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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.



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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.

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ISO Certification

This is a guest post from Michael Haile from ISO Quality Services Ltd, an independent organisation that specializes in the implementation, certification, training and continued auditing of ISO and BS EN Management Standards.


Our lead assessors have countless years of experience in helping organisations to achieve ISO Certification. No matter the industry, they have worked tirelessly alongside our clients to aid the growth of their business. Whether it’s a charity, manufacturer or translation company, they have seen numerous successes.

That being said, there is one issue that is actually very common in our industry and that is the perception of ISO Certification as a necessity rather than an aid. Some organisations, (whether they are aware of it or not) put the ISO Certification in one ‘box’ while putting their business in another.

Many articles have been written which make a point of explaining the benefits and the importance of management buy-in with regards to certification. These are great and they are very important topics to highlight but sometimes people appreciate practical examples.

The Myths of Non-Conformances

One key example that our assessors highlight is that of non-conformances. A non-conformance is something that has happened which should not have happened. From experience the following are the most common misconceptions surrounding non-conformances:

  • Their recording is felt to be adding to their workload
  • Some employees feel like they are ‘telling tales’ on their colleagues
  • Or it is seen as a weakness

The concern that the recording of non-conformances adds to current workloads is very common and we have a simple mantra which will hopefully ease this:

“If a non-conformance takes longer to record than to rectify, it is not a non-conformance”

We have in fact suggested to clients that they change their name to ‘Opportunities for Improvements’. Secondly, recording non-conformances and acting upon them enable organisations to have the ability to make significant improvements. After all, if everybody’s jobs can be made that little bit easier, why wouldn’t you?

In some circumstances employees are reluctant to highlight non-conformances as they see them as a weakness that can give management a reason to criticize. This should not be the case and one way this can be remedied is by management taking the lead and demonstrating that they too are recording non-conformances.

Don’t Forget Communication!

One of the main reasons why there are issues with the non-conformance processes and procedures, or any change within the workplace for that matter, is communication.

Internal communication in the form of departmental meetings for example is important to get ‘buy-in’ from all areas of the business. If everyone understands why change is happening, how it will impact positively upon their job and how they can help then this will help with employee buy-in.

Taking the time to explain why change is needed and creating a sense of inclusion makes everyone feel appreciated.

The Bottom Line

The bottom line is that the ISO Standards provide a flexible framework that run parallel to an organisation instead of being a separate entity. Furthermore, when embraced and fully integrated, they are able to enhance business performance and make everyone’s job that little bit easier.


This is a guest post from Michael Haile from ISO Quality Services Ltd, an independent organisation that specializes in the implementation, certification, training and continued auditing of ISO and BS EN Management Standards.

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Environmental Performance Indicators provide organizations with a tool for measuring, evaluating and controlling their performance. These quantifiable metrics reflect the performance of an organization in the context of achieving its environmental goals and objectives.

They are also useful in illustrating environmental improvements, identifying market opportunities, providing essential data for environmental reports and statements, providing feedback to motivate members of the organization and to support the implementation of the ISO 14001 standard.

However, not all performance indicators are useful to every organization. These must be identified and measured considering the nature and context of the organization and its specific targets and goals.

Even though there’s not a set of performance indicators that is right for every ISO 14001 management system, there are performance indicators that can be commonly seen in many environmental performance indicator reports. Some of these are:

Operational Performance Indicators

These measure environmental impact caused by an organization’s main activities.

