ISO 9001:2008

  • September 9th, 2011  

    Standards

    The ISO 9000 family of internationally recognised standards on good quality management practices. It consists of standards and guidelines relating to quality management systems and related supporting standards.

    ISO 9001:2008 – provides a set of standardised requirements for a quality management system, regardless of what the user organisation does, its size, or whether it is in the private, or public sector.

    ISO 9001 is the only standard in the 9000 series against which organisations can be certified.

    The standard allows organisations to;

      • develop a simplified set of standards, and
      • develop documentation more relevant to the desired results of the organisation’s process activities.

    Implementation

    The standard provides a framework to managing the organisation’s processes so that they consistently achieve customers’ expectations.

    The standard is based upon the Plan-Do-Check-Act methodology.

    The process lead approach to implementing ISO 9001, means that organisations must

      • Identifying the processes necessary for the effective implementation of the quality management system
      • understanding the interactions between these processes.
      • documenting the processes to the extent necessary to assure their effective operation and control. (It may be appropriate to document the processes using process maps. It is emphasized, however, that documented process maps are not a requirement of ISO 9001:2008.)

    ISO 9001:2008 sets down what requirements your quality system must meet, but does not dictate how they should be met. This leaves great scope and flexibility for implementation in different business sectors and business cultures, as well as in different national cultures.

    Quality Management Principles

    The ISO 9000 series of standards are based on eight quality management principles. These principles are defined in ISO 9000:2005, Quality management systems Fundamentals and vocabulary, and in ISO 9004:2000, Quality management systems Guidelines for performance improvements. These 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

    Documentation Required

    The QMS shall include in accordance with Clause 4.2.1:

      • documented quality policy and quality objectives;
      • a quality manual
      • documented procedures required by standard
      • documents needed by the organisation to ensure the effective planning, operation and control of its processes, and
      • records required by this International Standard;

    The notes after Clause 4.2 make it clear that where the standard specifically requires a “documented procedure”, the procedure has to be established, documented, implemented and maintained. It also emphasises that the extent of the QMS documentation may differ from one organization to another due to:

      • the size of organisation and type of activities;
      • the complexity of processes and their interactions, and
      • the competence of personnel.

    All the documents that form part of the QMS have to be controlled in accordance with clause 4.2.3 of ISO 9001:2008, or, for the particular case of records, according to clause 4.2.4.

    Quality Policy and Objectives:


      • Requirements for the quality policy are defined in clause 5.3 of ISO 9001:2008. The documented quality policy has to be controlled according to the requirements of clause 4.2.3.
      • Requirements for quality objectives are defined in clause 5.4.1 of ISO 9001:2008. These documented quality objectives are also subject to the document control requirements of clause 4.2.3.

     Quality Manual:

    • Clause 4.2.2 of ISO 9001:2008 specifies the minimum content for a quality manual. The format and structure of the manual is a decision for each organisation, and will depend on the organisation’s size, culture and complexity.
    • The quality manual is a document that has to be controlled in accordance with the requirements of clause 4.2.3.

Documented procedures:

ISO 9001:2008 specifically requires the organisation to have “documented procedures” for the following six activities:

    • 4.2.3 Control of documents
    • 4.2.4 Control of records
    • 8.2.2 Internal audit
    • 8.3 Control of nonconforming product
    • 8.5.2 Corrective action
    • 8.5.3 Preventive action

These documented procedures have to be controlled in accordance with the requirements of clause 4.2.3

Assessment to ISO 9001.

  • Stage 1 the third party accredited certification body will review the organisations documentation and carry out an initial audit of the site. This will look at the company's evaluation of environmental effects and ascertain if targets set for the management programme are measurable and achievable.
  • Stage 2 – a followed up visit consisting of a full audit to ensure that records and working practices demonstrate that the organisation is following its procedures.
  • After a successful audit and the issue of a certificate, there will then be surveillance visits (usually once or twice a year) to ensure that the system continues to work.

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