CHAPTER 9

Quality Standards
 Objectives:
● 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)
 Reporters

Jirah Mae D. Digal Maye Joie M. Retorca

BSAIS3
 What is standards?
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 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 organization
advantages in certain areas of the world.
Malcolm Baldrige
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 Raegan
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 (now American
Productivity and Quality Center). These conference 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, 187, 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 Raegan administration. Malcolm Baldrige was killed in
an accident shortly prior to the action of the Senate to the
legislation. Baldrige, a highly respected man by world
leaders had a key role on the trade policy of the Raegan’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 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 hoe to manage for
high quality through making accessible specified information on how winners were
able to transform their cultures and achieve distinction.
The award 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 award are
grouped to several categories such as manufacturing, small business, service, nonprofit
health care and non-profit organization.
Criteria to Become Baldridge
Awardees
1. Delivery of increasingly improving vale, adding to
market places 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 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 relationship with
customers; and acquires, satisfies, and retains customers.
4. Measurement, analysis, and knowledge management- Examines the
management, effective use, analysis, and improvements 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,
etc. 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 planning and customer and market focus must be
integrated. Human resource focus and process management the manner the
organizations perform their works to attain business results. The entire
framework is provided with fact-based system 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 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 (i.e.., 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 US

organizations 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:

Midway LISA, Columbia, Mo. (small business; won in the same

category in 2009)
Midway USA is an Internet retailer offering "Just About Everything
for 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, Midway USA employs more than 350 at its facility in Columbia,
Mo. Many in the company's workforce have a 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, Midway USA
has pursued its vision to be "the best-run, most respected business in
America, for the benefit of our Customers."
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 7-12 to engage,
graduate, or redirect these students.
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 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.
Mid-America Transplant Services, St. Louis, Mo. (nonprofit)

Mid-America Transplants a private, nonprofit organ procurement

organization and eye 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.
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
● 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. ISO covers a wide variety of standards with the exception of
electrical and electronic engineering standards covered by the International
Electrotechnical Commission (IEC), telecommunication standards covered by the
International Telegraph Union (ITU) and information technology covered by JTC
1 (a joint committee between ISO and IEC).The organization which today is
known as ISO began in 1926 as the International Federation of the National
Standardizing Associations (ISA). This organization focused heavily on
mechanical engineering. It was disbanded in 1942 during the second World War
but was re-organized under the current name, ISO, in 1946.
The organization which today is known as ISO began in 1926 as the
International Federation of the National Standardizing Associations
(ISA). This organization focused heavily on mechanical engineering.
It was disbanded in 1942 during the second World War but was re-
organized under the current name, ISO, in 1946.

Even the name of the organization is standardized. The name, "ISO"

is not an acronym but was derived from the Greek word "isos"
meaning "equal". (The relation to standards is that if two objects
meet the same standard, they should be equal.) This name eliminates
any confusion that could result from the translation of "International
Organization For Standardization" into different languages which
would lead to different acronyms.
Different Types of ISO
The International Organization for Standardization (ISO) is a 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 150 9000 family addresses various aspects of quality management contains some of
150'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 that quality consistently improved.

Standards in the ISO 9000 family include:

ISO 9001:2015-sets out the requirements of a quality management system
IS0 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 yet-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.
IWA 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 helping to conserve
resources and tackle climate change. ISO 50001 supports organizations in all sectors to use energy
more efficiently, through the development of an energy management system (EnMS).
ISO 50001-2011. This is based on the management system model of continual improvement also used
for other well-known standards such as ISO 9001 or ISO 14001. This makes it easier for
organizations to integrate energy management into their overall efforts to improve quality and
environmental management. ISO 50001:2011 provides a framework of requirements for
organizations to:
1. Develop a 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 economic performance and professional reputation, as
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 size, activity or sector. Using ISO 31000 can help organizations
increase 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 programmers. 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 ISO's food safety management standards help
organizations identify and control food safety hazards. As many of today's food products repeatedly cross
national boundaries,
International Standards are needed to ensure the safety of the global food supply chain. The 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

ISO 37001. Bribery is one of the world's most destructive and challenging issues. With over
US$ 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 of 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
product's 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 2-4 weeks in advance to fully review
all of the necessary documents.
Determining Pre-assessment Need
Though optional, this 2-4 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 logistics 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-
229 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 effectively
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.
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 a register, which the company can use to
publicize its registration and use in advertising.
 
Checking with 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 Gorres 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 come a
long way since 1991 when the original Mekeni Meat Products company has
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.

Food and Drug Administration (FDA)

International Standardization Organization (ISO)'s 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.
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 they comply with global standards.
Both companies received the country's first ISO 22301:2012 Business
Continuity Management System (BCMS) standard certification for its VITRO
Data Center from Société Générale de Surveillance (SGS) the world's leading
inspection, verification, testing and certification company.
ISO 22301:2012 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.