General

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The 2015 revision of ISO 9001 has removed the requirement of a Quality Manual, something that has been needed historically if your organization has wanted to achieve and maintain certification. This requirement appears no more! Woohoo! Shred those Quality Manuals and never look back!

Right? If the standard doesn’t say we need it, then we don’t need it. One less document to maintain. Finally, life as an ISO 9001 certified company is getting easier!

Let’s hold on a second…

A common practice to create and maintain a Quality Manual for the ISO 9001:2008 standard (and earlier versions) was to create an exact copy of the verbiage in the standard, change all of the “shall” words with “will” or similar term that fits, change all references to “the organization” to the name of your company, slap a few logos on it, give it a control number and publish it.

And then…nothing. Let it sit for years until the new standard is published and then repeat this copy-paste process all over again. That practice, although common, doesn’t help anyone.



It’s Time to Re-Think the Manual

Now is the perfect time to rethink the Quality Manual. Take a step back and really consider what a manual should do for your company – provide the framework for your entire management system. Here are a few ideas to get you started.

  1. Start thinking about the manual as something you can hand to a new employee that will help give them an introduction and overview as to how you do business – in plain English with the terms and acronyms that are used in your company – not in “standard speak”. Build this manual within the framework of the standard but in a way where the general employee won’t know it.
  2. Rename the Quality Manual. I don’t know how many times I have heard a Quality Manager complain about their organization’s culture viewing the management system as something separate from how business is done, as in, “the quality stuff is for the auditor”. Start dissolving that problem today – change the name to Business Manual. Because that is what it is – a document that describes how you do business. And we all know, well executed business processes result in top notch quality.
  3. Keep that thing updated! Considering many Quality Manuals were nearly a carbon copy of the actual standard language it was understandable that Quality Manual revisions were uncommon as well. In order to make this Business Manual an ally, it needs to be current.


Keeping your Business Manual Current

Even if your ISO Certified Company has a thorough and accurate Manual for the previous year, it is still very important to keep this document up to date. Here are some things to watch out for that may trigger the need for an update.

  1. Significant changes to business structure or business processes. Keep in tune to changing reporting structures, new processes (manufacturing or service), acquisitions, partnerships, etc.
  2. Rules and Regulations. International rules and regulations are fluid, and it is vital to integrate such changes into business operations. Any change in an Industrial Standard, big or small, could necessitate a change for your employees, external providers, managers, or customers.
  3. Technology. Technology changes very fast and new systems are installed yearly, monthly, weekly, and sometimes even daily. Technology changes can come in various forms: hardware, software, machines, equipment, etc.
  4. Safety. Changes to the physical building structure, layout and environment happen as time goes on and ensuring the manual stays up to date with these changes will assist with the awareness of the safety rules and conditions to ensure a safe work environment.

So, there are some things to think about. Even though the Quality Manual is not mandatory, it is still very much necessary. Use this opportunity to increase the role of the Manual within your business management system.


Christopher Spranger is the owner and CEO of Spranger Business Solutions; a management consulting firm that helps people run more efficient businesses across the United States. They have a team of Quality Management experts that assist companies with internal audits and in achieving Quality Management System Certification.

Find out more by clicking here.

Interested in having Spranger Business Solution do your internal audits click here.

This article was originally posted on Spranger Business Solutions website and is published here with permission.



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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. Being complex systems, organisations require all employees and all every process to function correctly. When employees have a strong sense of belonging with an organization, pride in their work and where participation and team work is promoted high levels of efficiency are reached.

Total Quality Management is 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 costumer’s expectation. Every employee, regardless of its 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 team work 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 customer’s 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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1. Research the Standards
Implementing an ISO management system is not something that is decided overnight. Organizations need to know what they are implementing, thus, there needs to be an understanding of the standard and what it’s expected to be gained with its implementation. Everyone in the organization needs to have basic knowledge of the standard being implemented, the importance of implementing it, and how their actions impacts the system. It is also recommended that a group of employees understand the standard thoroughly. Top management, even though they don’t necessarily need to be experts, they need to understand the importance of allocating resources for the implementation and maintenance of the desired ISO management system. You can learn more about specific standards here: http://isoupdate.com/standards/



2. Create a Timeframe
After understanding the requirements of the standard, organizations need to plan how these will be met. The organization needs to analyse where they are, where they want to be and which are the available resources. With this information a plan must be traced with details of the specific actions, investments and the resources needed. Another important point in the planning process is establishing reasonable timelines; implementing a management system based on any ISO standard.

