This webinar will focus on the significant changes between the previous and 2015 revisions of both ISO9001 and ISO14001 and review/clarify the transition process.
4. Previous Webinars
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
4
… IS Webinar on July 29, 2015 .
11. ISO 9000:2015 – Terms & Definitions
3.4.1 – PROCESS
Set of interrelated or
interacting activities
which transforms inputs
into outputs.
11
12. Section 4 - Context Of The Organization
12
4.1 Understanding the Organization
and Its Context
4.2 Understanding The Needs And
Expectations Of Interested Parties
4.3 Determining The Scope of The
Quality Management System
4.4 Quality Management System And Its
Processes
16. 4.4 - QMS and its Processes
16
The organization shall identify the processes and
shall determine:
The inputs
required and the
outputs expected
The sequence and
interaction of
these processes
The criteria,
methods, including
performance
indicators
The resources
needed
The assign of the
responsibilities
and authorities
The risks and
opportunities
17. 4.4 – STAMPING Process
OBJECTIVE ACTUAL GOAL ACTION
PPM 25 50 Continue to Monitor
Machine Up Time 82 % 95% Increase PM, have
spare parts
available, staffing
Parts Per Hour 235 215 Continue to Monitor
Cost of Rework $496 <$500 per month Continue to
Monitor/consider
risk
Quality Objectives For The Stamping Process
18. 4.4 – STAMPING Process Map
Quality Objectives For Support Process
Sales
• Revenue/Employee
• % Won
HR
• # of hires
• # of training hours
Cal
• # overdue
• # out of tolerance
Maint
• % On Time, MTTF
• Repair Time, Uptime
20. RISK
Effect of
uncertainty on
an expected
result.
The effect can
be positive or
negative
consequence
- Risk is
characterized
by potential
events and
consequences.
20
21. Section 6 – Planning for QMS
21
a) Incorporated in requirements for the
establishment, implementation, maintenance and
continual improvement of the QMS.
b) May Use ISO31000 - but not required.
c) Not all processes represent the same level of risk.
d) Considering Risk “qualitatively” to define the QMS,
processes and activities.
Risk is the effect of uncertainty on an
expected result.
22. 6.1 – Actions – Risks & Opportunities
22
Addressing Risks/Opportunities
Determine Risks
and Opportunities
per sections 4.1
and 4.2
Actions to Address
Risks
Establish Quality
Objectives
Manage QMS
Change
32. Life cycle
3.3.3
life cycle
consecutive and interlinked stages of a product (or service) system, from raw
material acquisition or generation from natural resources to final disposal.
Note 1 to entry: The life cycle stages include acquisition of raw materials,
design, production, transportation/ delivery, use, end-of-life treatment and final
disposal.
16.05.2017 32
42. 42
Actions to address risks and opportunities
4.1 external
and internal
issues
4.2 interested
parties
6.1.3 Compliance
obligations
6.1.2
Environmental
aspects
4.3 scope of the
environmental
management
system
determine risks and
opportunities
Risks and Opportunities
66. 66
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
67. 67
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 2-3 months prior to
Stage 2.
Develop the Stage 2/Upgrade Assessment agenda
Review of QF-0900-9 / confirmation of Stage 2 Assessment days