ISO establishes voluntary international standards to ensure quality, safety, and efficiency. ISO's most popular standards are ISO 9001 for quality management, ISO 14001 for environmental management, and ISO/IEC 27001 for information security. ISO 9001 focuses on meeting customer needs and continual improvement. ISO 14001 focuses on minimizing environmental impacts and conforming to regulations. Certification to ISO standards is done by independent auditors and provides benefits like improved operations, customer satisfaction, and international trade compliance.
Herbal medicines are popular because of experience and the abundant
availability of plants in India due to its varied climatic zones. India has
around 45,000 species of plants, out of which 15,000–20,000 plants have
proven medicinal value.
A brief presentation on the current good manufacturing practices employed in the manufacture of pharmaceuticals in the US.
Comprises of all aspects of good manufacturing practices
This presentation consist of what ISO 13485 is and why is it important to consider this standard while designing a medical device. It will help u understand what Quality actual is and its importance in medical device industry. It gives you insight about quality management system and its documentation.
Herbal medicines are popular because of experience and the abundant
availability of plants in India due to its varied climatic zones. India has
around 45,000 species of plants, out of which 15,000–20,000 plants have
proven medicinal value.
A brief presentation on the current good manufacturing practices employed in the manufacture of pharmaceuticals in the US.
Comprises of all aspects of good manufacturing practices
This presentation consist of what ISO 13485 is and why is it important to consider this standard while designing a medical device. It will help u understand what Quality actual is and its importance in medical device industry. It gives you insight about quality management system and its documentation.
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.
It contains details rules and regulations /legislation of Pharmaceuticals, Cosmetics, Active Substance Masters File, Investigational Medicinal Product Dossier for European Union
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
Medical devices – Quality management
systems – Requirements for regulatory
Purposes. ISO is an organization that develops Standards for use
worldwide.
ISO 13485 helps companies do their share in protecting
consumers and users of medical devices.
ISO 13485 Outlines criteria for a good Quality
Management System (QMS).
QMS criteria are good business practices ...
for example:
• Set Quality goals
• Ensure that regulations and other requirements are
understood and met
• Train employees
• Control your production processes
• Purchase from suppliers that can provide products that
meet your requirements
• Correct problems and make sure they do not happen again
This presentation contain introduction to Good Distribution Practices Guideline. and Legal GDP requirements put worldwide.
Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain
Each participant in the distribution chain must agree by the relevant requirements in order to retain the original quality of pharmaceutical products.
Each activity in the distribution of pharmaceutical products shall be carried out according to the principles of Good Distribution Practices (GDP) as applicable.
The risks involved are likely to be of a nature comparable to those that are present in the industrial environment, such as mix-ups, adulteration, contamination, cross-contamination, and spurious.
The guideline addresses
Personnel
Quality System
Premises Warehousing and Storage
Documentation
Traceability
Complaints and Returns
Transportation
[Note: This is a partial preview. To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
ISO 13485:2016 is an international standard that sets out the requirements for a quality management system (QMS) specific to the medical devices industry. The standard focuses on meeting customer and applicable regulatory requirements and is intended for any organization partially or fully involved in the medical device life-cycle.
This presentation can be used to brief your employees, new hires and potential auditees so as to create awareness of the ISO 13485:2016 standard. Alternatively, the presentation may be used to supplement your materials for the training of QA professionals and internal auditors in the medical devices industry.
It covers the what and why of ISO 13485, the QMS key clause structure, the audit approach and also offers practical tips on how to handle an audit session. When you are done teaching this material to your employees, they will be much more informed and comfortable with ISO 13485:2016.
LEARNING OBJECTIVES
1. Provide background knowledge on ISO 13485:2016
2. Gain an overview of ISO 13485:2016 structure and the certification process
3. Understand the audit approach
4. Gather useful tips on handling an audit session
CONTENTS
1. Overview of ISO 13485
About ISO
What are Standards?
Why are Standards Important?
What is ISO 13485?
Who is ISO 13485 For?
What is a Medical Device?
What is a Quality Management System?
How Does ISO 13485 Work?
