and risk management. Compile and analyze Customer Survey results. Document QMS review meetings and results. The program is ideal for small businesses striving for ISO 9001 and AS9100 compliance.
The webinar covers:
• Analysis of the 6 step approach to process auditing
• How to define processes through Generic Processes Model
• Overview of the process affecters 8 M’s, business processes and processes types.
Presenter:
This webinar was hosted by David Smart, PECB Certified Trainer and Managing Director of Smart ISO Systems / Smart Mentoring.
Link of the recorded session published on YouTube: https://youtu.be/X5rUniMYV_U
An in-depth discussion on the new automotive Quality Mangement System Standard 16949: 2016 and the challenges in moving to this new version from the old ISO/TS 16949. From processes to procedures, work instructions to risks, Michael Wolfe and Jonathan Brun discuss the best practices to stay in complete compliance with the standard.
Overview of the proposed Photovoltaic Solar Quality Management System standardGovind Ramu
The goal of this Technical Specification (standard) is to provide a guideline for manufacturers of PV modules to produce modules that, once the design has proven to meet the quality and reliability requirements, replicate such design in an industrial scale without compromising its consistency with the requirements. Expected timeline for release is June 2015.
Bridging the gap between quality and finance may 2013John Cachat
Quality in your organization: Is it a competitive advantage, or just another cost of doing business?
Quality and finance may not always see eye to eye, but are they really that different? Great gains can be made by quality and accounting working together when the main focus is cause and effect analysis. John Cachat, an expert in quality management system software and design, will share insight on how to more effectively open communication to get your project funded.
• Quality professionals need a better understanding of financial terms and approaches
• Finance professionals need a better understanding of Quality terms and approaches
• Everyone needs to learn how to significantly improve situations over which they have control
People and process will drive the correct application of technology. Culture will eat technology for lunch.
Apqp bumming you out briefing may 30 2013John Cachat
Sales can’t update the customer on launch status. Engineering spends more time updating Gantt charts than they do actually engineering stuff. Quality can’t find the documentation. Purchasing has no idea when the supplier status is. Sound familiar?
What this means is:
• Products are late
• Quality is unacceptable
• Resources are wasted
• Problems are repeated
What we have found is that Project Management is done with the wrong tools and/or people
• Resources are over-scheduled
• Issues are not resolved
• True costs are unknown / inaccurate
What we have found with Project Management Software
• Tools are cumbersome, force detailed information that is unknown
• People resort back to XLS
• Management cannot support the team and resort to firefighting issues
Learn about an approach to APQP and a SaaS technology that allows you to implement APQP the right way and engage your people and suppliers to improve communication, and launch higher quality products faster and on-time and under budget.
21 cfr part 820 quality system regulation applying principles of lean docume...Compliance Trainings
In this webinar, we apply the Theory of Lean documents and its corollary Theory of Lean Configuration to present a fresh approach to following 21 CFR Part 820, yet is based on solid principles and proven practices.
The good thing about being ISO 13485 standardized is that it offers a global valid guarantee over your product and your company can attract a lot of contracts. URS is offering value added assessment and certification services in all India.
PLM-Seminar at Gardermoen: How the idea of single BoM can fit variant and con...Oleg Shilovitsky
The slides from PLM-seminar at Gardermoen: Product Configuration and Variant Management
http://www.infuseit.com/no/Hovedmeny/Arrangementer/SubPages/Oslo2015/
This informative presentation on integration of PLM and ERP comes to you from Barry-Wehmiller International resources (BWIR), global services & solutions partner to SolidWorks Enterprise PDM, This was made at SolidWorks World 2010 in specific context to integration of various ERP systems to Enterprise PDM . This presentation covers:
1. Role of PDM & ERP in Product Lifecycle
2. Need for integration between PDM/PLM and ERP
3. Understanding Industry-specific demands
4. SolidWorks Enterprise PDM and ERP integration
5. Case Study 1 : SolidWorks EPDM – Infor XA Integration
6. Case Study 2 : SolidWorks EPDM – SAP Integration
Giacomo Squintani, PTC presenation at Spare Parts 2013Copperberg
"Spare Parts:from undervalued challengeto profit-boosting opportunity" Giacomo O. Squintani, Marketing Manager from PTC presentation at Spare Parts Business Platform 2013.