3. Gain Employee and Management Support
Organizations need to ensure that employees have the right competencies and technical knowledge for implementing the specific ISO management system. Training needs to be carefully planned and executed. Human capital is one of the most important resources an organization has for successfully implementing and certifying an ISO management system. Along with training employees, ensuring participation in the implementation and certification process is essential. Organizations can invest capital in infrastructure and technology, but if people do not participate in the improvement of processes, or worst, if people reject it, all the money and time invested will be lost. People need to be included from day one in the implementation and certification process of any ISO management system.

4. Implement the Standard
The next step it to map and understanding your organizations internal processes. Once the processes are mapped the standard you are utilizing can be implemented into these processes. You may wish to engage a consultant to assist in this process, or if you have the recourses available it can be done internally.

5. Choose a Registration Company
After an organization has advanced in the implementation process, it needs to choose the right Registration Company. The chosen Registrar will accompany the organization through the entire certification process. It is essential that the certification body has knowledge and experience in the ISO standard that has been implemented and in the type of industry/field of the organization seeking certification. Look for a Registration company who is certified themselves. You can find a range of Registration companies here: http://isoupdate.com/registrar-listing/



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ISO Certification

Organizations go through a great deal of work, time and effort to implement management systems such as ISO 9001, ISO 14001, and many others. These management systems are implemented and certified for many reasons, and one of these reasons is recognition. Organizations want their clients, customers, consumers and other interested parties to recognize that their management systems follow specific standards and comply with certain requirements.



When a certification body is accredited, it means that an accreditation body has verified that it follows a series of standards and requirements that guarantee that their service is impartial, consistent, reliable and recognized internationally. These strict and regular checks that certification bodies undergo provide trust and credibility to the certification. Thus, accredited certification can provide confidence to clients, customers, regulators and other interested parties that the organization is complying with the specific standard, code of conduct or requirement.

Additional to having a certification recognized by all the interested parties of an organization, there are other benefits of accredited certification. These are:

Ensures competency
Accreditation can guarantee that the certification body is competent in assessing specific standards. Organizations want to make sure that auditors are knowledgeable, experienced and that can provide an impartial assessment in the management system being certified.

Provides legitimacy

This legitimacy is based on the participation and recognition of public authorities in the structure of the accreditation body, which follow strict international regulations.

Ensures equality of criteria

The regular checks of the certification body can guarantee that over the years the organization’s management system will be assessed by the same criteria. This equality of criteria will assist in the maturity of the management system, by supporting its continuous improvement, innovation and internal prestige. It can also support organizations in focusing on the achievement of proposed goals.

Reduces risks

Organizations rely on the outcome of their certification body’s assessment to make important decisions regarding their management system. Thus, it reduces the probability of making bad decisions regarding the management system and misallocating resources.
In general, with accredited certification it is possible to ensure legal compliance, guarantee objective and impartial assessments, ensure confidence and credibility with interested parties, focus on activities that add value, focus on what is important to the interests of the organization, and improve the assessment of the management system that will consequently support decision making.

These are the main reasons for choosing accredited certification, however, there could be others. There could be the case that a client or a regulatory body requires an organization to have an accredited certification. Thus, before choosing, organizations need to consider the above benefits and any other that could apply to their particular situation and their specific goals.

There are many accredited Registrars’ listed on the ISO Update Registrar Directory. Fine one here: http://isoupdate.com/registrar-listing/



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Quality Management System Standards refers to an established policy framework which provides guidance on how organizations should manage their key processes. The International Organization for Standardization (ISO) has diversified standards for quality management systems, each of which focuses on a particular issue affecting businesses globally. Organizations who adhere to these standards can ensure their products and services consistently meet customer requirement, and improve in quality. Therefore, adhering to these guidelines and obtaining ISO Certification is vital for measuring business proficiency, increasing profitability and marketing potential.



Elements of a Quality Management System

Quality Management System Standards are tailored to suit an organization’s unique needs, however there are some elements all management systems have in common:

  • A framework of Management Responsibility
  • Product Realization
  • Resource Management
  • Statistical Analytics
  • Purchasing Guidelines
  • Inspection and Testing Standards
  • Quality Records
  • Training Protocols
  • Quality Audits

Why businesses implement quality management system standards:
ISO standards are currently applied in many organizations from a wide range of industries including; manufacturing, aerospace, automotive and pharmaceuticals. For many organizations, the choice to implement ISO Standards is twofold; they are seeking improved quality, profitability and efficiency but it is often, a requirement from their customers or consumers. Particularly internationally-focused businesses with regulatory bodies or for suppliers of quality-sensitive products products.
Benefits of Quality Management System Standards
Even when it is not a specific requirement from customers, there are still many benefits in implementing Quality Management System standards. Implementing a quality management system helps organizations achieve the following benefits;

