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ISO 9001.2015 Presentation To Process Owners

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0% found this document useful (0 votes)
92 views

ISO 9001.2015 Presentation To Process Owners

Uploaded by

Arlene Dacpano
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Quality Management

System Requirements

Awareness and Appreciation


TABLE OF
CONTENTS
BACKGROUND AND HISTORY OF ISO

QUALITY MANAGEMENT SYSTEM

ISO 9001:2015

WHAT'S IN FOR YOU?

DOCUMENTED INFORMATION
BACKGROUND

International Organization
for Standardization

“World’s most recognized management


system standard and is used by over a
million organizations across the world”

HISTORY

THE ISO STORY


In London, in 1946,
65 delegates from
25 countries met to discuss
the future of International
Standardization.

FOUNDERS OF ISO
HISTORY

THE ISO STORY


Founded in 1947
163 countries
Geneva, Switzerland
Have published more than
21,000 international standards
Covers all aspects of
technology and business
BACKGROUND

POPULAR MANAGEMENT
SYSTEM STANDARDS
NUMBER TITLE

ISO 9001 Quality Management Systems

ISO 50001 Energy Management

ISO 27001 Information Security Management

ISO 22000 Food Safety Management


ISO 9001 is a standard that sets

out the requirements for a

quality management system. It

helps businesses and

organizations to be more

efficient and improve customer

satisfaction.
ISO 9001 : QUALITY MANAGEMENT SYSTEMS

1994 2008

1987 2000 2015

Risk-Based Thinking
The QMS Model PLAN
Planning (6)
Organization and its
context
Customer
satisfaction

Customer ACT DO
requirements Improvement Leadership Support (7)
Result of the
QMS
(10) (5) Operations (8)

Products and
services
CHECK
Needs and
expectations of Performance
relevant interested Evaluation (9)
parties
RISK-BASED
THINKING
An organization needs to plan and implement
actions to address risks and opportunities

Preventive Action Correction/Corrective


Action
RISK

effect of uncertainty

assess risk by identifying its probability/likelihood and impact

effect can be positive or negative

Positive risk: OPPORTUNITY

Negative risk: THREAT


(-) RISK: THREAT

Avoided Transferred
- Should be the - Risk should be
first strategy to be managed by a party
considered best able to deal with it
effectively

Mitigated Accepted
- Presents a tradeoff - Not possible or
between doing nothing practical to respond
versus the cost of to the risk by the
mitigating the risk other strategies
(+) RISK: OPPORTUNITY

Exploited Shared
- An aggressive response - Allocate risk to a party
strategy, best reserved for who is best able to
these "GOLDEN maximize its occurrence
OPPORTUNITIES" and benefits

Enhanced Accepted
- Not possible or
- Aims to modify the
practical to respond
size of the positive risk
to the risk by the
other strategies
ISO 9001:2015
CLAUSE 1: Scope

CLAUSE 2: Normative References

CLAUSE 3: Terms and Definitions

CLAUSE 4: Context of the Organization

CLAUSE 5: Leadership

CLAUSE 6: Planning

CLAUSE 7: Support

CLAUSE 8: Operation

CLAUSE 9: Performance Evaluation

CLAUSE 10: Improvement


CLAUSE 4:
CONTEXT OF THE
ORGANIZATION
CLAUSE 4: Understanding the Context of the Organization

2008 Series New - 2015 Series Intended Results

Internal & External


Issues Company Policy

Customer Satisfaction
Interested Parties & Quality Products &
Requirements Services

Risk Opportunities Evaluation


CLAUSE 4: Understanding the Context of the Organization

In a business organization:
External
Issues

Internal Issues

Interested parties
CLAUSE 4: Understanding the Context of the Organization

VALUES

CULTURE
Internal Issues
KNOWLEDGE

PERFORMANCE
CLAUSE 4: Understanding the Context of the Organization

LEGAL

TECHNOLOGY
External
COMPETITION Issues

MARKET

CULTURE

SOCIETY

ECONOMIC ENVIRONMENT
CLAUSE 4: Understanding the Context of the Organization

Customers
Owners
Executive Board
Stockholders
Suppliers & Contractors
Residents
Law Enforcer/Regulators

Interested parties Banks


Employees
Insurers
CLAUSE 4: UNDERSTANDING THE
CONTEXT OF THE ORGANIZATION

Did we identify the issues affecting our


business process?

Who are the interested parties and what are


their needs?

