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Monday, January 18, 2016
Tags Posts tagged with "ISO"

ISO

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    All ISO standards are developed and published following a systematic process were ISO members and sector specific experts are involved.  When the need for a standard has been identified, a panel of experts, within an ISO technical committee (TC), meet to discuss and negotiate the first draft of the standard. As soon as a draft has been developed it is shared with ISO’s members who are asked to comment and vote on it. If a consensus is reached, the draft becomes an ISO standard, if not it goes back to the technical committee for further edits.

    Below is a more detailed explanation of each step a standard undergoes before it is released to the public.

    1. A new Standard is proposed to relevant TC.
      Contrary to what many believe, ISO does not decide when a new standard should be developed. ISO responds to a sector specific need when industry or other stakeholders make a formal request of a standard. Typically, an industry sector or group communicates the need for a standard to its national member who then contacts ISO. Practically every country (163 to be exact) has one ISO member that can be reached for this purpose.

      The TC reviews the proposal and if it’s accepted, the process will continue to step 2.

    2. Working groups of experts start discussion to prepare a working draft.
      These experts negotiate all aspects of the standard, including its scope, key definitions and content. These group of experts are from all over the world and they are part of larger groups that form a TC.
    3. First working draft shared with TC and with ISO CS.
      TCs are made up of representatives of industry, NGOs, governments and other stakeholders, who are put forward by ISO’s members. Each TC deals with a different subject; ISO has over 250 TC.

      The relevant TC reviews the first draft and if consensus is reached within the TC, the process moves on to step 4.

    4. Draft is shared with all ISO national members.
      As mentioned above, there is a member in almost every country. The draft is shared with these member (over 150) and each is asked to review and comment. All these comments are taken into account by the TC and if a consensus is reached, the process continues to step 5.
    5. Final Draft is sent to all ISO members.
      The final draft is sent to all members for approval. If it is approved by member vote, the process continues to its final step.

    6. ISO International Standard.
      The ISO International Standard is published and available for the public to purchase. This can be purchased from the ISO store or from the ISO national members. A full list of the ISO member of each country is available in the ISO website.

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    Measuring Supplier Performance

    The new ISO 9001:2015 is currently at the Final Draft International Stage (FDIS), the fifth stage of a six stage process, and the final revision is expected to be published by September 2015. There are a lot of expectations regarding the release of the new standard and many are wondering what the differences will be between ISO 9001:2008 and ISO 9001:2015.

    The recently published draft of the standard (DIS) has shown what the main differences are about; even though both standards cover essentially the same topics, there are some important changes. Some of these are:

    1. The most notorious difference between the standards is its structure. ISO 9001:2008 had five main sections and ISO 9001:2015 has seven. The new ISO 9001:2015 aligns with high-level organizational structure established on the ISO Guide 83 (“Annex SL”), requiring all new ISO management system standards to be aligned on a high-level structure with a set of common requirements. Such structure is as follow:
      • Scope
      • Normative References
      • Terms and Definitions
      • Context of the Organization
      • Leadership
      • Planning
      • Support
      • Operation
      • Performance Evaluation
      • Improvement 
    2. The new standard puts a greater emphasis on the “context of the organization”. Unlike ISO 9001:2008, the new standard will require organizations to consider the external and internal issues that may influence their quality management system (QMS) and they will need to determine how these will be addressed.
    3. With the new ISO 9001:2015, organizations will be required to take a risk-based approach to identify and address the risks that can jeopardize their ability to meet customer and regulatory requirements. In ISO 9001:2008, even though a risk-based approach is not explicit, the standard implicitly guides organizations in managing their risk.
    4. The new standard has eliminated the distinction between documents and records by referring only to “Documented information”. There also will be general requirements for documentation, with no reference to documented quality manual, documented procedures or to quality records.
    5. The specific requirements for preventive action present in ISO 9001:2008 have been removed in the new standard. This decision was motivated by the perspective that prevention is the task of the QMS in its entirety.
    6. Some concepts have been replaced in the new standard, such as the term “product” is replaced by “goods & services” and “continual” by “continual improvement.”“Purchasing” and “outsourcing” will be replaced by “external provision of goods and services”.
    7. The new standard also eliminates any reference to a “Management Representative”. Instead, management duties and responsibilities can now be assigned directly to top management (to one person in particular or to many).

