Module for Operation Management and TQM Part 9

Quality Standards

OBJECTIVES:

After reading this lesson, the student should be able to:

⮚ Recognize the quality using Malcolm Baldrige and International Organization for Standardization
(ISO).
⮚ Differentiate between quality standards of Malcolm Baldrige and International Organization for
Standardization (ISO).

In essence, a standard is an agreed way of doing something. It could be about making a product,
managing a process, delivering a service or supplying materials. Standards can cover a huge range of
activities undertaken by organizations and used by their customers.

Standards are important in international trade because incongruent standards can be barriers to
trade, giving some organizations advantages in certain areas of the world. Standards provide clear
identifiable references that are recognized internationally and encourage fair competition in free-market
economies. Standards facilitate trade through enhanced product quality and reliability, greater
interoperability and compatibility, greater ease of maintenance and reduced costs.

There are several quality awards and standards for organizations to strive towards. Most of the
organizations involved in these programs see them as tools to help improve their quality processes and
move toward implementing successful TOM.

MALCOLM BALDRIDGE

The Malcolm Baldrige Award is a United States quality award that covers an extensive list of
criteria evaluated by independent judges. In many cases, organizations use the Baldrige criteria as a
guide for their internal quality efforts rather than competing directly for the award.

History of Malcolm Baldrige Award

In October 1982 due to the declining of US productivity, President Ronald Reagan signed
legislation mandating a national conference on productivity. A seven computer networking conferences
in 1983 was prepared for the White House Conference on Productivity sponsored by the then American
Productivity Center Productivity and Quality Center). These conferences concluded in a
recommendation to have a National Quality Award just like the Deming prize in Japan. The supposed
award shall be given annually to those companies that productively dare and meet the award
requirements. The requirements and the evaluation process should be very parallel to the Deming Prize
system to be successful.
 Finally on August 20, 1987, the Baldrige Award was signed and became a law Public Law 100-
107). The name of the award was taken after the Secretary of Commerce under the Reagan
administration. Malcolm Baldrige was killed in an accident shortly prior to the action of the Senate to
the legislation. Baldrige, highly respected man by world leaders had a key role on the trade policy of the
Reagan's administration. He was able to provide solution to the technology transfer differences with
China and India. He successfully holds the first meeting with the Cabinets of Soviet Union in seven years.
These Cabinet-level talks made the way for an increased accessibility of US in the Soviet market.

Purposely the Baldrige Award was created to:

1. Assist encourage US firms to make quality and productivity improvement for pride of recognition at
the same time gain profit despite competition;

2. Distinguish the accomplishments of those firms that made quality improvements of their goods and
services and become an example for the rest;

3. Create guidelines and standards which business, industry, government and other enterprises can use
to assess their own quality efforts for improvements, and

4. Offer definite guidance for other US firms that desire to learn how to manage for high quality through
making accessible specified information on how winners were able to transform their cultures and
achieve distinction.

Excellence in quality management practice and performance by US firms are recognized by the
Baldrige Award. The award however does not exist plainly to recognize excellence in product nor for the
sake of winning. The main focus of the award is to encourage high-performance management practices
that lead to satisfied customer and good business outcomes. The awards are grouped into several
categories such as manufacturing, small business, service, nonprofit health care and non-profit
organizations.

Criteria to Become Baldrige Awardees

The evaluation for the award consist of a meticulous set of criteria named the Criteria for
Performance Excellence with the intention to persuade firms to enhance their competitiveness using an
aligned approach to organizational performance management with the following outcomes:

1. Delivery of increasingly improving vale, adding to market place success

2. Enhancement of the general company performance and capabilities

3. Learning on organization and personal level

The criteria to address are categorized as:

1. Leadership - Examines how senior executives guide the organization and how the organization
addresses its responsibilities to the public and practices good citizenship.
2. Strategic planning - Examines how the organization sets strategic directions and how it determines
key action plans.

3. Customer focus - Examines how the organization determines requirements and expectations of
customers and markets, builds relationships with customers, and acquires, satisfies, and retains
customers.

4. Measurement, analysis, and knowledge management - Examines the management effective use,
analysis, and improvement of data and information to support key organization processes and the
organization's performance management system.

5. Workforce focus - Examines how the organization enables its workforce to develop its full potential
and how the workforce is aligned with the organization's objectives.

6. Process management - Examines aspects of how key production delivery and support processes are
designed, managed, and improved.

7. Results - Examines the organization's performance and improvement in its key business areas:
customer satisfaction financial and marketplace performance. human resources, supplier and partner
performance, operational performance, and governance and social responsibility. The category also
examines how the organization performs relative to competitors.

The seven categories form an umbrella of an integrated management system which reflects the
concentration of organizations towards customers using their strategy and actions. The leadership triad
consisting of leadership, strategic ging and customer and market focus must be integrated. Human
resource s and process management the manner the organizations perform their works to attain
business results. The entire framework is provided with fact-based term for improvement as supported
by measurement, analysis and knowledge management.

Evaluation Process

The scoring of responses to Criteria Items and Award applicant feedback are based on two
evaluation dimensions namely process and results. Criteria users need to furnish information relating to
these dimensions. The specific factors for process are approach, deployment, learning, and integration,
are described below.

