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Quality System and Documentation Requirements Essay

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Updated: Jun 5th, 2020

Guidance on the Documentation Requirements of ISO 9001:2008

  1. Organizations preparing to implement a Quality Management System should identify processes involved, understand the processes and document them basing onorganizational needs and required standards. The management of an organization which wants to adopt an existing Quality Management System should rewrite its current documentation to meet ISO 9001:2008. However, if there is no existing system, the organization should pay attention to its processes by simplifying and consolidating existing documents. If an organization wishes to demonstrate conformity to ISO 9001:2008, its existing documentation may be sufficient. However, it must provide sufficient evidence of effectiveness of its Quality Management System using new and existing documents required by the standard.
  2. The most important objective of current ISO standards is to develop a simplified set of standards for organizations of all sizes to cope with any amount and details of documentation. Through ISO 9001:2008, these objectives can be achieved. These standards allow organizations to choose the form of documentation basing on their needs and capacities.The type and form of documentation depend on operations, processes and products of an organization. The level of communication skills and formality has an important role in choosing the type of documentation. Documentation should show some conformity to the company’s plan. Knowledge and information can be shared through papers, photographs, computer discs, magnetic mode and master sample. The system should include a high quality manual, documented procedure, records and documents statements required by the organization and international standard.

Environmental Auditing and ISO 19011

  1. The aim of ISO 19011 is to recognize the need for harmonizing Quality Management System and Environmental Management Auditing. The standard provides a guide to external and internal environmental audits in organizations. While implementing ISO 19011, joint and combined environmental audits are used to establish the real environmental situation. The purpose of ISO 19011 is to provide guidance during environmental audits only. Generally, ISO 19011 provides ageneralized guidance on planning, carrying out and reporting an environmental audit.
  2. Environmental audit is used by organizations to identify and determine their level of compliance to various laws and regulations. The audit identifies the type and extends environmental impacts caused by activities of an organization. Environmental auditors give their opinion on performance of a company as expected by stakeholders and how it can be improved. The audit is conducted in three different stages which are pre-audit, audit and post audit. These steps ensure that the auditprocess is exhaustive. There are three different typesof audit, they are Liability, Management and Activity Specific audit.

Importance of all Types of Auditors

  1. External auditors and internal auditors are equally important in management of an organization. After external auditors have conducted an audit, they give an opinion on issues in question. External auditors give their opinion on financial statements, and whether the assertion of managementis fairly stated in all materials respect based on reasonable criteria. External auditors should express an opinion on their independence during any audit process. Their opinion is important to management when making decisions in an organizationor when an overseer wants to act on allegations of misappropriation of fund and assets.
  2. Internal auditors have an important role in organizations management. Since all companies encounter challenges during their activities, internal auditors play an important role in detection of malpractices, misappropriation, fraud, omissions and other errors. Internal auditors contribute to good governance of an organization. They are best placed to detect fraud, omissions and any financial, environmentalor management errors because they are part of the organizational structure. Internal auditors can access all records and facilities in an organization. Furthermore, they can mingle easily with fellow employees in theorganization. Therefore, they are able to collect enough information which concerns any issue under investigation. As a result, importance of internal auditors is to identify mistakes and alert the management of organization about them.

Benefits of ISO-9000

There are several benefits of implementing ISO 9000 in an organization. A financial gain to a company is one of the benefits. Companies which implement ISO 9000 are likely to experience increased income during the time when these standards are operational. For a company to realize steady financialgain, it should have an organizational management which is improved over a long period of time. A company may increase its sales or performance against the cost of implementing ISO 9000. Companies which are determined to implement ISO 9000 gain recurring financial benefits. The benefits eventually outweigh the cost of maintaining these standards. Such organizations are able to realize financial improvements in a short time. However, the time for realizing financial gain varies with the size of acompany. Organizations which have big annual turnovers realize financial gain sooner than those with smaller annual turnovers. After implementing ISO 9000, net financial gain can be low for small organizations because they have small difference between cost and gross income. Compared to large organizations, small ones have to implement ISO 900 and wait for longer time before they realize some financial gain.

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IvyPanda. 2020. "Quality System and Documentation Requirements." June 5, 2020. https://ivypanda.com/essays/quality-system-and-documentation-requirements/.


IvyPanda. (2020) 'Quality System and Documentation Requirements'. 5 June.

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