General

0 41
ISO 8501 - ISO Update

The overall quality, as well as durability, of paint coatings are affected by the condition of the substrate they are applied on. This is especially concerning when dealing with steel. The surface itself needs to be prepared thoroughly beforehand and, in the case of steel which commonly faces issues pertaining to corrosion and rusting, the surface preparation varies depending upon the different grades of rust, the type of paint selected, the exposure of the finished product and possible environmental concerns.

Some widespread methods of surface preparation (used before or even without coating) are dry blast cleaning, power tool or hand cleaning, degreasing, and water jetting. All these treatments have individual pros and cons and need to be carefully selected after a suitable assessment on the existing condition of the steel substrate they will be used on.

Some notable factors to consider would be rust and mill grades, the profile and presence of contaminants such as oil, water, dust and grease. The process of identifying different rust grades and the subsequent preparation can be quite arduous and, therefore, the ISO 8501 standard was created to act as a guide throughout the process.

What is ISO 8501?

ISO 8501 was published in 1988 as a combination of manual content from other standards like the Swedish Standard SIS 055900 and the German DIN 55928. ISO 8501 is meant to be a pictorial guide to different rust grades at various levels of cleanliness and contains supplementary descriptions via text as well. It’s a method of making visual assessments on the rust grades of the cleanliness of steel surfaces and helps determine paint coats and systems to be used on the substrate. It also ranks the processes of cleaning in order of increasing work required:

  • Light Blast Cleaning
  • Thorough Blast Cleaning
  • Blast Cleaning to Visually Clean Steel

What does it consist of?

The standard is divided into 4 parts:
ISO 8501-1 – Includes different rust grades and the preparation of both uncoated steel substrates and steel substrates after overall removal of previous coatings.
This section of ISO 8501 identifies 4 different rust grades most commonly found on uncoated steel surfaces or on stored steel surfaces.
Specifically, the descriptions of rust refer to these 4 types (note that mill scale refers to a flaky blueish surface on hot rolled steel surfaces meant to protect against corrosion):

  • A steel surface mostly covered with the adhering mill scale with little rust if any at all. (possible slight cracks within the mill scale
  • A steel surface which has already begun to rust slightly, mostly the adhering mill scale has begun to flake or shows large cracks which enabled the corrosion.
  • A steel surface on which the adhering mill scale has largely rusted away from or it can be scraped (is severely weakened), but with slight pitting visible under normal vision. (pitting is a localized symptom of corrosion where holes start appearing on metal surfaces)
  • A steel surface on which the mill scale has almost entirely rusted away and on which general pitting is very obviously visible in normal vision.

ISO 8501-1 also identifies different cleanliness grades/ preparation grades for comparison purposes after you have completed preparing your uncoated surface or removed previous coatings from a surface.

Three preparation grades are identified and related to the cleaning method possibly used which is either:

  • Blast Cleaning- Light, thorough/very thorough blast cleaning, or cleaning until visually clean steel.
  • Hand and Power Tool Cleaning
  • Flame Cleaning (rarely used)

ISO 8501-2 – Focuses on steel substrates after the localized removal of their previous paint coatings and their possible preparation processes and grades.

This portion of the standard is based upon the prior experience that dictates that the complete removal of previous paint coatings is not always necessary, practical or economical. This holds true especially when regular maintenance is already being carried out and efforts need to be focused on specific portions exposed to a certain pollutant of rust stimulant.

ISO 8501-3 – Deals specifically with surface ‘imperfections’ such as edges, welds etc. and the preparation grades for them

ISO 8501-4 – Deals with pre-project surface conditions, and relevant preparation grades and flash rust grades for high-pressure water jetting.

To summarize, ISO 8501 proves to be a detailed and helpful guide to identifying various rust grades through different levels of cleanliness of steel substrates.

For a more in-depth look into ISO 8501, read TQC Sheen’s PDF on the standard and its history.

0 150
ISO Benefits Your Business - ISOUpdate.com

Standards, certification, testing and inspection help businesses to reduce costs, increase productivity and access new markets. ISO 9001 certification aims towards continual improvement based on a system of constant feedback and action, which works with your company’s goals and missions to help you achieve company objectives and targets. But, how does ISO 9001 certification benefit your business goals?

