ISO9001

ISO9001

Proper quality management system ISO9001 can improve business, often having a positive effect on investment, market share, sales growth, sales margins, competitive advantage, and avoidance of litigation. The quality principles in ISO 9000:2000 are also sound, according to Wade and Barnes, who says that “ISO9001 guidelines provide a comprehensive model for quality management systems that can make any company competitive”. Sroufe and Curkovic, (2008) found benefits ranging from registration required to remain part of a supply base, better documentation, to cost benefits, and improved involvement and communication with management. According to ISO9001 the 2015 version of the standard brings the following benefits:

  1. By assessing their context, organizations can define who is affected by their work and what they expect. This enables clearly stated business objectives and the identification of new business opportunities.
  2. Organizations can identify and address the risks associated with their organization.
  3. By putting customers first organizations can make sure they consistently meet customer needs and enhance customer satisfaction. This can lead to more repeat custom, new clients and increased business for the organization.
  4. Organizations work in a more efficient way as all their processes are aligned and understood by everyone. This increases productivity and efficiency, bringing internal costs down.
  5. Organizations will meet necessary statutory and regulatory requirements.
  6. Organizations can expand into new markets, as some sectors and clients require ISO9001 before doing business.

Essentially the layout of the standard is similar to the previous ISO9001:2008 standard in that it follows the Plan, Do, Check, Act cycle in a process-based approach, but is now further encouraging this to have risk-based thinking. (section 0.3.3 of the introduction) The purpose of the quality objectives is to determine the conformity of the requirements (customers and organizations), facilitate effective deployment and improve the quality management system.

Before the certification body can issue or renew a certificate, the auditor must be satisfied that the company being assessed has implemented the requirements of sections 4 to 10. Sections 1 to 3 are not directly audited against, but because they provide context and definitions for the rest of the standard, not that of the organization, their contents must be taken into account.

The standard no longer specifies that the organization shall issue and maintain documented procedures, however, ISO9001:2015 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.