ISO 9001 Standard / ISO 9001 Standards – ISO 9000 Standard / ISO 9000 Standards Certification & Implementation

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.

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.

How To Get ISO 9001 Certified

The ISO 9001 accreditation is part of the International Organization for Standardization 9000 standards. They are awarded to businesses for quality. The ISO 9001 is recognized worldwide as an award for a company’s internal quality management or actions that the company takes to ensure the product or service they provide is of the highest quality. Customer satisfaction is a major factor in whether a company will be awarded an ISO 9001 accreditation. The International Organization for Standardization in Geneva, Switzerland publishes thousands of international standards to help companies throughout the world more efficiently do business with one another. The 27 page ISO 9001 standard is focused on defining minimum business practices for the production and delivery of a company’s products and services through the implementation of a formal “quality management system”, or QMS. An ISO QMS is made up of certain processes, documentation and other formal practices that control internal company operations to ensure customer requirements are consistently met. To pass an audit, an organization must follow these guidelines: Develop a Quality Management System (QMS) manual. Develop the procedures required by the ISO  9001 Standard. Determine the additional processes and procedures that are needed by the organization to perform work and satisfy the requirements in the ISO Standard. Operate in accordance with the organization’s documented QMS. Provide evidence that the organization is operating according to the QMS. The achievement of an ISO 9001 certification is a milestone in demonstrating to your customers that you have implemented a reliable system of producing and delivering your products and services. The focus of this “system” is twofold: providing consistent products and services; and continual improvement in your processes leading to better results. The ISO 9001 certification is granted by a third-party auditing firm called a Registrar who specializes in quality system auditing. There are a wide variety of Registrars located in every ISO participating country. Some firms have offices internationally; others have a more regional focus. The selection of your Registrar is one of the more important decisions you will make to ensure the best alignment with your type of business, your location(s) and overall cost of maintaining the certification. The initial certification audit is conducted in two parts. The Stage 1 audit is a general review of your QMS documentation to ensure you have addressed all of the requirements of the ISO 9001 standard. Depending upon the size of your business, this can be conducted in a one to two day visit to your facility or virtually via phone. Any discrepancies noted during the Stage 1 audit will be documented in a formal report and must be corrected before the Stage 2 audit. The main part of the ISO audit is the Stage 2 audit which is always conducted onsite at your location(s) and will be focused on the implementation and effectiveness of your QMS. During this audit which can take 1 day (for very small companies) to several days, the auditor(s) will tour your company, speak to managers and employees, and review documentation and records (along with any Stage 1 discrepancies) to ensure that your system is fully implemented. If nonconformances are found, they will be documented in a formal report for correction. Following the Stage 2 audit, you are generally given thirty (30) days to submit corrective action plans for all audit nonconformances. Once corrective actions are received, your certification is complete and your certificate is issued. In order to maintain the certification, you will participate in an annual surveillance audit from your Registrar where they confirm that you are maintaining your QMS. Every third year, a more comprehensive re-certification audit is conducted, similar to the initial certification audit.

Who Is ISO 9001 Consultant?

ISO 9001 Consulting has been available ever since the ISO management system standards were initially published in the late 1970′s. As of now, nearly a million business companies internationally have been certified to one or more of several ISO business standards. These include ISO 9001, ISO 14001, AS9100, ISO/TS 16949, etc. The statistics that have been accumulated to date indicate that while many organizations deployed ISO standards using internal know-how, those that used outside ISO 9001 consulting services profited the most in terms of speed of implementation, effectiveness and return on investment.

ISO 9001 Consultancy firms provide a numberof services. Let’s take a look at some of these so that you can determine what collection of services would best suit your company:

How To Interpret The ISO 9001 Standard?

The ISO 9001 quality management system standard can be a hard document to understand. It is written in semi-legal language and specifies requirements in in a very general sense. This is deliberately so, as it is meant to consider just about any type of business activity. Many companies have problems relating it to their specific organizations. An experienced ISO 9001 consultant can show you exactly how to apply the standard to your specific business processes.

ISO 9001 Gap Evaluation

Prior to implementing the ISO standard within your organization, you need to know the gap between your existing business practices and controls relative to ISO 9001. Using ISO 9001 consulting services, you can have an evaluation done of your current management system practices, controls and documentation, to determine to what extent you comply to ISO 9001 requirements. The consultant will give you a detailed audit report listing the gaps in your company, along with their recommendations. This will assist in developing your ISO 9001 project implementation plan to accomplish full compliance.

