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qas international - isoupdate

by Scott Bishop of QAS International

What are Quality Objectives?

Clause 6.2 of ISO 9001:2015 Quality Management Systems Standard requires an organisation to establish quality objectives at relevant functions, levels, and processes needed for the quality management system ie – how will the performance of the quality management system be measured and what are the objectives we are hoping to achieve through implementation of the QMS.

How SMARTER Quality Objectives can Help

Whilst it is not specified in ISO 9001, we recommend SMARTER ISO 9001 Quality Objectives that underpin the delivery of the goals detailed the organisation’s strategic plan, support the Quality Policy, and are aligned with the SMARTER philosophy of:

  • S – Specific: quality objectives should be clearly articulate what is trying to be achieved. They should be relevant to the conformity of products and services and to enhance customer and stakeholder satisfaction.
  • M – Measurable: Quality Objectives should be quantitative and data to support performance able to be measured. This data is needed to identify baseline performance against the objectives and to allow for ongoing performance measurement.
  • A – Achievable: Quality Objectives should be realistic and attainable to be successful. There is no point in having an objective that is not achievable.
  • R – Relevant: Quality Objectives should support the Quality Policy and the organisation’s Strategic Plan.
  • T – Time-bound: When will the objective need to be achieved by? Is it an ongoing objective measured at a specified frequency or a targeted completion objective?
  • E – Evaluated: Quality Objectives are required to be evaluated at Management Review Meetings – Clause 9.3.2 of ISO 9001:2015.
  • R – Reviewed: Quality Objectives are required to be reviewed at Management Review Meetings – Clause 9.3.2 of ISO 9001:2015.

Clause 6.2.2 of ISO 9001:2015 also requires that when organisations are planning their Quality Objectives they determine:

  • what needs to be done,
  • resourcing requirements,
  • responsibilities,
  • schedules and due dates,
  • how the results of the performance will be evaluated

Who Needs to Know about the Quality Objectives?

Quality Objectives should also be communicated to all personnel whose roles and responsibilities have a direct or indirect bearing on the performance of the objective. This includes the results of monitoring, review and evaluation of performance data in order to ensure ownership and accountability of performance.

Summary

Quality Objectives and being able to measure the performance of the Quality Management System are key to identifying performance problems and also demonstrating continual improvement. Importantly, developing clear, concise SMARTER Quality Objectives also requires systems for capturing meaningful data to support performance against the objectives, and ultimately the achievement of the Quality Policy and goals as detailed in the organisation’s Strategic Plan.

This article was originally published here on QAS International and was published with consent.

About the Author

Scott Bishop is an ISO Consultant at QAS International with over 9 years of consulting experience. He holds a Diploma in Quality Management, Diploma in Occupational Health & Safety, is a Certified Six Sigma Green Belt and Lean Sensei, and is passionate about developing streamlined, practical business management systems to meet ISO requirements and improve business operations.

About QAS International

QAS InternationalQAS International are ISO Consultants – developing, implementing and internally auditing a range of ISO Management Systems including ISO 9001 Quality Management Systems, ISO 45001 Safety Management Systems and ISO 14001 Environmental Management Systems. Our speciality is designing business management systems that don’t just tick boxes, they make real improvements. We engage with your employees to develop and implement ISO management systems tailored specifically for your organisation. We consider ourselves as part of your team and take pride in our ability to deliver bespoke, compliant (100% success rate) and cost-effective management systems that put organisations on the path to continual improvement and business excellence. Certified First Time, Every Time, Guaranteed!

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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

Texas Quality AssuranceBased 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.

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How To Survive an Audit - ISOUpdate

Written by Nathaniel Smith of Beyond Improvement

Preparation is Not Everything

Contrary to common belief, there is only so far you can go to prepare for an audit and, depending on the nature of the audit, sometimes it is best not to prepare at all.

The reality may be that you don’t have the time or resources to make EVERYTHING ‘perfect’, or even just to make it look perfect for the audit.

What’s more, even with an agreed agenda, the challenge is often knowing what specific direction the auditor may take, and what evidence trails they will follow.

Consider for a moment, that if you went out for a meal with some friends to a restaurant you had not been to before, could you correctly predict what everyone would order to eat and drink?

