Tuesday, February 28, 2012

ISO 9001 Standard - ISO 9001 Standards

Tuesday, November 8, 2011

About ISO 14001:2004 Standards

The ISO 14001 aims to reduce the environmental carbon footprints that many businesses leave behind today because of not taking the right steps to be environmental sustainable. This standard promotes the decrease in the waste of necessary business resources and also reduces the pollution that can sometimes be a by product of a business.

About ISO 14001

The most updated version of the ISO 14001 was released in the year 2004 by the International Organisation of Standardization (ISO), which was attended by members from all the committees from around the world. In order for a company to be awarded the ISO 14001 standard certificate, an external auditor has to audit the company by an audit body that has been accredited by an accreditation body. The certification auditors are required to be accredited by the International Registrar of Certification Auditor and the certification body has to be accredited by the Registrar Accreditation Board in the USA or by the National Accreditation Board in Ireland.

The structure of ISO 14001 is very much like the ISO 9000, which is management standard, so these two standards can be implemented side by side to achieve the best results. As a part of the ISO 14000 family, which deals with different aspects of environmental issues, ISO 14001:2004 and ISO 14002 deal with environmental management system (EMS). ISO 14001 gives the requirements for the

EMS and ISO 14002 gives the basic guidelines for EMS.

Environmental Management System with ISO 14001:2004

The EMS, as per the requirements of the ISO 14001, enables the company, may it be of any size, location and income to:

  • It helps the company improve its environmental strategy and this positively affects their environmental performance.
  • It helps in identifying and controlling the environmental impact that the activities, services or products of the company might have.
  • And it helps in carrying out a systematic approach to set environmental targets and objectives, to achieve these and also to demonstrate that they have been achieved.

How does it work?

ISO 14001 does not specify or chalk out a definite level that each business has to reach. If the performance was determined, then it would have to be done for every specific business. But that is not how it works and has a very different approach, like:

  • The ISO has various standards dealing with environmental issues. ISO 14001 deals with a framework provided for a strategic and holistic approach to the businesses environmental policy, actions and plans.
  • It gives the general requirements for the EMS.
  • This also states the reference to the communication requirements for the communication of the environmental management issues between the company, stakeholders, the public and the regulators.
  • As these standards are not company specific, any and every business can undertake them as long as they are dedicated to the continued and improved environmental performance and they have a commitment to comply with the set norms.

Management Review IN ISO 9001 Standard

One of the most important factors in determining the success of an ISO 9001 implementation is management commitment and management understanding of what makes a good quality systems. Our turnkey Quality Management System (QMS) gives you everything you need to educate your entire company from top to bottom.

Management review is one of the key elements to building a sustainable quality system. To do this, management must be committed. This means that the management must do more than just say they are committed, they must allocate the resources to make sure that the company can continuously improve quality. Most quality systems fail from the top down! That is why external auditor almost always review the management review documentation every audit. External ISO 9001 auditors look for this commitment by evaluating the management review records. Management reviews should focus on both the quality of the products and the quality of the QMS. In general, it is very simple to maintain compliance of the management review portion of the standard. It can be done with a simple notebook that is maintained as a quality record. The Management review procedure includes a list of documentation that should be included in management review meeting. Management reviews should be done a least once per year and auditors like to see them quarterly.

Under ISO 9001, executive management has defined responsibilities. Although most of the work required to implement and maintain ISO certification is done below the executive level, ISO requires involve of personnel at the top of the organization.

It is the leader of an organization that set the goals and objectives for the quality of the company. It is also the leader that assigns resources (responsibility and authority) throughout the organization. Because of this, the leaders must be kept aware of the status of the quality system and product/service quality so they make good decision.
Much of how the company accomplishes these tasks is covered in the quality manual. Here are the 8 areas that should be address in the quality system to assure compliance to the ISO standard.

Top Management must:

Show A Commitment To The Customer

This requirement includes maintain records showing their commitment to the a customer focus, the quality system and the continuous improvement system. The use of a customer survey program is an excellent way to meet the ISO requirements for a customer focus. It is also an excellent way to keep in touch with your customers.

Make Quality Important

This includes communicating to the organization the importance of meeting the customer regulatory, legal needs as well as their produce or service needs (customer focus). Training and posting quality information around the building can do this.

Establish A Quality Policy

This should include a concise quality statement in conjunction with quality goals and a quality manual. The policy verbiage should include a commitment to continuous improvement. This information must be communicated to and understood by the entire organization.

Establish, Monitor And Update Quality objectives

These objectives should be measurable and should be relevant to all levels of the company. I recommend that they be publicly posted where everyone can see them and their status may also be posted.

Assign Resources

Ensure that resources are available to achieve the quality goals. This is the area where many companies do not meet the requirements but it is very hard to audit this general statement. Resources should be identified and planned. Planning includes manuals, procedure, work instructions and quality plans.

