Tags Posts tagged with "ISO"

ISO

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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 Implementation Process

Preparing for an ISO implementation process of any ISO standard can be overwhelming and frightening for many. How an organization prepares for implementation will depend on factors such as size and complexity of its processes, the current knowledge and culture related to the standard (quality, environmental, safety, etc), the maturity of any other existing systems related to the standard wishing to implement, and many others. Despite the differences there may be between organizations, there are a few tips that will facilitate the implementation process of any management system, these are:

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.

Inform everyone what is going on.

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 organizations prepare for the implementation process of any ISO management system. The most important aspect to keep in mind is to make sure that the whole organization is working for the same objectives and pulling in the same direction.

 

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  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.

  1. 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.

  1. 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.

  1. Define clear goals and objectives and make sure everyone knows them.

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.

  1. Make sure the right key performance indicators (KPI) are being used.

Organizations need to carefully select and review their KPI. These should 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.

  1. Listen to the suggestions of employees and customers.

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.

  1. Give people credit.

To encourage participation throughout the organization, motivate 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.

  1. 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.

  1. Create quality groups.

In many organizations workers from different departments or areas 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.

  1. 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.

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ISO 9001 System

Here are some of the most common mistakes made by organizations when managing an ISO 9001 system:

Mistake 1. Top management is not committed to the ISO 9001 system.  If top management is not involved in quality, if they don’t provide the resources and mechanism to plan, control and improve their products, services and processes, ISO 9001 can not be sustained over time. It’s essential for top management to take decisions that demonstrate that quality, improvement and customer satisfaction are an important issue.

 

Mistake 2. Not training key personnel in ISO 9001. Not knowing what ISO 9001 is all about can be a big mistake. It is important for organizations to train key personnel (someone who has a decision-making role) in ISO 9001, in order to understand what ISO 9001 really is and what it requires. Not knowing nor understanding ISO 9001 can take organizations through a path of disappointment and despair.

 

Mistake 3. Not training all personnel. Everyone must receive training on the important quality aspects of the activities and processes they work in. Everyone must understand the importance of quality and how they can achieve it. The training must be consonant with their responsibilities and the activities they perform.

 

Mistake 4. Making the system complex. If the organization is working to keep the system alive, it is a sign that it is too complex and all the work of filling out forms and documenting procedures is not adding value to the organization. The system must be kept simple and practical, and it should focus on results and improvements, and not on documents.

 

Mistake 5. Not using the corrective action process properly. Organizations need to take the time to investigate their problems and involve the right people in the investigation process. Most problems are recurrent, so using the corrective action process correctly will reduce or eliminate their recurrence.

 

Mistake 6. Not knowing what customers want. One of the objectives of ISO 9001 is to improve or increase customer satisfaction, and if organizations do not take the time to listen to their customers, they will not be able to reach this goal. A long and complicated survey is not necessary nor recommended, just by asking a few key questions will give organizations enough information to determine and plan for changes that will aim to fulfill this goal.

 

Mistake 7. Rushing into the implementation process. To build a solid ISO 9001 management system takes work and time.Trying to implement the system in a short time will be counterproductive. Organizations need to take the necessary time to plan, do, check and act in order to implement a system that will improve their products, services and processes.

 

Mistake 8. Not having a trained and experienced internal auditor. In many cases, internal auditors lack the necessary training and experience to distinguish small details from big issues in the QMS. Auditors need to focus on the issues that will help organizations improve their processes and the system itself.

 

Mistake 9. Believing that what works for one organization will work for their own. Every organization is different and what may work for one, may not work for another. Organizations need to focus on their specific context in order to build and develop their management system around it.

 

Mistake 10. Leaving the responsibility of the QMS to one person. ISO 9001 needs to be the work of an entire organization. If people do not take ownership of the QMS, it will not work out. People need to incorporate quality in their work and activities and an outsider will not achieve that. Guidance and training is needed, but if quality is not done on a daily basis in every process then the system will never add value to the organization.

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All ISO standards are developed and published following a systematic process were ISO members and sector specific experts are involved.  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. As soon as a draft has been developed it is shared with ISO’s members who 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.

