AN ORIENTATION INTO THE UPCOMING REVISION€¦ · AN ORIENTATION INTO THE UPCOMING REVISION 1...
Transcript of AN ORIENTATION INTO THE UPCOMING REVISION€¦ · AN ORIENTATION INTO THE UPCOMING REVISION 1...
ISO 9001:2015AN ORIENTATION INTO THE UPCOMING REVISION
1
Presented on January 14, 2015 by Dan Brown
President, DB Performance Solutions, LLC
Chicago Section, 1201, American Society for Quality
Key Objectives for ISO
9001:2015Extracts from ISO 9001:2015 "Design Specification":
Provide stable core set of requirements for
next 10 years or so
Maintain current focus on effective process
management to produce desired outcomes
Take account of changes in QMS practices
and technology since the last major revision
(in 2000)
Implement Annex SL
2
Key Changes
Reformatted to align with "Annex SL"
“Products and services" instead of
"product"
More emphasis on addressing "risks &
opportunities"
“Documented information” in place of
documents and records
3
Continued
Elimination of the term "preventive
action"
the concept still remains, and is actually
reinforced throughout the standard (by
addressing "risk")
"External provision of goods and
services" instead of "purchasing" —
includes outsourced processes
4
Harmonization Via “Annex SL”
New “Common Core” for all ISO
Management System Standards
10 Elements with identical sub-clause
titles
Common Vocabulary
Ease in managing multiple certifications
9001, 14001, AS9100, 18001, 26000, etc
5
Elements of Annex SL & 9001 6
Section 1 Scope
Section 2 Normative References
Section 3 Terms & Definitions
Section 4 Context of the Organization
Section 5 Leadership
Section 6 Planning for the QMS
Section 7 Support
Section 8 Operation
Section 9 Performance Evaluation
Section 10 Improvement
Annex A Clarification of Structure
Annex B Quality Management Principles
Annex C Portfolio of QM Standards (ISO 10000)
Quality Principles: 7
2008 2015Customer Focus Customer Focus
Leadership Leadership
Involvement of People Engagement & Competence
Process Approach Process Approach
Systems Approach Improvement
Continual Improvement Informed Decision Making
Factual Decision Making Relationship Management
Mutual Supplier Relations
Core Concepts Identify Key Processes
Those processes needed to achieve planned results
How do they relate to each other?
Continually Monitor those Processes
Cause & Effect
What is key metric for process?
Risks Associated, including from sub-standard
performance
Manage those Processes
Plan – Do – Check – Act
Show actions taken when targets not met
8
2000/2008 ISO MODEL
CU
ST
OM
ER
Re
qu
irem
en
ts
CU
ST
OM
ER
Sa
tisfa
ctio
n
CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM
Management Responsibility
Resource Management
Measurement, Analysis,
Improvement
Product
Inputs
Outputs
ProductRealization
Plan
Do
Check
Act
9
THE 2015 PROCESS MODEL
CU
ST
OM
ER
S &
OT
HE
RR
ELE
VA
NT
INT
ER
ES
TE
D P
AR
TIE
S
Requirements
CU
ST
OM
ER
S
AT
ISFA
CT
ION
CONTINUAL IMPROVEMENT
General Process Approach
PlanningPerformance Evaluation
Products & Services
Inputs
Outputs
Operations
Plan
Do
Check
Act
10
Leadership
EST SCOPE
OF QMS
Process Turtle Diagram
11
With What? (Materials & Equipment)
Inputs
Measurements How? (Procedures & Techniques)
Competencies,
Skills, Training
OutputsPROCESS
NOW
WITH
ADDED
RISK!
