The document discusses ISO9001 and its applicability to the IT industry. It provides an overview of ISO9001 including its history, benefits, and quality management system requirements. It also describes ISO9001's administration and key committees related to IT. Finally, it compares ISO9001 to CMM (Capability Maturity Model), noting several areas of similarity between the two standards, such as management responsibility, quality systems, design control, and corrective action.
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Product Technical Documents for Regulatory Submissions
Regulatory Submissions - US FDA
Regulatory Submissions - EU
The Medical Device Regulation (MDR)
The In Vitro Diagnostic Medical Device Regulation (IVDR)
ISO 13485:2016 - General Overview and Training
Risk management ISO 14971
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Regulatory Submissions - LATAM
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Artixio MedTech Training Brochure 2023.pdfY. Yogi Raj
Product Technical Documents for Regulatory Submissions
Regulatory Submissions - US FDA
Regulatory Submissions - EU
The Medical Device Regulation (MDR)
The In Vitro Diagnostic Medical Device Regulation (IVDR)
ISO 13485:2016 - General Overview and Training
Risk management ISO 14971
Regulatory Submissions - APAC
Regulatory Submissions - LATAM
Regulatory Submissions - ANZ
Quality Management System - Development
Quality Management System - Implementation
Labelling for Global Regulatory Submissions
UDI - EUDAMED Requirements
Medical Writing for Regulatory Submissions
Clinical Evaluation - Plan and Report
Performance Evaluation - Plan and Report
Post Marketing Surveillance Requirements
Medical Device Standards Training
Notified Bodies Experience
Why should you attend:
Understand Verification and Validation, differences and how they work together
Develop a "Working Definition" of V&V, Qualification, and related terms
Discuss recent regulatory expectations
Software Verification & Validation requirements of the FDA and ISO.
The latest FDA Software Guidance & Regulations, including Part 11 -impact on V&V strategies
Device and Manufacturing software requirements for V & V
How to determine & demonstrate an appropriate V & V strategy
How to determine & handle software for different Levels of Concern
What V&V is required for 3rd Party software-custom and Off-the-shelf
Impact of FDA, Mobile APPS, Cyber Security, and software standards such as IEC 62304
What to look for during software vendor audits.
V & V documentation and level of detail required for device submissions.
How to document a "risk-based" rationale, and use it in a resource-constrained environment
Determine key "milestones" and "tasks" in a project as well as discussing audience related projects for discussion points
ISO:9000 family means organization of a product or service assuring continued quality assurance to customer delight.ISO 9000 was created to produce an international set of process quality standards.It consists of Written procedures that were inspected to ensure consistency
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.
Introduction of conformity assessment principles for facilitating cross border trades and harmonizes the understanding of businesses in order to overcome Technical Trade barrier (TBT).
It is intended to ensure certification bodies operate certification schemes in a competent, consistent and impartial manner, thereby facilitating the recognition of such bodies and the acceptance of certification at the national and international level.
It also facilitates authorities to enforce their regulatory activities of certain particular high risk products.
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Why should you attend:
Understand Verification and Validation, differences and how they work together
Develop a "Working Definition" of V&V, Qualification, and related terms
Discuss recent regulatory expectations
Software Verification & Validation requirements of the FDA and ISO.
The latest FDA Software Guidance & Regulations, including Part 11 -impact on V&V strategies
Device and Manufacturing software requirements for V & V
How to determine & demonstrate an appropriate V & V strategy
How to determine & handle software for different Levels of Concern
What V&V is required for 3rd Party software-custom and Off-the-shelf
Impact of FDA, Mobile APPS, Cyber Security, and software standards such as IEC 62304
What to look for during software vendor audits.
V & V documentation and level of detail required for device submissions.
How to document a "risk-based" rationale, and use it in a resource-constrained environment
Determine key "milestones" and "tasks" in a project as well as discussing audience related projects for discussion points
ISO:9000 family means organization of a product or service assuring continued quality assurance to customer delight.ISO 9000 was created to produce an international set of process quality standards.It consists of Written procedures that were inspected to ensure consistency
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.
Introduction of conformity assessment principles for facilitating cross border trades and harmonizes the understanding of businesses in order to overcome Technical Trade barrier (TBT).
It is intended to ensure certification bodies operate certification schemes in a competent, consistent and impartial manner, thereby facilitating the recognition of such bodies and the acceptance of certification at the national and international level.