Below is a more detailed explanation of each step a standard undergoes before it is released to the public.

  1. A new Standard is 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 to step 2.

  2. Working groups of experts start discussion to 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. First working draft shared with TC and with ISO CS.
    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 to step 4.

  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 is 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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Measuring Supplier Performance

The new ISO 9001:2015 is currently at the Final Draft International Stage (FDIS), the fifth stage of a six stage process, and the final revision is expected to be published by September 2015. There are a lot of expectations regarding the release of the new standard and many are wondering what the differences will be between ISO 9001:2008 and ISO 9001:2015.

The recently published draft of the standard (DIS) has shown what the main differences are about; even though both standards cover essentially the same topics, there are some important changes. Some of these are:

  1. The most notorious difference between the standards is its structure. ISO 9001:2008 had five main sections and ISO 9001:2015 has seven. The new ISO 9001:2015 aligns with high-level organizational structure established on the ISO Guide 83 (“Annex SL”), requiring all new ISO management system standards to be aligned on a high-level structure with a set of common requirements. Such structure is as follow:
    • Scope
    • Normative References
    • Terms and Definitions
    • Context of the Organization
    • Leadership
    • Planning
    • Support
    • Operation
    • Performance Evaluation
    • Improvement
  2. The new standard puts a greater emphasis on the “context of the organization”. Unlike ISO 9001:2008, the new standard will require organizations to consider the external and internal issues that may influence their quality management system (QMS) and they will need to determine how these will be addressed.
  3. With the new ISO 9001:2015, organizations will be required to take a risk-based approach to identify and address the risks that can jeopardize their ability to meet customer and regulatory requirements. In ISO 9001:2008, even though a risk-based approach is not explicit, the standard implicitly guides organizations in managing their risk.
  4. The new standard has eliminated the distinction between documents and records by referring only to “Documented information”. There also will be general requirements for documentation, with no reference to documented quality manual, documented procedures or to quality records.
  5. The specific requirements for preventive action present in ISO 9001:2008 have been removed in the new standard. This decision was motivated by the perspective that prevention is the task of the QMS in its entirety.
  6. Some concepts have been replaced in the new standard, such as the term “product” is replaced by “goods & services” and “continual” by “continual improvement.”“Purchasing” and “outsourcing” will be replaced by “external provision of goods and services”.
  7. The new standard also eliminates any reference to a “Management Representative”. Instead, management duties and responsibilities can now be assigned directly to top management (to one person in particular or to many).

These are the main differences between the two standards which are based on the DIS version of ISO 9001:2015. There are still comments from over 90 countries that will be taken into account and it is yet to see which of these changes will be maintained in the final official version.

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Since the 1960s, HACCP has been recognized internationally as a logical tool for adapting traditional inspection methods to a modern, science-based, food safety system.
Since the 1960s, HACCP has been recognized internationally as a logical tool for adapting traditional inspection methods to a modern, science-based, food safety system.

ISO 14001 is under review. After its original publication in 1996, this is the first time it’s going through major changes. The review process is currently at the Draft International Standard (DIS) stage, the fourth stage of a six stage process, and  the final revised ISO 14001:2015 is due to be published by the end of 2015. Some of the main changes ISO 14001:2004 is undergoing are:

