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.
This presentation gives a bried overview of the various parts & purpose of the ISO 9001:2015 QMS.
It revolves around the PDCA Cycle and useful in Manufacture & construction Industry.
,
quality management systems
,
what’s iso?
,
getting to know iso
,
benefits of iso registration
,
requirements
,
requirements activity
,
quality management system (qms)
,
resource management
,
product realization
,
measure
,
analyze and improve
,
documentation activity
,
internal audits
,
how to do an internal audit
,
audit activity
,
registration process
,
two ways to be iso certified
ISO 9001 Documentation - You want to get certified to ISO 9001, with help from our ISO 9001 Masterclass you will be able to document all of your business processes in one week or less! YES! If you have been sitting around and contemplating you need to take time to document your business processes, well we have done all of the hard work for you. We have created the templates where you can just simply enter your process steps. All of the templates are in word editable version so you can edit the process flows in any way you want.
Although it is difficult to define quality as every organization looks at it differently but the totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs is most commonly considered as quality. If your organization is committed to ensure that its products and services are made as per customers’ requirements and intend to stay in the business by understanding and optimizing the whole system of value exchange; a quality management system can help you in fulfilling all these requirements.
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.
This presentation gives a bried overview of the various parts & purpose of the ISO 9001:2015 QMS.
It revolves around the PDCA Cycle and useful in Manufacture & construction Industry.
,
quality management systems
,
what’s iso?
,
getting to know iso
,
benefits of iso registration
,
requirements
,
requirements activity
,
quality management system (qms)
,
resource management
,
product realization
,
measure
,
analyze and improve
,
documentation activity
,
internal audits
,
how to do an internal audit
,
audit activity
,
registration process
,
two ways to be iso certified
ISO 9001 Documentation - You want to get certified to ISO 9001, with help from our ISO 9001 Masterclass you will be able to document all of your business processes in one week or less! YES! If you have been sitting around and contemplating you need to take time to document your business processes, well we have done all of the hard work for you. We have created the templates where you can just simply enter your process steps. All of the templates are in word editable version so you can edit the process flows in any way you want.
Although it is difficult to define quality as every organization looks at it differently but the totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs is most commonly considered as quality. If your organization is committed to ensure that its products and services are made as per customers’ requirements and intend to stay in the business by understanding and optimizing the whole system of value exchange; a quality management system can help you in fulfilling all these requirements.
The Checklist contains explanations and recommendations that:
- Facilitate the audit;
- May serve as a guide in the transition to the new version of ISO 9001: 2015 using 'fill the gap' methodology;
- Allow for QMS self-assessment for compliance with ISO 9001: 2015;
- Facilitate learning and understanding of the new version of ISO 9001:2015 requirements
- User-friendly format and professional layout - reviewed and approved by experienced ISO 9001 quality auditors.
- 72 pages
These Slides are related to the following topic:
> Quality Management System
> Definition
> Purpose
> Goal and Objectives
> QMS Documentation
> QMS Documentation Hiierarchy
> Industry Level
> Organization Level
Global Manager Group provides this presentation that talks about mandatory documents required for ISO 9001:2015 Certification. The key documents like quality manual, procedures, SOPs, audit checklist, etc required for certification are described in details. Also give information about how Global Mananger Group helps in quick certification by providing ISO 9001:2015 Documentation kit.
For more information visit @ http://www.globalmanagergroup.com/
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
All the information have the reference of
DAP, Overview of the ISO 9001:2015 QMS, Module 1: Introduction, iso-9001-2015-mod1_intro_to_qms.pdf, date retrieved: September 21, 2019
The Checklist contains explanations and recommendations that:
- Facilitate the audit;
- May serve as a guide in the transition to the new version of ISO 9001: 2015 using 'fill the gap' methodology;
- Allow for QMS self-assessment for compliance with ISO 9001: 2015;
- Facilitate learning and understanding of the new version of ISO 9001:2015 requirements
- User-friendly format and professional layout - reviewed and approved by experienced ISO 9001 quality auditors.
- 72 pages
These Slides are related to the following topic:
> Quality Management System
> Definition
> Purpose
> Goal and Objectives
> QMS Documentation
> QMS Documentation Hiierarchy
> Industry Level
> Organization Level
Global Manager Group provides this presentation that talks about mandatory documents required for ISO 9001:2015 Certification. The key documents like quality manual, procedures, SOPs, audit checklist, etc required for certification are described in details. Also give information about how Global Mananger Group helps in quick certification by providing ISO 9001:2015 Documentation kit.
