Workshop Integrated Management Systems ISO 9001 14001 18001 22000 and 27000

8/16/2019 Workshop Integrated Management Systems ISO 9001 14001 18001 22000 and 27000

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

© 2016. Workshop Designed & Conducted by: Gobburu Venkata 1

Integrated Management System-------------------------------------------------------------------------------------------------------------------

Using an Integrated Management System

To

Implement ISO 9001:2015-------------------------------------------------------------------------------------------------------------------

Webinar

Date 08 May 2016

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www.facebook/generationnext.in 9810052083 @gobburu https://ae.linkedin.com/in/subarao1


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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.

.

https://qualitydigest.webex.com/qualitydigest/onstage/g.php?MTID=e1ab25855d21f43ee41fb8ebe218b61aahttps://qualitydigest.webex.com/qualitydigest/onstage/g.php?MTID=e1ab25855d21f43ee41fb8ebe218b61aahttps://qualitydigest.webex.com/qualitydigest/onstage/g.php?MTID=e1ab25855d21f43ee41fb8ebe218b61aahttps://qualitydigest.webex.com/qualitydigest/onstage/g.php?MTID=e1ab25855d21f43ee41fb8ebe218b61aahttps://qualitydigest.webex.com/qualitydigest/onstage/g.php?MTID=e1ab25855d21f43ee41fb8ebe218b61aa


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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 systemstandards 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: ISO’s 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 won’t 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 Definitions4. 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 Supplement—Procedures 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,


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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 fourstandards 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:


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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 comparableseverity 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, there’s 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 riskassessments. 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.

http://www.qualitydigest.com/june05/articles/04_article.shtmlhttp://www.qualitydigest.com/june05/articles/04_article.shtmlhttp://www.qualitydigest.com/june05/articles/04_article.shtmlhttp://www.qualitydigest.com/june05/articles/04_article.shtmlhttp://www.qualitydigest.com/june05/articles/04_article.shtml


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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 can’t 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 satisfyAPQP, 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 services5. 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 costsof 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.

http://omnex.com/http://omnex.com/http://omnex.com/http://omnex.com/


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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 phase-gate 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.

Workshop Integrated Management Systems ISO 9001 14001 18001 22000 and 27000

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