Improve Company Performance through Improved Operational and Product Quality and Consistency

Consistency refers to decreased variation in operations and, subsequently, your product. Deviations from desired results should result in upper management not just questioning what went wrong, but how their process allowed for the mistake to be made. With a properly implemented management system, steps and controls are in place to prevent such occurrences. When implemented correctly, your management system should allow for seamless production and effective practices that reduce downtime, confusion, and non-conforming products from reaching the customer.

Consider your quality management processes the well-built foundation that your business is built on and grows upon. Controls are built upon objectives, data metrics, and procedure flexibility, the interaction of all these variables should contribute to a well-established Quality Management System, which should, in turn, improve the quality and consistency of the product.

Interested in learning about real-world applications and successes of ISO Certifications? Read these Case Studies on Improving Company Performance through ISO Standards

Expanding Market Opportunities and Customer Base through Improved Overall Quality of Products and Services

Your organization is constantly striving to improve your processes, adapting and accommodating to a forever changing global landscape and increase in international competition. Implementation of ISO 9001 provides your organization with a guideline for success, and measures to report against to prove your growth. Using a process approach to business, ISO 9001 enables your organization to focus on quality and consistency in your outputs while decreasing waste and increasing efficiency. The reduction, or elimination, of variation and improved consistency results in more efficient procedures that are less wasteful than their previous counterparts. In a case study from Shogyo International, the company leveraged the management system and ISO 9001 to qualify for projects they previously were not able to and to eliminate tedious practices like lengthy questionnaires. They also gained understanding, specifically with regards to nonconformities – when a customer requests corrective action, they now understand what process to follow. ISO 9001 also allowed Shogyo to gain better control of their vendor’s nonconformities, which in turn allowed them to track and monitor trends.

Shogyo International predicted that this increase in market potential and decrease in inefficient practices would result in over $200k in increased sales volume. “Given the reduction in their employees spending less time filling out long questionnaires during bids, they are already saving about $6,000 per year, enabling the business to recover their investment in ISO 9001 certification in less than 2 years.” Source

Interested in learning more about real-world applications and successes of ISO Certifications? Read these Case Studies on Expanding Market Opportunities through ISO Standards

Better Understand Production Procedure

ISO 9001 requires your organization to provide detailed and effective documentation of processes as well as identification of affecting external factors and appropriate courses of action or metrics. With increased attention to procedures, best practices, and improvement, organizations using ISO 9001 see dramatic increases in the understanding and effectiveness of their processes, and how to better them.

Utilizing ISO 55001, one organization improved its risk management and reliability, with work delivered more efficiently towards higher ‘risk to operations’ activities, reducing reactive work by nearly 40%. The organization saw more focus delivered to continuous improvement activities, enabling even more benefits to be realized and saw a 41% reliability improvement over 36 months with their certification. –Source

Summary

“Conformity assessment has a range of strands, all of which contribute to giving people confidence and assurance in using and buying products and services. These strands include testing, inspection, certification and accreditation. – Source

They can help to:

  • Build customer confidence that your products are safe and reliable;
  • Meet regulation requirements, at a lower cost;
  • Reduce costs across all aspects of your business; and
  • Gain market access across the world.

If you are interested in learning about how ISO 9001 can help your organization, speak to a local industry professional today:

Find a Consultant

Find a Registrar

0 91
ISO 13485 - ISOUpdate

What is ISO 13485

Specifically developed for the manufacture of medical devices, ISO 13485’s primary objective is to help facilitate harmonized medical device regulatory requirements in the industry. It contains a comprehensive list of requirements meant to guide organizations that belong to the pharmaceutical supply chain by referencing specific requirements for the manufacture, installation and servicing of supplies. Its applicability is extended by the fact that it is useful to companies that operate in any tier of the industry, with a special focus on organizations that service medical device manufacturers.
Despite it being based upon ISO 9001, ISO 13485 shifts its focus from continual improvement to meeting regulatory requirements and risk management. The system aligns its requirements to match those of the FDA and other foreign regulators, which provides it with the framework to expand upon with further regulatory as well as customer requirements.

Why is it important?

The requirements of ISO 13485 are flexible enough to be applicable to any organization within the production line regardless of their size. These organizations could be involved within design, production, distribution, servicing or even external suppliers. ISO 13485 establishes specific requirements for organizations to follow through on to ensure that they can meet customer and regulatory requirements.
Because of its versatility and range within the market, ISO 13485 has become a staple necessity for organizations in the market, especially competitive ones.

How do you become certified?

