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ISO 14001 ISO 14001 was first released in 1996 to assist organizations in formalizing their environmental management programs.

In addition to the formal approach of ISO 14001, organizations can receive the benefit of an external and impartial validation of their environmental activities through certification to ISO 14001. This ISO 14001 certification demonstrates to the community at-large the organization's commitment to sound environmental practices. Companies of all kinds and descriptions are increasingly concerned about their environmental performance. This concern has lead to their controlling the aspects of their activities, products and services on the environment. Of course, they do this in the context of increasingly tougher legislation and political pressure from non-governmental activist groups. However, many companies have found that being environmentally aware has produced a positive economic result. By controlling the operations in their companies for environmental concerns it has produced a savings due to their increased efficacy. Many companies perform environmental audits and reviews to determine their performance. However, on their own without a structured approach these audits may not be enough to provide a company with assurance that its performance meets and will continue to meet the legal and policy commitments. To be the most effective the audits need to be conducted within a structured management program that is an integral part of the company. The ISO 14001 standard for environmental management is designed to give companies the structure needed to integrate the activities into the company s management system. Thereby, helping them to reach their environmental and economic goals through a controlled methodology. This standard, like other ISO standards, is not intended to create trade barriers or change or increase the company s legal obligations. ISO 14001 sets requirements for an environmental management system to help companies develop and implement a policy and objectives. These must take into account legal requirements and information on their environmental aspects. The standard is designed to accommodate different types of organizations regardless of their business, geographical location, culture or social conditions. For additional information about ISO 14001 and its requirements follow the links below: ISO 14001 - Clause 4.1 ISO 14001 - Clause 4.2

ISO 14001 - Clause 4.3 ISO 14001 - Clause 4.4 ISO 14001 - Clause 4.5 ISO 14001 - Clause 4.6 ISO 14001 Clause 4.1 ISO 14001; Clause 4.1 ~ General Requirements: ISO 14001, clause 4.1 starts off with the phrase top management that is defined as the person or group of people who direct and control a company at the highest level. This is an important difference from the previous edition of ISO 14001 that used the terms executive management which went undefined in the standard. This permitted companies to lay the responsibility for the ISO 14001 system on the shoulders of anyone they called staff. Now, with the 2004 revision, top management is directly accountable for making certain the EMS is effective. The organization must define and document the scope of their environmental management system. This is generally accomplished with the writing and publishing of an ISO 14001 System Manual. Although the ISO 14001 standard does not specifically call for this manual it has become the most common method. An organization will further define and document their ISO 14001 system through written procedures and perhaps operating instructions. The ISO 14001 System manual is used to describe the organization's environmental policies and committments. It is generic in nature in that it does not decribe specifically what or how the organization will fulfill its environmental obligations. ISO 14001 Clause 4.2 ISO 14001 Clause 4.2 is the driver for the complete EMS. The environmental policy should reflect the commitment of top management to comply with the standard, legal requirements and any other environmental requirements they believe are needed to prevent pollution and continually improve. The EMS policy forms the basis upon which the company sets its objectives and targets. The environmental policy must be clear enough to be understood by all internal and external interested parties. It needs to be periodically reviewed and revised to reflect the changing conditions and information. Its scope should be clearly identifiable and needs to reflect the nature, size and environmental impacts of the activities, products and services within the defined scope of the EMS.

The environmental policy must be communicated to everyone who works for or on behalf of the company, including contractors working at the company s facilities. External contractors need not be told the complete environmental policy. They can be given the environmental rules, directives and procedures that apply to their specific activity. The policy should be defined and documented by top management and included in the wider company s policies that have been endorsed by top management. In other words, the environmental policy and its operational objectives are built-in to the company s culture.

