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ISO Standards and Industry Resources

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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.

 

0 2009
  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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No matter how many audits someone has gone through, knowing that someone will come and check your work always generates some tension and anxiety. Here are some recommendations to get rid of the fear and prepare for a successful ISO 9001 audit.

Prepare employees.

  • Refresh the quality policy and make sure everyone understands it. There is no need for workers to memorize it, but they should have a clear understanding of what the organization has committed to in terms of quality.
  • Refresh quality objectives. Workers should know what the organization’s quality objectives are and how they contribute in achieving them. They should know and be able to explain how their day to day activities can influence these objectives.
  • Ensure that everyone has been properly trained to perform their tasks.
  • Make sure everyone knows where to find procedures, work instructions and forms relevant to perform and record correctly a specific activity or process.
  • Let everyone know the scope of the audit, what will auditors be checking in their areas and when they will be audited.
  • Workers should have the confidence to answer what they know, and have the same confidence to say ‘’I don’t know” when they are not sure what they are going to answer.

Check all documented information.

  • Make sure document and record list has been updated.
  • Check that all documents have been reviewed, approved, communicated and followed by everyone involved in the process or activity.
  • Make sure no one is using obsolete documents.
  • Verify that all records are being used and that they are being filled out correctly.

Ensure all processes are being performed correctly.

  • Make sure that all the procedures (whether they are documented or not) are being followed.
  • Ensure that critical processes are being performed in the same way (correct way) by everyone.

Review the corrective and preventive action process.

  • Review the findings from previous audits and make sure they have been attended.
  • All nonconformities must be properly recorded, investigated and actions need to be in place or concluded by the time of the audit.
  • Corrective actions that have been executed and closed need to have a proper verification of its effectiveness.

Organize the workplace.

  • It is very hard for quality control and assurance to happen in a messy, dirty and unorganized workplace, and auditors know that. So, take time to organize the workplace (offices, desks, warehouses, workshop floor, etc.).
  • Make sure records, forms, procedures and any relevant documents are at hand and easy to find.

Prepare to have a nice and professional audit.

  • Make a good first impression. Treat auditors professionally and with respect from day 1.
  • Do not be predisposed. Auditors are not enemies, they will come to help the organization uncover their defects and weaknesses in order to take the necessary actions to improve.

Do not wait for the last minute to prepare for the audit.

  • Preparing for an audit takes time and effort. The sooner the organizations begins to prepare for their audit, the more successful it will be. So start soon!

 

0 2006
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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Top 5 Tips for Effective Procedures

The ISO 9001 quality management system requires for organizations to write different procedures to prevent non-conformances and to guaranty that specific jobs and processes are carried out correctly.

When writing these effective procedures it is essential to take the following into account:

1. Identify what type of procedure or document needs to be developed.

 

Different documents are essential in the QMS and each type of procedure or document has a specific role and objective. Some of the most commonly used documents in an ISO 9001 QMS are:

  • Manuals: define the general aspects of business management (Quality Management Manual).
  • Operating Procedures: Explain how an activity or process unfolds. Usually the most common documents.
  • Technical notes and instructions: further develop the content of an activity. They are mainly focused on fieldwork.
  • Guides: These are similar to the procedures and technical notes, but with the proviso that they are not binding guidance.

2. Know in detail the structure of a procedure or document.

Organizations need to define a structure and a standard way to write these effective procedures in order to guaranty that they are written in a consistent manner. Knowing the structure will facilitate the process of gathering the essential information necessary to write an effective procedure.

The structure may vary from organization to organization; however, a structure that many organizations use is provided below:

  • Home: the first page of the procedure usually includes the title, code, date of writing, version number (or revision), table of contents, total number of pages, name and signatures of the persons who have prepared, reviewed and approved it.
  • Purpose and Scope: Describes a summary of the purpose and content of the procedure.
  • References: documents that have influenced the development of the procedure are listed.
  • Definitions: technical words that are used in the content of the procedure.
  • Responsibilities: list of individuals or departments responsible for carrying out the activities described in the procedure.
  • Development (or description): describe in detail the activity performed.
  • Annexes: everything that is considered important but that takes up too much space to include it in the description section (tables, drawings, diagrams).

3. Review the document with the people that will use it.

In order for a procedure or any document to be effective, it must be understood by the people who will ultimately use it. That’s why it is important for these people to review the document at different stages of its development. Effective procedures have been reviewed directly by the people who will be using it the most.