1. Approach refers to the methods used by an organization to address the Baldrige Criteria Item
requirements in Categories 1-6. Features include:

a. Appropriateness of the methods to the Item requirements

b. Effectiveness of your use of the methods
c. Use of a systematic approach
d. Innovation
Questions to be asked in analyzing an approach are the following:

a. What approach or collection of approaches is discussed?

b. What Areas of the Criteria Item does the approach address?

c. Is the approach systematic (with repeatable steps, inputs, outputs, and time frames designed
to allow evaluation, improvement, and sharing)?

d. Is there evidence that the approach is effective?

e. Is this approach collection of approaches) a key organizational process? Is the approach

important to the applicant's overall performance? (If yes, clearly state why it is important, and
cite the key factors used to support your position.)

f. Are any of the multiple requirements of the Item that are not addressed (gaps) relevant and
important to the applicant?

2. Deployment refers to the extent to which an approach is applied in addressing the requirements of
the Baldrige, Criteria Item. Deployment is evaluated on the basis of the breadth and depth of application
of approach to relevant work units throughout the organization. Features included are the following:

a. Relevance
b. Complete coverage
c. Consistency
d. Breadth across all work units
e. Depth through multiple levels

Questions to be asked in analyzing deployment are the following:

a. What information is provided to show what is done in different parts of the organization (early stages,
well deployed but with some variation among areas/work units, well deployed with no significant gaps,
fully deployed)?

3. Learning refers to new knowledge or skills acquired through evaluation, study, experience, and
innovation. Organizational learning is achieved through research and development, evaluation and
improvement cycles, ideas and input from employees, customer ideas and input, faculty, staff, students,
patients, and other stakeholders, best practice sharing, and benchmarking Personal learning (for
employees, faculty and staff) is achieved through education training, and developmental opportunities.
To be effective, these types of learning should be embedded in the way an organization operates.
Features included are the following:

a. Organizational learning and Personal learning

b. Embedded in operations
🌹

Questions to be asked in analyzing learning,

a. Has the approach been evaluated and improved? If yes, is the evaluation and improvement
conducted in a fact-based, systematic manner (e.g. regular, recurring data driven)?

b. Is there evidence of organizational learning (ie, evidence that the learning from this approach
is shared with other organizational units/other work processes)? Is there evidence of innovation
and refinement from organizational analysis and sharing (e.g., evidence the learning is actually
used to drive innovation and refinement)?

c. Are the measures, information, improvement systems complementary across processes and
work units?

4. Integration refers to the harmonization of plans, processes, information, resource decisions, actions,
results, and analysis to support key organization wide goals. Effective integration goes beyond alignment
and is achieved when the individual components of a performance management system operate as a
fully interconnected unit. Features are the following:

a. Begins with alignment

b. Culminates in interconnectivity

Questions to be asked in analyzing integration:

a. How well is the approach aligned with the applicant's organizational needs identified in the other
Criteria Items and the Organizational Profile? How well is the approach integrated with these needs?
(Examples of needs are strategic challenges, objectives, and related action plans; organizational mission,
vision, and goals; key processes and measures; key customer/market segments and requirements; and
employee groups and requirements.)

Malcolm Baldrige Awardees for 2015

U.S. Commerce Secretary Penny Pritzker named four U.S. organizations as the 2015 recipients of
the Malcolm Baldrige National Quality Award, the nation's highest Presidential honor for performance
excellence. The honorees are recognized for their outstanding commitment to sustainable excellence
through innovation improvement and visionary leadership. This year's recipients represent four different
sectors and include a two-time winner for the seventh time in Baldrige history

The 2015 Baldrige Award recipients listed with their category are:

MidwayUSA, Columbia Mo (small business; won in the same category in 2009)

MidwayUSA is an Internet retailer offering Just About Everything ® tor shooting, hunting and the
outdoors. It is a world leader in its market sector, offering more than 110,000 products from more than
800 suppliers to 1.2 million active customers With gross sales in excess of $350 million, MidwayUSA
employs more than 350 at its facility in Columbia, Mo. Many in the company's workforce Eve deep
passion for shooting hunting and outdoor sports, which allows them to use personal knowledge and
insight to better serve their customers. Since first Adopting the Baldrige Criteria for Performance
Excellence in 2006, MidwayUSA has pursued its vision to be the best-run, most respected business in
America, for . the benefit of our Customers.

This is the second Baldrige Award for MidwayUSA as the company was honored in the same
category in 2009.

As a result of MidwayUSA's focus on their number one operational goal, customer satisfaction,
and the integration of customer satisfaction data into MidwayUSA's Performance Improvement System,
customer approval ratings have topped 90 percent since 2006, and have exceeded the performance of
its primary Internet retailing competitor for the past two years.

Since 2004 MidwayUSA has sustained a 43.8 percent average annual growth rate in net income
and a 21.3 percent average annual growth rate in gross sales, making it one of the fastest-growing
companies in its industry.

MidwayUSA improved its employee satisfaction and engagement rate from 76 percent in 2004
to 83 percent in 2015.

MidwayUSA is a community leader in waste recovery and resource management, recycling

paper, plastic, cardboard, pallets, and metal. In 2008, the company replaced Styrofoam packing peanuts
with inflatable air pillows made of recycled plastic MidwayUSA is virtually paperless; most marketing and
business transactions are done electronically and no "snail mail" orders are accepted.