Find out more http://www.sparepartseurope.com/
How to Prepare Your Organization for the Transition to ISO 13485:2016Greenlight Guru
The much anticipated revision to ISO 13485, the global medical device quality management system (QMS) standard, was released late February 2016.
The new ISO 13485:2016 ushers in a whole new wave of changes and requirements medical device manufacturers must adhere to, which we covered on our previous webinar here.
ISO tells us that there will be a three year transition period after which the guidance says, “any existing certification issued to ISO 13485:2003 will not be valid.”
The time to start planning your organization's transition to ISO 13485:2016 is now. Or face playing expensive catch up later.
In this presentation, you'll learn:
-What your organization needs to be doing to prepare for the transition to ISO 13485:2016
-Why the transition presents an opportunity for your organization to implement better processes
-An overview of the specific changes coming with ISO 13485:2016
-The actions you should be taking now and how to plan for the implementation of the standard
Access full presentation here: https://www.greenlight.guru/webinar/iso-13485-2016-transition-planning
QMS Effectiveness: Tracking and Trending Quality Data - OMTEC 2017April Bright
What measurements are useful, and which metrics’ baseline makes sense to show the effectiveness of your quality management system? This presentation takes an ISO 13485 and 21 CFR, Part 820 approach to deciding what measurements are important, how trending makes an impact on risk-based decision-making, and why management review is just one of the ways to discuss and document your Quality Data activities.
Quantum Associates, Inc has combined some of the principles of Agile and Lean to help deliver business process improvements quickly. Our approach uses teamwork and some of the lean tools to identify and eliminate non-value-added process steps within the agile framework of chunking the prioritized improvements in short time periods (2 to 4 weeks). Your team's focus is on developing solutions to process problems and deploying them quickly. Team collaboration, the focus on removing non-value-added steps/ quick deployment and the agile framework leads to a big impact in your organization, and therefore to increased organizational performance and business results.
Learn how two powerful concepts, Lean and Agile, can improve your company's performance and business results.
The big takeaway is improving processes using lean principles in an agile framework to reap the benefits of eliminating waste and quickly executing the improvements.
Successful leaders and managers are always keen to expect the unexpected and plan for it. the More you plan is the less you react, and the less you react, the less you make mistakes.
Disruptions to your business can result in data risk, revenue loss, and Failure to deliver services
That’s why organizations need strong business continuity planning.
Operations: Top Reasons for Long Lead Times and What to Do About ThemApril Bright
Long lead times remain one of the most vocalized challenges that orthopedic manufacturers face today. Customers, profits, plans and personnel are all negatively impacted by them. James Kwan has worked on the OEM and the supplier sides of orthopedics, and shared his ideas and successful experiences to help you optimally respond to lead times, reduce them and ultimately create and sustain an agile supply chain.
This presentation outlines the current state of equipment performance and reliability in the pharmaceutical and biotech industries, and the opportunity to leverage new international standards such as ISO 55000 to create asset management programs that are directly connected to corporate business strategies.
Also provided is an example of how to create a business case for improving asset reliability through increasing equipment availability. Outlines of both strategic and tactical approaches for asset management and equipment reliability improvements are also included.
Many organizations can benefit from developing ISO 9001 Quality Management Systems (QMS) to improve the effectiveness and efficiency of their business operations.
ISO 9001 Quality Management Systems: Implementation and Integration features the author’s patented Three Step Process – “Identify, Insure, Improve,” in use since 1995 and developed, tested, and applied in actual business situations. It also explains how to integrate ISO 9000, ISO 14000 and OHSAS 18000 programs. This guide is a valuable resource for companies wanting to update their QMS or become certified for the first time.
ISO 9001 Quality Management Systems: Implementation and Integration is used by Quality Assurance/Quality Control Managers, EHS Managers, Risk Managers, Consultants, Loss Control and Operations Managers within manufacturing and service organizations.