ISO 14001 Clause 4.3 ISO 14001 clause 4.3 is designed to provide a method for a company to identify environmental aspects and to determine those that are significant so they can be addressed as a priority activity. When identifying the environmental aspects within the defined scope of the EMS a company should consider the inputs and outputs, whether intended or not, associated with its current and relevant past activities, products and services. You should include planned or new developments, or new or changed activities, products and services. This method needs to include normal and abnormal operating conditions, shutdown and startup conditions, as well as reasonably predictable emergency situations. You don t have to consider each individual product, component or raw material for the input. You can choose categories of operations, families of products and services to identify their environmental aspects. There are as many approaches to this identification of environmental aspects as there are companies with an EMS. Regardless of the approach used you need to consider these environmental categories:
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Emissions to air Releases to water Releases to land Use of raw materials and natural resources Use of energy Energy omitted, (heat, radiation, vibration) Waste and by-products, and Physical attributes (size, material, shape, etc)

ISO 14001 Clause 4.4 ISO 14001 clause 4.4 is the most extensive clause in the standard. There are seven sub-clauses as follows: 4.4.1 Resources, roles, responsibility and authority 4.4.2 Competence, training and awareness 4.4.3 Communication 4.4.4. Documentation 4.4.5 Control of documents 4.4.6 Operational control 4.4.7 Emergency preparedness and response Let's take a brief look at each of the sub-clauses of ISO 14001 clause 4.4: 4.4.1 Resources, roles, responsibility and authority The successful implementation of an EMS requires a commitment from everyone in the company or on its behalf. Environmental responsibility should not be perceived as just a responsibility of the environmental function. A sound and practical EMS is played-out at all levels and functions of a company. The commitment and practice begins at the highest levels of a company. Therefore, top management should develop the company s environmental policy and make certain the EMS is properly implemented. They need to appoint a person or persons with defined (documented) responsibility, accountability and authority for implementing the EMS. Management also needs to ensure there are sufficient resources to make the EMS operational and effective. In addition, key environmental management roles and responsibilities are well defined and communicated to everyone in the company and to those that do work for the company. 4.4.2 Competence, training and awareness The company needs to determine the awareness, knowledge, understanding and skills needed by anyone with the responsibility and authority that performs work on its behalf. The standard requires:
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Those people whose work could cause significant environmental impact(s) identified by the company be competent to perform those tasks, The training needs are identified and actions are taken to satisfy the need,

Everybody is aware of the company s environmental policy and the EMS and the environmental aspects of the company s activities, products, and services that could be affected by their work.

The required environmental skills can be obtained or improved through training, education or work experience. The company should require that contractors working on its behalf are able to demonstrate that their employees have the required competence and knowledge about environmental aspects. The company s management should determine the level of experience, competence and training necessary to ensure the capability of personnel, especially those carrying out specialized environmental management functions. 4.4.3 Communication Communicating within the company about its environmental aspects and the EMS is necessary to implement an effective EMS. This can be accomplished through the chainof-command, work team meetings, newsletters, bulletin boards and intranet web site or any method that works for the company. The company should implement a procedure for receiving, documenting and responding to communications from interested parties. This procedure may include a dialogue with interested parties and consideration of their concerns. In some circumstances, responses to interested parties may include information about the environmental aspects and impacts associated with the company s operations. The procedure should also address necessary communication with public authorities regarding emergency planning and other issues. The company might want to plan its communication taking into account the decisions made on target groups, the appropriate messages and subjects, and the choice of means. 4.4.4. Documentation The detail and amount of documentation for the EMS should be sufficient enough to describe the EMS and how its various parts work together. And, to provide guidance on where to find more detailed information on the operations of particular parts of the EMS. You can integrate the EMS documentation into the documentation of other systems, if you wish. Although many companies develop an EMS manual, the documentation doesn t have to be in the form of a manual.