Charter School of San Diego, San Diego, Calif. (education)

The Charter School of San Diego (CSSD), authorized by the public San Diego Unified School
District, states that it "is committed to the development of a personalized instructional program with
intensive parental involvement that demonstrates positive outcomes for each student. Opened in 1994.
CSSD is specifically aimed at students whose futures are at risk because they were not successful at
conventional schooling. Students who enroll at CSSD are seeking an alternative educational environment
or fall into several at-risk categories On average, 14 percent of the student population is designated as
gifted and 13 percent require special education. CSSD provides free, individualized education in Grades 2
to engage, graduate, or redirect these students.

CSSD is headquartered in San Diego, Calif., operates 21 instructional and educational resources
centers in San Diego County, and employs 187 workforce members.

CSSD maintained overall student and parent satisfaction levels of close to 100 percent from
2010 to 2015. Furthermore, 95 percent of enrolled students for the past six years would recommend
CSSD to others, and 97 percent of students parents would recommend the school to a friend or family
member.

CSSD's overall dropout rate of 2.4 percent in 2013-2014 outperformed the county rate of 2.7
percent and the statewide rate of 3.1 percent, even though CSSD students are on average two to three
grade levels behind peers in language arts and three to four grade levels behind peers in math
achievement when they enroll.

CSSD has retained between 80-90 percent of its instructional staff for the past six years. For four
years, CSSD has maintained a greater percentage of teachers with advanced degrees than two of its
charter school competitors and most recently outperformed its county school system on this measure in
the 2013-2014 academic year.

Despite a combined decrease of 43.14 percent in state funding in recent years, CSSD's positive
end-of-year fund balances have increased for the last six years. Additionally, CSSD's innovative approach
in evaluating the financial performance of each resource center demonstrates that the number of
resource centers with deficits fell over the past three years from seven of 20 in FY 2012-2013, to six in FY
2013-2014, and most recently, to three in FY 2014-2015.

Charleston Area Medical Center Health System, Charleston, W.V. (health care)

The Charleston Area Medical Center Health System (CAMCHS) in Charleston, W.Va., operates
four hospitals within the Charleston Area Medical Center (CAMC): CAMC General Hospital, CAMC
Memorial Hospital, CAMC Women and Children's Hospital, and CAMC Teays Valley Hospital. The system
also includes the CAMC Foundation; the CAMC Health and Education Research Institute; document,
cancer, weight loss, and physical therapy centers; and the physician clinics of Integrated Health Care
Providers, Inc. Services at CAMC include a Level 1 Trauma Center, top-level neonatal intensive care unit
and pediatric intensive care, West Virginia's only kidney transplant center, and subspecialists in every
service line. CAMCHS operates with a revenue of $956 million and a workforce of just under 7,000
employees (including nearly 800 physicians) and more than 300 volunteers.

For the past two years, the Charleston Area Medical Center Health System has ranked in the top
5 percent for quality inpatient service by Healthgrades, a national service that rates the performance of
physicians, hospitals and health care providers and received the group's Distinguished Hospital Award.

CAMC ranks in the top 10 percent nationally for outpatient satisfaction in all areas, including
wait times, communication, staff courtesy and respect, doctor time with patient and information given
to patients for self care.
CAMCS Sepsis Performance Improvement Team saved 1798 lives from 2011 to 2014 through
increased awareness and early identification better than the national top 10 percent level since 2012.

As West Virginia's largest provider of uncompensated care, CAMC exceeds local and national
benchmarks for such activity, reflecting its mission to provide the best health care to every patient every
day. CAMCHS's commitment to improving the health of its neighbors is demonstrated by community
benefit expenditures that exceed the national average by 76 percent and total over $115 million
annually.

Mid-America Transplant Services, St. Louis, Mo. (nonprofit)

Mid-America Transplantisa private, nonprofit organ procurementorganization and eve and

tissue bank serving a designated service area (DSA) of 84 counties in eastern Missouri, southern Illinois,
and northeastern Arkansas. Mid-America Transplant works with its partner hospitals to procure donated
organs and tissues and then provide them to transplant centers and tissue processors, both in the DSA
and across the country. Mid-America Transplant also operates three stations at Department of Motor
Vehicles offices in the Greater St. Louis, Mo., area that support its mission by making it easy for
motorists to register as donors while renewing drivers' licenses or automobile registrations with an
annual budget of $39 million and a workforce of 193 employees, Mid-America Transplant operates from
its headquarters in St. Louis, Mo., and a satellite location in Springfield, Mo. A unique concept is the
Mid-America Transplant Family House, which provides short- and intermediate-term housing for
transplant patients and their families from outside the St. Louis area and gives Mid-America Transplant
leaders and staff the opportunity to interact with them.

To facilitate organ and tissue donations, Mid-America Transplant staff members are in residence
at the organization's key partner hospitals. This innovation has resulted in a 0.08 percent rate of missed
organ referrals since 2012 outperforming the reported best-in-class industry benchmark of 2 percent.