Emissions to air

  • Greenhouse Gases
  • Acid Rain
  • Eutrophication and Smog Precursors
  • Dust and Particles
  • Ozone Depleting Substances
  • Volatile Organic Compounds
  • Metal emissions to air Emissions to water
  • Nutrients and Organic Pollutants
  • Metal emissions to water

Emissions to land

  • Pesticides and Fertilisers
  • Metal emissions to land
  • Acids and Organic Pollutants
  • Waste (Landfill, Incinerated and Recycled)
  • Radioactive Waste

Resource use

  • Water Use and Abstraction
  • Energy use (Natural Gas, Oil, Coal, other)
  • Minerals
  • Aggregates
  • Forestry

Environmental Management Performance Indicators

These reflect organizational actions management is taking to minimize their environmental impact. These indicators serve as internal control measures and information, but do not provide valid information on the real environmental performance of an organization. These performance indicators should not be used exclusively for the evaluation of environmental performance, but as a support in evaluating the actions taken within the environmental management system. Some of these are:

  • Number of sites that have environmental management systems
  • Number of ISO14001 certification
  • Number of training sessions regarding environmental preservation and of people attended
  • Number of environmental audits by kinds (internal and external environmental audits)

Every organization is different and each one needs to carefully examine which environmental performance indicator suits it best. These indicators should summarize extensive environmental data to a limited number of significant key information points and ensure rapid assessment of the organization’s main improvements and weaknesses in environmental protection. This information should be comparable from year to year or period to period, allowing unfavorable trends to be quickly detected in order for timely actions to be taken to correct and improve the organisation’s environmental performance.

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ISO 45001 - Who Needs It? - ISOUpdate.com

Performance indicators for an Occupational Health and Safety (OH&S) management system are an important tool used by organizations to measure the effectiveness of their programs in reducing potential and actual OH&S risks. These performance indicators also provide information for organizations to:

  • Evaluate their OH&S management system.
  • Identify improvement opportunities.
  • Adapt objectives, goals and strategies.
  • Raise awareness among decision-makers and everyone in an organization about the benefits of OH&S programs.
  • Take timely preventive measures.
  • Communicate ideas, thoughts and values.

Performance indicators should be specific, easy to obtain, consistent over time, accurate and transparent in order to serve as a valuable tool in improving an organization’s OH&S performance. There are no fixed performance indicators that must be used by all organizations; however, below, a number of typical performance indicators of an OHSAS 18001 management system are mentioned.

Performance indicators for OHSAS 18001 communication and leadership management:

  • Percentage of management planned visits to the job site carried out on a specific time frame.
  • Degree of management commitment, measured through surveys in the workplace.
  • Percentage of planned formal reviews of the OH&S management system programs conducted over a period of time.
  • The percentage of training activities carried out vs. those that were planned.
  • The percentage of investigations of accidents / incidents / nonconformities completed vs. those that were required.

Performance indicators for measurements of the effects of accidental losses:

  • Number of accidents.
  • Number of days lost to illness.
  • Number of days lost due to accidents.
  • Percentage of workers with occupational diseases.

Performance indicators for basic and immediate causes of accidents:

  • Percentage of accidents caused by getting trapped.
  • Percentage of accidents caused by strokes.
  • Percentage of accidents caused by cuts.
  • Percentage of accidents caused by falls.

Performance indicators for OH&S resources management:

  • Level of funding provided to the OH&S programs as a percentage of operational funding.
  • Percentage of purchase orders with specific OH&S requirements.
  • OH&S approved budget against the actual budget spent.

Every organization is different and each should take the necessary time to define the performance indicators that will serve as tools in improving their OH&S management system; ones that will help management make sound decisions to maintain, improve and innovate their processes and keep their workers and everyone involved in their activities safe.

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In the past, most auditors used a formal clause approach when auditing a management system; today, many auditors are leaving behind the checklist that served as a useful guide to identify the conformance with applicable requirements, and are now using a process approach to perform their audits.

Some aspects that give importance to this approach are the following:

  1. Process Approach focuses on results, not on procedures.

    Management systems are not just a set of documented procedures; they are an active system of processes that address business risks and its applicable requirements. By reviewing the process and not just the procedures, it becomes easier to evaluate the results of the process and how effective these really are.

  2. Process Approach determines the effectiveness of the management system.

    Audits conducted using a process approach provide information on whether performance targets are being met, they identify opportunities to improve performance through better process control and determines how processes can be more effective and efficient in meeting the system’s applicable requirements.

