http://qualitymanagementsystem.com/total-quality-management/designing-a-quality-management-system/
When it comes to creating quality management systems (QMS), sometimes quality leaders just don’t know where to begin or what to do. Let’s review the basic steps to implementing Total Quality Management (TQM) with a quality management system.
Management review is the routine evaluation of whether management systems are performing as intended and producing the desired results as efficiently as possible. It is the ongoing “due diligence” review by management that fills the gap between day-to-day work activities and periodic formal audits.
ISO 9001 - It sets out the criteria for a quality management system and is th...Tushar Sadhye
ISO 9001 - It sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement).
ISO over one million companies and organizations in over 170 countries implement 9001:2008.
Checking that the system works is a vital part of ISO 9001:2008. An organization must perform internal audits to check how its quality management system is working. The presentation shows the basic steps and requirement
http://qualitymanagementsystem.com/total-quality-management/designing-a-quality-management-system/
When it comes to creating quality management systems (QMS), sometimes quality leaders just don’t know where to begin or what to do. Let’s review the basic steps to implementing Total Quality Management (TQM) with a quality management system.
Management review is the routine evaluation of whether management systems are performing as intended and producing the desired results as efficiently as possible. It is the ongoing “due diligence” review by management that fills the gap between day-to-day work activities and periodic formal audits.
ISO 9001 - It sets out the criteria for a quality management system and is th...Tushar Sadhye
ISO 9001 - It sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement).
ISO over one million companies and organizations in over 170 countries implement 9001:2008.
Checking that the system works is a vital part of ISO 9001:2008. An organization must perform internal audits to check how its quality management system is working. The presentation shows the basic steps and requirement
Quality Management: Nature of Inspection; Quality Control; Statistical Quality Control (SQC); Types of Control Charts; Acceptance Sampling Technique; Total Quality Management; What is Quality Management? Modern Quality Management;
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
Total construction quality management by mobile technology mtechStephen Au
Quality is one of the critical factors in the success of construction projects. Improvement in the quality of construction projects is linked with quality management in the project life cycle. And the quality management at the execution (construction) stage contributes significantly on final quality outcome of construction projects.
Now it is the time to place behind the old adversarial approach to managing construction work. It is time to develop better and more direct interaction with project stakeholders, to initiate more teamwork at the jobsite, and to produce better quality work. These goals drive the demand of using mobile and cloud computing technologies to do the quality management.
Management Review is always conducted in the organization who has received ISO 9001 certification. But the problems are, Management Review is not adding value.
This presentation helps you to understand the problems may occurred in the Management Review and finally to get add values from this Review.
Project Quality Management is step by step . This presentation gives us a brief explanation about quality management of each project you may think you are going to undertake.
Childhood Trauma CAN Result In Adult Money Management ProblemsMark Bristow
The Financial Healer, Mark Bristow, explains how childhood trauma CAN result in adult money management problems.
Using a powerful example of a client treated with Matrix Reimprinting, Mark explains how childhood trauma and its associated negative beliefs persist into adulthood.
Mark is an expert in the use of Matrix Reimprinting as well as a Practitioner of EFT and NLP. He uses all three disciplines to heal the financial issues of his clients.
Discover more, and get the first three chapters of Mark's book 'The Financial Healer' here: http://financialhealer.co.uk
Quality Management: Nature of Inspection; Quality Control; Statistical Quality Control (SQC); Types of Control Charts; Acceptance Sampling Technique; Total Quality Management; What is Quality Management? Modern Quality Management;
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
Total construction quality management by mobile technology mtechStephen Au
Quality is one of the critical factors in the success of construction projects. Improvement in the quality of construction projects is linked with quality management in the project life cycle. And the quality management at the execution (construction) stage contributes significantly on final quality outcome of construction projects.
Now it is the time to place behind the old adversarial approach to managing construction work. It is time to develop better and more direct interaction with project stakeholders, to initiate more teamwork at the jobsite, and to produce better quality work. These goals drive the demand of using mobile and cloud computing technologies to do the quality management.
Management Review is always conducted in the organization who has received ISO 9001 certification. But the problems are, Management Review is not adding value.
This presentation helps you to understand the problems may occurred in the Management Review and finally to get add values from this Review.
Project Quality Management is step by step . This presentation gives us a brief explanation about quality management of each project you may think you are going to undertake.
