ISO 9001 Quality Management System

ISO 9000 Standards defines a quality manual as a document specifying the quality management system of an organization. It is therefore not intended that the ISO 9000 Standards Quality Manual be a response to the requirements of ISO 9000 Standards. As the top-level document describing the management system it is a system description describing how the organization is managed.
Countless quality manuals produced to satisfy ISO 9000 :2008, were no more than 20 sections that paraphrased the requirements of the ISO 9000 standards.
Such documentation adds no value. They are of no use to managers, staff or auditors. Often thought to be useful to customers, organizations would gain no more confidence from customers than would be obtained from their registration certificate.

Health, Safety, and ISO 14001

Organizations considering the implementation of ISO 14001 often ask if the standard is applicable to safety and health programs as well as environmental issues. We believe that the answer is unequivocally yes.
Not only is ISO 14001 applicable to health/safety programs, it can also provide the same benefits that it makes possible in the environmental area. These include:
Meeting and/or exceeding regulatory requirements, Placing greater attention on significant issues not driven by regulations (establishing a safety culture, raising employee morale), Establishing a commitment to improve and measure performance, and Improving communications between managers and hourly employees.
In addition, using ISO14001 to integrate environmental/safety/health programs into the business system produces other benefits. Measures that reduce environmental incidents can decrease or eliminate worker exposures to hazardous materials. Conversely, increasing awareness of safety practices can focus employees’ attention on environmental concerns. In fact, the success of health, safety, and environmental programs often hinges on worker understanding, attitude, and commitment. The corporate culture must change to make these matters a natural part of each employee’s approach to his or her work.
The ISO 14001 standard assumes that such cultural transformation occurs through employee involvement and responsibility from the bottom up, not via dictates from the top. That assumption, and other concepts present in ISO 14001, is applicable to health and safety. Therefore, it’s reasonable to consider the use of the standard in an integrated approach that can bring about change for all three. Some organizations have done so, and many others will eventually see the wisdom of employing ISO 14001 for that purpose.
How can ISO 14001 be useful for health and safety when it was intended to address the environmental aspects of organizations? These three areas are so linked that a management standard for one can have equal applicability to the others. The reason ISO 14001 was not specifically aimed at health and safety had more to do with professional parochialism and the politics of international standards writing than with any concern about the logic of doing so. In ISO 14001, the only acknowledgement that it could be useful for health and safety appears in the introduction, which recommends its use to those who may need to apply the standard to those areas. No other specific references appear in the document, because the standard’s developers felt that health and safety professionals would eventually develop their own version of ISO 14001. This new version has not emerged, and the likelihood of it happening anytime soon is rather low, because current stakeholders’ views militate against it.

Health, Safety, and ISO 14001

Organizations considering the implementation of ISO 14001 often ask if the standard is applicable to safety and health programs as well as environmental issues. We believe that the answer is unequivocally yes.
Not only is ISO 14001 applicable to health/safety programs, it can also provide the same benefits that it makes possible in the environmental area. These include:
Meeting and/or exceeding regulatory requirements, Placing greater attention on significant issues not driven by regulations (establishing a safety culture, raising employee morale), Establishing a commitment to improve and measure performance, and Improving communications between managers and hourly employees.
In addition, using ISO14001 to integrate environmental/safety/health programs into the business system produces other benefits. Measures that reduce environmental incidents can decrease or eliminate worker exposures to hazardous materials. Conversely, increasing awareness of safety practices can focus employees’ attention on environmental concerns. In fact, the success of health, safety, and environmental programs often hinges on worker understanding, attitude, and commitment. The corporate culture must change to make these matters a natural part of each employee’s approach to his or her work.
The ISO 14001 standard assumes that such cultural transformation occurs through employee involvement and responsibility from the bottom up, not via dictates from the top. That assumption, and other concepts present in ISO 14001, is applicable to health and safety. Therefore, it’s reasonable to consider the use of the standard in an integrated approach that can bring about change for all three. Some organizations have done so, and many others will eventually see the wisdom of employing ISO 14001 for that purpose.
How can ISO 14001 be useful for health and safety when it was intended to address the environmental aspects of organizations? These three areas are so linked that a management standard for one can have equal applicability to the others. The reason ISO 14001 was not specifically aimed at health and safety had more to do with professional parochialism and the politics of international standards writing than with any concern about the logic of doing so. In ISO 14001, the only acknowledgement that it could be useful for health and safety appears in the introduction, which recommends its use to those who may need to apply the standard to those areas. No other specific references appear in the document, because the standard’s developers felt that health and safety professionals would eventually develop their own version of ISO 14001. This new version has not emerged, and the likelihood of it happening anytime soon is rather low, because current stakeholders’ views militate against it.