Many health care consulting vendors focus on technology issues surrounding ICD-10, but the organizational impact, skills, capabilities of your team are paramount. This presentation, originally given by Michael Arrigo, CEO of No World Borders focuses on an organizational strategy to implement ICD-10
Complete Guide To Input Output Business Process Model PowerPoint Presentatio...SlideTeam
It covers all the important concepts and has relevant templates which cater to your business needs. This complete deck has PPT slides on Complete Guide To Input Output Business Process Model PowerPoint Presentation Slides with well suited graphics and subject driven content. This deck consists of total of thirty six slides. All templates are completely editable for your convenience. You can change the colour, text and font size of these slides. You can add or delete the content as per your requirement. Get access to this professionally designed complete deck presentation by clicking the download button below. https://bit.ly/2YPjtsX
SR&ED: What you need to know about the changing landscape - MaRS Best PracticesMaRS Discovery District
The Scientific Research and Experimental Development (SR&ED) tax incentive program provides support in the form of tax credits to groups or individuals conducting scientific research or experimental development in Canada.
Some significant changes are on the way as a result of the last federal budget. See how these new rules could affect you!
Understanding the Medical device Single Audit Program (MDSAP) & How to Prepar...Greenlight Guru
The Medical Device Single Audit Program (MDSAP) is an international initiative spearheaded by the International Medical Device Regulatory Forum (IMDRF) to develop a standardized global approach to auditing and inspecting of medical device manufacturers that will be accepted by multiple regulators to address QMS/GMP requirements.
Although the program has seen relatively low participation to date, the promise to help reduce compliance cost for device makers by eliminating the need for multiple quality system audits and inspections means there is much to be gained by industry from a successful implementation the program.
This presentation will cover:
-Understand the goals and benefits of the MDSAP program
-What are the main differences between MDSAP and standard auditing
-How to benchmark your QMS against the MDSAP
-How the new non-conformance grading system works
-How to prepare your company for a successful MDSAP implementation
Watch the presentation here: https://www.greenlight.guru/webinar/medical-device-single-audit-program-mdsap
Optimizing Product Realization Costs Across the Value ChainCognizant
Across a range of industries, realization of cost optimization requires a holistic approach throughout the product lifecycle - requirements, design, manufacture and post-launch - in order to weed out cost overruns and ensure the highest quality process and products.
Similar to Harmonize your qms model to meet iso 13485 regulations april 2013 (20)
This conversation will discuss common problems / challenges for using spreadsheets for the APQP business process and will also include advice on how to get your project funded. It will include a review of a database application that was designed by volunteers that have been using spreadsheets for over 10 years. Their requirement included "Better than spreadsheets, but not too complicated, our we will go back to spreadsheets!"
Stop managing ppap submissions with xls and email mar 2 2020John Cachat
Discusses how the Production Part Approval Process (PPAP) can either be a significant risk or a significant benefit to your company.
Finance - PPAP approval impacts revenue recognition and cash flow
Engineering – on-time product launch makes money, delays cost money
Legal – the product liability lawyers are now asking more than just FMEA, they want to see the PPAP
Purchasing – if you do not actually review the Supplier PPAP information, don’t ask for it
Marketing – protect the brand – no recalls
Sales – use a robust PPAP process as a competitive advantage
As9145 readiness survey initial results feb 18 2020 cachatJohn Cachat
Survey Questions
1.Where are you in the Aerospace / Defense Supply Chain?
2.How is your organization responding to AS9145?
3.What software do you use to manage the AS9145?
4.What software do you currently use to create FMEAs, Control Plans, Process Flows, Core Tool checklists, etc..
5.What do you like about the current software you use?
6.What do you NOT like about the current software you use?
7.How many plants / locations do you have?
8.How many people in your organization are involved in AS9145 APQP / PPAP process?
9.Do you require PPAPs from your Suppliers?