    These are the main differences between the two standards which are based on the DIS version of ISO 9001:2015. There are still comments from over 90 countries that will be taken into account and it is yet to see which of these changes will be maintained in the final official version.

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    Since the 1960s, HACCP has been recognized internationally as a logical tool for adapting traditional inspection methods to a modern, science-based, food safety system.
    Since the 1960s, HACCP has been recognized internationally as a logical tool for adapting traditional inspection methods to a modern, science-based, food safety system.

    ISO 14001 is under review. After its original publication in 1996, this is the first time it’s going through major changes. The review process is currently at the Draft International Standard (DIS) stage, the fourth stage of a six stage process, and  the final revised ISO 14001:2015 is due to be published by the end of 2015. Some of the main changes ISO 14001:2004 is undergoing are:

    1. The first change to ISO 14001:2004 concerns its structure. This revision is based on the ISO Guide 83 (“Annex SL”) which defines a common high level structure, text and common terms and definitions for the next generation of management systems. This structure aims to facilitate the implementation process and the integration of several management systems in a harmonized, structured and efficient manner. Such structure is as follow:
      1. Scope
      2. Normative References
      3. Terms and Definitions
      4. Context of the Organization
      5. Leadership
      6. Planning
      7. Support
      8. Operation
      9. Performance Evaluation
      10. Improvement
    2. New concepts have been added, such as “supply chain”, “value chain” and “product life cycle” and existing definitions have been modified to give a different emphasis and to improve clarity.
    3. Two new clauses have been introduced which focuses on an organization’s context. These require organizations to determine the issues and requirements that can influence the scope of its EMS and take them into account.
    4. There’s a greater emphasis on top management, requiring them to take the lead in integrating the environmental management practices into their organization’s core strategies, processes, and priorities.
    5. Regarding environmental policy, organization should be committed to protecting the environment rather than just preventing its pollution, as stated in ISO 14001:2004.
    6. A greater emphasis is placed on an organization determining its own risk profile.
    7. Organizations are required to control or influence processes and services associated with significant environmental aspects, organizational risks, lifecycle and emergency preparedness.
    8. There is a greater focus on environmental performance improvement across the value chain.
    9. The DIS does not include specific requirements for preventive action. The new standard no longer thinks of preventive measures as a separate topic, but rather as a central component of all environmental-related activities.
    10. Environmental objectives have been given a separate sub-clause with the “planning actions to achieve environmental objectives.”
    11. The terms “document” and “record” have both been replaced throughout the DIS with the term “documented information”. The DIS states that documented information must be maintained to the extent necessary to have confidence that the processes have been carried out as planned.

    It is important to mention that this standard is still under review, and there is still to see which changes will make it to the final revision. However, it’s clear that the overall goal of ISO 14001:2015 is to respond to the latest environmental trends, help organizations improve their environmental performance and prepare them for future environmental challenges.

     

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    The quality management system (QMS) standard ISO 9001:2008 is currently under review. Like all ISO standards, which go through a revision every 5 years, ISO 9001 is being updated to reflect new technological advancements in the workplace and a to give a higher focus on the quality of outputs to customers.

    The review process is currently at the Final Draft International Stage (FDIS), the fifth stage of a six stage process and  the final revised ISO 9001:2015 is due to be published by September 2015. Some of the upcoming changes to ISO 9001:2008 are:

    1. The new ISO 9001 standard aligns with high-level organizational structure established on the ISO Guide 83 (“Annex SL”), requiring all new ISO management system standards to be aligned on a high-level structure with a set of common requirements. This structure aims to facilitate the implementation process and the integration of several management systems in a harmonized, structured and efficient manner. Such structure is as follow:
      1. Scope
      2. Normative References
      3. Terms and Definitions
      4. Context of the Organization
      5. Leadership
      6. Planning
      7. Support
      8. Operation
      9. Performance Evaluation
      10. Improvement
    2. Some concepts are replaced, such as the term “product” is replaced by “goods & services” and “continual” by “continual improvement.” “Purchasing” and “outsourcing” will be replaced by “external provision of goods and services”
    3. The new standard puts a greater emphasis on the “context of the organization” which implies a broader measurement, planning and implementation view.
    4. The new standard will take a risk-based approach to determine the type and extent of controls appropriate to each external provider and all external provision of goods and services. The proposed standard addresses risks which can affect conformity of goods and services as well as customer satisfaction.
    5. Senior management will be required to take a more active involvement in the quality management system.
    6. There will be general requirements for documentation, with no reference to documented quality manual, documented procedures or to quality records. The DIS refers to “Documented Information.”
    7. The need for exclusions may not be considered to be necessary in the new version of the standard but feedback on this is being sought as part of the revision process.

