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ISO

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Types of Audits - ISOUpdate.com

Looking to become certified to ISO 9001? Not sure what to expect from the process, and from ISO Audits? It’s a good idea to prepare yourself and your organization for what to expect from an auditor, what is needed from you, and what will happen at each stage of the certification process to have a smooth and stress-free experience. In this article, we will briefly explain the different types of audits an organization can expect to go through when seeking their first certification to ISO 9001 and subsequent audit cycles once you are certified.

If you have never been certified to ISO 9001 before, you should expect a long road ahead of you. The first step to certification is implementation. This can be done in house with your own people, or with a consultant. Learn more about how to implement ISO 9001 and what to expect [LINK]. It may take your organization a few months to fully implement your Quality Management System and have it effective and ready for a certification audit. While the standard is generic and concise, it can be quite overwhelming, so ensure you are asking questions and reaching out to professionals at every step.

One specific requirement of the standard is Internal Audits, that is the act of evaluating your own processes internally and recording evidence to report to your management, company and certification auditors.

Internal Audit:

Internal audits are self-examination done by the company itself at least once per calendar year. They are performed on-site and are useful in determining conformity, effectiveness, and opportunities for improvement. By going through internal auditing your organization will be able to compare your quality management system to the required standard(s) and prepare for the certification audit. There are no “stakes” with an internal audit, they are completed to meet a requirement of the standard and serve as a learning opportunity for your organization. It is during this process that you want to find as much as you can so you know what your certification auditor will see and so that you can be prepared with ways to improve. Your certification auditor, or external auditor, holds a lot more power in a sense because this is the person who is a representative of your certification body and will determine if you achieve third-party certification to ISO 9001.


Want to learn more about Internal Audits? Check out ISOUpdates Article on ISO Internal Audits Explained Iso here!


External Audit:

An external audit is performed by a third-party auditor associated with your hired Certification Body. The external auditor will conduct a certification audit or surveillance audit at least once during each calendar year to determine if your organization should be recommended for ISO certification or continue to hold your current certificate. An external auditor must perform audits based on a set of rules from their own ISO Standard for auditing best practices and must obtain strict qualifications set by the certification bodies. Auditors must also be selected by a certification body with consideration to the organization’s industry, the auditor’s understanding of their industry and the specific industry codes the auditor must hold to conduct the audit.

An external audit scope may include any number of processes, and the scope will be detailed to you ahead of time in an audit plan so you and your people can be prepared and present. In the 3-year cycle of certification, each process must be audited during the initial certification or recertification audit and at least once per the 2-year surveillance cycle to evaluate effectiveness.

Let’s go deeper into the different audits involved in obtaining and maintaining an ISO Certification:

Certification Audit:

A certification audit is conducted once every 3 years to verify the effectiveness of the whole QMS against the ISO 9001 standard. A third-party certification audit is conducted by an IAF-MLA signatory member Certification Body accredited to ISO 17021 – the standard for Management Systems Certification Bodies. The certification audit is broken down into 2 stages, a stage 1 audit and a stage 2 audit:

Certification audits consist of two stages

STAGE ONE audit is used to determine if your company is ready for stage two. A certification body will detail the minimum requirements your organization must meet to ensure you’re ready for a stage 2 audit, going through your documentation and comparing it to the requirements of the standard to assess compliance and readiness for an audit. It is best to be sure your organization is ready because, during a stage 2 audit, your certification body can raise non-conformities and other issues with your system that may require the auditor to return to audit your system, resulting in additional costs.

STAGE TWO is an on-site audit where a third-party auditor will review your documents, your processes, interview your employees and review your operations to determine compliance with the ISO 9001 standard. Your Certification Body will submit an audit plan ahead of the arrival of your auditor to allow you to prepare your documents, schedule the availability of relevant employees and allow for any necessary preparations. If your organization has more than one shift, the audit will be planned accordingly to sample as much evidence from each shift as needed to prove compliance. During the audit, you can expect the auditor or audit team (depending on the size of your organization) to hold an opening meeting which will detail their audit plan and schedule, after which the audit will begin. The scope and timeframe of the audit are dictated by ISO 17021. Certification Bodies cannot change the number of days the audit needs to be on-site, that is a predetermined guideline which is based on the number of employees at your organization and the level of risk associated with your QMS. Be upfront about how many employees you have, full-time, part-time and contract employees. If this number changes, inform your certification body as this may change your audit schedule.