  • Products, systems, and processes improvements
  • Increased customer service and satisfaction
  • A greater competitive advantage
  • Transparency in accountability
  • Increase market share potential
  • New avenues for marketing
  • Streamlined efficiency
  • Growth Management
  • Reduction in mistakes which improve margins
  • Greater consistency and time management
  • Development of training opportunities


Establishing a Quality Management System

Establishing a Quality Management System is a large undertaking. Written quality procedures which outline, what, who, where, when and how changes need to be implemented will be created. Working with a Quality Management Consultant is a great way to streamline the process. You can find a list of ISO Certified and Quality Management Consultants on the Consultant Listings page of ISO Update http://isoupdate.com/consultant-listing



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One of the key requirements of ISO 9001:2015 is to ensure you have a process based management system. Globally companies are looking for new strategies that can give them a competitive advantage and adopting this approach is one of the most effective ways.



One of the great benefits offered by a process based management system is it can be implemented in a gradual way. It is possible to start with certain processes or projects which serve as a starting point to extend a quality management system to the entire organization gradually.

1. Identify and sequence processes
Firstly, identify all the different types of processes which occur within the organization. These processes may be strategic, operational or support based. Once the processes are identified the impact they have on the organizations needs to be determined so the processes with the most significant impact or organizational value can be prioritized.

The next step is to document the sequence of these processes in order to observe the input and output elements of each process and the interaction between them. The best way to visualize all this information is through a graphical representation, a process map.

2. Describe and document the processes
Describe the different processes by documenting the activities which make up the process, and the key characteristics of the process. By understanding the process clearly its management and future improvement can be facilitated. Process documentation can be presented in a written or graphical way, through flowcharts which outline the existing relationships. Process tabs can also be used where information necessary for the control of the processes is detailed.

3. Establish measures
Establish indicators and controls to determine how affective processes are. Monitor the indicators throughout the process and document the results

4. Improve the processes
Analyses the results achieved along with the process indicators to understand whether the process has in fact achieved its purposes and if it is possible to improve that process.



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Choosing to apply for ISO9001:2015 Certification can be a daunting experience – as the third-party audit date approaches you are wondering why you have applied for it, will it bring a positive change to your company and is it really a necessary step for your business? But ask anyone who has achieved and embraced this certification and it is clear the benefits far outweigh the labour involved in obtaining and maintaining the standard. In fact, like a positive lifestyle change, once in place it feels a natural process in the everyday life of your organization. So, all you need to do is; choose a starting point, set a plan and begin the changes one step at a time.

ISO 9001:2015 is one of the world’s most sought after and recognised standards. Its implementation will instil a culture of quality and a sense of responsibility amongst your staff. It will pin-point focus and direction on the company’s quality goals and objectives. Just as the benefits begin to pile up when you implement a lifestyle change, the benefit of implementing ISO 9001:20015 will be vast.

Your customers benefit by knowing the products they are buying or the services they receive are of the highest standard, they know you have listened to what they want and reacted. Customers don’t necessarily need to know your Quality objectives, your KPI measurements and all the internal workings that bring first class quality but what they do need to get from your company is confidence that their needs are being met and that that you go over and beyond to meet their expectations. This establishes a bond of loyalty to your company based on the trust of a solid performing product or service.



Your company benefits by incorporating quality into everything they do. Employees begin to think about quality, they hold each other accountable and by setting measurable objectives they can work together to produce the best quality possible and track their progress. It becomes a team effort and with top management involved at every level, the whole company is striving to meet the same goals. Your business becomes more profitable with less mistakes/waste and this can be re-invested for future improvements. Orders increase as customers approval of your high-quality products creates repeat business, new orders and fresh markets for your business to move into. Being on the pulse of what is required of your company and being able to produce it efficiently will set you apart from the other companies who chose not to embrace quality.

Globally you become accepted into the ISO9001:2015 approved list of companies, a brand as such, that defines the attention to Quality your company places on its products and services – not only a reflection on what you produce but a statement that you chose to supply your company with first class suppliers too. It places you in a league of companies that care about what their customers want, companies that want to offer the best experiences and overall an acceptance and confidence that you know investing in Quality reaps rewards for you and you customers.

If you are ready to be ISO 9001:2015 certified you can find a Registrar on the Registrar listings page of ISO Update http://isoupdate.com/registrar-listing

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If your organization implements multiple ISO Standards and Quality Systems, automating and integrating these systems with an Integrated Management System is critical for maximizing business efficacy and eliminating workload duplication.