Benefits that ISO 13485 Will Bring to the Organization
Advantages of Certification
Development of ISO 13485
Why Was ISO 13485 Revised?
Key Improvements to ISO 13485:2016
Relationship of ISO 13485 with ISO 9001
2. ISO 13485:2016 Structure
The ISO 13485:2016 Structure
The Plan-Do-Check-Act (PDCA) Process Model
ISO 13485:2016 Approach is Based on the PDCA Cycle
Documentation Requirements
ISO 13485:2016 Key Clause Structure (4-8)
Clause 4: Quality Management System
Clause 5: Management Responsibility
Clause 6: Resource Management
Clause 7: Product Realization
Clause 8: Measurement, Analysis & Improvement
3. ISO 13485:2016 Certification
Becoming ISO 13485:2016 Certified
ISO 13485:2016 Certification Process
4. Audit Approach
What is a Quality Audit?
What Are Audits Used For?
Types of Quality Audits
Internal Quality Audit
Principles of Auditing
Audit Focus
Audit Approach
Audit Emphasis
Document Review
Audit Findings
5. Handling an Audit Session
Rights of Auditee
Rights of Auditor
How to Handle an Audit Session?
Auditee's Conduct
Interacting with Auditors: Do's
Interacting with Auditors: Don'ts
ISO 9001: 2008 Quality Management System (QMS) is a Process Standard & not Product Standard
ISO QMS International Standard ensure that products and services are safe, reliable and of good quality. For business, they are strategic tools that reduce costs by minimizing waste and errors and increasing productivity. They help companies to access new markets, level the playing field for developing countries and facilitate free and fair global trade
This PPT is for creating basic awareness on Standard for Implementation, understanding the importance & Benefits of Standard to improve Business & journey towards Excellence
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.
It contains details rules and regulations /legislation of Pharmaceuticals, Cosmetics, Active Substance Masters File, Investigational Medicinal Product Dossier for European Union
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
Medical devices – Quality management
systems – Requirements for regulatory
Purposes. ISO is an organization that develops Standards for use
worldwide.
ISO 13485 helps companies do their share in protecting
consumers and users of medical devices.
ISO 13485 Outlines criteria for a good Quality
Management System (QMS).
QMS criteria are good business practices ...
for example:
• Set Quality goals
• Ensure that regulations and other requirements are
understood and met
• Train employees
• Control your production processes
• Purchase from suppliers that can provide products that
meet your requirements
• Correct problems and make sure they do not happen again
This presentation contain introduction to Good Distribution Practices Guideline. and Legal GDP requirements put worldwide.
Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain
Each participant in the distribution chain must agree by the relevant requirements in order to retain the original quality of pharmaceutical products.
Each activity in the distribution of pharmaceutical products shall be carried out according to the principles of Good Distribution Practices (GDP) as applicable.
The risks involved are likely to be of a nature comparable to those that are present in the industrial environment, such as mix-ups, adulteration, contamination, cross-contamination, and spurious.
The guideline addresses
Personnel
Quality System
Premises Warehousing and Storage
Documentation
Traceability
Complaints and Returns
Transportation
[Note: This is a partial preview. To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
ISO 13485:2016 is an international standard that sets out the requirements for a quality management system (QMS) specific to the medical devices industry. The standard focuses on meeting customer and applicable regulatory requirements and is intended for any organization partially or fully involved in the medical device life-cycle.
This presentation can be used to brief your employees, new hires and potential auditees so as to create awareness of the ISO 13485:2016 standard. Alternatively, the presentation may be used to supplement your materials for the training of QA professionals and internal auditors in the medical devices industry.
It covers the what and why of ISO 13485, the QMS key clause structure, the audit approach and also offers practical tips on how to handle an audit session. When you are done teaching this material to your employees, they will be much more informed and comfortable with ISO 13485:2016.
LEARNING OBJECTIVES
1. Provide background knowledge on ISO 13485:2016
2. Gain an overview of ISO 13485:2016 structure and the certification process
3. Understand the audit approach
4. Gather useful tips on handling an audit session
CONTENTS
1. Overview of ISO 13485
About ISO
What are Standards?
