Unit 2
Unit 2
People are responsible for the implementation of ISO 9000. An implementation team, headed
by a Service Provider and a Management Representative (MR), is to be established. The Service
Provider and MR is the coordinator and is responsible for planning and overseeing the
implementation of the quality management system. He is thus the link between top
management and the ISO 9000 registrar. All departments within the organisation should be
represented on the implementation team.
Conducting ISO 9000 awareness programs will inform all employees about the aim of a quality
management system. These include the advantages offered to customers and employees,
their respective responsibilities and roles within the system, and how the quality
management system operates. The benefits that an organisation hopes to realize through
aquality management system implementation should be emphasized through ISO
9000awareness programs.
All personnel and all areas in an organisation are affected by a quality management system.
Training regarding the quality management system should thus be provided for all
employees. The quality management system implementation plan should make provision for
this training. All basic concepts of quality management systems and its impact on the
organisation should be covered.
A quality management system conforming to the ISO 9000 standard should be created.
However, this does not preclude incorporating, adapting, or adding onto quality programs that
already exists. Thus, this step basically involves comparing an organization’s existing quality
management system (if there is one) with the requirements of ISO 9001:2008.
Once an organization’s quality management system has been compared with the ISO
9001:2008 standard, a documented implementation plan is used to address any non-
conformances. The documented implementation plan identifies and describes processes in
order to make the organization’s current quality management system in full compliance with
the ISO 9000 standard.
Step 9: Implementation
Through management review and an internal quality audit, the implementation progress is
monitored to ensure that the quality management system is effective and thus conforms to
the IS0 9000 standard
The effectiveness of the installed system should be checked regularly by means of an internal
quality audit. Below are some reasons for conducting an internal quality audit into a quality
management system:
A management review should be conducted three to six months after quality management
system implementation took place. The reasons for conducting management reviews are to
ensure continuous effectiveness, adequacy, and suitability of the quality management
system.
Before applying for certification, a pre-assessment audit usually takes place. Certification bodies
provide a qualified but independent auditor to conduct this service. Some degree of confidence
is gained before application for certification if the pre-assessment audit goes well
A formal application for certification is made at a certification body as soon as the quality
management system has been operating for a few months and has stabilized. An audit of the
documents (known as an adequacy audit) is first carried out, and if it conforms to the
requirements of the quality standard, it is followed by an on-site audit. A certificate is only
awarded to the organisation if the certification body is satisfied with the workings of the system.
However, the certificate is valid for a period of three years only, after which the certification
body will carry out periodic surveillance audits.
Step 14: Continual Improvement
Although an organisation gained certification, it is important to note that it has to try and
improve the suitability and effectiveness of the quality management system on a continuous
basis.
Certification Documentation
As an open and transparent standard, the following information is posted here for all potential manufacturers, suppliers
and interested parties to view and use. The four sections encompass usage of the level certification mark, the level
certification program, the certification guidelines, and a level certification mark usage agreement.
While biased regarding the value of the content, we admit that it may be a bit dry for those only interested in a cursory
overview of the program. However, if you really want to understand level and its components, this is a great place to read
more comprehensive information about the program.
Certification of products is a very important part of innovation and production in general to ensure that products and
services are both safe and ethical. In the past fifteen years, there has been a great increase in the usage of
certification. More specifically, third party certifiers have become much more widely used, and there are many more
of them. The idea of a third party certifying companies and products can give consumers a feeling of comfort in what
they purchase, knowing that an independent organization has certified what they are using. Third party certifiers can
be extremely helpful to companies as well. With no real authority to punish a company for not upholding certain
standards, other than withholding certification, a third party certifier is more in the role of motivator or advisor,
showing companies what they need to change about their practices in order to be certified. Essentially, third party
certification can act as a “filter” for innovation, providing guidelines that new products must follow before being put
into use.
Most third party certifiers have at least one other organization that ensures that they follow and enforce
proper quality standards on themselves and on the companies that they are certifying. As can be seen in the figure
below, there are generally three levels of certification. The lowest level is the certification body (CB). These
organizations are the ones actually doing the audits on the companies who will, depending on the outcome, be
certified. CBs may be as small as a few people, while some are transnational and have tens of thousands of
employees. Some of these certification bodies are unaccredited. CBs take this route for several reasons, most
commonly because being accredited is too expensive, or they disagree with some of the standards that the
accreditors hold.(14) Most, however, have been accredited to audit companies by an accreditation body (AB). An
accreditation body sets standards and guidelines by which to audit companies, and then certifies CBs to do the
auditing. Accreditation bodies then continuously make sure that CBs and their employees are following the standards
that the AB has set up. CBs may be a part of many different ABs as well. For example, National Sanitation
Foundation International (NSF), one of the largest CBs in the world, is accredited by The Standards Council of
Canada (SCC), The United Kingdom Accreditation Service (UKAS), and The American National Standards Institute-
American Society for Quality National Accreditation Board (ANAB). Finally, the third level of checks is through
accreditor associations. These are groups that ABs join voluntarily with a desire for consistent, mutually agreed upon
standards which many different ABs in different markets will promote. Just like the CBs that they audit, accreditation
bodies are audited by their accreditor association in order to join and continue to be audited during their membership.
Not all third party certifiers are a part of an accreditor association, and some unaccredited CBs may be a part of an
accreditor association, but this three-leveled auditing system is the typical format for third party certification
organizations.
Third party certification is much more trustworthy than self-certification, and more nurturing of innovation
than government regulation. However, it cannot produce complete certainty of safety and quality in a product. Despite
this lack of complete trust, innovation in third party certification has shown how much a well-run certification body can
do, both for people and for the companies that they are certifying. They can use licensing and auditing fees to help
support the community through health and education, like GoodWeave. B Lab is trying to get the business world to
the point where certification of quality and sustainability are used as a marketing tool by smaller companies. Third
party certification is attempting to encourage and foster innovation in a way that government agencies cannot,
supporting companies in more of an “arm over the shoulder” type of relationship.(46) In other words, it is help, not a
hindrance, to good innovation, and more than just a regulatory agency.