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ISO Update aims to provide information, resources, and updates around the Standards and Certification industry. We believe that organizational standards can help businesses of all shapes and sizes become more efficient and successful on a local, federal, or global scale.

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When Quality Fails - ISO Update

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

Case Study – Toyota Unintended Acceleration Recall, 2009

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

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

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

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


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


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

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

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


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


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

Why is Quality Important for My Business?

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

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

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The Cost of Quality Equation - ISO Update

The Cost of Quality operates on the premise that companies need to invest in upfront quality and prevention rather than suffer the grave consequences of failed services or product recall. “CoQ” Cost of Quality Equation is a methodology used to determine and consequently measure the number of resources that an organization is using for prevention activities to maintain the consistent quality of a product. Mathematically speaking, the calculation can be showcased as a simple equation where the Cost of Good Quality and the Cost of Poor Quality equals the total Cost of Quality.

CoQ = CoGQ + CoPQ

Effective use of this methodology allows for companies to accurately measure the costs of each factor which aids in identifying problematic sectors. Companies can then allocate resources to improve product and process quality in said areas. According to estimation, the cost of quality amounts to around 15-40% of total business costs; therefore, the methodology provides key information to management in order to maximize the quality of the finished goods/services as well as minimize overall costs. Any analysis done on these factors ensures easy identification of problem areas where there is room for improvement. – Source

Cost of Good Quality (CoGQ)

The first part of the equation, “CoGQ”, includes all the various costs accumulated from prevention steps such as quality planning, developing a Quality Management System, employee training, etc. It also includes costs incurred to maintain an acceptable quality standard, or “Appraisal Costs” which include routine inspections, quality audits, process controls and supplier assessments.

Cost of Poor Quality

The second part of the equation, “CoPQ”, includes both internal failures as well as external failures. Internal Failure costs are associated with defects in a product or service that are identified before it reaches the customer such as machine breakdown due to maintenance failure, re-work on service/product, excessive scrap of waste due to poor process, etc. External Failures, however, are found after the product has already been supplied to the market or customer, these may include repair costs, shipping damage, product returns, warranty claims or customer complaints.

Using this methodology allows your organization to determine the extent of resources used that allow your products to maintain high quality and expectations and allows your organization to determine your potential savings gained from the implementation of your systems. Once established, your quality cost equation should be dynamic, constantly revised and updated to reflect the dynamic nature of your business and its needs. The overall outcome of this evaluation should be positive with its impact not just on your business expenses and quality system, but on your organization’s core mission, values and objectives.

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Purpose of a QMS - ISO Update

What is a QMS?

“A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization’s purpose and strategic direction”.
A QMS is defined as an extensive system meant to document important processes and procedures and facilitate the implementation of these procedures to achieve high-quality outputs that align with a company’s goals and objectives. A QMS aids in coordinating and directing the activities of a business in order to achieve customer satisfaction and meet international requirements, to enhance efficiency and work towards continual improvement.

What is the Purpose of a QMS?

A quality management system is not simply a group of documents your organization refers to, it is a whole system that aims to incorporate conformance to international standards of excellence and, through the process, takes a look at executions, costs and conveyance. In doing so, and in succeeding to continually improve upon company procedures and consequently products, the system brings about a whole array of advantages. A QMS integrates the various internal processes within the organization and intends to provide a process approach for project execution. A process-based QMS enables your organization to identify, measure, control and improve the various core business processes that will ultimately lead to improved business performance. – Source

Increasingly, top QMS have attempted to converge initiatives revolving around sustainability and transparency as they recognize that customer and investor satisfaction are tied to these factors. Out of the top regimes, the ISO 9000 family of standards is considered the top international standard and deals with both quality and sustainability integration in company values.

What are the Advantages of a QMS?

“A well-designed and implemented quality management system can help you plan, simplify, and control your operations”

The popularity of QMS can be credited to the many advantages that incorporating a quality management system into company policy has proven to bring about. Alongside showcasing an immense dedication to providing quality products and services, having a QMS in the company allows you to establish a brand identity, create consumer loyalty, and consistently meet client necessities and improve upon existing frameworks. A quality management system operates as a basic framework to help organizations manage services and document relevant changes and corrective measures for internal and external audits.

The ISO9000 Store describes the purpose and advantages of a QMS as “At its core, a quality management system is an integrative element, uniting diverse aspects of a company into a unified purpose of delivering products/services in their best form. Rather than be seen as a cost burden, an effective quality management system is viewed as a key component of success.”

