Is ISO 9001 A Failure & Add Burden to Business Organizations?

Writer : Ooi Soo Kang, Director/Country Manager, CI International Certification Sdn Bhd ; Rev.#:1 ; 12/12/2004

ISO 9001 International Standard supposed to add values to organizations which pursue the
implementation of the management system based on the ISO 9001 requirements. Otherwise ISO
9001 certification will not become the trend in the world market today where business organizations,
even non-profit organizations or government agencies, either voluntarily, or regulatory required, or
due to customer pressures, are moving towards pursuing the ISO 9001 quality management system to
manage their businesses or day-to-day organization activities.
The values behind the adoption and implementation of ISO 9001 in an organization are definitely
undeniable.
However, after ISO 9001 has been introduced to the international market for almost 17 years since its
inception in 1987, the ISO 9001 system seems to be receiving quite tremendous unfavorable
comments from the market. Market feedback have also shown that out of 10 organizations that
achieved ISO 9001/2 certification, only half of the organizations are effective and reap the values of
ISO 9001/2 implementation. The other half of the organizations have had bogged down by this
system and feel difficult with ISO 9001. Owners and bosses of these organizations have no choice
but because they need the ISO 9001 certification for marketing and goodwill reasons have chosen to
live with this difficult system.
Historical has also shown some organizations which tried to adopt ISO 9001 system has had
abandoned this system while trying half way through, some even takes 2 to 3 years to complete the
cycle to achieve the certification.
If this situation is not corrected or the market perception on ISO 9001 is not changed, given another
10 years, ISO 9001 may face rejection from the world market. But question is, who is responsible to
correct this situation?
To answer this, we have to look into what have had actually caused the negative comments on ISO
9001 and why ISO 9001 has become a failure and add burden to organizations which adopt it to
manage their businesses?
Failure factor #1:
The International Standard ISO 9001 requirements have been weakly addressed and widely
misinterpreted in the market.

Exactly like many religion thoughts such as Buddhism and Muslim 'Al-Quran', it is a hard fact that
ISO 9001 requirements and its meanings have been widely misinterpreted in the market. It is also a
fact that the real requirements which are stipulated in ISO 9001 have been weakly addressed (not
fully complied and implemented) in many organizations which adopted the standard. However, it is
not surprised that these organizations are managed to achieve the ISO 9001 certificates that issued by
some registrars which are non-genuine and equally ineffective in conducting assessments prior to the
award of ISO 9001 certification.
ISO 9001 itself is actually a very beautiful system which lays the management system requirements
that are able to deliver good values to organizations that are sincere, committed and effective in
addressing and implementing the requirements in the organizations. The requirements which are
stipulated in ISO 9001 in fact are the controls to manage a business if they are correctly and
effectively addressed in an organization will definitely make the business more effective and
efficient.
Wrongly and misinterpreting the ISO 9001 requirements has caused many organizations developed
redundant documents or lengthy procedures which do not called for by the ISO 9001. Therefore it is
very crucial that an organization management team should have a very good, in-depth and correct
understanding of ISO 9001 requirements prior to writing and documenting the procedures and other
documents in the process of establishing an effective management system in the organization. One
who has clear and correct understanding of ISO 9001 requirements will be able to establish a precise
and straight to the point procedures or documents which will carry weight and able to operate and
control the processes within the organizations.
Misinterpretation of the ISO 9001 requirements has been also causing unnecessary records generated
that cause burden to organizations. If one clearly and correctly understand the requirements of the
ISO 9001, one should realize that there are only certain mandatory records that required by the
standard to be maintained in order to demonstrate conformance to product as well as to the system
requirements.

Failure factor #2:

The management system procedures or documents are not set-up / written by management team.
If you are managing your business for a period of time, you should know well the best ways and the
critical elements and controls within the functions you are managing. In the context of ISO 9001
certification, the basis step to the certification is to get the procedures, work instructions, guidelines,
criteria and methods which are critical and relevant to the functions and processes within the
business documented in accordance with the requirements of ISO 9001.