4. Consider different people’s views and perspectives.

A procedure should not be developed with the view or information of just one person. Most processes or activities that need to be document could be complex and having different perspectives can enrich the procedure. Effective procedures will multiple views into account.

 

5. Make it simple.

Procedures should not be difficult to read. On the contrary, they must be clear and concise. Sentences must be as short as possible to make sure that it is comprehensive and easy to read. If procedures are never read or understood by the intended audience, they are not likely to serve as an effective tool in any process. Effective procedures need to be readable by everyone involved in the process.

 

0 1894

ISO 9001 and ISO 9004 are standards that complement each other and their implementation aims to ensure quality success and reach improved performance in any organization. Both these standards can be implemented independently or simultaneously; however, the most common scenario is for organizations to implement ISO 9001 and later use ISO 9004 to improve their processes and to obtain long term benefit from a more broad-based Quality Management System.

These standards are both similar in terms of structure and terminology used to allow easy integration. They are also based on the same quality management principles, therefore, when an organization has successfully implemented ISO 9001, it is relatively simple to integrate ISO 9004 and achieve an improved performance.

The best way to integrate these complementary standards is by doing the following:

Organizations need to identify and rank their quality needs, where the most basic needs are at the bottom and address ISO 9001 requirements and at the top are the needs to achieve improved performance. After identifying and ranking these needs, organizations must work up from ISO 9001 to ISO 9004 one step at a time.

Effectiveness

One of the basic needs that should be addressed is the effectiveness of the quality management system, that include areas such as

  1. meeting customer requirements;
  2. prevention of customer dissatisfaction;
  3. recalls and defects; and
  4. the production of safe products.

Efficiency

After meeting the effectiveness of the system, the efficiency should be then addressed. Here the focus should be

  1. the efficient use of resources;
  2. the reduction of material costs;
  3. the decrease of cycle times; and
  4. the increase of the organizations productivity.

Competitive Advantage

Achieving competitive advantage should be the last need to address; here it is essential to focus on ensuring delighted customers, increasing market share and increasing profitability.

This process is continuous, because an organization may never relegate it’s basic needs to address its top ones. It must constantly work in meeting all of them and ISO 9004 gives guidance on how to achieve this continuous improved performance.

Before attempting to integrate ISO 9001 and ISO 9004, it is essential to fully understand them both; even though they complement each other, they have different roles and different approaches. They each have a role to play in providing value to any organization that decides to embrace them both to improve their quality management system and achieve long term success.

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Here are five key elements that will help organizations reach a successful ISO 14001 Environmental Management System (EMS):

1. Employee Involvement

The first key element for having a successful EMS is to achieve full participation of all employees, from top management to shop-floor workers. If people are not involved, every goal and target will require a lot more time and effort to be reached. Many believe that only a small group of people in an organization are responsible for the EMS but nothing is farther from the truth; the whole organization is responsible for the implementation, maintenance and improvement of the EMS.

2. Regulatory Compliance

One of the main objectives of an ISO 14001 EMS is for organizations to obtain regulatory compliance. Organizations need to use the EMS as a tool to effectively define and monitor applicable legal requirements and other requirements. By using the EMS as a tool for assuring regulatory compliance, an organization can better plan the expenses associated with permits, reporting and monitoring legal requirements, which will reduce the frequency and severity of violations and their associated costs.

3. Higher Efficiency

Organizations need to focus on improving the efficiency of their processes and not just on controlling environmental aspects after they have been generated. It’s essential to control and prevent contamination, but an ISO 14001 EMS needs to go beyond this point and focus on improving processes. For example, a higher level of administrative efficiency may reduce legal liabilities and shorter permitting procedures due to better relations with regulators and communities. A greater operational efficiency usually involves renewal of equipment or facilities, and an improved design of production processes that will result in a reduction of inputs (energy, water and other resources) and also a reduction of waste.

4. Using the Right Performance Indicators

Every organization is different and so are their environmental aspects and impacts. It is essential to define and use the performance indicators that will allow organizations to effectively monitor their performance and identify opportunities for improvement.

5. Improving Customer Relations

Organizations need to establish relationships based on trust and respect with regulatory bodies, communities and everyone that may affect their EMS. Good relationships with internal and external customers will contribute in the success of the ISO 14001 EMS.

It is important to remember that every EMS is different and a continuous monitoring process is essential in determining the organization’s progress in meeting its goals and objectives.

