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quality

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What is Quality in ISO 9001?

The Concept of Quality in ISO 9001

Quality can be defined as “fitness for use,” “customer satisfaction,” “doing things right the first time,” or “zero defects.” Webster’s dictionary defines quality as “a degree of excellence” and “superiority in kind”.

Within an organization, quality is controlled and measured using a quality system – a mechanism that coordinates and maintains the activities of the organization needed to ensure that the characteristics of products, processes or services are within certain bounds. A proper quality system considers all interested parties – everyone directly or indirectly affected by these activities and is typically documented in a quality manual. The quality manual dictates the associated processes and documents that specify procedures and standards to achieve and maintain quality of goods, services and outputs of the company.

Basic Elements in a Quality System

There are three basic elements in a quality system: Quality Management, Quality Control, and Quality Assurance.

  • Quality Management being the means of implementing and carrying out the quality policy.
  • Quality Control being all the techniques and activities of an organization that continuously monitor and improve the conformance of products, processes or services to specifications.
  • Quality Assurance being all the planned and systematic actions necessary to assure that a product or service will satisfy the specified requirements.

As stated in an ANSI/ASQ standard: “Quality control has to do with making quality what it should be, and quality assurance has to do with making sure quality is what it should be.”

Quality Audits

How can an organization determine if their Quality System is effective? This is done through a quality audit – an independent assessment comparing the various management and quality activities to a specific standard.

An independent assessment implies that the person performing the audit is not associated with the activity being audited. In the past, the specific standard to which a quality system was compared was up to the business owners themselves. Be it customer satisfaction, internal approval or whatever was deemed acceptable to leave the factory. It wasn’t until 1987 that an ISO technical committee developed and published the ISO 9000 family of standards – quality standards that set the benchmark for the minimum requirements for an adequate quality system. – Source

What are Quality Standards?

Quality Standards can be defined as “documents that provide requirements, specifications, guidelines, or characteristics that can be used consistently to ensure that materials, products, processes, and services are fit for their purpose”. – Source

Using standards, an organization can effectively share their goals, processes, procedures, and vocabulary needed to meet the expectations of their stakeholders. Standards provide organizations with an effective road map for the understanding, procedures, and vocabulary needed to meet the expectations of their stakeholders. Because standards provide descriptions and terminology, they allow for ease in international communication and help increase trust between international consumers, suppliers and trade.

One specific standard that is most well known and attributed to Quality is ISO 9001.

ISO 9001 is the internationally recognized QMS standard that was designed as a business improvement tool to help organizations of any size continually improve and streamline operations, reduce operating costs, satisfy more customers and win more business. 


Read more from ISO Update:


ISO 9001 helps organizations from the ground up, working to standardize their processes effectively to work towards the end goal of providing exceptional outputs to their customers. Your whole system should work in a way that it constantly measures and checks that you are working in such a way as to produce the highest quality output. This is not simply in measuring the weight or using the right material, but this also encompasses your hiring process, your training methods, and your day to day activities. ISO 9001 sets up the framework for how you can properly measure, monitor and improve your processes in such a way that sets you up for success in the short and long term. ISO 9001 is an internationally recognized and trusted standard, often required to do business internationally.


Want to learn more about ISO 9001? Are you considering certification? Ask an expert:

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When Quality Fails - ISO Update

Standards function to provide the end-user with quality products and services, but they also protect the vitality and reputation of a business. Your system should be built in such a way that it is constantly putting measures and checkpoints in place that does not allow product to leave your hands until it is safe, and up to yours and your customers’ standards. So, how does a product of subpar quality leave your plant? Who is responsible? How did your management system allow this failure to happen? When your product fails, or worse, you must issue a recall and you want to assign blame. Who is to blame? Why did your system fail you?

Case Study – Toyota Unintended Acceleration Recall, 2009

If an auto manufacturer finds flaws in their cars and lists a product recall, the public’s perception of this company will suffer. No greater example of this exists than the 2009 recall of Toyota sedans.

Toyota issued a recall of 8.5 million of their sedans in 2009 due to unintended acceleration caused by floor mat issues, brake problems and “sticky” gas pedals. The recall was issued in response to accidental deaths and provides an example of the grave consequences that may arise from poor execution of a QMS. In this case study, findings suggest that Toyota ignored quality warnings when failures began to happen. This is not a problem that is exclusive to Toyota, but rather an industry, and worldwide, problem. Read the full case study here.

