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Quality standards

Table of contents:

Anonim

DEFINITION OF QUALITY.

Speaking of quality, we can highlight its characteristics, these can be: A physical or chemical requirement, a dimension, a temperature, a pressure or any other requirement that is used to establish the nature of a product or service. Quality does not have a popular meaning of the best in the absolute sense, industrially it means, better within certain conditions of the consumer, since it is he who ultimately determines the class and quality of the product he wants.

Taking into account the above, the quality of a product can be defined as:

"The result of a combination of engineering and manufacturing characteristics, determining the degree of satisfaction that the product provides to the consumer, during its use."

This definition leads us to think in terms such as reliable, serviceable, and durable, terms that are actually individual characteristics that together constitute the quality of the product. Establishing what we understand by quality requires a balance between these characteristics.

The term quality can be used with different meanings such as:

  • Design quality, that is, the conformity between what the customer needs or wants for a certain price and what the design function projects. Quality of agreement or degree of conformity between what is designed and what is produced. Quality in use, that is, the degree in which the product fulfills the function for which it was designed, when the consumer so requires Quality of the After-Sales service, that is, the degree to which the company pays attention to maintenance, service, claims, guarantees or guidance in using.

In general, both the first definition used and the following ones are involving responses to the consumer for what they pay and they act in different ways and intensity depending on the type of product that is being produced.

Control

In industrial terminology Control, it is the act of delimiting responsibility and authority in order to free management of unnecessary details, preserving the means to ensure that the results are satisfactory.

The steps for quality control are, in general, the following:

  • Establishment of standards, For the costs of quality, for the operation and for the reliability of the product. Estimate of conformity. Comparison of the concordance between the manufactured product and the standards Take action when necessary. Apply the necessary correction when the standards are exceeded. Make plans for improvement. Develop a continuous effort to improve the standards of costs, performance and reliability of the product.

Here are definitions of the ISO 8402 standard.

  • Quality: Set of properties and characteristics of a product or service that give it its ability to satisfy express or implicit needs.Quality control: Techniques and activities of an operational nature used to satisfy the requirements related to quality.Quality assurance: A set of planned and systematic actions that are necessary to provide adequate confidence that a product or service will satisfy the given requirements on quality Quality Policy: General guidelines and objectives of a company related to quality, formally expressed by the general management.Quality management: Aspect of the general management function that determines and applies the quality policy. Quality system: Set of the organizational structure of responsibilities,of procedures, processes and resources that are established to carry out quality management. HISTORICAL DEVELOPMENT.

Before the Industrial Revolution, products were made by hand. Quality was guaranteed by the knowledge of the artisan, who had the global vision of all the processes that were involved in the final product.

Industrialization and the increase in mass production have led to specialization within companies. Each of the people concentrates on their small section of the company and it is not possible to have a global vision of it. It became impossible to rely on the knowledge and ability of the employee to prevent defective products from going to market. The inspection was necessary and initially this was carried out by the chief or foreman of each section. Inspection activities increased progressively with industrial development and it was then necessary to relieve the foreman of some functions in which he was involved. Later a new task force, called inspectors, was developed at the beginning of the first world war.This group is later separated into an independent organizational unit: the inspection department that started in the 1920s.

During the Second World War, mass production increased, but at the same time access to the labor force decreased. In order to cope with this, the inspection work had to be more efficient. Statistical quality control was then found to be an effective means for this purpose. In particular, the military authorities in the United States were interested in this type of procedure and instructed the suppliers of war materials with statistical methods. Later these methods reached a wide distribution and at the same time they were developed consecutively.

The complexity of the products increased and therefore the risk of defects in the functions of the products. There was then an incipient interest in the reliability of the products, and during the 1950s the development of special methods to increase the reliability began. At first the interest was concentrated in electronic products for military purposes and space programs. The reliability technique is used primarily in product development and design work.

During the sixties people began to talk about total quality control. In order to manufacture products with high quality and reasonable costs, it was found that concentrating on isolated functions was not enough, but required quality planned activities that covered all functions. For this reason, this way of working with functional crossover was called total quality control.

At the end of the sixties a new concept emerged that was noticed, called quality assurance. However, there is no complete agreement as to the meaning of this term. (despite the one we have given above referring to ISO 8402).

