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QUALITY MANAGEMENT SYSTEMS AND STANDARDS APPROACH

The ISO 9000: The International Standard for Quality Management Systems
The ISO 9000 is a family of standards and guidelines. It sets the requirement for quality assurance and
management’s involvement. The main objective of ISO 9000 is for the organizations to implement the
following standard requirements:

1. Improve customer satisfaction by fulfilling customer requirements.

2. Achieve continual improvement of organizational performance and competitiveness.
3. Continually improve organizational processes, products, and services.
4. Comply with regulatory requirements.

How ISO 9000 is Applied to Organizations

• Organizations must develop and use Quality Management Systems (QMS) conforming to the
established standards and guidelines of ISO 9001 in order to secure a registration to ISO 9000.
• ISO 9001 is part of the ISO 9000 family which determines the requirements of a Quality Management
System (QMS).
• Quality Management System (QMS) is composed of all the organization’s policies, procedures, plans,
resources, processes, and delineation of responsibility and authority, all deliberately aimed at
achieving product or service quality levels consistent with customer satisfaction and the organization’s
objectives. The quality management system must include the following documentation:
1. A quality policy. It refers to a statement that describes how the organization approaches quality.
2. The quality manual. It refers to a collection of guiding policies that address each clause of the ISO
9001 standard. It typically includes an organizational chart which illustrates management
responsibility for operating the quality system.
3. Quality objectives. It refers to the goals related to quality and must be in harmony with the quality
policy of the company.
4. Quality procedures. It refers to a step-by-step method which describes how the company meets
the quality policy.
5. Forms and records. It refers to the proof of activities of the firm that will support the quality
procedures.
• The following is the step-by-step guide in ISO 9000 certification:
1. Develop a quality manual or upgrade an existing quality manual that describes how the
organization will assure the quality of its products or services.
2. Document procedures that describe how the various processes for design, production, and
continual improvement will be accomplished. In addition, the documentation must include
procedures for management reviews and audits.
3. Secure the commitment of the top management to Quality Management Systems (QMS) and
continual improvement.
4. Ensure that customer requirements are determined and consistently met by the organization.
5. Hire an accredited registrar company to examine the systems, processes, procedures, quality
manual, records, and related items of the organization. If everything is in order and if the registrar
is convinced that the organization is effectively using the QMS, registration will be granted.

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Otherwise, the registrar will inform the organization pertaining to the areas that require
improvement, and another audit will be scheduled.
6. Conduct internal audits to ensure that the systems, processes, and procedures are working
effectively.
7. Practice continual improvement since the outside registrar will make periodic audits which
requirements must be complied by the organization in order to retain their ISO 9000 registration.

Benefits of ISO 9000

The following are the benefits associated with ISO 9000 certification:

• Increased marketability. ISO 9000 certification provides businesses with heightened credibility to
current and prospective clients. An ISO certified company denotes a consumer perception that
the company brings quality to their customers which helps increase customer retention and
acquisition.
• Reduced operational expenses. ISO 9000 registration exposes significant shortcomings in various
operational areas of the business which can be improved to save company’s time and financial
resources.
• Better management control. ISO 9000 registration process results to a realization of the
company’s overall direction since the certification requires self-assessment of the business
process.
• Increased customer satisfaction. ISO 9000 registration uncovers areas in which the quality of the
final product can be improved resulting to continual improvement in the outputs which eventually
brings higher levels of customer satisfaction.
• Improved internal communication. ISO 9000 registration process puts emphasis on self-analysis
and operations management issues encouraging various departments of a company to interact
with one another in hopes of gaining a more complete understanding of the needs and desires of
their internal customers.
• Improved customer service. ISO 9000 registration serves to refocus company priorities on
pleasing their customers in all respects including their customer service.
• Reduction of product-liability risks. ISO 9000 certification limits the chance of a company to be
charged with product liability lawsuits because of the established ISO standards incorporated in
their processes.
• Attractiveness to investors. ISO 9000 certification increases the likelihood of a company to secure
funding from venture capital firms.

ISO 9000 Versions/Updates

The various updates to ISO 9000 are summarized as follows:

• ISO 9000:1987. This initial version of the ISO 9000 standard puts emphasis on conformance with
procedures rather than the overall process of the management. It contains three (3) models for
quality management systems as follows:
o ISO 9001:1987. Quality assurance in design, development, production, and installation
services
o ISO 9002:1987. Quality assurance in production, installation, and servicing
o ISO 9003:1987. Quality assurance in final inspection and test

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• ISO 9000:1994. This version emphasizes quality assurance by enforcing preventive actions instead
of just merely conforming to the procedures and checking the final product. However, this version
still requires a comprehensive evidence of compliance with properly documented procedures.

• ISO 9001:2000. This version combined ISO 9001, 9002, and 9003 into one (1) document that is
ISO 9001. It sought to create a radical change in the concept of process management by
monitoring and optimizing the company’s activities to achieve quality improvement. In addition,
it also emphasizes the contribution of upper executives in integrating quality into the business
system. It also gives emphasis on enforcing performance metrics as a numerical measurement of
the effectiveness of the different tasks and activities of a company. Also, it highlights continual
process improvement and tracking customer satisfaction. The established requirements of this
version for ISO certification were the following:
o Approved documents before distribution
o Provided correct version of documents at points of use
o Presented company records to prove that requirements have been met
o Developed a procedure to control company records

• ISO 9001:2008. This version is not substantively different from ISO 9001:2000, but several
important requirements were added as follows:
o The quality policy must be a formal statement from upper management that is linked to
the organization’s business and management plan.
o The quality policy must be understood and used by all personnel at all levels.
o Each member of the personnel must have a measureable work objective.
o The quality system must be audited regularly for conformance and effectiveness.
o Decisions about the quality system must be based on recorded data.
o Records must trace problems directly to its source. Records must include where and how
raw materials were processed.
o The organization must have a comprehensive system for communicating with customers
about any and all aspects of the relationship.
o Product development must have planned stages with testing at every stage, and test results
must be documented to indicate whether the product meets all applicable requirements.
o Organizational performance must be regularly reviewed.
o The organization must have documented procedures for dealing with nonconformance.

• ISO 9001:2015. This version is constructed around the seven (7) quality management principles
such as customer focus, leadership, engagement of people, process approach, improvement,
evidence-based decision making, and relationship management. This ISO version puts emphasis
on measuring and properly assessing the input and output of processes. It encourages risk-based
thinking by employing risk analysis to determine the challenges in the business process of an
organization. In addition, the concept of stakeholders in the business is also extended from
customers to suppliers, personnel, shareholders, legislative bodies, society, and internal
customers. This version recommends that organizations must be aware of the importance of
these stakeholder’s changing requirements and standards. Organizations must anticipate these

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changing standards and must be able to incorporate them in the features of their products and
services as a way of promoting continual improvement.

References
Goetsch, D. (2014). Quality management for organizational excellence: Introduction to total quality.
United Kingdom: Pearson Education Limited.

Pauwels consulting – Important differences between ISO 9001:2015 and ISO 9001:2008. (2015).
Retrieved on July 10, 2018 from https://www.pauwelsconsulting.com/blog/iso-9001-2015/

Reference for business – ISO 9000. (n.d.). Retrieved on July 10, 2018 from
http://www.referenceforbusiness.com/small/Inc-Mail/ISO-9000.html

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