How much documentation a company develops will depend on principally three conditions as follows: 1. The size and type of company and its activities, products and/or services, 2. The complexity of processes and their interactions, and 3. The competence of the people in the company. 4.4.5 Control of documents The primary focus of the company should be the effective implementation of the EMS and improving environmental performance, not documentation. Create and issue documents only where absolutely necessary to guarantee the effective operation of the EMS. However, the documents that are issued must be controlled to ensure the current and correct information is being used. 4.4.6 Operational control The company needs to evaluate its operations where significant environmental aspects are present and develop methods to ensure that exposure is controlled and that it meets the objectives and targets. Don t forget, this includes all operations (office, janitorial, maintenance, etc.). This sub-section of the standard gives direction on how to take the EMS requirements into the day-to-day operations by requiring a documented procedure to control situations where absence of documentation could lead to deviations from the required method and the environmental policy, objectives and targets. 4.4.7 Emergency preparedness and response Every company should have procedures for responding to emergencies and accidents that could impact the environment. When developing its procedure(s) the following should be taken into consideration:
y y y y y y y y

The nature of the on-site hazards (i.e. flammable materials, compressed gases, storage tanks and facilities), The most likely type and size of an emergency situation or accident, The best way to respond to the situation, Internal and external communication methods The actions that will be absolutely necessary to minimize environmental damage, The different type of action needed based on the situation, A procedure/method for post-accident investigation and corrective action, and many additional items are covered in our ISO 14001 Implementation Guide

ISO 14001 Clause 4.5 ISO 14001 clause 4.5 has five sub-clauses as follows: 4.5.1 4.5.2 4.5.3 4.5.4 4.5.5 Monitoring and measurement Evaluation of compliance Nonconformity, corrective action and preventive action Control of records Internal Audit

Here's what each of the sub-clauses of ISO 14001 clause 4.5 briefly covers: 4.5.1 Monitoring and measurement The operations within a company will have a variety of characteristics. For example, wastewater discharge might include biological, chemical oxygen, temperature and acidity that need to be monitored. The data collected from monitoring and measuring can be analyzed to identify patterns and obtain information for potential impacts. Preventive action can then be instituted before the actual impact occurs.

4.5.2 Evaluation of compliance The company needs to show that it has a method for evaluating its compliance to all requirements, whether legal or others that they have agreed to comply with. This can be done in way the company chooses including subscriptions to environmental publications and regulations, use of environmental consultants or environmental legal firms. 4.5.3 Nonconformity, corrective action and preventive action The use of established procedures for handling nonconformities can help minimize the amount of formal planning needed to handle the situation. Or, it may be necessary to take more complex and long-term activity. The documentation kept needs to be appropriate to the level of action required to correct the nonconformity. 4.5.4 Control of records The company needs to have records that shows it is complying with the standard. The records have to be kept safe, legible, accessible and retrievable.

Many of these records will be considered confidential and proprietary and the necessary precautions need to be taken. Records are not the sole source of evidence to demonstrate compliance to the standard. 4.5.5 Internal Audit The scope of the audit program needs to include the entire EMS. However, not all the operations of the EMS need to be audited at once and the audit process can take place over a period of time. The internal audits can be performed by employees of the company or by persons from outside the company that are working on its behalf (consultant/auditor). In either case, the auditors need to be competent and in a position to be impartial and objective. In smaller companies, auditor impartiality and objectivity can be shown by the auditor being free of responsibility from the activity being audited. If a company wishes to combine audits of the EMS with environmental compliance audits, the intent and scope of each audit must be clearly defined. Environmental compliance audits are not covered by the standard. Refer to ISO 19011 for additional guidance on auditing.