Quality management systems focus on:

Being centred on the customer or consumer of the good or service, actively providing that customer with the best value possible.

Some type of continuous improvement program, which implies that there is not a “perfect” state, all processes can be continually improved upon.

An efficiency imperative that says waste must be reduced and all resources maximized.

Top management is to support and provide adequate resources to achieve goals.

It aids or facilitates a clear understanding of expectations between all participants.

Measurement and accurate data collection are incorporated to support data-driven decision making.

Documentation of QMS processes is maintained and controlled. – Source


Looking for tips on how to implement a QMS, check out these resources:

Top 10 Tips for Implementing an ISO 9001 Management System – By ISO Update

12 Steps to Implementing a Quality Management System – by Thriving Small Business

Implementing ISO 9001 Improves Business Performance – by ISO Global

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ISO 26000 - ISO Update

What is ISO 26000?

ISO 26000 is an international standard that provides guidance and establishes the principles and guidelines of social responsibilities. Developed to aid organizations with both assessing and addressing social responsibilities such as customers and communities as well as environmental impacts of their processes. The standard offers thorough guidance and effective suggestions for organizations to operate in socially responsible ways, such as through implementation procedures to adopt the standard. You cannot become ISO 26000 certified, as this standard only offers guidance.
“ISO 26000:2010 provides guidance rather than requirements, so it cannot be certified to, unlike some other well-known ISO standards. Instead, it helps clarify what social responsibility is, helps businesses and organizations translate principles into effective actions and shares best practices relating to social responsibility, globally. It is aimed at all types of organizations regardless of their activity, size or location […] ISO 26000 was developed to respond to a growing world need for clear and harmonized best practice on how to ensure social equity, healthy ecosystems and good organizational governance, with the ultimate objective of contributing to sustainable development.” – ISO.org

What are the guidelines?

The guidelines of the ISO 26000 standard revolve around 7 central points highlighted below:

  1. Organizational governance;
  2. Human rights;
  3. Labour practices;
  4. Environmental responsibility;
  5. The fairness of organizational practices;
  6. Consumer and consumer protection issues;
  7. Evolving and developing communities.

These 7 points are then further divided into several subsequent areas that may overlap. Depending on each issue, the standard provides appropriate guidelines and implementation strategies for organizations to self-assess their current status and set achievable goals for improvement.

What is social responsibility and why is it important?

Social responsibility dictates that companies have an inherent duty to act in the best interests of the environment and society. The primary goal of social responsibility is to contribute to sustainable development. Organizations, after all, play a critical role in relation to the society in which they operate, and they have a moral responsibility to operate in a manner that ensures they maintain healthy ecosystems and social equity.

ISO 26000 has emphasized that a critical factor in operating efficiently for a business is its ability to pursue economic performance whilst adhering to social and environmental laws. Organizations are becoming increasingly aware, due to social pressure, of the importance and need for socially responsible behaviour, in part because their activities depend on the health of the world’s ecosystems in the long term.

How does an organization benefit from being socially responsible?

Implementation of the policies and guidelines outlined in ISO 26000 provides companies with:

  • Better reputation;
  • Increased ability to attract and retain workers as well as customers and stakeholders;
  • Upkeep of employee morale, commitment and productivity;
  • Favourable public perception with investors, owners, donors and financial interests.
  • Improved external relationships with other companies, media and community.

ISO 26000 also offers guidance for companies to find a competitive advantage by adopting a sustainable position which distinguishes your company as the better option among your competitors. Social responsibility can easily be incorporated into brand building. You want to associate your company name with a positive image and a great way to do this is to implement socially responsible strategies into company policies that can be universally commended. You might even be opening the door for further marketing opportunities and co-brands as well.

ISO 26000 also offers an avenue for you to maintain employee morale. People want to feel like they’re making a significant difference in the world, something that gives them a purpose to work better and harder. Encouraging better and more socially responsible strategies allows employees to feel proud of the company they work for which in turn fosters a keen sense of loyalty and can aid in retaining good talent. Multiple studies have found employees to be considerably more satisfied with their job when belonging to companies that market themselves as socially responsible. – Source

For example, Bell Canada has released a 2019 Corporate Responsibility Report, covering the company’s performance in 2018 and how through strong corporate responsibility practices, they were able to recruit and retain talented team members, reduce risk, build customer loyalty and long-term shareholder value.

