JP2020155134A - Method for achieving registration to industrial standard - Google Patents

Abstract

To timely execute a management system for a quality, environment, wellness and safety on business.SOLUTION: The method for achieving registration to an industrial standard comprises: a step (12) for identifying a request of a client; a step (14) for visiting the client; a step (16) for writing a quality procedure and a quality guide; a step for visiting the client again, for updating the quality procedure and quality guide, and for supporting execution; a step (22) for planning a prior evaluation and a registration inspection by a quality management system registration institution; a step for updating the quality procedure and quality guide based on the prior evaluation and registration inspection, and for making the quality procedure and quality guide adapt to an applicable reference; and a step for monitoring a state of the client, and for making a consultant surely grant a request of the client in an allocated time frame. The method is followed by scheduling and project software.SELECTED DRAWING: Figure 1

Description

The present invention generally relates to the fields of quality, environment, operational health and safety, and other management systems, strictly speaking, ISO9001: 2000, ISO9001 / 9002: 1994, QS-9000, ISO / TS16949. , VDA6.1, TL9000, ISO13485, Jigs and Tools (TE) Addendum, Semiconductor Addendum, ISO14001, AS9100, ISO / IEC17025 and OHSAS18001 for registration, certification, qualification or conformity Within 180 days, it relates to providing a process to assist the organization in achieving this in a series of clear but coordinated ways.

The fierce competition of the 1980s taught US businesses and industries a memorable lesson that companies that do not provide quality products and services will not succeed or survive.

From the 1990s to the beginning of the 21st century, the definition of quality extended beyond the grade of the product or service itself. This extended scope includes all aspects of providing a product or service, from sale to delivery to billing and post-sale services.

When choosing a supplier of materials, parts or services, customers need and seek assurance that they will receive all qualities at all levels, whether for industrial use, wholesale or retail. A comprehensive approach to quality control will meet your requirements.

The term "quality" itself is the source of much confusion. Quality is defined in ISO 9000: 2000, 3.1.1 as "the degree to which a set of unique properties meet the requirements", and in ISO 8402: 1994, 2.1, "stated and implied requirements". It is defined as "the completeness of the traits of nature related to the ability to meet." To achieve a satisfactory level of quality, you will be involved in all activities that affect quality.

For the purpose of obtaining customer satisfaction, quality means suitability for purpose or suitability for use. Simply put, it is the ability to meet a given requirement. The appropriate quality of a product or service depends on the requirements that must be met. For example, whether the tiles on the floor of a washroom fit into a restroom in a rural commercial facility is determined by very different criteria than the tiles applied to a washroom in a private residence. Similarly, cleaning services used in laboratories must meet different standards than those used in insurance company offices.

To determine or judge quality, it is necessary to understand the customer's requirements. However, these requirements are not limited to products or services. These requirements include all other aspects of the transaction, including price, delivery and timing, and post-sales service.

The history of quality can be traced back to the primordial era. The self-sufficient primitive man was a supplier and a user. To be both, the primitive man had to know exactly what was needed to meet the customer's requirements, and then became a supplier by creating or making the item. This common-sense procedure has been passed down through generations of mankind and is still alive today.

The same concept can be applied to internal suppliers and customers. Internally, quality also means delivering the products or services needed to meet the defined requirements on time. For example, the correct, well-made material castings must be delivered in the correct quantity, in the right place, when needed. Company mail must be properly classified and delivered correctly according to plan.

In any business, the main goal is to benefit the owner, whether an individual, a consortium or thousands of shareholders, by selling goods or services.

For a long time, businesses have used many different strategies to improve their profit-making prospects. Quality control provides significant benefits to customers, but is even more valuable to the company.

Quality control allows companies to improve their income and save money. Superior quality helps the company better compete with new customers. Quality control is also important for retaining current customers. It is well known that attracting new customers is more expensive than retaining current ones, and is estimated to be 5 to 20 times more, depending on the industry. At the same time, internal efficiency can be improved and additional costs can be reduced. Quality control prevents inefficiencies and associated labor, materials, machinery and inventory costs. Quality control will also help companies avoid the costs of late payments, transshipments and repeated service calls.

There is no doubt that quality norms are healthy for business and industry, consumers, and the economy as a whole.

Quality expert W. Dr. Edward Deming, who introduced the concept and process of quality to Japan in 1950 and brought about the result of shaking business and industry worldwide, described the result of quality achievement as "quality improvement --- production". He explained that it was a chain reaction of "improvement of sex --- cost reduction --- price reduction --- increase in market share --- continuing business --- providing more jobs --- recovery of investment".