The process of becoming certified to ISO 13485 involves developing a management system based on the standards’ guidelines customized to your company and then hiring a recognized third party to conduct regular audits.

The primary objective of your management system development process must revolve around your product policy and quality manual; these set the basis for the implementation of the system. Starting with management support and identifying the customer requirements for the management system, you will need to start with defining your quality policy, objectives, and manual which will work to determine the scope and extent of implementation of the management system.
Additional processes and procedures – including mandatory ones, need to be created to ensure efficient delivery of products and services. For this, you must consult the list of mandatory documents required by ISO 13485:2016.
Once all of this is accomplished, your management system will need to be operational for a period to collect necessary records and documentation required for audits and system reviews to become certified. This length of time will be stated by your certification body.

Steps to Get Certified:

Internal audit- Provides the ideal opportunity for you to check that all the records are in place and to verify that all the processes of the management system are being followed and there is total compliance.
It also serves as an opportunity to investigate potential issues and threats and to rectify them prior to a third-party audit. For this reason, the internal audit needs to be followed up with a Management Review.

Management review- A formal review conducted by management to meticulously go over the management system processes and make appropriate decisive plans and assign resources based on them. Certain key variables need to be looked upon based on the results of the internal audit and action plans must be created that will need to be implemented within a reasonable timeframe. These new procedures must be communicated with all relevant parties prior to being set in place.
Corrective Procedures- Any previously identified non-compliances or opportunities for improvement found during the internal audit need to be resolved with procedures set in place to ensure this. Documentation, procedures and results shall be kept for third-party certification auditor’s review.

Certification:

After these actions have been performed, the organization will begin the certification process which is further divided into 2 stages, Documentation Review (Stage 1) and Certification Audit (Stage 2).

Documentation Review – Auditors from the selected certification body will review all company documentation to ensure it meets the ISO requirements.

Certification Audit – The certification body will conduct a comprehensive audit of your organization to assess whether your activities conform to ISO 13485 as well as your own provided documentation.

If your certification body deems it fit, your company will become certified after these steps.

0 126
texas quality assurance blog - isoupdate

by Kyle Chambers of Texas Quality Assurance

Competence, Training, Awareness….  Organizational Knowledge too?

When compared to the ISO 9001:2008 standard the requirement in ISO 9001:2015 is more heavily weighted towards Competence.  In facilities, where competence is often based on compliance to a WPS or ASNT training, along with standard common in house training such as Control of Nonconforming Outputs some simple systems are required to effectively identify and track these records.

By utilizing the method detailed in this post, you will be able to develop a complete, comprehensive and well-executed Competence, Training and Awareness program.

Organizational Knowledge | ISO 9001 7.1.6

The ISO 9001:2015 Standard concerning Competence, Training and Awareness technically starts at clause 7.2 Competence.  However, it really has it’s roots going back to 7.1.6 Organizational Knowledge and further still to 5.2.1 Establishing the Quality Policy and 5.2.2 Communicating the Quality Policy.  So much is based on the awareness as described in 5.2.2.  Little is given on what the awareness or any evaluation of it should or should not look like.  We will explore some methods below.  Next, we jump forward to 7.1.6 for Organizational Knowledge.  Organizational Knowledge comes in a variety of forms, some documented such as intellectual property (documented information for specs and manuals generally).  Other undocumented forms include knowledge gained from experience, such as lessons learned, and “undocumented knowledge” from experience.  Somehow, we have to ensure the appropriate people have access to this organizational knowledge.  This is often not in a documented manner that we might have used in the previous 9001:2008 edition of the standard.  In the previous standard, we could easily have reached the conclusion that a Metallurgist with 10 years experience must account for his skills and abilities in a matrix, with required documentation for each new method “tip or trick” developed in his department.  Today, under ISO 9001:2015, we have to ensure everyone has access to such information and can “tell the same story”.

Competence | ISO 9001 7.2

The 2015 edition of the standard is well developed in that one section rolls into the next.  Much, not all, but much of what can be considered organizational knowledge can be evaluated as a part of the Job Descriptions, or Offer Letters, Cross Training Reports, and Annual Evaluations.  It is at these junctures where appropriate documented information can be attained to demonstrate base competence for a particular job without the requirement for more lengthy processes.  By utilizing these methods, keeping Organizational Knowledge in mind, we are able to quickly meet letters a) “determine the necessary competence of person(s)”, b) “ensure that these persons are competent on the basis of appropriate education, [not yet on ‘training’], or experience;”, and much of d) “retain appropriate documented information”

Training (the missing clause) and The Matrix

Clause 7.2 Competence letters b) and c) make it necessary for most (nearly all) organizations to have an official training program.  Below, we will outline one such method.