Near Death Awareness During End of Life Apr 21 2014John Cachat
Understanding the special awareness, needs, and communications of the dying
An impending death sends ripples through all relationships in the life of the dying
Software validation do's and dont's may 2013John Cachat
Software validation is often times a very misunderstood concept. For FDA regulated industries, there are clear expectations including “the least burdensome approach.” Validation alone does not guarantee software quality—many other aspects of software engineering are required.
Join software expert, John Cachat, as he discusses how to solve several software validation issues, including:
Requirements
Defect Prevention
Time and Effort
Software Life Cycle
Plans
Procedures
Software Validation After a Change
Validation Coverage
Independence of Review
Flexibility and Responsibility
An exciting alternative for quality management software april 2013John Cachat
John Cachat has created a new Quality Management System (QMS) software platform. This is not just another application; it is the next generation platform. As an internationally recognized visionary in the QMS software space, this is a must attend event.
Size of your organization
Skills, experience, workload of resources
Budget
Control
Timeline
Security concerns
Supply chain and regulatory issues
Number of expected annual transactions
Why we keep old systems
People
Political
Technical
Financial
Data issues
The technology adoption life cycle
Legacy systems
Ignorance is bliss
johncachat@hotmail.com
www.peproso.com
Why organizations implement new systemsJohn Cachat
The cost of resisting change
Organization growth
Business Imperatives
Cost savings
System envy
We hate our vendor
johncachat@hotmail.com
www.peproso.com
Types of consulting firms
Fixed bid versus time & material contracts
Warnings
Consulting agreements
Questions between client and consultants
johncachat@hotmail.com
www.peproso.com
Why Projects Fail
Recognizing The Challenges
How To Create Success
Keys to Project Recovery
How KeyedIn Consulting Group Can Help You Today
johncachat@hotmail.com
www.peproso.com
Project Teams - people issues, roles, and responsibilitiesJohn Cachat
Project Managers
Consultants
Four types of Users
User Responsibilities
Sufficient Resources
Get in the game – this is not practice!
johncachat@hotmail.com
www.peproso.com
Cracking the Workplace Discipline Code Main.pptxWorkforce Group
Cultivating and maintaining discipline within teams is a critical differentiator for successful organisations.
Forward-thinking leaders and business managers understand the impact that discipline has on organisational success. A disciplined workforce operates with clarity, focus, and a shared understanding of expectations, ultimately driving better results, optimising productivity, and facilitating seamless collaboration.
Although discipline is not a one-size-fits-all approach, it can help create a work environment that encourages personal growth and accountability rather than solely relying on punitive measures.
In this deck, you will learn the significance of workplace discipline for organisational success. You’ll also learn
• Four (4) workplace discipline methods you should consider
• The best and most practical approach to implementing workplace discipline.
• Three (3) key tips to maintain a disciplined workplace.
Putting the SPARK into Virtual Training.pptxCynthia Clay
This 60-minute webinar, sponsored by Adobe, was delivered for the Training Mag Network. It explored the five elements of SPARK: Storytelling, Purpose, Action, Relationships, and Kudos. Knowing how to tell a well-structured story is key to building long-term memory. Stating a clear purpose that doesn't take away from the discovery learning process is critical. Ensuring that people move from theory to practical application is imperative. Creating strong social learning is the key to commitment and engagement. Validating and affirming participants' comments is the way to create a positive learning environment.
Affordable Stationery Printing Services in Jaipur | Navpack n PrintNavpack & Print
Looking for professional printing services in Jaipur? Navpack n Print offers high-quality and affordable stationery printing for all your business needs. Stand out with custom stationery designs and fast turnaround times. Contact us today for a quote!
Unveiling the Secrets How Does Generative AI Work.pdfSam H
At its core, generative artificial intelligence relies on the concept of generative models, which serve as engines that churn out entirely new data resembling their training data. It is like a sculptor who has studied so many forms found in nature and then uses this knowledge to create sculptures from his imagination that have never been seen before anywhere else. If taken to cyberspace, gans work almost the same way.