Find more reports from organizations like Pearson, Caterpillar and Canary Wharf Group on how they and others use Corporate Social Responsibly and standards like ISO 26000 to grow their business.

ISO.org has provided basic training materials for the standard to help your organization in the implementation of ISO 26000 including a PowerPoint presentation and Training Protocol Guidance PDF document. They, along with other supports, can be found here.

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Setting Up an Effective QMS - ISO Update

The certification process for ISO 9001 requires an extensive external audit to ensure the requirements of the standard are being met and the company is conforming to the standard and their own Quality Management System (QMS). For an organization to succeed in these stages of audits, it is crucial to ensure they are implementing the system according to the standard and their businesses needs, not simply using blanket statements to satisfy the auditor. Your organization should strive to set up an effective management system that will help your business thrive.

What is the Purpose of an Effective QMS?

The overarching purpose of a quality management system is to ensure your business is operating effectively, and in a way that not only sustains itself using smart practices but produces goods and services of the highest quality.

For an example of how a QMS can help your business use better practices to achieve quality results, let’s explore ISO Standards and Training. Your business needs to be dynamic in nature, as processes and procedures are constantly changing alongside a changing market. Your team needs to be adaptive and so do your processes.

ISO 9001:2015 has an increased emphasis on Management Reviews, which should be a cause for celebration, not concern. This is where your staff members can demonstrate to their management better modes of operation that allow them to make superior products and present these to upper management. It is during these reviews that upper management should be reviewing the evidence and crunching numbers to determine if old practices or “the way it’s always been done” is truly the best course of action in this expanding global market. If it’s not, management needs to review their process and determine the best course of action for improvement.

This improvement can be provided through external learning as well as company training programs. These training activities could be development sessions or team-related activities and are great opportunities to communicate your organization’s commitment to employee growth and ideas and demonstrate what your company needs from each employee.

What to Consider When Setting Up Your QMS

No two quality manuals should ever be the same. This is because no two businesses are the same. Even within a multi-site operation, your two locations operate with different sets of shared experiences, successes and hardships that need to be considered when you set up your processes.

For example, if you run a multi-site operation with one location providing mostly warehouse operations, and the other providing office and administrative duties, you should not have the same manual dictating hiring needs. The training requirements for your warehouse could be far more extensive and may even be legally mandated compared to those who work in the administration buildings. You might also need different onboarding training to follow, as warehouse workers might need to be trained for ergonomics differently than those who spend 8 hours at a desk.

You don’t treat the hiring processes the same, so don’t assume your whole process manual can be the same.

It is here in the process that you may want the help of a consultant. Consultants should be seen as an important resource for your organization, even an extension of your own team, who take the time to learn about your unique situations and develop a plan alongside you that not only follows the standard you are looking to certify to, but also pushes your organization towards continued and sustainable growth. If you have an internal quality department, consultants can also act as an impartial team member to help your organization prepare for your certification audit.

Another thing to consider when setting up your QMS is not to be afraid of NCR’s and OFI’s. Non-conformities and opportunities for improvement should be celebrated in the early stages of your certification journey. You want to find holes and problems from your consultant and internal auditors, and you do not want to hide things from your auditor. It is here that you can discover problems and implement solutions prior to your third-party certification audit. Use these audits to switch your mindset of the audit process.

So, how can you ensure your QMS is effective? Easy, don’t assume copying-and-pasting another organisation’s manual will help. If you state in your manual that you perform a process a certain way, and if in practice you don’t follow that process, well that’s an NCR. Write your manual specifically for your organization, either through your own internal quality department, or with the help of a consultant, or both. Use audits as a way to grow, not as a way to stress. And lastly, use management reviews to grow your business, not waste your time. Time is money they say, so be mindful how you are using management review meetings.

Some food for thought: Effective management systems will do nothing but help your organization, but an ineffective management system is the reason organizations don’t like ISO 9001. Consider this when you are pitching the idea of implementing an ISO Standard to your organization.


A key to understanding ISO Standards is to understand the 7 Quality Management Principles that Standards are based on. We have summarized the key points for you here.

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ISO 9001 as a Strategic Planning Model - ISO Update

Written by Kashif Mumtaz

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

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

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

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

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

About the Author

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

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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 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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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.

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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

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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.