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Quality only way to survive in ever changing & turbulent Competitive Market

Integrated Management System


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Using an Integrated Management System


To
Implement ISO 9001:2015
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Webinar
Date 08 May 2016
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www.facebook/generationnext.in

9810052083

2016. Workshop Designed & Conducted by: Gobburu Venkata

@gobburu

https://ae.linkedin.com/in/subarao1

Quality only way to survive in ever changing & turbulent Competitive Market

Gobburu VS Rao comes with 30 years he has worked in automotive, aerospace, food, medical
devices, semiconductor, high technology, and various manufacturing and service industries
implementing management systems, performance-based systems, quality operating systems,
and top management training.
GVS RAO, conducted webaniarin ISO 9001, 14001,18001, 22000, 27000 +
including
Implementing Integrated Management Systems: QMS, EMS, OHSMS, FSMS Including Aerospace,
Service, Semiconductor/Electronics, Automotive and Food and Workshop s How to Audit ISO
9001:2015.
GVS Rao also working on a book on Leadership for ISO 9001:2015
A webinar "Implementing ISO 9001:2015 using Integrated Management Systems and
Enterprise Wide Quality Software" for all those who are keen, on 03 May 2016 at 2 p.m.
Eastern/11 a.m. Pacific. This is the 4 th of a series of articles on the ISO 9001 revision,
enterprise quality, and enterprise integrated management systems.

2016. Workshop Designed & Conducted by: Gobburu Venkata

Quality only way to survive in ever changing & turbulent Competitive Market

ISO 9001:2015 released in July 2015, and the revised standard is slated for publication in
September. Per Annex SL of the Consolidated ISO Supplement, some elements of the standard
have been restructured to allow for easier integration of multiple management systems.

This restructuring follows a high level structure (HLS) required for all ISO management system
standards and will result in the same subclause names, common texts, and terms and definitions
for all the ISO management system standards. This is one of the major changes that will act as a
catalyst for integration between standards or what we call integrated management systems.
Generally speaking, integrated management systems refers to integrated processes that result in
one management system to implement ISO 9001, ISO 14001, OHSAS 18001 (the new ISO number
will be ISO 45001) or food safety standards such as FSSC 22000.

Key changes: ISOs high-level structure


The HLS shown below is the one adopted by ISO. This structure is common between ISO 9001,
ISO 14001, ISO 45001 (the new OHSAS 18001 standard), and FSSC 22000. In other words, each of
the standards requires an organization to understand the context of the organization,
leadership, planning, and so forth. It wont be difficult for implementers to understand that
common requirements can be satisfied by the same process, i.e., one process could identify the
context of the organization, and this context would apply to quality, environmental, health and
safety, or food safety.
1. Scope
2. Normative References
3. Terms and Definitions
4. Context of the Organization
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance Evaluation
10. Improvement
Figure 1: High-level structure (HSL), from Annex SL, Appendix 2 of ISO/IEC Directives, Part 1
Consolidated ISO SupplementProcedures specific to ISO (Sixth Edition, 2015)

Proliferation of standards and the cost of maintaining them


Organizations in many sectors face a proliferation of standards. Not only are there management
standards for quality, environmental, occupational health and safety, and food safety, but also
other standards such as ISO 17025 for laboratory quality management systems or ISO 26262 for
functional safety in automotive organizations. Typically these standards are implemented as
stand-alone management systems with their own manuals, procedures, work instructions,

2016. Workshop Designed & Conducted by: Gobburu Venkata

Quality only way to survive in ever changing & turbulent Competitive Market

forms, and checklists as well as their own process owners. The cost of implementing and
maintaining these standards is becoming cost-prohibitive.
For example, a food organization that Omnex works with has different specialists focusing on
food safety, quality, environment, and health and safety. Consolidating these stand-alone
standards into a single management system that satisfies all the requirements of the four
standards will result in reduced documentation and processes to manage, which in turn saves
costs in implementation and maintenance. (See figure 2 below.)

Figure 2: The HLS, proliferation of standards, and the costs of maintaining stand-alone standards
will create an increasing need for integrated management systems.