    Regardless of the upcoming changes, ISO 9001 will continue to be a generic standard, relevant to all sizes and types of organizations in any sector and it will continue to deliver “confidence in the organization’s ability to consistently provide product or services that meets customer and applicable statutory and regulatory requirements”.

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      No one can deny the increasing impact of human activities on our environment. Our society is ever more preoccupied and occupied on the many issues affecting our environment today, such as pollution, over-consumption of resources, degradation of ecosystems and biodiversity, and an increasing world population that demands resources in the amount and quality that will ensure a decent and fulfilling life.

      Organizations everywhere have implemented environmental management systems (EMS) to ensure compliance with an increasingly stringent legislation, control the impacts of their activities, products or services, and increase sound environmental performance.

      Implementing and conforming to an EMS based on the ISO 14001 standard not only shows that an organization is environmentally responsible, but it also brings numerous benefits within the organization by:

      • Identifying cost savings with greater emphasis on resources, waste and energy management.
      • Quantifying, monitoring and controlling the impact of operations on the environment, now and in the future.
      • Increasing profits through potential process improvements and energy conservation.
      • Reducing costs as a result of potentially lower insurance rates.
      • Verifying your systems for recognizing and complying with environmental laws and regulations.
      • Improve environmental performance of supply chain.
      • Ensuring that information is properly documented, communicated and retained.
      • Increasing employee awareness and participation by making it clear that environmental performance is an important part of the organization’s culture
      • Improving management of environmental risks and emergency preparedness and response procedures.

      Other benefits of ISO 14001 come from how the organization is seen from outside by interested parties, some of these are:

      • Improved corporate image among business partners, regulatory agencies, and community by showing that the organization is environmentally responsible.
      • Improved relationships with government regulatory agencies; organizations that have implemented ISO 14001 find that regulators are quicker to provide technical support, and find that the regulators are much more supportive in general.
      • Advantage over competitors when tendering for business.
      • Grow access to business partners and potential customers.

      ISO 14001 provides organizations with knowledge, tools and techniques to build success over the long term and create new opportunities for development and growth. These tools can be aligned with an organization’s priorities, strategy and decision-making by integrating them with other business requirements and embedding environmental governance into its overall management system, thereby achieving both environmental and economic goals.

      The market is driving organizations to demonstrate their success in protecting our environment; more and more people want to be environmentally responsible and they are doing so by choosing products and services that have been designed, produced, developed and delivered in an environmentally friendly way. Therefore, in the near future, ISO 14001 will become a prerequisite for doing business worldwide.

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        If your organization is ready to become ISO 9001 certified, there are a number of steps you can expect to go through on your path to certification. Once an organization has decided to obtain certification and has made a choice of the certification body (CB), the organization must:

         Make a formal certification application to the CB.

        • Fill out the application forms, which require a large amount of information about the organization and its operations. This will enable the CB to determine the scope of the certification activities and to appoint the team leader for the audit process.

         The initial certification audit consists of a two-stage audit as described below:

         The Stage 1 Audit determines if an organization is ready or not for a compliance audit.

        • Organizations need to supply all relevant management and quality documentation to the CB.
        • The CB determines if the organization is ready or not to undergo Stage 2 or compliance audit.
        • If the organization is not ready, the CB will inform accordingly and stop the process.
        • If the organization is ready, but a few nonconformities have to be rectified before the compliance audit can take place, the CB will provide the organization with a report.
        • After nonconformities have been corrected, the organization must inform the CB, and if they concur with the actions taken, a compliance audit is arranged.

         The Stage 2 Audit evaluates the implementation and effectiveness of the organization’s QMS.