  1. The first change to ISO 14001:2004 concerns its structure. This revision is based on the ISO Guide 83 (“Annex SL”) which defines a common high level structure, text and common terms and definitions for the next generation of management systems. This structure aims to facilitate the implementation process and the integration of several management systems in a harmonized, structured and efficient manner. Such structure is as follow:
    1. Scope
    2. Normative References
    3. Terms and Definitions
    4. Context of the Organization
    5. Leadership
    6. Planning
    7. Support
    8. Operation
    9. Performance Evaluation
    10. Improvement
  2. New concepts have been added, such as “supply chain”, “value chain” and “product life cycle” and existing definitions have been modified to give a different emphasis and to improve clarity.
  3. Two new clauses have been introduced which focuses on an organization’s context. These require organizations to determine the issues and requirements that can influence the scope of its EMS and take them into account.
  4. There’s a greater emphasis on top management, requiring them to take the lead in integrating the environmental management practices into their organization’s core strategies, processes, and priorities.
  5. Regarding environmental policy, organization should be committed to protecting the environment rather than just preventing its pollution, as stated in ISO 14001:2004.
  6. A greater emphasis is placed on an organization determining its own risk profile.
  7. Organizations are required to control or influence processes and services associated with significant environmental aspects, organizational risks, lifecycle and emergency preparedness.
  8. There is a greater focus on environmental performance improvement across the value chain.
  9. The DIS does not include specific requirements for preventive action. The new standard no longer thinks of preventive measures as a separate topic, but rather as a central component of all environmental-related activities.
  10. Environmental objectives have been given a separate sub-clause with the “planning actions to achieve environmental objectives.”
  11. The terms “document” and “record” have both been replaced throughout the DIS with the term “documented information”. The DIS states that documented information must be maintained to the extent necessary to have confidence that the processes have been carried out as planned.

It is important to mention that this standard is still under review, and there is still to see which changes will make it to the final revision. However, it’s clear that the overall goal of ISO 14001:2015 is to respond to the latest environmental trends, help organizations improve their environmental performance and prepare them for future environmental challenges.

 

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The quality management system (QMS) standard ISO 9001:2008 is currently under review. Like all ISO standards, which go through a revision every 5 years, ISO 9001 is being updated to reflect new technological advancements in the workplace and a to give a higher focus on the quality of outputs to customers.

The review process is currently at the Final Draft International Stage (FDIS), the fifth stage of a six stage process and  the final revised ISO 9001:2015 is due to be published by September 2015. Some of the upcoming changes to ISO 9001:2008 are:

  1. The new ISO 9001 standard aligns with high-level organizational structure established on the ISO Guide 83 (“Annex SL”), requiring all new ISO management system standards to be aligned on a high-level structure with a set of common requirements. This structure aims to facilitate the implementation process and the integration of several management systems in a harmonized, structured and efficient manner. Such structure is as follow:
    1. Scope
    2. Normative References
    3. Terms and Definitions
    4. Context of the Organization
    5. Leadership
    6. Planning
    7. Support
    8. Operation
    9. Performance Evaluation
    10. Improvement
  2. Some concepts are replaced, such as the term “product” is replaced by “goods & services” and “continual” by “continual improvement.” “Purchasing” and “outsourcing” will be replaced by “external provision of goods and services”
  3. The new standard puts a greater emphasis on the “context of the organization” which implies a broader measurement, planning and implementation view.
  4. The new standard will take a risk-based approach to determine the type and extent of controls appropriate to each external provider and all external provision of goods and services. The proposed standard addresses risks which can affect conformity of goods and services as well as customer satisfaction.
  5. Senior management will be required to take a more active involvement in the quality management system.
  6. There will be general requirements for documentation, with no reference to documented quality manual, documented procedures or to quality records. The DIS refers to “Documented Information.”
  7. The need for exclusions may not be considered to be necessary in the new version of the standard but feedback on this is being sought as part of the revision process.

Regardless of the upcoming changes, ISO 9001 will continue to be a generic standard, relevant to all sizes and types of organizations in any sector and it will continue to deliver “confidence in the organization’s ability to consistently provide product or services that meets customer and applicable statutory and regulatory requirements”.

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No one can deny the increasing impact of human activities on our environment. Our society is ever more preoccupied and occupied on the many issues affecting our environment today, such as pollution, over-consumption of resources, degradation of ecosystems and biodiversity, and an increasing world population that demands resources in the amount and quality that will ensure a decent and fulfilling life.

Organizations everywhere have implemented environmental management systems (EMS) to ensure compliance with an increasingly stringent legislation, control the impacts of their activities, products or services, and increase sound environmental performance.

