General

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PAS 99 Integrating Common Management Systems - ISOUpdate.com

Management systems are designed to add value to the organization by saving resources, time, and money. PAS 99, developed according to the ISO standards for writing management system standards, is a single framework developed by the British Standards Institution (BSI) which assists in proficient management of all ISO certified systems. PAS 99 was developed in response to the need for a reference document for the implementation of a real and effective integrated management system. Prior to the publication of PAS 99, there was confusion in the market about what should be considered an integrated management system as organizations were only able to merge the reference documentation (manuals, procedures, etc). This approach was far from a real integrated management system and insufficient for many organizations.

PAS 99:2006 was created to enable organizations to integrate common management system requirements into one framework. PAS 99:2012 is based upon the structure of ISO Guide 83, and now sets a common structure to be followed by all management system standards moving forward.

PAS 99 is designed to be used by organizations that have a management system standard or are implementing various management system standards. It applies to organizations of all sizes and industries.

To integrate different management systems, some elements of the standards were restructured to enable easier integration of various management systems. The high-level structure as adopted by many of the new standards has the following elements:

  1.  Scope
  2. Normative Reference
  3. Terms and Definitions
  4. Context of the Organization
  5. Leadership
  6. Planning
  7. Support
  8. Operation
  9. Performance Evaluation
  10. Improvement

Benefits of PAS 99 Integrated Management Systems:

PAS 99 has gained success because it provides a great number of benefits to users.

Some of the benefits of implementing the PAS 99 system include, but are not limited to:

  1. Meet differently implemented standard requirements of your business with a single set of policies and procedures. This helps govern the standards in a more coherent and less cumbersome manner, which results in a more streamlined and smooth approach to meeting the multiple different requirements.
  2. A single audit can cover all the various management systems in place, providing a way to achieve the same end goal but with far fewer resources involved.
  3. Improve the overall efficiency of your business by systematically removing redundancy and duplicate tasks. The duplicate tasks with different targets are now replaced by singular tasks that cover all the different targets of the individual management systems.
  4. Roles and responsibilities are clearly defined with roles now being responsible for all the areas that have an overlap causing the merger of multiple roles into one. This new role will now be responsible for all the common objectives that were previously being looked after by multiple different roles.
  5. Continuously improve multiple management systems by providing an integrated overview of the systems which allows growth to be driven without handling and executing improvements on multiple disparate systems.

Implementation and certification of PAS 99 Integrated Management Systems:

PAS 99 can be tailored for specific business needs and can be built to suit any organization that utilizes multiple certified systems. The developers of your organization’s specific PAS 99 will help your management design and implement a tailored PAS 99 integrated management system. Then, your staff must be trained to ensure effective implementation of PAS 99. The type of training your staff receives can vary and is based on your organization’s specific needs.

In the process of getting PAS 99 certified you can expect the following:

1. Gap analysis

It is during a Gap Analysis that discrepancies between PAS 99 requirements and the organization’s existing integrated management system are assessed before any further formal assessment.

2. Formal Assessment

It is during a Formal Assessment that, firstly, your organization is assessed for preparedness for the assessment of PAS 99 controls and procedures. If there is any gap found, it will be communicated to you for rectification. Then, if the primary requirements are fulfilled, an assessment of the actual implementation of controls and procedures is carried out.

3. Certification and beyond

After the Formal Assessment, a PAS 99 certificate is issued having validity for three years and during this time the client manager of PAS 99’s developers would stay in touch with the user’s organization and would help in any improvements.

Compliance with this specification does not in itself ensure conformity with any other management system standards or specifications. The requirements of each management system standard will still need to be addressed to achieve certification. Organizations that wish to certify compliance with PAS 99, can do so to demonstrate that an effective integrated management system is in place.

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ISO 17021 Requirements for Certification Bodies - Video

ISO 17021 is an International Standard that provides Certification Bodies (CB) with a set of requirements that will enable them to ensure that their management system certification process is carried out in a competent, consistent and impartial manner.

The conformity assessments done by ISO 17021 certified CBs provide value to all types of organizations.
ISO/IEC 17021 Conformity assessment — Requirements for bodies providing audit and certification of management systems, as it is officially called, was prepared by the ISO Committee on conformity assessment (CASCO) in 2006. It was developed to fulfil the need to have an International Standard that could facilitate the recognition of bodies that were performing conformity assessments and the acceptance of their certifications on a national and international basis; making it easier to recognize management system certification in the interests of international trade.