However, in the process of getting the procedures and other documents documented, many
organizations have been opting the very ineffective way by hiring outsider to the management (which
includes 'consultant') to write the whole company procedures. This is the most crucial factor that
causes failure to these organizations which implement ISO 9001.
The top management has always perceives that by hiring a consultant to write procedures for them
will help to solve all those troubles in the path to achieve the certification including avoiding
interruption to the routine busy business agenda, but on the other side, they are not aware that the
certificate which they will get will not going to serve any value to them and instead troubles will
surface later on after achieving the certificate which will become the burden to the organization.
Imaging an outsider to the management activities who does not know the critical elements and
controls of the business can write the correct and adequate procedures (meaning the proper ways of
operating the company) that are able to operate and control the business? It is unlikely and
impossible, and not to mention in the later stage when such procedures are implemented will
undoubtedly difficult to be adopted therefore will face resistance from the heads of departments and
the employees in the process of implementation.
A 'consultant' that is hired by an organization supposed to consult the unknowns (including the ISO
9001 requirements) and provide advices to the client, as the word 'consultant' derives from the word
'consult'. A consultant's role is analog to the role of a teacher which is to teach, guide and coach and
is not supposed to help the student to do up their homework (i.e. to write the procedures) which in
turn will make the student never learn and grow. In the case of an organization, if the procedures are
not written by the management staff, the staff will not appreciate much when the procedures are
hand-over to the organization for implementation. Moreover, if the procedures which are written by a
consultant are not adequate (does not address the critical elements or controls the business), or some
cases too simple or too generic, it will make the implementation difficult, therefore not effective.
It is acceptable if in setting the organizational procedures and quality manual, the management team
are based on the sample procedures / documents which are given by the hired consultant as a guide to
write their own system or to modify accordingly, but not to the extent to copy and adopt directly, it
will never ever able to fit to the organization practices.
Failure factor #3:
No involvement of top management (e.g. CEO, MD, GM, senior managers) or lack of management
commitment in the setting-up, implementation and maintenance of the ISO 9001 management system
in the organization.
No involvement or lack of top management commitment in the process of setting-up the quality

management system, subsequently the implementation and maintenance of the system is another
crucial factor that cause ISO 9001 failure in many organizations.
It is a fact that business is always a busy life and top management focus is always given to sales and
marketing activities. However, it should not trade off the importance of the operation and quality
aspects of the business otherwise customers that were brought in are not going to be locked in the
long run.
Despite the busy schedule of the top management, commitment should be given to the system that
helps to run and operate the business. Therefore it is very important that top management of an
organization should show leadership by example in spearheading the ISO 9001 setting-up as well as
in the implementation stage.
Minimal efforts that top management can do that will yield greater values of the ISO 9001
implementation are to commit on the followings:
a) Appoint a senior management staff, disregard of his existing responsibilities, to co-ordinates the
setting-up and implementation of ISO 9001 system (in ISO 9001, such person is termed as
management representative);
b) Extend full supports to him in the process of setting-up, implementation and maintenance of the
quality management system, including present and resolve those difficult issues that may be faced by
the coordinator / management representative in dealing with heads of department / senior employees
who may be due to the old mindset resist to accept some changes required;
c) Ensure a competent consultant is hired to train, guide and coach the organization in the path of
developing and implementing the quality management system;
d) Ensure a committee encompasses all departments and section heads are set-up who should involve
in writing their own functional procedures or required documents under the guidance and reviewed
by the appointed consultant;
e) Ensure all relevant departments and section heads attend the training that deliver the explanation
of the ISO 9001 requirements in in-depth manner normally takes 2-3 days prior to writing of
procedures or required documents by the Standard;
f) If affordable by the organization, ensure all employees including workers levels are attending at
least half a day class of ISO 9001 awareness training to enable them to have some basic
understanding of ISO 9001 such as document control, proper completion of records at work, basic
housekeeping, proper arrangement of goods, and due diligent following procedures or work
instructions at works. Such half a day ISO 9001 awareness training can be arranged group by group

