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SIEN Consultant adalah perusahaan jasa Consultant ISO 9001 / Konsultan ISO 14001 / Training ISO/TS 16949 / Konsultant ISO 22000 / Pelatihan OHSAS 18001 / Consultants SA 8000 / Internat Audit dan Konsultasi IT Accounting System, Integrasi System ISO 9001:2000 dengan ISO14001 dan OHSAS, juga menyediakan konsultasi Sigma Balance dan Balance ScoreCard
SIEN Consultant adalah perusahaan jasa Consultant ISO 9001 / Konsultan ISO 14001 / Training ISO/TS 16949 / Konsultant ISO 22000 / Pelatihan OHSAS 18001 / Consultants SA 8000 / Internat Audit dan Konsultasi IT Accounting System, Integrasi System ISO 9001:2000 dengan ISO14001 dan OHSAS, juga menyediakan konsultasi Sigma Balance dan Balance ScoreCard
SIEN Consultant adalah perusahaan jasa Consultant ISO 9001 / Konsultan ISO 14001 / Training ISO/TS 16949 / Konsultant ISO 22000 / Pelatihan OHSAS 18001 / Consultants SA 8000 / Internat Audit dan Konsultasi IT Accounting System, Integrasi System ISO 9001:2000 dengan ISO14001 dan OHSAS, juga menyediakan konsultasi Sigma Balance dan Balance ScoreCard
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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. The rules are updated, the time and changes in the requirements for quality, motivate change. Recently, on November 15, 2008, has made changes to the requirements of ISO 9001.
Some of the requirements in ISO 9001 (which is one of the standards in the ISO 9000 family) 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 and 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 9001 standard does not guarantee any quality of end products and services; rather, it certifies that formalized business processes are being applied.
Although the standards originated in manufacturing, they are now employed across several types of organizations. A "product", in ISO vocabulary, can mean a physical object, services, or software.
ISO 9000 series of standards
ISO 9000 includes the following standards:
- ISO 9001:2008 Quality management systems – Requirements is intended for use in any organization regardless of size, type or product (including service). It provides a number of requirements which an organization needs to fulfill to achieve customer satisfaction through consistent products and services which meet customer expectations. It includes a requirement for continual (i.e. planned) improvement of the Quality Management System, for which ISO 9004:2000 provides many hints.
This is the only implementation for which third-party auditors can grant certification. It should be noted that certification is not described as any of the 'needs' of an organization as a driver for using ISO 9001 ( see ISO 9001:2000 section 1 'Scope') but does recognize that it may be used for such a purpose ( see ISO 9001:2000 section 0.1 'Introduction').
- ISO 9004:2000 Quality management systems - Guidelines for performance improvements covers continual improvement. This gives you advice on what you could do to enhance a mature system. This document very specifically states that it is not intended as a guide to implementation.
There are many more standards in the ISO 9001 series (see "List of ISO 9000 standards" from ISO), many of them not even carrying "ISO 900x" numbers. For example, some standards in the 10,000 range are considered part of the 9000 group: ISO 10007:1995 discusses Configuration management, which for most organizations is just one element of a complete management system. ISO notes: "The emphasis on certification tends to overshadow the fact that there is an entire family of ISO 9000 standards ... Organizations stand to obtain the greatest value when the standards in the new core series are used in an integrated manner, both with each other and with the other standards making up the ISO 9000 family as a whole".
Note that the previous members of the ISO 9000 series 9002 and 9003 have been integrated into 9001. In most cases, an organization claiming to be "ISO 9000 registered" is referring to ISO 9001.
Contents of ISO 9001
ISO 9001:2008 Quality management systems — Requirements is a document of approximately 30 pages which is available from the national standards organization in each country. Outline contents are as follows:
- Page iv: Foreword
- Pages v to vii: Section 0 Introduction
- Pages 1 to 14: Requirements
- Section 1: Scope
- Section 2: Normative Reference
- Section 3: Terms and definitions (specific to ISO 9001, not specified in ISO 9000)
- Pages 2 to 14
- Section 4: Quality Management System
- Section 5: Management Responsibility
- Section 6: Resource Management
- Section 7: Product Realization
- Section 8: Measurement, analysis and improvement
In effect, users need to address all sections 1 to 8, but only 4 to 8 need implementing within a QMS.
- Pages 15 to 22: Tables of Correspondence between ISO 9001 and other standards
- Page 23: Bibliography
The standard specifies six compulsory documents:
- Control of Documents (4.2.3)
- Control of Records (4.2.4)
- Internal Audits (8.2.2)
- Control of Nonconforming Product / Service (8.3)
- Corrective Action (8.5.2)
- Preventive Action (8.5.3)
In addition to these, ISO 9001:2008 requires a Quality Policy and Quality Manual (which may or may not include the above documents).
Summary of ISO 9001:2008 in informal language
- The quality policy is a formal statement from management, closely linked to the business and marketing plan and to customer needs. The quality policy is understood and followed at all levels and by all employees. Each employee needs measurable objectives to work towards.
- Decisions about the quality system are made based on recorded data and the system is regularly audited and evaluated for conformance and effectiveness.
- Records should show how and where raw materials and products were processed, to allow products and problems to be traced to the source.
- You need to determine customer requirements and create systems for communicating with customers about product information, inquiries, contracts, orders, feedback and complaints.
- 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.
- 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).
- 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.
1987 version
ISO 9000:1987 had the same structure as the UK Standard BS 5750, with three 'models' for quality management systems, the selection of which was based on the scope of activities of the organization:
- ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing was for companies and organizations whose activities included the creation of new products.
- ISO 9002:1987 Model for quality assurance in production, installation, and servicing had basically the same material as ISO 9001 but without covering the creation of new products.
- ISO 9003:1987 Model for quality assurance in final inspection and test covered only the final inspection of finished product, with no concern for how the product was produced.
ISO 9000:1987 was also influenced by existing U.S. and other Defense Standards ("MIL SPECS"), and so was well-suited to manufacturing. The emphasis tended to be placed on conformance with procedures rather than the overall process of management—which was likely the actual intent.
1994 version
ISO 9000:1994 emphasized quality assurance via preventive actions, instead of just checking final product, and continued to require evidence of compliance with documented procedures. As with the first edition, the down-side was that companies tended to implement its requirements by creating shelf-loads of procedure manuals, and becoming burdened with an ISO bureaucracy. In some companies, adapting and improving processes could actually be impeded by the quality system.
2000 version
ISO 9001:2000 combines the three standards 9001, 9002, and 9003 into one, called 9001. Design and development procedures are required only if a company does in fact engage in the creation of new products. The 2000 version sought to make a radical change in thinking by actually placing the concept of process management front and center ("Process management" was the monitoring and optimizing of a company's tasks and activities, instead of just inspecting the final product). The 2000 version also demands involvement by upper executives, in order to integrate quality into
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