Assign Responsibility And Authority

Ensure that responsibilities and authorities are assigned and communicated to individuals. Responsibilities can be assigned as part of the personnel records ( see training summary sheet). Having authority means that the individual must be empowered to make changes.

Designate A Management Representative

This person will report the QMS status at periodic management reviews and promote awareness of the importance of meeting the customers needs. This is usually the quality, engineering or production manager.

Conduct Periodic Management Reviews

Management review meetings should include inputs from audits, customer feedback, process performance analysis, preventive and corrective actions system, follow-up from previous management meetings and areas for improvement. The output from the management reviews should include resource assignments, action targeting improvement of the products, processes and QMS.

The records for the management review are frequently audited so I recommend keeping a organized notebook with tabs for each management review. The creation of a check sheet (listing all the reports to be shown to top management) will make this periodic task simple to maintain. The check shee

Sunday, August 21, 2011

ISO 9001 Standard Quality Manual Template

The quality manual is the necessary cornerstone for any business venturing out on the ISO 9001:2008 accreditation route as it exhibits top management’s determination to managing an useful quality management system. The quality manual is a type of most essential document which provides the right impression to clients, staff, inspectors and all the parties interested in your company, about your company’s efforts to satisfy all their clientele’s needs. People through your company will relate to it whenever they prefer to find the big picture of the system, or exactly what guidelines have been organized. You can save your valuable time and hard earned money with the quality manual template we offer you. If you really compile the quality manual, you will easily comprehend and apply ISO 9001:2008, which is one of the best methods to do so.By reading by the needs one-by-one and assigning each prerequisite a specific document, process or technique that exists within your company, you will get that over half of the demands have already been resolved. Quality manual makes the relation, between the process and the documents, an official one. Format and content Write your quality manual to ensure that it works for you, for your company and also the manner you work, it is totally your selection however generally make sure that it supports your organisation’s targets. The quality manual should not contain any confidential or proprietary information as it should be readily available to third party auditors and customers. You should also ensure that a clear distinction is made between the contents of the quality manual and the procedures. The quality manual identifies the intention of top management for the operation of the quality management system, whilst the operations explain how these kind of purposes are integrated. There are three things that must be included in the quality manual:

1. The probability of the quality management system such as details of the validation of any exclusions

2. For quality management system, the procedures should be standard or should be mentioned in them

3. A explanation of the discussion between the procedures of the quality management system Who will use your Quality Manual and why?

In general, the clients and the prospective customers need it in order to know how your company system meets their requirements. If your quality manual includes two pages, it may not motivate trust that your system is strong enough to be an useful quality management system. Customers and Clients want assurance that you know how to plan, implement, and control the processes that affect their products or service delivery. The third party inspectors will b interested to know how your company meets their standard needs and also if perhaps the quality management system is useful in accomplishing your organization’s targets. Auditors will use the quality manual as a guide to help out discover and also form the purpose facts that they have to find in exhibition of your company’s compliance with the standard. Internal inspectors can review and inspect their own company for their needs rather than referring to standard documents from external sources. Management ought to be able to determine, from the manual, how the numerous processes and also systems have interaction, and at a high level what policies and methods have been established to maintain and control the processes and systems . The quality manual is usually presented to fresh recruits to familiarize themselves with the organization’s quality management system and also the manuals are often used as an in-house training resource. Most importantly, your quality manual ought to not sit on a dirty shelf or be hidden in an obscure position on the computer network; it is an active and powerful document that requires coverage in order for it to grow and also improve. Please click on the links below to learn more about Quality Manual Templates and view some free examples.

ISO 9000 Standards Document Control System

The ISO 9000 Standards requires that a documented procedure be established to define the controls needed.

This requirement means that the methods for performing the various activities required to control different types of documents should be defined and documented.

Although the ISO 9000 standards implies that a single procedure is required, should you choose to produce several different procedures for handling the different types of documents it is doubtful that any auditor would deem this noncompliant. Where this might be questionable is in cases where there is no logical reason for such differences and where merging the procedures and settling on a best practice would improve efficiency and effectiveness.

Documents are recorded information and the purpose of the document control process is to firstly ensure the appropriate information is available where needed and secondly to prevent the inadvertent use of invalid
information. At each stage of the process are activities to be performed that may require documented procedures in order to ensure consistency and predictability. Procedures may not be necessary for each stage in the process.