Read the full description of the standard at ISOUpdate.com/standards/iso17021

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Calibration Explained - ISOUpdate.com

When developing a Quality Management System, companies often struggle with the calibration requirement and the expectations that surround it. As a matter of fact, because it is misunderstood, people try to exclude it as fast as you can say calibration. Let us attempt to explain what calibration is, why it is important, what is required by ISO 9001:2015 and some common pitfalls while implementing this requirement. In this article, Factor Quality keeps it as simple and relatable as possible so you can easily understand the concept of Calibration and it’s importance.

“One accurate measurement is worth a thousand expert opinions.”

– Rear Admiral Grace Hopper

Why is Calibration important?

Let us give you 2 great examples of why calibration is such an important activity of your business:

  1. Imagine weighing 10 lbs. of screws and shipping it to a customer. 

When the customer receives it, they weigh the screws at 8 lbs. Expect this customer to complain. When they do, you will have to investigate what happened and resolve the matter promptly. So, what happened? Is your scale accurate? Is their scale accurate? The only thing that you know with certainty is that you have essentially cheated your customer unknowingly. Calibrating your tools and equipment should give you the confidence that your devices are measuring, in this case weighing, the way they are supposed to.

  1. You buy a piece of furniture that is supposed to fit at a specific spot at home.

Only to find out that when you put it together the furniture is too big for the area. It makes you wonder if the dimensions were published correctly or if the pieces of furniture were measured correctly.

Measurements can become more critical when we are talking about items in the medical, automotive & aerospace industries. A piston that is too heavy in racing can slow the car down. A part that does not measure as expected will not work in a satellite and potentially delay a launch. A catheter size change could potentially be damaging to a patient.

Calibration is needed to help us confirm that the measurements we perform are being done with accurate devices.

It is a concept that has been around shortly after civilizations were started. Measurements were needed to calculate weights and lengths for early trades- calibration was done of devices to ensure fair trade. As time went by and technology evolved other measurements and means to ensure accuracy were introduced.

As inventions have evolved over time the demand on accuracy has also increased. When we say “lighter, faster, better!” Somehow these items must be measured to validate the statement. If you think about it, calibration is quietly a key component of any economy and hence it ought to be considered a key component of businesses.

In this image, you will notice that at 1 inch, all rulers are measuring the same. But look at the 2- & 3-inch marks? They are all different. Which is the right measurement?

The quote by Rear Admiral Grace Hopper now makes more sense, right? It is extremely important to have a measuring device that you can rely on.

“One accurate measurement is worth a thousand expert opinions.”

Okay, I get it is important, but what is calibration?

Calibration simply put is ensuring a measurement meets a known standard.

So, let’s dissect this statement.

What do we mean by known standard? A known calibration standard.

What is a known calibration standard? An object with a universally recognized value (for example a centimetre, a millimetre, a kilo, etcetera). Normally these standards are traceable to a national agency. Here in the US, we use the National Institute of Standards and Technology, NIST. Therefore, most organizations in the USA use the term “NIST traceable” when speaking about their measurement devices.

How do you ensure it is meeting that standard?

The idea is that the device used (ruler, calliper, micrometre, scales, etcetera) gives you the certainty that your measurements are accurate. The act of calibrating means that you are verifying the tool to see if it meets those standards. If it does not meet the standard, then you will need to adjust, fix or scrap the item.

Since the introduction of Quality Systems calibration requirements have been present. In ISO 9001:2015, the requirement is called “Measurement Traceability” and calibration is a component of this requirement. It is written in such a manner that your company needs to first decide if “measurement traceability” is a requirement that applies to your company. It is quite possible to have businesses where no measurement devices are used (mostly service organizations). If that is the case, then you can deem the requirement as not applicable to the business.

For those companies that do have measuring devices then the question becomes “What items require calibration?” Normally we like to say that there are two categories:

  1. Equipment used to approve products- usually, this equipment that is carried by Quality personnel in the organization and it is used to determine if the product meets requirements at any point of the manufacturing or realization process. Not just final inspection.
  2. Equipment that is used to monitor a key factor in the process- a means to assure the process is performing as needed. An example of this can be a thermometer for a furnace where the temperature has been determined to be a critical factor in the process.

What are the ISO 9001 Requirements?

The intent of the calibration requirement is that, once you determined you have equipment/devices that need to be calibrated that you need to control it. What does this control mean?

It means that:

  1. you identify these devices, so you are aware of their calibration status;
  2. these devices are handled with care as not to affect their accuracy;
  3. you retain proof that these devices have indeed been calibrated.