In 2001, Mid-America Transplant built the nation's first stand-alone organ recovery facility, a
system that has significantly reduced the expense of procuring organs compared to the cost of in-
hospital organ procurement. Since 2012, the cost-per-donor for in-house cases has decreased from
approximately $7,000 to under $4,000, compared to approximately $20,000 when completed in the
hospital.

In 2015, Mid-Amenca Transplant was selected as a top workplace by the St. Louis Post Dispatch
newspaper The overall employee retention rate approaches 90 percent and has exceeded the
Association of Organ Procurement Organizations industry average since 2012.

Mid-America Transplant uses customer data to determine their satisfaction with the donation
process Customer complaints per case have been close to zero since 2013 for eye and tissue donations
and declined from approximately 7 percent in 2013 to approximately 3 percent in 2015 for organ
donations.

ISO STANDARDS

The International Organization for Standardization (ISO) is an international standard-setting

body composed of representatives from various national standards organizations. Founded on 23
February 1947, the organization promotes worldwide proprietary, industrial and commercial standards.

ISO International Standards ensure that products and services are safe, reliable and of good
quality. For business, they are strategic tools that reduce costs by minimizing waste and errors, and
increasing productivity. They help companies to access new markets, level the playing field for
developing countries and facilitate free and fair global trade.

History of ISO

In London, in 1946, 65 delegates from 25 countries meet to discuss the future of International
Standardization. In 1947, ISO officially comes into existence with 67 technical committees (groups of
experts focusing on a specific subject). In 1949, ISO moves into offices in a small private house in
Geneva. In the early 1950s the Central Secretariat has 5 members of staff.

In 1951, the first ISO standard (called Recommendations at this time), ISO/R 1:1951 Standard
reference temperature for industrial length measurements, is published. Since then, the standard has
been updated numerous times and is now ISO 1:2002 Geometrical Product Specifications (GPS) -
Standard reference temperature for geometrical product specification.

Since its creation ISO has published monthly information about its technical committees, the
standards published and administrative changes to the organization and its members.

In 1955, ISO members gather in Stockholm for the 3rd General Assembly. At the beginning of
1955, ISO has 35 members and 68 standards (called recommendations) Henry St Leger is the Secretary
General.

In 1960, ISO publishes the standard ISO 31 on quantities and units (which has since been
replaced by ISO 80 000). ISO 31 is based on SI (Système international d'unites) The SI sets out one unit
for each quantity, for example the meter Tor distance and the second for time The objective of the SI
system is to reach world Wide uniformity in units of measurement. ISO 80 000 sets out these units and
how to use them.

During the 1900 is works to include more developing countries in ifs International
Standardization work In 1961 it establishes DEVCO, a committee for developing country matters, and in
1968 introduces Correspondent membership This allows developing countries to be informed of
International Standardization work without the full costs of ISO membership. Correspondent
membership continues to be a popular option for many countries today. At the start of 2012, ISO had 49
correspondent members Learn more about ISO and developing countries.

In 1968, ISO publishes its first standard on freight containers. Freight and packaging is one of the
areas where ISO has been particularly active, changing the way goods travel across the world. In 1969
Olle Sturen becomes Secretary General of ISO, In one of his first speeches he says International
Standardization is the end of "technical nationalism.

In 1971, ISO creates its first two technical committees in the environmental field: Air quality and
Water quality. Today, these committees have been joined by other groups of environmental experts
focusing on many subjects including soil quality, environmental management and renewable energy.
During the 1970s, ISO's Secretary General Olle Sturen focuses on turning ISO into a truly international
organization.

While ISO s members come from all over the world, in the early 1970s relatively few are fully
active in the development of International Standards. Sturen's visits to members result in active
participation from countries such as Australia, Japan and China. The Central Secretariat also reflects this
international feel, with an average of 25 nationalities represented.

In 1986, Lawrence D. Eicher takes over as Secretary General. Sadly, Eicher passed away in 2002
while still serving as ISO Secretary General. The Lawrence D. Eicher award for excellence in
standardization has been set up in his memory.

In 1987, ISO publishes its first quality management standard Standards in the ISO 9000 family
have gone on to become some of the most well known and best selling standards.

In 1995, ISO launches its first website. Five years later, in 2000, ISO starts selling its standards
online. In 1996, ISO launches its environmental management system standard, ISO 14001. The standard
provides tools for companies and organizations to help them identify and control their environmental
impact.

In 2003, Alan Bryden is appointed Secretary General. Under his 5 year term ISO expands its work
to cover new technologies such as nanotechnology and biofuels. Bryden also actively supports ISO's
work on social responsibility, which leads to the launch of ISO 26000 in 2010.

In 2005, ISO and IEC's joint technical committee JTCI launches ISO/IEC 27001, a management
system standard on information security. As businesses become increasingly reliant on information
technology, securing the system and minimizing risks is ever more important. ISO 27001:2005 has
become one of ISO's most popular standards.

În 2007, ISO moves to its current offices in La Voie Creuse, Geneva. Today the Central Secretariat
employs almost 150 people, a significant increase from the staff of 5 in the early 1950s.

In 2008, ISO, ITU and IEC are congratulated with an Emmy Award for their work in producing an
advanced video coding standard.

In 2009, ISO's current Secretary General Rob Steele is appointed. ISO takes on a new mission to
be simpler, faster, better to cut down standards development time and to better serve the needs of
today's society.

