Origin Of ISO 9001 Standards

Origin Of ISO 9001 Standards

The story of ISO 9001 Standards is a story of standards, methods and regulation. The brief
history that follows is in no way comprehensive but is intended to illustrate
four things:
1. that ISO 9001 standards are an ancient concept that survived several millennia;
that a means of verifying compliance often follows the setting of
standards;
2. that the formalizing of working practices is centuries old and seen as a
means to consistently meet standards;
3. that market regulation (relative to the standard of goods and services) has
been around for centuries for the protection of both craftsmen and
traders.
4. ISO 9001 is a symptom of practices that were around centuries before anyone
coined the term quality management. It is in some respects a natural
progression that will continue to evolve. The story is told from a British
viewpoint.

ISO 9001 grew out of BS 5750, a standard published by the British Standards Institution (BSI) in 1979. Initially, it was used only in manufacturing industries. ISO 9000 is now employed across a variety of other types of businesses. It is a set of international standards of quality management systems. ISO 9000 has been accepted by more than 100 countries as their national quality assurance standard by the end of 1997.
The history of ISO 9000 Standards dates back to Mil-Q-9858a, the first quality standard for military procurement established in 1959 by the US. By 1962, NASA (National Aeronautics and Space Administration) developed its quality system requirements for suppliers. In 1965, NATO (North Atlantic Treaty Organization) accepted the AQAP (allied quality assurance procedures) specifications for the procurement of equipments.
During the 1970s, BSI published BS 9000 (the first UK standard for quality assurance) and BS 5179 (guidelines for quality assurance) norms. In 1979, it created BS 5750, a series of standards for use by manufacturing companies. They were enforced through assessments and audits. In 1988, ISO (International Standards Organization) adopted the BS 5750 standard without changes and published it globally under the name ISO 9000. The ISO adopted this standard with a view to create an international definition of the necessary characteristics of a quality system for all businesses, regardless of industry. In 1994, the ISO revised the ISO 9000 standard and published it globally.
In the beginning, ISO 9000 was implemented exclusively by large companies. But by mid-1990s, small and mid-sized companies began to increasingly implement these standards. In the United States, the total number of registrations increased from a little more than 2,200 in 1993 to more than 17,000 in 1998. Of these 17,000 registrations, almost 60 percent were held by businesses with annual sales of $100 million or less.

What is ISO 9001 Standards?

What is ISO 9001 Standards?
ISO 9001 is a set of interrelated ideas, principles and rules and could therefore be considered a system in the same way that we refer to the metric system or the imperial system of measurement. ISO 9001 is both an international standard and until year 2008, was a family of some 20 international standards. As a standard, ISO 9001 was divided into 4 parts with part 1 providing guidelines on the selection and use of the other standards in the family. The family of standards included requirements for quality assurance and guidelines on quality management. Some might argue that none of these are in fact standards in the sense of being quantifiable. The critics argue that the standards are too open to interpretation to be standards anything that produces such a wide variation is surely an incapable process with one of its primary causes being a series of objectives that are not measurable. However, if we take a broader view of standards, any set of rules, rituals, requirements, quantities, targets or behaviours that have been agreed by a group of people could be deemed to be a standard. Therefore by this
definition, ISO 9001 is a standard.

Outsourced Processes In ISO 9001 Standards

Outsourced Processes In ISO 9001 Standards
One of the changes in ISO 9001:2008 is clarification of the role of outsourced processes in a quality management system. Guidance on ‘Outsourced processes’ helps clarify the intent and shows the linkage between Clause 4.2, where outsourced processes appear, and the purchasing controls in clause 7.4.An outsourced process is a process that the organization needs for its quality management system and is performed by an external party. This party could be another company, a corporate service, another division, etc.The organization needs to ensure the outsourced process is conducted in accordance with ISO 9001:2008 and other requirements of the quality management system. This brings in the purchasing controls of 7.4. The service may not be purchased in the traditional sense of a monetary transaction. The guidance document explains that the controls in clause 4.2 and 7.4 apply. For example, a “no charge” service from a corporate head office requires documentation of supplier selection and, most importantly, control.The guidance document addresses two important cases and gives guidance on the appropriate level of control. The cases are:• The organization has the competence and ability to carry out a process, but chooses to outsource it (for commercial or other reasons).• The organization does not have the competence to carry out the process itself, and chooses to outsource it.

Outsourced Processes In ISO 9001 Standards

Outsourced Processes In ISO 9001 Standards
One of the changes in ISO 9001:2008 is clarification of the role of outsourced processes in a quality management system. Guidance on ‘Outsourced processes’ helps clarify the intent and shows the linkage between Clause 4.2, where outsourced processes appear, and the purchasing controls in clause 7.4.An outsourced process is a process that the organization needs for its quality management system and is performed by an external party. This party could be another company, a corporate service, another division, etc.The organization needs to ensure the outsourced process is conducted in accordance with ISO 9001:2008 and other requirements of the quality management system. This brings in the purchasing controls of 7.4. The service may not be purchased in the traditional sense of a monetary transaction. The guidance document explains that the controls in clause 4.2 and 7.4 apply. For example, a “no charge” service from a corporate head office requires documentation of supplier selection and, most importantly, control.The guidance document addresses two important cases and gives guidance on the appropriate level of control. The cases are:• The organization has the competence and ability to carry out a process, but chooses to outsource it (for commercial or other reasons).• The organization does not have the competence to carry out the process itself, and chooses to outsource it.

