ISO 9001:2015




  • Global Adoption of ISO 9001 Certification

    The global adoption of ISO 9001 may be attributable to a number of factors. In the early days, the ISO 9001 requirements were intended to be used by procuring organizations, as the basis of contractual arrangements with their suppliers. This helped reduce the need for "supplier development by establishing basic requirements for a supplier to assure product quality. The ISO 9001 requirements could be tailored to meet specific contractual situations, depending on the complexity of product, business type (design responsibility, manufacture only, distribution, servicing etc.) and risk to the procurer. If a chosen supplier was weak on the controls of their measurement equipment (calibration), and hence QC (Quality Checker)/inspection results, that specific requirement would be invoked in the contract,

    What is ISO 9001:2015?

    ISO 9001 helps you to establish an effective system in your organization. ISO 9001-2015 is not product certification but ensures that an organization's management systems are effective and meet the requirement of the ISO 9001-2015 standards which is the latest version of the QMS. ISO 9001:2015 sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity.

    Content of ISO 9001:2015

    ISO 9001:2015 Quality management systems — Requirements is a document of approximately 30 pages available from the national standards organization in each country. Only ISO 9001 is directly audited against for third party assessment purposes.

    Contents of ISO 9001:2015 are as follows: 
    Section 1: Scope 
    Section 2: Normative references
    Section 3: Terms and definitions
    Section 4: Context of the organization
    Section 5: Leadership
    Section 6: Planning
    Section 7: Support
    Section 8: Operation
    Section 9: Performance evaluation
    Section 10: Continual Improvement
    What is the Benefit of ISO 9001?
    • Organize a quality management system (QMS)
    • Create satisfied customers, management, and employees
    • Continually improve their processes
    • Save costs
    • Improvement of your credibility and image
    • Improvement of customer satisfaction
    • Better process integration
    • Improve your evidence for decision making
    • Create a continual improvement culture
    • Engagement of employees

    ISO 9001 Standard Describe 

    The standard no longer specifies that the organization shall issue and maintain documented procedures, however, ISO 9001:2015 requires the organization to document any other procedures required for its effective operation. The standard also requires the organization to issue and communicate a documented quality policy, a quality management system scope, and quality objectives. The standard no longer requires compliant organizations to issue a formal Quality Manual. The standard does require retention of numerous records, as specified throughout the standard. New for the 2015 release is a requirement for an organization to assess risks and opportunities (section 6.1) and to determine internal and external issues relevant to its purpose and strategic direction (section 4.1). The organization must demonstrate how the standard's requirements are being met, while the external auditor's role is to determine the quality management system's effectiveness. More detailed interpretation and implementation examples are often sought by organizations seeking more information in what can be a very technical area.

    There are varying statistics, but there were more than 1.3 million ISO 9001 certificates in effect at the end of 2014 in 190+ countries around the globe. Each revision of ISO 9001 has focused more on the success of the organization, rather than on the tools of quality management. The more we can contribute to business success, the more valuable will be the contribution of Quality Management Systems.