ISO 14001 Clause 4.6 ISO 14001 clause 4.6 has no sub-clauses. Top management will review the company s EMS at planned intervals to make sure its continuing suitability, adequacy and effectiveness. The management review process must include the entire EMS. However, not all elements need to be reviewed at once and the reviews and can take place over a period of time. The management review requirement is critical to the success of the EMS as well as its improvement. Therefore, top management is required to actually conduct these reviews. Records of reviews need to be maintained showing what was discussed and the decided on action. ISO 9001 Requirements The ISO 9001 requirements are in clauses 4 through 8 with sub-clauses in each of those primary clauses. We have translated the requirements into plain English. ISO 9001 General Information

The 1987 and 1994 editions of ISO 9001 were focused on standardizing processes primarily through extensive documentation. Although the intent was to provide customer satisfaction and improvement those terms never actually appeared in the standard. The ISO 9001 requirements in the 1994 edition, the ISO 9001 edition before the 2000 revision, had one clause with 20 sub-clauses. Each of the sub-clauses focused on a specific type of operation in companies. For example, there was a clause (4.3) titled "Contract Review" that focused on customer order review. Another one was a clause titled "Process Control" (4.9). However, it focused on production processes, not all processes. Each was considered a separate entity and was treated that way when documenting and implementing, as well as being audited. The ISO 9001 requirements in the 2000 edition was completely reformatted and refocused. This edition contains only five clauses. They are based of the processes most companies have. The new formatting is geared toward the interaction of the processes in companies. All processes in companies rely on others for their input and provide output to other processes. The Process Approach ISO 9001:2008 requires companies to identify the processes in their organization as well as the interaction of these processes in order to enhance customer satisfaction through continual improvement. The process approach starts with customer requirements as the initial input and customer satisfaction and continual improvement as the output. The phrases "customer satisfaction" and "continual improvement" actually appear in this standard. And, requirements have been set for measuring and monitoring activities based on objective measurements. The clauses are: (click on the title of the clause for its plain English translation) 4 - Quality management system 5 - Management responsibility 6 - Resource management 7 - Product realization 8 - Measurement, analysis and improvement

Another of the significant changes from previous editions is there is only one standard opposed to three. The 2000 revision of ISO 9001 includes everything from product design or development to servicing the product after the sale. Speaking of design and development, under the previous edition of the standard companies could simply choose not to include specific operations or processes in the scope of their certification. For example, if they didn t want to include product design engineering, sometimes referred to as "wild cards" because of the lack of standardization between engineers, they chose certification to ISO 9002. ISO 9002 didn t include design control. This is no longer possible. You can only exclude a process by justifying that it doesn t affect customer or regulatory requirements. That's tough to prove when you design and/or develop the product or service what customers buy. This initially resulted in many companies not transitioning from the 1994 edition to the 2000 standard and therefore eventually losing their certification. ISO 9001-2008 The proposed changes for the 2008 revision are editorial in nature. The changes are intended to clarify the intent of the original 2000 requirements and to help in implementing the ISO 9001 Quality Management System. ISO 9001 Section 4 Quality Management System ISO 9001 Section 4 - Quality Management System 4.1 General Requirements The important tasks in your company must be identified and then the sequence that they occur. This must include those tasks that you farmed out to other companies (subcontractors) that affect product quality or customer requirements. When you can perform all these tasks correctly the first time you have an effective quality management system. You will also need to monitor and measure these operations and record the information from time to time. This tells you how the operation is doing. If things aren t going according to plan, action is needed to fix it. 4.2 Documentation Requirements

4.2.1 General Requirements and, 4.2.2 Quality Manual The general basis of a quality management system is the quality manual. It describes the important tasks and how they work together. You don t want repeat the wording of the standard. This doesn t provide anyone with helpful information about your management system. And, they probably wouldn t read it anyway. The quality manual can have the six (6) required procedures included in it. Most companies don t include them, so they just list the procedures in the manual. This tells people they exist and what they are about. The procedures usually have their own manual separate from the quality manual. Most company procedures have proprietary information and shouldn't be released outside of the company. However, many customers ask there suppliers and vendors for a copy of their quality manual. If the procedures are in the quality manual they could be accidently released. Or, a customer only copy of the quality manual is created. This is extra work and can be avoided by not including the procedures in the quality manual. 4.2.3 Control of Documents 4.2.4 Control of Records Make instructions available for as long as they are needed to help people do their job. Keep these instructions up-to-date. Keep records of the controlled documents including the document title, revision date and/or level. The list can be used by anyone who needs to determine if the document they have is the current and correct one. Determine what records are needed to prove what was done and if it was done correctly. Records are a critical part of the QMS. They are the hard evidence that the required activities have been completed. A list, log or database of all the company's documents and records must be kept. There can be separate lists for documents and records. The lists must be kept up-to-date to show the current revision of the document or record. A history of the documents life needs to be kept, also. The idea here is to show that improvement has taken place and the documents were revised to reflect the new methods. ISO 9001 Section 5 Management Responsibility ISO 9001 Section 5 - Management Responsibility

