Quality Management System awareness for all ANUPAM RAY
I covered benefit and utilization ISO 9001:2015 standard, 8 quality principle, Root cause analysis, what is ISO, and basic auditing principle. Kindly comment and let me know how I can improve this.
Quality Management System awareness for all ANUPAM RAY
I covered benefit and utilization ISO 9001:2015 standard, 8 quality principle, Root cause analysis, what is ISO, and basic auditing principle. Kindly comment and let me know how I can improve this.
Over a million organizations in 170 countries have adopted ISO 9001:2015 as their quality management standard. Many more are pursuing this certification. Why? Because ISO 9001 helps your company assure quality, save money and customers expect it. ISO 9001 applies to all types of organizations.
This presentation can be used to brief your employees, new hires and potential auditees so as to create awareness of the ISO 9001:2015 standard. Alternatively, the presentation may be used to supplement your materials for the training of QA professionals and internal auditors.
It covers the what and why of ISO 9001, the QMS 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 9001.
LEARNING OBJECTIVES
1. Provide background knowledge on ISO 9001
2. Gain an overview of ISO 9001 structure and the certification process
3. Understand the audit approach
4. Gather useful tips on handling an audit session
CONTENTS
1. Overview of ISO 9001
2. ISO 9001 Structure
3. ISO 9001 Certification Process
4. Audit Approach
5. Handling an Audit Session
To download this complete presentation, please go to: https://www.oeconsulting.com.sg
Use this ppt presentation to educate groups on what is ISO 9001:2015 standard, what are the requirements of ISO 9001:2015 certification, etc.
For more information visit: https://www.globalmanagergroup.com/
ISO 9001-2015 Revision Training PresentationDQS Inc.
ISO 9001 is a great tool that is used for managing an organization and implementing continuous improvement. More than one million organizations worldwide are certified to ISO 9001 in order to help ensure that good quality products and services are provided to customers.
Get an in-depth overview of the upcoming changes to ISO 9001:2015, including:
- Revision timing and roll out
- Details on structure change
- In-depth review of changes including risk assessment
- Transitioning from ISO 9001:2008 to ISO 9001:2015 timing and requirements
- and more.
QCC is one of the leading providers of training solutions in India for management systems, process improvement, business improvement and auditing. QCC helps companies understand, implement and manage business systems and processes through its training solutions in its endeavor to equip your staff with the confidence and expertise they need to attain their goal.Our training solutions are built on innovative experimental methodologies with global delivery capacity. Our presenters (trainers) are auditors, business improvement specialists, consultants, industry experts as well as trainers who have been exposed to a wide range of companies and industries in India and overseas. They develop and deliver courses for both public & in-house training, thus bringing along firsthand experience and knowledge to the delegates.
How to Perform a Successful Internal Quality AuditGreenlight Guru
You already know internal quality audits are required by both FDA 21 CFR Part 820 and ISO 13485.
You also probably already know they are a big hassle to conduct.
What you might not know is that they are one of the most powerful weapons at your disposal for preventing 483's and observations.
Why?
Because they are one of the most effective and efficient ways to make sure you and your team are always prepared if FDA or NB decided to show up unexpectedly.
So how do you “establish” the right procedures? How do you ensure your auditor is competent and properly qualified? And what do you do if you find non-conformances?
View this presentation by our guest Kyle Rose, President at Rook Quality Systems, where you will find the answers to all those questions and more.
Specifically, you will learn:
- How to conduct an effective internal quality audit based on process identification, sampling and questioning
- How to plan a internal quality audit and develop an audit schedule
- How to find and use competent and qualified auditors
- Why certain auditors shouldn’t audit certain areas
- How to properly report the findings of your internal quality audit
- How to concisely document non-conformances
- How to determine what needs corrective actions and how to follow up on them
The new ISO 9001:2015 committee draft is published and distributed. There are changes which affect organizations who applied this standard. As it is among most famous ISO standards, follow up the changes would be critical and it is time to consider changes which might affect organizations' management systems.
HSE Training Presentation for ISO 14001, ISO 45001 IntegrationGlobal Manager Group
Global Manager Group provides ppt presentation for HSE training. It provides brief information on requirements of ISO 14001:2015, ISO 45001:2018, implementation steps, internal audit, etc.
