Tags Posts tagged with "ISO 9001"

ISO 9001

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ISO 9001 and ISO 9004 are standards that complement each other and their implementation aims to ensure quality success and reach improved performance in any organization. Both these standards can be implemented independently or simultaneously; however, the most common scenario is for organizations to implement ISO 9001 and later use ISO 9004 to improve their processes and to obtain long term benefit from a more broad-based Quality Management System.

These standards are both similar in terms of structure and terminology used to allow easy integration. They are also based on the same quality management principles, therefore, when an organization has successfully implemented ISO 9001, it is relatively simple to integrate ISO 9004 and achieve an improved performance.

The best way to integrate these complementary standards is by doing the following:

Organizations need to identify and rank their quality needs, where the most basic needs are at the bottom and address ISO 9001 requirements and at the top are the needs to achieve improved performance. After identifying and ranking these needs, organizations must work up from ISO 9001 to ISO 9004 one step at a time.

Effectiveness

One of the basic needs that should be addressed is the effectiveness of the quality management system, that include areas such as

  1. meeting customer requirements;
  2. prevention of customer dissatisfaction;
  3. recalls and defects; and
  4. the production of safe products.

Efficiency

After meeting the effectiveness of the system, the efficiency should be then addressed. Here the focus should be

  1. the efficient use of resources;
  2. the reduction of material costs;
  3. the decrease of cycle times; and
  4. the increase of the organizations productivity.

Competitive Advantage

Achieving competitive advantage should be the last need to address; here it is essential to focus on ensuring delighted customers, increasing market share and increasing profitability.

This process is continuous, because an organization may never relegate it’s basic needs to address its top ones. It must constantly work in meeting all of them and ISO 9004 gives guidance on how to achieve this continuous improved performance.

Before attempting to integrate ISO 9001 and ISO 9004, it is essential to fully understand them both; even though they complement each other, they have different roles and different approaches. They each have a role to play in providing value to any organization that decides to embrace them both to improve their quality management system and achieve long term success.

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One of the main objectives of an ISO 9001 management system is “continuous improvement”; however, the standard ISO 9001 provides little information on how organizations can reach and maintain it. In this specific aspect is where a lean system will provide the biggest benefit to any quality management system. Lean systems require the implementation of different methodologies that will provide organization with the tools to continuously improve their processes and systems.

Lean manufacturing is characterized for aiming to reduce all the unnecessary in order to use a minimum amount of resources in every aspect of a system, especially on: human effort, manufacturing and storage space, and time.

This tool helps to eliminate all operations that do not add value to products, services and processes, increasing the value of each action and eliminating what is not required. By reducing waste and improving processes, lean manufacturing gives organizations the tool to survive in a global market that demands higher quality, faster delivery and an increase on customer satisfaction.

Some of the most common methodologies used in a lean system are 5S, Value Stream Mapping (VSM), Kanban, Key Performance Indicators (KPI), Shadow boards, Poka-yoke and many others. The implementation of these methodologies can bring many benefits to an ISO 9001 quality management system, such as:

  • Reduction in production costs.
  • Inventory reduction.
  • Reduction on delivery time (lead time).
  • Improved quality.
  • Decrease in labor.
  • Greater  equipment efficiency.
  • Waste reduction.
  • Reduction of overproduction.
  • Decrease on delays.
  • More efficient transport.

The requirements of ISO 9001 have many common aspects with lean production systems, especially in its design and mode of operation, suggesting a high potential for integration.

The integration of both systems will facilitate the implementation of a continuous improvement philosophy based on a systematic elimination of all types of waste, the respect and consideration of all employees and the continuous improvement of productivity and quality. This will enable organizations to reduce costs, improve processes and eliminate waste in order to increase customer satisfaction.

Furthermore, lean systems requires the ability to manage raw materials and components in small batches, which requires supply policies based on stable relationships with suppliers.