Quality management systems or audit perspectives can also create fear, confusion, or excessive optimism. Managers ponder the loss of decision-making power, downtime for tedious and thorough inspections, reduced productivity, piles of paperwork and huge costs. Workers are often afraid of disciplinary action. Conversely, both managers and workers may expect quality control to solve all company problems.

However, quality control does not solve everything. It can solve some problems, but it does not provide a miraculous solution. Do not do any of the above items.

Quality auditors are not responsible for technical decisions, and quality control audits are not inspections. Reports are produced, but the clerical work of managers and workers is modestly minimal. Quality control costs are relatively small and are generally well offset by cost savings.

Businesses are increasingly adopting quality control as an important profit-making strategy today. The fact that quality control has become such an important strategy in a relatively short period of time attests to its extraordinary effectiveness.

A main object of the present invention is to enable timely implementation of quality, environmental, operational health and safety, and other management systems. The present invention is, but is not limited to, ISO9001: 2000, ISO9001 / 9002: 1994, QS-9000, ISO / TS16949, VDA6.1, TL9000, ISO13485, jigs and tools (TE) addendum, semiconductor addendum, ISO14001. , AS9100, ISO / IEC17025, OHSAS18001, CE marking, other management system standards not listed herein and can be tailored to a variety of standards including future management system standards.

Another object of the invention is, but not limited to, the step of identifying aspects to which the value of implementation has been added and the step of providing support to the organization after a pre-evaluation of the management system or a stage 1 audit. And write management system policies, guidance and procedures to reflect the actual practice of the organization, as well as the steps to provide support to the organization after management system registration, certification, qualification, conformity or stage 2 audit. It includes a stage and a stage of acting as a liaison or accreditation body with the management system registration body.

In achieving the above and other objectives and advantages of the present invention, a method for registering with an industrial standard is provided, which comprises a step of identifying the client's request and a step of visiting the client. , The stage of writing the quality procedure and quality guide, the stage of revisiting the client to update the quality procedure and quality guide and support the implementation, and the stage of planning the pre-evaluation and registration audit by the registration body of the quality control system. , Update quality procedures and quality guidance based on pre-evaluation and registration audit, to ensure compliance with industry standards, and to monitor the client's situation and ensure that the consultant is within the assigned time frame. It includes steps to meet the client's request. The invention can be tracked by scheduling and project software.

The above and other objectives and advantages of the present invention are discussed below. Drawings are attached, explanations and examples are provided to further disclose and provide preferred embodiments of the present invention.

It is a flowchart which shows the preferable embodiment of this invention.

Meaning of quality control The basis of quality control is to meet given requirements according to customer requirements. This is because the basic concern is that every element of the company, whether process, procedure, system or person, ensures that the right product or service, the delivery of the product or service to the right customer, the right place at the right time. Delivery to, delivery of products or services that meet requirements, delivery of products or services that satisfy customers, provision of appropriate post-sales services, information necessary to respond to quality-related issues related to producer liability, and It means that all of the above items should be adjusted for delivery at the agreed price.

Quality control is essential for every company. The quality management system established by any company is determined by its current and target markets and the quality requirements of that market. The company must use reasonable requirements when implementing its quality management system.

In any company, quality improvement begins with four basic operating stages. The first stage is the stage of adopting the definition of quality. This includes the steps to meet the requirements, especially the customer's requirements. The second step is to set up the system to achieve this defined quality. This is a preventive system that identifies and removes mistakes. The third stage is the stage of establishing a performance standard. These should be error free. Defects and errors are neither unavoidable nor acceptable. The fourth stage is the stage of measuring expenses. This means the step of calculating the cost of quality by comparing the cost of nonconformity resulting from not doing it right in the first place with the price of conformity resulting from ensuring that things are done correctly first. are doing.

The problem of detection vs. prevention is the difference between the quality control approach and the quality assurance approach of quality management systems. The former pursues detection and the latter strives to prevent nonconformity. Quality assurance-focused systems capture nonconformities as they occur in the process. This system is ideal because it is easy, inexpensive, and repairable at that point. Systems that focus on quality control, on the other hand, drive nonconformities until the process is complete. When nonconformity issues are detected, they tend to be much more difficult and expensive to repair.

Quality Standards Various types of quality standards have been used for centuries. In the Middle Ages, when craftsmen began to unite into one to form a guild, they set their own standards and used their expertise to measure various techniques. On the user side, quality standards arose from military needs. The King of England ordered officials about a thousand years ago to oversee the production of warships. Almost at the same time, another official was tasked with overseeing the quality and effectiveness of land-based weapons manufacturing and engineering.