Enterprise Excellence is Inclusive Excellence.pdfKaiNexus
Enterprise excellence and inclusive excellence are closely linked, and real-world challenges have shown that both are essential to the success of any organization. To achieve enterprise excellence, organizations must focus on improving their operations and processes while creating an inclusive environment that engages everyone. In this interactive session, the facilitator will highlight commonly established business practices and how they limit our ability to engage everyone every day. More importantly, though, participants will likely gain increased awareness of what we can do differently to maximize enterprise excellence through deliberate inclusion.
What is Enterprise Excellence?
Enterprise Excellence is a holistic approach that's aimed at achieving world-class performance across all aspects of the organization.
What might I learn?
A way to engage all in creating Inclusive Excellence. Lessons from the US military and their parallels to the story of Harry Potter. How belt systems and CI teams can destroy inclusive practices. How leadership language invites people to the party. There are three things leaders can do to engage everyone every day: maximizing psychological safety to create environments where folks learn, contribute, and challenge the status quo.
Who might benefit? Anyone and everyone leading folks from the shop floor to top floor.
Dr. William Harvey is a seasoned Operations Leader with extensive experience in chemical processing, manufacturing, and operations management. At Michelman, he currently oversees multiple sites, leading teams in strategic planning and coaching/practicing continuous improvement. William is set to start his eighth year of teaching at the University of Cincinnati where he teaches marketing, finance, and management. William holds various certifications in change management, quality, leadership, operational excellence, team building, and DiSC, among others.
Digital Transformation and IT Strategy Toolkit and TemplatesAurelien Domont, MBA
This Digital Transformation and IT Strategy Toolkit was created by ex-McKinsey, Deloitte and BCG Management Consultants, after more than 5,000 hours of work. It is considered the world's best & most comprehensive Digital Transformation and IT Strategy Toolkit. It includes all the Frameworks, Best Practices & Templates required to successfully undertake the Digital Transformation of your organization and define a robust IT Strategy.
Editable Toolkit to help you reuse our content: 700 Powerpoint slides | 35 Excel sheets | 84 minutes of Video training
This PowerPoint presentation is only a small preview of our Toolkits. For more details, visit www.domontconsulting.com
Tata Group Dials Taiwan for Its Chipmaking Ambition in Gujarat’s DholeraAvirahi City Dholera
The Tata Group, a titan of Indian industry, is making waves with its advanced talks with Taiwanese chipmakers Powerchip Semiconductor Manufacturing Corporation (PSMC) and UMC Group. The goal? Establishing a cutting-edge semiconductor fabrication unit (fab) in Dholera, Gujarat. This isn’t just any project; it’s a potential game changer for India’s chipmaking aspirations and a boon for investors seeking promising residential projects in dholera sir.
Visit : https://www.avirahi.com/blog/tata-group-dials-taiwan-for-its-chipmaking-ambition-in-gujarats-dholera/
Discover the innovative and creative projects that highlight my journey throu...dylandmeas
Discover the innovative and creative projects that highlight my journey through Full Sail University. Below, you’ll find a collection of my work showcasing my skills and expertise in digital marketing, event planning, and media production.
3.0 Project 2_ Developing My Brand Identity Kit.pptxtanyjahb
A personal brand exploration presentation summarizes an individual's unique qualities and goals, covering strengths, values, passions, and target audience. It helps individuals understand what makes them stand out, their desired image, and how they aim to achieve it.
Memorandum Of Association Constitution of Company.pptseri bangash
www.seribangash.com
A Memorandum of Association (MOA) is a legal document that outlines the fundamental principles and objectives upon which a company operates. It serves as the company's charter or constitution and defines the scope of its activities. Here's a detailed note on the MOA:
Contents of Memorandum of Association:
Name Clause: This clause states the name of the company, which should end with words like "Limited" or "Ltd." for a public limited company and "Private Limited" or "Pvt. Ltd." for a private limited company.
https://seribangash.com/article-of-association-is-legal-doc-of-company/
Registered Office Clause: It specifies the location where the company's registered office is situated. This office is where all official communications and notices are sent.
