Weitere ähnliche Inhalte Ähnlich wie ISO 9001:2015 Revision Overview: part 3 (20) Kürzlich hochgeladen (20) ISO 9001:2015 Revision Overview: part 33. DQS-ULManagementSystemsSolutions©
Today’s Presentation ISO9001:2015
1. Scope
2. Normative reference
3. Terms and definitions
4. Context of the organization
5. Leadership March 25, 2015
6. Planning
7. Support April 29, 2015
8. Operation
9. Performance evaluation May 26, 2015
10. Improvement
ISO 9001: Annex A-C – Clarifications, Quality Management Principles, QMS family of standards.
3
… Final Webinar on July 29, 2015 .
6. DQS-ULManagementSystemsSolutions©
Questions From The Last Webinar
6
Q38: In 7.1.5, it is noted to do
assessment if an equipment is found
to be “defective”. Would this
include out of tolerance conditions
as well.
Defective is defined in
3.40 as “a nonconformity
related to an intended or
specified use”.
11. DQS-ULManagementSystemsSolutions©
Sections 8 – Operation
11
8.1 –
Operational
Planning
8.2
Determination
of
requirements
8.3 Design
and
Development
8.4 Control of
External
Sources
8.5 Production/
Service
Provision
8.6 Release of
Products
8.7 Control of
Nonconformity
12. DQS-ULManagementSystemsSolutions©
Sections 8 – Operation
12
a) Determining Requirements
b) Establishing Criteria
c) Determining Resources
d) Implementing Controls
e) Retaining documented Information
8.1 - OPERATIONAL PLANNING AND CONTROL
13. DQS-ULManagementSystemsSolutions©
Sections 8 – Operation
13
8.2.1 – Customer Communication
8.2.2 – Requirements for Products/Services
8.2.3 – Review of Requirements
8.2 – DETERMINATION OF REQUIREMENTS FOR
PRODUCTS AND SERVICES
18. DQS-ULManagementSystemsSolutions©
Sections 8 – Operation
18
• 8.7 - Control of Nonconforming outputs, products
and services
• - Correction
• - Segregation, Containment, Return or Suspension
• - Informing the Customer
• - Obtaining Authorization For Release
20. DQS-ULManagementSystemsSolutions©
Section 9 – Performance Evaluation
20
9.1.3 – Analysis and Evaluation
Demonstrate Conformity, Enhance Customer Satisfaction…
9.1.2 – Customer Satisfaction
Monitor Customer Perception
9.1.1- General
What, Methods, When and How
9 – Performance Evaluation
23. DQS-ULManagementSystemsSolutions©
9.2 – Internal Audits
23
a- Plan, Establish, Maintain with defined
Frequency, method, responsibilities, reporting
b- Define the criteria and scope
c- Use of Independent Auditors
d- Reporting of Results to Management
e- Taking Actions Without Undue Delay
f- Maintain and Retain Documented
Information
26. DQS-ULManagementSystemsSolutions©
9.2 – Internal Audits
26
Process When Shift 4.1 4.2 4.3 4.4 5.1 5.2 5.3 6.1 6.2 6.3
Sales 9-4-15 1
Engineering W 45 1,2
Planning Jan. 1
Production
1
Q1 1,2,3
Production
2
Q2,
Q3
1,2,3
Pack and
Ship
Q4 1
HR Dec. 2
27. DQS-ULManagementSystemsSolutions©
9.2 – Internal Audits
27
Process When Shift 4.1 4.2 4.3 4.4 5.1 5.2 5.3 6.1 6.2 6.3
Sales 9-4-15 1
Engineering W 45 1,2
Planning Jan. 1
Production
1
Q1 1,2,3
Production
2
Q2,
Q3
1,2,3
Pack and
Ship
Q4 1
HR Dec. 2
Primary Secondary
28. DQS-ULManagementSystemsSolutions©
9.2 – Internal Audits
28
Process-oriented auditing with focus on results and
effectiveness (4.4)
Responsibilities,
Authorities, Ownership
Risks, Opportunities,
Undesired Effects
Activities, Methods Of
Operation, Documented
Information, People
Involved.
Results,
Measurements,
Records, Performance
Indicators, Control
DesiredOutput
ImprovementOpportunities
Input
Resources
Interaction with other processes,
external providers
29. DQS-ULManagementSystemsSolutions©
9.2 – Internal Audits
29
Process-oriented auditing with focus on results and
effectiveness (4.4)
Responsibilities,
Authorities, Ownership
Risks, Opportunities,
Undesired Effects
Activities, Methods Of
Operation, Documented
Information, People
Involved.