Recently, quality standards have been driven by military needs. In 1912, the British Government established a department to ensure the quality of military planes. In the United States, the establishment of standards for the MILSTD series during and after World War II made quality standards stand out. This standard has been the leading quality standard imposed on suppliers to the US Department of Defense for decades.

Quality standards of non-military character have recently emerged. As quality became inevitable for many multinational corporations in the late 1970s, it became clear that output quality was directly related to input quality. Therefore, major companies that rely extensively on subassembly and component suppliers have begun to develop their own quality standards and instructed their suppliers to make them supply standards.

In Europe, the approach to quality standards has taken a somewhat different course. The driving force on standards was played by the government, not the private sector. For example, the British Empire compiled a set of national quality system standards, BS5750, in 1979. This standard became a requirement for government, especially military suppliers, and the government put all its efforts into encouraging the private sector to BS5750.

The government actively recommended registering with the company. The government has created an institution to certify registered bodies and has allowed another institution to empower instructors and courses. The government promoted the BS5750 and sought to ensure that the standard was noticed and accepted by the public.

The European Union (EU) has also adopted the quality system standard EN-29000, which is similar to BS5750 in many respects. Both EN-29000 and BS5750 became models of ISO9000, and ISO9000 was adopted in 1987 and revised in 1994 and 2000. ISO9000 is used throughout the EU. In the years that followed, the three standards were synonymously harmonized.

Established in 1946, the International Organization for Standardization (ISO) is a community of 132 national standards bodies. The representative member organization of the United States is the American National Standards Institute (ANSI).

The International Organization for Standardization, headquartered in Genoa, Switzerland, has created a series of ISO quality management system standards, including ISO 9001: 2000, ISO 9001/9002: 1994, and the American version of Q9000. .. ISO9000 was developed to facilitate the international exchange of goods and services through a common set of globally accepted quality standards.

ISO9000, a standard derived from BS5750 and the US military standard MIL-Q-9858A, is a set of standards related to quality assurance and quality control. Standards are not specific to a product or service and also apply to the process of making them.

This standard was designed to be comprehensive for use in any industry in the world. This series specifies goals, objectives and philosophies, but not procedures.

Since its creation, ISO9000 has served as a fundamental element of many other standards. Derivatives of this quality management system include QS-900 for automobile big three, international automobile standard ISO / TS16949, German automobile standard VDA6.1, international telecommunications standard TL9000, international aerospace standard AS9100, international medical equipment standard ISO13485, and Includes two QS-9000 derivatives, Jig Tools and Equipment (TE) Addendum and Semiconductor Addendum. Other international and national standards configured similar to ISO9000 include environmental management system standard ISO14001, calibration and testing laboratory quality management system and technical performance standard ISO / IEC17025, business health and safety management system standard OHSAS18001, And currently good manufacturing methods (CGMP) for US Food and Drug Administration (FDA) medical devices.

Quality plan The quality plan (ISO 9001: 2000, element 5.4; ISO 9001/9002: 1994, element 42.3) is often a contract document, in which the customer is the production contracted by the supplier. It specifies that a certain quality scale should be adopted when producing goods. The content of the quality plan, also called the control plan, includes inspection plans, design key control points, and important and / or key subcontractors and requirements.

With the consent of the customer, the quality plan or control plan becomes an integral part of the contract. When developing a quality plan or control plan, the following activities, ie, if applicable, identify and acquire the controls, processes, equipment, equipment, resources and skills necessary to meet the quality objectives; design, Make sure that processes, installation procedures, services, inspection and testing activities, and any suitable documentation are coordinated with the product (product), renewal methods for quality control, and inspection and testing techniques when needed. Identify any unusual measurement requirements; identify verification actions suitable for both the product and the manufacturing process; understand and record acceptance criteria to eliminate any subjectivity; maintain the required quality record Consideration must be given to exemplify the implementation and effectiveness of the quality management system.

A quality plan or control plan consists of quality documents such as procedure manuals and work instructions, which specify general activities and tasks that must be completed.

Documents serve as the basis of a quality management system. Documents are essential for ISO9000 as they provide objective / audit evidence of system status. In addition, documents are an invaluable reference resource and play an important role in auditing quality management systems. Documents explain the company's policies, prescribe authority, establish work procedures and work instructions, and help employers fulfill their work responsibilities.

When the documents are applied to the quality management system, it is structured like a pyramid. This document is divided into four stages as shown in Table 1.

Quality Guide (Stage 1)
The Quality Guide is considered the highest level of documentation and is located at the top of the Quality Management System Documentation Pyramid. It describes the company's quality policy and describes the organization's quality management system.

