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ISO 9000

ISO 9000 is a family of standards for quality management systems. ISO 9000 is maintained by ISO, the International Organization for Standardization and is administered by accreditation and certification bodies. Some of the requirements in ISO 9001 (which is one of the standards in the ISO 9000 family) would include:

  • a set of procedures that cover all key processes in the business;
  • monitoring processes to ensure they are effective;
  • keeping adequate records;
  • checking output for defects, with appropriate corrective action where necessary;
  • regularly reviewing individual processes and the quality system itself for effectiveness; and
  • facilitating continual improvement

A company or organization that has been independently audited and certified to be in conformance with ISO 9001 may publicly state that it is "ISO 9001 certified" or "ISO 9001 registered." Certification to an ISO 9000 standard does not guarantee the compliance (and therefore the quality) of end products and services; rather, it certifies that consistent business processes are being applied.

Although the standards originated in manufacturing, they are now employed across a wide range of other types of organizations. A "product", in ISO vocabulary, can mean a physical object, or services, or software. In fact, according to ISO in 2004, "service sectors now account by far for the highest number of ISO 9001:2000 certificates - about 31% of the total" - source:

Summary of ISO 9001:2000 in informal language

1)       The quality manual is a formal statement from management, closely linked to the business and marketing plan and to customer needs. The quality manual is understood and followed at all levels and by all employees. Each employee needs measurable objectives to work towards.

2)       Decisions about the quality system are made based on recorded data and the system is regularly audited and evaluated for conformance and effectiveness.

3)       You need a documented procedure to control quality documents in your company. Everyone must have access to up-to-date documents and be aware of how to use them.

4)       To maintain the quality system and produce conforming product, you need to provide suitable infrastructure, resources, information, equipment, measuring and monitoring devices, and environmental conditions.

5)       You need to map out all key processes in your company; control them by monitoring, measurement and analysis; and ensure that product quality objectives are met. If you can’t monitor a process by measurement, then make sure the process is well enough defined that you can make adjustments if the product does not meet user needs.

6)       For each product your company makes, you need to establish quality objectives; plan processes; and document and measure results to use as a tool for improvement. For each process, determine what kind of procedural documentation is required. (Note: a “product” is hardware, software, services, processed materials, or a combination of these.)

7)       You need to determine key points where each process requires monitoring and measurement, and ensure that all monitoring and measuring devices are properly maintained and calibrated.

8)       You need to have clear requirements for purchased product. Select suppliers appropriately and check that incoming product meets requirements.

9)       You need to determine the skills required for each job in your company, suitably train employees and evaluate the effectiveness of the training.

10)    You need to determine customer requirements and create systems for communicating with customers about product information, inquiries, contracts, orders, feedback and complaints.

11)    When developing new products, you need to plan the stages of development, with appropriate testing at each stage. You need to test and document whether the product meets design requirements, regulatory requirements and user needs.

12)    You need to regularly review performance through internal audits and meetings. Determine whether the quality system is working and what improvements can be made. Deal with past problems and potential problems. Keep records of these activities and the resulting decisions, and monitor their effectiveness. (Note: you need a documented procedure for internal audits.)

13)    You need documented procedures for dealing with actual and potential nonconformances (problems involving suppliers or customers, or internal problems). Make sure no one uses bad product, determine what to do with bad product, deal with the root cause of the problem and keep records to use as a tool to improve the system.

Industry-specific interpretations

The ISO 9001 standard is generalized and abstract. Its parts must be carefully interpreted, to make sense within a particular organization. Developing software is not like making cheese or offering counseling services; yet the ISO 9001 guidelines, because they are business management guidelines, can be applied to each of these. Diverse organizations—police departments (US), professional soccer teams (Mexico) and city councils (UK)—have successfully implemented ISO 9001:2000 systems.

Over time, various industry sectors have wanted to standardize their interpretations of the guidelines within their own marketplace. This is partly to ensure that their versions of ISO 9000 have their specific requirements, but also to try and ensure that more appropriately trained and experienced auditors are sent to assess them.

  • The TickIT guidelines are an interpretation of ISO 9000 produced by the UK Board of Trade to suit the processes of the information technology industry, especially software development.
  • AS 9000 is the Aerospace Basic Quality System Standard, an interpretation developed by major aerospace manufacturers. The current version is AS 9100.
  • PS 9000 is an application of the standard for Pharmaceutical Packaging Materials.
  • QS 9000 is an interpretation agreed upon by major automotive manufacturers (GM, Ford, Chrysler). It includes techniques such as FMEA and APQP. QS 9000 is now replaced by ISO/TS 16949.
  • ISO/TS 16949:2002 is an interpretation agreed upon by major automotive manufacturers (American and European manufacturers); the latest version is based on ISO 9001:2000. The emphasis on a process approach is stronger than in ISO 9001:2000. ISO/TS 16949:2002 contains the full text of ISO 9001:2000 and automotive industry-specific requirements.
  • TL 9000 is the Telecom Quality Management and Measurement System Standard, an interpretation developed by the telecom consortium, QuEST Forum. The current version is 4.0 and unlike ISO 9001 or the above sector standards, TL 9000 includes standardized product measurements that can be benchmarked.
  • ISO 13485:2003 is the medical industry's equivalent of ISO 9001:2000. Whereas the standards it replaces were interpretations of how to apply ISO 9001 and ISO 9002 to medical devices, ISO 13485:2003 is a stand-alone standard. Compliance with ISO 13485 does not necessarily mean compliance with IS0 9001:2000

Provides Consultancy Services for ISO 9001, 14001, TS 16949, OHSAS 18001, CMM-4, ISRS, HACCP