For more information visit @ http://www.globalmanagergroup.com/
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
All the information have the reference of
DAP, Overview of the ISO 9001:2015 QMS, Module 1: Introduction, iso-9001-2015-mod1_intro_to_qms.pdf, date retrieved: September 21, 2019
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auditing is an examination of accounting
records undertaken with a view to establish whether they correctly and completely reflect the transactions to which they relate.
organizations should have to maintain their businesses in a marketing oriented way. It doesn’t matter whether the organization is large scale or small but almost all the organizations have to achieve their best not because they have to but to survive in the market. In order to survive in the market they have to provide quality for customers which is better than the competing organizations. So therefore every organization need to have a quality oriented businesses for their survival.
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We have chosen “Coca-Cola” which is the leader in beverage industry for our assignment. As the leading beverage brand in Sri Lanka they have good quality strategies within their organization. So it’s one of the best chances we’ve got to study the quality oriented strategies of this company as they have reached their best level.
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3. before we begin, lets agree on
9common definitions
based on ISO 9000:2008
4. productis defined as result of a process
processis defined as set of interrelated or interacting activities which transforms inputs into outputs
5. quality
defined as degree to which a set of inherent characteristics fulfils requirements
requirement
need or expectation that is stated, generally implied or obligatory
customer satisfaction
customer’s perceptionof the degree to which the customer’s requirements have been fulfilled
6. conformity
fulfilmentof a requirement
nonconformitynon-fulfilmentof a requirement
preventive action
action to eliminate the cause of a potentialnonconformity or other undesirable potential situation
corrective action
action to eliminate the cause of a detectednonconformity or other undesirable situation
8. the facts.
QMS is created and maintained by International
Organization of Standardization.
It’s a National Standard of Indonesia.
there are no laws indicating any law implication
for not having the certification.
9. the facts.
BUT…
ISO certified meansthe company operate in
away to produce good quality, in a good price,
with reliable delivery, and world class service
11. she got two
business pitches
SHAFCO
‘the’ Brand
12. strive to satisfy its customer
by meeting customer requirements
control over operation to prevent any
non-conformance or defective process
by following a certain international
standards
strive to satisfy its customer
by meeting customer requirements
control over operation to prevent any
non-conformance or defective process
by its own standards
SHAFCO
‘the’ Brand
18. the benefit of a systemic process
is to create consistency
19. who’d wants an occasionalsuccess?
who’d wants an occasional
world class products?
20. in order to sustain our business
and win the market
21. we need our processes to consistently
creating world class products
22. HOW TO
IMPLEMENT
ISO 9001
photo by Mehmet Goren (mgoren) freeimages.com
23. 8 QMS
PRINCIPLES
customer
focus
Involvement
of people
process
approach
system
approach
continual
improvement
factual
approach
to decision
making
mutually
beneficial
supplier
relationship
leadership
dinar.indra|qms|shafco
26. THE 8 CLAUSES
1. Scope; 2. Reference; 3. Terms and Definitions
4. Quality Management System
•4.1 General Requrements
•4.2 DocumentativeRequirements
5. Management Responsibility
•5.1 Management commitment
•5.2 Customer focus
•5.3 Quality policy
•5.4 Planning
•5.5 Responsibility, authority and communication
•5.6 Management review
6. Resource Management
•6.1 Provision of resources
•6.2 Human resources
•6.3 Infrastructure
•6.4 Work environment
7 Product Realization
•7.1 Planning
•7.2 Customer related process
•7.3 Design and development
•7.4 Purchasing
•7.5 Production and service provision
•7.6 Control of monitoring and measuring equipment
8. Measurement, analysis, and improvement
•8.1 General
•8.2 Monitoring measurement
•8.3 Control of nonconforming products
•8.4 Analysis of data
•8.5 Improvement
29. but first,
documentation.
Documentation is the heart of quality management system. You do what you write, and you write what you do.
30. Quality
Policy
Quality Manual
Procedure
Working Instructions
Records
a statement of a quality policy
and quality objectives
4.2.1
31. Quality
Policy
Quality Manual
Procedure
Working Instructions
Records
provide scopeof the system and exclusion,
list of procedures, and description of
processinteractions
4.2.2
32. Quality
Policy
Quality Manual
Procedure
Working Instructions
Records
A good procedure and working
Instruction are those with clear “What”,
“Why”, “When”, “Where”, “Who”, and “How.”