Of all the elements that make up an ISO9000 quality management system, nothing is more important than a quality guide. This controlled circular document serves a number of essential purposes. It is a living and active document, which means it is being actively used.

The quality guide has many functions. It assists in creating and implementing a quality management system, describes the purpose and structure of the quality management system, indicates the referral of the manager to the system, and acts as a mutual reference between the quality management system and ISO 9001: 2000. Acts as a mutual reference to facility procedures and acts as a quality management system standard document for auditors and other designated bodies such as registered institutions, investors and customers.

The Quality Guide not only deals with the corresponding fields of ISO9000, but also the following items: a brief statement about the company's referral to quality, a brief policy statement that states the image and reputation of the company's quality, customers and A short profile of the company to the supplier, a facility mission statement about how the company plans to accomplish quality objectives, a distribution list (controlled circulation), a standard list of facility procedures, and authority and responsibility. Statement, may include, and usually includes.

Procedure (step 2)
The procedure is the second level of paperwork. The procedure is referred to as a stage 2 document.

The procedure provides information about what activities are carried out within the organization, how they are performed, and who is directly responsible for them.

Whereas the quality guide is a company-wide document, the procedure is an extension of the quality guide directed to different departments. The procedure is activity-based and describes the methods and practices used to carry out the activities of various quality management systems that cross functional or organizational lines.

The procedure does not have to be long and verbose. The procedure should be simple and easy to understand. Both ISO 9001: 2000 and ISO 9001/9001: 1994 state that the facility only needs to document the procedures and work instructions "required by this international standard" (4.2.1c).

Effective procedures that clearly define responsibilities reduce the amount of training required for new employees. They can easily perform tasks by following the steps.

Work instructions (stage 3)
Work instructions are placed at the next level of quality documentation, stage 3. Work instructions are directed to the actors of the organization, including operators who carry out activities with the assistance of quality management systems and workers on the production line.

Whereas procedures describe activities, work instructions describe how to perform the various tasks specified in the procedure. Work orders are generally completed by individuals or departments. The work procedure indicates to the operator the steps that must be followed, the equipment and resources required for the work, the preventive actions that must be taken, and other necessary matters.

Work instructions should be as detailed as possible, including specifics, to ensure clarity and compliance. Since work instructions are "how-to" documents, they tend to change more often than quality guides.

Quality record (stage 4)
A quality record is a document that contains objective / audit evidence that a) quality requirements have been met or b) the quality management system is working effectively. These records may be written or stored on any data medium. Records shall be kept in a protected place to prevent loss, damage and deterioration. The quality management system must specify how long records should be kept and how they should be disposed of.

Quality Audits In today's customer-oriented global business environment, remedial measures must be implemented to stay on the cutting edge of competition. Almost all activities within an organization will benefit from improvements, including the process of monitoring the quality of products and services.

One effective tool a company can use in its continuous improvement mission is quality assurance (QA) audits. Since the dawn of the quality era, the term quality audit has come to mean different things from person to person.

Audit Objectives Audits have long been perceived as disgraceful. The process often appears to employees and managers to contribute to disciplinary action or control, rather than assisting in error reduction and elimination, compliance, confirmation and communication.

Audits help achieve many positive goals. Most importantly, auditing is essential to the process of verifying the suitability of a facility's quality management system.

Audit Team The command auditor is in a position to be responsible for the entire audit team, which consists of one or more auditors. The audit team may also need to include experts with a specialized background, depending on the situation. The team may include auditor apprentices or observers with the consent of the client, the auditee, and the command auditor.

Nonconformity According to ISO 9000: 2000, 3.6.2 and ISO 8402: 1994, 2.10, nonconformity is a non-compliance with (specific) requirements. Nonconformities are categorized as important or non-important. Nonconformities are written as a result of some kind of quality audit. If the auditor identifies a nonconformity, it must confirm it through objective / audit evidence. Evidence of objective / audit is information such as a record or statement of facts about a quality management system that is captured by observation, measurement, testing or other means and can be proven to be true or is characteristically factual. ..

ISO9000: 2000.3.8.1 defines objective evidence as "data in support of the existence or truth of something". ISO 8402: 1994, 2.19 defines objective evidence as "information that can be proven to be true based on facts obtained by observation, measurement, testing or other means." ISO9000: 2000, 3.9.4 defines audit evidence as "records, factual statements or other information relevant to the audit criteria and identifiable." ISO 1011-1: 1990, 3.7 states that objective evidence is "related to the quality of goods or services, or the presence and implementation of quality system elements, and is based on observation, measurement or testing and confirming. Qualitative or quantitative information, records or factual statements that can be made. "

If you find a nonconformity, you will often be warned, but it should not happen. Nonconformity is not necessarily a bad thing. Nonconformity can lead to continuous improvement by identifying weaknesses that can be converted into strength and pointing out areas that can be improved.

