What does ISO mean?
ISO (from the Greek word isos meaning "equal") is a network of 156 national standards bodies, based in Geneva, Switzerland. In English, ISO stands for the International Standardization Organization.
ISO is a non-governmental organization: its members are not delegations of national governments. Consequently, ISO is able to act as a bridge between the requirements of business and the needs of consumers and users. Many of its member bodies are part of the governmental structure of their own countries, while other members are rooted in the private sector.
What is the process approach?
The 2008 revision features a concept called the 'process approach'. This means that you should consider how the inputs and outputs of your key processes flow from one activity to the next, what sub-processes might exist within that and how the support processes link in.
How do I determine processes?
When defining your organization’s processes, think about each process and department and try to define those processes around the current organizational model and not around the requirements of the standard. In deciding which processes should be documented, you may wish to consider factors such as:
- Effect on quality
- Risk of customer dissatisfaction
- Statutory and/or regulatory requirements
- Economic risk
- Effectiveness and efficiency
- Competence of personnel
- Complexity of processes
How do I implement ISO 9001?
Before you begin, buy a copy of ISO 9000:2005 and ISO 9001:2008 - read it and make yourself familiar with it. Although it is written in a dense, formal language the clause titles self-explanatory
There are a wide range of quality publications, training courses and software tools designed to explain and help you understand, implement and become registered to ISO 9001:2008.
You should begin by preparing your organizational strategy with top management. Responsibility for a QMS lies with Senior Management, therefore it is vital that Top Management are involved from the start.
You can receive advice from independent consultants on how to implement your quality management system. Or you can do it yourself using our products and free White Papers which explain ISO 9001:2008 and provide a realistic, small business model.
The registrar (certification body) is the 3rd party who will assess your quality management system, and issue a certificate if it meets the requirements of ISO 9001:2008. In choosing a registrar you should consider industry experience, geographic coverage, price and service level offered.
The key is to find a registrar who can meet your requirements. Get information on potential UK certification bodies, please visit UKAS. NOTE: Accreditation Bodies audit and 'accredit' the Certification Bodies who audit and 'certify' you.
Prepare the quality manual and procedures. The procedures support and implements quality Manual. Quite simply, it should outline what you do to complete a task. It describes who does what, in what order and to what standard.
Implement your quality management system through communication, training and awareness. During the implementation phase everyone operates to the procedures and collects records that demonstrate you are doing what you say you do. Carry out internal audits and management review.
A pre-assessment audit by your registrar normally takes place about 6 weeks before Registration (at extra cost). The purpose of the pre-assessment is to identify areas where you may not be operating to the standard. This allows you to correct any areas of concern before assessment (registration).
For the ISO 9001 registration audit, you should arrange an initial assessment with your registrar. At this point the registrar will review your QMS (by interviewing staff, observing activities and checking records) to decide whether you should be recommended for Registration.
Continual assessment is required to maintain your Registration, you need to continue to use and review your quality manual, procedures and processes. This will be periodically checked by your registrar to ensure that your quality management system continues to meet the requirements of the standards.