ISO 9001- Quality management system

 

The ISO 9000 family of standards is related to quality management systems and designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to the product. The standards are published by ISO, the International Organization for Standardization, and available through National standards bodies. ISO 9000 deals with the fundamentals of quality management systems, including the eight management principles on which the family of standards is based. ISO 9001 deals with the requirements that organizations wishing to meet the standard have to fulfill
ISO 9001 certification is frequently used in both private and public sectors to increase confidence in the products and services provided by organizations, between partners in business-to-business relations, in the selection of suppliers in supply chains and in the right to tender for procurement contracts.

Expected Outcomes for Accredited Certification to ISO 9001

 (from the perspective of the organization’s customers)

 “For the defined certification scope, an organization with a certified quality

management system consistently provides products that meet customer and

applicable statutory and regulatory requirements, and aims to enhance

customer satisfaction.”

Notes:

  1. “Products” also include “services.”
  2. Customer requirements for the product may either be stated (for example in a 
    contract or an agreed specification) or generally implied (for example in the
    organization’s promotional material, or by common practice for that
         economic/industry sector).
  3. Requirements for the product may include requirements for delivery and post-
    delivery activities.

What accredited certification to ISO 9001 means

To achieve conforming products, the accredited certification process is expected to provide confidence that the organization has a quality management system that conforms to the applicable requirements of ISO 9001. In particular, it is to be expected that the organization:

  1. has established a quality management system that is suitable for its products and
    processes, and appropriate for its certification scope
  2. analyzes and understands customer needs and expectations, as well as the
    relevant statutory and regulatory requirements related to its products
  3. ensures that product characteristics have been specified in order to meet
    customer and statutory/regulatory requirements
  4. has determined and is managing the processes needed to achieve the expected 
    outcomes (conforming products and enhanced customer satisfaction)
  5. has ensured the availability of resources necessary to support the operation and
    monitoring of these processes
  6. monitors and controls the defined product characteristics
  7. aims to prevent nonconformities, and has systematic improvement processes in 
    place to:
  • Correct any nonconformities that do occur (including product 
    onconformities that are detected after delivery)
  • Analyze the cause of nonconformities and take corrective action to avoid
    their recurrence
  • Address customer complaints
  1. has implemented an effective internal audit and management review process
  2. is monitoring, measuring and continually improving the effectiveness of its quality   

   management  system

What accredited certification to ISO 9001 does not mean

1) It is important to recognize that ISO 9001 defines the requirements for an organization’s quality management system, not for its products. Accredited certification to ISO 9001 should provide confidence in the organization’s ability to “consistently provide product that meets customer and applicable statutory and regulatory requirements”. It does not necessarily ensure that the organization will always achieve 100% product conformity, though this should of course be a permanent goal. 

2) ISO 9001 accredited certification does not imply that the organization is providing a superior product, or that the product itself is certified as meeting the requirements of an ISO (or any other) standard or specification.

To fill in the application for ISO 9001 please press here