There are various causes of nonconformity. Significant nonconformities are caused by lack of procedures or inconsistencies in implementing a quality system. Significant nonconformities have a significant impact on the quality of products or services, putting facilities or employees at risk of losing customers, endangering businesses, or jeopardizing government qualifications, and / or , Causes great damage to other activities of the company.

Examples of significant nonconformities are the lack of documented procedures for contracts or design reviews, internal audit reports where system defects are left unattended with no evidence of follow-up, numerous inspections, and recently calibrated. Examples include unmeasured and testing equipment, and in many cases unofficial and unapproved changes to drawings or plans.

Registration cannot be obtained until corrective action has been taken for all nonconformities.

Minor shortcomings, non-significant nonconformities, are nonconformities that do not directly affect the quality of the product or service or that appear to be easily correctable.

Examples of non-significant nonconformities include sporadic examples of drawings marked with unapproved designs or tolerance changes, sporadic examples of instruments without calibration data, and corrective actions that stand out in internal audit nonconformity reports. Evidence, sporadic examples of inadequate record keeping of contracts or design reviews, inadequate documentation of employee training experience, etc.

In addition to the above, there are two different variants of possible nonconformities: "fatal but few nonconformities" and "minor but many nonconformities".

"Fatal but few" nonconformities, in small numbers, have a significant impact on quality. They are usually harmful to safety or the economy. These may be chronic issues detected in the early audit or may be specifically addressed to the auditor as an ongoing concern.

"Minor but many" nonconformities are often non-significant and occur in large numbers, usually with three or more non-significant nonconformities for one requirement. "Minor but many" nonconformities reflect systematic errors and can affect quality due to their high volume. When applied to one requirement, "trivial but many" can be a significant nonconformity.

If the process does not conform to the quality guide or ISO9000, a nonconformity will be issued.

Nonconformities usually occur if the procedure is not performed properly. This makes the process ineffective.

Other important nonconformities are a single defect in the quality management system, product or service, lack of quality management system documents to meet the requirements, inconsistent implementation of quality management system documents, and collective. There is a series of non-critical nonconformities, etc. that indicate the weaknesses of the overall quality management system in areas or activities of importance to.

Other examples of non-critical nonconformities are defined quality management systems, documented procedures and work instructions, which are generally acceptable implementation levels, but follow the requirements or documentation of the quality management system. There are some insignificant discrepancies or minor mistakes.

Observation is another audit classification. Observations, in the auditor's discretion, represent weaknesses in existing conditions that provide a valid basis for elucidating or investigating to improve the overall condition and effectiveness of the quality management system being audited.

In the course of an audit, for example, objective / audit evidence was inadequate to clearly determine whether the activities of the quality management system being audited met or did not meet certain requirements. If this is the case. Observations represent potential nonconformities in the future, but do not require a response by the auditor.

Nonconformity Records Nonconformities, if found, must be recorded in the Nonconformity Report (NCR). The auditor must ensure that the nonconformity report is accurate, concise and easy to read.

The auditor must state in NCR the audit number or identification code, audit date, area of consideration, reference standard, report of nonconformity based on a statement of facts, and the identities of the responsible auditor and the representative of the auditee. Must be.

Upon completion, the NCR will require the signatures of both the auditor and the auditor's representative. This confirms that the auditor is aware of the nonconformity and agrees that corrective action is required. It is important that there is a clear and ongoing dialogue between the audit team and the auditor and that it is not surprising at the final meeting.

Upon recognizing a nonconformity, the command auditor and the auditee must agree on a follow-up method as well as a deadline for the correction activities to be completed.

Correction activities and follow-up After the quality management system audit is completed and the final audit report is submitted, the auditee must make decisions regarding correction and preventive activities. The auditor is responsible for identifying nonconformities and documenting them by observations supported by objective / audit evidence.

The auditor must also make the auditee aware of the nonconformity during the audit itself or at the final meeting. The auditor makes recommendations when requested, but only the auditor can create and carry out correction activities.

It is the duty of the audit process to determine whether the first party (internal), the second party or the third party follows up on past nonconformities by assessing the creation, execution and effectiveness of the correction activity. .. Nonconformity removal is considered only if the correction activity has been performed and proved to be objectively valid.

Activities to eliminate the cause of nonconformities result from market feedback, customer complaints, administrator reviews, nonconformity reports, and internal and external audits.