33. Quality
Policy
Quality Manual
Procedure
Working Instructions
Records
Records are Evidence!
Any documented evidence to
a process. It doesn’t have to be in a
form of a form(:D), it could be anything
that could prove what actually happen.
Including photograph.
34. Quality
Policy
Quality Manual
Procedure
Working Instructions
Records
all document should be controlled!
4.2.3
35. two of the most
important principles are
process approach and continual improvement
36. Continual improvementis a set of recurringactivities that an organization carries out in order to enhance its ability tomeet requirements.
www.praxiom.com
39. process approachis a management strategy. It means that they managethe processes that make up their organization, the interactionbetween these processes, and the inputs and outputs thattie these processes together.
www.praxiom.com
40. plan
act
check
do
dinar.indra|qms|shafco
plan
act
check
do
plan
act
check
do
plan
act
check
do
process approach
Process A
Process B
Process C
Process D
(wholeness)
53. before we begin, lets agree on
5common definitions
based on ISO 19011:2011
54. audit
Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled.
audit criteria
set of policies, procedures or requirements used as a reference against which audit evidence is compared
audit evidence
Records, statements of fact or other information which are relevant to the audit criteria and verifiable
55. audit findings
results of the evaluation of the collected audit evidence againsaudit criteria
audit conclusion
Outcome of an audit, after consideration of the audit objectives and all audit findings.
64. establishing objectives
establishing audit programme
Implement audit programme
competence evaluation of auditors
performing an audit
monitoring audit programme
reviewing and monitoring audit programme
plan
do
check
act
dinar.indra|qms|shafco
65. audit objectives are top down by Top Management
and should be inline with management system policy
and objectives
this is Harry,
he’s the Management Representative/Lead Auditor
66. planning is essential.
Management Representative should plan programme
duration, procedures, and all necessary resources.
he/she should also evaluate any potential risk.
67. AUDIT PROGRAMME
get approval.
after all programmehas been planned
it’s time to face the Board.
68. individual audit plan.
a programmeconsist of several (if not much)
individual audit activities. Each of these activities
should also be well prepared. Every individual plan
should not conflicts the programmeplan.
69. best practice of selecting team.
number of people should equal the audit scope,
organization structure, and human resources.
Select peoplefrom all functions or departments,
from staff to senior management.
70.
71. inititatingaudit
preparing audit
conducting audit
prepare and distribute reports
completing audit
conducting audit follow-up
audit activities
preparation meetingwith auditeerepresentative. Agreement on schedule
and documents needed.
75. inititatingaudit
preparing audit
conducting audit
prepare and distribute reports
completing audit
conducting audit follow-up
audit activities
Audit is complete when all programmehas been done and declared done by client.
76. inititatingaudit
preparing audit
conducting audit
prepare and distribute reports
completing audit
conducting audit follow-up
audit activities
Auditeeis responsible in taking actions. All actions should have due date. Auditor will verify the actions.
78. DO!
Default question is open questions, with 5W+1H. If you want to follow the trail, use leading questions. If you want a quick response (or the auditeeis just nervous) use closed questions.
79. DO!
Always check the documents. Documents should be updated, correct, complete, and consistence.
80. DO!
Audit findings is always one of four brother:
-Conformity
-Non Conformity
-Opportunity for Improvement
-Recommendation
81. DO!
You can easily write audit findings by using PLOR system. P = problem, L = location, O = objective evidence, R = reference.
82. Example:
During the course of the audit in Purchasing dept. we identified Purchase Order number 1234 does not show the price and shipment date. This is not in accordance with Procedure QMS/002, where all Purchase Order must have complete information.
83. Example:
During the course of the audit in Purchasing dept(L). we identified Purchase Order number 1234 (O)does not show the price and shipment date (P). This is not in accordance with Procedure QMS/002 (R), where all Purchase Order must have complete information.
84. DON’Ts!
Don’t loose track! Beware of bogged down. Don’t assume. Speak by data.
85. Beware of aggressive auditee, nervous auditee, missing people or documents during audits (:D).
If sample is chosen by auditee, its fishy.
If you are being bullied by auditee, it’s fishy.
86. dinar.indra@shafco.com
dinar surtikarani
click here for icon set
References:
Quality Management System ISO 9001:2008 Interpretation & Internal Audit Course, SGS Academy
SNI ISO 9001:2008
SNI ISO 9000:2008
ISO 19011:2011(E)
Pictures from all-free-download.com