Surveillance Audits:

In the 3-year cycle of an ISO Certificate, you will receive 2 surveillance audits, once each calendar year after your certification audit the first year of your cycle. Once you receive your ISO certification, the next 2 years will include smaller surveillance audits, with the auditor only auditing select processes and departments. The length and duration of these audits are again dictated by ISO 17021. Between the time of your certification audit and your surveillance audit, you will need to ensure you are continuing to meet the requirements of ISO 9001, for example holding internal audits, management review meetings, etc. within the timeframes dictated by the standard. You will also need to continue upholding the internal requirements your organization has documented as part of your QMS, i.e., hiring processes, performance reviews,  etc. Failure to meet the requirements of your own system or the standard will result in non-conformances being raised during your external audit.

Non-conformities:

As mentioned in this article, failure to meet the requirements of ISO 9001 will result in a non-conformity which must be addressed and resolved via corrective action within a certain timeframe before your organization can be granted certification. The timeframe given for resolution is dependent on the severity of the non-conformance. Non-conformances can be Major, Minor, or an Opportunity for Improvement.

Summary

The road to Certification for ISO 9001 can seem long and daunting, but the payoff is well worth it. Setting your business up for long term success by utilizing ISO 9001 and the world’s leading quality management system to effectively and efficiently run your business is just good business. Ensuring your organization has rules and processes in place that ensure you produce exactly what you say you will make good business sense. Having a third-party come in to verify this once a year holds you and your staff accountable to your rules and processes as well as the standard. Holding an accredited ISO 9001 certificate is outward proof to your customers that you hold their values and hopes for the quality of your products and services to the highest standard, the ISO Standard. Being ISO 9001 certified proves to your customers, your suppliers and your stakeholders that you care about the quality and consistency of your work above anything else, and you care about the longevity of your business practices. It may seem like a long road when you first embark on it, but the hardest step is always the first step. Once you have created momentum and movement within your organization of quality first, your organization will see the rewards that certification brings.

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What is ISO Certification - ISOUpdate.com

What does it mean to be ISO Certified?

Even if you’re relatively new to the quality business, you might have heard of “ISO” being frequently namedropped especially in the context of quality management. Far from a simple buzzword, it’s quite a big deal in the marketplace and as an aspiring new business, a business person looking to grow your business, or even an entrepreneur looking to set your business up for long-term success, you need to be informed about ISO Standards and standardization.

ISO Certification

ISO is the International Organization for Standardization – It’s an independent, international organization that produces various standards spanning throughout the business sector that help improve and ensure quality, efficiency, consistency, and safety of operations and their consequent products and services.

Relevant business sectors include health and safety, information security, energy management, environmental management, aerospace and defense, medical devices, and many more. The standards are deliberately made to be both comprehensive yet generic enough to be incorporated into any business regardless of size, sector or context.

It is important to note here that ISO cannot certify you themselves. ISO develops the standards, but the certification process is performed by external certification bodies and ISO cannot certify a company or organization directly.  Despite this, their committee on conformity assessment (CASCO) has produced a set of guidelines and standards that these external certification bodies are expected to use as a reference to help adequately measure conformance and quality during the certification process.

ISO 9001 is an internationally recognized and trusted quality management system that has been adopted by companies all over the world to help achieve standardization and quality assurance. The first step to ISO 9001 Certification is to understand the standard. You will want to download the standard document first to get familiar with the requirements of certification. The ISO 9001 standard is basically a rule book stating what you need to have or do. The standard is generic in nature, allowing any organization in any industry to benefit from it. ISO 9001:2015 is currently the most recent version of the standard and is the version you should be using to develop your quality management system.

By following these requirements you are “compliant with the ISO 9001 Standard and therefore can be recommended for certification by your Certification Body.


