The document provides guidance for bodies operating product certification systems on the application of ISO/IEC Guide 65:1996. It aims to enable accreditation bodies to harmonize their assessment of certification bodies and facilitate mutual recognition of accreditation. The guidance notes the terms that shall and should be used and covers topics like scope, definitions, organization of certification bodies, personnel qualifications, certification requirements and procedures, surveillance, use of licenses and marks, and complaints. It is intended to form the basis for mutual recognition agreements between accreditation bodies.
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
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
ISO 9001-2015 IATF 16949-2016 Numeric Structure Ramona Kellner
ISO 9001:2015 IATF 16949; 2016
Numeric Structure Changes
Dear quality professionals, just in case you have not already done so for yourself, I am sharing a helpful sheet listing the new numeric structure for the emerging automotive standard. As I’m sure you are aware, there are differences between TS structure and IATF, something to keep in mind when auditing and addressing transition and corrective action. Applying IATF changes now, will confidently make it easier for all to save time effort and resources during this transition as well as current corrective actions as opposed to restarting in a year from now. Enjoy!
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
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
ISO 9001-2015 IATF 16949-2016 Numeric Structure Ramona Kellner
ISO 9001:2015 IATF 16949; 2016
Numeric Structure Changes
Dear quality professionals, just in case you have not already done so for yourself, I am sharing a helpful sheet listing the new numeric structure for the emerging automotive standard. As I’m sure you are aware, there are differences between TS structure and IATF, something to keep in mind when auditing and addressing transition and corrective action. Applying IATF changes now, will confidently make it easier for all to save time effort and resources during this transition as well as current corrective actions as opposed to restarting in a year from now. Enjoy!
This webinar goes over the major changes of the new ISO 13485:2016 standard, including the upgrade process. Program Manager Rick Burgess presented and responded to questions live on the webinar.
Explanation of ISO standard 13485 (QUALITY MANAGEMENT SYSTEM OF MEDICAL DEVICES) in a clarified way to understand it well in a simplified way through this mode. Your comments are appreciated.
PECB Webinar: Proposed changes for medical device quality management systems ...PECB
We will cover:
• Overview of proposed changes to ISO 13485:201X, MDSAP
• New EU regulations and unannounced audits
• New directions for QMS and regulatory audits
Presenter:
This webinar will be presented by Danny Kroo, the founder and principal consultant at Docusys Corporation.
PECB Webinar: ISO 29001:2010 – Supplemental Requirements & Impact of ISO 9001...PECB
If you have wondered what are the similarities and differences of ISO 29001 and ISO 9001, this is your chance to learn it. You will also see the requirements and what impact does Quality Management System has in Oil and Gas industry, especially the requirements of ISO 29001.
You will learn all this in two sessions, which will be presented by PECB trainer David Smart, Managing Director of Smart ISO Systems / Smart Mentoring. David’s personal experience spans more than 40 years as a Manager, Auditor and Consultant, specializing in multiple fields related to ISO standards. He is a Lead auditor for ISO 27001, ISO 13485, ISO 9001, ISO 14001, ISO 29001, ISO 17025 and OHSAS 18001, and an active member of various institutes.
This document has been prepared to provide a summary on the changes between ISO 13485:2003 and ISO 13485:2016. The documents contains the following:
a. Benefits of the new version of the standard.
b. Few key definitions
c. Mapping between the versions as per ISO.org.
d. Summary of key changes between the versions of the standard
This webinar goes over the major changes of the new ISO 13485:2016 standard, including the upgrade process. Program Manager Rick Burgess presented and responded to questions live on the webinar.
Explanation of ISO standard 13485 (QUALITY MANAGEMENT SYSTEM OF MEDICAL DEVICES) in a clarified way to understand it well in a simplified way through this mode. Your comments are appreciated.
PECB Webinar: Proposed changes for medical device quality management systems ...PECB
We will cover:
• Overview of proposed changes to ISO 13485:201X, MDSAP
• New EU regulations and unannounced audits
• New directions for QMS and regulatory audits
Presenter:
This webinar will be presented by Danny Kroo, the founder and principal consultant at Docusys Corporation.
PECB Webinar: ISO 29001:2010 – Supplemental Requirements & Impact of ISO 9001...PECB
If you have wondered what are the similarities and differences of ISO 29001 and ISO 9001, this is your chance to learn it. You will also see the requirements and what impact does Quality Management System has in Oil and Gas industry, especially the requirements of ISO 29001.
You will learn all this in two sessions, which will be presented by PECB trainer David Smart, Managing Director of Smart ISO Systems / Smart Mentoring. David’s personal experience spans more than 40 years as a Manager, Auditor and Consultant, specializing in multiple fields related to ISO standards. He is a Lead auditor for ISO 27001, ISO 13485, ISO 9001, ISO 14001, ISO 29001, ISO 17025 and OHSAS 18001, and an active member of various institutes.
