ISO 9001.2015 Presentation To Process Owners
ISO 9001.2015 Presentation To Process Owners
System Requirements
ISO 9001:2015
DOCUMENTED INFORMATION
BACKGROUND
International Organization
for Standardization
HISTORY
FOUNDERS OF ISO
HISTORY
POPULAR MANAGEMENT
SYSTEM STANDARDS
NUMBER TITLE
organizations to be more
satisfaction.
ISO 9001 : QUALITY MANAGEMENT SYSTEMS
1994 2008
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
effect of uncertainty
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 5: Leadership
CLAUSE 6: Planning
CLAUSE 7: Support
CLAUSE 8: Operation
Customer Satisfaction
Interested Parties & Quality Products &
Requirements Services
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
Leading Influencing
People people
Commanding Guiding
People People
ACCOUNTABLE
CLAUSE 5: Leadership
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 demonstrate a commitment to
achieve the quality policy?
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
II. Control
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
MONITORING, MEASUREMENT,
ANALYSIS & EVALUATION
Determine what and when to
Evaluate the results
Retain evidence
PERFORMANCE
EVALUATION
Determine Determine
WHAT: WHEN:
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?
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
I. Nature of NC
2. Actions taken
3. Results of CA
Organization shall continually improve the
suitability, adequacy and effectiveness of
QMS.
WHAT FOR?