During the 1970s, questions arose concerning the safety of products and the damages they produced, so attention was paid to these relevant aspects. This was the result of the rapid development of the legal responsibility of manufacturers, distributors, sellers, etc., to pay compensation when goods cause injury to people or damage to property, the high compensations that apply to manufacturers have led to the principles of quality control being applied to a greater extent. Quality control has been found to be an effective workplace means of manufacturing products safely.

In recent years, executives and senior managers of companies began to show interest in the quality of the products. The reason for this growing interest was that it became obvious to many of them that quality meant a lot to the future of companies. The recognition of this was obtained through the increase in competitiveness and the high quality demands of the client.

RULES ON QUALITY MANAGEMENT

INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (ISO)

The International Organization for Standardization (ISO) is a worldwide federation of national standards bodies (ISO Member Committees). ISO technical committees are generally responsible for the development of international standards. National member committees interested in a particular topic have the right to form part of the technical committee created for this purpose. International organizations, both governmental and non-governmental, related to ISO are equally involved in this work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on electrotechnical standardization.

The publication in 1987 of the International Standards of the ISO 9000 series obeyed the basic requirements of generic quality management programs.

The ISO 9000 series standards are written in generic terms and are equally applicable to service companies such as banks, hospitals, hotels and restaurants. They were developed primarily for use within businesses and in buyer-seller relationships. The latter application implied for companies the possibility of multiple evaluations and, in a number of countries, the practice of entrusting the evaluation of supplier quality systems to third parties, which has developed rapidly.

Currently, there is no ISO mechanism that governs the mutual recognition of registration certificates issued by third-party bodies to companies whose quality systems have been evaluated. However, to promote convergence between national standards, the Council Committee for Conformity Assessment (ISO / CASCO) has prepared and published guides that are part of the ISO / IEC guide collection. Some guides are directly applicable, such as the ISO / IEC guide 40 “General Requirements for the Acceptance of Certification Bodies” and the ISO / IEC guide 48 “Requirements for the Evaluation and Registration of the Quality System by Third Parties. from a Provider ”,which have been adopted in many countries both in their regulations on certification programs and in national standards or regional standards such as the European Standards of the EN 45000 series of CEN / CENELEC.

While the ISO 9000 certificates in question are not delivered on behalf of ISO, it has been deemed necessary for ISO to play a role in disseminating information on national programs operating in member countries.

BS 5750, THE STANDARD

The BS 5750 is a series of rules governing quality in the UK, appearing before ISO 9000, and continues in this nation, with its standards equivalent to those of the latter.

The BS 5750 standard, which is that of quality systems, has its origin in military purchases. Due to the crucial nature of these products and the practical problems of investigating defective products used in stocks, emphasis was placed on seeing how the products are made and the quality systems of the corresponding suppliers. Appropriate standards for quality systems were set, including at the international level (NATO) for cooperating governments and allied governments and with corresponding national standards. In the UK there are a variety of Defense regulations, for example 05-21.

When those standards are established and publicized throughout the industry, demand for comparable goods or services increases, outside of defense grounds. This probably led to BS 5750 in 1979. The 1987 revised version of BS 5750 was broader and continues to be the recognized and accepted standard for quality systems.

Not only was BS 5750 written to cover non-military supply activities, it was also tried to make it applicable globally. Consequently, it can be applied to all quality systems of all business organizations. This means that in addition to being relevant for manufacturers, it is also relevant for service providers; however, a service provider is unlikely to be encouraged by reading BS 5750. It is clear that the language, terminology and apparent assumptions are more accessible to the manufacturer than to the service provider. There are even non-engineering manufacturers who feel the standard was written without regard to their business. Despite this, BS 5750 is intended to be universally applicable; and,in practice, the manufacturing elements of the standard can be adapted in all cases to the situation of the services, even when these are the main basis.

The ISO 9000 series is the equivalent international standard for quality systems and, like BS 5750, is available in a number of documents. Apart from some differences in the way it is expressed, the content of the ISO 9000 series is the same as that of BS 5750, and the key parts have their equivalence numbers. These equivalents are no coincidence. The ISO 9000 series was modeled on BS 5750, which was the pioneer of quality systems internationally.