Calibration Program Setting & Management

Managing a calibration program can be a costly expense to any business. Not only from the out-of-pocket expense of sending out items to get calibrated at a defined frequency but also the time it takes to manage the program. By the way, ISO 9001:2015 never defines the frequency of calibration for any given device. Some companies do counter the expense of external calibration by doing it themselves. Maintaining a calibration program can be achieved by using simple spreadsheets. We have seen software packages that help you manage, remind you and keep records of calibration activities. There are some calibration houses that have started offering “calibration data” solutions.

The most common pitfalls of calibration programs:

1. Dealing with out of tolerance items.

Many organizations do not deal with “Out of Tolerance” items. Small businesses are often happy to receive their calibration certificates and quickly file them without taking a close look at them. But if you do not read it properly, you might miss that the calibration house notified you about an item being out of tolerance. Luckily, nowadays the calibration companies do not only report it on the certificate, but they also provide a quote for the adjustment/ fix.

If you used an item that was out of tolerance you need to know the effects of the failure. People forget to analyze if the “Out of Tolerance” condition could have affected any of the measurements taken with the device. If the out of tolerance item does not affect your products then, no need to do more. However, if the out of tolerance device affects your product then you might have your hands full trying to figure out what product(s) were measured with the device and how far back in time you need to go to assess product quality. This might even have you recalling the product to ensure it is safe.

2. Proper handling of measurement devices.

For example, what if someone was to bump into equipment X and it falls onto the floor? Do you need to know as soon as it happens? Yes! It is extremely important to verify that the calibrated item still functions as expected. If not, you would have to deal with the consequences. Normally, months later, through a customer return/ complaint or through an Out of Tolerance condition detected at calibration that you will need to investigate. Another frequent calibration pitfall is that items are not identified properly to show their calibration status. Calibration stickers are the easiest way to identify your equipment and tools. The picture here is a snapshot of items you can find in google when searching for “calibration stickers”. You choose which best suits your organization and then start using it on all items that are calibrated. This is an easy way for everyone to know when to get the item calibrated.

3. Calibrated equipment missing proper identification.

Calibration stickers are the easiest way to identify your equipment and tools. The picture here is a snapshot of items you can find in google when searching for “calibration stickers”. You choose which best suits your organization and then start using it on all items that are calibrated. This is an easy way for everyone to know when to get the item calibrated.

Some companies identify measuring devices with stickers that state “For Reference Only”. This is an acceptable practice if the device is not being used to determine if the product/ test is viable or not. The litmus test comes when auditors ask the employee how they use device “X” and what decisions they might make based on the device readings.

Now granted calibration stickers can fall off, especially if the devices are being used in an environment where the stickers are being exposed to chemicals or are prone to wear due to use. So, some companies keep the status of their calibrations using alternate methods. Which is fine, but you must prove that they make sense for your organization.


Need More Help?

We understand that you might still have questions at the end of this blog and might not know where to start when creating your calibration system.

Don’t stress! We get it!

Factor Quality is here to help!

We can come in or meet online and check if your organization is calibrating the right items and controlling them correctly? We have vast experience setting up calibration systems that make sense and are sustainable. One size does not fit all and we are here to help you determine what fits your organization.

Check out our Process Improvements services but remember that we can always add a la carte services to ensure more value for you. We are not about just charging you money, we are here to ensure we make your QMS better. That is our goal.


About the Author

Pierre Servan | CEO, Principal Consultant, Factor Quality Inc.

Factor Quality was founded in 2011, with a vision to help fix quality issues, improve businesses, and help them get certified. Pierre never thought he would encounter such a rewarding industry with clients that appreciated his work, students that appreciated his words, partners that helped him and consultants/colleagues that appreciated him and what he had to say. Today, Factor Quality helps organizations take the next step in their quality journey and service the following certification: ISO 9001, ISO 14001, ISO 13485, ISO 16949, ISO 17025, ISO 45001, AS9100, AS9110 & AS9120. If you are interested in learning more about Factory Quality, visit them at www.factorquality.com/

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Stakeholders in ISO 9001:2015 - Video

ISO Management Systems consider Interested Parties an essential element in the success of any business. Interested parties, also referred to as Stakeholders must be managed in order to obtain and retain their support. Additionally, many ISO Management Standards including; ISO 9001, ISO 14001, and ISO 45001, require organizations to understand and manage the interests and expectations of their Interested Parties as part of the certification process.

Most organizations have many Interested Parties. Determining which are the most relevant is a critical step towards developing a plan to prioritize and manage them.

How can an organization begin this process? Read the full article here!

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Understanding ISO 55001 - ISOUpdate.com

Understanding ISO 55001

ISO 55001 lays down the prerequisites for an asset management system. It gives a framework for the establishment and regulation of objectives, policies, processes, governances, and facilities involved in any organization’s pursuit of their goals and objectives. The standard highlights the necessity of having a management system.