Implementing and conforming to an EMS based on the ISO 14001 standard not only shows that an organization is environmentally responsible, but it also brings numerous benefits within the organization by:

  • Identifying cost savings with greater emphasis on resources, waste and energy management.
  • Quantifying, monitoring and controlling the impact of operations on the environment, now and in the future.
  • Increasing profits through potential process improvements and energy conservation.
  • Reducing costs as a result of potentially lower insurance rates.
  • Verifying your systems for recognizing and complying with environmental laws and regulations.
  • Improve environmental performance of supply chain.
  • Ensuring that information is properly documented, communicated and retained.
  • Increasing employee awareness and participation by making it clear that environmental performance is an important part of the organization’s culture
  • Improving management of environmental risks and emergency preparedness and response procedures.

Other benefits of ISO 14001 come from how the organization is seen from outside by interested parties, some of these are:

  • Improved corporate image among business partners, regulatory agencies, and community by showing that the organization is environmentally responsible.
  • Improved relationships with government regulatory agencies; organizations that have implemented ISO 14001 find that regulators are quicker to provide technical support, and find that the regulators are much more supportive in general.
  • Advantage over competitors when tendering for business.
  • Grow access to business partners and potential customers.

ISO 14001 provides organizations with knowledge, tools and techniques to build success over the long term and create new opportunities for development and growth. These tools can be aligned with an organization’s priorities, strategy and decision-making by integrating them with other business requirements and embedding environmental governance into its overall management system, thereby achieving both environmental and economic goals.

The market is driving organizations to demonstrate their success in protecting our environment; more and more people want to be environmentally responsible and they are doing so by choosing products and services that have been designed, produced, developed and delivered in an environmentally friendly way. Therefore, in the near future, ISO 14001 will become a prerequisite for doing business worldwide.

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If your organization is ready to become ISO 9001 certified, there are a number of steps you can expect to go through on your path to certification. Once an organization has decided to obtain certification and has made a choice of the certification body (CB), the organization must:

 Make a formal certification application to the CB.

  • Fill out the application forms, which require a large amount of information about the organization and its operations. This will enable the CB to determine the scope of the certification activities and to appoint the team leader for the audit process.

 The initial certification audit consists of a two-stage audit as described below:

 The Stage 1 Audit determines if an organization is ready or not for a compliance audit.

  • Organizations need to supply all relevant management and quality documentation to the CB.
  • The CB determines if the organization is ready or not to undergo Stage 2 or compliance audit.
  • If the organization is not ready, the CB will inform accordingly and stop the process.
  • If the organization is ready, but a few nonconformities have to be rectified before the compliance audit can take place, the CB will provide the organization with a report.
  • After nonconformities have been corrected, the organization must inform the CB, and if they concur with the actions taken, a compliance audit is arranged.

 The Stage 2 Audit evaluates the implementation and effectiveness of the organization’s QMS.

  • The team leader assembles a team of auditors and experts concomitant with the organization’s scope of activities, complexities and size of operations.
  • A time for the audit is agreed and scheduled.
  • Auditors will assess whether the contents of the documentation provided is consistent with the activities of the organization as well as the requirements of the standard.
  • Overall findings and the list of non-conformities (if any) are presented.
  • If the QMS complies with the requirements, the team will recommend to the certification committee of the CB that the organization should be certified.
  • If there are non-conformities found, the team will agree with the organization a time schedule (typically 3 months) and the modalities for rectifying the non-conformities.
  • The team may wish to witness the new procedures, or if the non-conformities are of a minor nature, the organization can send them evidence that these non-conformities have been fixed.
  • The team will recommend to the certification committee of the CB that the organization should be certified.

Learn more about Stage 1 and 2 audits.

Certification

  • Authorized persons or a committee which was not involved in the audit will review the audit report and the clearance report of the nonconformities and make a decision regarding certification.
  • The decision will be followed by the issue of certification documents.

 Surveillance Audits

  • The CB will conduct a surveillance audit usually once a year.
  • There are a few areas that will always be included in the surveillance audit, such as internal audits and management reviews as well as the non-conformity system.
  • If any non-conformity is raised during the surveillance audits, the organization must correct them efficiently within an agreed time frame, otherwise certification may be lost.

 Recertification Audit

  • In the third year of certification, a re-certification audit will be conducted, similar to the original compliance audit.
  • If this is negotiated successfully, the organization will be recertified for another three-year period, and the whole cycle repeats itself.