Objective Clause: This clause delineates the main objectives for which the company is formed. It's important to define these objectives clearly, as the company cannot undertake activities beyond those mentioned in this clause.
www.seribangash.com
Liability Clause: It outlines the extent of liability of the company's members. In the case of companies limited by shares, the liability of members is limited to the amount unpaid on their shares. For companies limited by guarantee, members' liability is limited to the amount they undertake to contribute if the company is wound up.
https://seribangash.com/promotors-is-person-conceived-formation-company/
Capital Clause: This clause specifies the authorized capital of the company, i.e., the maximum amount of share capital the company is authorized to issue. It also mentions the division of this capital into shares and their respective nominal value.
Association Clause: It simply states that the subscribers wish to form a company and agree to become members of it, in accordance with the terms of the MOA.
Importance of Memorandum of Association:
Legal Requirement: The MOA is a legal requirement for the formation of a company. It must be filed with the Registrar of Companies during the incorporation process.
Constitutional Document: It serves as the company's constitutional document, defining its scope, powers, and limitations.
Protection of Members: It protects the interests of the company's members by clearly defining the objectives and limiting their liability.
External Communication: It provides clarity to external parties, such as investors, creditors, and regulatory authorities, regarding the company's objectives and powers.
https://seribangash.com/difference-public-and-private-company-law/
Binding Authority: The company and its members are bound by the provisions of the MOA. Any action taken beyond its scope may be considered ultra vires (beyond the powers) of the company and therefore void.
Amendment of MOA:
While the MOA lays down the company's fundamental principles, it is not entirely immutable. It can be amended, but only under specific circumstances and in compliance with legal procedures. Amendments typically require shareholder
Memorandum Of Association Constitution of Company.ppt
Harmonize your qms model to meet iso 13485 regulations april 2013
1. Copyright 2010-2013 John Cachat
Harmonize Your QMS
Model to Meet ISO
13485 Regulations
John M. Cachat
jmc@peproso.com
2. Copyright 2010-2013 John Cachat
Housekeeping
Phones are muted
Use the question
block for questions Copy of presentation
available upon request
3. Copyright 2010-2013 John Cachat
About John M. Cachat
• Driving Business Performance
– Helping companies align their business and technology
– Focus on people, process, and then the technology
– Subject matter expert on business process management
– On-going research into next generation of technology for enterprise
systems
• 28 years experience in enterprise systems
– USAF Research Project (1985)
– Founder of enterprise quality software company (1988)
– Chair of ASQ technical committee on computerizing quality (1992)
• Trusted advisor to global organizations, government agencies,
and professional groups
http://www.linkedin.com/in/johncachat
4. Copyright 2010-2013 John Cachat
Agenda
• The requirements of ISO 13485
• Why you should become registered to this
standard
• The best quality management software
strategy to help you achieve compliance
4
5. Copyright 2010-2013 John Cachat
• The medical device market will present greater opportunity
and greater challenges for device companies, as it grows
by 19.9 percent from 2009-2013
• The medical market is one of the most demanding sectors
to serve, as rigorous oversight from regulators and
customers requires "robust operational management"
• United States remains the largest consumer and producer
of medical devices, others are growing rapidly
• United States’ medical device market was valued at more
than $100 billion in 2008, accounting for roughly 42% of
the world’s total
Medical Device Opportunity
5
7. Copyright 2010-2013 John Cachat
ISO13485 = ISO9000 plus
• The promotion and awareness of regulatory
requirements as a management responsibility. An
example of market specific regulatory
requirements is 21 CFR 820 Quality System
Regulation for Medical Devices sold in the United
States.