In 2010, ISO 26000, the International Standard providing guidelines for social responsibility is
launched. The working group that developed ISO 26000 is one of the largest and most diverse groups to
develop an ISO standard. The resulting document is truly multi-stakeholder.

At the startof 2012, ISO has 163 members and hasa total of over 19,000 standards Today, ISO
International Standards cover almost all aspects of technology and business.

Different Types of ISO

The International Organization for Standardization (ISO) isa non-governmental network of

national agencies whose purpose is the development of international standards for business and
government International standards are designed for trade between countries. They provide a
technological base and a system of best management practices. Standards ensure safe products and
organizational procedures that reduce environmental impact Standards benefit trade and business by
simplifying procedures and reducing an organization's environmental risk. Consumers benefit by the
knowledge that state-of-the-art practices are developed for global relevancy.

Quality Management

The ISO 9000 family addresses various aspects of quality management and contains some of
ISO's best known standards. The standards provide guidance and tools for companies and organizations
who want to ensure that their products and services consistently meet customer's requirements, and
quality is consistently improved.

Standards in the 150 000 family include:

ISO 9001:2015 - sets out the requirements of a quality management system

ISO 9000 2015 - covers the basic concepts and language

ISO 9004 2009 focuses on how to make a quality management system more efficient and effective

ISO 19011 2011- sets out guidance on internal and external audits of quality management systems

ISO 9001:2015. This ISO sets out the criteria for a quality management system and is the only standard
in the family that can be certified to (although this is not a requirement) It can be used by any
organization, large or small, regardless of its field of activity In fact, there are over one million
companies and organizations in over 170 countries certified to ISO 9001. This standard is based on a
number of quality management principles including a strong customer focus, the motivation and
implication of top management the process approach and continual improvement. Using ISO 9001:2015
helps ensure that customers get consistent, good quality products and services, which in turn brings
many business benefits.

Environmental Management

ISO 14001:2004. This ISO standard is the basis of development of an environmental management
system (EMS). An EMS is a set of guidelines and procedures developed by an organization to ensure
compliance. An EMS benefits an organization by increasing environmental awareness and investigating
ways to reduce its costs.

ISO 14004:2004. This ISO standard provides more specific information for implementation and
maintenance of an EMS, with the aim to continually improve the plan based on its performance. The
standard is applicable to any industry.

ISO 5001. This vet-to-be released standard will address energy management and ways to increase
energy efficiency and reduce environmental impact of organizations. It will consider technical and
topical issues, such as climate change and dependence on foreign oil.

Health and Safety

ISO 22000. This ISO standard sets global guidelines for food safety and handling. Major corporations
have embraced this standard, including Arla Foods and Kraft Foods. Its aim is to focus on the entire food
chain and reduce hazards and safety issues such as food-borne illnesses.

WA 1:2005. This standard addresses issues in the healthcare sector. It provides guidelines for health
care organizations to respond to natural and manmade disasters. Specifically, the standard gives
recommendations for reducing error and organizational waste, while embracing a customer-centric
framework.

ISO 9001:2000. This standard addresses quality management in the medical device industry It
specifically provides suggestions and guidelines for industries involved in the development production
and installation of these devices. The standard also considers continual monitoring within the industry.

Transportation
ISO/TS 16949. This standard reviews all areas of the automotive industry supply chain. It concentrates
on areas of training, monitoring, analysis and improvements within the industry. The standard also
focuses on ways for suppliers to reduce their costs and improve efficiency.

ISO/PAS 30003:2008. This standard looks at specific concerns within shipping and marine technology. It
focuses on areas such as ship recycling management and other material handling that can have potential
environmental impacts. It addresses industry-specific concerns such as hazardous materials and
asbestos
emission.

Social Responsibility

ISO 26000. This standard assures that business and organizations do not operate in a vacuum. Their
relationship to the society and environment in which they operate is a critical factor in their ability to
continue to operate effectively. It is also increasingly being used as a measure of their overall
performance. ISO 26000 provides guidance on how businesses and organizations can operate in a
socially responsible way. This means acting in an ethical and transparent way that contributes to the
health and welfare of society.

ISO 26000:2010. This standard provides guidance rather than requirements, so it cannot be certified to
unlike some other well-known ISO standards. Instead, it helps clarify what social responsibility is, helps
businesses and organizations translate principles into effective actions and shares best practices relating
to social responsibility, globally. It is aimed at all types of organizations regardless of their activity, size
or location. The standard was launched in 2010 following five years of negotiations between many
different stakeholders across the world. Representatives from government, NGOs, industry, consumer
groups and labor organizations around the world were involved in its development, which means it
represents an international consensus.

Energy Management

ISO 50001. Using energy efficiently helps organizations save money as well as Nng to ie resources and
tackle climate change ISO 50001 supports gahoations in allseiors to use energy more efficiently, through
the development of an energy system (EnMS).