There are many organizations that are considering to integrate a lean system into their ISO 9001 management system. This is being done in a pursue to identify and reduce waste from their processes, reach an overall process that flows smoothly and ensure that the organization’s resources are effectively used to meet or exceed customer satisfaction.

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4 Steps to an Effective Internal Audit - ISOUpdate.com

ISO 9001 and 9004 are both part of the ISO 9000 family of standards. These standards, even though they’re both about quality management systems (QMS), they have some important aspects that differentiate them. Many organizations, when seeking to establish or improve a QMS, tend to get confused about which standard to use or if they should use both. In exploring ISO 9001 vs 9004, the main differences between them will be highlighted.

Purpose.

  • ISO 9001 provides a framework for a systematic approach to managing an organization’s processes so that their products or services are consistent and meet client expectations. It also ensures the organization meets applicable laws, regulations and other requirements.
  • The ISO 9004 standard is intended to help organizations extend the benefits of their QMS to stakeholders and all other interested parties, helping to give sustained success.
Exploring ISO 9001 vs 9004: These standards complement each other, so they can be used simultaneously by an organization, and they can also be used independently.

Certification.

  • ISO 9001 is a requirements document. It is the only ISO 9000 family standard which an organization can be certified against in order to demonstrate conformance to its requirements.
  • On the other hand, ISO 9004 is a guidance document on how to achieve continuous improvement to get excellence for the organization. It is not intended for certification.

Focus.

  • ISO 9001 standard’s main focus is on customer requirements. This standard focuses on assuring conformance to defined customer requirements and ensure effective response to customer feedback.
  • ISO 9004 focuses mainly on meeting the requirements of customers and all other interested parties. It aims at balancing the needs of all stakeholders in order to achieve sustained success.

Continual Improvement.

  • In ISO 9001 continual improvement of the QMS is achieved mainly by performing management reviews, internal/external audits and corrective/preventive actions.
  • ISO 9004 promotes self-assessment in order for organizations to identify areas of strength or weakness and opportunities for either improvements or innovations, or both. It guides organizations on setting realistic and challenging improvement goals for their processes.

There are many other differences between both these standards; however, what is important to understand is that:

  • They are both intended to be used by any organization, regardless of their size and nature, to establish and improve their QMS;
  • ISO 9001 is intended for certification and ISO 9004 is not and;
  • ISO 9001 is focused mainly on customer satisfaction and ISO 9004 has a broader focus that include all stakeholders in order to achieve sustained success.

Many people believe that ISO 9004 is a guideline for the implementation of ISO 9001, however, this is not true. These standards complement each other, so they can be used simultaneously by an organization, and they can also be used independently. Some organizations decide to use ISO 9001 to establish and improve their QMS and then move on to ISO 9004 as a guide to obtain long term benefit from a more broad-based QMS.

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Many small and medium sized organizations (SMOs) have decided to implement a quality management system (QMS) based on the well-known standard ISO 9001. After reviewing the costs and benefits associated with the implementation and certification process, it is essential to take a look at what are the costs involved with maintaining a successful QMS.

The main costs associated with maintaining a QMS after ISO 9001 certification are:

  • Periodically checking the condition of measuring instruments for their repair, maintenance and calibration.Here, the costs depends on the nature of the organization and in the complexity of its processes estblished with ISO 9001. In most SMOs, processes tend to be simpler with less specialized and sophisticated machines, which reduces the resources needed to keep their machines and instruments working in good conditions.
  • Performing periodic internal QMS audits.Effective internal audits need to be planned, executed and their results monitored by qualified and experienced auditors for ISO 9001. For many SMOs, it can be time consuming and costly to train existing workers to perform these audits, that’s why it is highly recommended for these organizations to consider contracting out their internal audits in order to reduce the overall cost associated with this process.
  • Training and raising awareness on matters related to the ISO 9001 QMS such as customer satisfaction, quality and improvement.These activities are easier and less expensive to do by SMOs than by large enterprises. It is far less expensive to train 100, 50 or less workers than attempting to train 500, 1000 or more.
  • Surveillance and re-certification audits.Organizations have to cover the fees for the periodic surveillance audits by the certification body, and every three years a re-certification audit must be performed in order to maintain certification. It is important to note that certification is not mandatory; many organizations decide to implement ISO 9001 without seeking certification by an independent third party audit.
  • Continuous improvement.This is one of the most important factors that will determine if a QMS will survive and thrive. A QMS must be used to continuously improve the efficiency of an organization’s processes, reduce waste and meet customer requirements on a continuous basis. Continuous improvement involves investing in correcting problems that may arise and eliminating their recurrence (associated with Corrective actions) and preventing problems from ever occurring (Preventive actions). The costs associated with this process varies with each organization. However, SMOs have an advantage because there is less bureaucracy and the decision makers are closer to the processes that need improvement, thus there is a greater probability that resources will be assigned exactly where and when they are needed.

Despite the resources needed, by maintaining a successful QMS, SMOs will benefit from lowering costs by reducing waste, improving the efficiency of their processes and having more satisfied customers who will come back for more products or services, which will contribute to the organization’s overall success.

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Quality Control and Quality Assurance
Quality Control and Quality Assurance are both players of the same team and it is not possible to guarantee customer satisfaction if either one is missing.

Since the first publication of ISO 9001 in 1987, over one million organizations around the world have been certified to it. Today, the number of organizations deciding to use ISO 9001 as their guide to implement or improve a quality management system continues to grow. The reasons for implementing and seeking certification differ from company to company. Some make this decision hoping to improve customer satisfaction, gain new customers, improve process efficiency, meet legal or customer’s requirements or simply to become more competitive in their market.

Regardless of the reasons, deciding to embark an organization in the implementation and certification process needs to be carefully planned, as it involves a significant amount of effort regarding time and money. Therefore, the initial question that leaders seek to answer is if all that effort will be worth it?

There are many opinions for and against ISO 9001 certification, and even though surveys have shown that there are organizations that have reported no benefits at all after their certification, most organizations acknowledge numerous benefits after obtaining certification.

Surveys have shown that many organizations have perceived external benefits after their organization has been certified. Some of these are:

  • Improved perceived quality
  • Improved customer satisfaction
  • Competitive advantage
  • Reduced customer audits
  • Increased market share
  • Quicker time to market

Additional to these external benefits, organizations have also reported the following internal benefits:

  • Greater quality awareness and better documentation
  • Increased efficiency
  • Positive cultural change
  • Improved financial performance
  • Improved employee morale

Another study published by the International Organization for Standardization (ISO) in 2002, compared the performance of similar certified and non-certified organizations over a 10 year period. The results of the study showed that the certified organizations improved their relative performance substantially, compared to the non-certified ones. The study concluded that organizations that did not seek certification experienced substantial deteriorations in their performance, while organizations that obtained certification generally managed to avoid such declines.

Most of the information available suggests that ISO 9001 is worth the investment if it is perceived as a valuable tool that organizations can use to improve their processes, meet their customer’s requirements and continuously improve their quality performance. If an organization gets certified and shortly forgets about maintaining and improving their processes, it is likely that their initial investment will not pay off, and ISO 9001 certification will end up being a waste of time and money.

ISO 9001 will be a positive and well perceived investment if it is planned, implemented and maintained correctly. There are information and tools available for organizations to make the best of the most widely used standard in the world.

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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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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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Today, more and more organizations are deciding to adopt the ISO 9001 standard as a guideline for their quality management system (QMS). With the implementation of ISO 9001, an organization demonstrates its ability to consistently provide products or services that comply with applicable law and meet the demands of its customers. If an organization implements and maintains a successful QMS it will gain a number of benefits.

