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ISO 20000

In order to meet and improve customer satisfaction it’s essential to monitor and measure performance by using different indicators. Performance indicators are tools used for determining how and to what degree an organization is meeting guidelines, policies, objectives, requirements and targets set in their ISO 9001 QMS.

These performance indicators are set by the organization and they vary from one organization to another. Each organization must decide which performance indicators are more suitable to the nature of their industry sector and their objectives.

What should be considered is that these indicators must be measurable and achievable. They must refer to the system’s critical processes, they must accurately represent the target to be measured, and they should be quantifiable, cost-effective, reliable and allow management to know the information in real time.

Below, the critical areas to be measured and some examples of indicators are mentioned.

Cost Indicators

These are performance indicators that evaluate the activities that consume economic resources in different processes.

  • Percentage costs spent on energy consumption.
  • Percentage return on investment.
  • Percentage cost of carrying out reworking or correcting errors.

Time Indicators

These performance indicators measure the time consumed in an activity or process and considers the time from the beginning to the end of the selected process or activity. For example:

  • Percentage number of products or services delivered on time.
  • Percentage number of products or services delivered late.

Productivity Indicators

These performance indicators measure the efficiency of resources in the operation. Some of these could be:

  • Percentage machine/equipment utilization.
  • Percentage of downtime.

Quality Indicators

These performance indicators calculate the effectiveness in the development of activities or processes, delivering results based on the number of errors, number of perfect and flawless deliveries. An example is:

  • Percentage number of products or services needing rework.
  • Percentage of customers ‘very satisfied’.

While these indicators may vary, the important thing to keep in mind is that they should serve as a tool for improving the quality of decisions regarding the processes and the ISO 9001 QMS itself.

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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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Exploring the Pre-Assessment Audit

A pre-assessment audit is one that is performed before a certification/registration audit takes place. This pre-assessment audit determines the degree of conformance of an organization’s management system(s) with the requirements of a standard (e.g. ISO 9001, ISO 14001, ISO 27001, etc.)

After putting the time and effort to implement a management system and before diving into a certification audit, many organizations choose to contracting the services another organization or person to perform a pre-assessment audit. This is a full audit of a management system against the requirements of a specific standard that allows organizations to identify any nonconformities and implemented corrective actions before the certification audit.



A pre-assessment audit is performed with the same independence and objectivity as a certification audit. The auditor(s) will conduct activities such as documentation review, process review, interview of process owners, etc, in order to gather the necessary information that evidence compliance.

A pre-assessment audit is performed on-site and are a complete assessment of the management system against the requirements of the relevant standard. As any other audit, all nonconformities and observations found will be presented in an audit report that will be delivered at the end of the process; this report will serve as a baseline for the organization to improve its processes and implement the necessary corrective actions.

Any organization that has implemented a management system and wishes to determine its readiness to undergo a certification audit can seek a pre-assessment audit. Some of the benefits of performing this audit are:

  • Helps organizations identify any non conformities and implement corrective actions.
  • Contributes in the optimal preparation for the certification audit.
  • An organization can focus its resources on weaknesses that might lead to nonconformities.
  • Depending on the outcome, organizations can decide to postpone a certification audit that has already been scheduled or, on the contrary, face the certification audit with a renewed confidence.
  • Helps organizations avoid unnecessary additional costs.

This type of audit can be conducted by qualified consultants, registrars, or competent individuals with experience and knowledge regarding the relevant industry sector and standard. It is important to remember that, just as an organization carefully chooses  a certification body or any other service, it should also take the time to choose the correct organization or person to perform its pre-assessment audits.



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When going about creating a new business and you’re in the stages of being a startup, some startups might gloss over ISO 9001. The price may be a turnoff to people who see themselves only digging a bigger hole if they invest and go along with ISO 9001 implementation and certification. With any part of business, companies have to weigh the benefits and the cons of investing into something – ISO 9001 is no different. We’re here to tell you about the strongest benefits of investing in ISO 9001. You’re investing in yourself first off, and that’s a big help to startups looking to get their foot in the door.