For more information visit: https://www.globalmanagergroup.com/
PECB Webinar: ISO Internal Audits - A signpost to ISO compliancePECB
The webinar covers:
• Why you should do ISO Internal Auditing?
• Who should do ISO Internal Auditing?
• How you should do ISO Internal Auditing?
• When you should do ISO Internal Auditing?
Presenter:
This webinar was presented by Mr. Oladapo Ogundeji, from Digital Jewels and PECB Partner.
Link of the recorded session published on YouTube: https://youtu.be/FtM6n95wNmE
Over a million organizations in 170 countries have adopted ISO 9001:2015 as their quality management standard. Many more are pursuing this certification. Why? Because ISO 9001 helps your company assure quality, save money and customers expect it. ISO 9001 applies to all types of organizations.
This presentation can be used to brief your employees, new hires and potential auditees so as to create awareness of the ISO 9001:2015 standard. Alternatively, the presentation may be used to supplement your materials for the training of QA professionals and internal auditors.
It covers the what and why of ISO 9001, the QMS 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 9001.
LEARNING OBJECTIVES
1. Provide background knowledge on ISO 9001
2. Gain an overview of ISO 9001 structure and the certification process
3. Understand the audit approach
4. Gather useful tips on handling an audit session
CONTENTS
1. Overview of ISO 9001
2. ISO 9001 Structure
3. ISO 9001 Certification Process
4. Audit Approach
5. Handling an Audit Session
To download this complete presentation, please go to: https://www.oeconsulting.com.sg
Use this ppt presentation to educate groups on what is ISO 9001:2015 standard, what are the requirements of ISO 9001:2015 certification, etc.
For more information visit: https://www.globalmanagergroup.com/
ISO 9001-2015 Revision Training PresentationDQS Inc.
ISO 9001 is a great tool that is used for managing an organization and implementing continuous improvement. More than one million organizations worldwide are certified to ISO 9001 in order to help ensure that good quality products and services are provided to customers.
Get an in-depth overview of the upcoming changes to ISO 9001:2015, including:
- Revision timing and roll out
- Details on structure change
- In-depth review of changes including risk assessment
- Transitioning from ISO 9001:2008 to ISO 9001:2015 timing and requirements
- and more.
QCC is one of the leading providers of training solutions in India for management systems, process improvement, business improvement and auditing. QCC helps companies understand, implement and manage business systems and processes through its training solutions in its endeavor to equip your staff with the confidence and expertise they need to attain their goal.Our training solutions are built on innovative experimental methodologies with global delivery capacity. Our presenters (trainers) are auditors, business improvement specialists, consultants, industry experts as well as trainers who have been exposed to a wide range of companies and industries in India and overseas. They develop and deliver courses for both public & in-house training, thus bringing along firsthand experience and knowledge to the delegates.
How to Perform a Successful Internal Quality AuditGreenlight Guru
You already know internal quality audits are required by both FDA 21 CFR Part 820 and ISO 13485.
You also probably already know they are a big hassle to conduct.
What you might not know is that they are one of the most powerful weapons at your disposal for preventing 483's and observations.
Why?
Because they are one of the most effective and efficient ways to make sure you and your team are always prepared if FDA or NB decided to show up unexpectedly.
So how do you “establish” the right procedures? How do you ensure your auditor is competent and properly qualified? And what do you do if you find non-conformances?
View this presentation by our guest Kyle Rose, President at Rook Quality Systems, where you will find the answers to all those questions and more.
Specifically, you will learn:
- How to conduct an effective internal quality audit based on process identification, sampling and questioning
- How to plan a internal quality audit and develop an audit schedule
- How to find and use competent and qualified auditors
- Why certain auditors shouldn’t audit certain areas
- How to properly report the findings of your internal quality audit
- How to concisely document non-conformances
- How to determine what needs corrective actions and how to follow up on them
The new ISO 9001:2015 committee draft is published and distributed. There are changes which affect organizations who applied this standard. As it is among most famous ISO standards, follow up the changes would be critical and it is time to consider changes which might affect organizations' management systems.
HSE Training Presentation for ISO 14001, ISO 45001 IntegrationGlobal Manager Group
Global Manager Group provides ppt presentation for HSE training. It provides brief information on requirements of ISO 14001:2015, ISO 45001:2018, implementation steps, internal audit, etc.