A company that meets the requirements of BS 5750 also meets those of the equivalent in the ISO 9000 series. The practical value of the equivalence of BS 5750 and ISO 9000 is found in exporting or conducting business throughout the simple market of the European Community. In all industrialized nations there is a national standard for quality systems, compatible with ISO 9000; and therefore the valuation and registration of BS 5750 have worldwide recognition and commercial value.

BS 5750 and ISO 9000 series

BS 5750 ISO 9000 Series
* Guide for the selection and use of the appropriate part of the standard. Part 0 / 0.1 9000
* Guide for all quality management and elements of the system Part 0 / 0.2 9004
* Quality specifications for:
Design / development, installation and service. Part 1 9001
Production according to customer specifications (or published specifications). Part 2 9002
Final inspection and tests. Part 3 9003
* Scheme for distributors (equivalent to part 2). Scheme of registered distributors, levels A and B -
* Guide for the use of parts 1,2 and 3. Part 4 -
* Guide to quality management and quality elements for services. Part 8 9004-2
* Guide for the application of BS 5750.

Part 1 for the development, supply and maintenance of software.

Part 13

(Tick IT initiative)

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INTERNATIONAL STANDARDS FOR QUALITY SYSTEMS

COUNTRY Specifications for design / development, production, installation and service. Specifications for production and installation. Specifications for final inspection and testing.
International ISO 9001: 1.987 ISO 9002: 1987 ISO 9003: 1987
Australia AS 3901 AS 3902 AS 3903
Austria

Belgium

OE NORM-PREN 29001

NBN X 50-003

OE NORM-PREN29002

NBN X 50-004

OE NORM-PREN29003

NBN X 50-005

China GB / T 10300.2-88 GB / T 10300.3-88 GB / T 10300.4-88
Denmark DS / EN 29001 DS / EN 29002 DS / EN 29003
Finland SFS-ISO 9001 SFS-ISO 9002 SFS-ISO 9003
France NF X 50-131 NF X 50- 132 NF X 50- 133
Germany DIN ISO 9001 DIN ISO 9002 DIN ISO 9003
Holland NEN- ISO 9001 NEN- ISO 9002 NEN- ISO 9003
Hungary MY 18991-1988 NI 18992-1988 NI 18993-1988
India IS: 10201 Part 4 IS: 10201 Part 5 IS: 10201 Part 6
Ireland IS 300 Part 1 / ISO 9001 IS 300 Part2 / ISO 9002 IS 300 Part3 / ISO 9003
Italy UNI / EW 29001-1.987 UNI / EN 29002-1987 UNI / EN 29003-1987
Malaysia MS 985 / ISO 9001-1987 MS 985 / ISO 9002-1987 MS 985 / ISO 9003-1987
New Zealand NZS 5601-1987 NZS 5602-1987 NZS 5603-1987
Norway NS-EN 29001: 1988 NS-ISO 9002 NS-ISO 9003
South Africa SABS 0157: Part 1 SABS 0157: Part II SABS 0157: Part III
Spain UNE 66 901 UNE 66 902 UNE 66 903
Sweden SS-ISO 9001: 1988 SS- ISO 9002: 1988 SS- ISO 9003: 1988
Switzerland SN-ISO 9001 SN-ISO 9002 SN-ISO 9003
Tunisia NT 100.19-1987 NT 110.20-1987 NT 110.21-1987
UK BS 5750: Part1 BS 57590: 1987: Part 2 BS 5750: 1987: Part 3
U.S ANS / ASQC 091 ANSI / ASQC 092 ANSI / ASQC 093
Russia 40.9001-88 40.9002-88
Yugoslavia JUS AK 1012 JUS AK 1013 JUS AK 1014
European Community EN 29001 EN 29002 EN 29003

List of International Standards on quality management

ISO 8402: 1986 Quality - vocabulary. Trilingual edition.
DIS 8402 Quality management and quality assurance - vocabulary

(Revision of ISO 8402: 1986). Trilingual edition.