ISO 9001 – The Benefits
The first thing about ISO 9001 is thinking about the cost. Most startup companies may have to consider a lot of things in their starting stages, and the return that can yield from that investment. When looking towards ISO 9001, you’re investing in practicalities and the foundation for a business. With the foundation set for success, all it takes is time and work for you to be on the road to success. Here are a few things that ISO 9001 can bring you.

ISO 9001 offers the process towards getting your product and sending it out towards the people who are interested in it. The process for building any startup up is complex and lot of work is needed. What are all of the things that are needed from the start of the end of this? What is needed at the start to make the product, finalize the product, send the product and make sure that it fits the requirements of what the customer needs from you? When looking at these processes, you cannot just think about it as a whole – each little thing is its own entity. These all come together and make one large thing in the end – the process. All steps in the process must flow smoothly or you may risk an error that can alter everything later on.

Using ISO 9001, you’re also finding a way to plan, act and find a way to interact to people properly. This goes from customers, analyzing your sales and communicating with them through customer service, monitor and reviewing the effect of these practices, and your employees. By setting a proper environment for your employees who will monitor and act properly to ensure the business flows and thrives. By properly managing customers and employees, the environment will feel great and this can help maximize profits and risks early in time.

ISO 9001:2015 also offers a great view into the goals, objectives, and elements for any startup business. With these, businesses will be able to take action against errors and fix them to move onto bigger and better things.



Why does ISO 9001 matter?

Implementation of ISO 9001 and getting a certification with it can help a startup. With ISO 9001, businesses are given a head start into the world and given a glimpse into what they can be. By pointing out errors, giving tips into what can be and how to go along with doing it, owners are able to maximize their profits, satisfy their customers and please their employees. Although the road to certification can take some time and can certainly be from six months to a year, ISO 9001 offers benefits instantly that can help any business. These habits and guidelines set up a business for success, and give startups access to exclusive markets. ISO 9001 is quickly becoming the normal for those who which to have local and federal contracts with the government – what are you waiting for?



 

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Management systems such as ISO 9001, ISO 14001 and OHSAS 18001, require internal audits are scheduled at planned intervals; they do not established a specific frequency nor do they establish that all processes need to have a yearly internal audit. Therefore, organizations need to establish a frequency which is right for their business. Audits can be performed monthly, quarterly, twice a year or once a year. There are some criteria which should be considered before defining a frequency.



Complexity of the processes.

  • Crucial or high risk processes should be audited on a more frequent basis, perhaps quarterly or twice a year
  • Low risk processes can be audited just once a year or every other year

Maturity of the processes.

  • Well established processes that run efficiently can be audited once a year or every other year
  • New developed processes should be audited quarterly until they are stable

Past experience.

  • Processes that have a history of frequent deficiencies or non-conformities, can be audited quarterly or twice a year
  • Processes with troubles achieving targets and objectives can also be audited quarterly or twice a year

There are other factors that can influence the frequency of auditing, such as:

  • An organization’s budget for the execution of internal audits
  • Regulatory or customers’ requirements

There is no need to audit every process all at once, it is more suitable to spread out the internal audits throughout the year auditing different processes at different times. Auditing many processes all at once can be exhausting and process deficiencies or areas for improvements may be overseen.

Although most standards do not require that all process be audited every year, it is a common practice in many organizations. There are even some organizations, with mature and well-establish management systems, which schedule their audits over a three year time plan. Every organization needs to take a close look at each of their processes, their management systems and other applicable requirements in order to establish a rational schedule which fits their needs and is right for them.



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Procedures for ISO 9001:2015

ISO 9001:2015 does not identify any required documented procedures, at least not as it was required in the 2008 version of the standard. The new standard refers to requirements of “documented information” and in the clause 7.5 it states that:

The organization’s quality management system must include:

  1. Documented information required by this International Standard;
  2. Documented information determined by the organization as being necessary for the effectiveness of the quality management system.



