What is ISO?
The International Organization for Standardization (ISO) is a worldwide federation of national standards bodies from approximately 140 countries.
ISO is a non-governmental organization established in 1947.
The mission of ISO is to promote the development of standardization and related activities in the world, with the idea that it facilitates the international exchange of goods and services, and the cooperation that develops in the spheres of intellectual activity, activity scientific, technological and economic.
ISO's work brings about international agreements that are published as International Standards.
ISO is a word, derived from the Greek isos, which means (thinking) "equal", it is the root of the prefix "iso-" that occurs in a host of terms (conditions), such as "isometric" (of equal measure or dimensions) "And isonomy" (the equality of laws, or of people before the law).
'From equal' to 'standard', the line of thinking that led to the choice of 'from ISO' as the organization name is easy to follow. Furthermore, the name ISO is used throughout the world to denote the organization, thus avoiding the plethora of acronyms resulting from the translation of "the International Organization for Standardization" into the different national languages of members, for example. IOS in English, OIN in French (from International Organization for Standardization). Regardless of the country, the short form of the Organization's name is always ISO.
Why is international standardization needed?
The existence of non-harmonized standards for similar technologies in different countries or regions can contribute to alleged »technical barriers to trade«. Industries engaged in import and export for a long time, have felt the need to agree on global standards that help streamline the international trade process. This is the origin of the establishment of ISO. International standardization is well established for many technologies in fields as diverse as computing and communications, textiles, packaging, distribution of goods, energy production and use, shipbuilding, banking, and financial services. In addition to this it will certainly continue to grow in importance for all sectors of industrial activity for the foreseeable future.
The main reasons are:
All over the world there is progress in market liberalization
Today's free market economies increasingly encourage diverse sources of supply and provide opportunities for expanding markets. With regard to technology, the fair competition has to be based on identifiability, clearly defined common references that are recognized from one country to the next, and from one region to the other. An internationally approved, industry-wide standard, developed in accordance with general agreement between trade with other companies, serves as the language of trade.
The interpenetration of sectors
The various sectors of industry in the world today cannot really claim to be completely independent of components, products, rules of use, etc., that have been developed in other sectors. Locks are used in aviation and agricultural machinery, and electronic computing has penetrated every industry. Green products, recycling processes or biodegradable packaging are pervasive concerns (interests).
Global communication systems
The services that the computer industry offers are a good example of technology that needs to be rapidly and increasingly standardized on a global level. Compatibility between open systems forms healthy competition between producers, and offers real choices to users as it is a powerful catalyst for innovation, improved productivity and cost reduction.
Global standards for emerging technologies
Standardization programs in completely new fields are currently being developed. Such fields include advanced materials, the environment, life sciences, urbanization, and construction. In the very early stages of new technology development, uses can be imagined but functional prototypes do not exist. The need for standardization is in the definition of the terminology and the accumulation of databases of quantitative information.
Developing countries
More and more they recognize that a standardization infrastructure is a basic condition for the success of economic policy aimed at achieving sustainable development. The creation of such infrastructure in developing countries is essential for improving productivity, market compatibility, and export capacity.
Industry-wide standardization is a condition that exists within a particular industrial sector when the vast majority of products or services conform to the same standards. This is the result of general agreements reached between all the economic participants in that industrial sector - suppliers, users, and often governments. They agree on specific data and criteria to be applied consistently in the choice and classification of materials, the manufacture of products, and the provision of services. The objective should facilitate trade, exchange and technology transfer by:
- Enhanced product quality and reliability at a reasonable price Improved health, safety and environmental protection, and reduction of waste (waste) High compatibility and interoperability of goods and services
that allow simplification for improved utility.
- Reduction in the number of models, thus reducing costs, increased distribution efficiency and ease of maintenance.
Users have more confidence in products and services that conform to International Standards. They can provide assurance of conformity to manufacturers' declarations, or this can be through independent audits.
IMPLEMENTATION OF ISO 9001: 2000
By way of explanation, we have decided to carry out the work on the basis of the Quality Management System belonging to the ISO 9001: 2000 standard, taking into account its details and its relationship with the previous ISO 9001: 1994 standard.
Introduction:
0.1 General:
This International Standard presents the requirements for a quality management system, which can be used by an organization to demonstrate its ability to satisfy customer requirements and for the evaluation of such ability by internal or external parties.
