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Monday, January 18, 2016
Tags Posts tagged with "iso 9000"

iso 9000

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    The ISO 9000 series of quality standards is the most used management system worldwide; thousands of organizations rely on these standards to establish an effective quality management system. Here are some facts every organization pursuing to implement ISO 9001 should know.

    1. The ISO 9000 family of standards are a set of standards and guidelines that have global reputation as being the basis for the establishment of quality management systems (QMS).
    2. The adoption of all standards published by ISO, including standards in the ISO 9000 family, is voluntary in nature.
    3. In the ISO 9000 series, all standards can be implemented without certification. Any business can use the models from the standards to improve quality management systems.
    4. Many countries have adopted the ISO 9000 family of standards and have also appropriated its numbering system for their national standards. For instance in the United Kingdom, ISO 9001 is referred to as BS EN ISO 9001:2008, with BS standing for British Standard and EN for European Norm. In Sri Lanka, the standard is numbered SLS ISO 9001:2008, with SLS denoting Sri Lankan Standard.
    5. Any organization, regardless of the type of products or services they offer, can use ISO 9001 as their guideline to implement, maintain and improve a successful QMS.
    6. ISO 9001 provides a process approach for its execution, which enables the QMS to connect with other organizational processes; and its focus on continuous improvement and customer satisfaction will lead to an improved business performance.
    7. ISO 9001 specifies what an organization “should” do, but not “how” they should do it, giving great flexibility for any company, large or small, to use this standard. Additionally, ISO 9001 does not establish specific quality requirements; this is a decision taken by each organization; the standard is only a guide to achieve the goals and objectives set by each organization.
    8. Specific industry requirements were added to ISO 9001 to create standards for organizations in the automotive, telecommunications, aerospace, medical devices, oil and gas, and information technology sectors. These QMS standards have not diluted or modified the requirements of the ISO 9001 generic standard, but have added some sector-specific requirements, guidelines and clarifications. Some of these are:
      • Automotive industry:  ISO/TS 16949
      • Medical devices: ISO 13485
      • Primary packaging materials for medicinal products: ISO 15378
      • Petroleum, petrochemical and natural gas industries: ISO/TS 29001
      • Telecommunications industry: TL 9000
      • Aerospace Industry: AS 9100; AS9110 and AS9120
    9. Certification of your QMS by an accredited certification body generates confidence among your existing and potential customers and other interested parties that you are capable of supplying consistently conforming products or services.
    10. Adherence to the ISO standards can be publicized to gain market access abroad, because many foreign buyers place a premium on these standards.

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      Ready to implement ISO 9001 in your organization? Here are some ISO 9001 tips that will help make the process easier.

      Implement ISO 9001 for the right reason.

      When implementing a quality management system (QMS) for ISO 9001, management should be clear about the purpose of the QMS. If the only driver is to get on customers’ tender lists or because a competitor has already got one, it’s highly likely that the QMS will remain a set of documents for certification purposes only. Rather, management should aim for a QMS that will help the organization produce quality products or services, continuously improve its process, and provide confidence to customers that the organization is capable of meeting their requirements all the time.

      Motivate your workforce.

      In order for organizations to achieve a desired level of quality, people need to get involved. People are the essence of organizations and their full involvement is essential to implement and maintain ISO 9001. Employees can be motivated by:

      • Ensuring that everyone knows and understands the organization’s quality policy;
      • Defining and communicating responsibilities and authorities within the organization;
      • Building the competence of employees;
      • Providing adequate infrastructure and work environment;
      • Initiating improvements, e.g. by implementing employees’ suggestions.

      Hire a consultant if…

      If an organization’s staff does not have the time or skills to develop the QMS by themselves, a good consultant will make possible a speedy transfer of knowledge and skills. If the staff does have the time, there are enough published materials available from the web that will help staff obtain the necessary skills to develop the QMS.

      Take the necessary time to implement your QMS.

      All too often organizations are in a hurry to obtain certification and do not spend the time needed to implement the system effectively. Before applying for certification, your QMS needs to be in place for at least three months and its effectiveness checked through an internal audit, followed by corrective actions on audit findings.

      Define SMART objectives.

      Many organizations set quality objectives that are impossible to meet. Objectives need to be specific and relevant to the process or task to which they are being applied. They also need to be measurable and achievable within the resources that can be made available in a realistic and timely manner. It’s helpful to have a start and completion date.

      Go easy with the paperwork.

      Many believe that everything in the system needs to be elaborately documented. ISO 9001 only requires one quality manual, six procedures, and approximately 20 records. Many organizations are better off sticking to what is required and keeping those documents simple; additional procedures and records should be considered only if they add value to the system.

      Set the example.

      Some employees, especially mid-level managers, may find it difficult to change their ways of doing things and some can have a tendency to deviate from defined procedures. To change this, top management should ‘walk the talk’, i.e. they should not allow deviations from set procedures or permit the release of materials with deviations. Under such an approach, the mid-level managers will start respecting system requirements and everyone will take account of their responsibilities for the success of the QMS.

       

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