of employee and the hired consultant should plays the role as the trainer. Normally one class can
takes up to 50 or 60 participants;
g) Spend probably 1-2 hours a week or every two weekly to have a meeting with the committee
which should attended by the department and section heads, and during the meeting find out the
progresses of the procedures / documents be writing and implementation problem, and discuss the
possible solutions to the problems. Normally the time period required to set-up the required
procedures and documents including minimum implementation for certification take only 6 to 9
months, and if the management is committed to have this kind of regular meeting during this period,
it will definitely guarantee a return of an effective system to the organization. Ensure all those
important discussions especially comments made including necessary actions are recorded;
h) Ensure quality objectives are adequately established at all relevant business functions (e.g. by
division, department, section and/or unit) and that the quality objectives are measurable and
significant to each business functions. The targets set for each of the quality objectives should be
reasonable and achievable and agreed between the top management and the functional heads taking
into the consideration if the respective functions are operated effectively based on existing available
resources in the organization. The quality objectives by functions are meant to measure and control
the performances of the various functions which will serve as indicators of the effective
implementation of ISO 9001 within each relevant functions;
i) Top management should lead and create the ISO 9001 awareness at all levels of employees by
communicating the importance of following ISO procedures or documents at works from time to
time and this will able to inculcate a strong ISO culture in the organization.

Failure factor #4:

Lack of involvement and awareness among employees; ISO 9001 is always perceived as the job of
ISO 9001 coordinator or quality management representative.
Organization that achieves the ISO 9001 certification supposed to be an organization that involves all
employees who are collectively worked towards the achievement of the certification. However, there
are organizations that achieved ISO 9001 certification yet most of the employees are still in the dark
how the certification can achieve without their involvement and change in the culture of their work.
In these organizations, despite ISO 9001 certified, there is no differences between before and after
certification, thus not to mention the expected intended values.
Those organizations that do not involve employees to implement the system are always perceived
ISO 9001 is the job of the ISO 9001 coordinator or quality management system. The employees are
not interested and always resist to give the necessary co-operations in the implementation of the

relevant procedures and documents at the work places. There will be tendency refuse to initiate the
necessary corrective actions for non-compliance to the system, process or product reported to the
function or process and trying to avoid internal quality audit whenever conducted to their processes
or functions.
In order to reverse the situation, it is crucial that management provides ISO 9001 awareness training
to these employees group by group in order to change their mindset of resisting the ISO 9001 system
and procedures at work places. The relevant procedures, guidelines and work instructions may need
to be rewritten to reflect the actual works and subsequently ensure the relevant documents are retrained to the relevant employees.

Failure factor #5:

Failure to maintain and update the documented management system from time to time as changes
take place in the organization.
In this fast changing business world, the processes and ways of doing in many organizations are
experiencing tremendous changes from time to time. It is very crucial that such changes are reflected
in the existing documented procedures and relevant documents when changes take place in the
organizations.
Failure to review and update the existing documented procedures and other relevant documents after
achieving ISO 9001 certification will cause the integrity of the management system affected
therefore become not effective over time as the documented procedures and relevant documents will
become obsolete and unable to be followed by the employees.
Therefore it is very important that the top management should encourage and ensure that the
functional heads are made responsible in collaboration with the management representative to review
their own functional relevant documented procedures and documents from time to time when
changes takes place in the organization, or on periodic basis such as at least once yearly to
consciously look into the existing procedures and relevant documents within their own functional
areas and reviewed against the likely changes that have taken place in the organization in the past
one year and make amendment to the relevant procedures or documents accordingly coordinated by
the management representative. In order to facilitate and encourage the functional heads to make
amendment to their respective functional procedures and documents, the management representative
should on the specified month, example beginning of the year, make one set of the relevant
procedures and documents for each functions from the 'Master' copy that controlled by the
management representative, visibly stamp 'Copy for Amendment Purpose Only' or equivalent, and
issue to the relevant functional heads and encourage them to review and update within next 2-3
weeks time, and subsequently re-approve and re-distribute as per document control procedure. The