ISO This is based on the management system model of continual pent shed to other well-known
standards such as ISO 9001 or ISO hs maeseasiet for organizations to integrate energy management
inihveralletforts torove quality and environmental management ISO provide a itasework of
requirements for organizations to:

1. Develop policy for more efficient use of energy

2. Fix targets and objectives to meet the policy

3. Use data to better understand and make decisions about energy use

4. Measure the results

 5. Review how well the policy works, and

6. Continually improve energy management

Risk Management

ISO 31000. This standard is about the risks affecting organizations that can have consequences in terms
of conomic performance and professional reputation A well as environmental safety and societal
outcomes. Therefore, managing risk effectively helps organizations to perform well in an environment
full of uncertainty.

ISO 31000 2009 This standard offers principles and guidelines, provides principles framework and a
process for managing risk. It can be used by any organization regardless of its site, activity or sector.
Using ISO 31000 can help organizations erase the likelihood of achieving objectives, improve the
identification of opportunities and threats and effectively allocate and use resources for risk treatment.

However, ISO 31000 cannot be used for certification purposes, but does provide guidance for internal or
external audit programmes Organizations using it can compare their risk management practices with an
internationally recognized benchmark providing sound principles for effective management and
corporate governance.

Food Safety Management

ISO 22000. The ISO 22000 family of International Standards addresses

food safety management. The consequences of unsafe food can be serious and IS0's food safety
management standards help organizations identify and control food safety standards. As many of
today's food products repeatedly cross national boundaries, international Standards are needed to
ensure the safety of the global food supply ISO 22000 family contains a number of standards each
focusing on different aspects of food safety management.

ISO 22000:2005 contains the overall guidelines for food safety management.

ISO 22004 2014 provides generic advice on the application of ISO 22000

ISO 22005:2007 focuses on traceability in the feed and food chain

ISO/TS 22002-1:2009 contains specific prerequisites for food manufacturing

ISO/TS 22002-2:2013 contains specific prerequisites for catering

ISO/TS 22002-3:2011 contains specific prerequisites for farming

ISO/TS 22002-4.2013 contains specific prerequisites for food packaging manufacturing

ISO/TS 22003:2013 provides guidelines for audit and certification bodies

ISO 22000:2005. This sets out the requirements for a food safety management system and can be
certified to. It maps out what an organization needs to do to demonstrate its ability to control food
safety hazards in order to ensure that food is safe. It can be used by any organization regardless of its
size or position in the food chain.

Information Security Management

ISO/IEC 27001. The ISO 27000 family of standards helps organizations keep information assets secure.

Using this family of standards will help the organization manage the security of assets such as
financial information, intellectual property, employee details or information entrusted to you by third
parties. ISO/IEC 27001 is the best-known standard in the family providing requirements for an
information security management system (ISMS). An ISMS is a systematic approach to managing
sensitive company information so that it remains secure. It includes people, processes and IT systems by
applying a risk management process. It can help small, medium and large businesses in any sector keep
information assets secure.

Occupational Health and Safety

ISO 45001. Over 6300 people die each day from work-related accidents or diseases - that's nearly
2.3million every year. The burden of occupational injuries and diseases is significant, both for employers
and the wider economy, resulting in losses from early retirements, staff absence and rising insurance
premiums. To combat the problem, ISO is developing a new standard, ISO 45001 Occupational health
and safety management systems. The requirements here will help organizations reduce this burden by
providing a framework to improve employee safety reduce workplace risks and create better, safer
working conditions, all over the world. The standard is currently being developed by a committee of
occupational health and safety experts, and will follow other generic management system approaches
such as ISO 14001 and ISO 9001.

Anti-bribery Management Systems

1S0 37001 Bribery is one of the world's most destructive and challenging Issues. With over USS 1 trillion
paid in bribes each year, the consequences are catastrophic reducing quality of life, increasing poverty
and eroding public trust. Yet despite efforts on national and international levels to tackle bribery, it
remains A significant issue. Recognizing this, ISO is currently developing a new standard to help
organizations fight bribery and promote an ethical business culture.

ISO 37001 This is the future anti-bribery management systems, specifies a series af measures to help
organizations prevent, detect and address bribery. These include adopting an anti-bribery policy,
appointing a person to oversee anti bribery compliance, training risk assessments and due diligence on
projects and business associates, implementing financial and commercial controls, and instituting
reporting and investigation procedures. ISO 37001 can be used by any organization, large or small,
whether it be in the public private or voluntary sector, and in any country. It is a flexible tool, which can
be adapted according to the size and nature of the organization and the bribery risk it faces.

Medical Devices
ISO 13485. Safety and quality are non-negotiable in the medical devices industry. Regulatory
requirements are increasingly stringent throughout every step of a products life cycle, including service
and delivery. More and more, organizations in the industry are expected to demonstrate their quality
management processes and ensure best practice in everything they do. Requirements for regulatory
purposes, is an internationally agreed standard that sets out the requirements for a quality management
system specific to the medical devices industry. A medical device is a product, such as an instrument,
machine, implant or in vitro reagent that is intended for use in the diagnosis, prevention and treatment
of diseases or other medical conditions. ISO 13485 is designed to be used by organizations involved in
the design, production, installation and servicing of medical devices and related services. It can also be
used by internal and external parties, such as certification bodies, to help them with their auditing
processes.

Registration Steps to become ISO Certified

After the company made the plans, built the quality system and conducted the audit, the next
step is the ISO Registration Process. The purpose of registering the company is to show that it met the
requirements. In order to do this effectively here are essential steps.