ISO 55001 does not include or specify any financial, technical, or accounting needs for managing various types of assets.

ISO 55001 uses an organized and effective system for driving ongoing improvement and creation of value.

This is possible by effectively managing all assets and the costs, risks, and performances related to these assets.

ISO 55001 is complemented by the two other additions in this category namely ISO 55002 and 55000. They provide the principles, overviews, application, guidance and terminology.

Read the full article on ISO 55001

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Easily Overlooked ISO 9001 Tricks - Video ISOUpdate.com

Ready to implement ISO 9001 in your organization? Here are some ISO 9001 tricks to the process to be aware of and prepare for.

Trick: Only Hire a Consultant if…

If an organization’s staff does not have the time or skills to develop the QMS by themselves, a good consultant will make possible a speedy transfer of knowledge and skills. If the staff does have the time, there are enough published materials available from the web that will help staff obtain the necessary skills to develop the QMS.

Certification Bodies also often offer in-class and online training that are specifically designed to fit your industry needs. If you cannot find a course, seek CB’s that offer to tailor courses to your needs, or offer on-site training and will bring their training to your office, making the process easier for you and your staff.

Find a Training Program

Trick: Define SMART Objectives

Many organizations set quality objectives that are impossible to meet. Objectives need to be specific and relevant to the process or task to which they are being applied. They also need to be measurable and achievable within the resources that can be made available in a realistic and timely manner.

It’s helpful to have a start and completion date.

Read the full article here

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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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What is ISO 8601 Proper Notation of Dates and Times - ISOUpdate.com

As we welcome in the new year, if you are like us, you might struggle to remember the new date, let alone the order it should appear in when you denote it. The transition from 2018 to 2019 can be a headache, but did you know that ISO has a standard for that. Yes, even the date has a proper format, and it’s laid out in ISO 8601, the Date and Time Format Standard. ISO 8601 presents dates and times in a standardized format thereby removing confusion in international communication.

What is ISO 8601?

ISO 8601 is the international standard for recording and denoting dates and times using numbers to avoid confusion from different interpretation.

What is the ISO 8601 Date Format?

The internationally agreed way to represent the date is YYYY-MM-DD.

The internationally agreed way to represent time is hh:mm:ss.ffffff

When denoting time alongside the date, the Standard format is YYYY-MM-DDThh:mm:ss.ffffff +|-hh:mm

YYYY = four-digit year
MM = two-digit month
DD = two-digit day of the month
T = a set character indicating the start of the time element
hh = two digits of an hour (00 through 23)
mm = two digits of a minute
ss = two digits of a second
mmm = three digits of a millisecond (000 through 999)
+|- = time zone designator (Z or +hh:mm or -hh:mm), the + or – values indicate how far ahead or behind a time zone is from the UTC (Coordinated Universal Time) zone.

US time zone values are as follows:

EDT = -4:00
EST/CDT = -5:00
CST/MDT = -6:00
MST/PDT = -7:00
PST = -8:00

The History of ISO 8601

The first edition of the ISO 8601 standard was published as ISO 8601:1988 in 1988. It unified and replaced several older ISO standards on various aspects of date and time notation: ISO 2014, ISO 2015, ISO 2711, ISO 3307, and ISO 4031. It has been superseded by a second edition ISO 8601:2000 in 2000 and by the current third edition ISO 8601:2004 published on 2004-12-01. ISO 8601 was prepared by, and is under the direct responsibility of, ISO Technical Committee TC 154.

ISO 2014, though superseded, is the standard that originally introduced the all-numeric date notation in most-to-least-significant order [YYYY]-[MM]-[DD]. The ISO week numbering system was introduced in ISO 2015, and the identification of days by ordinal dates was originally defined in ISO 2711.

ISO 8601 is currently in the process of being updated and split into two parts anticipated to be released in March 2019. – Source


Read more about ISO Standards

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Understanding ISO 21041 and Unit Pricing - ISOUpdate.com

With ISO 21041, consumers can now make better and easier buying decisions that allow them to compare the values of related products and decide accordingly which one to spend their valuable dollars on. Following ISO 21041 and its protocol is not only beneficial for the consumers but also for the retailers through unit pricing.

Did you know: ISO 21041 is the result of an international effort that was led by a team of experts from Australia?

What is ISO 21041?

ISO 21041:2018, namely, Guidance on unit pricing, sets down several prerequisites that will allow consumers to compare the prices of similar items to make more informed buying choices.