Correction activities There are several forms of correction and prevention activities used to address nonconformities. One is rapid repair correction or short-term correction activity, which may be performed spot-on to mitigate the spread of damage until permanent long-term preventive activity is performed.

Long-term preventive activities aim to eliminate the cause of nonconformity and usually involve changes in procedures and systems. This is time consuming to perform as it involves complex process changes.

Auditors must carefully document the process of performing and monitoring correction and preventive activities to facilitate proper follow-up.

Affected employees should be outlined and properly trained in corrective action, if necessary, especially if they are responsible for monitoring effectiveness. A written statement regarding the implementation of correction activities from the responsible area must be obtained. If the written statement has not been received by the prescribed deadline, the manager of the responsible area must be contacted to determine why the activity did not take place. The auditee must document the correction action process by completing the second part of the nonconformity report form. This includes a description of the correction activities developed by the auditor and the preventive actions taken to prevent repeated nonconformities, and the auditor's signature in both areas.

Follow-up audits are periodic activities. When developing the scope and plan of the next audit, the results of the previous audit will be used as a reference and sometimes as a guide. The initial audit findings trigger another full or simplified audit to confirm that corrective action has been taken to address a particular nonconformity.

To be effective, the initial audit plan includes requirements and processes for conducting follow-up activities and addressing nonconformities.

The audit team will outline the findings justifying these activities and communicate them to the auditee and client prior to the first audit to form consent.

Auditor and Client Responsibilities As mentioned above, auditors are only responsible for identifying nonconformities. It is the auditor's responsibility to determine and initiate correction activities.

Follow-up audits must be planned based on audit findings, in particular the systematic issues found or the number of significant or fatal but small nonconformities. This audit may only review nonconformity and correction activities, or it may be a full-scale audit. Judgment of the necessity and degree of follow-up audit is determined by the client, and it also depends on the number of factors determined by the audit process.

Organizations wishing to achieve registration with an industrial standard within 180 days are treated through a series of clear but linked steps. These steps are the process of defining the organization's requirements for management system implementation and registration, the process of defining expectations for management system implementation and registration, and the added value that results from management system implementation and registration. Track the implementation process through the process of defining, the process of implementing aspects that add value through the implementation and registration of the management system, and the appropriate computer software application (ie, database, project management, schedule manager, etc.) The process, the process of tracking the progress of implementation through the monitoring of general managers and consultant managers, the process of creating management system policies and guidance for the organization in the central position, and the procedure guidance of the management system in the central position. Includes a review process and.

FIG. 1 shows a preferred embodiment of the present invention, which includes
As shown in block 12, the stage of identifying the client's request and
As shown in block 14, the stage of visiting the client and
As shown in block 16, the stage of writing the quality procedure and quality guide, and
As shown in block 18, the stage of review through consultation with the client, tracking of the project manager, decision of any changes to the document, and
As shown in block 20, the consultant revisits the client's location, corrects the documents, and assists in the implementation.
As shown in block 22, the stage in which the consultant assists the quality management system registration body in planning pre-evaluation and registration audits:
As shown in Block 24, the consultant will make any further corrections to the required documentation after the pre-assessment and registration audit to ensure compliance with applicable standards.
As shown in block 26, including one or more of the steps in which the project coordinator monitors the client's condition and the consultant ensures that the client's requirements are met within the allotted time. There is.
At least steps 1-7 should be tracked with scheduling and project manager software.
These steps are discussed in more detail in the following chapters.

Techniques for Identifying Identity Client Needs Client requests are identified through three main channels: sales agents, project coordinators and consultants.

Sales agents are referred to promising clients through a number of means, including referrals, the Internet and / or visitation appointments set within defined geographic areas. After the referral, the sales agent determines the client's request through a brief interview with the key manager.

When the sales agent signs the contract with the client, the project coordinator first contacts him / her. If the client's request differs from the sales agent's findings, it is recorded and amended.

The consultant then contacts the client. During the first site visit, the consultant will interview the key manager again to confirm the request first defined by the sales agent and confirmed and / or modified by the project coordinator.

Through these three methods, the client's request is defined in two main categories.

The first category is ISO9001: 2000, ISO9001 / 9002: 1994, QS-9000, ISO / TS16949, VDA6.1, TL9000, ISO13485, jigs and tools and as a result of business marketing or customer pressure. Registration, certification, qualification or compliance with international and national management system standards such as Equipment (TE) Addendum, Semiconductor Addendum, ISO14001, AS9100, ISO / IEC17025 and OHSAS18001.