InfoTrend dives into the deteriorated public opinion of Toyota immediately following the recall from the period of 2009-2011 in the United States. They deeply investigated the effects the media had on the public’s opinion, and how the recall shaped their opinion of the brand, being pro-, con- or neutral about the brand.

In 2014, Simply Communicate discussed the strategy Toyota took to rebuild their company image, and their internal culture and morale after the damage took its toll on the company. The shift in the culture at Toyota was substantial, losing talent, working hard to keep talent, and striving to keep employees, even if it meant shifting their jobs, all without losing more profits.


The NHTSA has a handy recall check for those in North America to verify their VIN number against any product recall it may be involved in.


It’s not easy to bounce back from catastrophic product failure, and that is especially true for organizations without multi-millions of profits and bail-out opportunities. It is the goal of a properly implemented ISO 9001 QMS to prevent these failures from happening in the first place. How did my system allow this failure to happen?

How does Failure Occur, and who is to Blame for a Product Failure?

If, or when, a product failure occurs, your organization shouldn’t point fingers. The first question you need to ask is “how did my quality management system allow this failure to occur?”. A simple investigation tactic you may want to implement is “Root-Cause Analysis – 5 Whys”. This method prompts you to ask yourself and your organization “why” until you have a root-cause (this could take fewer or more than 5 “why’s”). The basic framework allows you to develop pathways for why a failure happened in the first place, and where you can identify areas for improvement.


Read more about the 5-Why’s Method and Root-Cause Analysis from ISixSigma


Failures should not be a cause for removal of your certification or attempted to be hidden from your auditor. Failures, especially those caught by your system, should be celebrated. Consider them an indication that your system is working if the problem is caught, and an area for improvement is identified. Feedback is essential for growth, and even negative feedback should be viewed in a positive light and mentality.

Why is Quality Important for My Business?

The aim of any business is to maintain quality to an acceptable standard and failure to do so can result in any number of serious consequences. Quality control is important to guarantee customer satisfaction and more importantly retention. Customers are only likely to be retained and return for another experience if previous services have lived up to their expectations of a certain quality. More importantly, quality also has an effect on company reputation which is paramount to attracting new customers and profits.

Perhaps to customers, the quality of goods or services is the most important aspect of your company, this role proves to be vitally important for the survival and growth of an organization. Maintaining consistent quality without incurring massive costs should then be a primary goal for any organization.

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ISO 9001 as a Strategic Planning Model - ISO Update

Written by Kashif Mumtaz

Regardless of the other terms used in ISO 9001:2015, the term, Strategic Direction has not been defined in ISO 9000:2015 Quality Management Systems – Fundamentals and Vocabulary. However, ISO 9001:2015 contains the following strong linkages to the strategic direction of the organization:

  • Clause 4.1 – External and internal issues must be relevant to the Strategic Direction of the organization.
  • Clause 5.1 – The Quality Policy and Quality Objectives must be compatible with the Strategic Direction of the organization.
  • Clause 5.2 – The Quality Policy must support the Strategic Direction of the organization.
  • Clause 9.3 – Management Review Process must ensure the suitability, adequacy effectiveness and alignment of the Quality Management System with the Strategic Direction of the organization.

Strategic Direction as we believe is the organization vision of where the organization wants to be in the future and the development of an overall Strategic Plan is affected by various internal and external factors. Refer to the clause 4.0 of ISO 9001:2015 Context of the Organization which states that the organization shall determine external and internal issues relevant to its purpose and its strategic direction and those affect its ability to achieve the intended results of its Quality Management System. ISO 9001:2015 further elaborates in Notes (1 – 3) of the clause 4.1 that issues can include positive and negative factors or conditions for consideration – Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social and international, national or regional economic environments. Understanding of the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization.

The strategic planning process is a continual process and if we look at the traditional strategic planning process, it very much resembles with the Plan-Do-Check-Act (PDCA) Cycle of which ISO 9001:2015 is a big promoter to apply this cycle to all organizational processes and the Quality Management System as a whole to implement plans to achieve objectives including strategic.  In addition, various functions within the organization having their own strategies can closely be aligned and integrated within the Context of the Organization which is basically overall strategic plan of the organization highlighting all internal and external factors with their resulting impact on the organization along with the approaches to managing risk(s) at the functional and company-wide levels for the achievement of larger mission of the organization.