This international standard is generic and independent of any industry or economic sector, and is applicable to all types and sizes of companies, as well as in the case that the company is of products and / or services, complementary to its technical requirements.
The design and implementation of a company's quality management system are influenced by its objectives, customer requirements, product and / or services, and processes.
0.2 Process model:
It shows the requirements of the quality management system specified in this international standard (Fig. 1), integrating the four main headings of “clauses” 5, 6, 7 and 8 of this standard.
Since it is a model of the complete processes of the quality management system, it can demonstrate the vertical and horizontal integration of the process in the form of a closed loop.
As an example of a vertical circuit, management defines the requirements in Management Responsibility (clause 5), resources are determined and applied in Management Resources (clause 6), processes are determined and implemented in Process Management (clause 7), the results are measured, analyzed and improved by Measurement, Analysis and Improvement (clause 8). The Critical Analysis of Management closes the circuit and the cycle returns to Management Responsibilityfor authorization of changes and initiation of improvements. As an example of a main horizontal circuit, the model recognizes the fact that the customer plays a significant role during the entry into the process of the needs and requirements, then the processes of realization of the identified product and / or service are carried out and the customer satisfaction at the end of the process. The output data is used to improve customer inputs, completing the closure of the horizontal loop of the process.
The subordinate horizontal or vertical processes will be found or created as the main processes of the company are carried out.
0.3 Compatibility with other disciplines of other quality systems:
This International Standard has been developed to be compatible with the disciplines of other management systems. For example, it shares common principles and management systems with international standards for environmental management systems of the ISO 14000 series.
It is not directed at or includes the requirements for aspects of the disciplines of other management systems, but nonetheless, it is not intended to discourage the development of integration of similar elements of management systems by an organization.
Scope:
1. Generalities:
This standard specifies the requirements for quality management systems to be used when the ability of an organization to provide products and / or services in conformity needs to be demonstrated.
It seeks to satisfy the client, meeting or exceeding their requirements, through the application of the system, its continuous improvement and the prevention of non-conformities. The intention of this International Standard is that all its requirements are applicable, however, in certain situations its adequacy can be accepted.
1.2 Scope, reduced and adequacy:
1.2.1 General:
The application of the reduced scope and the adequacy of the requirements does not absolve the organization of the responsibility of providing products and / or services that meet the client's requirements.
Regulatory requirements are always applicable to the organization and its products and / or services.
1.2.2 Reduced scope - design and development excluded:
When the products and / or services of an organization are expressed in terms of an established design or specification, the requirements of clause 7.3 Design and Development of this International Standard do not apply.
1.2.3 Adequacy:
When customer requirements or the nature of the product and / or service prevent the application of certain requirements for the processes specified in this International Standard, such requirements may be excluded. This exclusion needs to be restricted to the processes of realization of those products and / or services within clause 7 Process Management, which are not carried out by the organization.
2. Reference Standards:
The following standard contains provisions which, through citation in this text, constitute provisions of this International Standard.
At the time of publication, the edition indicated was current. Every standard is subject to revision and the parties that enter into agreements based on this international standard should endeavor to seek the possibility of applying the most recent edition of the standard indicated below (as is the case with this update of the ISO 9001 standard: 1994).
3. Terms and Definitions:
For the purposes of this International Standard, the terms and definitions given in ISO 9000: 2000 - Quality Management Systems - Concepts and vocabulary apply.
Note 1: The supply chain terminology used in this edition of this International Standard is as follows:
Note 2: The term "organization" used in this International Standard replaces the term "supplier" previously used to denote the unit to which this International Standard applies. The term "supplier" is now used instead of the former term "subcontractor". The changes have been made to reflect the current vocabulary used in the industry.