How To Get ISO 9001 Certified

How To Get ISO 9001 Certified

The ISO 9001 accreditation is part of the International Organization for Standardization 9000 standards. They are awarded to businesses for quality. The ISO 9001 is recognized worldwide as an award for a company’s internal quality management or actions that the company takes to ensure the product or service they provide is of the highest quality. Customer satisfaction is a major factor in whether a company will be awarded an ISO 9001 accreditation. The International Organization for Standardization in Geneva, Switzerland publishes thousands of international standards to help companies throughout the world more efficiently do business with one another. The 27 page ISO 9001 standard is focused on defining minimum business practices for the production and delivery of a company’s products and services through the implementation of a formal “quality management system”, or QMS. An ISO QMS is made up of certain processes, documentation and other formal practices that control internal company operations to ensure customer requirements are consistently met. To pass an audit, an organization must follow these guidelines: Develop a Quality Management System (QMS) manual. Develop the procedures required by the ISO 9001 Standard. Determine the additional processes and procedures that are needed by the organization to perform work and satisfy the requirements in the ISO Standard. Operate in accordance with the organization’s documented QMS. Provide evidence that the organization is operating according to the QMS. The achievement of an ISO 9001 certification is a milestone in demonstrating to your customers that you have implemented a reliable system of producing and delivering your products and services. The focus of this “system” is twofold: providing consistent products and services; and continual improvement in your processes leading to better results. The ISO 9001 certification is granted by a third-party auditing firm called a Registrar who specializes in quality system auditing. There are a wide variety of Registrars located in every ISO participating country. Some firms have offices internationally; others have a more regional focus. The selection of your Registrar is one of the more important decisions you will make to ensure the best alignment with your type of business, your location(s) and overall cost of maintaining the certification. The initial certification audit is conducted in two parts. The Stage 1 audit is a general review of your QMS documentation to ensure you have addressed all of the requirements of the ISO 9001 standard. Depending upon the size of your business, this can be conducted in a one to two day visit to your facility or virtually via phone. Any discrepancies noted during the Stage 1 audit will be documented in a formal report and must be corrected before the Stage 2 audit. The main part of the ISO audit is the Stage 2 audit which is always conducted onsite at your location(s) and will be focused on the implementation and effectiveness of your QMS. During this audit which can take 1 day (for very small companies) to several days, the auditor(s) will tour your company, speak to managers and employees, and review documentation and records (along with any Stage 1 discrepancies) to ensure that your system is fully implemented. If nonconformances are found, they will be documented in a formal report for correction. Following the Stage 2 audit, you are generally given thirty (30) days to submit corrective action plans for all audit nonconformances. Once corrective actions are received, your certification is complete and your certificate is issued. In order to maintain the certification, you will participate in an annual surveillance audit from your Registrar where they confirm that you are maintaining your QMS. Every third year, a more comprehensive re-certification audit is conducted, similar to the initial certification audit.

Certification In ISO 9001 Standards

Certification In ISO 9001 Standards

Certification involves an independent assessment of your quality system to confirm that it meets the requirements of ISO 9001. You will need to design, document and implement your own quality system.The system will need to cover all the requirements of the ISO 9001 standard. Many certification bodies will not conduct a formal assessment until the system has been operating for at least three months. Your quality system cannot be audited until you have generated documentary evidence to show that you are meeting the standard. To find a certification body with relevant experience in your sector and accreditation from the United Kingdom Accreditation Service (UKAS). Certification by a non-UKAS accredited body is likely to lead to credibility problems with your customers. Arrange a visit from the certification body’s auditors. UKAS prohibits auditors from acting as consultants. They will not tell you how to meet the standard but can offer advice. They will seek objective evidence that you are complying with each of the clauses of the ISO 9001 standard. The auditors will tell you of any shortcomings in your system. If you satisfy the standard, the auditors put your name forward for certification. You will be required to correct these problems within a specified timeframe. You can also be certificated if the auditors only identify a small number of ‘minor’ problems. Once you are certificated, you can display the certification body’s logo, and if the body is UKAS-accredited, the UKAS ‘tick and crown’ symbol (consult UKAS about exceptions to this rule). If the auditors identify more serious ‘major’ problems, you will be required to correct these before certification. These surveillance visits normally take place twice a year at agreed dates. All certification bodies are required torevisit registered companies to ensure they still meet the requirements of the standard. You will be given time to deal with any minor or major problems which are identified before any action is taken to withdraw your certificate.