0 1966
Auditor Training

Internal Auditors require theoretical and practical auditor training. Usually, when organizations train a group of internal auditors, the theoretical training is done by an outside organization.

This formal auditor training will have to consist of the following:

  • Audit principles
  • Objectives of an audit.
  • Types of audits.
  • Benefits of implementing internal audits.
  • Different auditing approaches.
  • Competences of an auditor.
  • Responsibilities of an auditor.
  • How to prepare for the audit: Establishing the audit program, defining the elements of the management system to be audited, preparation of checklists, selecting the audit team.
  • How to conduct an audit: How to contact the auditee, developing the audit plan, carrying out the opening meeting, how to gather evidences, defining findings, conducting the closing meeting.
  • Reports and Follow-up: Categorization of findings, preparing the report, approval and distribution of the report, monitoring.
  • Competence and evaluation of auditors: General, personal attributes, knowledge and skills, training and work experience, maintenance and enhancement of skills, auditor evaluation.

In addition to this basic auditor training regarding the skills, knowledge and competences of auditors and how to prepare, conduct and monitor audits, it is essential for internal auditors to fully know and understand the standard that they will be auditing against. Here an additional training session will be required. The most frequent standards that organizations use that require the execution of internal audits are ISO 9001, ISO 14001 and OHSAS 18001; however, the standards use will depend on the needs and objectives of each organization.

After an auditor has received this theoretical auditor training, they can now begin their practical training by participating in an internal audit. This practical auditor training usually is done following these steps:

  1. Participate in at least 2 audits as an observer or auditor in training. Here they usually participate in the planning stage of the audit but when the audit is being conducted they only observe; they do not take any actions in any of the activities during the audit.
  2. Participate in at least 2 internal audits with supervision of a lead auditor. Here they take a more active role in the preparation and in the conducting of the audit.
  3. After having successfully carried out a number of internal audits and having sufficient skills, knowledge and experience as an internal auditor, he or she may start to conduct audits as an internal auditor leader. This leader takes full action in all of the stages of the audit.

The above explanation is how internal auditors are usually trained; however, each organization may decide which way to train their auditors is best for them. What is important is for auditors to receive a constant and progressive auditor training that allows them to acquired the necessary skills and knowledge to conduct objective and impartial audits that meet the objectives for which they audits are carried out for.

Looking for auditor training? Check our listing to see what’s available near you.

0 2018

One of the main objectives of an ISO 9001 management system is “continuous improvement”; however, the standard ISO 9001 provides little information on how organizations can reach and maintain it. In this specific aspect is where a lean system will provide the biggest benefit to any quality management system. Lean systems require the implementation of different methodologies that will provide organization with the tools to continuously improve their processes and systems.

Lean manufacturing is characterized for aiming to reduce all the unnecessary in order to use a minimum amount of resources in every aspect of a system, especially on: human effort, manufacturing and storage space, and time.

This tool helps to eliminate all operations that do not add value to products, services and processes, increasing the value of each action and eliminating what is not required. By reducing waste and improving processes, lean manufacturing gives organizations the tool to survive in a global market that demands higher quality, faster delivery and an increase on customer satisfaction.

Some of the most common methodologies used in a lean system are 5S, Value Stream Mapping (VSM), Kanban, Key Performance Indicators (KPI), Shadow boards, Poka-yoke and many others. The implementation of these methodologies can bring many benefits to an ISO 9001 quality management system, such as:

  • Reduction in production costs.
  • Inventory reduction.
  • Reduction on delivery time (lead time).
  • Improved quality.
  • Decrease in labor.
  • Greater  equipment efficiency.
  • Waste reduction.
  • Reduction of overproduction.
  • Decrease on delays.
  • More efficient transport.

The requirements of ISO 9001 have many common aspects with lean production systems, especially in its design and mode of operation, suggesting a high potential for integration.

The integration of both systems will facilitate the implementation of a continuous improvement philosophy based on a systematic elimination of all types of waste, the respect and consideration of all employees and the continuous improvement of productivity and quality. This will enable organizations to reduce costs, improve processes and eliminate waste in order to increase customer satisfaction.

Furthermore, lean systems requires the ability to manage raw materials and components in small batches, which requires supply policies based on stable relationships with suppliers.

There are many organizations that are considering to integrate a lean system into their ISO 9001 management system. This is being done in a pursue to identify and reduce waste from their processes, reach an overall process that flows smoothly and ensure that the organization’s resources are effectively used to meet or exceed customer satisfaction.