ISO 9001 version 2008

The Origins of ISO 9001:2008

BS EN ISO 9001:2008, to give it its full title, is an internationally recognised standard

for quality management systems requirements, formerly know as BS 5750. During the
First World War it was noted that some munitions were particularly unreliable. This
meant that not only were they ineffective, but also in some cases, they caused loss of
life to those attempting to deploy them. This lead to the development of a defence
standard for the management of quality in the production of munitions.

Over the following 60 years this standard evolved into BS 5750, which was widely
adopted by industry (both commercial and military). In a move towards the
globalisation of standards, BS 5750 was combined with international standards and
evolved into BS EN ISO 9000 in 1987.

Recognition for the need of quality management systems in all areas of business (i.e.
service industries as well as the traditional manufacturing sector) throughout the
1990's lead to the demands on the standard (ISO 9000 series) changing. Because it
had its roots in the manufacturing industry, it was difficult for other industries (the
service sector in particular) to adopt the standard.

In the year 2000 this was addressed in the most significant amendment to ISO 9001
since its inception. It re-evaluated the principles of quality management and the result
was a restructuring of the standard. The most recent review of the standard was
published in 2008, but this revision was not a major change.

The principles of ISO 9001:2008

There are eight management principles that underpin the standard. These are all
recognised principles of good management and ISO 9001 brings them together to
form the model for a robust and effective management system.

The principles are:

• Customer focus
• Leadership
• Involvement of people
• Process approach
• System approach to management
• Continual improvement
• Factual approach to decision making
• Mutually beneficial supplier relationships

When developing any element of a management system each of these principles needs
to be considered.

What is required
The 2008 version of the standard adopts a business process management approach.
Only

four core elements now exist in the standard and these apply equally to any business

process whether engaged in the manufacturing or service industries.. These elements

are:

• Management responsibilities
• Resource management
• Product realisation
• Measurement, analysis and improvement

In summary, this means that the standard requires that your management systems
cover the following issues:

1. Management responsibilities

The roles and responsibilities of management and staff need to be clearly defined and
understood. This includes an understanding of the structure of the organisation and
how the groups within it interrelate. This enables adequate planning, objective setting
and effective management of the organisation.

2. Resource management

Adequate resources (including human resources) need to be made available and

managed to ensure the implementation of a quality management system. These
include:

• Providing methods for identifying the level of resource required for key tasks
and functions.
• Understanding the knowledge and skills required to effectively manage the
business, both now and in the future.

3. Product realisation

These are the controls employed to ensure that any product or service delivered to the
customer meets their requirements. These include the traditional controls for
manufacturing and the definition of customer requirements for services. This will
usually form the largest part of a management system and will identify how the
organisation controls its business from identifying customer requirements, through
contract review, planning and execution of the tasks that deliver the product or service
to the customer. These controls will contain a definition of the checks and balances
that are in place to ensure that each stage of the process achieves what is required to
deliver satisfaction to the customer.

4. Measurement, analysis and improvement

For the effectiveness of any management system to be monitored it is necessary to
measure its performance. The need to continually improve is now integral to ISO
9001.

Gaining third party certification

ISO 9001:2008 provides an internationally recognised model for quality management

systems. There are many tangible benefits to adopting the ISO 9001 model. These
include improvements to organisation effectiveness, efficiency and the continual
improvement of the business. Gaining third party certification can also bring benefits.
It allows you to demonstrate to your customers and potential customers that you are a
well organised, capable supplier who provides consistently high levels of customer
satisfaction and operates best practice in business management. Certification means
using an accredited independent third party to objectively assess your management
system to certify that it complies with the standard. It is achieved by having an
independent third party assessor audit your management system. There are a number
of certification companies in the UK and worldwide who provide this service. In the
UK these assessment bodies are regulated by the United Kingdom Accreditation
Service (UKAS http://www.ukas.com ). This organisation provides the assessment
bodies with an accreditation service that regulates the process and provides the
industry with assurance that consistent standards are applied. Any organisation can
issue a certificate that claims compliance with the standard but this only has
independent credibility in the UK if the issuing authority is a UKAS accredited body.
The process of certification typically takes the form of a pre-assessment followed by
an initial assessment that is maintained by ongoing periodic surveillance audits.

• Pre-assessment - takes place 3 to 6 months after the management system has

been established. This allows time for records to be generated as evidence of
the operation of the system. The pre-assessment allows the assessment body
assessor to familiarise themselves with the system and identify any major
omissions in the system before the assessment.
• Time Period - usually 6-12 weeks between the pre-assessment and initial
assessment to allow amendments to the system to be completed and
implemented.
• Initial assessment - formal assessment of the management system against the
standard. This involves an examination of the documentation that forms the
management system plus an assessment of the evidence gathered. This
demonstrates that the documented system is working in practice.
• Initial assessment process - involves interviewing a number of managers and
staff. An assessment is carried out on a sample basis, so not all records will be
examined and not all staff will be interviewed. When issued, a certificate is
only valid for a limited period of time and can be removed or cancelled by the
certification company at any time. A certificate is normally valid for three
years.
• Maintenance of certificate - the certification body re-visits and carries out
surveillance audits to ensure standards are maintained. These are typically
conducted every 6-9 months, dependent upon the size and complexity of the
business under assessment. Where an initial assessment will need to evaluate
the entire system, a surveillance audit is likely to be of more limited scope and
 will sample areas of the system in rotation. Over the 3-year period it is
necessary for the certification body to have re-visited all areas of the system.
• Renewal of certificate - a full reassessment of the system is required after
three years.

A copy of the standard can be obtained from the International Organisation for
Standardisation (ISO) or British Standards Institute (BSI). Certification services are
offered by a large number of companies worldwide. A full list is available from
UKAS. What to do next If you are considering implementing ISO 9001:2008 or are
simply looking to develop a quality management system and think you may need help
and advice, please contact The Quality Team today for an informal no obligation chat.