We have chosen, in search of a better understanding of the standard, to develop the rest of the clauses in the form of a synoptic table:
7 PROCESS MANAGEMENT | |
7.1 GENERAL | Identify and manage the processes that affect the quality of products and / or services. Process control methods, parameters, standards, measurements must be defined. |
7.2 PROCESSES RELATED TO THE CLIENT | |
7.2.1 Determination of customer-related requirements | Identify customer requirements, the extent to which the customer has specified product and / or service requirements, including legal ones. |
7.2.2 Analysis of customer-related requirements | Defined and documented requirements, record verbal requests, resolve differences |
7.2.3 Analysis of the ability to meet the requirements | Each commitment to provide a product must be analyzed to ensure that the organization will have the capacity to meet the requirements, defined for the products and / or services. |
7.2.4 Communication with the customer | They are the organization's requirements related to: handling of inquiries and orders, product and / or service information, customer voice, cancellation processes |
7.2.5 Customer property | The client's properties must be taken care of, while they are under the supervision of the organization, or are being used by it. Any loss will be reported to the customer |
7.3 DESIGN AND DEVELOPMENT | |
7.3.1 Design and development planning | Design plans: stages, equipment, review, responsibilities, verification and validation. The plans and related documentation must:
|
7.3.2 Design and development inputs | Client, legal and environmental requirements. Previous experience |
7.3.3 Design and development outputs | Meet entry requirements, acceptance criteria, special characteristics for its safe and appropriate use and the application of the product and / or service. Design and development output documents must be analyzed and approved prior to circulation. |
7.3.4 Design and development review | In the appropriate stages of the design and development process, formal reviews should be carried out, Identify problems, evaluate capacity to comply with the requirements. File must be kept |
7.3.5 Design and development verification | Verification in planned stages, to ensure that the design output meets the design input requirements |
7.3.6 Design and development validation | Verification that the product and / or service meets the defined requirements. |
7.3.7 Control of design and development changes | Before making the change, the effect on the rest of the design, as well as between the parts of the product and / or service, must be determined. |
7.4 SHOPPING | |
7.4.1 General | Evaluation of the purchase process, to ensure that the product and / or service purchased is in compliance with the requirements of the organization and selection of suppliers |
7.4.2 Purchase information | Product requirements, clear description of the product, documentation of purchases for the adequacy of the requirements specifications, prior to its circulation. |
7.4.3 Verification of the products and / or services purchased | Taking and implementing the necessary provisions. When you want to verify the supplier, the organization must specify the provisions and the method of verification required. Verification of products and / or services. |
7.5 PRODUCTION AND DELIVERY OF THE SERVICE | |
7.5.1 General | The organization must control production and service operations through:
|
7.5.2 Identification and traceability | Product or service identification through appropriate methods in all production processes. Traceability will be implemented when it is a specified requirement. |
7.5.3 Handling, packaging, storage, preservation and delivery | The organization shall ensure that during internal processing and final delivery, identification, packaging, storage, preservation, and handling do not adversely affect conformance to requirements. |
7.5.4 Process validation | The organization must determine any production and / or service process in which the resulting output cannot be easily or economically verified by monitoring, inspection and testing, then it will be validated. Provisions for validation have to take into account at least the need that:
|
7.6 CONTROL OF NON-CONFORMITIES | |
7.6.1 General | For those products and / or services that are not in compliance with the requirements, and can be controlled to prevent their use, application or unplanned installation. Provisions must be defined to ensure that the non-conforming product and / or service is controlled |
7.6.2 Analysis and disposition of non-conformities | It must be determined what action to follow. Products and / or services out of compliance will be:
The responsibilities and authority for the analysis and resolution of nonconformities must be defined. If it is required by contract, the action to follow must be informed to the client. Record modifications |
7.7 POST-DELIVERY SERVICES | In the case of support services, after the delivery of the product, the provision of such services must be subject to planned provisions. Such provisions shall be consistent with the requirements of 7.1 together with other requirements of clause 7, as appropriate. |
Correspondence between the clauses of ISO 9001: 1994 and ISO 9001: 2000