ISO 9000: 1987 Standards for quality management and quality assurance. Guidelines for their selection and use.
DIS 9000-2 Standards for quality management and quality assurance. General guidelines for the application of ISO 9001, ISO 9002 and ISO 9003.
ISO 9001: 1987 Quality systems. Model for quality assurance in design / development, production, installation, after-sales service.
ISO 9002: 1987 Quality systems. Model for quality assurance in production and installation.
ISO 9003: 1987 Quality systems. Model for quality assurance in inspection and final tests.
ISO 9004: 1987 Quality management and elements of a quality system. General rules.
ISO9004: 2: 1991 Quality management and elements of a quality system. Rules for services.
DIS 9004-3 Quality management and elements of a quality system. Rules for processed materials.
DIS 9004-4 Quality management and elements of a quality system. Rules for quality improvement.
ISO10011-1: 1990 General rules for audits of quality systems. Part 1: Audits.
ISO10011-2: 1991 General rules for auditing quality systems. Part 2: Criteria for the qualification of auditors.
ISO10011-3: 1991 General rules for auditing quality systems. Part 3: Management of audit programs.

BENEFITS OF QUALITY SYSTEMS BASED ON ISO 9000

The tangible benefits of such quality systems include:

  • Better product design Better product quality Reduced waste, rectifications and customer complaints Efficient use of labor, machines and materials resulting in higher productivity Elimination of bottlenecks in production and creation of a relaxed work environment, which leads to good human relations Creation of an awareness regarding quality and greater satisfaction of employees at work, improving the quality culture of the company Improvement of trust among customers.Improving the image and credibility of the company in international markets, which is essential for the success of the export activity.

ICONTEC

The Colombian Institute of Technical Standards and Certification, ICONTEC, is the national standardization body, according to Decree 2269 of 1993.

ICONTEC is a private, non-profit entity whose mission is fundamental to provide support and development to the producer and consumer protection. It collaborates with the government sector and supports the country's private sector to achieve competitive advantages in the internal and external markets.

The presentation of all the sectors involved in the technical standardization process is guaranteed by the technical committees and the public consultation period. The latter characterized by the participation of the general public.

Colombian Technical Standards

The Colombian Institute of Technical Standards and Certification, ICONTEC, has established a series of standards for quality control, following the parameters established at the international level by the International Organization for Standardization, ISO. These standards are presented below:

  • NTC - ISO 8402: Quality management and quality assurance. NTC - ISO 9000-1: Standards for quality management and quality assurance. Part 1: Guidelines for its selection and use. NTC - ISO 9001: Quality systems. Model for quality assurance in design, development, production, installation and after-sales service. NTC - ISO 9002: Quality systems. Model for quality assurance in production, installation and after-sales service. NTC - ISO 9003: Quality systems. Model for quality assurance in inspection and final tests. NTC - ISO 9004-1: Quality management and elements of the quality system. Part 1: Guidelines. NTC - ISO 9004-2: Quality management and elements of the quality system. Part 2: Guidelines for services. NTC - ISO 9004-3: Quality management and elements of the quality system. Part 3: Guidelines for Processed Materials. NTC - ISO 9004-4: Quality management and elements of the quality system. Part 4: Guidelines for quality improvement. NTC -ISO 10005: Quality management. Guidelines for quality plans. NTC - ISO 10013: Guidelines for preparing quality manuals.

ISO 9000 PARTICULAR ASPECTS.

The evolution of quality (as we saw in section 2) and of the standardization system has varied greatly. At the beginning of the sixties it was when the three standards that served as the basis for the current ISO 9000 Standards were created. These were created for military purposes under the name MIL - Q - 9858 A (requirements for a quality program), MIL - STD - 45662 A (requirements for a calibration system), MIL - I - 45208 A (requirements for inspection). Subsequently, the British Standards Institution issued its BS 5750 series that describes the basic elements of quality and that was adapted by the International Organization for Standardization regrouping it into different thematic series (previous Numeral).

When a company has taken the step of deciding to implement a quality system, it encounters the problem of choosing the model that best suits it. The ISO 9000 series of standards offers three options. The most demanding of all is ISO 9001, which consists of 20 points that must be implemented and documented. For its part, ISO 9002 only differs from the previous one in the elimination of the aspect concerning the design (it consists of 19 points), Finally the ISO 9003 standard, much shorter since it does not contain the points concerning:

Design.

Purchases.

  • Process control.

After sales.