Purchase the ISO 9001:2015 Standard Here


When choosing a Certification Body (CB) to provide certification and auditing services to your company, verify that they are accredited. This simply means the CB is compliant with their own set of standards for being a CB, specifically ISO 17021. Check out our video on “requirements for certification bodies” to learn more.

Complying to ISO 17021 means the demands of the standard are assessed by an external agency called an Accreditation Body that is a member of the IAF-MLA in the CB’s region. Consider this a license to issue certificates or a degree to do a certain job, without which you are not qualified. To issue a certification of compliance to ISO 9001:2015, your CB should be accredited to ISO 17021.

What does it mean to be ISO Certified?

Being ISO 9001 Certified means your organization has a quality management system in place that utilizes international best practices to standardize your processes and system using the ISO 9001:2015 standard to ensure you consistently produce products and services that meet and exceed your customer’s expectations.

Since the guidelines of ISO 9001 are quite comprehensive and the process of implementing a system, having multiple audits, and maintaining compliance is quite stringent, achieving certification is recognized as an impressive feat and speaks volumes about your company’s commitment to providing your customers with high-quality service.

What Next?

If you are considering ISO 9001 certification, but do not have relevant experience, check out these resources to help you get started:

What is ISO 9001?

Tips for Implementing the Standard

Choosing a Certification Body – Choosing the best Certification Body for your Business

Tips for Audits:

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AS9100 & The Importance of OASIS - ISOUpdate.com

As competition grows, the need for quality management is becoming more and more critical for every industry. Many industries have taken the backbone to all quality management system standards, ISO 9001, and added elements to ensure it works perfectly for them. The Aviation, Space and Defence industry was one of the first to do this when they released their own unique management systems standard in 1999. If you have been working in the aerospace industry, you understand the importance and criticality that the AS9100 standard now plays.

Defining AS9100

AS9100, which can also be written as EN 9100, was released in October of 1999, by the Society of Automotive Engineers and the European Association of Aerospace Industries. The intent was to create an aerospace standard that would ensure the safety of the consumer and provide the best quality to the customer. Almost all major aerospace companies have adopted these standards in their operations as well as throughout their supply chains.

AS9100 has also been endorsed by the major regulators in the industry: The Federal Aviation Administration (FAA), The U.S. Department of Defense (DoD) and National Aeronautics and Space Administration (NASA).

The AS9100 series of quality standards adds over 100 requirements to the ISO 9001 standard that apply specifically to the aerospace industry, including the following:

  • Additional configuration management
  • Special risk management
  • Industry-critical items
  • Increased focus on timely delivery
  • Focus on product management
  • Approval process and scope for suppliers
  • Prevention of counterfeit parts

Did you know? The AS9100 document was originally introduced by the American Society of Automotive Engineers and the European Association of Aerospace Industries. The document was subsequently picked up by the IAQG as a method of maintaining industry quality levels on a global scale. – Source

What are the Benefits of AS9100 to you as a Business Owner?

AS9100 is an effective way to promote that your organization is consistently capable of providing products and services that meet customer requirements and comply with all relevant and regulatory requirements. AS9100 also demonstrates your organization’s ability to enhance customer satisfaction and improve both processes and practices, and products and/or services.

Engagement in Employees

Understanding the value of engaging employees and having conversations directly about QMS and quality can improve not only the processes they are actively involved in but also the quality of their workmanship. ISO 9001 and AS9100 work to make the most efficient improvements throughout your organization, but engaging employees creates employees who are fully absorbed by and enthusiastic about their work and so take a positive action to further the organization’s reputation and interests. – Source

Engaged employees are more likely to: positively influence other employees; be more productive and profitable; provide better customer service; be more enthusiastic about their work; be comfortable staying in their role; offer positive suggestions for the organization, and offer word of mouth promotion for your organization.

Read a more detailed look into employee engagement.

Customer Satisfaction

Being customer-centric means you are able to extract and fulfil customer requirements and then follow up with feedback and steps that act upon that feedback. Happy customers are repeat customers, and in a study by Bain & Company detailing e-commerce shoppers, the study demonstrated that repeat customers can actually increase their profitability by attracting more clients to your organization through referrals.

