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QMS

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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.

Quality Control and Quality Assurance are both aspects of an organization’s quality management system (QMS), and even though they are closely related concepts, they are different in many ways. Understanding their differences is fundamental for any organization to effectively manage its resources and processes in order to deliver quality products and services.

To start, one of their main differences is that Quality Assurance is a prevention strategy oriented to prevent defects and Quality Control is a detection strategy oriented to detect defects. Here, an explanation of some of their differences is presented.

Focus of Quality Control and Quality Assurance:

  • Quality Assurance aims to prevent defects with a focus on the process that produces the product or service; thus it is process oriented.
  • Quality Control aims to detect (and correct) defects in the finished product, which makes it product oriented.

Goal of Quality Control and Quality Assurance:

  • The goal of Quality Assurance is to develop processes and procedures that will ensure that quality products and services are produced.
  • The goal of Quality Control is to check the products and services for defects that may have arisen during their development in order to deliver defect-free products or services to customers.

How Quality Control and Quality Assurance are Conducted:

  • Quality Assurance is conducted by establishing and defining standards and methodologies that must be followed during a process to ensure products and services meet customer requirements.
  • Quality Control is carried out by conducting tests and inspections to detect errors and flaws in products or services.

When Quality Control and Quality Assurance are Conducted:

  • Quality Assurance is a proactive process that takes place before the product or service is produced or delivered.
  • Quality Control is a reactive process that is performed during the manufacturing process and after the products are produced.

Despite their differences, Quality Assurance and Quality Control are both players of the same team and it is not possible to guarantee customer satisfaction if either one is missing. Achieving success requires both; if only Quality Assurance is applied, there will be no way of knowing if the procedures and processes are producing the expected outcomes. On the other hand, if only Quality Control is conducted an organization will not have a way of making repeatable and reliable results.

Quality is ensured by an organization performing the right tasks in the right way and by making sure that their efforts have produced the expected results. Quality Assurance and Quality Control complement each other and both these processes provide the necessary information for the continuous improvement of a QMS that meets the requirements of an organization’s customers.

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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

Implementing and seeking certification for ISO 9001 is an important decision many organizations make to improve their quality management system (QMS) and increase their competitiveness within their market. After the decision is made, one of the first concerns is: how long will this process take? Will it take three months? six months? a year maybe? or two years?

This question does not have a definite answer, implementing and seeking certification for ISO 9001 requires time, money and effort and the overall time spent will depend on several factors:

  • The size and complexity of the organization.
    Is it a small or medium-sized organization? Is it a single site organization or a multinational? Does the organization have complex processes such as design, manufacture, installation, test, etc.?
  • The maturity of the quality system that is in use.
    Does the organization have a well developed and structured QMS? Does it have a simple one with deficiencies?.
  • The resources available (money and time).
    Does the organization have a team dedicated exclusively on the implementation of ISO 9001? Do employees have only a couple of hours a week to dedicate to this project? Will the organization be able to hire a consultant to guide them through all the process?

The major time consuming activities organizations need to consider when implementing ISO 9001 are:

  • Understanding ISO 9001. Time will need to be spent in studying and training the people responsible for the implementation.
  • Conducting a gap analysis. This analysis will allow organizations to identify exactly what needs to be done to meet ISO 9001 requirements.
  • Getting busy with the documentation. A number of documents (policy, manual, procedures and forms) need to be developed.
  • Implementation and training. Employees need to know and understand key ISO 9001 requirements, and their work needs to be aligned with what is required.
  • Preparing and conducting an internal audit. At least one internal audit needs to take place before the certification audit.
  • Correcting non-conformities. Audit findings need to be addresses with an action plan to permanently correct them.
  • Selecting the certification body (CB). A registrar or CB needs to be selected to undertake the audit certification.
  • The certification audit. After all the hard work, a certification audit is scheduled with the CB and if the audit is a success, the organization is certified.

Carrying through all these activities can take an organization from 9 to 18 months; however, it will all depend on the organization and its specific situation.

It is recommended that organizations take the time needed to effectively implement ISO 9001; a well established and implemented QMS will provide organizations with a valuable tool to improve their quality performance and continuously meet their client’s expectations.

 

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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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As any other manager, role of the Management Representative is that of planning, organizing, monitoring, evaluating, and reporting.
As any other manager, role of the Management Representative is that of planning, organizing, monitoring, evaluating, and reporting.

Corrective Action is a reactive process; something needs to have gone wrong in order for an organization to take actions to solve the problem or non-conformity. Depending on the way they are approached, non-conformities can be corrected and its recurrence prevented.

Organizations with well-established management systems can find that problems/non-conformities, in their processes, products or services, recur, in spite of all the efforts (time, work and money) spent to eliminate them. In order to ensure that a problem is fixed immediately and in the long-term, an effective corrective action process needs to be established. Here are some characteristics of what makes an excellent corrective action process:



Problems are identified. Problems can occur in processes, in the workplace, in a product or service provided, or in the management system itself. Some of these problems are easier to identify than others; that’s why organizations need to establish ways to identify them through:

  • Workplace and process inspections.
  • Testing, inspecting, and monitoring of equipment.
  • Reviewing interested party’s communications.
  • Audits.
  • Hazard reporting.
  • Investigating complaints, incidents and accidents.
  • Reviewing system failures.
  • Reviewing regulatory requirements.

Problems are temporarily fixed or contained. Most problems need a quick reaction. For that reason, the owner of the task or process needs to be located and informed immediately in order to take the necessary actions to solve the problem temporarily.

The problem’s root cause is found. This is the most important characteristic of an effective corrective action process. If an organization is unable to determine the root cause of a problem/non-conformity, it is condemned to face the same problem over and over, which can be exhausting and discouraging to everyone involved in the process.

There are numerous techniques to determine the root cause of a problem. An organization needs to make sure their employees have the time, resources and the required skills to investigate and draw the right conclusions from these investigations.

A long lasting solution is put in place. After identifying the root cause, an appropriate solution that will prevent the problem from happening again must be proposed. These actions need to be put in place. It’s useless to go through all the work of understanding the problem and identifying its root cause, if the actions to solve it, will not be taken.

Permanent changes are verified. After an appropriate period of time, a person needs to be assigned to verify if the actions were successful in preventing recurrence. It’s recommended that this person is someone that was not involved in the previous steps of this process, to ensure is impartiality.

Corrective actions are recorded. It’s essential to report all the details of the corrective actions: problem found, immediate actions taken, root cause, corrective actions, and verification.

If an organization learns to solve their problems by applying an effective corrective action process, they will ultimately improve their processes, their management system and their business.



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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.