Tags Posts tagged with "quality"

quality

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How to Prepare for a Successful ISO 9001:2015 Audit - ISOUpdate.com

No matter how many audits someone has gone through, knowing that someone will be auditing your work always generates some tension and anxiety. Here are some recommendations from The Registrar Company, a North American Certification Body with over 20 years of auditing experience, to help your organization prepare for a successful ISO 9001:2015 audit.

Prepare Employees

  • Quality Policy – Review the quality policy, refresh it if needed, and make sure everyone understands it. There is no need for workers to memorize the policy, but they should have a clear understanding of what the organization has committed to in terms of quality.
  • Quality Objectives – Workers should know what the organization’s quality objectives are and how they themselves contribute to achieving them. Employees should know and be able to explain how their day to day activities can influence these objectives.
  • Training – Ensure that everyone has been properly trained to perform their tasks.
  • Documented Information – Make sure everyone knows where to find current copies of procedures, work instructions, and forms that are relevant to their position.
  • Audit Schedule – Let everyone know the scope of the audit, when they will be audited, and what the auditor may be checking in their areas.
  • Interviews – Workers should have the confidence to answer what they know, and have the same confidence to say ‘’I don’t know” when they are not sure how to respond during an audit.

Review Documented Information

  • Make sure document and record listings are up-to-date.
  • Check that all documents have been reviewed, approved, communicated, and followed by everyone involved in the process or activity.
  • Ensure obsolete documents have been removed from circulation and are no longer in use.
  • Verify that all records are being used correctly.

Ensure all Processes are Being Performed Correctly

  • Make sure that all procedures (whether they are documented or not) are being followed.
  • Ensure that critical processes are being performed in the same way (the correct way) by everyone.

Review Corrective Action Process

  • Review the findings from previous audits and make sure they have been addressed.
  • All non-conformities must be properly recorded, investigated, and actions need to be in place or concluded by the time of the audit.
  • Corrective actions that have been executed and closed should also have been verified for effectiveness.

Organize the Workplace

  • It is difficult for quality control and assurance to take place in an untidy, dirty, or unorganized workplace. Take time to organize the workplace (offices, desks, warehouse, workshop floor, etc.).
  • Make sure records, forms, procedures, and any relevant documents are on-hand or easy to access.

Practice Positivity and Professionalism

  • Make a good first impression – treat auditors professionally and with respect.
  • Do not be predisposed. Auditors are not enemies, they are there to establish conformance and to help your organization uncover any weaknesses so that you can take the necessary actions to improve.

The Registrar CompanyTRC is internationally recognized and trusted. With a large network of auditors, TRC is an international certification body with local benefits. With dedicated Client Services Managers and family-owned and entrepreneurial values, our clients are family. We take the time to understand your business and your unique needs. TRC audits are more than a checklist, we highlight your corporate strengths, and find opportunities for improved processes to ensure you stay competitive and thriving. TRC works with you to ensure minimal disruptions so you receive the highest benefits from the auditing process.



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Even if you have an informal quality management system within your business it is often difficult to implement the requirements of ISO 9001:2015. Depending on the size of your business this could be a task that may take six to twelve months to complete depending on the established current systems. It is vital that your staff are fully trained and engaged to make any implementation a success. The following 10 tips are vital to smoothly and effectively implementing an ISO 9001 management system:

  1. Get senior management commitment; while this may sound a little cliché, without the full commitment of your management team throughout the business it is going to be very difficult to drive home the changes and improvements that are required.
  1. Provide training at all levels in the business. Your staff needs to understand not only about the requirements of ISO 9001 but also the different quality principles that they should strive to implement within their every day work. Training should be provided on an ongoing basis according to perceived needs.
  1. Ensure that you have effective internal communication. Without this you are not going to be able to maintain the constancy of purpose that is required.
  1. Establish an implementation team with the authority to make things happen. You cannot just implement an ISO 9001 management system by assigning a management representative and expecting them to do everything in isolation. You need to identify the staff that will be required at all levels throughout the business to craft your system.
  1. Conduct a Gap Analysis; you need to fully understand where your current system meets or fails to meet the expectations of ISO 9001:2015 so that you can allocate resources accordingly.
  1. Involve customers and suppliers in analyzing your current systems. It is important to understand how others view the effectiveness of what you currently do and what they expect from you to improve things.
  1. Plan your implementation fully; responsibilities, roles and schedule. As with any project, the better that you plan it the more likely you are to have success.
  1. Create clear and concise policies and objectives for quality to provide the company with a common direction. Well communicated and understood these will help your company to move forward together.
  1. Encourage everyone to question and improve. It is not enough to only have auditors looking for issues with the systems; everyone should continually seek better ways to do things.
  1. Conduct regular reviews of your ISO 9001 management system through your auditing process to ensure that you are continually improving how your systems function.

In addition to the above, foster a good relationship with your certification body. Your auditor is not there to catch you out. They will want to help you to develop and grow a system that will significantly benefit your business, so use them fully.

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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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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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There are different approaches to auditing; these can be performed by clause, department, tasks, etc. The most commonly used by auditors is the clause approach,  where the auditor goes by each clause, usually with a checklist, searching for evidence of requirement conformance and writing nonconformities (minors or majors) if any are found.

These approaches tend to focus mainly on procedures and not on the performance, outcomes and results of the organization’s processes. Hence, audits result in the correction of minor problems and not in the improvement of the system and its processes.