What are your action plans to achieve the


requirements of your interested parties?
CLAUSE 5:
LEADERSHIP
CLAUSE 5: Leadership

Top management shall demonstrate leadership and


commitment to the QMS

Leading Influencing
People people

Commanding Guiding
People People

ACCOUNTABLE
CLAUSE 5: Leadership

Top management shall demonstrate leadership and commitment to


CUSTOMER FOCUS by ensuring:

Customer requirements → understood and


consistenly met

Risks/opportunities → determined and met

Focus on enhancing customer


satisfaction → maintained
Available and maintained
as documented
information

QUALITY
POLICY
✔ Appropriate to the purpose
and context of the
organization and supports
the strategic direction
Communicated,
Available to relevant
understood and applied
interested parties, as
within the organization
appropriate
CLAUSE 5: LEADERSHIP

Do we know the quality policy of


Megaworld?

Do we demonstrate a commitment to
achieve the quality policy?

Do we properly communicate the roles and


responsibilities assigned to our team in
achieving the quality policy?
CLAUSE 6:
PLANNING
CONSIDERATIONS
1. External and internal issues (4.1)
2. Needs and expectations of
interested parties (4.2)
3. Risks and opportunities
ACTIONS TO ADDRESS
RISKS & OPPORTUNITIES
RISKS ✔ Avoid risk
Escalating Cost ✔ Take risk to pursue an
Missed Shipment opportunity
Integrate and
Natural Disasters ✔ Eliminate source
implement actions
Limitation of Resources ✔ Change likelihood/consequence
Loss of Traceability'
into QMS
✔ Sharing risk
Legal Exposure ✔ Retaining risk by informed
Etc. decision

OPPORTUNITIES ✔ Adoption of new practices Evaluate


Cost Rationalization ✔ Launching of new product effectiveness of
Localized Sourcing ✔ Opening new markets actions
Poke Yoke ✔ Addressing new clients
Reduce Cycle Time ✔ Building partnerships
Reduce Paperwork ✔ Using new technology
/Redtape
Quality
Objectives What will be done?

What resources will be


required?
✔ Be consistent with the quality policy/strategic
direction Who will be
✔ Be measurable
responsible?
✔ Take into account applicable requirements
✔ Be relevant to conformity of products and services
and to enhancement of customer satisfaction When it will be
✔ Be monitored completed?
✔ Be communicated
✔ Be updated as appropriate How results will be
evaluated
CLAUSE 6: PLANNING

What are the objectives of our team? Is it


aligned to the quality policy of Megaworld?

What are the risks and opportunities


associated to my business process?

Do we conduct planning in connection to


our business processes?
CLAUSE 7:
SUPPORT
SUPPORT
Resources
re

Documented
re
information Competence
re

Communication
re
Awareness
re
RESOURCES
1. People
2. Infrastracture
3. Environment for the
operation processes
4. Monitoring & measuring
resources
5. Measurement traceability
6. Organizational knowledge
COMPETENCE
Determine competency for those who "affect the
performance and effectiveness of the QMS"
Education, training, experience
Actions to achieve competence can include:
- Provision of training
- Mentoring
- Re-assignment of currently employed
persons
- Hiring or contracting of competent persons
Evaluate effectiveness of action
AWARENESS
Implications of not Contribution to the
effectveness of the QMS,
conforming to benefits of improved
QMS performance

Quality Relevant quality


Policy objectives
DOCUMENTED
INFORMATION
I. Creating & Updating

a.) Identification and description (e.g. title,


date, author, reference number)

b.) format (e.g. language, software version,


graphics) & media (paper, electronic)

c.) review and approval for suitability and


adequacy
DOCUMENTED
INFORMATION

II. Control

a.) available and suitable for use

b.) adequately protected


REQUIRED DOCUMENT INFORMATION
Quality Policy Traceablity
Quality Objectives Actions taken on nonconforming
Evidence of competence process outputs, products, and
Conformance of products and services
services Results of monitoring and
Design and development process measurement activities
Design and development changes Audit program and audit results
Evaluation results Results of management review
Performance monitoring Nonconformities, actions taken,
Re-evaluation of external providers and results
CLAUSE 7: SUPPORT

Did we identify the support needed to carry


out the operations of the org.?

Do we attend trainings? Do we let our


people attend trainings?