ISO 9001 Standards New Blogs

Some of the new blogs on ISO 9001 Standards & ISO 14001 standards was found as below:

http://iso14000standards.blogspot.com/

http://iso-9001-standards.blogspot.com/

http://iso14001environmentmanagementsystem.blogspot.com/

http://iso9001qualitymanagementsystem.blogspot.com/

http://iso9001qualitymanual.blogspot.com/

http://iso9000standards.blogspot.com/

http://iso9001-standards.blogspot.com/

http://iso14001standards.blogspot.com/

KEY CONSIDERATIONS IN IMPLEMENTING ISO 9001 IN SMEs

KEY CONSIDERATIONS IN IMPLEMENTING ISO 9001 IN SMEs

There are many issues that must be addressed in moving the QMS from the initial state to the desired state. For example, all organizations implementing ISO 9001 will need to consider the unique culture within the organization, its size, and the resources available. Beyond those widely discussed points, three issues that merit particular attention are (1) consideration of the QMS as a parallel function, (2) training, and (3) auditing. Key points associated with these issues are discussed below.

Consideration of QMS as Parallel Function

In the case of all of the transitions depicted, real benefits from the QMS are more likely to be experienced if the QMS is implemented directly into the core structure of the organization. SMEs must be cautious against establishing a QMS that is run separately in parallel to its other systems. In SMEs, the parallel subsystem most commonly exhibits itself as a separate Quality Assurance, or in some cases, ISO 9001 department. Possible reasons for this may include the existence of rigid departmental boundaries in some SMEs or overemphasis on core activities. As Yauch and Steudel [10] note, SMEs tend to focus their attention on “…necessary routine activities (such as sales, production, shipping, etc.) rather than activities aimed at improving processes or systems.” If a SME insists on establishing a separate quality department, its level of effectiveness can be increased by embedding the QMS in widely-used organizational systems where practical. The integration is largely a function of how well the QMS manages to share information with other subsystems and its ability to align with the policies, norms, goals, and values in place throughout the organization.

Training

In SMEs, training and staff development is more likely to be ad hoc and small scale because of modest human and financial resources and the absence of a specific training budget. To prevent the problems arising from lack of education and training, two things must be done:

1. Education of Top Management: The centralization of decision-making processes within many SMEs means that the management can either be the main stumbling block to change or the main catalyst for change. Therefore, any approach to ISO 9001 implementation must involve considerable education for the top management of the organization to create awareness and understanding of the implementation process as a change initiative. Implementing a fully functional and documented QMS requires motivation by top management to appreciate, achieve, and implement the necessary measures to meet the standards’ criteria.

2. Education and Training of Employees: SMEs are often under pressure to quickly gain ISO 9001 registration. Meeting the requirements of the standard in a short period of time can prove a formidable obstacle for a small company. Since most SMEs do not possess the needed expertise internally, they may be inclined to hire external experts to provide the necessary technical expertise and manpower. However, having a functioning and documented QMS requires more than that. It requires ensuring that all employees in the organization clearly know what is expected of them and how they can contribute to the attainment of their organizations’ goals. This will likely require the preparation and implementation of a training plan tailored specifically to the unique characteristics and maturity level of the SME.

Auditing

As emphasized throughout the paper, a QMS is not going to produce the expected results unless it is fully functional. While auditing must therefore verify the existence of the necessary documentation, it must also focus on the functionality of the QMS. The measurement of the functionality and the qualitative and financial impacts of a QMS have been the subject of several studies, including Kaynak [11]. Among the categories used to measure functionality and performance improvement, two are particularly noteworthy for our purposes: management commitment and employee involvement. A QMS cannot be functional in the absence of those two characteristics. Therefore, as a minimum, internal and external auditors should continually verify top management’s commitment to increased company-wide quality awareness and improvement in addition to employee involvement in the design, implementation, operation, and improvement of quality related processes and procedures.