For more information visit: https://www.globalmanagergroup.com/
PECB Webinar: ISO Internal Audits - A signpost to ISO compliancePECB
The webinar covers:
• Why you should do ISO Internal Auditing?
• Who should do ISO Internal Auditing?
• How you should do ISO Internal Auditing?
• When you should do ISO Internal Auditing?
Presenter:
This webinar was presented by Mr. Oladapo Ogundeji, from Digital Jewels and PECB Partner.
Link of the recorded session published on YouTube: https://youtu.be/FtM6n95wNmE
Una norma de calidad es un papel, establecido por consenso y aprobado por un organismo reconocido, que se proporciona para un uso común y repetido, una serie de reglas, directrices o características para las actividades de calidad o sus resultados, con el fin de conseguir un grado óptimo de orden.
PECB Webinar: The significance of auditing in maintaining a certified ISO 900...PECB
We will cover:
• The role of auditing in the implementation, development, and continuous improvement of a QMS based on ISO 9001
• Best audit practices
• The shift towards risk based auditing with the advent of the 2015 version of the ISO 9001 Standard
Presenter:
This webinar will be presented by Jacob Alexander McLean, the Principal Consultant and Managing Director of Kaizen Training & Management Consultants Limited.
Environmental auditing originated in the United States in the 1970s as a way of checking whether a company was complying with a multitude of new environmental laws and regulations. More recently, it is used as an extremely valuable tool for assessing a company's environmental management systems, policy, and equipment. It provides the company with recommendations on how it can improve its environmental management practices, and reduce the environmental impact. Beside, improved environmental practices often save money in the long run.
AS 9100:2016 and ISO 9001:2015 - Clause 9.3 Management Review : What's New?Meghana Ransing
This presentation gives a holistic overview of key changes in AS9100:2016 and ISO9001:2015. The authors prepared these slides for an invited presentation at the 14th World Conference on Investment Casting held in Paris at the Le Palais des Congrès between 17th and 20th April 2016.
Description of proposed changes to ISO 14001:2015 Environmental Management Systems. These are the slides from the webinar - http://www.mangolive.com/blog-mango/iso14001-changes-2015-environmental-management-webinar-recording
Certification Body Approach to ISO 9001:2015 by NQANQA
ISO 9001:2015 and ISO 14001:2015 are one year old this month! Here we discuss our experiences and lessons learnt during the first year of assessments to the 2015 standards.
This presentation is about ISO 17021:2015 Documentation kit which is required for accreditation of certifying body. It talked about ISO 17021 Documentation in details. This ISO 17021 Documentation kit having sample documents required for ISO 17021:2015 certification.
ISO 9001 2015 ASQ Workshop by Colin GrayColin Gray
The current and expected development of ISO 9001 - Annex SL reviewed. Gain insight into the ISO 9001 Draft International Standard (DIS) of ISO 9001 which has recently been released.
SAI Global Webinar: Tips for Effective Internal AuditingSwitzerland09
Tips and Techniques for Managing an Effective Audit Program
A key source of information for the leadership of any organization is the internal audit process. A well-managed and comprehensive internal audit program is invaluable to the leadership as it provides them with a clear photograph of the current state of the enterprise. Implemented properly the internal audit process can not only focus attention on nonconforming processes, it should also be a driver for best practice sharing and identification of continual improvement opportunities. The success or failure of an internal auditing program starts with leadership support. Too often however, leadership does not fully appreciate or understand the value the audit process can provide to an organization. It is simply viewed as another in a series of requirements to be completed.
Join Carmine Liuzzi, Industry Leader and Management Systems Consultant with SAI Global for a free 1-hour webinar to discover tips on how organizations can gain the maximum business benefits from an effective internal audit program.
Agenda:
• Why We Audit?
• The Ideal Audit Process – Items for Consideration
• How to Gain Leadership Support for Audits - Value-Added Nonconformity Statements
• Q&A
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
How to Prepare Your Organization for the Transition to ISO 13485:2016
T410 iso 19011
1. Using ANSI/ASQ QE 19011S
for QMS and EMS Auditing – a
Practitioner’s Perspective
Gary L. Johnson
U.S. EPA
Research Triangle Park, NC 27711
May 2004
2. Today We Will Cover
• What is QE 19011S and its benefits?