It also facilitates authorities to enforce their regulatory activities of certain particular high risk products.
Secrets for Successful Regulatory Compliance ProjectsChristopher Foot
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The presentation begins with a quick overview of the most popular industry standards and regulatory requirements. MegaplanIT continues with a deep dive into the 12 PCI DSS requirements and discusses risk assessment key considerations.
RDX then follows with a discussion on AICPA's SOC 1, SOC 2 and SOC 3 compliance frameworks and 5 Trust Principles. RDX finishes the webinar by sharing numerous helpful hints, tips and best practices for implementation and ongoing adherence.
A link to a video of the presentations is provided on the last slide.
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1. Jump to first page
ISO9001
Devi Annisetty
Hemalatha Dama
2. Jump to first page
Introduction
ISO9001
Evolution & History
Importance
Statistics
Implementation In IT
Relation to CMM
3. Jump to first page
ISO9001
"International Organization for
Standardization"
Equal (Greek)
network of the national standards
institutes of 148 countries
Central Secretariat in Geneva
non-governmental organization
position between the public and private
sectors
bridging organization between
requirements of business and broader
needs of society
4. Jump to first page
History
voluntary technical standards for sectors of
business, industry and technology since 1947
documented agreements containing technical
specifications or other precise criteria to be
used consistently as rules, guidelines, or
definitions of characteristics to ensure that
materials, products, processes and services
are fit for their purpose.
ISO brought to the attention of a much wider
business in 1987
Generic management system standards
ISO 9000 is primarily concerned with "quality
management".
5. Jump to first page
Benefits to the Society from Standards
For businesses
suppliers can base the development of their products and
services on specifications that have wide acceptance in their
sectors
free to compete on many more markets around the world
For customers
worldwide compatibility of technology
wide choice of offers & competitor prices
For governments
health, safety and environmental legislation
For trade officials
level playing field for all competitors
technical barriers to trade
For developing countries
international consensus of technological know-how
right decisions in investing their scarce resources
For consumers
provides assurance about their quality, safety and reliability
For everyone
quality of life in general
For the planet
International Standards on air, water and soil quality, and on
6. Jump to first page
Examples of Benefits
Standardization of screw threads helps to keep
chairs, children's bicycles and aircraft together
freight containers, international trade would be
slower and more expensive without standards
public transport and buildings is a problem if the
dimensions of wheel-chairs and entrances are
not standardized
Standardized symbols to provide danger
warnings and information across linguistic
frontiers.
Standardized protocols allow computers from
different vendors to "talk" to each other
More than half a million organizations in more 60
countries are implementing ISO
7. Jump to first page
Administration of ISO
Membership of ISO is open to national standards
institutes or similar organizations most
representative of standardization in their country
Member bodies
Correspondent members
Subscriber members
individuals or enterprises are not eligible for
membership
ISO's national members pay subscriptions
that meet the operational cost of ISO's
Central Secretariat
ISO standards are developed by technical
committees comprising experts on loan from
the industrial, technical and business sectors
which have asked for the standards, and
which subsequently put them to use.
8. Jump to first page
Statistics
Members
148 national standards bodies
97 member bodies
36 correspondent members
15 subscriber members
Technical Committee structure
2981 technical bodies
188 technical committees
546 subcommittees
2224 working groups and
23 ad hoc study groups
Staff
Technical secretariats
37 member bodies provide the administrative and technical
services for the secretariats of technical committees (TC) and
subcommittees (SC) These services equal a full-time staff
of 500 persons
Central Secretariat
Geneva
151 full-time staff
from 24 countries coordinate
140 million CHF per year is estimated as the
operational expenditure for the ISO work
9. Jump to first page
Definitions
Certification : refers to the issuing of
written assurance (the certificate) by an
independent, external body that has
audited an organization's management
system and verified that it conforms to
the requirements specified in the
standard.