Everyone has different tastes, which can vary from one day to the next depending on a whole raft of variables and factors.

Trying to predict specifically what an auditor will look at can be a shot in the dark. Perhaps you have repeat audits with the same auditor, looking at the same processes each time. However, in my experience, many auditees have spent late nights preparing for an audit in an effort to cover all possible areas. Ever had that feeling of please don’t look in ‘that’ file or cupboard?

Priority is key here, focussing on bigger gaps, areas you know to be not right, not compliant or could be most severe. Your auditor is likely to look at the biggest risks first.

Consider what your business priorities are, and the type of audit i.e. regulatory compliance, insurance, customer, supply chain, certification. All will have biases or ‘risks’ they will focus on, use these as key start points. And try to at least formally record/identify those areas you know are gaps but have not yet been able to address, as this at least demonstrates self-awareness and intention.

There can be a good reason to not prepare at all…

If the audit is internal, or you are paying for a third-party audit to improve your business/maintain certification, then consider not preparing at all. This will better reflect your current situation (i.e. business as usual) and can maximise the benefit and value from the audit process. Should documents/processes not occur normally throughout the year?

Audit findings can provide great impetus and buy-in from stakeholders to address areas for improvement or get any necessary resources.

Be Open and Honest

It should go without saying, but being open and honest will always be better received by the auditor. Most auditors will be able to tell if you are trying to pull the wool over their eyes, fictitious stories and fabrication of evidence can often fall apart, possibly making an auditor more determined to catch you out and resulting in more severe findings.

Try to also look at these situations from the auditor’s point of view – would you like to be conned or lied to? Auditors have a job to do too. Sometimes they can be helpful allies, providing further guidance or insight into any issues. They are not always out to ‘get you’ and are often keen to make a difference to help improve your business, so don’t see them as the enemy.

An audit may help to keep people safe, aid the business to be legally compliant or financially secure, boost customer satisfaction, be environmentally sustainable – and much more.

If you have gaps, talking about them proactively can be very beneficial, especially if you have already identified or recorded along with your plans to address it. The auditor may still raise it as an issue but they may mitigate this or reduce the severity in recognition of your plans to address it.

A third-party auditor may have even more experience, visiting up to hundreds of businesses each year, seeing what works and what doesn’t, resulting in genuinely helpful feedback.

So, look for the benefits rather than dreading the outcome.

And Breathe!

Understandably some people can get very nervous, before and during an audit. Try to relax, taking on board the points above.

Remember that whilst the audit has a purpose and the auditor has a job to do, many auditors (including those of a regulatory purpose), like to help.

Asking relevant questions, examples of best practices or ideas (where they can be given) can be very valuable to you and your business.

I personally have seen many auditees go from a state of physical nervous shaking at the start to a happy, warm smile at the end of the audit, finding it informative, helpful and even sometimes fun!

Contact Beyond Improvement for more advice

About the Author

Nathaniel Smith has over 20 years’ experience in management systems, including working as an assessor at BSI (British Standards Institute), a leading global certification body.

Nathaniel is passionate about implementing best practice and providing real value going beyond small basic improvements – he helps businesses go further and can help you create real significant change, improving growth, performance and reducing risk.

About Beyond Improvement

beyond improvement logoHaving seen and experienced the challenges working with some consultants, Beyond Improvement strives to offer a genuine value-led solution based on the following principles:

– You and your business needs come first

– A tailored approach to your business, its culture, and how you would like to work

– Consistency. You won’t be passed between a team of consultants; services will always be delivered by me, Nathaniel Smith, the person who understood your original requirements and brings the experience and expertise that you need

– Coaching-led, so that you and your business understands the system and can maintain it, your business/system doesn’t depend on me

– Ongoing support, only if you need it and always value based

Learn more about Beyond Improvement

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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.

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Predict, Survive, Grow - ISOUpdate.com

ISO 31000 is a standard on risk management developed by the International Organization for Standardization firstly in 2009 and updated in 2018. It is the international codification of the principles and guidelines of risk management, which emerged as a necessity to have one international standard which applied to all industries and organizations of all sizes. In other words, because there were a number of standards on risk management that different organizations in different industries were implementing, experts deemed it necessary for a new family of standards to emerge and to unify all the concepts in one single standard which would provide guidelines and strategies for implementing risk management. Later on, we will discover how ISO 31000 and ISO 22301 can be intertwined, and how can ISO 31000 deepen the risk management control in an organization that has already implemented ISO 22301 – business continuity management system.