Lower Costs

A study undertaken through the American Society for Quality (ASQ) showed that for every $1 spent on your QMS, you could expect to see an additional $6 in revenue, a $16 reduction in costs, and a $3 increase in profits. On average, they saw that quality management systems reduced costs by 4.8%.

Another study undertaken by the Harvard Business School showed that companies that adopted ISO 9001 had the following benefits:

  • Higher rates of survival
  • Increased Sales
  • Growth in employment
  • Increased wages
  • Less waste
  • Improved worker productivity

Read more about the ROI of Quality


The AS9100 Certification Process

AS9100 certification is conducted through an external and impartial audit by an accredited certification body. AS9100D certification is for 3 years, with your first audit being the certification audit, and 2 surveillance audits happening each consecutive year after certification. Every 3 years, if your organization wishes to continue to be certified to AS9100, your certification body will conduct a recertification audit and 2 surveillance audits in this same order.

It is important to note that before the certification audit can take place, your organization will need to internally assess that all AS9100 requirements are met. Consider this in layman’s, the period your organization needs to prepare for and study for a test.

You should also note that because of the complementary nature of ISO 9001 and AS9100, any organization seeking AS9100:2016 certification must first comply with ISO 9001:2015.

More on the Relationship Between ISO 9001 and AS9100

Some of the most important alterations between the 2008 and 2015 iterations of ISO 9001 that directly relate to AS9100 include:

  • A 10 clause structure based on the Annex SL formatting model
  • An increased focus on external processes, products and services
  • An expanded focus on stakeholder satisfaction and company performance
  • An improved approach to risk-based thinking and risk mitigation

Source

The AS9100 Certification Process starts with your organization understanding the guidelines that have been set out by AS9100 and ensuring the requirements are being met. Your organization might want to consider looking for a Consultant to help implement processes. To remain impartial, your AS9100 auditor and your Certification Body cannot offer suggestions to help you pass requirements, you will need to work with a third party to ensure success for your certification.


Find a Consultant here.


After you’re satisfied that your efforts will meet AS9100 requirements, your organization will then appoint an internal auditor that periodically checks whether those standards are being conformed to or not. In the case that an internal employee with the capability or experience does not exist, outsourcing to an auditor should be considered.

After your organization is satisfied with your capacity to achieve certification, you will want to start finding quotes from AS9100 Certification Bodies. Consider your choice of Certification Body carefully as you will be working with them consistently through the certification process, and at least once per year during recertification and surveillance audit periods.

It is important to note that if you are dissatisfied with your current CB, you can transfer your certificate to a different Certification Body at any time during the process. There is a transfer fee involved in moving your certificate, and to transfer your data in OASIS. However, you might find it is worth the investment.


You can find a Registrar here.  


What is OASIS

OASIS or Online Aerospace Supplier Information System, is an online directory of members of the IAQG that houses information on certified suppliers and their audits, accredited certification bodies, AQMS auditors, accreditation bodies, and participating National Aerospace Industry Associations (NAIA). – Source

The IAQG website defines themselves as “a cooperative organization within the aerospace & defence industry comprised of 3 sectors (Americas – AAQG, Asia/Pacific – APAQG and Europe – EAQG)” … and their purpose is defined to “establish and maintain a dynamic cooperation based on trust between aerospace & defence companies on initiatives to make significant improvements in quality performance and reductions in cost throughout the value stream”. – Source

The Importance of OASIS

Online Aerospace Supplier Information System (OASIS) is a database used to assist in the management and transparency of AS9100. OASIS is free to join and provides organizations with access to a list of CB’s, training providers, and accreditation bodies. OASIS can also be used to find other certified organizations or auditors who can perform AS audits.

Did you know? Through OASIS, you can check other organizations’ certification status and additional information regarding their certification such as approval status and the date of their last audit. The results of an organization’s audit can also be requested through OASIS.