Integrated management systems


Integrated management systems (IMS) conform to the requirements of quality management
systems (QMS), environmental management systems (EMS), occupational health and safety
management systems (OHSMS), and food safety management systems (FSMS). The book
Integrated Management Systems (ASQ Quality Press, 2015) defines an integrated management
system as having integrated processes, risk, and audits:

2016. Workshop Designed & Conducted by: Gobburu Venkata

Quality only way to survive in ever changing & turbulent Competitive Market

Integrated processes are defined as management systems processes that are integrated to a
large degree, i.e., greater than 70 percent, and have a common process owner between the
QMS, EMS, OHSMS, and FSMS.
Integrated management systems have integrated risks (i.e., a common risk methodology)
between quality, environmental, health and safety, and food safety and have comparable
severity and occurrence risk ratings between the categories. Optimally, one team conducts the
risk analysis for the three different categories.
An integrated audit uses one common audit process and audit program for quality,
environmental, health and safety, or food safety management systems in one site. The audit
process uses an integrated audit checklist and an audit team capable of auditing the integrated
system.
Integration and standardization
Stand-alone systems duplicate training processes, document control, and internal audit
processes for each standard within the company. Therefore, theres a tremendous loss of value
associated with stand-alone management systems within an organization as discussed above.
Worse yet, many organizations continue this duplication of effort among their different sites
including plants, design centers, and sales offices. If there is a lack of efficiency and confusion
caused by the duplication in one site, one can imagine the magnification of these same problems
when they are repeated multiple times in a large organization. The article Juggling Multiple
Standards, which appeared in Quality Digest in 2005, provided a case study of a large European
organization and included examples of duplication of management reviews and risk
assessments. This same organization had processes such as document control that were
repeated no less than 30 to 50 times in their large sites, called campuses, in Silicon Valley or in
France.
Here are some of the costs and benefits of integrated management systems, which are based on
the cost of implementing three management system standards, $200,000; maintenance costs,
$90,000 per year; and third-party auditing costs, $45,000 for three years:
Savings from implementation (one-time cost): $200,000 x .50 = $100,000
Savings from maintenance: $90,000 x .66 = $60,000 per year for each site (NPV at 10% would
be $600,000)
Savings from third-party audit costs: $3,000 each year (NPV is $30,000)
Total savings: $100,000 + $600,000 + $30,000 = $730,000
Implementation savings: 50 percent, and maintenance savings: 66 percent
Third-party savings: 20 percent
Reducing process duplication within one organization is referred to as integration, and
reducing duplication between sites is referred to as standardization. Although there is much
discussion about integration, there is not much regarding standardization.

2016. Workshop Designed & Conducted by: Gobburu Venkata

Quality only way to survive in ever changing & turbulent Competitive Market

Integration and standardization refers to common integrated processes, such as integrated risk
processes and integrated audits, across the enterprise. The importance of software in
implementing enterprisewide integration and standardization cant be overstated.
In 2002 Kymal - CTO and founder of Omnex Inc: published a number of papers emphasizing the
need and advent of a class of software called enterprisewide quality management system
(EwQMS). At that time, we at Omnex defined an EwQMS as one that would satisfy all the
requirements of ISO 9001:2000 and that optimally including advanced product quality planning
(APQP), failure mode and effects analysis (FMEA), and production parts approval program
(PPAP), a risk-based defect prevention tool used in many sectors. The awareness of enterprise
quality has finally arrived in 2015; however, the market need has gone up a notch to enterprise
integrated management systems (EIMS).
EIMS software can satisfy the requirements of ISO 9001:2015, ISO 14001:2015, and ISO
45001:2016. In fact, the software must satisfy and conform to the high level structure of all ISO
standards in order to meet the core requirements of them all. EIMS software must also satisfy
APQP, FMEA, and PPAP, or risk-based phase-gate new product launch processes including
design, process, and project risk. Additionally, EIMS should be able to assess risks in the process
map, EMS, OHSMS, or social responsibility risk (i.e., any risk from any standard).
EIMS have at a minimum these characteristics:
1. Enterprisewide web-based system or equivalent
2. Manage multiple sites
3. Support multiple languages and multiple date conventions
4. Integrate with email notification, reminders, and escalation services
5. Integrate with legacy and ERP systems
6. One-point user authentication
7. Role-based security
8. Fully integrated solutions; lean data entry
9. Include enterprise-integrated processes
10. Include minimum functionality of ISO 9001, ISO 14001, OHSAS 18001/ISO 45001, and FSSC
22000
11. Be able to add one site or management system and then scale up
In summary, the advent of the HLS, increased proliferation of standards, and the increased costs
of implementing and maintaining standards require integration and standardization of
management systems in an organization. Integration is defined as integrated processes, risk, and
audits. Organizations need EIMS software to integrate and standardize processes, risk, and
audits.

2016. Workshop Designed & Conducted by: Gobburu Venkata

Quality only way to survive in ever changing & turbulent Competitive Market

EIMS software must satisfy and conform to the high level structure of ISO standards that satisfies
all their core requirements. It must be able to satisfy APQP, FMEA, and PPAP or risk-based phasegate new product launch processes including design, process, and project risk. Additionally, it
should be able to assess the risks of processes in the process map, EMS, OHSMS, or social
responsibility risk.

2016. Workshop Designed & Conducted by: Gobburu Venkata