Uncertainty is an inseparable part of every business, and as such, every company has to tackle the risks associated with uncertainty in every dimension of business operations. First, risks have to be identified, after which they are categorized and preventive and responsive measures for each identified risk are implemented. The nature of risk nowadays has evolved into unprecedented complexity, because the amount of data that goes in and out of companies is rapidly increasing. As such, unsurprisingly, contracts and insurance companies require mechanisms in place which make sure that the company is identifying and tackling risks.

ISO 31000 helps organizations protect their assets as well as increase the likelihood of achieving objectives by providing direction and risk management strategies. It is adaptable to the context of every organization and it helps mitigate risk within the organization by implementing risk-based decision-making and risk-based corporate culture. That is to say that both employees and stakeholders make decisions by always bearing in mind the risks associated with each decision, but at the same time, apart from seeing negative consequences, it helps a company also identify positive opportunities.

On the other hand, one of the most famous international standards which deal with the continuation of business operations and business security is ISO 22301. This is a standard on business continuity management and it is widely-implemented in organizations of all sizes and all industries. Differing from ISO 31000, ISO 22301 does lead a company to certification if the latter proves to have implemented the standard and its requirements.

The main goal of this standard is to offer a management system which makes sure that in case of incidents, of every nature, an organization can continue its crucial business operations – in other words, it can survive. Incidents can have a very different nature from each other, ranging from natural disasters to cyber-attacks, and ISO 22301 includes all of these kinds of incidents. It also helps a company to mitigate risk and to evaluate which risks are more imminent and more probable.

Based on these factors, and a proper understanding of the organization and its context, a Business Continuity Plan should be developed (BCP). This plan includes actions and measures to be taken in case of different scenarios, the persons in charge of every scenario and how to contact these persons in case that one of the scenarios happens. In other words, a BCP should be composed, but there should also be instruments to activate the BCP and responsible managers should be appointed for every situation, and the information should be communicated clearly so that every employee is aware of who to contact in different scenarios.

So, among other things, risk assessment and risk management are integral parts of business continuity, and this is where ISO 31000 and ISO 22301 intersect. In ISO 22301 there are two important clauses which deal specifically with risk: close 6.1 on “Actions to address risks and opportunities” and clause 8.2 on “Business impact analysis and risk assessment”.

Every business is exposed to risk, ranging from market risks, investment (or stock) risks, natural risks, cyber risks and so on. Depending on the scale of risk exposure, a company might choose to implement and get certified against ISO 22301, but at the same time have ISO 31000 as a guiding tool for risk-based thinking, risk strategies and risk-based corporate culture. It is a very good integration (but not an integrated management system, since ISO 31000 does not offer requirements but guidance) of two standards which can produce a very detailed and accurate platform, that can serve a business well in difficult times – and as history has often proved, it can help a company stay in business when faced with risks and challenges.

It is often argued that civilization started when the first humans learned to domesticate plants and were able to farm and harvest. In order to be able to farm, one must at least be able to recognize and know seasons, humidity and temperature as minimum requirements to be successful. So, in other words, it was the event of being able to predict which marked the beginning of civilization and its continuation and evolution to this point. We have developed immaculate methods (e.g. scientific method) to predict and forecast in order to survive, thrive and evolve. The same concepts apply to a business if you see it as thinking, living organism which is striving to evolve and thrive, but which also has to deal with the bad days where survival is the main objective. We can consider standards such as ISO 22301 and ISO 31000 as the scientific methods of the world of management, which help a business as a living organism to survive in these bad days while helping them reach their objectives and grow in good times.

About PECB

PECBpecb logo is a certification body for persons, management systems, and products on a wide range of international standards. As a global provider of training, examination, audit, and certification services, PECB offers its expertise on multiple fields, including but not limited to Information Security, Business Continuity, Resilience and Recovery, Governance, Risk Management, and Compliance, Quality Management, IT Governance & Service Management, Health, Safety, and Sustainability.