Childhood Trauma CAN Result In Adult Money Management ProblemsMark Bristow
The Financial Healer, Mark Bristow, explains how childhood trauma CAN result in adult money management problems.
Using a powerful example of a client treated with Matrix Reimprinting, Mark explains how childhood trauma and its associated negative beliefs persist into adulthood.
Mark is an expert in the use of Matrix Reimprinting as well as a Practitioner of EFT and NLP. He uses all three disciplines to heal the financial issues of his clients.
Discover more, and get the first three chapters of Mark's book 'The Financial Healer' here: http://financialhealer.co.uk
Presented for ASQ India on 3/22/2016 7PM - 8PM IST (6.30 AM -7.30AM PST). Govind will briefly discuss key changes, new requirements and a high level transition plan. The new standard is more aligned with business than ever. However this new standard also bring challenges for auditing. As a QMS manager, auditor or even a practitioner you will be expected to apply this management system standard at work.
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
The presentation discuss in detail the Project Quality Management in light of PMI PMBOK prospective. After highlighting the basic concepts from PMBOK initial chapter, it captures the details from all the processes of PQM, mainly Plan Quality Management, Perform Quality Assurance and Control Quality. The presentation also includes some of the sample questions related to Project Quality Management.
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.
A quick slideshow to enforce some of the basics of giving good customer service in a call center. I made a few modifications to it so I hope this one is better liked. :)
Audits are a way to document the procedures, quality standards, and management techniques in an enterprise. Enterprises that value quality standards conduct process audits and factory audits to identify the gaps and make improvements to their systems. For more information visit our website www.amrepmexico.com
Second Party Audit and External Third Party AuditShantanuThakre3
Second Party Audit:- Second-party audit is when a company performs an audit of a supplier to ensure that they are meeting the requirements specified in the contract.
External Third Party Audit:-
A third-party audit occurs when a company has decided that they want to create a Quality Management System (QMS) that conforms to a standard set of requirements, such as ISO 9001 and hire an independent auditing company to perform an audit to verify that the company has succeeded in meeting these standards.
Quality Management System ISO 9001 Interpretation and Internal Audit
Core Knowledge about QMS
1. P R E S E N T E D B Y
MUHAMMAD ASIM
B . E H A M D A R D U N I V E R S I T Y
M B A I Q R A U N I V E R S I T Y
L E A D A U D I T O R T U V A U S T R I A
Core Knowledge about
QMS (Quality Management System)
2. What is QMS?
A Quality Management System (QMS) is a collection
of business processes focused on achieving your Quality
Policy and Quality Objectives i.e. what your customer
wants and needs. It is expressed as the organizational
structure, policies, procedures, processes and resources
need to implement Quality Management System.
3. What is an Audit ?
Audit is a systematic, independent, planned and
documented activity performed by qualified
personnel to determine by Investigation,
Examination, or Evaluation of Objective
Evidence, the adequacy and compliance with
established procedures, or applicable documents,
and the effectiveness of implementation of QMS.
4. Types of Audit
First Party Audit
The company Audit its own system (Internal Audit)
Second Party Audit
Customer based Audit (because of Commercial
Interest)
Third Party Audit
An Independent body certifies an Organization.
5. What is an Auditor ?
An auditor is a professional who is responsible for
Evaluating or Examining some aspects of a
project, business, organization or any individual.
Auditor guidelines ISO 19011:2011
6. Discussion on following Terms useful for an
Auditor
Audit Criteria (Policies, Procedures)
Audit Evidence (Objective evidence)
Audit Team (Members)
Audit Client (Organization)
Audit Findings (Conformance or Non-
Conformance)
Audit scope (depend upon organization structure)
Audit plan (Plan Activities & Arrangements)
Audit Checklist (List of Task’s)
Risk (Uncertainty)
Audit Conclusion (Outcome)
7. An Auditor must be aware about
Audit Plan
Audit Checklist
Audit Summary Report
Audit Sampling Method
Boundaries of an Audit
Recommendation
Roles and Responsibilities
9. Audit Trick
Ask (Mainly open ended question which provide
information).
Look (Observe what is happening)
Check (Availability of procedures, awareness of
Auditees, Conformance of procedures,
consistency)
Record (The Objective evidence Positive & Negative)
10. Performing an Audit Program
Initiating the Audit
(Contact with client and determine feasibility).