The ISO 9001 standard is reserved for those companies that have design or development of services. If the company does not have a design, it must adhere to 9002 or 9003. To find out which one to choose, check if the company has a service provision process that must be controlled. If it exists, you must choose ISO 9002 and otherwise 9003.

The ISO 9001 standard contains 20 points that describe the requirements that must be implemented in a company to ensure that it complies with a predefined quality standard. These points are:

Management Responsibility.

In this first point, the standard tries to define the strategic and organizational criteria of the company. You must think about the strategies that the company needs to have control and a more secure future, so objectives must be set, verify that they are met and make sure that the company and has sufficient means to produce the product in acceptable conditions. This point is divided into three aspects:

Quality policy: It is written in writing signed by the senior management where the primary goals of the company are established. Here we are not talking about specific objectives but about general principles, such as customer satisfaction, the image to be projected, etc.

Organization: The structure of the company (organization chart), the responsibilities and authorities of its members and the person in charge of carrying out the project are defined.

Management Review: As one of the objectives of the quality system is the continuous review, continuous reviews must be carried out to know the real operation of the system and the result it is giving in terms of the achievement of the objectives.

Quality system.

The skeleton of this system is in the documentation. This section lists the documents that make up the system, that is, the quality manual, the procedures manual, work instructions and quality records.

Review of the contract.

To prevent misunderstandings with the customer, specifications are written and agreed upon defining their technical and economic needs so that the product that is reaching customers responds as widely as possible to their needs.

Design Control.

The design process is one that covers the interaction between market research, contract review and specification definition. The company captures the needs of the environment and detects that it is in a position to meet them. Then you need to develop specifications that reflect exactly how you are going to meet these needs.

Design is understood in several stages:

1. Design and development planning.

Organizational and technical interfaces.

Design starting data.

Final design data.

Design review.

Design verification.

Design validation.

Design changes.

In each of these stages, the company must study the system with which it is going to act and define the responsibilities of each employee in this regard.

Control Of Documentation And Data.

Ensuring quality implies controlling the documents and data that are related to the running of the company, through the appropriate procedures. The responsibility for preparing, reviewing, approving, filing and distributing documents and data is consigned at this point.

Purchases.

The quality of the suppliers or subcontractors is reflected in the product offered to the client, therefore it is necessary to properly evaluate and document the relationships with these suppliers, to ensure that they do not transmit their quality problems to the company. For this, a contract is established with the suppliers where the technical and economic conditions of the supply are specified, which must be approved by a person in charge of the company who has the power to affirm whether these conditions are met or not.

There are three important aspects to this process:

Purchases must be made from approved suppliers and to approve a supplier you can choose one of the following options among others:

Carry out a visit or audit to check the supplier's capacity

That the supplier has a certificate of conformity with the ISO 9001/2/3 standard from an authorized body.

For having a quality contract agreed based on specific data.

There is a system to review the necessary parameters of the products and services provided. Based on the specifications, some parameters are defined, these are reviewed with a certain frequency and the result is recorded in a specific format.

It is not mandatory but it is considered useful to have a process of continuous reevaluation.

Control Of Products Supplied By The Customer.

This point determines the process that the product or service provided by the client must follow to incorporate it into the final service, the material that is delivered must be reviewed to verify its suitability since the fact that some components are supplied by the client in a product or service does not exempts the company from the responsibility of providing a compliant product or service.

Identification And Traceability Of Products.

Any product or service that is part of the final product that may cause confusion or errors must be identified. From the identification of the product or service throughout the entire process, and the components that are added to it, a “history” of the final service is made, that is, the path that has been followed is traced.

Process control.

To put into practice the specifications that have been defined, it is necessary to ensure the optimal conditions of the entire production process of the product and for this the company must be able to control all the parameters that influence these conditions. One of the objectives that the implementation of an ISO 9000 system pursues is prevention. To prevent the production of a product, production must be planned very well. For this, it is necessary to write the work instructions, documentation for all the activities that could have an impact on the final quality. These activities are the basis of planning.

Inspection And Testing.

Before, there was talk of prevention and it was said that it was one of the bases of quality because it eliminates errors before they occur. However, reality tells us that on very few occasions zero defects are achieved. The main point of this section is quality control and three aspects can be differentiated:

Control of reception.

Control during the process.

Final check.