While OASIS is a free database, it is mandatory. If any aerospace certified supplier refuses to be a part of OASIS or refuses to set up an OASIS administrator, Certification Bodies are required by the IAQG to revoke their certificate of registration. Your CB will be responsible for collecting and uploading information, including certificates, pertaining to individual aerospace companies into OASIS.


Why is AS9100 and its regulation so important? Consider the relationship you have and want to portray to your customers, suppliers, clients, and major interested parties. Certification to AS9100 is a way to demonstrate to these bodies that you are taking an active interest in promoting quality and efficiency in your industry. AS9100 is a cost-effective ROI, a confidence builder, and employee engaging solution to your inefficiency problems.

Get a Quote for AS9100D Certification

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Understanding ISO 21041 and Unit Pricing - ISOUpdate.com

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

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

What is ISO 21041?

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

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

What is Unit Pricing?

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

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

Understanding ISO 21041 and Unit Pricing Labels - ISOUpdate.com

Why is Unit Pricing Necessary?

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

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

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

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

Unit Pricing and Global Consumerism

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

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

Summary

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

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

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

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

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

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

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

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How Does ISO 45001 Differ to OHSAS 18001? - ISOUpdate.com

The new ISO 45001 standard has been published and supersede OHSAS 18001. It is a truly international standard as scores of countries will agree to it.

Note: Companies already certified to OHSAS 18001 will have 3 years’ to become certified to the new standard.

The new standard applies the ISO High Level Structure and is compatible with ISO 9001:2015 and ISO 14001:2015 thus easily integrated with these management systems and give more value to the organizations.



What are the Differences Between ISO 45001 and OHSAS 18001?

Context of Organization

Companies will have to define the Context of their Organizations, meaning the External and Internal Issues in the environment in which they operate. The Context will have to be systematically determined and monitored.

The organization shall have to look the conditions affecting the operations such as regulations, stakeholders and governance. They have to understand the drivers of their organizational culture.

Needs and Expectations of Workers

The Needs and Expectations of Workers and other Interested Parties such as Shareholders, Customers and Board Members have to be defined. From this step the requirements and deliverables of the Management System will be further developed.

Risks and Opportunities

Organizations will be required to determine the Risks and Opportunities that may impact its ability to deliver planned results which shall include enhancement of health and safety of employees during the job. Legal and other requirements have also got to be identified and considered.

Leadership

There is increased emphasis on the Leadership of the company to become engaged in and be responsible for the management system to be more effective.

Objectives and Performance Reviews

There is an increased focus on the Objectives determined by the organization as improvement drivers and their achievement shall be evaluated during Performance Review. The Objectives should support the Policy and shall be considered within the available resources. The responsibility for achieving Objectives, the time frame and measures to establish progress has to be decided and should evaluate whether Objectives have been achieved. Documented information has to be retained about objectives and plans to achieve them.



Communication Requirements

Communications requirements have been enhanced in terms of defining the objective of communication and if it was effective in addition to Who, What and When it should take place.

Removal of Preventive Action

Preventive Action has been removed from Corrective and Preventive Actions. The Preventive Actions are now undertaken in the Risk Management Processes while determining the risks and opportunities and ways to reduce or eliminate risks and undertake opportunities.

Health and Safety

It also allows the participation and consultation of workers to a higher degree in the Health and Safety Management System.

The new standard has requirements for taking care of and monitoring the health and safety of workers in the Contractor’s organizations and in Outsourced Processes and during Procurement Processes.

Risk Control

For the reduction of OH&S risks and eliminating Hazards the new standard specifies hierarchy of controls in an order of preference with reference to risk management. Hazards and risk controls are required to be planned in the operational controls. The standard introduces requirements for management of planned changes in operations such as working conditions, work force, equipment as well as changes in risks and known hazards.

Implementation of the new ISO/FDIS 45001 standard will result on overall better Health and Safety of Workers and reduced accidents.


Learn more about ISO 45001 Standard

Read more about Monitoring and Measurement in ISO 45001




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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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Quality

Have you ever stood staring at a range of products in a supermarket trying to make up your mind which one to buy?  They all look quite similar, but one stands out and you buy it.  Why?  It’s got a sign on the shelf and a logo on the product to tell you that it’s won an award for quality.