5.1 Management Commitment Quality starts at the top rather than the lower levels of a company. Top management must perform the duties show in clause 5.1. Top management determines the vision, communicates it to the rest of the company. They must provide the resources for the system and they are charged with checking up on the vision from time to time. Top management may be one person in smaller companies or the board of directors or corporate officers in large companies. For most of use, top management is "The Boss". 5.2 Customer Focus Customers are the reason the lights are on, the doors are open for business and the bills get paid. Top management is to focus their attention on making your customers happy. 5.3 Quality Policy The company should adopt a policy it can live with and not one that promises things that are not possible. What is said in the quality policy must be put into play. Everyone in the company has to know what the policy is and what it means. You don t need to memorize it word for word. Just have a good understanding of what it is and what it means. Top management must also review the policy at each management review to determine if it needs to be updated. 5.4 Planning 5.4.1 Quality Objectives The objectives are the things we measure to determine if everything is going okay. The quality policy doesn t have to contain the quality objectives, just be the framework for them. The objectives tell us the goals and purposes of what we are doing. 5.4.2 Quality Management System Planning We have to plan out what we are going to do before we do it. No shooting from the hip. We have to make sure we are complying with the items in clause 4.1. 5.5 Responsibility, Authority and Communication 5.5.1 Responsibility and authority Have you ever wondered just exactly what your job is? It s very difficult to do a great job when no one has told you exactly what it is you re suppose to do. This clause of the standard requires that job responsibilities and authorities be written down. The word define means write it down.

5.5.2 Management Representative The company must assign one person to be responsible overall for the QMS. This person may be called the management representative, quality manager or whatever their regular job title is. You must know who this person is in your company. 5.5.3 Internal Communications Top management must make sure that they communicate with everyone in the company about the ISO 9001 system. 5.6 Management Review Now that we have defined our quality policy, planned the implementation of the QMS, identified and defined the responsibilities and authorities to reach our goals, we need to periodically check and measure our progress and continually improve. This is called management review. Top management gets together and reviews all the processes to see how they are working. ISO 9001 Section 6 Resource Management ISO 9001 Section 6 - Resource Management 6.1 Provision of Resources Before you can give the customer what they want you need to get some stuff to accomplish the work. This stuff is called resources and includes people, equipment, machines, materials, facilities, etc. However, since companies have a limited amount of money. Management has to find a balance between what you want and what you can afford and still satisfy the customer. This is one of the really fun management jobs of trying to balance need with capital. 6.2 Human Resources 6.2.1 General 6.2.2 Competence, Awareness and Training Resources include people and people need to be trained to run their processes. We need to make sure that we have the right number of good people and that they are trained good enough to handle the operation. A job assessment needs to be done so we know what training and experience the people require. Records of all this has to be kept so you can prove they are competent to do the work.