Registration: means that the auditing
body then records the certification in its
client register
Accreditation: refers to the formal
recognition by a specialized body - an
accreditation body
Certification is not compulsory
10. Jump to first page
Committees(JCT1) for IT
SO/IEC 2382-7:2000 Information technology --
Vocabulary -- Part 7: Computer programming
ISO/IEC 2382-20:1990 Information technology --
Vocabulary -- Part 20: System development
ISO/IEC 9126:1991 Software engineering --
Product quality
ISO/IEC 12207:1995 Information technology --
Software life cycle processes
ISO/IEC TR 14471:1999 Information technology -
- Software engineering -- Guidelines for the
adoption of CASE tools
ISO/IEC 14764:1999 Information technology --
Software maintenance
ISO/IEC 15026:1998 Information technology --
System and software integrity levels
11. Jump to first page
Applicability of ISO 9001 to Software Development
ISO 9001's focus is on all factors except
"technology".
ISO 9000-3 provides "guidance" on implementing
an ISO 9001 compliant set of processes (QMS)
Guidance is for software development, supply
and maintenance environments
12. Jump to first page
Quality
Totality of characteristics of an entity that bear on its ability to
satisfy stated and implied needs.
Quality system requirements
The quality system requirements for ISO 9001 consist of
twenty standards. In each case, the people involved specify
who does what, how, and who is responsible.
Management responsibility
Quality policy
Defined by executive management
Establishes objectives and commitment to quality
Considers organizational goals and customer
needs
Understood and carried out throughout the
organization.
Organization
Responsibility and authority is defined for people
whose work affects product and service quality
13. Jump to first page
Resources
Adequate resources are provided ,including
qualified people, materials, equipment and
internal quality auditors
Management representative
Appointed by executive management
Ensures the requirements of Iso9001 are met
Reports on the performance of the Quality system
Acts as liaison with the registration agency
Management review
To ensure the continuing suitability in satisfying:
The iso9001 requirements
The quality policy
At defined intervals
Maintain review records
14. Jump to first page
Quality system
Quality manual:
Defines the scope of the quality system
Outlines documentation related to the standard
Documented Procedures:
Meet all the requirements of the Standard.
Describe which tasks affecting product and
service quality each process must carry out.
Quality plan
To improve overall performance
15. Jump to first page
Contract Review
Reviewed to ensure that:
Requirements are clearly defined and
documented
Verbal order requirements are agreed before
being accepted any differences from the
original offer are resolved
you have the capability to meet the contract
requirements carry out amendments to the
contract in a prescribed manner and
communicate the changes within your
organization.
Maintain records of contract review
16. Jump to first page
Design Control System
Carry out design projects according to
established procedures
Plan design projects
Assign each design and development task
to qualified personnel
Identify the organizations involved, and describe the
information flow to carry out the design project.
Transmit the necessary information among
organizations
Create clear design input requirements:
written, complete, clear, reviewed
Create design output that meets design stage input
requirements
Review design results with representatives concerned
with the design stage
Verify the design to establish that design output meets
design input requirements
Validate that the product meets defined user needs
and requirements
Review and approve all design changes
Document and Data control:
The documents and data shall be reviewed and
approved for adequacy by authorized personnel prior
to issue
17. Jump to first page
Purchasing:
Purchasing procedures ensure that purchased
products and services conform to requirements
Select vendors based on their ability to meet
requirements, including quality requirements.
define controls over vendors based on the type
of product, it's impact on the final product , and
the vendor performance record.
maintain records of acceptable vendors.
Purchasing documents clearly describe the product
ordered:
Clearly specified type, class, grade, etc.
Identification of product, applicable drawings,
technical data, approval requirements, etc.
Relevant quality system standard.
Reviewed prior to release
Arrangements may be made for you or your
customer to verify the product at the vendor's site.
18. Jump to first page
Control of customer-supplied product:
Verify, store and maintain customer-supplied product
provided for incorporation into the final product.
Record and report to the customer any lost and
damaged product.
Product identification and traceability:
Identify the product from receipt and during all
stages of production, delivery and installation.
process control:
Carry out processes under control conditions.
Documented procedures define the manner of
production, installation and servicing.
Suitable production, installation and servicing
equipment
Suitable working environment
Compliance with :
reference standards and codes
quality plans or procedures
Monitoring and control of suitable process
parameters and product characteristics
19. Jump to first page
Approval of processes and equipment
Criteria for workmanship stipulated in the clearest
practical manner.
Suitable maintenance of equipment
Inspection and testing:
Verify incoming material before use
Identify and maintain inspection and test status
Maintain inspection and test records
Complete testing before releasing the product
Control of inspection ,measuring and test
equipment :
All equipment used for inspection, measurement and
testing, has to fulfill the specified quality
requirements( for instance, calibration of measuring
instruments, or verifying software dependability).