So you’ve just based your purchase on Quality – Your customers are making the same decision every day!

Quality is more than just finished product, it’s the processes, systems and people that are behind the product.   Quality is everybody’s responsibility.



Quality is the pursuit of excellence, striving to be the best we can and getting ahead of our competitors.  It is meeting the needs and expectations of all stakeholders – our customers, our suppliers, our staff and the community at large.

How can we ensure that we are exploiting all avenues to be the very best?  A recognized standard such as ISO 9001 certification promotes the use of quality tools in business.   The ASQ (American society for quality) estimates that for every €1 spent on a quality management system, such as ISO 9001, returns €6 in revenue, €16 in cost reduction and €3 in profit – that’s €25 for every €1 spent!

93% of organisations agree that the implementation of a quality management system such as ISO9001 was a significant driver of success and most would agree that without it they could not justify their pricing to customers.

If you are looking at ways to improve your ROI by improving your quality then consider ISO certification.   Using an expert to help you implement a quality management system will ensure ISO 9001:2015 accreditation which will in turn help you make significant improvements and lead to significant growth.

 

This post has been a guest posting from Joann O’Brian over at our friends at CG Business Consulting Ireland .



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ISO standards are developed and published following a systematic process involving ISO members and sector specific experts. When the need for a standard has been identified, a panel of experts, within an ISO technical committee (TC), meet to discuss and negotiate the first draft of the standard. Once a draft has been developed, ISO’s members are asked to comment and vote on it. If a consensus is reached, the draft becomes an ISO standard, if not it goes back to the technical committee for further edits.

6 Steps to Creating an ISO Standard

1. Standard Proposed to Relevant TC.

Contrary to what many believe, ISO does not decide when a new standard should be developed. ISO responds to a sector specific need when industry or other stakeholders make a formal request of a standard. Typically, an industry sector or group communicates the need for a standard to its national member who then contacts ISO. Practically every country (163 to be exact) has one ISO member that can be reached for this purpose.The TC reviews the proposal and if it’s accepted, the process will continue.

2. Experts Prepare a Working Draft

These experts negotiate all aspects of the standard, including its scope, key definitions and content. These group of experts are from all over the world and they are part of larger groups that form a TC.

3. Working Draft Shared

TCs are made up of representatives of industry, NGOs, governments and other stakeholders, who are put forward by ISO’s members. Each TC deals with a different subject; ISO has over 250 TC. The relevant TC reviews the first draft and if consensus is reached within the TC, the process moves on.

4. Draft is Shared with all ISO National Members

As mentioned above, there is a member in almost every country. The draft is shared with these member (over 150) and each is asked to review and comment. All these comments are taken into account by the TC and if a consensus is reached, the process continues to step 5.

5. Final Draft Sent to all ISO Members

The final draft is sent to all members for approval. If it is approved by member vote, the process continues to its final step.

6. ISO International Standard

The ISO International Standard is published and available for the public to purchase. This can be purchased from the ISO store or from the ISO national members. A full list of the ISO member of each country is available in the ISO website.

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ISO Implementation Process

Preparing for an ISO implementation process of any ISO standard can be overwhelming and stressful for organizations of any size. How an organization prepares for an ISO implementation process will depend on factors such as size and complexity of its processes, the current knowledge and culture related to the standard; i.e., quality, environmental, safety, etc; the maturity of any other existing systems related to the standard wishing to implement, and many others.

6 Tips to Facilitate the ISO Implementation Process

Despite the differences there may be between organizations, there are a few tips that will facilitate the ISO implementation process of any management system.

Know the Standard

It is essential that some personnel knows the management system’s requirements. Everyone does not need to be an expert on the requirements of the specific standard that will be implemented, but key workers need to fully know and understand all of the requirements of the standard.

Keep Everyone Informed

The implementation process is not a task of just a few chosen ones. Everyone needs to be involved in this process. Every worker needs to know what is being implemented, why is it being implemented, which are the benefits for the organization and for themselves, and how they will be involved in the process. When people are informed, they will be more open and willing to collaborate in the implementation.