Having said that, we can say that framework provided by ISO 9001:2015 can be used by the organizations for strategic planning but when the management rejects QMS as strategic planning model and make intuitive decisions then ISO 9001:2015 cannot address or contribute in the overall strategic planning process.

About the Author

Kashif Mumtaz is serving as QA Manager at Omrania in Riyadh, Saudi Arabia and has more than 17 years’ experience in quality assurance & management systems. He is Chartered Quality Professional (CQP) and holds a master’s degree in Quality Management from UK

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How Can Total Quality Management Improve Organizational Effectiveness? - ISOUpdate.com

Today’s organizational environment is filled with constant and rapid change; technology changes with the blink of an eye, competition is increasing, and customers are demanding greater quality and lower costs. To adapt to these changes and still meet their goals, organizations need to be efficient. Efficiency requires an overall approach and cannot be reached by focusing on a particular process, or on a specific area within an organization. But, how can total quality management improve an organization’s effectiveness?

What is Total Quality Management?

Total Quality Management: a business philosophy which focuses on customer satisfaction and relies on an understanding that a strong focus on employees is necessary to achieve efficiency within an organization.

Total Quality Management is oriented to create quality awareness across an organization, and it considers both the organization’s processes and the employees as integral aspect in an organization quality improvement capacity.



Total Quality Management promotes commitment, participation, cooperation and continuous improvement within organizations. Because every employee and every process is important in achieving organizational effectiveness, Total Quality Management can assist in this matter by empowering all employees and making everyone responsible for meeting internal and external customers expectation.

Every employee, regardless of their role within the organization, can improve quality within their processes.

Total Quality Management can also help organizations achieve effectiveness is by encouraging a dynamic approach to quality improvement. Variations can occur within processes that can negatively alter the desired results.

These variations need to be detected, communicated and addressed promptly to prevent deviations from proposed goals. Therefore Total Quality Management, by encouraging teamwork and empowering employees to make decisions, can facilitate good communication and an effective response within and across different functional units within an organization.

Organizational effectiveness is reached by achieving common goals. Since internal and external customers expectations drive organization’s processes, by meeting and exceeding these expectations, organizations can reach their goals and also obtain a competitive advantage.

Many organizations can utilize Total Quality Management to increase their efficiency. Total Quality Management has been implemented in manufacturing, education, government administration and services. Any type of organization can benefit from Total Quality Management and use it to adapt to constant changes, improve their effectiveness and thus increase competitiveness.



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Key Performance Indicators for an ISO 14001 Management System

Why Do You Need Performance Indicators for Your Environmental Management System?

Performance Indicators are the measures that you put in place on your processes and business that provide you with the information that you need to see how well your ISO 14001 management system is performing. Each process could have a whole series of measures that will let you know how well it is performing financially, with regards to quality, H&S compliance and of course environmentally. After all, as the saying goes, “what gets measured gets done.”

Each process could potentially have many different measures that are important to it. Many of these measures will be monitored, and action taken at a local level. While others that are more important could be elevated to being Key Performance Indicators (KPIs) for the business. This ensures that those measures that are vital to your business or have a potential risk associated to them are highlighted.



What Performance Indicators Do You Need for Your ISO 14001 Management System?

Many businesses are used to implementing performance measures as part of their quality management system, however they are equally as important as part of your ISO 14001 management system. Your measures need to be selected with great care for each process within your business and only those that are truly important should be elevated as KPIs for management monitoring.

Each business is of course different as are each of your processes. Therefore, your indicators and measures will always be different to those employed by other businesses. However, some typical measures are detailed below to give you some idea as to what you should implement within your own business:

Use of Natural Resources:

  • Water, electricity, and gas usage by the business
  • The amount of paper used within the business

Discharges to Air, Land, and Water:

  • Pollutant parts per million measures
  • Weight to landfill

Incidents and Potential Incidents:

  • Number of actual and potential incidents
  • Time lost due to incidents

Proactive Measures:

  • Risk reduction measures implemented
  • Environmental audit scores

Learn about ISO 45001 and how Performance Indicators have changed since OHSAS 18001



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Quality

Have you ever stood staring at a range of products in a supermarket trying to make up your mind which one to buy?  They all look quite similar, but one stands out and you buy it.  Why?  It’s got a sign on the shelf and a logo on the product to tell you that it’s won an award for quality.