6.3 Infrastructure It s not enough to have good people. It s a great start, but they need all the tools, equipment, etc. to perform the job correctly. 6.4 Work Environment People work better when they are in a good environment. This means good housekeeping, clean breakrooms and restrooms. Hearing and other personal protective gear should be provided. Basically, anything that makes for good working conditions. Work environment also includes the culture of the work place including such things as:
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the social atmosphere the psychological philosophy, and employee recognition programs. ISO 9001 Section 7 Product Realization

ISO 9001 Section 7 - Product Realization 7.1 Planning of Product Realization We are to determine the process steps ahead of time. Determine the important steps, checks, records and objectives. This can be done in any manner the company chooses. Some companies use flowcharts, process maps, and/or process descriptions. Most people like the flowcharting or mapping methods because they can see the process interactions and linkages. 7.2 Customer-related Processes 7.2.1 Determination of requirements related to product This clause is one of the most important in providing customer satisfaction. It requires you to have a complete understanding of the customer s requirements. Including something the customer may have overlooked but you know is needed based on the customer s use of the product. 7.2.2 Review of requirements related to product Before we provide a quote or accept an order we must make certain we can do what the customer wants. This includes anything from a written description of the product or service to how soon they want to pay you for the product. Don t forget shipping schedules, packaging and labeling!

If any of the requirements change we must make sure everyone involved is told of the change. 7.2.3 Customer Communication Figure out the best way to communicate with the customer from the order to the delivery of the product. It could be by phone, fax, email, personal visit or any combination. We must keep the customer up-to-date. Listen to them about changes and their expectations. 7.3 Design and Development There are seven sub-clauses in this section. 7.3.1 Design and development planning The complete design process should be laid out in a documented plan. This can be accomplished through a written procedure. Or, sometimes a checklist showing all the steps in the design process works. 7.3.2 Design and development inputs The design group must make sure that they have all the needed customer input. This can include specifications, material and production methods, packaging requirements. Basically anything that ensures the customer requirements are understood and met. 7.3.3 Design and development outputs Simply stated: The design output must match the design input. All requirements are known and incorporated into the design. Or, negotiations with the customer have produced altered criteria that is included. 7.3.4 Design and development review The reviews of the developing design are conducted according to the design plan from 7.3.1. The reviews are to include any departments that have an interest in the design at that stage. Different departments can participate in the reviews at different stages of the design development. 7.3.5 Design and development verification Design verification is usually analytical in nature. This may be alternate calculations for stacked tolerances, known limits of materials in the design, etc.

7.3.6 Design and development validation Design validation is testing of designs and materials. Laboratory and bench testing, prototyping, field tests, etc. 7.3.7 Control of design and development changes All changes to designs must be reviewed to ensure compatibility with customer requirements. All changes must be approved by an authorized person before the change is released to production. The organization must keep records of all design changes including when the change was implemented into the product. 7.4 Purchasing 7.4.1 Purchasing process 7.4.2 Purchasing information 7.4.3 Verification of purchased product It is customary to buy some of the things you need for your product from other suppliers. This could be anything from completed assemblies to raw materials. It might be sub-contracting some of your work to a specialist, (i.e.); painting or plating or welding. Let s say we make computers and you buy the monitor from another company with your name on it. When the monitor breaks and your customer calls, do they call you or the maker of the monitor. You, of course. You can try and tell the customer it was the monitor maker, but they won t care. They bought the computer from you. You are responsible in the customer s eyes. It is the responsibility of the company selling the product to make sure it meets the customer s requirements, regardless of where the materials or parts came. Your company must evaluate the quality of their suppliers and approve the supplier for use. This means there has to be some criteria for that evaluation and suppliers are held to meeting those needs. If they don t they will need to take action to fix the situation so it won t happen again. But, regardless of the fact the supplier is approved, your company is charged with making certain the goods you get meet all the requirements. The requirements need to be spelled out in the purchase documents sent to the supplier. Also, if anyone from your company or your customer wants to inspect the goods at the supplier s location, this is to be written in the purchase documents as well. 7.5 Production and Service Provisions