        • The team leader assembles a team of auditors and experts concomitant with the organization’s scope of activities, complexities and size of operations.
        • A time for the audit is agreed and scheduled.
        • Auditors will assess whether the contents of the documentation provided is consistent with the activities of the organization as well as the requirements of the standard.
        • Overall findings and the list of non-conformities (if any) are presented.
        • If the QMS complies with the requirements, the team will recommend to the certification committee of the CB that the organization should be certified.
        • If there are non-conformities found, the team will agree with the organization a time schedule (typically 3 months) and the modalities for rectifying the non-conformities.
        • The team may wish to witness the new procedures, or if the non-conformities are of a minor nature, the organization can send them evidence that these non-conformities have been fixed.
        • The team will recommend to the certification committee of the CB that the organization should be certified.

        Learn more about Stage 1 and 2 audits.

        Certification

        • Authorized persons or a committee which was not involved in the audit will review the audit report and the clearance report of the nonconformities and make a decision regarding certification.
        • The decision will be followed by the issue of certification documents.

         Surveillance Audits

        • The CB will conduct a surveillance audit usually once a year.
        • There are a few areas that will always be included in the surveillance audit, such as internal audits and management reviews as well as the non-conformity system.
        • If any non-conformity is raised during the surveillance audits, the organization must correct them efficiently within an agreed time frame, otherwise certification may be lost.

         Recertification Audit

        • In the third year of certification, a re-certification audit will be conducted, similar to the original compliance audit.
        • If this is negotiated successfully, the organization will be recertified for another three-year period, and the whole cycle repeats itself.

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          The ISO 9000 series of quality standards is the most used management system worldwide; thousands of organizations rely on these standards to establish an effective quality management system. Here are some facts every organization pursuing to implement ISO 9001 should know.

          1. The ISO 9000 family of standards are a set of standards and guidelines that have global reputation as being the basis for the establishment of quality management systems (QMS).
          2. The adoption of all standards published by ISO, including standards in the ISO 9000 family, is voluntary in nature.
          3. In the ISO 9000 series, all standards can be implemented without certification. Any business can use the models from the standards to improve quality management systems.
          4. Many countries have adopted the ISO 9000 family of standards and have also appropriated its numbering system for their national standards. For instance in the United Kingdom, ISO 9001 is referred to as BS EN ISO 9001:2008, with BS standing for British Standard and EN for European Norm. In Sri Lanka, the standard is numbered SLS ISO 9001:2008, with SLS denoting Sri Lankan Standard.
          5. Any organization, regardless of the type of products or services they offer, can use ISO 9001 as their guideline to implement, maintain and improve a successful QMS.
          6. ISO 9001 provides a process approach for its execution, which enables the QMS to connect with other organizational processes; and its focus on continuous improvement and customer satisfaction will lead to an improved business performance.
          7. ISO 9001 specifies what an organization “should” do, but not “how” they should do it, giving great flexibility for any company, large or small, to use this standard. Additionally, ISO 9001 does not establish specific quality requirements; this is a decision taken by each organization; the standard is only a guide to achieve the goals and objectives set by each organization.
          8. Specific industry requirements were added to ISO 9001 to create standards for organizations in the automotive, telecommunications, aerospace, medical devices, oil and gas, and information technology sectors. These QMS standards have not diluted or modified the requirements of the ISO 9001 generic standard, but have added some sector-specific requirements, guidelines and clarifications. Some of these are:
            • Automotive industry:  ISO/TS 16949
            • Medical devices: ISO 13485
            • Primary packaging materials for medicinal products: ISO 15378
            • Petroleum, petrochemical and natural gas industries: ISO/TS 29001
            • Telecommunications industry: TL 9000
            • Aerospace Industry: AS 9100; AS9110 and AS9120
          9. Certification of your QMS by an accredited certification body generates confidence among your existing and potential customers and other interested parties that you are capable of supplying consistently conforming products or services.
          10. Adherence to the ISO standards can be publicized to gain market access abroad, because many foreign buyers place a premium on these standards.

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            Ready to implement ISO 9001 in your organization? Here are some ISO 9001 tips that will help make the process easier.

            Implement ISO 9001 for the right reason.

            When implementing a quality management system (QMS) for ISO 9001, management should be clear about the purpose of the QMS. If the only driver is to get on customers’ tender lists or because a competitor has already got one, it’s highly likely that the QMS will remain a set of documents for certification purposes only. Rather, management should aim for a QMS that will help the organization produce quality products or services, continuously improve its process, and provide confidence to customers that the organization is capable of meeting their requirements all the time.