Why are Standards Important?
What is ISO 13485?
Who is ISO 13485 For?
What is a Medical Device?
What is a Quality Management System?
How Does ISO 13485 Work?
Benefits that ISO 13485 Will Bring to the Organization
Advantages of Certification
Development of ISO 13485
Why Was ISO 13485 Revised?
Key Improvements to ISO 13485:2016
Relationship of ISO 13485 with ISO 9001
2. ISO 13485:2016 Structure
The ISO 13485:2016 Structure
The Plan-Do-Check-Act (PDCA) Process Model
ISO 13485:2016 Approach is Based on the PDCA Cycle
Documentation Requirements
ISO 13485:2016 Key Clause Structure (4-8)
Clause 4: Quality Management System
Clause 5: Management Responsibility
Clause 6: Resource Management
Clause 7: Product Realization
Clause 8: Measurement, Analysis & Improvement
3. ISO 13485:2016 Certification
Becoming ISO 13485:2016 Certified
ISO 13485:2016 Certification Process
4. Audit Approach
What is a Quality Audit?
What Are Audits Used For?
Types of Quality Audits
Internal Quality Audit
Principles of Auditing
Audit Focus
Audit Approach
Audit Emphasis
Document Review
Audit Findings
5. Handling an Audit Session
Rights of Auditee
Rights of Auditor
How to Handle an Audit Session?
Auditee's Conduct
Interacting with Auditors: Do's
Interacting with Auditors: Don'ts
ISO 9001: 2008 Quality Management System (QMS) is a Process Standard & not Product Standard
ISO QMS International Standard ensure that products and services are safe, reliable and of good quality. For business, they are strategic tools that reduce costs by minimizing waste and errors and increasing productivity. They help companies to access new markets, level the playing field for developing countries and facilitate free and fair global trade
This PPT is for creating basic awareness on Standard for Implementation, understanding the importance & Benefits of Standard to improve Business & journey towards Excellence
Iso 9000
The ISO 9000 family of quality management systems standards is designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product or service.
The standard represents a certificate of international recognition that provides a written assurance that a particular company does follow the set guidelines and direction that has been set out by the International Standardization Organization, and is in line with the standard accordingly.
These standards are guidelines on how to document the processes in specific industries. The goal is consistency and a set of complete, easy to follow instructions. ISO 9000 is a set of five guideline standards that define the requirements for an effective quality management system.
Hierarchical Digital Twin of a Naval Power SystemKerry Sado
A hierarchical digital twin of a Naval DC power system has been developed and experimentally verified. Similar to other state-of-the-art digital twins, this technology creates a digital replica of the physical system executed in real-time or faster, which can modify hardware controls. However, its advantage stems from distributing computational efforts by utilizing a hierarchical structure composed of lower-level digital twin blocks and a higher-level system digital twin. Each digital twin block is associated with a physical subsystem of the hardware and communicates with a singular system digital twin, which creates a system-level response. By extracting information from each level of the hierarchy, power system controls of the hardware were reconfigured autonomously. This hierarchical digital twin development offers several advantages over other digital twins, particularly in the field of naval power systems. The hierarchical structure allows for greater computational efficiency and scalability while the ability to autonomously reconfigure hardware controls offers increased flexibility and responsiveness. The hierarchical decomposition and models utilized were well aligned with the physical twin, as indicated by the maximum deviations between the developed digital twin hierarchy and the hardware.
Sachpazis:Terzaghi Bearing Capacity Estimation in simple terms with Calculati...Dr.Costas Sachpazis
Terzaghi's soil bearing capacity theory, developed by Karl Terzaghi, is a fundamental principle in geotechnical engineering used to determine the bearing capacity of shallow foundations. This theory provides a method to calculate the ultimate bearing capacity of soil, which is the maximum load per unit area that the soil can support without undergoing shear failure. The Calculation HTML Code included.
Student information management system project report ii.pdfKamal Acharya
Our project explains about the student management. This project mainly explains the various actions related to student details. This project shows some ease in adding, editing and deleting the student details. It also provides a less time consuming process for viewing, adding, editing and deleting the marks of the students.