  3. Process Approach evaluates links between departments and processes.

    Interactions between the processes of an organization can often be complex, resulting in a network of interdependent processes where the output of a process can be the input of another. By following the flow and continued work throughout the organization, it’s possible to review and evaluate the sequence and interactions of processes, their inputs and outputs and the effectiveness of these interactions.

  4. Process Approach determines whether the operations are under control and whether the controls are effective.

    The process approach not only focuses on whether controls are in place but also on how efficient these really are in maintaining and improving the effectiveness of the process and the system.

  5. Process Approach helps determine the depth of the problems through the organization.

    When a problem is found, it is easier to determine the severity of its impact on the system by reviewing the entire process and it’s interactions with other processes.

  6. Process Approach focuses on the benefits of correcting non-conformities related to improving organizational effectiveness.

    Process based audits help organizations in evaluating the effectiveness of their processes. It serves as a tool to identify weaknesses and opportunities to improve the existing connections between policy, requirements, performance, objectives and goals, which will ultimately contribute to the overall success of an organization.

Management systems are a complex set of interactions between different activities carried out in different areas of an organization. When these activities are viewed as being part of a process, it is easier to understand these interactions and how they go beyond the boundaries of a specific functional unit. Also, by auditing an entire process, the people involved in it will have a greater understanding of how their activities influence the overall effectiveness of the organization’s management system.

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Measuring Supplier Performance

Organizations that have contracted work, services or goods from a supplier must have a way of knowing if what they’re getting is what they paid for. Measuring supplier performance is a common good practice implemented by many organizations in order to identify in what extent are supplier’s meeting their obligations, facilitate performance improvement and improve relationships between both parties.

There are many tools and techniques for measuring supplier performance. This process requires time and resources, and organizations need to carefully consider which method adapts best to its circumstances and needs. Below, the main factors to take into account when carrying out this process are briefly described.

Determine what is good performance

The first step to measuring performance is to determine which activities are critical for the success of the contract and what are the characteristics of good supplier performance. From this understanding of the dimensions of a good performance, Key Performance Indicators (KPIs) should be developed.

Develop KPIs

KPIs should meet the following criteria:

  • Completeness: all significant aspects of the goods/service should be included in the measurement of performance.
  • Clarity: both parties should have a clear understanding of the performance measures to be used.
  • Measurability: performance requirements should be expressed in measurable terms and should be based on data which it is possible to gather.
  • Focus: specifications should be focused on the agency’s procurement objectives (which translate to outputs and outcomes), not on processes.

Some of the aspects of the contract that are usually measured are:

  • On-time delivery.
  • Correct quantity.
  • Number of customer complaints.
  • Product/service cost.
  • Service/product quality (against agreed terms).

Determine which measurement approach to use

There are many approaches for measuring supplier performance. Some are more complex than others and they all have their advantages and disadvantages. Here, some commonly used approaches will be mentioned:

  • Categorical system: this method is easy to use but it is subjective. The aspects being measured are weighted equally and it relies on a person’s perception about performance and not on quantitative data.
  • Weighted-point method: this method assigns a weight to each aspect being measured depending on its importance. This is considered a reliable and flexible method.
  • Cost-based system: with this method it is possible to quantify the additional costs incurred if a supplier fails to perform as expected. This is a very objective but complex method.

This process is usually time consuming for many organizations, especially for those that have a large number of suppliers along their supply chain. A well carried out process will ensure useful and objective results that will serve to improve performance and business relationships between an organization and its supplier(s).

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External Audits

An audit is a process performed to gather evidence that support an organization’s compliance to specific requirements. Audits can be Internal (first party audits) or External (second and third party audits). The differences between the two types of external audits generates some confusions that we will clarify in this article.

The main differences rely on the interests between the organization performing the audit and the one being audited, and in the purpose of the audit.