            Motivate your workforce.

            In order for organizations to achieve a desired level of quality, people need to get involved. People are the essence of organizations and their full involvement is essential to implement and maintain ISO 9001. Employees can be motivated by:

            • Ensuring that everyone knows and understands the organization’s quality policy;
            • Defining and communicating responsibilities and authorities within the organization;
            • Building the competence of employees;
            • Providing adequate infrastructure and work environment;
            • Initiating improvements, e.g. by implementing employees’ suggestions.

            Hire a consultant if…

            If an organization’s staff does not have the time or skills to develop the QMS by themselves, a good consultant will make possible a speedy transfer of knowledge and skills. If the staff does have the time, there are enough published materials available from the web that will help staff obtain the necessary skills to develop the QMS.

            Take the necessary time to implement your QMS.

            All too often organizations are in a hurry to obtain certification and do not spend the time needed to implement the system effectively. Before applying for certification, your QMS needs to be in place for at least three months and its effectiveness checked through an internal audit, followed by corrective actions on audit findings.

            Define SMART objectives.

            Many organizations set quality objectives that are impossible to meet. Objectives need to be specific and relevant to the process or task to which they are being applied. They also need to be measurable and achievable within the resources that can be made available in a realistic and timely manner. It’s helpful to have a start and completion date.

            Go easy with the paperwork.

            Many believe that everything in the system needs to be elaborately documented. ISO 9001 only requires one quality manual, six procedures, and approximately 20 records. Many organizations are better off sticking to what is required and keeping those documents simple; additional procedures and records should be considered only if they add value to the system.

            Set the example.

            Some employees, especially mid-level managers, may find it difficult to change their ways of doing things and some can have a tendency to deviate from defined procedures. To change this, top management should ‘walk the talk’, i.e. they should not allow deviations from set procedures or permit the release of materials with deviations. Under such an approach, the mid-level managers will start respecting system requirements and everyone will take account of their responsibilities for the success of the QMS.

             

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              Small and large organizations recognize that the implementation of an ISO 9001 quality management system (QMS) in their processes gives them a competitive value. However, the task of implementing and successfully obtaining the certification requires time and money. Therefore, a popular question when deciding to implement is “What is the Cost to Implement ISO 9001?”

              There are 2 kinds of costs associated with the implementation of ISO 9001. These are:

              1. The costs for implementation.
              2. The costs for the certification.

              In order to effectively estimate the cost for implementation, an organization will have to go through a gap analysis or assessment. However, there are three main factors that an organization should take into account when estimating cost:

              1. The size and complexity of the organization. Is it a small single location organization? or is it a large company  with processes such as design, manufacture, installation, test, etc.?
              2. The type of quality system that is currently in use. Does it have a structured and disciplined system in place? Is the system documented, and how well?
              3. The time that staff and other members of the organization have to devote to the project. Will the organization create everything with its current members? Will it hire someone to guide them? Or, will it hire an ISO consultant to complete the entire process?

              The major cost items that every organization needs to consider when implementing ISO 9001 are:

              • Training managers to get them to understand the requirements of ISO 9001
              • Assessment of current quality control practices and creating additional testing facilities routine if necessary
              • Renew the workspace, equipment, machines, public services, supporting facilities, etc, if necessary
              • Review and revamping arrangements for the handling and storage of raw materials, semi-finished and finished products, as appropriate necessary and safe
              • Review existing procedures / practices and listing of new procedures, checklists and records to be prepared
              • Development of QMS related documents
              • Conduct outreach activities of everyone who has roles and responsibilities for implementing the QMS
              • The various expenses such as word processing, stationery and other supplies necessary for the production of manuals, procedures and the like

              Regarding the cost of initial certification and costs associated with maintaining certification the main cost items are:

              • Registration and certification fee payable to the certification for a period of three years
              • Fees for the two-stage audit visit nominated by the certification body
              • Audit Committees regularly monitored by the certification agency nominated
              • Travel, accommodation and meals for auditor(s) of certification

              The implementation and consequent maintenance of a QMS based on ISO 9001 is an investment of time and money for any organization. The success of the system will rely mainly in the commitment of all its members, especially on how senior management is committed to making ISO 9001 an effective tool to integrate their processes, continuously improve their QMS, and satisfy their customer’s expectations.

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