significantly revised procedures or documents should then be re-trained to the relevant affected
employees and such training records should be maintained accordingly.
Failure factor #6:
Ineffective internal quality audit / self-check system in the certified organization.
Internal quality audit to self check in order to ensure the integrity of management system by the
organization's management staff cross-functional and independently is the requirement of the
International Standard ISO 9001. It is however, the internal audit has not been effectively
implemented and conducted by many organizations.
Very often the top management of the certified organizations do not encourage the conduct of
internal audit nor willing to allocate sufficient time for the internal auditors to conduct such audits,
reasons being may be due to lack of awareness the importance and values of the internal audit and
the busy agenda of day to day business. Top management should recognize that the purpose of
internal audit is to ensure the employees are to cross-check each other to ensure that works are
carried out in the intended manners as stipulated in the documented criteria, methods and procedures
which have been approved by the top management them self. Due to the busy agenda, top
management definitely do not have time to check whether the employees are adhere to the right
procedures and practices, therefore internal audit is definitely serves as a good tool to ensure the
integrity of management system as intended of the top management.
A size of 150-200 employees organization should have a size of 8-10 internal auditors who are
competent (i.e. know well the ISO 9001 requirements) and capable to conduct an effective internal
audit. Internal audit should be conducted throughout the entire year instead of waiting until end of
the year to conduct a company-wide internal audit which will not gain the full benefit of the element.
Spreading the audits out over a year allows for more complete and effective assessment of the system.
As stipulated by the ISO 9001 requirements, internal audit shall be based on the 'status' and
'importance' of the areas or processes to be audited, as well as the results of the previous audits, i.e.
the areas or processes which are having much problem (reflects the poor 'status') or relatively more
activities or more important (reflect the 'importance' status) or areas or processes received more nonconformity reports from the previous year audit, should be audited more times or more frequents in
the current year, and vise-versa. The frequency of audits for each processes or areas should be
reflected in the yearly audit schedule or program. Observing this principle will ensure more effective
internal audit whereby the internal auditors can be mobilized to focus audit in the more problem and
relatively more activities areas or processes in the organization, and spend less time in the stable or
less important areas or processes.

Another factor that causes ineffective internal audit in many organizations is the lack of
understanding of ISO 9001 requirements among the appointed auditors. Very common an internal
audit conducted does not serve much value to ensure conformity to the organization management
system. Many times internal audits conducted will turn out to find faults among the employees
instead of finding facts that address the real ISO 9001 requirements that serves value to the business,
or most of the time the audit will ended up raising small or irrelevant matters which are not
significant to the control of the business, and in many cases frictions may surface between the
internal auditors and the audited functional heads and over time there will be tendency the staffs are
trying to avoid to conduct or attend to the audits.
In order to improve the competency of the internal auditors, it is very crucial that the internal auditors
are sent for retraining in order to have an in-depth and correct interpretation and effective
understanding of ISO 9001 requirements. With clear understanding of ISO 9001 requirements will
enable the internal auditors to be more confident and know what exactly to look for based on ISO
9001 requirements when conducting such audit to the relevant functions or processes within the
organization such as contract review, purchasing control, document control, management review,
design control, process control / product realization and so forth.

Failure factor #7:

Choosing a registrar / certification body for the wrong reason.
It is common practice for an organization seeking certification to obtain quotations from a variety of
registrars and choose the lowest bidder, and it is a tendency of organization to listen to the appointed
consultant who has a strong influent in the decision making of the organization management to select
a registrar which is easy going and able to work with or feel comfortable by the consultant.
Choosing a registrar based on price can result in missing an opportunity to learn from the knowledge
and experience of competent ISO 9001 auditors, and choosing a registrar influenced by the
consultant may lead to the selection of non-genuine registrar that is not impartial and unprofessional
in conducting the audits and therefore the integrity of the quality management system that has been
certified is not assured.
It is very crucial that registrar that chosen by an organization is genuine and professional and the
auditors are competent in carrying out their duties to thoroughly assess the organization against the
requirements of ISO 9001 and ensure the management system is effectively implemented prior to the
certification.

If the organization management system does not adequately address the ISO 9001 requirements i.e.
the necessary controls as needed to be addressed by the international standard are not in place, the
registrar auditors shall impartially raise these as non-conformity reports to the management for the
necessary corrective actions.

The organization management should not fear or worry of not getting the certification as there is rare
changes that organization will fail if appropriate corrective actions are taken to address the necessary
requirements in the management system and reply to the registrar within the due time agreed
between the organization with the registrar auditor, normally between one to three months period.
Certification will normally be awarded by registrar within a month period after receiving of
satisfactory replies of corrective actions from the organization.
The non-conformity reports raised by the registrar auditors are values added to the organization as
the registrar auditors have played important roles to ensure the necessary requirements or controls as
needed or intended by the ISO 9001 are addressed in the organization prior to the certification.
Corrective actions which were taken by the organization are for the organization and these are values
to the business which will in turn serve as the controls in the business in the long run. One
organization should feels more proud to achieve such genuine certification after going through a
thorough assessment, rather than receiving an easy going certificate which will not serves much
value except a short happiness when announced such achievement by the non-genuine registrar or
subsequently a certificate that hang on the wall for show which will rather give more burden to the
organization than the intended values.