Preparing an Audit Activity
(Document review, Audit Plan, Distribution of
Activity.)
Conducting an Audit Activity
Opening meeting, demand of guide (Auditee),
document verification, collection of information.
Meeting of all Auditor’s (Info. Collection)
Preparing Audit Conclusion.
Closing Meeting ( Discuss all NCR’s with Auditee)
Preparing and Distribution of Audit Report.
Must ensure the follow-up on NCR’s.
13. 08 Principles of Quality Management
Leadership
Involvement of Peoples
Customer focus
Process Approach (relates to productivity)
System Approach (relates to QMS)
Factual Approach to Decision Making
Continual Improvement
Mutually beneficial supplier relationship
14. 08 Clauses of Quality Management System
(ISO 9001:2008)
1 - Scope
2 - Normative reference
3 - Terms and Conditions
4 – Quality Management System
General requirements
Documentation requirements
5 – Management Responsibility
Customer Focus
Quality Policy
Planning
Quality Objectives
Responsibilities, Authority & Communications
Management Representative.
15. 08 Clauses of Quality Management System
(ISO 9001:2008)
Management Review
6 - Human Resources
Competence, training and awareness
Infrastructure
Work environment
7 – Product Realization
Customer related processes
Design and Development
Purchasing
Product and service provision
8 – Measurement, analysis and improvements.
Internal Audit
Analysis of Data
Control of Non-Conforming Product
Corrective Actions
Preventive Actions
16. Discussion
Relationship of 08 Principles of Quality
Management.
With
08 Clauses of Quality Management System
ISO 9001:2008
18. What is Factual Approach to Decision
Making ?
Identify minimum Four Clauses that support such an
approach?
19. Identify two ways in which an Auditor can
verify that agreed corrective actions have
been implemented ?
20. The level of customer satisfaction is
one measure of the performance of
a Quality Management System.
List Two methods which can use to
determine its satisfaction level?
22. Situation # 01
At opening meeting of an External Audit, MR inform you
that a recent Internal Audit has found many non-
conformities relating to the in-house purchasing
department.
Corrective Action has already been planed. The MR
suggested that to Audit this department again would add
no value and ask if you could delete this depart from
Audit Plan and spend more time in production area.
Is it correct ???
If not then outline at least four issues that can be face.
23. Situation # 02
During a routine Audit visit, Auditee of Design and
Development department informs you that they no
longer carry out any design work. The activity is now
outsourced to a contractor.
Give four examples of Audit Evidence you would look for
determine the conformance of the current system with
ISO 9001.
Must mention Clauses of ISO 9001 standard that relates to
this situation.
24. Situation # 03
During an Audit of an Insurance co. you ask Training
Manger to show training record and you found that all
employees attend trainings.
You ask that how they are evaluated, manager replies that
we evaluate via questionnaire after completion of each
training.
You did a sampling audit and examine 03 questionnaire,
and surprisingly all 3 persons got highest marks and
awarded satisfactory score from Trainer.
What is your Thinking ??? Express in your words ???
Is this NCR or Audit Trail ???
25. Situation # 04
You are Auditing a design department of Industrial
equipment.
They are currently dealing with a serious customer complaint
relating to faulty safety mechanism, and their engineers
have some difficulty in repairing of safety mechanism due to
the Old drawing issue and drawing does not contain
modification step of safety mechanism, Engineer’s opinion
is to incorporate modification step in drawing.
Manager reply that it is not recorded due to some minor
changes and did not affect customer contract.
What is your Opinion ????
Is this a Major non-compliance or not ???
Raise NCR or perform Audit Trail ???
26. Situation # 05
You found a problem during Audit at Testing department that
the word ‘OK’ is written with initial of junior inspector on
testing report.
You ask with supervisor that Who has authorized to test and
release this product, and he replied that authorization is
not necessary in routine product, and it is clear from Chief
Inspector if any abnormality or a problem is occur.
You verify the documented procedure and found that Chief
Inspector is responsible for authorizing final release of all
products.
What is happening there ???
Is this NCR or Audit Trail ???
27. Preparation of Checklist with reference to
Standard Clause
You are conducting an ISO Audit in an Injection
Molding company (a process by which components
are manufactured). The next activity on your Audit
Plan is the organization Final Inspection and Testing
department.
Outline your checklist on a paper with clause reference