About the Author

Julian Kuci is the Marketing Quality Assurance Manager at PECB. He is an honour graduate of RIT in Economics & Statistics and Public Policy & Governance. Julian holds a diploma in Transitional Justice from the Regional School of Transitional Justice and is certified against ISO 9001 – Quality Management and ISO/IEC 27001- Information Security Management.

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Implementing ISO 9001 Improves Business Performance - ISOUpdate.com

Contemporary marketplaces work in a highly competitive environment. It has become imperative for organizations to improve their business performance and stay ahead of their competition. Improving business performance requires cost reduction without compromising quality. Implementing ISO 9001 can help organizations easily improve their business performance. ISO 9001 is an international standard that defines requirements for Quality Management Systems. It has all the ingredients which can ensure that a business runs in the most optimized manner and improves its performance. Let’s explore how various aspects of ISO 9001 help achieve higher business performance.

How does ISO 9001 help improve business performance factors?

Business Performance is defined by product quality, waste control, cost reduction, competitiveness improvement, sales volume, and profitability. An ISO 9001 system ensures each of these factors improves with the implementation of requirements which are built-in to various clauses of the standard.

Product Quality

Product Quality and achievement of higher customer satisfaction is at the core of the ISO 9001 standard. ISO 9001 defines various controls within its clauses that ensure that an organization provides high-quality output to its clients and meet its customers’ expectations. Some of the ISO 9001 requirements that ensure these are:

  • Understanding the Context: ISO 9001 requires that an organization understands the requirements of all its interested parties and internal/external issues that are relevant to the organization while defining the scope of the Quality Management System. This ensures that the requirements of customers are well understood and catered to when defining the Quality Management System. ISO 9001 requires that top management actively involves themselves in defining the strategic direction and ensuring that the Quality Management System runs in conjunction with the business scenario and aligns with the companies’ long term and short-term objectives. Understanding the requirements of its customers and setting of objectives ensures that an organization understands the needs of its customers well and processes defined are more customer-centric.
  • Risk Management: Risk-based thinking is introduced in the new version of ISO 9001 and is an important tool to understand the risks involved in delivering a quality product/service to the customer and to take actions to address these risks.
  • Operational Controls: Various controls are built in the standard in various clauses to ensure all deliveries are reviewed and tested before it reaches the customer. Some of these are requirement/design reviews, quality inspections of both raw materials/final product, monitoring of suppliers, etc.
  • Resources and Infrastructure: ISO 9001 touches on all the aspects of a business and support systems required to ensure product quality to the customer. This includes infrastructure, communication, resources, both human resource and equipment/tools that may be required.
  • Data-Driven Approach: ISO 9001 is a standard that is driven by data and has efficient monitoring mechanisms applied. It requires that the organization defines its quality objectives and constantly improves on their performances. Organizations with a continuous focus on the quality objectives and with improvement in the goals, achieve their business objectives.
  • Process-Approach: ISO 9001 focuses on having a standard set of procedures and having streamlined processes in all departments of an organization. This ensures processes are repeated and produce the same quality of product every time. This approach provides the necessary controls that are required to keep the risks at an acceptable level and deliver a more consistent result.
  • Empowered and Engaged Employees: ISO 9001 also stresses having empowered and engaged employees, a suitable work environment, access to organizational knowledge and training. This helps to improve the overall morale of employees and employees put in their best efforts towards customer satisfaction and ensure better product quality.

Waste Control

To achieve higher business performance, waste control is important as it makes your processes leaner and more efficient and you deliver faster. This also ensures that the procedures are optimized and the product quality improves.

  • Non-Conforming Product/Process: ISO 9001 requirements define a very detailed approach for handling non-conforming product /processes. It requires that an organization analyse all aspects of the non-conformities and ensure that the non-conformities do not re-occur. This pro-active approach improves processes and reduces waste in the processes.
  • Continual Improvement: The new version of the ISO 9001 standard has captured various aspects of running a business beyond just a Quality Management System. It gives a framework or a tool to improve performance. ISO 9001 focuses on continual improvements which require that organizations explore various ways to improve the current set of processes and develop optimized ways of working.