Finding an ISO 9001 Registrar

There is a need to begin searching for an ISO registrar during the 2 to 3 months the company is
still building its quality system. Search can be done in the ANSI-ASQ National Accreditation Board (ANAB)
to select the registrar right for the company. Registrars must meet the requirements of the ISO
Accreditation Bodies. These requirements include things such as independence. Registrars cannot
consult for instance. This system ensures uniformity in the registration process. Accreditation Bodies
maintain directories of the Registrar organizations that they accredit. These directories are available on
their websites. Any company can normally find these websites by doing a search on the Accreditation
Body's name or initials. All other countries except USA and Canada should consult the accreditation
authority or member body for their country. Any company applying for registration can consult the ISO
website for a complete list of ISO Member bodies.

Selecting an ISO Registrar

A company applying for registration should select a registrar that has experience within the
scope category of its specific industry, which can be found also on the ANAB site. Accreditation,
scheduling issues, fees and comfort level should be considered by the company when selecting for the
right registrar. Registrar qualifications are a key consideration. There are registrars that have very
limited in scope just based on their names. Registrars must be accredited in a particular industrial sector
in order for them to be able to certify a company in that sector. Some registrars are accredited in several
if not all sectors. While, other registrars are specialized in certain sectors. The best approach to
evaluating a registrar's qualifications for a specific industrial sector is to contact the registrar.

After qualifications, price is always a concern. In evaluating the total cost include expenses, fees
and the cost of surveillance. As important as price is the overall experience a client gets with a registrar.
Important areas to consider are the interpersonal skills of the auditors, the office support and ability to
get questions answered, are the audits a value-added experience, will the registrar work with the
company, how flexible are they in adjusting dates and how many weeks notice.
Creating an ISO Application

A company and a registrar will agree on the application contract. This is an important step of the
ISO Registration Process because it defines the rights and obligations of both parties, and includes
liability issues, confidentiality and access rights.

Conducting a Quality Document Review

The registrar will require a copy of the company quality manual and procedures to verify that all
the requirements of the standard are addressed. The ISO Registration Process is not a quick process, the
registrar should be allowed around 244 weeks in advance to fully review all of the necessary documents.

Determining Pre-assessment Need

Though optional this 24 week initial review of the system identifies any Significant omissions or
weaknesses. It saves time and allows the registrar to assess any issues and resolve logisties before the
actual assessment audit.

The Pre-assessment is an initial review of the company's Quality Management System to identify
any significant omissions or weaknesses in the system and provide the organization an opportunity to
correct any deficiencies before the regular registration assessment is conducted.

During ISO 9001 Registration, only one pre-assessment may be conducted and Registrars cannot
provide quality consulting or advice on system implementation. Evaluating the quality system and
documentation to meet ISO requirements is allowed but registrars cannot provide guidance on how to
implement a quality system.

Issuing an ISO Assessment

During the audit, or physical onsite inspection of procedures in action the auditors will issue
findings if they assess anything that doesn't meet requirements, or nonconformities. The length of this
step of the ISO Registration Process will depend on the scope of the audit and the size of the
organization.

In general, the flow of activities during the audit is as follows:

1. Opening Meeting - An introduction of the audit team and key personnel in the company. The scope
and general approach to the audit is discussed. This is also the time to question anything that is unclear
in the audit schedule and communicate any last minute changes to the system or schedule.

2. Brief tour of the facility - Keep it brief, the auditors just want to get a general feel for the layout and
processes involved. This may also be done at the pre assessment.

3. Additional review of documents - Audit team members review documentation for areas they will audit

4. Examination - The audit is conducted, personnel are interviewed, and objective evidence is collected
to show the system has been eftectively implemented.
5. Daily review - At the end of each day or the beginning of the next, the audit Team reviews any issues
identified during the assessment Potential findings or nonconformities may be clarified at this time.

6. Closing Meeting- The audit team states their conclusions regarding the audit and presents any
findings or nonconformities that were identified along with any observations they may have

7. Audit Report issued - Within a few weeks of the audit, the Registrar issues the audit report. The report
generally restates what was discussed in the closing meeting.

During the audit, if the auditors find anything that does not meet with the requirements of the
ISO standard or that does not meet the requirements of the procedures; they determine the severity
and issue a finding Audit findings are usually called nonconformities and fall into one of two categories
depending on severity.

1. A Minor Nonconformance deals with minor infractions of procedures or minor failures of the system
in meeting the ISO 9001:2008 requirements. These will not hold up the registration.

2. A Major Nonconformance deals with issues where nonconforming product is likely to reach the
customer or where there is a breakdown in the Quality System that results in the system not being
effective in meeting the requirements of the standard. This will hold up the registration

The primary difference to a company between a major and minor nonconformance is that the
registration cannot proceed until all major nonconformities are closed and verified by the Registrar. This
usually involves a re-audit of the involved areas and, of course, the associated costs. Minor
nonconformities require a corrective action plan and they are closed at the first surveillance.

Auditors work for or contract to Registrars to perform registration assessments and

surveillances. They are the "front line" in the process. The Registrars are responsible for ensuring
Auditors meet qualification requirements. Their requirements include training in auditing, ISO 9001
training and at least one member of the audit team must have experience in the industrial sector of the
company being audited. Verify credentials. If a person claims to be certified as an ISO 9000 lead auditor,
ask to see proof of his certification. Make sure the certification is current by checking the expiration
date.