Results,
Measurements,
Records, Performance
Indicators, Control
DesiredOutput
ImprovementOpportunities
Input
Resources
(e)
(f)
(c)
(c)
(a1)
(d)
(a2)
(c,h)
Interaction with other processes,
external providers
(b)
8.4
30. DQS-ULManagementSystemsSolutions©
9.2 – Internal Audits
30
Process-oriented auditing with focus on results and
effectiveness (4.4)
Responsibilities,
Authorities, Ownership
Risks, Opportunities,
Undesired Effects
Activities, Methods Of
Operation, Documented
Information, People
Involved.
Results,
Measurements,
Records, Performance
Indicators, Control
DesiredOutput
ImprovementOpportunities
Input
Resources
(e)
(f)
(c)
(c)
(a1)
(d)
(a2)
(c,h)
Interaction with other processes,
external providers
(b)
8.4
1
2
3
4
5
6
7
33. DQS-ULManagementSystemsSolutions©
4.4 - QMS and its Processes
33
Risks and
Opportunities
W.O.
Sheet
Metal
Parts Per Million
Machine Up Time
Parts Per Hour
Cost of Quality - rework
Documented
Information
Press, Dies,
Inspection Tools Set-Up Lead,
Operator,
Supervisor
Finished
Products
34. DQS-ULManagementSystemsSolutions©
4.4 - QMS and its Processes
34
Risks and
Opportunities
W.O.
Sheet
Metal
Parts Per Million
Machine Up Time
Parts Per Hour
Cost of Quality - rework
Documented
Information
Press, Dies,
Inspection Tools Set-Up Lead,
Operator,
Supervisor
Inspectors
Finished
Products
5
2
3
4
1
6
7
5
Interactions with
other processes
35. DQS-ULManagementSystemsSolutions©
4.4 - QMS and its Processes
35
Risks and
Opportunities
W.O.
Sheet
Metal
Parts Per Million
Machine Up Time
Parts Per Hour
Cost of Quality - rework
Documented
Information
Press, Dies,
Inspection Tools Set-Up Lead,
Operator,
Supervisor
Inspectors
Finished
Products
5.2, 6.1,
6.2, 7.5,
8.5, 8.7,
9.1
5
2
3
4
1
6
7
5
Interactions with
other processes
39. DQS-ULManagementSystemsSolutions©
Section 9.3 – Management Review
39
Reviews at Planned Intervals
Ensue its continuing suitability,
adequacy and effectiveness
a) Status of actions from previous
reviews
b) Changes / Strategic Direction
ManagementReview
Inputs
40. DQS-ULManagementSystemsSolutions©
Section 9.3 – Management Review
40
c) Information on Quality
Performance
• Nonconformities and
CARs
• Monitoring and
Measurement Results
• Audit Results
• Customer Satisfaction
• Issues with Relevant
Parties /External
Providers
• Adequacy of resources
• Process Performance
• Conformity of Products
Management
Review
Inputs
41. DQS-ULManagementSystemsSolutions©
Section 9.3 – Management Review
41
a) Continual
Improvement
Opportunities
b) Any change needed
for QMS, including
resources
Retain document
information as evidence
of results of
management review.
Management
Review
Outputs
45. DQS-ULManagementSystemsSolutions©
Section 10 – Improvement
45
NCMR,
CAR
React
Take Action,
Control,
Correct Deal with it
Evaluate
Action for
Cause
Review the
NCMR
Determine
Cause
Impact on
others
Implement
Action
Needed
Review for
effectiveness
Make
changes
10.2.2 – retain
documented information
as evidence of nature of
NC and result of
Corrective Action taken.
47. DQS-ULManagementSystemsSolutions©
Today’s Presentation ISO9001:2015
1. Scope
2. Normative reference
3. Terms and definitions
4. Context of the organization
5. Leadership March 25, 2015
6. Planning
7. Support April 29, 2015
8. Operation
9. Performance evaluation May 26, 2015
10. Improvement
ISO 9001: Annex A-C – Clarifications, Quality Management Principles, QMS family of standards.
47
… Final Webinar on July 29, 2015 .
50. DQS-ULManagementSystemsSolutions©
50
as part of its
scheduled
Recertification
Audit;
- in a planned manner
through the Continuous
Assessment process
with additional audit
time, or
- through a Special
Transition Audit.
Transition Plan
An organization
may be
upgraded:
51. DQS-ULManagementSystemsSolutions©
51
2008 to 2015 Transition
Identification of Interested Parties and their
requirements.
Identification of Gaps and actions needed
Identification of Risks and Opportunities
Identification of Processes
Context of the Organization and
Leadership Requirements
52. DQS-ULManagementSystemsSolutions©
52
2008 to 2015 Transition
Review of one round of process-based
Internal Audits to ISO9001:2015
At least one management review after
the completion of the audits.
Ensure Understanding of the
Requirements
Deployment of Process-based
Management System
Stage 1 to be done about eight weeks
prior to Stage 2.