Welcome to WIPAC Monthly the magazine brought to you by the LinkedIn Group Water Industry Process Automation & Control.
In this month's edition, along with this month's industry news to celebrate the 13 years since the group was created we have articles including
A case study of the used of Advanced Process Control at the Wastewater Treatment works at Lleida in Spain
A look back on an article on smart wastewater networks in order to see how the industry has measured up in the interim around the adoption of Digital Transformation in the Water Industry.
Final project report on grocery store management system..pdfKamal Acharya
In today’s fast-changing business environment, it’s extremely important to be able to respond to client needs in the most effective and timely manner. If your customers wish to see your business online and have instant access to your products or services.
Online Grocery Store is an e-commerce website, which retails various grocery products. This project allows viewing various products available enables registered users to purchase desired products instantly using Paytm, UPI payment processor (Instant Pay) and also can place order by using Cash on Delivery (Pay Later) option. This project provides an easy access to Administrators and Managers to view orders placed using Pay Later and Instant Pay options.
In order to develop an e-commerce website, a number of Technologies must be studied and understood. These include multi-tiered architecture, server and client-side scripting techniques, implementation technologies, programming language (such as PHP, HTML, CSS, JavaScript) and MySQL relational databases. This is a project with the objective to develop a basic website where a consumer is provided with a shopping cart website and also to know about the technologies used to develop such a website.
This document will discuss each of the underlying technologies to create and implement an e- commerce website.
Hybrid optimization of pumped hydro system and solar- Engr. Abdul-Azeez.pdffxintegritypublishin
Advancements in technology unveil a myriad of electrical and electronic breakthroughs geared towards efficiently harnessing limited resources to meet human energy demands. The optimization of hybrid solar PV panels and pumped hydro energy supply systems plays a pivotal role in utilizing natural resources effectively. This initiative not only benefits humanity but also fosters environmental sustainability. The study investigated the design optimization of these hybrid systems, focusing on understanding solar radiation patterns, identifying geographical influences on solar radiation, formulating a mathematical model for system optimization, and determining the optimal configuration of PV panels and pumped hydro storage. Through a comparative analysis approach and eight weeks of data collection, the study addressed key research questions related to solar radiation patterns and optimal system design. The findings highlighted regions with heightened solar radiation levels, showcasing substantial potential for power generation and emphasizing the system's efficiency. Optimizing system design significantly boosted power generation, promoted renewable energy utilization, and enhanced energy storage capacity. The study underscored the benefits of optimizing hybrid solar PV panels and pumped hydro energy supply systems for sustainable energy usage. Optimizing the design of solar PV panels and pumped hydro energy supply systems as examined across diverse climatic conditions in a developing country, not only enhances power generation but also improves the integration of renewable energy sources and boosts energy storage capacities, particularly beneficial for less economically prosperous regions. Additionally, the study provides valuable insights for advancing energy research in economically viable areas. Recommendations included conducting site-specific assessments, utilizing advanced modeling tools, implementing regular maintenance protocols, and enhancing communication among system components.
2. ISO stands for International Organization for Standardization
ISO would have different acronyms in different languages (IOS in English, OIN in
French), so the founders decided to give it the short form ISO.
ISO is derived from the Greek isos, meaning equal.
They are a network of national standards bodies. These national standards bodies make
up the ISO membership and they represent ISO in their country.
ISO is an independent, non-governmental organization.
Through its members, it brings together experts to share knowledge and develop
voluntary, consensus-based, market relevant International Standards that support
innovation and provide solutions to global challenges.
They have a Central Secretariat in Geneva, Switzerland, that coordinates the system.
3. How did they come to existence ?
The ISO story began in 1946 when delegates from 25 countries met at the Institute of
Civil Engineers in London and decided to create a new international organization ‘to
facilitate the international coordination and unification of industrial standards’.
On 23rd February 1947 the new organization, ISO, officially began operations.
Since then, ISO has published 21542 International Standards and related documents,
covering almost every industry, from technology, to food safety, to agriculture and
healthcare.