Cost Reduction

Implementing ISO 9001 means that the business operates a set of consistent processes which are continuously improving with time. This brings in efficiency and you deliver more with the same set of resources. Waste control and lesser rework reduce the cost of deliveries.

Competitiveness

Efficient risk management which is embedded in all the processes of the organization ensures that the organization has analysed business needs well. This reduces all risks due to external factors like competition, market, trends, technological advancements, etc. and improves business sustainability in a competitive marketplace. ISO 9001 also improves customers trust in the organization’s processes when an organization is ISO 9001 certified. ISO 9001 focuses on increasing customer satisfaction and working towards improving customer relationships at all levels. This itself improves the competitiveness of an organization as old customers are retained and new customers are introduced.

Sale Volume and Profitability

The overall increase in the reputation of the organization in the market due to excellent customer satisfaction and improved product deliveries brings in new business and increases sales volume. Reduced costs and increases in sales result in increased profitability in business.

Conclusion

ISO 9001 is all about: Improved product quality + process improvements.

Both of these factors, when implemented through the various clauses of ISO 9001, ensure that there is less waste in the system. This further ensures cost reduction. The reduced cost helps the organization to pass on better value to its customers. As you provide value to the customer within the same cost, the customer is “delighted” and you gain more business. Each delighted customer provides you with new references and your competitiveness improves. A surge in sales volume is what follows which increases your profitability. So, just by applying the ISO 9001 standard, you achieve higher business performance with improvement in all the parameters that define performance.

About the Author

Avital Koren is the Director of ISO Global

 

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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!

Factor Quality - ISOUpdate.comWe 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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document_control_isoupdate

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

Do I need Document Control?

In my years of performing third party Quality Management System (QMS) audits, gap assessments and internal audits, a common question about document control people ask is:

 “Do I need to control this document?”

Over the years I’ve noticed Document Control has received “a bad reputation” in quality circles.  It does not matter if it’s a procedure, work instruction, or form; One of these pesky documents is bound to be in the wrong place at the wrong time.

Recently, I have noticed that these document control issues are decreasing due to new tech solutions that help organizations manage documents. Nevertheless, the question persists, “to control or not control a document?”

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To Control or not Control a Document?

Without dwelling in the details of ISO 9001 requirements regarding document control and in the spirit of keeping it simple, the intent of the standard’s requirement is straightforward. The aim of the standard is once your organization determines the need for a document (i.e. means to convey critical information or template to collect data) then logic dictates that you want to make it available to those who need it and want to make sure the information is always accurate.

“Document Control is having a way to ensure that information remains relevant, up-to-date, accessible and aligned to the strategy”. – Pierre Survan, Factor Quality

ISO 9001 does not handcuff organizations in dictating specific required procedures. Each organization is free to decide what documents need to be created and controlled.

The expectation is that when you make the decision you ensure the document aligns with the nature of the business and any requirements that need to be met.

Thou shall not use the standard’s name in vain

The ISO gives general rules for document control, that when used appropriately, do help businesses.

At Factor Quality, we’ve heard statements about document control such as:

“This document cannot be used because it is not in an ISO format.”

“That document requires to be approved by two supervisors, a manager and the CEO per ISO requirements.”

“That document is missing a document #, what section of the standard it belongs to so that I know how to number it.”

“That document is only important to our department, so it does not need to be controlled.”

Did you know ISO provides a general requirement for organizations, it does not tell you how many approvers certain documents need to have?

Nor does it prescribe a document format or a document ID# (i.e. QAP-1001ab). These are misconceptions that have been circulating for a long time.

Let’s clear some misconceptions:

  1. ISO 9001 does not establish a minimum of approvals required,
  2. ISO 9001 it does not provide a format for documents nor does it require you to have a document number.

“In my opinion, the “bad rep” of document control has mostly been driven by the way companies have decided to control their documents and some lack of understanding of the standard, leaving many confused and somewhat irritated. All these requirements are self-imposed by each organization. The company defines the policy of how many approvers are needed for documents, what type of format is to be used and how to identify it.” – Pierre Survan, Factor Quality

Important Note: Stay Curious and Question Decision Making – If you don’t like current document control methods within your organization, ask the owners of document control why they consider the current method correct. And under no circumstance should you accept “Because ISO requires it,” as an answer.