The training matrix is a simple list that identifies the following:

  1. Training/Competence by title: IE Orientation, WPS-XYZ, Control of Nonconformities Process, ASNT UT Level II, etc….
  2. Departments/Job Title Required
  3. Retrain/Recert frequency
  4. Type of Training (Dem, Comp, Aware) – see below

Dem – Demonstrated Competency trainings require a hands on demonstration, IE qualification for a WPS, or ASNT cert

Comp – Competence Training require a test or simple evaluation of understanding, IE the process of nonconformities

Aware – Awareness only Training require no more documentation than a signing sheet for the training event

Training Records

The training records should be in direct reference to the individual training title, reference the employee, and the date taken.

Follow-up Actions

Follow-up actions can be tough to identify and account for.  Without a Learning Management Tool in place, a simple monthly or even quarterly review is sufficient.  In this case, it is my recommendation that you add an extra value to your training matrix, the “retrain date”.  Then a simple filter or query for dates less than or equal to today (or some interval of days in the future) will quickly and easily tell you who is due for training.


About the Author

Kyle Studied at the University of Houston in the Architecture program for some time and graduated with a degree in Management Information Systems. Soon he began work with a Gas Turbine Repair company as the systems administrator. Having worked himself out of a job as the local systems administrator within a year, he was placed in charge of facilitating the development and implementation of the first health and safety system for his employer in 2009. Soon additional environmental and quality concerns arose, and Kyle was officially the QHSE & IT Manager for a growing company. By the end of 2013, they were certified to ISO 9001, OHSAS 18001 running an ISO 14001 compliant Integrated QMS.

Since then Kyle has gone on to providing custom QMS solutions including QMS Software, Internal Auditing, Consulting and Training. Through knowledge and firsthand experience with the standards that he has learned inside and out, Kyle is able to quickly and effectively conduct audits, and identify positional solutions, and bring organizations into compliance fostering continual improvement.

About Texas Quality Assurance

Based in Friendswood, just outside of Houston, TX, Texas Quality Assurance was developed out of a need to save time and energy managing quality systems. The end goal is to save folks time, and make business more efficient, and more profitable for everyone in the process.

0 162
Simple Tips for Implementing ISO 9001:2015 - Video

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

 

Tip: Implement ISO 9001 for the Right Reason

When implementing a quality management system (QMS) for ISO 9001, management should be clear about the purpose of the QMS. If the only driver is to get on customers’ tender lists or because a competitor has already got one, it’s highly likely that the QMS will remain a set of documents for certification purposes only.

Management should aim for a QMS that will help the organization produce quality products or services, continuously improve its process, and provide confidence to customers that the organization is capable of meeting their requirements all the time.

Tip: Motivate your Workforce

In order for organizations to achieve a desired level of quality, people need to get involved. People are the essence of organizations and their full involvement is essential to implement and maintain ISO 9001.

Employees can be motivated by:

  • Ensuring that everyone knows and understands the organization’s quality policy;
  • Defining and communicating responsibilities and authorities within the organization;
  • Building the competence of employees;
  • Providing adequate infrastructure and work environment;
  • Initiating improvements, e.g. by implementing employees’ suggestions.

Tip: Take the Necessary Time

All too often organizations are in a hurry to obtain certification and do not spend the time needed to implement the system effectively. Before applying for certification, your QMS needs to be in place and its effectiveness checked through an internal audit, followed by corrective actions on audit findings.

Tip: Go Easy with the Paperwork

Many believe that everything in the system needs to be elaborately documented. Often, organizations are better off sticking to what is required and keeping those documents simple; additional procedures and records should be considered only if they add value to the system.

Tip: Set the Example

Some employees may find it difficult to change their ways of doing and may have a tendency to deviate from defined procedures. To change this, top management should ‘walk the talk’, i.e., should not allow deviations from set procedures or permit the release of materials with deviations.

Under such an approach, employees will start respecting system requirements and everyone will take account of their responsibilities for the success of the QMS.


Learn more about ISO 9001 and how to engage top-level management to ensure the success of your QMS.

0 161
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.

1 239
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

0 254
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/

0 269
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!

0 215
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