When an organization does not utilize an Integrated Management System the following issues may arise:

  • No simple and automated system to raise a finding which results in:
    • Recurrence of non-conformities
    • Products and services losing quality and credibility to stakeholders
    • Management systems losing all their preventive and corrective efficacy
  • Delays in the management and consolidation of indicators leading to:
    • A loss in productivity
    • A loss of credibility of information reporting systems
    • Erroneous decision making through incorrect data
  • Workload duplication causing:
    • Management Coordinators spends too much time managing the system.
    • A reduction in time-oriented improvement
    • Low motivation due to excessively bureaucratic work
  • Limited communication of system changes which leads to:
    • A lack of control, disorganization, lack of communication
    • Non-conformity in the system produced by documentary errors.
    • Low credibility of our management system against employees, management, customers, suppliers and other stakeholders.
  • Little control of the information generated in the different locations resulting in:
    • Decrease in control by the manager of the management system.
    • Inability to integrate information
  • Excessive time to apply surveys to customers
  • Revenue loss due to reoccurrence of errors
  • Lack of exhaustive analysis of the records and information generated by the system

    Automating and integrating ISO management systems have extensive business benefits including:

    • Simplifies document management which facilitates the deletion of redundant information and prevents duplication of documents and tasks.
    • Facilitates unification of the methods defined by the organization both for internal and external communication,
    • Unification of Training Plan methodologies
    • Streamlines processes for assessments and certification
    • Strengthens the foundations of continuous improvement
    • Reduction of the time spent in conducting audits

    To find a consultant who can assist your business with the integration of multiple standards into an Integrated Management System visit the Consultants Listings page on ISO Update http://isoupdate.com/consultant-listing

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In many organizations (manufacturing or services) the processes present variability, this means they are not completely stable. The ISO 10017 standard seeks to help organizations in the identification of statistical techniques which can be useful in the development, implementation, maintenance and improvement of a quality management system, in compliance with the ISO 9001:2015 standard requirements.

Variability can be confirmed in those quantifiable characteristics of the products and processes, and can be observed at the exit of various stages in the total life cycle of the products.

The main benefit of the application of statistical techniques is they facilitate the measurement, description, analysis and interpretation of variability in the processes, even with a relatively limited amount of data. In fact, statistical analysis of this data can provide a greater understanding of the nature, extent, and causes of variability. This contributes to solve and even prevent problems that could result from such variability.

This is how statistical techniques become tools for the proper handling and use of data available for decision-making, which undoubtedly contributes to the continuous improvement of the quality of products and processes to achieve Customer Satisfaction. These techniques can be applied in various activities, such as market research, design, development, production, verification, installation and service.



ISO 10017: Guidance on statistical techniques for the ISO 9001 standard

The ISO 10017 standard is a technical report that aims to guide and assist any organization in the consideration and selection of statistical techniques appropriate to their needs. It should be noted that the criteria for determining the need for statistical techniques, and the appropriateness of the techniques selected, is a decision subject to each company. The aforementioned techniques can be useful in the development, implementation, maintenance and improvement of a quality management system in compliance with the ISO 9001 standard.

To this end, it is essential that the requirements of the ISO 9001 standard which involve the use of quantitative data are examined, and in this way, the statistical techniques that are useful in applying them to these data are identified and described.

The ISO 10017 standard clarifies that its content of statistical techniques is not complete or exhaustive, and does not exclude the use of any other technique which may be considered beneficial for the organization. It does not try to establish which techniques should be used, nor does it advise on how to implement them. Even this standard specifies that statistical techniques can be applied from qualitative data as long as they can be transformed into quantitative data.

Major statistical techniques that can be used by organizations

  • Descriptive statistics
  • Design of experiments
  • Hypothesis test
  • Measurement analysis
  • Process capacity analysis;
  • Regression analysis
  • Reliability analysis
  • Sampling
  • Simulation
  • Statistical process Control charts (CEP);
  • Fixation of statistical tolerances;
  • Time-series analysis.

From this group of techniques, descriptive techniques (including graphical methods) are an important aspect of many of these techniques.

Application of statistical techniques in accordance with ISO 9001:2015 standard

The chapters in which statistical techniques are required to be applied in accordance with ISO 9001:2015 are as follows:

Chapter 6: Planning, in number 6.1. Actions to address risks and opportunities

Chapter 7: Support, in the numeral 7.1.5. Monitoring and measuring resources

Chapter 9: Performance evaluation, in numeral 9.1. Monitoring, measurement, analysis and evaluation

Definitively, the use and application of statistical techniques is essential for organizations, because decision-making must be based on objective data.

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AS9100 applies to large aerospace suppliers only 

Although only intended to be used by aerospace companies, AS9100 is not meant for only the largest of organizations. Requirements have been determined in a descriptive way, but not by prescriptive means. The standard contains what must be done (requirements), but does not dictate how they must be accomplished by the organization (processes). Therefore, the requirements of AS9100 can be implemented in a way that works best for each individual organization, be they large or small. Using this particular method, the organization is provided with the best possible practices of what the QMS requires to be effective, regardless of the size of the aerospace organization.