How Do We Control Documents?

While ISO 9001 does not mandate specific formats, identifier or number of approvals, the documents created for the organization must meet a certain set of criteria to be considered as controlled effectively.

Remember –when you create a document you need to make sure the correct version is available to all in the business.

Requirements You Need to be Aware of with ISO 9001

Documents can be in any media

“Any Media” means document scan be written in paper, electronic, even video formats. The documents can be written, pictorials, flow charts, or a combination of these. Just remember it needs to make sense to your organization.

Documents Need to be Identified

There is no need to have document numbers unless you believe these are needed and are helpful to your business. A simple identifier is the title of the document and if this appears in the footer or header of each page, the document is indeed identified.

Documents Need to be Approved

Designate a person or group of people with the authority to determine suitability for your business. Ideally, that person is always aligned to the strategic direction of the business and understands the implications of such a document.

Documents Need to be Controlled

  • Version Control: Documents must have an identifiable version visible throughout the document. This allows you to determine if the right version of the document is being used. The version can be alphanumeric or by date.
  • Distribution Control: Documents must be made available and accessible for use. They need to be maintained in a manner so points of use can be readily updated when changes occur, that only authorized changes are made, and documents remain legible over time.

Keeping Document Control Effective

Over the years some of the most infamous controls deployed by overly careful document control administrators have been:

  • Document Stamps: Stamps showing the document status such as: “Reference Only,” “Uncontrolled,” “Not a Controlled Document,” “Master Copy,” etc.
  • Footer Controls: “Not valid if printed,” “Check system for latest version,” “Not valid after 24 Hours,” etc.
  • Watermark Controls: Using watermark to notate “Draft”, “Controlled”, “Uncontrolled”, etc.

All these are methods of control but can be misunderstood by those using them. For example, could you have the correct stamp, footer, or watermark, but have no way to ensure that people do not change the document, even on accident? Can these controls show that the document approvals were adequate? Can a stamp prevent someone from receiving an outdated version of the process?

Do not assume that if the correct stamp, footer, or watermark is used, that is enough to demonstrate robust document controls.

Remember, these are just controls and as such, auditors will always check for effectiveness.

It doesn’t matter how big and bright the stamp, footer, or watermark is – when evaluating Document Control, auditors will consider valid the document the employee/operator points or shows.

What is the Most Common Document Control Issue When Employees are Asked: “What Document do you Use?”

“Employees proudly say, ’this one’, as they pull it out from their toolbox or desk drawer, and in most cases, these copies are out of date”. – Pierre Survan, Factor Quality

Summary of document control

Document Control’s purpose is to help the business document those items that are critical to its own functionality. 

These documents should align with the strategy and help the business meet requirements in a consistent manner.

How much or how little you control these documents is a decision made by each company.

At Factor Quality, our best advice is to Keep it Simple! The well-being of the organization should always be put before the need of a group or department. Make sure every document is needed, because when a document is really needed it will be easy to control, maintain and keep relevant.

Document control structures can be reviewed, revamped and reset during the lifetime of a Quality Management System. Organizations should review their systems and ensure that they are leveraging existing and available resources to support their own documented systems. Factor Quality is here to guide you through this unpopular mythical creature called Document Control without Process Improvement Services. We have experience using several document control systems, from software solutions to self-contained systems, we can recommend the best simple, but effective solution for your business.

Let us help you set a new document control structure or revamp your current system to its most effective. Take advantage of our knowledge in the industry! This article was originally published here by Factor Quality and has been published on ISOUpdate with permission from Pierre Servan.

About the Author

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

Factor Quality - ISOUpdate.comFactor 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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    Tips and Tricks for ISO 9001 - ISOUpdate.com

    Ready to implement ISO 9001 in your organization? Here are some ISO 9001 tips that will help make the process easier, and tricks to 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.

    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.

    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.

    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.


    Tip: Go Easy with the Paperwork

    Many believe that everything in the system needs to be elaborately documented. ISO 9001 only requires one quality manual, six procedures, and approximately 20 records.

    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.


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