Process Interaction Sample 12
Process 7
Process 4
Process 8
Process 5
Process 2Process 1
Process 3
Process 6
Defined Management
System
No Mgmt Rep Requirement, but defined roles
& responsibilities
No quality manual, but a defined quality
system:
identification of interested parties
Scope of system
Identification and justification of non-application
Processes, interactions, metrics, risks
13
No Required Procedures
Records Required:
Operation of Processes (4.4)
Quality Objectives (6.2.1)
Monitoring & Measuring
Resources (7.1.6)
Competency Evaluation (7.2)
Ops Planning & Control (8.1)
Requirements Review (8.2.3)
Design & Development (8.3.5)
Design & Devel Changes (8.3.6)
Externally Provided Products &
Services (8.4.1)
Traceability (8.5.2)
Control of Changes (8.5.6)
Release of Products /Services (8.6)
Control of NC Products, Services,
or Process Outputs (8.7)
Monitoring, Measurement,
Analysis, and Evaluation (9.1.1)
Internal Audits (9.2)
Management Review (9.3)
NC and Corrective Action (10.2)
14
Primary External
• Customers
• Suppliers
• Debt Holders inc:ShareholdersBanksFinancial Institutions
• Regulators
Secondary External
• Public inc:Local Community
• Interest Groups inc: Employee Families
• Media
• Marketplace inc:CompetitorsPotential Customers
Internal
• Board of Directors
• Management Team (Top & Middle)
• Employees
• Unions (inc: Union Management)
Interested Parties – Examples
Additional Considerations
“Post Delivery” continues through to what
happens to the product after useable life
Don’t Rush to determine design as non-
applicable
SWOT can be an effective Risk Management
Tool
Six Sigma, Lean, Etc can dovetail more readily
into your QMS
Analysis is not enough, evaluation also
required
16
17
Learn More
1- Day Workshop by the Training Institute:
Title: ISO 9001-2015 Revisions and Changes
Location: Triton College
Date: February, 7, 2015
18
ISO 9001:2015
SOME KEY CHANGES BY CLAUSE
19
4.1 Organizational Context
The organization shall determine
external and internal issues that
are relevant to its purpose and
that affect its ability to achieve
the intended results of its quality
management system.
20
4.2 Needs of Interested
Parties
The organization shall determine
the interested parties that are
relevant to the quality
management system and their
related requirements.
21
5.1 Leadership - General
Persons in top management and other relevant management roles throughout the organization shall demonstrate leadership with respect to the quality management system.
NOTE This can be shown, for example, bymotivating and empowering persons to contribute to the effectiveness of the quality management system."
22
5.2 Management
Commitment…
providing the resources to establish, implement, maintain and continually improve the quality management system
communicating the importance of effective quality management and conforming to the quality management system requirements;
ensuring that the quality management system achieves its intended outcomes
directing and supporting continual improvement"
23
6.1 Actions to Address Risks &
Opportunities
"The organization shall consider the issues referred
to in 4.1 and the requirements referred to in 4.2
and determine the risks and opportunities that
need to be addressed to
• assure the management system can achieve its
intended outcome(s)
• prevent undesired effects
24
7.1 Resources
Outsourcing as a resource
Change management for new or
additional resources
Infrastructure includes supporting services
Knowledge resources
25
8.1 Operational Planning &
Control….
The organization shall control planned changes
and review the consequences of unintended
changes, taking action to mitigate any adverse
effects, as necessary The organization shall
ensure that outsourced processes are controlled."
26
9.1 Monitoring, Measurement
Analysis and Evaluation….
The organization shall evaluate the performance and the effectiveness of the quality management system.
Additionally, the organization shall:
take action when necessary to address adverse trends or results before a nonconformity occurs.
retain relevant documented information as evidence of the results."
27
10.1 Improvement
10.1 Nonconformity and corrective action
"When a nonconformity occurs, the organization shall:
a) react to the nonconformity, and as applicable
take action to control and correct it, and deal with the consequences;
b) evaluate the need for action to eliminate the causes of the nonconformity, in order that it does not recur or occur elsewhere, by
28
Credits/References
International Organization for Standardization (ISO), Geneva, Switzerland
ISO/DIS 9001:2014(E) 2014-07-10
Technical Advisory Group (TAG) 176 to ISO
American Society For Quality (ASQ)
American National Accreditation Board (ANAB)
Exemplar Global, Transition Course
DNV, Nigel Croft
Presentation, October 31, 2013
29
Contact Information
Daniel J. Brown
President, DB Performance Solutions, LLC
(312) 615-3530
www.dbpsllc.us
30