Implementing ISO 9001-2008 Quality Management System


Implementing ISO 9001-2008 Quality Management System
Implementation of ISO 9000 affects the entire organization from the start. If pursued with
total dedication, it results in a ‘cultural transition’ to an atmosphere of continuous

The process of implementing ISO 9000 depends on:

  • The sophistication of your existing quality program,
  • The size of your organization, and
  • The complexity of your process.

The 14 essential steps, briefly described below, are to be followed through to implement
an ISO 9000 quality management system successfully:

Step 1: Top Management Commitment
The top management (managing director or chief executive) should demonstrate a
commitment and a determination to implement an ISO 9000 quality management system
in the organization. Without top management commitment, no quality initiative can
succeed. Top management must be convinced that registration and certification will
enable the organization to demonstrate to its customers a visible commitment to quality.
It should realize that a quality management system would improve overall business
efficiency by elimination of wasteful duplication in management system.

Step 2: Establish Implementation Team
ISO 9000 is implemented by people. The first phase of implementation calls for the
commitment of top management – the CEO and perhaps a handful of other key people.
The next step is to establish implementation team and appoint a Management
Representative (MR) as its coordinator to plan and oversee implementation. Its
members should include representatives of all functions of the organization – Marketing,
Design and development, Planning, Production, Quality control, etc.

Step 3: Start ISO 9000 Awareness Programs
ISO 9000 awareness programs should be conducted to communicate to the
employees the aim of the ISO 9000 quality management system; the advantage it offers
to employees, customers and the organization; how it will work; and their roles and
responsibilities within the system. Suppliers of materials and components should also
participate in these programs.

Step 4: Provide Training
Since the ISO 9000 quality management system affects all the areas and all personnel
in the organization, training programs should be structured for different categories of
employees – senior managers, middle-level managers, supervisors and workers. The
ISO 9000 implementation plan should make provision for this training. The training
should cover the basic concepts of quality management systems and the standard and
their overall impact on the strategic goals of the organization, the changed processes,
and the likely work culture implications of the system. In addition, initial training may also
be necessary on writing quality manuals, procedures and work instruction; auditing
principles; techniques of laboratory management; calibration; testing procedures, etc.

Step 5: Conduct Initial Status Survey
ISO 9000 does not require duplication of effort or redundant system. The goal of ISO
9000 is to create a quality management system that conforms to the standard. This does
not preclude incorporating, adapting, and adding onto quality programs already in place.
So the next step in the implementation process is to compare the organization’s existing
quality management system, if there is one — with the requirements of the standard (ISO
9001:2000). For this purpose, an organization flow chart showing how information
actually flows (not what should be done) from order placement by the customer to
delivery to this customer should be drawn up. From this over-all flow chart, a flow chart
of activities in each department should be prepared. With the aid of the flow charts, a
record of existing quality management system should be established. A significant
number of written procedures may already be in place. Unless they are very much out of
date, these documents should not be discarded. Rather, they should be incorporated
into the new quality management system.

Step 6: Create a Documented Implementation Plan
Once the organization has obtained a clear picture of how its quality management
system compares with the ISO 9001:2000 standard, all non-conformances must be
addressed with a documented implementation plan. Usually, the plan calls for identifying
and describing processes to make the organization’s quality management system fully in
compliance with the standard.

Step 7: Develop Quality Management System Documentation

  • Documentation of the quality management system should include:
  • Documented statements of a quality policy and quality objectives,
  • A quality manual,
  • Documented procedures and records required by the standard ISO 9001:2000,
  • and
  • Documents needed by the organization to ensure the effective planning, operation
  • and control of its processes.

Step 8: Implementation
It is good practice to implement the quality management system being documented as
the documentation is developed, although this may be more effective in larger firms. In
smaller companies, the quality management system is often implemented all at once
throughout the organization. Where phased implementation takes place, the
effectiveness of the system in selected areas can be evaluated.

Step 9: Internal Quality Audit The PEN Group, LLC.
As the system is being installed, its effectiveness should be checked by regular internal
quality audits. Internal quality audits are conducted to verify that the installed quality
management system:

  • Conforms to the planned arrangements, to the requirements of the standard (ISO9001:2000) and to the quality management system requirements established by your organization, and
  • Is effectively implemented and maintained.

Step 10: Management Review
When the installed quality management system has been operating for three to six
months, an internal audit and management review should be conducted and corrective
actions implemented. The management reviews are conducted to ensure the continuing
suitability, adequacy and effectiveness of the quality management system.

Step 11: Pre-assessment Audit
When system deficiencies are no longer visible, it is normally time to apply for
certification. However, before doing so, a pre-assessment audit should be arranged with
an independent and qualified auditor. Sometimes certification bodies provide this service
for a nominal charge. The pre-assessment audit would provide a degree of confidence
for formally going ahead with an application for certification.

Step 12: Certification and Registration
Once the quality management system has been in operation for a few months and has
stabilized, a formal application for certification could be made to a selected certification
agency. The certification agency first carries out an audit of the documents (referred to
as an “adequacy audit”). If the documents conform to the requirements of the quality
standard, then on-site audit is carried out. If the certification body finds the system to be
working satisfactorily, it awards the organization a certificate, generally for a period of
three years. During this three-year period, it will carry out periodic surveillance audits to
ensure that the system is continuing to operate satisfactorily.

Step 13: Continual Improvement
Certification to ISO 9000 should not be an end. You should continually seek to improve
the effectiveness and suitability of the quality management system through the use of the corrective action and preventive action process.

Description of Services
Provide training to facilitate ISO 9001:2008 certification

1.   Introducing ISO 9001:2008 to Management
2.   Introducing ISO 9001:2008 to the Employees Plant-wide
3.  Developing an ISO 9001:2008 Quality Manual from an ISO
4.   Developing Procedural Documentation for ISO 9001:2008
5.   ISO 9001:2008: Internal Auditing
6.   ISO 9001:2008: Implementing Continuous Improvement,
Corrective Action (Plan-Do-Check-Act), and Preventive
7.  Implementing ISO 9001:2008 in Your Area