Throughout the new version of the standard, there are a number of references for organizations to maintain and retain documented information. It can be inferred that where the standard states that the organization is required to maintain documented information sufficient to support the operation of processes it is implying the need of documented procedures.

The specific procedures required for the quality management system will depend on the organization itself. The standard also states that:

The extent of documented information for a quality management system can differ from one organization to another due to the:

  1. Size of organization and its type of activities, processes, products, and services;
  2. Complexity of processes and their interactions;
  3. Competence of persons

Each organization will need to identify which procedures are essential for the correct operation of their processes in order determine which ones they’ll need to create. If an organization does not have any documented procedures, it will need to demonstrate how people know what to do and show acceptable evidence to support that their processes are carried out effectively without them.

Organizations that have already implemented ISO 9001 will not need to throw away the procedures that are in place. If these procedures serve as a useful tool within the organization, they should be maintained. However, the new standard presents an opportunity for organizations to take a second look at the procedures that are part of their management system in order to determine which add value to the system and which don’t.

Organizations wishing to be certified with ISO 9001:2015 must meet all of the requirements within a standard, including those regarding documented information, and they must be able to show evidence that they have all the necessary procedures in place.



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Small and large organizations recognize that the implementation of an ISO 9001 quality management system (QMS) in their processes gives them a competitive value. However, the task of implementing and successfully obtaining the certification requires time and money. Therefore, a popular question when deciding to implement is “What is the Cost to Implement ISO 9001?”

There are 2 kinds of costs associated with the implementation of ISO 9001. These are:

  1. The costs for implementation.
  2. The costs for the certification.




In order to effectively estimate the cost for implementation, an organization will have to go through a gap analysis or assessment. However, there are three main factors that an organization should take into account when estimating cost:

  1. The size and complexity of the organization. Is it a small single location organization? or is it a large company  with processes such as design, manufacture, installation, test, etc.?
  2. The type of quality system that is currently in use. Does it have a structured and disciplined system in place? Is the system documented, and how well?
  3. The time that staff and other members of the organization have to devote to the project. Will the organization create everything with its current members? Will it hire someone to guide them? Or, will it hire an ISO consultant to complete the entire process?

The major cost items that every organization needs to consider when implementing ISO 9001 are:

  • Training managers to get them to understand the requirements of ISO 9001
  • Assessment of current quality control practices and creating additional testing facilities routine if necessary
  • Renew the workspace, equipment, machines, public services, supporting facilities, etc, if necessary
  • Review and revamping arrangements for the handling and storage of raw materials, semi-finished and finished products, as appropriate necessary and safe
  • Review existing procedures / practices and listing of new procedures, checklists and records to be prepared
  • Development of QMS related documents
  • Conduct outreach activities of everyone who has roles and responsibilities for implementing the QMS
  • The various expenses such as word processing, stationery and other supplies necessary for the production of manuals, procedures and the like

Regarding the cost of initial certification and costs associated with maintaining certification the main cost items are:

  • Registration and certification fee payable to the certification for a period of three years
  • Fees for the two-stage audit visit nominated by the certification body
  • Audit Committees regularly monitored by the certification agency nominated
  • Travel, accommodation and meals for auditor(s) of certification

The implementation and consequent maintenance of a QMS based on ISO 9001 is an investment of time and money for any organization. The success of the system will rely mainly in the commitment of all its members, especially on how senior management is committed to making ISO 9001 an effective tool to integrate their processes, continuously improve their QMS, and satisfy their customer’s expectations.



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How to Prepare for a Successful ISO 9001:2015 Audit - ISOUpdate.com

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 9001:2015 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.
  • Understand quality objectives. Workers should know what the organization’s quality objectives are and how they themselves contribute in achieving them. Employees 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 Corrective & Preventive Action Process

  • Review the findings from previous audits and make sure they have been addressed.
  • All non-conformities 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.
  • 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 Procrastinate

  • 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!