7.5.1 Control of production and service provisions This may be the most important clause in the ISO 9001:2008 standard. The standard is based on this concept: If you control the input to your process and make sure it is good, the output has to be good. Why? Because the process consists of the input, that s all there is. If it is good going in it will be good coming out. Therefore, this clause tells the company the things they need to do make sure the input is okay. 7.5.2 Validation of processes for production and service This requirement is for processes where the output can t or isn t inspected or tested to see if it is okay. You have to make sure that everything in the process is controlled. Like how to do the work, what equipment and material must be use. It could even require the operator(s) be certified to run the operation. Once that s all settled, it has to be checked on from time to time or what the standard calls revalidation . 7.5.3 Identification and traceability The standard defines quality as conformance to requirements. Earlier we discussed the importance of clearly defining the customer s requirements that are measurable. This clause reminds us it is necessary to always keep these requirements in mind. As items move through the steps of processing, we need to know if they are ready for the next step. As obvious as this seems, at one time companies didn t know what was what and where it was because it wasn t always clearly identified. The other condition in this clause is about traceability. This means we can look back and find where the materials came from, when it was made and who bought it. 7.5.4 Customer-owned property The first thing you need to ask is Do I have any customer owned property? This can be anything the customer retains title to. It can be parts, materials, tooling, packaging and labels. Also include is intellectual property like blueprints, methods, formulas and recipes. You are responsible for the care, custody and control of customer property and that means keeping it safe from damage and loss. It can also mean keeping it clean, properly identified and in useable condition. If anything happens to it you must tell the customer and keep a record of the problem. 7.5.5 Preservation of product You have to be careful in handling the materials and goods while being processed. You must use the appropriate containers and fillers so items won t be chipped, broken or bent. Reducing the distance between operations inside the plant and fixing cracks and

holes in the floor so the tow motors aren t bouncing your stuff around like an eight-year old on a trampoline may be needed. The final stage is seeing the goods are packaged correctly for the method of shipping; truck, air or sea. Sometimes a supplier doesn t get to choose the shipping method or the carrier because the customer is paying the freight. Unfortunately, you are still responsible for seeing the goods arrive at your customer s in good shape. We need to always keep in mind the customer pays for the product quality at their dock, not yours. 7.6 Control of monitoring and measuring devices A lot people think this clause is about inspection gages and instruments. It s not. It s about data, good useable data. If we are to make a decision regarding the quality of something we must be able to rely on the data we use to make the decision. In order to feel comfortable about the data we have to be comfortable about the methods used to gather the data. This does include making sure the gages and instruments used in the data gathering method are stable and reliable.

ISO 9001 Section 8 Measurement, Analysis and Improvement ISO 9001 Section 8 - Measurement, Analysis and Improvement 8.1 General This clause asks you to do 3 things: 1) Identify the important measuring processes, 2) Use the data to make sure things are okay and to make them better, 3) Determine where you need to use statistics You need to determine the information you need to collect and how to use it. Ask if the right information is being collected and if it is useful. Many companies collect and keep data that has no value. Others fail to analyze data that can provide insights for valuable improvements. Get a picture of your data and information plan by identifying the sources of the data, how the data are collected and where the data goes. Data may come from measuring product characteristics, process performance, audit results, complaint reports, customer surveys, etc. It can be useful to flowchart the collection, use and analysis of data. 8.2 Monitoring and Measurement