• Controls in the work environment to ensure
product safety
• Focus on risk management activities and design
transfer activities during product development
7
8. Copyright 2010-2013 John Cachat
ISO13485 = ISO9000 plus
• Specific requirements for inspection and
traceability for implantable devices
• Specific requirements for documentation and
validation of processes for sterile medical
devices
• Specific requirements for verification of the
effectiveness of corrective and preventive
actions
8
9. Copyright 2010-2013 John Cachat
Comparison of ISO900 and ISO13485
(source 13485store.com)
9
Blue Text = This Clause Has Additional Requirements for ISO 13485 Beyond ISO 9001
10. Copyright 2010-2013 John Cachat
Comparison of ISO900 and ISO13485
(source 13485store.com)
10
Blue Text = This Clause Has Additional Requirements for ISO 13485 Beyond ISO 9001
11. Copyright 2010-2013 John Cachat
Comparison of ISO900 and ISO13485
(source 13485store.com)
11
Blue Text = This Clause Has Additional Requirements for ISO 13485 Beyond ISO 9001
12. Copyright 2010-2013 John Cachat
Comparison of ISO900 and ISO13485
(source 13485store.com)
12
Blue Text = This Clause Has Additional Requirements for ISO 13485 Beyond ISO 9001
13. Copyright 2010-2013 John Cachat
Comparison of ISO900 and ISO13485
(source 13485store.com)
13
Blue Text = This Clause Has Additional Requirements for ISO 13485 Beyond ISO 9001
14. Copyright 2010-2013 John Cachat
“Quality” in Your Organization
Is it just a cost of doing business?
OR
Is it a competitive advantage?
14
15. Copyright 2010-2013 John Cachat
Quality as a Competitive Advantage
• Quality professionals need a better
understanding of financial terms
and methods
• Executives need a better
understanding of Quality terms and
methods
• Everyone need to focus on
profitable business growth
15
16. Copyright 2010-2013 John Cachat
Are We That Different?
Finance – SOX, GAAP Quality
Documentation Documentation
Training Training
Audits Audits
Risk Management Controls
16
17. Copyright 2010-2013 John Cachat
Are We That Different?
Finance Quality
Likes Numbers Likes Numbers
Likes Processes and Audits Likes Processes and Audits
Discusses Cash, Profit, etc. Discusses PPM, CAR, Cpk, etc.
Reports what happened Can explain why it happened
17
18. Copyright 2010-2013 John Cachat
The Disconnect between
Accounting and Manufacturing
• Finance has been consumed with GAAP and
audited financial statements for external
reporting
• These traditional GAAP reports do not help
manufacturing
• What information can Quality provide the
organization to help make better decisions?
• How can this “quality” stuff help profitable
growth?
18
19. Copyright 2010-2013 John Cachat
Quality Costs Model
• Prevention—cost to
prevent mistakes
• Inspection—cost to
find mistakes
• Failure—cost of
mistakes (internal &
external)
19
20. Copyright 2010-2013 John Cachat
Management Accounting
• Information for internal business support
• Great gains can be made by Quality and
Accounting working together
• The main focus should be cause and effect
analysis
• What makes this number go up or down?
20
21. Copyright 2010-2013 John Cachat
Cause and Effect Example
Increase Profit on New Products
21
PEOPLE
MFG PROCESS
EQUIPMENTPRODUCT
DESIGN PROCESS PURC PROCESS
INCREASE
PROFIT ON
NEW PRODUCTS
22. Copyright 2010-2013 John Cachat
Increase Profit on New Products
22
INCREASE
PROFIT ON
NEW PRODUCTS
0
20
40
60
80
100
120
Design Proto Pre-Prod Production
Program A
Program B
Number of Engineering Changes by Product Stage
23. Copyright 2010-2013 John Cachat
Increase Profit on New Products
23
Supplier Changes by Program
0
2
4
6
8
10
12
New Suppliers Suppliers Dropped Same Suppliers
Program A
Program B
INCREASE
PROFIT ON
NEW PRODUCTS
24. Copyright 2010-2013 John Cachat
Cause and Effect Example
24
PEOPLE
MFG PROCESS
EQUIPMENTPRODUCT
DESIGN PROCESS PURC PROCESS
INCREASE
MARKET SHARE
INCREASE CUSTOMER
SATISFACTION
REDUCE COST OF
NONCONFORMACE
REDUCE
INVENTORY LEVELS
INCREASE
PRODUCTIVITY
25. Copyright 2010-2013 John Cachat
Why ISO13485?