So you’ve just based your purchase on Quality – Your customers are making the same decision every day!

Quality is more than just finished product, it’s the processes, systems and people that are behind the product.   Quality is everybody’s responsibility.



Quality is the pursuit of excellence, striving to be the best we can and getting ahead of our competitors.  It is meeting the needs and expectations of all stakeholders – our customers, our suppliers, our staff and the community at large.

How can we ensure that we are exploiting all avenues to be the very best?  A recognized standard such as ISO 9001 certification promotes the use of quality tools in business.   The ASQ (American society for quality) estimates that for every €1 spent on a quality management system, such as ISO 9001, returns €6 in revenue, €16 in cost reduction and €3 in profit – that’s €25 for every €1 spent!

93% of organisations agree that the implementation of a quality management system such as ISO9001 was a significant driver of success and most would agree that without it they could not justify their pricing to customers.

If you are looking at ways to improve your ROI by improving your quality then consider ISO certification.   Using an expert to help you implement a quality management system will ensure ISO 9001:2015 accreditation which will in turn help you make significant improvements and lead to significant growth.

 

This post has been a guest posting from Joann O’Brian over at our friends at CG Business Consulting Ireland .



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Improving your Quality Management System is simpler than you think. By learning about ways to improve, you are already well on your way to achieving success with your organization or auditor training. Follow these 10 simple suggestions and you will see changes.

10 Simple Ways to Improve your Quality Management System

1. Commit to improvement

For any QMS to improve, it is essential that everyone is committed to seeking problems, evaluating efficiency and effectiveness of processes and implementing better and improved ideas. Management should be the first to make this commitment and if management “walks the talk” then everyone will follow.

2. Analyse and assess current QMS

Organizations need to take a closer look at their current practices in order to identify any gaps between what is being done and what should be done. This can be achieved by interviewing workers in critical control points, reviewing procedures and records and observing how processes are occurring. Any steps that are not adding value to the process, the system or the organization must be identified, removed or improved.

3. Include everyone in training programs

A QMS is not the responsibility of one person or one department. Everyone must be involved in improving the quality of products, services and processes.

Organizations should establish a training program for new employees and existing ones.  These programs should promote knowledge, produce skills and capacities and reduce resistance when implementing new ideas for improvement.

4. Define clear goals and objectives

QMS should aim at achieving specific goals. If a clear path is not drawn, there’s a risk that people will be working real hard but in different directions. Time should be spent in assuring everyone knows these goals, how they’ll be achieved, how they’re measured and periodically they should be informed of where the organization is standing in relation to these goals.

5. Use the correct key performance indicators

Organizations need to carefully select and review their KPI’s (Key Performance Indicators). KPI’s let an organization know how efficient and effective processes are, and indicate where possible problems could be. If they are not giving a real overall picture of where the organization is at regarding quality, then another look should be taken to change or improve what and how performance is being measured.

6. Listen to the suggestion

Create a system that will promote workers and customers to share improvement ideas. Many great improvement ideas come directly from the people processing a product or the people that actually use it.

7. Give credit

Giving credit to those who deserve it encourage participation throughout the organization and motivates workers by recognizing their work and their ideas. Compensation or recognition should not necessarily be monetary, a simple public recognition in working meetings to can have great effects in lifting workers morale.

8. Make the system simple

A QMS that is extremely complex and overloaded with documents is not necessarily the best one. If documents and procedures are long and complicated, it is very likely that people will never use them.

Evaluate the system and make sure that it makes sense and that it’s as simple as possible.

9. Create quality groups

Some organizations face difficulty with workers from different departments or areas that are reluctant with sharing information. By bringing together people from different areas to evaluate processes and recommend improvements, an open and more effective communication can be achieved between areas that operationally seem to be apart.

10. Have a quality attitude

In order to reach the goals that have been set, organizations need to identify and detect problems and weaknesses but they must focus on improvements. If managers are constantly focusing on failures and defects and not on how to remove or improve them, the right attitude and mindset for quality will never be achieved.

Learn how to prepare your company for the ISO Implementation Process.