  • Second party audits are external audits that occur when one organization audits another with which it either has, or is going to have, a contract or agreement for the supply of goods or services. They can also be done by regulators or any other external party that has a formal interest in an organization. These are usually done to verify operating conditions of a supplier to ensure it meets applicable requirements.
  • Third party audits are also external audits that are done independent of the organization being audited. They are performed by independent organizations such as registrars (certification bodies) or regulators, usually for certification, registration or verification purposes.

The reasons why these are performed also serves to set them apart.

Second party audits are carried out to:

  • ™Help customers ensure that suppliers have proper capabilities and controls in place.
  • ™Improve communication between both organizations.
  • Promote a clear understanding of the customer’s expectations.
  • ™Provide a path for the transfer of knowledge and good practices between both organizations.
  • Build customer confidence that the supplier will comply with legal and other applicable requirements.
  • Create good and mutually beneficial working relationships.

Third party audits are performed to:

  • Verify compliance to a specific standard or regulation.
  • Demonstrate compliance with all the requirements of a standard such as ISO 9001, ISO 14001, OHSAS 18001 to customers and other stakeholders.
  • Give confidence to customers that the best business practices are being implemented regarding quality, environmental or other management systems.

As mentioned before a second party audit is usually done by a customer and a supplier that wish to establish a business relationship and, in some cases, the audit is one of the requirements necessary to seal the deal.

On the other hand, third party audits can be mandatory (depending on the standard/regulation and the industry sector) or they can be voluntary. In both cases, the organization wishing to be audited will have to contract the services of a qualified organization to perform an independent and objective audit.

Both types of audits are done prior to executing a contract (Second party) or obtaining a certification/registration (Third party) and they both require periodic surveillance audits for verification purposes.

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Quality Control and Quality Assurance
Quality Control and Quality Assurance are both players of the same team and it is not possible to guarantee customer satisfaction if either one is missing.

Quality Control and Quality Assurance are both aspects of an organization’s quality management system (QMS), and even though they are closely related concepts, they are different in many ways. Understanding their differences is fundamental for any organization to effectively manage its resources and processes in order to deliver quality products and services.

To start, one of their main differences is that Quality Assurance is a prevention strategy oriented to prevent defects and Quality Control is a detection strategy oriented to detect defects. Here, an explanation of some of their differences is presented.

Focus of Quality Control and Quality Assurance:

  • Quality Assurance aims to prevent defects with a focus on the process that produces the product or service; thus it is process oriented.
  • Quality Control aims to detect (and correct) defects in the finished product, which makes it product oriented.

Goal of Quality Control and Quality Assurance:

  • The goal of Quality Assurance is to develop processes and procedures that will ensure that quality products and services are produced.
  • The goal of Quality Control is to check the products and services for defects that may have arisen during their development in order to deliver defect-free products or services to customers.

How Quality Control and Quality Assurance are Conducted:

  • Quality Assurance is conducted by establishing and defining standards and methodologies that must be followed during a process to ensure products and services meet customer requirements.
  • Quality Control is carried out by conducting tests and inspections to detect errors and flaws in products or services.

When Quality Control and Quality Assurance are Conducted:

  • Quality Assurance is a proactive process that takes place before the product or service is produced or delivered.
  • Quality Control is a reactive process that is performed during the manufacturing process and after the products are produced.

Despite their differences, Quality Assurance and Quality Control are both players of the same team and it is not possible to guarantee customer satisfaction if either one is missing. Achieving success requires both; if only Quality Assurance is applied, there will be no way of knowing if the procedures and processes are producing the expected outcomes. On the other hand, if only Quality Control is conducted an organization will not have a way of making repeatable and reliable results.

Quality is ensured by an organization performing the right tasks in the right way and by making sure that their efforts have produced the expected results. Quality Assurance and Quality Control complement each other and both these processes provide the necessary information for the continuous improvement of a QMS that meets the requirements of an organization’s customers.