Due to the widespread use of quality, environment, operational health and safety, and other management system standards, for subcontractors and suppliers, ISO9001: 2000, ISO9001 / 9002: 1994, QS-9000, ISO / TS 16949, VDA6.1 Registered, certified or qualified for international and national management system standards such as TL9000, ISO13485, Jigs and Tools (TE) Addendum, Semiconductor Addendum, ISO14001, AS9100, ISO / IEC17025 and OHSAS18001. Or there is increasing pressure to become fit. For example, if customer A requires supplier B to be registered, certified, qualified, or compliant with international or national management system standards, supplier B will subcontract. Contractor C will also be required to register, be certified, qualify, or become compliant with the same standards. At this rate, international or national management system standards become part of the requirements issued by supply chain members to suppliers. Companies are required to register, be accredited, qualify, or comply with international or national management system standards, even if they do not see any actual profits other than satisfying their customers. You will feel the customer pressure to become.

In addition, some marketing benefits resulting from registration, accreditation, qualification, and conformity with international or national management system standards can be recognized. The basic idea is that a company can more effectively bring its products and services to market by having registration, accreditation, qualification or conformity with international or national management system standards. is there.

The second category of client's request is a mode in which value is added that surpasses the desire for registration, certification, qualification or conformity, for the sole purpose of obtaining registration, accreditation, qualification or conformity. It is a thing.

In addition to one, both, or neither of the above potential client requirements, any company seeking registration, accreditation, qualification, or compliance with international or national management system standards may be another. You will be able to identify the aspect to which the value has been added. These are company-specific and vary from organization to organization.

One example of adding value is correction. The implementation of management system standards raises several issues or sets of issues within an organization. They include all aspects of the business, including reduced scrap rates, refurbishment, increased customer satisfaction and continuous improvement.

Another example of adding value is achieving consistency in an operation within an organization. Management system standards can be implemented multiple times to bring consistency to organizations that do not yet exist or need improvement.

A third example is the use of implementation of management system standards as a tool for discussion, which provides a framework for group thinking, brainstorming, and team activities, and breakthrough solutions to common problems. Is produced.

The fourth example is that documenting good business practices reduces exposure to burden.

Another example of adding value involves pursuing discounts on global, specific, and product liability insurance premiums as a result of the implementation of effective management system standards.

Yet another example involves examining internal and external costs associated with the implementation of management system standards as a direct investment within a business, and using the results to calculate an acceptable return on investment.

Techniques for consultant site visits In addition to further scrutiny of the client's requirements as described above, the consultant will have the following during the first visit:
The task of gathering information to prepare the management system guide, and
Interviewing key managers and employees and
With the task of gathering enough information to prepare the first draft of the management system procedure,
Tasks to determine the scope of registration, certification, qualification or conformity,
Perform pre-evaluation, stage 1, registration, certification, qualification, conformity, or stage 2 auditing tasks to estimate the timing.

In addition, if the pre-assessment or stage 1 audit is accurately established, the consultant will work with the selected management system registration or accreditation body to schedule it and pre-assessment, stage 1, registration, accreditation. Perform the first site visit as close as possible to qualification, conformance or stage 2 audit. The consultant's visit should have an agenda similar to the audit plan, start and end meetings, and an activity plan for management system standard implementation similar to the correction action plan.

Techniques for Writing Policies, Procedures and Guidance Consultants gather the information needed to write management system procedures as a result of their first visit. The content of the quality procedure is based on the applicable elements of the management system standard, specifically the procedure addresses or is consistent with the requirements of the standard.

Moreover, it can be difficult to apply management system standards to any unique business. To use the criteria applicable to a unique application requires empirical knowledge-based arguments, abstract thinking and a basic process model for the business. Considering these factors, the consultant needs a huge amount of insight to write the procedure. Good information exchange skills are also important as they will be able to recognize the necessary information from the company.

Techniques for reviewing client consultations, etc. Once the draft document is completed, it is sent to the central source. Employees there are responsible for reviewing guidance and other documents to ensure that they meet all the requirements of applicable management system standards. Experienced and highly trained consultants review the documents. If all requirements are not met, the guide is considered non-conforming. Guidance is returned to the consultant. The consultant will make the necessary changes to adapt the guidance. If the guidance is met, the guidance will be processed and sent to the client for review.

Techniques for revisiting the client's site Providing motivation and leadership to the client is an important factor in successful registration, certification, qualification, or conformance. For this reason, the definition of a consultant's registration, certification, qualification or conformance process is important. The company will be repeatedly provided with a copy of the draft management system policies, guidance and procedures. However, it takes time to review it. This delay is due to other time-consuming delegations, lack of interest and other reasons.