ISO 21041 guides store owners and retailers on an effective way to display unit pricing on all the products in their stores, regardless of whether they are on shelves or in packages, as well as in the advertisements for these products and demonstrates how important it is to educate and provide clarity to consumers to maintain transparency.

What is Unit Pricing?

Unit Pricing, also known as comparative pricing, is the way of pricing products or services such that the price displayed shows the price of one standard unit of measure. This way, consumers can easily determine which product provides more value.

For example, if one milk company offers milk in a liter pack and another company offers milk in a half liter pack, then unit pricing demands that the prices of both companies be displayed according to one liter. This way, consumers can easily decide which company to opt for instead of having to perform calculations.

Why is Unit Pricing Necessary?

Inconsistent pricing methods can lead to a confusing shopping experience for consumers, which can lead to purchase trade off, where a potential customer determines your product is less than a competitor based on value. Even worse, this confusion can increase their decision avoidance, where a purchase could have been made but was bypassed to avoid emotional costs of making the decision. – Source

This level of confusion leads to distrust among the consumers for the retailer. By opting for an easy to understand and evaluate method of pricing, retailers can demonstrate that they believe in transparency and aiding their consumers. This is because price transparency is one of the most effective ways to gain the trust of consumers as it makes it easier to make purchasing choices.

This relationship between consumer trust and pricing transparency was apparent in a study conducted by Australia’s Queensland University of Technology, where consumers remarked that unit pricing helped them make easier purchasing decisions so that they could shop with a higher confidence.

The research also showed that adopting unit pricing also led to a positive change in the attitudes of the consumers towards retailers.

Unit Pricing and Global Consumerism

Standardized unit pricing will also make it easier for consumers to make more informed buying decisions on a more global level.

By adopting ISO 21041 ambiguity and confusion around the pricing system can be nearly eliminated.

Summary

“ISO 21041 includes guidance on the provision of unit price, their units of measure used to express unit price including weight, length, volume, count, area and other forms of measure. ISO 21041 also highlights guidance on the display of unit price, and the implementation, communication and education of consumers.

ISO 21041 is applicable to any retailer, including supermarkets, hardware stores, pharmacies, convenience stores, automotive parts suppliers and pet product suppliers.

Note: ISO 21041 is applicable to packaged and non-packaged food and consumer products where the price is displayed, including

— at point of sale, including in-store and online, and

— when relevant communications about the product are released (including advertising by electronic and printed formats).

Note: ISO 21041 excludes services and merchandise, such as clothing and electronic goods sold as a single item.”  – Source

In short, adopting ISO 21041 and standardized unit pricing not only helps the consumers make better choices but is also beneficial for the retailers as it promotes positive consumer attitudes and increases customers trust in your brand.

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ISO and Agriculture - ISOUpdate.com

This document, originally posted on ISO.org details the role ISO standards have within the agricultural industry, the benefits seen, and technology available. We have summarized the key points for you to digest. View the full document on ISO.org.

ISO and Agriculture

“ISO Standards are used in agriculture to ensure sustainable practices are used to efficiently make use of farmland by providing guidance and best practices for farming methods, machinery and tools.
ISO standards for agriculture cover all aspects of farming, from irrigation and global positioning systems (GPS) to agricultural machinery, animal welfare and sustainable farm management. They help to promote effective farming methods while ensuring that everything in the supply chain – from farm to fork – meets
adequate levels of safety and quality. By setting internationally agreed solutions to global challenges, ISO standards for agriculture also foster the sustainability and sound environmental management that contribute to a better future”.

ISO Standards facilitate global trade by providing internationally agreed best practices and specifications for the agricultural industry processes, thus ensuring production is seamless. A common language is also provided in the standards, ‘widening opportunities for cross-border trade of foodstuffs and farm animals’.

This helps increase efficiencies for industries, and benefits the end consumer who receives higher-quality and more selection.

“ISO standards help organizations meet legal and industry requirements by setting benchmarks for the functional safety, traceability and quality of everything from the machinery and materials used in agriculture to the final food products. Developed through international expertise and consensus, they provide a sound basis for implementing public policy”.

Technology

The introduction of drones can potentially revolutionize farming with cost and time savings. Fitted with technology, cameras and sensors, drones are able to rapidly access farmland, assess and measure conditions, and map land accurately. ISO 21384 series ” ISO technical committee ISO/TC 20/SC 16, Unmanned aircraft systems, is working on the world’s first set of formalized International Standards in this area – the ISO 21384 series, which will define general specifications, product systems and operational procedures. They ill support the development of safe and effective drones for use in all settings, including agriculture, providing a platform for even better technology in this area”.

Source: Read more about technological advances, and a more detailed look into ISO and Agriculture.