Analyze the Organization’s Current Situation

Before starting to implement any ISO management system, an organization needs to know its level of compliance with the standard. This will allow the organization to understand beforehand its strengths and weaknesses regarding the ISO management system wishing to implement and estimate the time needed for implementation.

Map Your Processes

Establish and record current processes in order to know the relationships between departments and how the processes flow within the organization. This will allow organizations to plan their implementation by processes and not just by areas and departments.

Review Existing Procedures and Work Instructions

Many processes need written and documented information that will guarantee that activities are carried out in the correct manner. Organizations need to review which processes are documented and how many work instructions there are. It is not the same to develop a few documents and just review work instructions than to develop them from scratch. Organizations need to have an idea of how much time they will have to invest in developing and reviewing documents.

Review Current Training Programs

Evaluate existing training and awareness programs. Training and awareness are an important part in the implementation process and if an organization has not considered training its workers, it would be best to redefine these programs to make sure that a large percentage of workers are trained and informed about policies, procedures, regulations, etc that will be a part of their daily activities.

These are some recommendations that will help your organization prepare for the ISO implementation process of any ISO management system.

Note: Make sure that the whole organization is working for the same objectives and pulling in the same direction.

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Improving your Quality Management System is simpler than you think. By learning about ways to improve, you are already well on your way to achieving success with your organization or auditor training. Follow these 10 simple suggestions and you will see changes.

10 Simple Ways to Improve your Quality Management System

1. Commit to improvement

For any QMS to improve, it is essential that everyone is committed to seeking problems, evaluating efficiency and effectiveness of processes and implementing better and improved ideas. Management should be the first to make this commitment and if management “walks the talk” then everyone will follow.

2. Analyse and assess current QMS

Organizations need to take a closer look at their current practices in order to identify any gaps between what is being done and what should be done. This can be achieved by interviewing workers in critical control points, reviewing procedures and records and observing how processes are occurring. Any steps that are not adding value to the process, the system or the organization must be identified, removed or improved.

3. Include everyone in training programs

A QMS is not the responsibility of one person or one department. Everyone must be involved in improving the quality of products, services and processes.

Organizations should establish a training program for new employees and existing ones.  These programs should promote knowledge, produce skills and capacities and reduce resistance when implementing new ideas for improvement.

4. Define clear goals and objectives

QMS should aim at achieving specific goals. If a clear path is not drawn, there’s a risk that people will be working real hard but in different directions. Time should be spent in assuring everyone knows these goals, how they’ll be achieved, how they’re measured and periodically they should be informed of where the organization is standing in relation to these goals.

5. Use the correct key performance indicators

Organizations need to carefully select and review their KPI’s (Key Performance Indicators). KPI’s let an organization know how efficient and effective processes are, and indicate where possible problems could be. If they are not giving a real overall picture of where the organization is at regarding quality, then another look should be taken to change or improve what and how performance is being measured.

6. Listen to the suggestion

Create a system that will promote workers and customers to share improvement ideas. Many great improvement ideas come directly from the people processing a product or the people that actually use it.

7. Give credit

Giving credit to those who deserve it encourage participation throughout the organization and motivates workers by recognizing their work and their ideas. Compensation or recognition should not necessarily be monetary, a simple public recognition in working meetings to can have great effects in lifting workers morale.

8. Make the system simple

A QMS that is extremely complex and overloaded with documents is not necessarily the best one. If documents and procedures are long and complicated, it is very likely that people will never use them.

Evaluate the system and make sure that it makes sense and that it’s as simple as possible.

9. Create quality groups

Some organizations face difficulty with workers from different departments or areas that are reluctant with sharing information. By bringing together people from different areas to evaluate processes and recommend improvements, an open and more effective communication can be achieved between areas that operationally seem to be apart.

10. Have a quality attitude

In order to reach the goals that have been set, organizations need to identify and detect problems and weaknesses but they must focus on improvements. If managers are constantly focusing on failures and defects and not on how to remove or improve them, the right attitude and mindset for quality will never be achieved.

Learn how to prepare your company for the ISO Implementation Process.