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: ______________________________________

Elements of the Six Sigma Framework

Elements Of The Six Sigma Framework
Management strategies, such as TQC, TQM, and Six Sigma, are distinguished from each other by their underlying rationale and framework. As far as the corporate framework of Six Sigma is concerned, it embodies the five elements of top-level management commitment, training schemes, project team activities, measurement system and stakeholder involvement.
Stakeholders include employees, owners, suppliers and customers. At the core of the framework is a formalized improvement strategy with the following five steps: define, measure, analyse, improve and control (DMAIC) which will be explained in detail in Section 2.3. The improvement strategy is based on training schemes, project team activities and measurement system. Top-level management commitment and stakeholder involvement are all inclusive in the framework.
Without these two, the improvement strategy functions poorly. All five elements support the improvement strategy and improvement project teams. Most big companies operate in three parts: R&D, manufacturing, and non-manufacturing service. Six Sigma can be introduced into each of these three parts separately. In fact, the color of Six Sigma could be different for each part. Six Sigma in the R&D part is often called “Design for Six Sigma (DFSS),” “Manufacturing Six Sigma” in manufacturing, and “Transactional Six Sigma (TSS)” in the non-manufacturing service sector. All five elements are necessary for each of the three different Six Sigma functions. However, the improvement methodology, DMAIC, could be modified in DFSS and TSS. These points will be explained in detail in Sections 2.6 and 2.7.2.2 Top-level Management Commitment and Stakeholder Involvement
(1) Top-level management commitment
Launching Six Sigma in a company is a strategic management decision that needs to be initiated by top-level management. All the elements of the framework, as well as the formalized improvement strategy, need top-level management commitment for successful execution. Especially, without a strong commitment on the part of top-level management, the training program and project team activities are seldom successful. Although not directly active in the day-to-day improvement projects, the role of top-level management as leaders, project sponsors and advocates is crucial. Pragmatic management is required, not just lip service, as the top-level management commits itself and the company to drive the initiative for several years and into every corner of the company.
There are numerous pragmatic ways for the CEO (chief executive officer) to manifest his commitment. First, in setting the vision and long-term or short-term goal for Six Sigma, the CEO should play a direct role. Second, the CEO should allocate appropriate resources in order to implement such Six Sigma programs as training schemes, project team activities and measurement system. Third, the CEO should regularly check the progress of the Six Sigma program to determine whether there are any problems which might hinder its success. He should listen to Six Sigma reports and make comments on the progress of Six Sigma. Fourth, he should hold a Six Sigma presentation seminar regularly, say twice a year, in which the results of the project team are presented and good results rewarded financially. Finally, he should hold a Champion Day regularly, say once in every other month, in which Champions (upper managers) are educated by specially invited speakers and he should discuss the progress of Six Sigma with the Champions.
It is also the responsibility of top-level management to set “stretch goals” for the Six Sigma initiative. Stretch goals are tough and demanding, but are usually achievable. Some companies set the stretch goal for process performance at 6 sigma or 3.4 DPMO for all critical-to-customer characteristics.
However, the goals can also be set incrementally, by stating instead the annual improvement rate in process performance.
The industry standard is to reduce DPMO by 50% annually.
(2) Stakeholder involvement
Stakeholder involvement means that the hearts and minds of employees, suppliers, customers, owners and even society should be involved in the improvement methodology of Six Sigma for a company. In order to meet the goal set for improvements in process performance and to complete the improvement projects of a Six Sigma initiative, top-level management commitment is simply not enough. The company needs active support and direct involvement from stakeholders.
Employees in a company constitute the most important group of stakeholders. They carry out the majority of improvement projects and must be actively involved. The Six Sigma management is built to ensure this involvement through various practices, such as training courses, project team activities and evaluation of process performance. Suppliers also need to be involved in a Six Sigma initiative.
A Six Sigma company usually encourages its key suppliers to have their own Six Sigma programs. To support suppliers, it is common for Six Sigma companies to have suppliers sharing their performance data for the products purchased and to offer them participation at in-house training courses in Six Sigma. It is also common for Six Sigma companies to help small suppliers financially in pursuing Six Sigma programs by inviting them to share their experiences together in report sessions of project team activities. The reason for this type of involvement is to have the variation in the suppliers’ products transferred to the company’s processes so that most of the process improvement projects carried out on suppliers’ processes would result in improvement of the performance.
Customers play key roles in a Six Sigma initiative. Customer satisfaction is one of the major objectives for a Six Sigma company. Customers should be involved in specific activities such as identifying the critical-to-customer (CTC) characteristics of the products and processes. CTC is a subset of CTQ from the viewpoint of the customers. Having identified the CTC requirements, the customers are also asked to specify the desired value of the characteristic, i.e., the target value and the definition of a defect for the characteristic, or the specification limits. This vital information is utilized in Six Sigma as a basis for measuring the performance of processes. In particular, the R&D part of a company should know the CTC requirements and should listen to the voice of customers (VOC) in order to reflect the VOC in developing new products.