Evidence that monitoring and measurement


resources are fit for purpose?
CLAUSE 8:
OPERATION
OPERATION
INTERESTED
PARTIES/NEEDS
EXPECTATIONS

DO
CUSTOMER RESOURCES
REQUIREMENTS NEEDED
OPERATION

PLAN IMPLEMENT

CONTROL APPLY
Mitigation Action
CUSTOMER
COMMUNICATION
✔ Provide information on the product/
service
✔ Handle inquiries, contract/orders,
changes
✔ Obtain customer feedback on the
product/service
Customer complaints
✔ Handle/control customer property
Identify, verify, protect
Ex: materials, tools, intellectual
property, personal data
Establish a process
DETERMINE
Statutory/Regulatory
REQUIREMENTS Meet the claims/requirements

Check requirements
REVIEW
RETAIN DOCUMENTED
REQUIREMENTS INFORMATION

Amend documented
CHANGES TO information
REQUIREMENTS Inform relevant persons
of the changes
DESIGN AND DEVELOPMENT OF
PRODUCTS AND SERVICES
CONSIDERATIONS (PLANNING)
✔ Activities and controls (interfaces)
✔ Process stages - reviews
✔ Verification and validation activities
✔Responsible and authorized personnel
✔ Internal and external resources
✔ Involvement of customers and users/relevant interested parties
✔ Retain documented information to demonstrate that
requirements have been met
DESIGN AND DEVELOPMENT

INPUTS CONTROLS
✔ Standards or codes ✔ Define results to be achieved
✔ Potential consequences of failure ✔ Verification and validation activities
due to the nature of products and ✔ Necessary actions taken to address
services problems determined
✔ Retain documented ✔ Retaind documented information
information on inputs on these activities
DESIGN AND DEVELOPMENT

OUTPUTS CHANGES
✔ Meet input requirements ✔ Identified, reviewed and
✔ Ensure that the produts/ controlled
services are fit for their ✔ Retain documented
intended purpose information
✔ Retain documented
information
DESIGN AND DEVELOPMENT

RESULTS OF
CHANGES
REVIEWS
DOCUMENTED

ACTIONS
AUTHORIZATION
TAKEN
CONTROL OF EXTERNALLY PROVIDED
PROCESS, PRODUCTS AND SERVICES

EVALUATION

SELECTION

MONITORING OF
PERFORMANCE

RE-EVALUATION

EFFECTIVENESS
OF CONTROLS
CLAUSE 8: OPERATION

Do we have controls over externally provided


processes, products and services?

Are changes on products and services


reviewed, approved and with appropriate
actions taken?

How do we protect customer property?


CLAUSE 9:
PERFORMANCE
EVALUATION
CLAUSE
PERFORMANCE EVALUATION
9

MONITORING, MEASUREMENT,
ANALYSIS & EVALUATION
Determine what and when to
Evaluate the results
Retain evidence
PERFORMANCE
EVALUATION
Determine Determine
WHAT: WHEN:

to monitor and monitoring & measurements


measure is performed
methods to use results are analyzed and
evaluated
EVALUATE THE RESULTS
✔ Products and services conforms to requirements
✔ Customers' requirements are met
✔ QMS is effective in delivering the intended
results
✔ Planning has been implemented effectively
✔ Actions taken are effective in addressing risks
and opportunities
✔ External providers meets organization's
requirements
✔ Improvements are still needed in the QMS
MONITOR CUSTOMERS'
PERCEPTION
✔ Provide information on the product/
service
✔ Handle inquiries, contract/orders,
changes
✔ Obtain customer feedback on the
product/service
Customer complaints
✔ Handle/control customer property
Identify, verify, protect
Ex: materials, tools, intellectual property,
personal data
CONDUCT INTERNAL
AUDIT

To provide info whether QMS:


conforms to requirements of
the company
conforms to ISO standard
effectively implemented and
maintained
CONDUCT MANAGEMENT
REVIEW

To ensure QMS:
Continuing suitability
Adequacy
Effectiveness
Alignment with strategic
objectives
DOCUMENTED
INFORMATION

DOCUMENTED INFORMATION:
1. Results of monitoring & measurement
activities
2. Evidence of implementation of the
audit program and audit results
CLAUSE 9: PERFORMANCE
EVALUATION
What needs to be monitored and measured in
your department?

What methods are needed for monitoring,


measurement, analysis and evaluation to ensure
valid results?

When do monitoring and measurement shall be


performed?

When the results from monitoring and


measurement shall be analyzed and evaluated?
CLAUSE 10:
IMPROVEMENT
HOW DO WE IMPROVE?

a. Improving products
and services;

b. Correcting, preventing
or reducing undesired
effects

c. Improving the
performance and
effectiveness of the QMS
Corrective Action Innovation

EXAMPLES
OF
Continual
IMPROVEMENT
Improvement Re Organization

Correction
Occurrence of Nonconformity

React (control, correct or


deal)
Evaluate the cause
Corrective Action
Review effectiveness of
action taken
Update risks and
opportunities, if necessary
Make changes to QMS, if any
DOCUMENTED
INFORMATION

I. Nature of NC

2. Actions taken

3. Results of CA
Organization shall continually improve the
suitability, adequacy and effectiveness of
QMS.

WHAT FOR?

✔ To meet customer requirements

✔To enhance customer satisfaction


THANK
YOU

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