Demonstrating conformity with ISO 9001:2008

Demonstrating conformity with ISO 9001:2008
For organizations wishing to demonstrate conformity with the requirements of ISO 9001:2008, for the purposes of certification/registration, contractual, or other reasons, it is important to remember the need to provide evidence of the effective implementation of the QMS.Organizations may be able to demonstrate conformity without the need for extensive documentation.To claim conformity with ISO 9001:2008, the organization has to be able to provide objective evidence of the effectiveness of its processes and its quality management system. Clause 3.8.1 of ISO 9000:2005 defines “objective evidence” as “data supporting the existence or variety of something” and notes that “objective evidence may be obtained through observation, measurement, test, or other means.”Objective evidence does not necessarily depend on the existence of documented procedures, records or other documents, except where specifically mentioned in ISO 9001:2008. In some cases, (for example, in clause 7.1(d)Planning of product realization, and clause 8.2.4
Monitoring and measurement of product), it is up to the organization to determine what records are necessary in order to provide this objective evidence.Where the organization has no specific internal procedure for a particular activity, and this is not required by the standard, (for example, clause 5.6 Management Review), it is acceptable for this activity to be conducted using as a basis the relevant clause of ISO 9001:2008. In these situations, both internal and external audits may use the text of ISO 9001:2008 for conformity assessment purposes.

Records required by ISO 9001:2008

Records required by ISO 9001:2008
Clause Record required5.6.1 Management reviews6.2.2 e) Education, training, skills and experience7.1 d) Evidence that the realization processes and resulting product fulfil requirements7.2.2 Results of the review of requirements related to the product and actions arising from the review7.3.2 Design and development inputs relating to product requirements7.3.4 Results of design and development reviews and any necessary actions7.3.5 Results of design and development verification and any necessary actions7.3.6 Results of design and development validation and any necessary actions7.3.7 Results of the review of design and development changes and any necessary actions7.4.1 Results of supplier evaluations and any necessary actions arising from the evaluations7.5.2 d) As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement7.5.3 The unique identification of the product, where traceability is a requirement7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable for use7.6 a) Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist7.6 Validity of the previous measuring results when the measuring equipment is found not to conform to requirements7.6 Results of calibration and verification of measuring equipment8.2.2 Internal audit results and follow-up actions8.2.4 Indication of the person(s) authorizing release of product.8.3 Nature of the product nonconformities and any subsequent actions taken, including concessions obtained8.5.2 e) Results of corrective action8.5.3 d) Results of preventive action

ISO 14001 ENVIRONMENTAL ASPECTS AND IMPACTS

ISO 14001 Environmental Aspects And Impacts
The fundamental purpose of the EMS is to control and reduce the environmental impacts of your facility’s processes and products. For this reason, a critical element of the EMS involves identifying and prioritizing the environmental aspects and impacts associated with your facility. An environmental aspect is an element of an organizations activities, products, or services that can interact with the environment. For example, chrome plating is a metal finishing activity and an associated aspect is chrome air emissions.This aspect may have an impact on the environment in several ways, for example, ambient air quality degradation.The environmental aspects and impacts of your metal finishing operations can be identified, prioritized, and documented in several ways. This Template includes two approaches, either of which can be used during EMS implementation. Use the approach that works best for your circumstances. This process is important because high-priority environmental aspects and impacts will be considered when environmental objectives and targets are established.
Aspects and Impacts Form A — The first approach uses the experience and judgment ofemployees familiar with facility processes to identify the top five environmental issuescurrently facing the facility. These issues and their specific aspects and impacts shouldbe summarized using Aspects and Impacts Form A.
Aspects and Impacts Form B — The second approach uses detailed, structured matricesto list and prioritize environmental aspects and impacts according to the followingcategories:• Environmental Aspects and Impacts: Wastewater• Environmental Aspects and Impacts: Air Emissions• Environmental Aspects and Impacts: Hazardous and Solid Waste• Environmental Aspects and Impacts: Raw Materials• Environmental Aspects and Impacts: Water and Energy
The matrices that comprise Form B will help facility staff identify and document environmental aspects and impacts. The matrices also provide criteria for prioritizing environmental aspects and impacts; this process is important because high-priority environmental aspects and impacts will be considered when environmental objectives and targets are established. One possible way to prioritize environmental aspects and impacts using Form B is described as follows:Step 1:For each aspect and impact, score each prioritization criterion on a scale from 1 to 5, where 1 indicates the criterion is very important or relevant to that aspect (for example, the aspect is strictly regulated, is the subject of compliance violations, or is a waste generated in large uantities), and 5 indicates the criterion is relatively unimportant or irrelevant to that aspect (for example, the aspect is an unregulated waste, is generated infrequently, and is inexpensive to manage).Step 2:Add the scores of all criteria for each aspect and write the total in the right-most column of the form.This number indicates the relative priority of the aspect compared to other aspects and impacts in the same category. The lower the total score, the higher the priority.Purpose Of This procedure is used to identify, document, and update the environmental aspects and impacts of facility processes and operations.
Step 1 The environmental manager and other facility personnel selected by the environmental manager are responsible for identifying and prioritizing the environmental aspects and impacts of facility operations during EMS planning and development.Environmental aspects are characteristics of facility processes and products that interact with the environment. Only environmental aspects the company can control or influence will be considered. Environmental impacts are the effects of an organization’s activitie , products or services on the environment.
Step 2 Environmental aspects and impacts will be documented and prioritized.Environmental aspects and impacts will be associated with the following categories:• Wastewater• Air emissions• Hazardous and solid waste• Raw materials• Water and energyHigh-priority environmental aspects and impacts will be considered when environmentalobjectives and targets are set.
Step 3 The environmental manager and other facility personnel will review and updatethe environmental aspects and impacts documentation annually.
Step 4 Environmental aspects and impacts documentation will be retained at the facilityfor at least 2 years.
Responsible Person: _____________________________________Signature and Date: ______________________________________