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Since its first publication in 1999, OHSAS 18001 has been a recognized occupational health and safety management system (OH & SMS) standard against which management systems can be assessed and certified.  19 years later, a new ISO standard has been released to replace OHSAS 18001; this standard is ISO 45001.

ISO 45001 is an OH SMS standard developed by an ISO Project Committee which was published on March 12th 2018. A number of differences are evident between ISO 45001 and OHSAS 18001. Some of the main differences between the two standards are explored below.



The first difference concerns its structure. ISO 45001 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 (e.g. ISO 9001, ISO 14001, etc.). 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

In the new standard there is a stronger focus on the “organization’s context”. With ISO 45001, organizations will have to look beyond their own health and safety issues and consider what the society expects from them, in regard with health and safety issues.

Some organizations that use OHSAS 18001 delegate health and safety responsibilities to a safety manager, rather than integrating the system into the organization’s operations. ISO 45001 requires the incorporation of health and safety aspects in the overall management system of the organization, thus driving top management to have a stronger leadership role with respect to the OH&S management system.

ISO 45001 focuses on identifying and controlling risks rather than hazards, as it is required in OHSAS 18001.

ISO 45001 requires organizations to take into account how suppliers and contractors are managing their risks.

In ISO 45001 some fundamental concepts are changed, like risk, worker and workplace. There are also new definitions of terms such as: monitoring, measurement, effectiveness, OH&S performance and process.

The terms “document” and “record” have both been replaced with the term “documented information” in ISO 45001. The standard also states that documented information must be maintained to the extent necessary to have confidence that the processes have been carried out as planned.

In spite of these changes, the overall aim of ISO 45001 remains the same as OHSAS 18001, which is to reduce unacceptable risks and ensure the safety and wellbeing of everyone involved in an organization’s activities.

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Become a Third Party Auditor

Third party auditors are those who perform an external and independent audit of an organization’s management system to evaluate if it meets the requirements of a specific standard; if successful, this third-party audit will provide the organization with certification or registration of conformity with the given standard.

A third party audit is carried out by a Registrar/Certification Body (CB) hired by the organization; therefore, in order for someone to be a third-party auditor, he/she needs to be employed by a CB.

All CB’s need to ensure that the auditor possesses the knowledge and skills necessary to achieve the intended results of the audits they are expected to perform. Standard interviews are typical.

  • Personal attributes that will enable them to act in accordance with the principles of auditing, which include ethical conduct, fair presentation, due professional care, independence, and free use of an evidence-based approach.
  • Knowledge on the contents of ISO 19011: 2011, Guidelines for auditing management systems.
  • Knowledge and skills on audit principles, procedures and methods, which will enable them to conducted audits in a consistent and systematic manner.
  • They should be able to exhibit professional behavior during the performance of audit activities, including being ethical, open-minded, diplomatic, observant, perceptive, versatile, tenacious, decisive, self-reliant, open to improvement, culturally sensitive, and collaborative.
  • Knowledge and skills on management system and reference documents that will enable them to comprehend the audit scope and apply audit criteria.
  • Sector specific knowledge which will enable them to comprehend the organization’s structure, business, management practices and the legal and contractual requirements applicable to the organization being audited.

As indicated in ISO 19011, someone pursuing to become a third-party auditor can acquired all these knowledge and skills by using a combination of the following:

  • Formal education/training and experience that contribute to the development of knowledge and skills in the management system discipline and sector the auditor intends to audit.
  • Training programs that cover generic auditor knowledge and skills.
  • Experience in a relevant technical, managerial or professional position involving the exercise of judgment, decision making, problem solving and communication with managers, professionals, peers, customers and other interested parties.
  • Audit experience acquired under the supervision of an auditor in the same discipline.

After acquiring all the necessary knowledge and skills and successfully being employed by a CB, third-party auditors must pledged to advocate a particular code of ethical conduct in the performance of an audit and they must abide the internal policies and rules of the CB that hires them. All these requirements must be followed in order to protect everyone involved in the audit process.

Find a CB that is hiring in your area by visiting our Career Resources.