• How will QE 19011S be used?
• Why supplemental guidance is needed?
• What is the structure of QE 19011S?
• What is the status of QE 19011S?
3. What is QE 19011S?
• An consensus-based American National Standard
for use with ISO 19011 in auditing management
systems.
• Provides specific guidelines for auditing:
– Quality Management Systems
– Environmental Management Systems
• Applicable to ISO 9001:2000 QMS and ISO
14001:1996 EMS.
4. QE 19011S
• Supplements ISO standard by
addressing full range of auditing
activities, including:
- Internal audits – first party
- Supplier audits – second party
- Certification and other third party
audits
- Use by small organizations
5. International Standard
• ISO published the final approved ISO
19011 standard in October 2002.
• U.S. adopted ISO 19011 as American
National Standard (QE 19011:2004)
in spring 2004.
• American National Standard is
identical to ISO version.
6. Benefits of ISO 19011
• Replaced six existing standards with one:
– Quality Auditing Standards - ISO 10011
Parts 1, 2, and 3
– Environmental Auditing Standards - ISO
14010, ISO 14011, ISO 14012
• Accepted for registration/certification
audits in U.S. (ANSI-RAB NAP).
7. U.S. Concerns about ISO
19011 Limitations
• ISO 19011 guidance on auditor
competence was insufficient:
– Implied minimum levels
– Not based on sound science
• ISO standard did not adequately address:
- Internal Audits
- Supplier Audits
- Use by Small Organizations
8. U.S. Concerns contd.
• ISO 19011 text largely reflected 3rd Party
and Certification Audits.
– ISO 19011 JWG experience was strongest for
3rd Party Audits.
– U.S. efforts to broaden guidance were
rejected.
• ISO 19011 text was often too burdensome
for 1st and 2nd Party audits and small
organization users.
9. U.S. Solution
• Developed Supplement to ISO
19011:2002
• Added to ISO text to supply needed
guidance.
• Supplement format is modeled after
ISO 9004:2000.
• Supplement contains complete ISO
text with added guidance.
10. U.S. Supplement
• ANSI/ASQ QE 19011S:2004 was
developed by ANSI ASC Z1
Committee Joint Task Group.
• Ballot for approval as American
National Standard is in progress.
• Approval is expected – Summer
2004.
11. QE 19011S Format
• ISO 19011:2002 text presented in boxes.
– Unchanged from ISO
– Cannot be changed unless standard is
revised. JTG had no authority to do so.
• When ISO text is inadequate, Supplement
text follows to add guidance as needed
for:
– Internal (1st Party) audits
– Supplier (2nd Party) audits
– Use by small organizations
12. QE 19011S Format
• When ISO 19011:2002 text needs no
change:
– Supplement notes that no additional
text is needed.
• Supplement text generally builds on
the ISO text to augment the
guidance.
13. Structure of QE 19011S
• 0 Introduction
• 1 Scope
• 2 Normative References
• 3 Terms and Definitions
• 4 Principles of Auditing
• 5 Managing an Audit Program
• 6 Audit Activities
• 7 Competence and Evaluation of
Auditors
14. 0 Introduction
• Provides background on why the ISO
Standard and U.S. Supplement are
needed.
• Provides a general outline of how the
Supplement is structured and how its
contents should be used.
• Briefly outlines the use of the Supplement
for different audit programs.
15. 1 Scope
• Brief statement of the intent and
application of the standard, including
internal and external audits, and use by
small organizations.
• Emphasizes flexibility and broad range of
users.
• Notes that the standard may be applied to
other types of audits as well (OHS?).
• Few additions made by the Supplement.
16. 2 Normative References
• Identifies other documents whose
provisions are included in ISO 19011:2002
by reference and which apply to the
Supplement.
• There are two normative references:
– ISO 9000:2000 QMS Vocabulary
– ISO 14050:1998 EMS Vocabulary
17. 3 Terms and Definitions
• Provides for additional definitions not specifically
covered in normative references or elsewhere.
• Key terms in ISO 19011 include:
– Audit criteria
– Audit findings
– Audit team leader
– Audit program
– Competence (of Auditors)
• No additional terms/definitions were
included.