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ISO 9001:2015 represents a major change to the 9001:2008 version. One of these changes regards the Quality Management Systems (QMS) documentation.

The 2008 version of the standard, uses two separate terms “documents” and “records” to identify its documentation, whereas, in the recently published Draft International Standard of the new revision, both these terms are combined as “documented information”.



For those familiar with the 2008 version, it can be said that where it refers to “documented procedures” in the new revision it is expressed as a requirement to maintain documented information. Also, where the 2008 version refers to as “records” it is now expressed as a requirement to retain documented information. Below, there’s a list of the documented information that the new standard requires to be maintained and retained.

Documented information that is required to be maintained with ISO 9001:2015

  • The scope of the QMS, including the products and services it covers and the justification of those requirements that the QMS will not be able to apply.
  • Information that supports the operations of processes.
  • The quality policy.
  • Information that defines characteristics of products and services, activities to be performed, and the results to be achieved.

Documented information that is required to be retained with ISO 9001:2015

  • Information necessary to have confidence that processes are being performed as planned and conform to requirements.
  • Information on the quality objectives.
  • Information as evidence of fitness for purpose of monitoring and measurement resources.
  • Information as evidence of competence.
  • Information describing the results of the review of requirements related to products and services.
  • Information resulting from the design and development process.
  • Information on review of design and development changes.
  • Information of the results of the evaluation, monitoring of performance and re-evaluation of the external providers.
  • Information necessary to maintain traceability when required.
  • Information describing the results of the review of changes, personnel authorizing the change, and any necessary actions
  • Information providing traceability to the person(s) authorizing release of products and services for delivery to the customer.
  • Information on actions taken on nonconforming process outputs, products and services.
  • Results of monitoring and measurement activities.
  • Information as evidence of the implementation of the audit programme and the audit results
  • Information as evidence of the results of management reviews.
  • Information as evidence of the nature of the nonconformities, actions taken, and the results of any corrective action.

As it can be seen from the above list, in the new version of the standard, it will not be required to create and maintain a Quality Manual, which has been around since the creation of ISO 9001 in 1987.



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ISO 20000

To meet and improve customer satisfaction, it’s essential to monitor and measure performance by using different indicators. Performance indicators for ISO 9001:2015 are tools used for determining how and to what degree an organization is meeting guidelines, policies, objectives, requirements and targets set in their ISO 9001 QMS.

Note: These performance indicators are set by the organization and they vary from one organization to another. The team at The Registrar Company (TRC) created this list as a tool for organizations to learn from and decide which performance indicators are most suitable to the nature of their industry sector and their objectives.

What should be considered is that these indicators must be measurable and achievable. They must refer to the system’s critical processes, they must accurately represent the target to be measured, and they should be quantifiable, cost-effective, reliable and allow management to review the information in real time.

Cost Indicators

Cost indicators are performance indicators that evaluate the activities that consume economic resources in different processes. For example, the spend on energy consumption or other overhead costs, the percentage return on investments, or the percentage costs of carrying out corrections for errors are all cost indicators. 

Time Indicators

Time performance indicators measure the time consumed by an activity or process and consider the time from the beginning to the end of the selected process or activity.

For example:

  • Percentage number of products or services delivered on time.
  • Percentage number of products or services delivered late.

Productivity Indicators

Productivity performance indicators measure the efficiency of resources in the operation. For example, the percentage of downtown a particular machine or process experiences.

Quality Indicators

Quality performance indicators measure the effectiveness of the development of activities or processes, delivering results based on the number of errors, or the number of perfect and flawless deliveries.

For example:

  • Percentage number of products or services needing rework.
  • Percentage of customers ‘very satisfied’.

Summary

Remember, performance indicators are set by the organization and they vary from one organization to another, and while these indicators may vary, they should serve as a tool for improving the quality of decisions regarding the processes, and the ISO 9001 QMS itself.

Looking to expand your knowledge base? The Registrar Company, TRC, has designed over 500 courses and trained over 10,000 individuals since 1990. Our approach is based on current adult learning principles and uses proven, highly interactive participatory sessions and practical techniques that offer real behavioural change that can be implemented and applied immediately in the workplace. Learn more about training with TRC.


Learn about Performance Indicators in ISO 14001

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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.

TRC 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.