Benefits of ISO 9001 within the market:

  • Improved image of products or services offered.
  • Level playing field with large companies when bidding for new contracts.
  • Preferential treatment from potential customers who themselves have implemented ISO 9001.
  • Adherence to the ISO standards can be publicized to gain market access abroad, because many foreign buyers place a premium on these standards.
  • For organizations that obtain certification, most certification bodies keep an updated list of certified companies and organizations and provide this list upon request to potential customers or other interested parties.

Benefits of ISO 9001 with customers:

  • Improved customer satisfaction.
  • Obtaining certification will reduce the frequency of audits of the QMS by different customers.
  • Secure customers’ loyalty as their needs and expectations will be continually met, leading to more business opportunities.

Benefits of ISO 9001 for the organization’s QMS:

  • Quality will be seen as everyone’s responsibility instead of being the sole responsibility one person (the quality control inspector or manager).
  • Serve as a means to maintain and improve the effectiveness and adequacy of the QMS, by highlighting areas with potential for improvement.
  • Increase motivation and participation of staff and improve resources management.
  • QMS will provide you with a means of documenting the organization’s experience in a structured manner (quality manual, procedures, instructions, etc).
  • You will generate savings, as the costs of reprocessing, rework, repeat inspections, replacing products, penalties due to delayed deliveries, customer returns, customer complaints and warranty claims will gradually fall.

The biggest benefit to be gained from maintaining a QMS from ISO 9001 is the huge savings an organization can make by considerably reducing the cost of failures. By aiming to consistently produce quality products or services, organizations will reduce waste and thus lower costs. They will have more satisfied customers who will have fewer problems with their product or service.

All these will have a major effect on sales revenue, improve market share and engender in an organization’s customers a higher level of satisfaction.

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In order for organizations to successfully implement an ISO 9001 Quality Management System (QMS) that provides confidence to customers and serves as an instrument for continuous improvement, the implementation process should be taken up as a project, following these steps and recommendations:

Step 1: Nominate a Team.

  • A small team consisting of a senior person from each department should be appointed by management for system development.
  • A coordinator must be designated.
  • The team should undergo awareness and documentation training on the ISO 9000 family of standards with a professional training organization.

Step 2: Carry out a gap analysis

  • Start with a flow chart showing how information currently circulates, from order placement by the customer to delivery of the product or service.
  • Follow with a flow chart of activities in each department.
  • Formulate a list of existing procedures and work instructions for the most relevant activities in each department.
  • Other activities and processes that are considered relevant at this point can be added.
  • Identify gaps throughout this process.
  • A time-bound action plan to close the gaps identified during this exercise should be prepared and action taken as planned.

Step 3: Prepare documentation

  • Procedures should be limited the documentation that is required.
  • Additional procedures and records should be devised only if they add value to the system.
  • Involve all personnel concerned in the development of the procedures and work instructions applicable to their areas.
  • Documentation should reflect current practice and not ideas of what should be implemented.
  • New forms and checklists should be created if necessary; otherwise adopt existing ones to the extent possible.

Step 4: Train and implement

  • Train all employees. Everyone should know their responsibilities in order to successfully implement and maintain the QMS.

Step 5: Conduct Internal audit and improvement

  • Some managers and staff members should be trained by a professional trainer to carry out internal auditing.
  • Conduct the first internal audit approximately three months from implementation.
  • Correct any gap found during the audit.
  • Once the system stabilizes, internal audits should be conducted at planned intervals.
  • To improve the system internal audits, customer feedback data, process and product monitoring data, evidence of the attainment or not of quality objectives, corrective actions taken, etc. should be used.
  • Management should provide financial and other resources for improvement projects and monitor the progress of improvement.

Step 6: Management review

  • Top management should review the QMS.
  • As a result of this review, management may decide to set new targets for quality objectives and to make the improvements needed in the QMS.

Step 7: Certification

  • Certification is voluntary; therefore the need for it should be decided by management.
  • Once the system has been in operation for a few months, organizations may consider making an application for certification.

An action plan for developing QMS covering the above activities should be prepared. The plan should define the responsibilities of team members and management and set target dates. Full implementation may require six to nine months.

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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.