ISO 9001: 1994 | ISO 9001: 2000 |
1 Scope | one |
2 Reference Standard | two |
3 Definitions | 3 |
4.1 Responsibility of the Management. | |
4.1.1 Quality Policy | 5.1 + 5.2 + 5.3 + 8.4.3 |
4.1.2 Organization | 5.5.2 |
4.1.2.1 Responsibility and Authority | 5.5.2 + 6.2.1 |
4.1.2.2 Resources | 5.1 + 6.1 |
4.1.2.3 Management Representative | 5.5.3 + 5.5.5 |
4.1.3. Management Analysis | 5.6. + 8.1 + 8.4.2 + 8.4.3 |
4.2 Quality System. | |
4.2.1 General | 4 + 5.1 + 5.2 + 5.4 x + 5.5.3 + 5.5.4 |
4.2.2. Quality System Procedures | 5.5.4 |
4.2.3 Quality planning | 5.4.2 + 7.1 |
4.3. Review of the contract | 7.1 + 7.2 x |
4.4 Design Control | 7.1 + 7.3 x |
4.5 Control of Documentation and Data. | 5.5 x |
4.6 Purchases. | 7.1 + 7.4 x |
4.7 Control of Products Supplied by Clients. | 7.2.5 |
4.8 Identification and Traceability of Products. | 7.5.2 |
4.9 Process Control. | 6.3 x + 7.1 + 7.5 x |
4.10 Inspection and Testing. | 7.1 + 7.5.1 + 8.1 + 8.2.3 |
4.11 Control of Inspection, Measurement and Testing Equipment. | 7.5.1 + 8.2.4 |
4.12 Inspection and Testing Status. | 7.5.1 |
4.13 Control of Non-Conforming Products. | 7.6 |
4.14 Corrective and Preventive Actions | 8.1 + 8.2 x + 8.3 + 8.4 |
4.15 Handling, Storage, Packaging, Conservation and Delivery | 6.3 x + 7.1 + 7.5 x + 7.7 |
4.16 Control of Quality Records. | 5.5.7 + 6.3 x |
4.17 Internal Quality Audits. | 8.1 + 8.2.1.2 |
4.18 Training. | 6.6.2 |
4.19 After Sales Service. | 7.1 + 7.7 |
4.20 Statistical Techniques | 8.3 |
Everything analyzed above is part of the requirements established for compliance with the international standard ISO 9001: 2000, but there are certain data related to this standard that cannot be explained, at first glance, with these requirements, for which we have considered carry out a questionnaire with the corresponding answers to different types of doubts that may have arisen regarding this rule and its changes:
What is a process?
An activity or operation that receives inputs and converts them into outputs can be considered a process. Almost all activities and operations related to a service or product are processes.
In an organization there are different processes connected to each other. Often times, the output of one process can be the input of another. The systematic identification and management of the different processes developed in an organization, and particularly the interaction between such processes, can be referred to as "the process approach" to the management or management of processes.
What will happen to ISO 9002 and 9003 standards?
The 1994 versions of ISO 9002 and 9003 will be obsolete from the moment of publication of ISO 9001: 2000. The applicable requirements of the new version of the Standard must be followed.
Why are the standards revised?
The ISO organization requires a review of its standards periodically, to ensure that they are current and meet the needs of users.
In the case of ISO 9001: 2000, it has focused on emphasizing:
- Measure Customer Satisfaction Continuous Improvement Resource Management Process Management
What happened to the other standards and documents in the ISO 9000: 1994 family?
The ISO 9000: 1994 family of standards comprised around 20 standards and documents. In the new version, only three standards will be available: ISO 9000, 9001 and 9004.
The rest of the standards and documents are intended to be withdrawn or replaced by technical reports (with the exception of ISO 10011 and ISO 10012).
How should you approach the transition to ISO 9001: 2000?
The previous versions of the ISO 9000 family were in force until the publication of the ISO: 2000 standard. Once the ISO 9001: 2000 standard has been published, the previous revisions will be withdrawn, but a period is foreseen during which a company may opt for the 1994 revision or revision 2000.
With what standard must my Company be certified?
The choice is clear and simple. The only standard available is ISO 9001: 2000, and the scope of the certification should clearly reflect the activities of the Company.
Can companies stay certified according to the 1994 version?
Certifications according to ISO 9001, 9002, 9003: 1994 will remain valid for a period of time after the publication of ISO 9001: 2000.
It is foreseen that there will be a transition period before the quality management systems comply with the 2000 revision.
To define the scope of the system it is necessary to clearly define the scope of the certification. By providing a single standard in the new revision, the scope should be further emphasized to define the processes, products and services covered by the certification. This need is being discussed with the certification bodies, who will provide guides at the appropriate time.
What are the main changes to the rules?
The main changes that have been introduced at the CD2 level are:
- Process-oriented structure and a more logical sequence of processes Continuous Improvement Measurement of Customer Satisfaction as an indicator of Improvement Attention to resources such as communication and work environment Improvements in terminology for easier interpretation Compatibility with the System Environmental Management Specific reference to quality management principles Self-assessment as a means of improvement (ISO 9004).