Inspection and test status:
The firm ensures that the article concerned has
passed all the specified inspections and tests in(10) ,
and that the tests have been satisfactorily conducted
and completed.
20. Jump to first page
Control of nonconforming product:
This standard involves the recognition that no matter
how tight the firm's control systems are, something
may go wrong. What is important is to establish that
the error has occurred, and to have procedures to
deal with the situation.
Corrective and preventive action:
For non-conformities, the firm specifies how it
determines what went wrong, who should fix it, how
that person is to be accurately informed, when the
problem is to be solved, how it controls that the
problem is solved, and how to prevent reoccurence.
Handling, storage, packaging,
preservation and delivery:
Prevent damage during product handling
Prevent damage or deterioration during product
storage
Control product packaging
Preserve the product
Protect product during delivery
21. Jump to first page
Control of quality records:
The firm defines what documents are classified as
quality records, as well as how, and by whom, a
record should be stored. This includes all records
that provide evidence that the quality system itself is
functioning as it should.
Internal quality audits:
Verify whether quality activities and related results
comply with planned arrangements.
.Determine the effectiveness of the quality
system
Schedule on the basis of status and importance of
the activity being audited
Auditors:
Observe work practices
Examine quality records
Identify non compliances
Audit results are:
recorded
brought to the attention of those having
responsibility for the area audited.
Executive management reviews the effectiveness of
the quality system
22. Jump to first page
Training
Identify training needs
Quality workers before assigning them to
tasks
Maintain training records
Servicing:
Perform, verify and report servicing to meet
specified servicing requirements
Statistical techniques:
Identify the need for statistical techniques to
establish, control and verify process capability and
product characteristics
Carry out and control the application of
identified statistical techniques
24. Jump to first page
Management Responsibility
ISO: Quality Policy be define, documented, understood, implemented
and Maintained.
CMM:Management responsibility for quality policy and verification
activities primarily addresses in Software Quality Assurance.
Quality System
ISO: Documents quality system, including procedure and instructions be
established
CMM: Quality primarily addressed in Software Quality Assurance
distributed thru KPA’s
Contract Review
ISO:contracts be reviewed to determine whether the requirements are
adequately defined, agree with bid and can be implemented
CMM: Review customer requirement is spanned in Requirement mgnt.
Design Control
ISO: Procedure to control& verify Design be established(planning, Inputs,
outputs, design)
CMM:Life cycle activities , design , code, test are described in Software
Project Planning
Similarities between ISO9001 & SEICMM
25. Jump to first page
Continued..
Document Control
ISO:Distribution & modification of documents be controlled
CMM:Document control are described in configuration mgmt
Purchasing
ISO:purchased products conform their specified requirements(assessment of
subcontractors, verification of purchased products)
CMM:Addressed in Activity 2 & 12 of acceptance testing of subcontracted software
Purchaser -supplied product
ISO: purchaser supplied material verified and maintained
CMM:Activity 6.3 in integrated software mgmt in using purchased software
Product identification & Traceability
ISO: during all stages of production delivery & installation
CMM:covering Software Configuration Mgmt
Process Control
ISO:Production process be defined & planned
CMM: Software Production process controlled in thru KPA’ in various actvites
26. Jump to first page
Continued..
Inspection & Test Status
ISO:Inspection and test be maintained for items as they progress through various
processing steps
CMM: Testing practices in software product Engineering
Corrective Action
ISO: causes of non conforming product be identified,products eliminated,
procedures are changed from corrective action
CMM: Analysis, updates, patches
Training
ISO:Training needs be identified and training provided
CMM:Training program, Orientation practices
Servicing
ISO:servicing activities be performed as specified
CMM:maintenance
27. Jump to first page
Summary
What is ISO and its benefits
How is it applicable in IT industry
Detail explanation of Quality
management system
Its comparison to CMM
28. Jump to first page
Reference
http://www.palaulive.com/iso/
http://www.asq.org/stand/types/iso9000.html
http://www.iso9000data.com/ISO9000.html
http://www.tantara.ab.ca/iso_list.htm
http://www.tantara.ab.ca/iso90003.htm
http://www.sei.cmu.edu/pub/documents/94.report
s/pdf/tr12.94.pdf