To avoid these issues, the manager and schedule manager set a time for the consultant to return to the site, review the documents directly with the client, and make the necessary changes. This will provide the definitions that the company needs and will force a review and correction of the document.

In addition to document reviews and changes, the consultant will begin implementing an applicable management system. Ultimately, it is the company's responsibility to effectively implement the applicable management system. This is reflected in the applicable elements of management system standards. However, the consultant will first guide this effort and show the most effective practice techniques.

Methods to assist in planning pre-evaluation and registration audits Consultants should assist in planning pre-evaluation, stage 1, registration, accreditation, qualification, conformity or stage 2 audits by management system registration or accreditation bodies. Assist.

In addition to documentation and implementation guidance, the consultant also acts as a liaison with the management system registration or accreditation body, planning pre-evaluation, stage 1, registration, accreditation, qualification, conformity or stage 2 audits. To do. In this role, the consultant ensures that audits are planned and performed in a timely manner and that registration, accreditation, qualification or conformity is achieved within 180 days.

Methods for Relationships Consultants make necessary document corrections after pre-evaluation, stage 1, registration, accreditation, qualification, conformity or stage 2 audits to ensure that applicable management system standards and registration bodies Or make it meet the requirements of the accreditation body.

Any pre-evaluation, stage 1, registration, certification, qualification, conformity or stage 2 audit will require changes to the documentation. Documenting is a living part of the applicable management system and always needs to be coordinated after every audit, including inspection audits.

The consultant writes the paperwork first, is usually highly trained in applicable management system standards, and is also responsible for making changes. Consultants are widely knowledgeable, especially from an experience standpoint. Audits may reveal nonconformities that require creative solutions. The consultant's extensive knowledge and experience can provide these solutions when document changes must be made.

Techniques for Tracking Project Status All project stages are tracked using scheduling and project management software. The project manager monitors the client's condition and ensures that the consultant fulfills the identified client's request within the allotted time frame.

Allocations are time sensitive, so it is important for the consultant to guide and manage the client. As a result, consultants must also be managed and have organizational leadership. This is done through the consultant's coordinator, project manager and project management software. The basic software is Paradox, which is configured to meet specific requirements for reporting and monitoring.

In addition to software, consultant coordinators and project managers can be used to effectively monitor consultants and projects. Most importantly, it is possible to quickly identify current or possible problems and take appropriate corrective and preventive actions.

Although preferred embodiments of the present invention have been illustrated and described above, these embodiments do not show and explain all possible embodiments of the present invention. Rather, the terms used in this specification are for explanation, not limitation, and it should be understood that various changes can be made without departing from the spirit and scope of the present invention.

Claims (8)

In the method of achieving registration to industrial standards
The stage of identifying the client's request and
The stage of visiting the client and
At the stage of writing quality procedures and quality guides,
The stage of revisiting the client, updating the quality procedure and quality guide, and supporting the implementation.
At the stage of planning pre-evaluation and registration audit by the quality management system registration body,
The stage of updating the quality procedure and quality guide based on the preliminary evaluation and registration audit to ensure compliance with the industrial standard, and
A method comprising the steps of monitoring the client's condition and ensuring that the consultant fulfills the client's request within an allotted time frame. The method of claim 1, wherein the method is tracked by scheduling and project software. The method of claim 1, wherein the method is completed within 180 days. The industrial standards are ISO9001: 2000, ISO9001 / 9002: 1994, QS-9000, ISO / TS16949, VDA6.1, TL9000, ISO13485, jigs and tools (TE) addendum, semiconductor addendum, ISO14001, AS9100, ISO / IEC17025. The method of claim 1, wherein the method is selected from the group consisting of and OHSAS 18001. In the method of achieving registration to industrial standards
Steps to identify the client's request and
Steps to visit the client and
Steps to write quality procedures and quality guides,
Steps to revisit the client, update the quality procedures and quality guidance, and assist in implementation.
Steps for planning pre-evaluation and registration audits by the Quality Management System Registration Organization and updates the quality procedures and quality guidance based on the pre-evaluation and registration audits to ensure compliance with the industry standards. Steps for and
A method comprising: a step of monitoring the client's condition and ensuring that the consultant fulfills the client's request within an allotted time frame. The method of claim 5, wherein the method is tracked by scheduling and project software. The method of claim 5, wherein the method is completed within 180 days. The industrial standards are ISO9001: 2000, ISO9001 / 9002: 1994, QS-9000, ISO / TS16949, VDA6.1, TL9000, ISO13485, jigs and tools (TE) addendum, semiconductor addendum, ISO14001, AS9100, ISO / IEC17025. The method of claim 5, characterized in that it is selected from the group consisting of and OHSAS 18001.