Auditors collect the objective evidence demonstrating the effectiveness or lack thereof) of the
company's quality management system and make registration recommendations to the Registrar. The
Registrar has the ultimate decision, however.

Completing ISO 9001 Registration

After all of the findings are put into the ISO audit report and nonconformities are addressed, the
registering company has the option to register as ISO 9001 conformant. The company will receive a
certificate and can also be listed in register, which the company can use to publicize its registration and
use in advertising.

Checking the Surveillance Audits

 To ensure that the system is maintained-and that changes don't result in deficiencies in the
system, registrars perform regular surveillances of the system. Over the three-year period of the
certificate, auditors will perform one full and two partial checks of the company's system.

Some ISO Certified Companies in the Philippines

SyCip Gortes Velayo & Co (SGV & Co.)

SyCip Gorres Velayo & Co. (SGV & Co.) is the Philippines largest multidisciplinary professional
services firm with eight offices across the country. As of 2007, the company has employed over 1,800
professionals from various disciplines, including CPAs, lawyers, economists, HR experts, engineers,
statisticians, financial analysts, and other business and technical experts.

Since 1996, it has been the only ISO 9002-certified professional services firm in the Philippines
since 1996. SGV & Co. became an affiliate of Ernst & Young International on June 6, 2002.

Mekeni Food Corporation (MFC) of Pampanga

The Mekeni Food Corporation (MFC) of Pampanga in the Philippines has come a long way since
1991 when the original Mekeni Meat Products company managed to survive the devastating Mount
Pinatubo volcanic eruption which killed 800 people, made 100 000 homeless and sent an ash cloud
around the world. While many companies closed shop or pulled out, Mekeni decided to ride out the
disaster and help rebuild the local community

Today, despite being further challenged by a serious outbreak of foot and mouth disease in 1996
and the Asian financial crisis of 1997, MFC is now a major food processing organization, employing over
1 000 people on a 14.8 hectare site in Pampanga. The company produces local "longganisa" and "tocino"
sausages and hotdogs, and processes ham and bacon.

In 2006, MFC became reportedly one of the first meat processing plants in to implement and
certify to ISO 22000:2005, Food safety management stems - Requirements for any organization in the
food chain. The company also Se Hazard Analysis & Critical Control Point (HACCP) accreditation issued
the National Meat Inspection Service (NMIS) of the Republic of Philippines Department of Agriculture.

MFC takes its corporate social responsibilities seriously and has been involved in outreach
programmes for orphanages, depressed communities and homes for the elderly. The company has also
invested in a wastewater plant to reduce the impact of its operations on the environment.

Food and Drug Administration (FDA)

International Standardization Organization (ISO) quality management system standards (ISO

9001:2008) is awarded to organizations or companies that want to implement international standards to
improve the efficiency and effectiveness of its operations. The ISO certificate for Quality Management
System (QMS) has been awarded to the Food and Drug Administration (FDA) by the TUV Rheinland
Philippines. The FDA was able to achieve this notable accomplishment as a move towards good
governance and a belligerent fight against graft and corruption.

FDA score transactions, which are licensing of health-concerned establishments and registration
of food drugs, cosmetics, medical device, and household products, are in the scale of the ISO
accreditation.

This testament attests that the Philippine FDA has taken another step in facing a more complex
regulatory environment without compromising public health and awareness. This substantiates the
FDA's continuous process of developing new strategic plans to build a bridge connecting the
government authorities, the industry, and the market while ensuring that the safety, quality and efficacy
of these health products are still intact upon reaching the end users.

In view of that fact, the FDA spearheads the promotion of straight, righteous governance
towards excellence, practice of efficient and effective programs, and the openness to innovation using
advanced technologies. For that reason, transactions offered at the administration will be swiftly
attended to, without compromising client satisfaction in order to reach the market at no cost where the
increase of public demand for products and health commodities are to be achieved.

Philippine Long Distance Telephone Company (PLDT)

The Philippine Long Distance Telephone Company (PLDT) and its Information Communications
Technology (ICT) arm ePLDT, were recently ISO-certified, proving the comply with global standards.

Both companies received the country's first ISO 22301:2012 Business Continuity Management
System (CMS) Standard certification for its VITRO Data Center from Societe Generale de Surveillance
(SGS) - the world's leading inspection, verification, testing and certification company.

ISO 22012012 is the world's first international standard for Business Continuity Management
and was created to assist organizations in developing risk reduction measures in the event of business
disruptions, be these natural disasters or manmade crises.

The standard outlines requirements that will guide an enterprise in planning implementing
monitoring and maintaining their Business Continuity Management System (BCMS), which will enable
them to better respond to unexpected and disruptive events.

BCMS serves as a framework to build the organization's resiliency and ensure that it is able to
continue operations even in uncertain times.

The VITRO data center was also the first data center in the country to be certified for the ISO
14001:2004 Environmental Management System and ISO 9001:2008 Quality Management System
standards.

It has also been consistently recertified for the ISO 27001:2005 Information Security
Management System standard.