This document has been prepared to provide a summary on the changes between ISO 13485:2003 and ISO 13485:2016. The documents contains the following:
a. Benefits of the new version of the standard.
b. Few key definitions
c. Mapping between the versions as per ISO.org.
d. Summary of key changes between the versions of the standard
Product certification or product qualification is the process of certifying that a certain
product has passed performance tests and quality assurance tests, and meets
qualification criteria stipulated in contracts, regulations, or specifications (sometimes
called "certification schemes" in the product certification industry).
Most product certification bodies (or product certifiers) are accredited to or aligned with
ISO/IEC 17065 Conformity assessment -- Requirements for bodies certifying products,
processes and services (previously ISO/IEC Guide 65:1996) an international standard
for ensuring competence in those organizations performing product, process and service
certifications. The organizations that perform this accreditation are called Accreditation
Bodies, and they themselves are assessed by international peers against the ISO 17011
standard. In India Product certification is being monitored by BUREAU OF INDIAN
STANDARDS.
Examples of some certification schemes include the Safety Equipment Institute for
protective headgear, the U.S. Federal Communications Commission (FCC)
Telecommunication Certification Body (TCB) program for radio communication devices,
the U.S. Environmental Protection Agency Energy Star program, the International
Commission on the Rules for the Approval of Electrical Equipment Product Safety
Certification Body Scheme (IEECE CB Scheme), MAS (Materials Analytical Services)
Certified Green IEQ program, and the Greenguard Environmental Institute Indoor Air
Quality program. Certification schemes are typically written to include both the
performance test methods that the product must be tested to, as well as the criteria that
the product must meet to become Certified.
ISO 9001:2008 helps ensure that customers get consistent, good quality products and services, which in turn brings many business benefits. This presentation will guide you in upgrading your quality management system to the latest version of the standard
This document provides an overview of the key changes between the 2005 and 2018 version of ISO 22000 – there are several new requirements in addition to changes to key definitions. You will need to prepare for these changes and adapt your food safety management system to meet the new requirements within the transition timeline.
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.
Personal Brand Statement:
As an Army veteran dedicated to lifelong learning, I bring a disciplined, strategic mindset to my pursuits. I am constantly expanding my knowledge to innovate and lead effectively. My journey is driven by a commitment to excellence, and to make a meaningful impact in the world.
Taurus Zodiac Sign_ Personality Traits and Sign Dates.pptxmy Pandit
Explore the world of the Taurus zodiac sign. Learn about their stability, determination, and appreciation for beauty. Discover how Taureans' grounded nature and hardworking mindset define their unique personality.
Improving profitability for small businessBen Wann
In this comprehensive presentation, we will explore strategies and practical tips for enhancing profitability in small businesses. Tailored to meet the unique challenges faced by small enterprises, this session covers various aspects that directly impact the bottom line. Attendees will learn how to optimize operational efficiency, manage expenses, and increase revenue through innovative marketing and customer engagement techniques.
What is the TDS Return Filing Due Date for FY 2024-25.pdfseoforlegalpillers
It is crucial for the taxpayers to understand about the TDS Return Filing Due Date, so that they can fulfill your TDS obligations efficiently. Taxpayers can avoid penalties by sticking to the deadlines and by accurate filing of TDS. Timely filing of TDS will make sure about the availability of tax credits. You can also seek the professional guidance of experts like Legal Pillers for timely filing of the TDS Return.
Skye Residences | Extended Stay Residences Near Toronto Airportmarketingjdass
Experience unparalleled EXTENDED STAY and comfort at Skye Residences located just minutes from Toronto Airport. Discover sophisticated accommodations tailored for discerning travelers.
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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.
RMD24 | Debunking the non-endemic revenue myth Marvin Vacquier Droop | First ...BBPMedia1
Marvin neemt je in deze presentatie mee in de voordelen van non-endemic advertising op retail media netwerken. Hij brengt ook de uitdagingen in beeld die de markt op dit moment heeft op het gebied van retail media voor niet-leveranciers.
Retail media wordt gezien als het nieuwe advertising-medium en ook mediabureaus richten massaal retail media-afdelingen op. Merken die niet in de betreffende winkel liggen staan ook nog niet in de rij om op de retail media netwerken te adverteren. Marvin belicht de uitdagingen die er zijn om echt aansluiting te vinden op die markt van non-endemic advertising.
Business Valuation Principles for EntrepreneursBen Wann
This insightful presentation is designed to equip entrepreneurs with the essential knowledge and tools needed to accurately value their businesses. Understanding business valuation is crucial for making informed decisions, whether you're seeking investment, planning to sell, or simply want to gauge your company's worth.
RMD24 | Retail media: hoe zet je dit in als je geen AH of Unilever bent? Heid...BBPMedia1
Grote partijen zijn al een tijdje onderweg met retail media. Ondertussen worden in dit domein ook de kansen zichtbaar voor andere spelers in de markt. Maar met die kansen ontstaan ook vragen: Zelf retail media worden of erop adverteren? In welke fase van de funnel past het en hoe integreer je het in een mediaplan? Wat is nu precies het verschil met marketplaces en Programmatic ads? In dit half uur beslechten we de dilemma's en krijg je antwoorden op wanneer het voor jou tijd is om de volgende stap te zetten.