• The goal of ISO
13485 compliance
and the FDA's 21
CFR Part 820
requirements is to
ensure medical
device quality,
safety, and
effectiveness
25
26. Copyright 2010-2013 John Cachat
The Business Goal for ISO13485
• Reduce costs
• Reduce risk
• Fast product launch
• Increase market
share
26
27. Copyright 2010-2013 John Cachat
Strategy & Culture of a Quality
Management System
• Adoption must be a strategic decision
• Design and implementation is influenced by:
– Needs
– Objectives
– Products provided
– Processes employed
– Size and structure of the organization
• It is not the intent to imply uniformity in the structure
or uniformity of documentation
27
29. Copyright 2010-2013 John Cachat
Quality Management System (Next Level of Detail)
29
PROJECT MANAGEMENT
New Business Product/Process Validation Risk Management
PEOPLE
Customers Employees Suppliers
DOCUMENTATION
Process Flows/Procedures Product Information Records
EQUIPMENT
Capital Tooling Inspection
MANUFACTURING
Receiving Work Orders, Routers,Inspection Shipping
CONTINUOUS IMPROVEMENT
NCM and CAPA Project Teams Audits
32. Copyright 2010-2013 John Cachat
My Quality Projects
Never Get Funded!
• You are choosing
between several projects
• You have limited money
to invest
• How do you decide
which project to fund?
32
34. Copyright 2010-2013 John Cachat
Finance Terms
34
• Return on Investment (ROI)
• Net Present Value (NPV)
• Internal Rate of Return (IRR )
• Payback Period
36. Copyright 2010-2013 John Cachat
Cost Justification
36
Labor
Prevention
• People that design parts/processes
• People that work with suppliers
• People that define customer expectations
Inspection
• People that check parts
• People that check paperwork
Failure
• People that scrap, rework, repair parts
• People that scrap, rework, repair
paperwork
• People that put out fires
37. Copyright 2010-2013 John Cachat
Cost Justification
37
Time Prevention
• Time to design new parts/processes
• Time to process ECRs
• Time to generate reports
Inspection
• Delays in receiving inspection
• Manufacturing waiting on inspection
• Cannot ship until paperwork is done
Failure
• Time to get MRB disposition
• Time to solve problems
38. Copyright 2010-2013 John Cachat
Cost Justification
38
Material Failure (Scrap, Rework, Repair)
• Buying incorrect material
• Making to incorrect revision
• ECR makes inventory obsolete
• Downgrades
• MRB inventory sitting around
39. Copyright 2010-2013 John Cachat
Cost Justification
39
Increase Revenue
I want to give you this $10M order,
but you are only a $5M company.
I am concerned about the risk of
rapid growth at your company.
40. Copyright 2010-2013 John Cachat
How Do I Get Started?
• Where Am I?
• Costs/Risks
• People/Process Issues
Point A
• Where Do I Want to Go?
• Savings/Benefits
• Technology Required
Point B
40
41. Copyright 2010-2013 John Cachat
ISO13485 Implementation Program
41
• ISO13485 Overview
• Gap Analysis
• Registrar Liaison
• Management Representative Selection
• Process/Procedures Implementation
• Internal Audit Assistance
• Corrective Action Assistance
• Pre-assessment of prior to registration audit
• Consulting during the registration audit
42. Copyright 2010-2013 John Cachat
ISO13485 Maintenance Program
42
• Internal Audits, which are a crucial
component in QMS checks and balances
• Corrective Actions, which are performed
after surveillance audits to close out
nonconformities
• Software technology support
44. Copyright 2010-2013 John Cachat
Software Technology Support
44
WORKFLOW
BUILT IN REPORTING
SUPPORT
MOBILE
DEVICES
45. Copyright 2010-2013 John Cachat
About Us
John Cachat
jmc@peproso.com
Contact
Proven expertise in business
information systems
Rapid Solution
Development™ process
Services
Assess Current Status
Develop Short and Long
Term Plans
Develop Specific Solutions
to Your Problems
Assist in ROI Analysis
45
47. Copyright 2010-2013 John Cachat
Harmonize Your QMS Model to Meet ISO 13485 Regulations
&
Contact:
John Cachat
jmc@peproso.com
Copy of Presentation
&
Request a Demo
Visit:
http://peproso.com/webinars
Future Webinars
47