ISO 9001 Standards – Quality Policy and Objectives

A ISO 9001 Standards quality policy and its corresponding quality objectives are established to direct the organization towards two specific goals of a quality management system:

-Provision of products – goods and services – that meet customer and applicable legal requirements, and

- Enhancement of customer satisfaction

The quality policy and the objectives are also a means of controlling the quality management system’s processes. Simply, if you want to control a process, assign an objective to it (or more) and make sure it is aligned to the quality policy, then monitor and measure the process’ performance against the assigned objective. You need to provide adequate resources to the process to ensure that it is capable of achieving the objective. You continually improve the whole process by upgrading the objective, make corrective and preventive actions or introduce innovation to it. Corrective action addresses an undesirable situation’s cause in order to prevent its recurrence. Preventive action, by contrast, addresses the probable cause of a potentially undesirable situation. This is what the quality policy and objectives are supposed to do. They provide focus, direction and control.

The quality objectives need to be consistent with the quality policy and the commitment to continual improvement, and their achievement needs to be measurable. The achievement of quality objectives can have a positive impact on product quality, operational effectiveness and financial performance and thus on the satisfaction and confidence of interested parties. When an organization has established a quality policy and a set of operational objectives, this means the only thing left to do is to design or plan the necessary processes or tasks that can realize those objectives. Therefore, the processes determine if the objectives will be met in full, partially or not at all. This is where the ISO 9001 standard play a critical role in specifying the required processes and the operating criteria. This is what ISO 9001 is all about. It even specifies criteria for the policy and the objectives.

A quality policy needs to satisfy the following requirements:

  • It is appropriate to the purpose of the organization,
  • It includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system,
  • It provides a framework for establishing and reviewing quality objectives,
  • It is communicated and understood within the organization, and
  • It is reviewed for continuing suitability

Quality objectives must be established in order to enable the organization to comply with requirements and continually improve the effectiveness of the quality management system. Quality objectives must achieve four things:

  • Enable the organization to meet customer requirements
  • Enable the organization to enhance customer satisfaction
  • Enable the organization to comply with all legal requirements applicable to the product
  • Continually contribute to the effectiveness of the quality management system

Therefore, when you are in the meeting room with your management brainstorming on the appropriate objectives, have these four points in mind.

ISO 9001:2000 requires that management periodically review changes to both the policy and objectives. An organization’s objectives must be measurable and its processes designed to meet those objectives. An organization’s overall business goals, quality objectives and quality policy are all interrelated and must work together to achieve business improvement. To do this, it’s necessary to understand which processes are key to achieving business goals and align those processes with the quality objectives. It means aligning business goals, quality objectives and process measures to create real improvement. And it means using process mapping. Process mapping involves more than just flow charting. Among other things, it can manage and improve processes by illustrating process measures as well as process flows and interactions. One process-mapping method begins by involving the people who work in the process. Another entails mapping the process as is, taking action to improve it and then preparing a final map of the improved process.

Process owners are directly responsible for the attainment of the objectives. They must be given adequate resources, including competent human resources. They need to review the objectives periodically to ensure the key performance indicators are heading towards their objectives on schedule. If not, they need to initiate corrective actions and if the risks of non-achievement are visible, take preventive actions to control them and steer the KPI’s back on course.

Examples of quality objectives:

  • Production rejects <>
  • Machine breakdown <>
  • Returned products = 0/mth
  • Purchasing >95% on-time delivery
  • Inventory damage = 0/mth

Conclusion: ISO 9001 requires that the quality management system achieves its objectives in order to realize the quality policy.


The economy has already met with various endeavours and concepts to build an effective quality management system. From the historical point of view, the most important ones are Deming Prize (1950), followed by Malcom Baldrige National Award (1987) and
international standards pertaining to ISO 9000 (1987) family. The implementation of this last standard grows continuously, either in Europe or in the world. In the period from 2001 to 2003, there was a slight stagnation, which was the consequence of the organisations having to adapt to the requests of ISO 9001:2000 edition of the standard. Croatia also actively participates in this trend, which show that at the end of 2004, organisations were certified, of which 970 of them were from Croatia.

The economy has already met with various endeavours and concepts to build aneffective quality management system. From the historical point of view, the most importantones are Deming Prize (1950), followed by Malcom Baldrige National Award (1987) andinternational standards pertaining to ISO 9000 (1987) family. The implementation of thislast standard grows continuously, either in Europe or in the world, as shown in the picture1. In the period from 2001 to 2003, there was a slight stagnation, which was theconsequence of the organisations having to adapt to the requests of ISO 9001:2008 editionof the standard. Croatia also actively participates in this trend, as illustrated by figures fromthe table 2, which show that at the end of 2004, 670,399 organisations were certified, ofwhich 970 of them were from Croatia.

The implementation of the stated standard in educational activities took a somewhat slower pace. Trends in Croatia do not completely follow the World ones . The 2002 and 2003 stagnation, which, as already mentioned, was mainly caused by transfer from one issue of the standard to the next one, had no particular impact to Croatia, partially because the data for Croatia includes standards from both the previous and the new issue of the ISO 9001 standard.