Are financial aspects considered in ISO 9001: 2000?
Financial aspects are not contemplated in the ISO 9001: 2000 standard.
The added requirements include:
- Customer Satisfaction Measure Continuous Improvement Availability of Resources Extensive measurements to system, processes and product (including service) Analysis of compliance and effectiveness of the Quality System
Why has the Customer Satisfaction measure been included in the new revision of ISO 9001?
Customer Satisfaction should be one of the basic principles of any organization. The measurement of customer satisfaction allows to know the degree of effectiveness of the Quality System.
What are the benefits of revising the Standards?
The main ones are:
- Applicability to all sectors and to all company sizes Simple to use, clear in language, easily translatable and understandable Connect Quality Management Systems with organizational processes Provide a foundation stone for improvement Greater guidance to continuous improvement and customer satisfaction Compatibility with other systems such as ISO 14000 Provide a consistent basis for addressing interests and needs in specific sectors (e.g. medical devices, telecommunications, automotive, etc.) The concept of consistent ISO 9001 e pair ISO 9004 so that the System goes beyond the requirements of the standard and manages to improve the effectiveness of the organization.
Will the revision of the Standards improve Customer satisfaction?
The Quality Management System described in the review of the standards is based on the principles of quality management that includes an approach to the process and customer orientation. Adoption of these principles should provide customers with a higher level of confidence that the product (including service) will satisfy their requirements and increase their degree of satisfaction.
Will I have to redo the documents of my System?
No. If the Quality Management System is implemented correctly, meets the needs and objectives of the organization, and reflects the way the organization works, there will be no need to redo the documentation. However, it is likely that some adjustments will have to be made to meet specific requirements such as measuring Customer satisfaction and updating the cross-references of the ISO 9001: 2000 Document System.
How will the specific requirements of each sector be included in the ISO 9001: 2000 standard?
The text of the ISO 9001: 2000 standard is more generic than that of the 1994 revision, so that it is applicable to different sectors and companies of different sizes. Due to this generic nature, some industries may identify additional requirements to meet their specific needs.
How can a small organization adapt the requirements of the Standard? What flexibility is there?
The requirements of the ISO 9001 revision are applicable to small, medium and large companies. However, it is up to each company, in consensus with the certification body, to determine the complexity of the system necessary to demonstrate its ability to meet the Customer's requirements for its product and / or service.
How does the implementation of ISO 9001: 2000 help to improve the effectiveness of the organization?
ISO 9001: 2000 helps ensure the effectiveness of the organization (not effectiveness). Using ISO 9004: 2000 in addition to ISO 9001: 2000 allows to improve the effectiveness of the organization.
Does the revision of the year 2000 affect the current certification of my Company (94 ”)?
Yes. The transition strategy adopted by your company for ISO 9001: 2000 compliance should include adequate planning for updating certification.
A smooth transition process that is compatible with the requirements of the Certification Body is recommended. It is advisable to contact him.
CONCLUSIONS:
Finally, we must bear in mind that our Human Resources function is not limited to training, employing, remunerating, training, developing, and retaining the people necessary for organizations, using administrative approaches, but rather that our function deals with managing suitable personnel who develop creativity to find better ways to use the latest technology, this requires that the personnel under our charge, like us, are suitable personnel with solid knowledge, since the position of our services occupies a strategic place in the organization.
As we can see, today Human Resources provide the advice and support necessary for line management to achieve the objectives of the organization. Today the strategic conception is imperative and pro-activity is what is demanded by management.
We know that the Human Resources function has to do with the human being, but this view is no longer enough, now it requires the integral approach of different disciplines that help from their perspective to complete the function of strategic partner, having direct participation in the management of the organization, influenced on the direction and strategic issues, also expanding the degree of responsibility in training activities, team building, reading different graphs that reflect the productive activity or that serve as support in the increase policies that are establish in the organization.
It is imminent that human resources is being restructured, that its function in globalized organizations requires complete services that cause mobility and professional growth in its employees, thus leading them to establish dynamic and large-scale businesses that in turn trigger new employment contracts, that generate reactivation to the Argentine economy.
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