Also Read: Understanding the Process Approach to Auditing

Also Read: Get Your Company Ready for the ISO Implementation Process



The process approach to auditing focuses on reviewing the sequence and interaction of processes and their inputs and outputs. It analyzes the management system not just as if it were a set of documented procedures, but rather as an active system of processes that addresses business risk and its applicable requirements. The main elements that a process-approach audit reviews are:

  • Process Owners
  • Inputs and Outputs of the process
  • Resources
  • Methods/ Procedures/ Instructions
  • Controls/ Measurements/ Metrics
  • Documents/Records
  • Efficiencies/ Effectiveness

In order to take this approach, it is required to plan and perform the audits so they are based on the processes that achieve organization’s objectives. The audit needs to be conducted through business processes and across department boundaries; some of the processes that need to be audited are:

  • Business management
  • Marketing and sales
  • Resource management
  • Purchasing
  • Product / service production processes

Audits conducted with a process approach provide information on whether performance targets are being met, they identify opportunities for improving performance through a better control of processes and determine how processes can be more effective and efficient in meeting the applicable requirements. Some of the aspects that make this approach a valuable one are:

  • It focuses on results, not on procedures.
  • Determines the management system’s effectiveness.
  • Evaluates the outcomes and results of the system.
  • Evaluates linkages between departments and processes.
  • Follows flow of work throughout organization.
  • Determines if operations are under control and if controls are effective.
  • Allows judgment on significance of findings.
  • Helps determine depth of problems across organization.
  • Focuses on benefits of correcting nonconformities related to improving organizational effectiveness.

Organizations that wish to comply with a standard have to meet the requirements established in it, but in some cases, just meeting these requirements does not necessarily add value to the organization. In order for an organization to be competitive and successful, its operational processes must work together in achieving its goals and objectives. A process based audit assists organizations in assessing the effectiveness of these processes; it serves as a tool to identify weaknesses and opportunities to improve the connections between policy, requirements, performance, objectives and targets, which will ultimately contribute to an organization’s overall success.

Also Read: Understanding the Process Approach to Auditing

Also Read: Get Your Company Ready for the ISO Implementation Process



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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
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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Become a Third Party Auditor - ISOUpdate.com

An accreditation body (AB) is an organization that provides accreditation services, which is a formal, third party recognition of competence to perform specific tasks. In other words, it means that organizations seeking accreditation can demonstrate to their customers that they have been successful at meeting the requirements of international accreditation standards.

In the last few decades many specified standards have been developed, and with them the number of organizations that check conformity and compliance with these standards has grown. These organizations provide services such as testing, inspection, calibration and certification and they may be laboratories, inspection bodies, certification bodies or other types of organizations. Anything or anyone can be evaluated (products, equipment, people, management systems or organizations) and the role of an accreditation body is to assess the technical competence and integrity of the organizations offering these kinds of evaluation services by:

  • Ensuring that certification bodies, inspection agencies, calibration/testing laboratories and other conformity assessment bodies meet established standards that will enable them to provide a service in an objective and independent manner.
  • Ensuring compliance with codes of ethics/conduct when providing assessment services.
  • Examining the competence of the organization’s staff.
  • Verifying the scope of an organization’s services. There are many sector specific standards and because not all organizations perform the same work or have similar capabilities, accreditation bodies can help identify and qualify those that are competent to perform a defined scope of work.

Regarding the quality of products and services, accreditation bodies play an important role because many are motivated to define and measure quality in a particular field. In their vision and mission statements, most accreditation bodies include quality improvement in their respective field. This helps keep accredited programs constantly focused on quality improvement as one of their own measures of success.

When an organization has been accredited by an accreditation body it means that they have been assessed against internationally recognized standards to demonstrate their competence, impartiality and performance capability. This serves as a means to identify a proven, competent evaluator so that the selection of a laboratory, inspection or certification body is an informed choice.  Most accreditation bodies provide a list of the organizations they have accredited, facilitating the search of these accredited organizations.

 

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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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The ISO 9000 family of standards is the most extensively used standards worldwide. They address various aspects of quality management and provide organizations with guidance and tools to ensure that their products and services consistently meet customer’s requirements, and that quality is consistently improved.

The best known standard of the ISO 9000 family is ISO 9001:2008, Quality management systems- Requirements, which establishes the criteria for a quality management system (QMS) and is the only standard in the family that can be certified to. ISO 9001 certification is not a requirement; however, organizations of all kinds and sizes all around the world decide to seek certification for a variety of reasons. These include to ensure clients, customers and stakeholders that they can provide quality products and services that continuously meet their expectations, improve the image of their product or services, increase their competitiveness and also because, nowadays, it is essential in order to do business in many industry sectors.

ISO 9001 has been around for over 20 years, and since its release, over one million organizations have been certified and many more have used it as a guide to establish and improve their QMS.

As stated in the 2013 edition of the ISO Survey, by the end of 2013, “at least 1,129,446 certificates had been issued in 187 countries and economies”.

In recent years, China has shown a rapid growth of the number of certificates issued there, placing it as the number one country with more ISO 9001 certifications (over 290.000 certifications). China is followed by Italy and Germany for being, respectively, the second and third country with most certificates.

Trends show that in the years to come, many more organizations will become ISO 9001 certified. It is expected that, with the upcoming revision of the standard (ISO 9001:2015), organizations will find that implementing and certifying to ISO 9001 will support them in overcoming the many challenges faced by businesses today.

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.