8.2.1 Customer Satisfaction This clause reinforces what the standard is all about. Remember from earlier in the discussion that the customer defines quality? Companies have two types of assets, tangible and intangible. Tangible assets are the physical things they own like buildings, machinery, automobiles and everything else that is real. Intangible assets aren t physical things. That can t be touched or seen. Things such as goodwill, brand recognition, market position, customer loyalty. 8.2.2 Internal Audit Auditing is one of the four primary controls specified in the standard: 1) Planning your processes 2) Controlling your processes 3) Examine your processes (auditing) 4) Correct or improve the process. These four controls are the basis of the Plan Do Check- Act cycle. Therefore, auditing is a critical function in your QMS. The first thing you need is an audit schedule. The schedule shows what processes are to be audited, when they are to be audited and who will be the auditor(s). The audit schedule should be developed and published by the lead auditor or audit program manager. It should cover a year s worth of audits. Although this isn t required by ISO 9001 it has become an industry guideline. At the very least the schedule should cover 6 months, but 1 year is preferred. 8.2.3 Monitoring and measurement of processes 8.2.4 Monitoring and measurement of product One of the primary rules of quality is Do it right the first time. The processes for providing product must be monitored and measured against an acceptance criteria. A company should know when processes are operating effectively. If the production and delivery processes are performing okay, it is likely to result in acceptable product and customer satisfaction. Product quality is defined as conformance to requirements. These are measurable features and need to be verified through inspection and test procedures. The three most common product inspections are: 1) Receiving inspection,

2) In-process inspection, and 3) Final inspection. These are the classic quality control concepts used for years by companies. They provide us with the data to show the customer that you are making product to the requirements. The amount of inspection will decrease as your processes become more capable through continually improvement activities. However, some inspection will always be necessary. 8.3 Control of Nonconforming Product What is meant by nonconforming product? If we go back to the definition of quality being conformance to requirements therefore, nonconforming is not meeting the requirement. This is a go/no go issue. It s determined through testing and inspection. There are five possible choices in dealing with nonconforming product: 1) Reject 2) Rework 3) Repair 4) Regrade 5) Release Which one of the five that is used depends on the product itself, the customer, the industry and of course the cost? 8.4 Analysis of Data Here is where you decide what data will be analyzed to effectively measure performance and identify areas for improvement. The information from this clause will provide empirical (factual) data that can be used to determine progress and make management decisions. You should collect and analyze all the data that will let you determine process and system effectiveness. And, then figure out where improvement is needed. At the very least you will need to provide and analyze data for these four issues: 1) Customer satisfaction, 2) Product quality,

3) Product and process trends, and 4) Supplier performance. 8.5 Improvement 8.5.1 Continual improvement 8.5.2 Corrective action 8.5.3 Preventive action Although you have planned, implemented, controlled and measured your processes sometimes things go bad. Usually we give it a quick fix and life goes on. However, once in awhile the mistake is serious. Customers are angry and dissatisfied. Internal costs are getting out-of-hand. The most serious mistake causes injury to people. Something needs to be changed. The QMS needs to be corrected or improved. Before you can change the QMS, you need to know which problems need the most attention. You need to focus on the BIG problems. The small stuff will probably take care of itself during the course of normal activities. The important thing here is to figure out the difference between the small and big problems. Many times the only criteria a company uses is which wheel squeaks the loudest. Everyone runs around in frantic action constantly putting out fires. You need to develop a method to evaluate which problem comes first. .Perhaps cost, risk to customer satisfaction or compliance with regulations, or current events (those things your company or group are currently focused on). If the kick-in threshold is too low you see every problem as an immediate crisis. If the threshold is too high it will let serious problems continue and eventually close you down. There has been an ongoing debate over the difference between corrective action and preventive action. The generally accepted explanation is if a problem has occurred, corrective action is needed. If the problem has not happened, but could, preventive action is needed. The potential severity of the problem needs to be determined so a decision can be made. Since no company has enough resources to address everything all at once, a priority must be set. Whether you need corrective action or preventive action, the method for taking the action needs to formal and disciplined. Flowcharting, data analysis, and root cause analysis are some of the methods that can be used. What if there haven t been any serious problems in the process? Is action needed? The answer is a definite maybe. Those processes that are critical to producing an output for your customer should be analyzed for continual improvement. Raise the bar a little. Figure out how you could reduce cycle time, increase throughput and maybe improve yield. Continual improvement doesn t need to be a home run or grand slam every time. Small changes on a continuous basis can have a tremendous impact.

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