Today they have members from 162 countries and 3914 technical bodies to take care of
standard development.
More than 135 people work full time for ISO’s Central Secretariat in Geneva, Switzerland.
5. ISO has 3 most popular standards:
ISO 9001 Quality management
Makes sure your products and services meet customers needs with this
family of standards.
ISO 14001 Environmental management
Improves your environmental performance with this family of standards.
ISO/IEC 27001 Information security management
Ensure your organization's information is secure with this family of
standards.
6. EVOLUTION OF ISO 9000 STANDARDS
1987 version
The emphasis was placed on conformance with procedures rather than the overall
process of management.
1994 version
Emphasized on quality assurance via preventive actions, instead of just checking
final product, and continued to require evidence of compliance with documented
procedures.
2000 version
It replaced all three former standards of 1994 issue (ISO 9001, ISO 9002 and ISO
9003).
This version sought to make a radical change in thinking by introducing the concept
of process management (the monitoring and optimisation of a company's tasks and
activities, instead of just inspection of the final product).
7. ISO 9000 Requirements include:
• Approve documents before distribution;
• Provide correct version of documents at points of use;
• Use your records to prove that requirements have been met; and
• Develop a procedure to control your records.
2008 version
The 2008 version only introduced clarifications to the existing requirements of ISO
9001:2000 and some changes intended to improve consistency with ISO 14001:2004.
There were no new requirements.
ISO 9001 was supplemented with adding a new standards to the family:
• ISO 9000:2005 "Quality management systems.”
8. ISO 2015 version
In 2012, the ISO TC 176 (responsible for ISO 9001 development) celebrated 25
years of implementing ISO 9001, and concluded that it is necessary to create a new
QMS model for the next 25 years.
The 2015 version is also less prescriptive than its predecessors and focuses on
performance. This was achieved by combining the process approach with risk-based
thinking, and employing the Plan-Do-Check-Act cycle at all levels in the organization.
The scope of the standard was not changed, however, the structure and core terms were
modified to allow the standard to integrate more easily with other international
management systems standards.
9.
10.
11. Quality refers to all those features of a product (or service) which are required by
the customer.
Quality management means what the organization does to ensure that its products
or services satisfy the customer's quality requirements and comply with any
regulations applicable to those products or services.
Quality management also means what the organization does to enhance customer
satisfaction, and achieve continual improvement of its performance.
ISO 14001 is for environmental management. This means what the organization
does to:
Minimize harmful effects on the environment caused by its activities.
To conform to applicable regulatory requirements.
Achieve continual improvement of its environmental performance.
12. ISO 9001 and ISO 14001 are generic standards.
Generic means that the same standards can be applied:
To any organization, large or small, whatever its product or service, in any sector of
activity, and whether it is a business enterprise, a public administration, or a government
department.
Generic also signifies that:
No matter what the organization's scope of activity if it wants to establish a quality
management system, ISO 9001 gives the essential features.
Or if it wants to establish an environmental management system, ISO 14001 gives the
essential features.
13. Management Systems
Management system means what the organization does to manage its processes, or
activities in order that its products or services meet the organization’s objectives, such
as satisfying the customer's quality requirements, complying to regulations, or meeting
environmental objectives.
To be really efficient and effective, the organization can manage its way of doing things
by systemizing it. So that Nothing important is left out.
Everyone is clear about who is responsible for doing what, when, how, why and where.
Management system standards provide the organization with an international, state-of-
the-art model to follow.
Companies in such fields as aerospace, automobiles, defence, or health care devices have
been operating management systems for years.
14. Both ISO 9001 and ISO 14001 concern the way an organization goes about its work.
They are not product standards.
They are not service standards.
They are process standards.
They can be used by product manufacturers and service providers.
Processes affect final products or services.
ISO 9001 gives the requirements for what the organization must do to manage
processes affecting quality of its products and services.
15. Certification and registration
Certification is known in some countries as registration.
It means that an independent, external body has audited an organization's
management system and verified that it conforms to the requirements
specified in the standard (ISO 9001 or ISO 14001).