18. 4 Principles of Auditing
• Provides basic auditing principles for
auditors, including:
– Ethical conduct
– Fair Presentation
– Due professional care
• For audits, including:
– Independence
– Evidence-based approach
19. 5 Managing an Audit
Program
• Provides guidance on establishing
and maintaining an effective audit
program
– For one, few, or many audits,
– Includes consideration of internal and
external audits,
– Introduces guidance on combined or
joint audits.
20. 5 Managing an Audit
Program
• Key elements include:
– Implementing the audit program.
– Monitoring and reviewing the audit program.
– Establishing the authority for the audit
program.
– Improving the audit program.
– Establishing the audit program.
• Expands guidance on audit program
performance beyond ISO text, particularly
for internal audits.
21. 5 Managing an Audit
Program - Example
• Clause 5.2.1 – Objectives of an Audit
Program
– See Handout 1
22. 6 Audit Activities
• Auditing process includes:
– Initiating the audit
– Conducting document reviews
– Preparing for on-site audit activities
– Conducting on-site audit activities
– Preparing, approving, and distributing the
audit report
– Completing the audit
– Conducting audit follow-up (if in audit plan)
23. 6 Audit Activities
• Uses “graded approach” in applying
activities to particular audits, not
“one size fits all.”
• Reflects major differences between
internal and external audits for:
– Opening/closing meetings
– Auditor competence needed
– Reporting audit results
24. 6 Audit Activities
• Guidance is applicable to auditing the
process approach in ISO 9001.
– Also applies to ISO 14001 audits.
• Guidance applies to combined and joint
audits.
– Combined - auditing QMS and EMS in one
audit.
– Joint – two parallel audits at the same time.
25. 6 Audit Activities -
Example
• Clause 6.5.1 – Conducting the
Opening Meeting
– See Handout 2
26. 7 Competence and
Evaluation of Auditors
• Auditor – person competent to conduct an audit.
• Competence of an auditor is based on:
– Personal attributes.
– Ability to apply sufficient knowledge and skills
gained through education, work experience,
auditor training, and audit experience.
• Audit team leaders need additional knowledge
and skills, work experience, auditor training, and
audit experience specific to leadership.
27. 7 Competence and
Evaluation of Auditors
• Competence of auditors needed:
– Should be left to audit program managers.
– Should fit the needs of the audit program.
– Should be maintained through appropriate
methods.
• Guidance is provided on:
– Selecting auditors for a particular audit
program,
– Evaluating auditors and audit team leaders.
28. Knowledge and Skills
• Generic knowledge and skills on:
– Audit principles and techniques.
– Relevant management systems reference
documents.
– Organizational situations.
– Applicable laws, regulations, and
requirements.
• Specific knowledge and skills on:
– QMS or EMS methods and techniques.
– Related processes, science, and technology.
– Technical aspects of operations.
29. Demonstrated Credentials
• Demonstrated evidence of:
– Education
– Work experience
– Auditor training
– Audit experience
• Supplement does not set levels.
– Levels should be based on Audit Program
needs.
– Table 1 in ISO 19001:2002 is specific to
registration audits.
30. Other Considerations
• Audit team leader.
• Auditor for both QMS and EMS.
– What is needed to audit in both
disciplines.
• 1st, 2nd, and/or 3rd party audit
situations.
– What differences exist.
31. Maintenance and
Improvement of Competence
• Maintaining competence needs:
– Continual professional development.
– Regular participation in audits.
• Reflects “graded approach” in application.
32. Auditor Evaluation
• Evaluation process has four general steps:
– Identify needed personal attributes and
knowledge and skills.
– Set the evaluation criteria.
– Select an appropriate evaluation method.
– Conduct the evaluation.
• Guidance is provided on different
evaluation methods and techniques.
33. Summary
• QE 19011S offer a complete, process
approach to QMS and EMS auditing.
• ISO 19011 as written appears to be
best suited for 3rd Party/Certification
audits.
• QE 19011S provides more complete
guidance on 1st and 2nd Party audits.
34. Summary
• ISO 19011 and QE 19011S will be
useful to QMS and EMS auditors and
audit programs in the U.S. and
elsewhere.
• ISO 19011:2002 is available now.
• QE 19011S should be available this
summer.