Once the control has been carried out at these points, it is important to record it in a standardized format that will have two purposes:

Have proofs to use them before the client or auditors.

Have information that you can later use to discover trends or potential conflict points, customer dissatisfaction.

Control Of Inspection, Measurement And Testing Equipment.

Any element that collects measurements or information needs to be reliable, and therefore must be calibrated. Two basic types of elements can be used: Equipment that gives physical measurements and equipment that gives attribute measurements. Among the first we would include all the devices that measure lengths, weights, temperatures, etc. The process would consist of periodically checking that the measure they give is correct.

Inspection And Test Status.

If controls have been defined, you should know the products or services that have passed them and which ones are waiting to do so so that none of them is considered good without first going through the relevant controls. For this to happen, products or services can be marked in different ways after inspection. This point is complementary to 10 but has been added to place greater emphasis on its realization.

Control Of Non-Conforming Products.

Getting non-conforming products to be removed from the process, being valued and studying what has caused this non-conformity is the purpose of this point. As a result of an inspection of the service or product that comprises it, a deviation may be detected. In these cases it is defined.

How nonconformities will be identified and set aside so that they are not confused with the correct products.

What criteria are used for selection.

What action is taken with the non-conformities. Once a conformance is detected, you could: reprocess it to be acceptable again, scrap it, requalify it, etc.

  • How and where the non-conformity is recorded How the affected are notified of what happened.

Corrective And Preventive Actions.

What is stated in the previous point indicates that it is convenient to carry out methodical studies in cases in which serious or repetitive non-conformities appear or could appear. Helping to be more effective day by day is the object of this point.

A standard format must be developed in which to define:

  • What is the problem. What causes motivate it. What actions will be taken to solve it. Once the actions have been implemented based on the result, is it possible to close the action or have the expected results not been obtained and should it be re-studied? the format should be specified responsible, planned and actual implementation dates.

Corrective and preventive actions are not simply a claim sheet, it is an instrument that will help achieve continuous improvement.

Handling, Storage, Packaging, Preservation And Delivery.

Many losses in the business are avoided by improving the storage and handling of materials. For this reason, the quality system standardizes everything related to this issue, in order to disseminate it throughout the company and get everyone to act in a certain way. This point is especially important in the event that the product produced by the company needs a special type of conservation, is delicate or may deteriorate if it does not receive adequate treatment.

Control Of Quality Records.

The information that is collected during the execution of the process is called a quality record. This information is a very valuable instrument that the company will have once the quality system is implemented. You must make a list with the records that the system generates and discover the flow that the information follows, and then define a filing system that allows you to evaluate the records. From this information you can find the answers to many of the problems that affect the organization of a company.

Internal Quality Audits.

For a quality system to be effective, it is periodically reviewed with internal audits. Every so often, a manager does a study of the degree of implementation of the quality system, from which he can draw conclusions and implement improvements.

Training.

The human capacity of the company rests on the training given to all its employees. The company has a potential that it must take advantage of in order to survive, this is the human potential. And to take advantage of it, you must implement the following aspects:

  • Motivation Training Communication

After-sales service.

In case it is specified contractually or by guarantee, the company can carry out an after-sales service. In the after-sales service you can define types of guarantee, warranty limitation clauses or response to rejections, etc.

Statistical Techniques.

Statistical techniques are used to assess the information we collect from the system. Apart from mathematical statistical methods there are many others that are aimed at improving the quality of simple application and very useful.

AUDITS.

The audit is a basic element of the quality system, since it allows us to review its implementation and examine its effectiveness. During its development, it is analyzed whether everything stated in the quality and procedures manual is being carried out. The audit is not an employee judgment. Nor is it an exclusive weapon of the quality manager to get even with her colleagues. The audit is the effort that all workers must pay before receiving a common benefit, a quality system tailored to all workers in the company. These are the objectives of the audits:

  • Check the adequacy of the quality system with a standard (ISO 9000) Check that the actions of all personnel are in accordance with what is documented Calibrate the effectiveness of the processes to achieve the company's objectives Seek continuous improvement by proposing actions corrective and preventive. In some cases, change the planned procedures based on the conclusions drawn Obtain registration or approval of a client (external audit) Evaluate the capacity of a supplier (external audit)
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Quality standards