ISO does not carry out certification and does not issue or approve
certificates.
16. Accreditation
Accreditation is like certification of the certification body.
It means the formal approval by a specialized body - an accreditation
body - that a certification body is competent to carry out ISO 9001:2008 or
ISO 14001:2004 certification in specified business sectors.
Certificates issued by accredited certification bodies - and known as
accredited certificates - may be perceived on the market as having
increased credibility.
ISO does not carry out or approve accreditations.
17. Certification not a requirement?
Certification is not a requirement of ISO 9001 or ISO 14001.
The organization can implement and benefit from an ISO 9001 or ISO 14001 system
without having it certified.
The organization can implement them for the internal benefits without spending money
on a certification programme.
Certification is a decision to be taken for business reasons:
if it is a contractual, regulatory, or market requirement,
If it meets customer preferences
it is part of a risk management programme, or
If it will motivate staff by setting a clear goal.
18. The ISO 9000 family
ISO 9001 is the standard that gives the requirements for a quality management
system.
ISO 9001:2008 is the latest, improved version.
It is the only standard in the ISO 9000 family that can be used for certification.
There are 16 other standards in the family that can help an organization on specific
aspects such as performance improvement, auditing, training etc..
19. The ISO 14000 family
ISO 14001 is the standard that gives the requirements for an environmental
management system.
ISO 14001:2004 is the latest, improved version.
It is the only standard in the ISO 14000 family that can be used for certification.
The ISO 14000 family includes 21 other standards that can help an organization
specific aspects such as auditing, environmental labelling, life cycle analysis etc..
20. Creates a more efficient, effective operation.
Increases customer satisfaction and retention.
Reduces audits.
Enhances marketing.
Improves employee motivation, awareness, and morale.
Promotes international trade.
Increases profit.
Reduces waste and increases productivity.
Common tool for standardization.
Enables to meet the requirements of an internationally uniform quality system.
Motivates the employees and develops pride in them for achieving excellence.
ADVANTAGES
21. QUALITY MANAGEMENT PRINCIPLES
1. Customer focus
2. Leadership
3. Involvement of people
4. Process approach
5. System approach to management
6. Continual improvement
7. Factual approach to decision making
8. Mutually beneficial supplier relationships
22. Customer focus:
Organizations depend on their customers and therefore should understand current
and future customer needs, should meet customer requirements and strive to exceed
customer expectations.
Leadership:
Leaders establish unity of purpose and direction of the organization. They should
create and maintain the internal environment in which people can become fully involved in
achieving the organization's objectives.
Involvement of people:
People at all levels are the essence of an organization and their full involvement
enables their abilities to be used for the organization's benefit.
Process approach:
A desired result is achieved more efficiently when activities and related resources
are managed as a process.
23. System approach:
Systems approach is based on the generalization that everything is inter-related
and interdependent. A system is composed of related and dependent element which when
in interaction, forms a unitary whole.
Continual Improvement:
Improvement of the organization's overall performance should be a permanent
objective of the organization.
Evidence-based decision making:
Effective decisions are based on the analysis of data and information.
Relationship management:
An organization and its external providers (suppliers, contractors, service
providers) are interdependent and a mutually beneficial relationship enhances the ability
of both to create value.
24. Benefits of ISO 9001 and ISO 14001
Common language for dealing with customers and suppliers worldwide in B2B.
Increase efficiency and effectiveness.
Model for continual improvement.
Model for satisfying customers and other stakeholders.
Build quality into products and services from design onwards.
Address environmental concerns of customers and public, and comply with government
regulations.
Integrate with global economy.
Sustainable business.
Qualify suppliers for global supply chains.
Technical support for regulations.
26. The worldwide total of certificates to ISO 9001:2001 at the end of
2007 was 951 486.
This was increase of 6 % over 2006 when the total was 896 929
certificates.
Certificates had been issued in 175 countries compared to 170 the
previous year.
27.
28. The worldwide total of ISO 14001 certificates at the end of 2007
was 154 572.
This was an increase of 21 % over 2006 when the total was 128
211.
Certificates had been issued in 148 countries compared to 140
the year before.