ISO 9001 Project Planning and Organization

Depending size and complexity of your business, an ISO 9001 implementation project can take as few as 4 months to over 18 months to complete. Your ISO project needs to well-planned in terms of time and resources needed, specific activities to be carried out, who will be responsible for each activity, milestone reviews, authorizations, training, dealing with problems, etc. A good ISO 9001 consultant can be an invaluable resource in assisting a business address with this important activity.

ISO 9001 Business Process Identification and Documentation

ISO 9001 views business processes as the main point of control. These include internal as well as outsourced processes. Quite a few companies have issues differentiationg between processes, departments and functional activities. ISO 9001 consulting experts can assist you identify and effectively document all organizational processes pertaining to your quality management system. These include customer-oriented, management, product realization, resource planning, measurement, support and outsourced processes.

ISO 9001 System Development and Implementation

The main thrust of the ISO 9001 standard is on effective planning, operation and control of thrust all relevant quality management system processes. This is probably the most time-consuming and difficult aspect of any ISO implementation project. Many questions may arise as to what processes must be be controlled, what should be an effective control, how best to communicate and implement it, the inter-process impact, how to set process goals and objectives and what records to keep. Here is where using external ISO 9001 consulting will significantly help in answering these questions, provide focus and speed up implementation.

ISO 9001 Management System Documentation

The latest ISO 9001:2008 standard minimizes the emphasis on documentation and maximizes its attention on effective planning and control. Adequate documentation is however needed for many business processes in order to establish consistent application of effective controls. Some business have either too much or too little documentation. An experienced consultant can help your organization determine where it is needed, how much and how it should be documented.

ISO 9001 Pre-assessment

ISO 9001 Registrars (also referred to as Certification Bodies) conduct their certification audit in two stages. In stage 1, they determine your state of readiness (which includes your planning, documentation and internal review activities) and in stage 2 they evaluate your management system for effective implementation of planned controls, in both cases relative to the ISO 9001 standard. After spending several months of implementation, you feel your company ready for the certification audit, it might be useful to use external consulting to do an assessment to determine if you are truly ready, identify any issues and help you take appropriate corrective action, prior to the Registrar audit.

ISO 9001 Training

ISO 9001 Consultancy services generally provide a number of training alternatives. These include

- ISO 9001 awareness training to employees at all levels

- An executive summary of the ISO standard to senior management

- Process identification, mapping, analysis and improvement

- ISO project management

- ISO documentation and implementation

- Internal audit

- Use of problem-solving tools

Based on the amount of internal expertise inside your organization, you may want to have an external ISO 9001 consulting service provide some or all of this training.

Develop and Maintain your ISO 9001 Internal Audit Program

To be certified and maintain your certification, the ISO 9001 Standard requires your organization to plan and conduct an internal audit program of its quality management system. In these days, some comapnies are short on resources, internal audit expertise and personnel availability outsource the upkeep of their internal audit programs to ISO 9001 consulting firms.

ISO 9001 Continual Improvement Process

The ISO 9001 standard requires your quality management system to be dynamic and work towards continually improving the effectiveness and efficiency of your organization and enhance customer satisfaction. Some ISO 9001 consulting firms have diversified skills and experience in continual improvement strategies and methods. These mayinclude problem-solving, six sigma, lean manufacturing, use of various business software and tools, etc. They can significantly accelerate your pace at gaining further operational efficiency, customer satisfaction and increased business profitability.

Successful firms are good at two things: increasing sales and reducing costs. However, these two things may prove irrelevant if the quality of the product or service is poor. ISO 9001 Standard is concerned with improving the quality of operations which can affect both top and and bottom line growth. Implementation of ISO 9001 Standard affects the entire organization by providing a transition to both a new common language and a new way of thinking about continuous process improvement. Here’s how you can bring the benefits of ISO 9001 Standard to your organization.

1. Obtain management buy-in. The most important step to any quality initiative is to obtain management commitment. This will increase both the visibility and awareness of your efforts.

2. Create an implementation team. This should include a representative from all functional areas of the organization including marketing, finance, planning, production and design. Also be sure to assign a Management Representative. This should be your strongest upper-level advocate for the success of ISO 9001 Standard implementation.

3. Communicate the goals of the program and provide training. This should include employees as well as major suppliers. The communication should be concise, tied to improving the success of current goals and objectives, and in a language in which employees are familiar with.

4.  Map out the most critical processes of the current system. Use an organizational flow chart to show how information flows from the placement of an order to delivery. Compare this flowchart with the ISO 9001  system (see Resources for a link to Management Standards) and identify areas for improvement.

5.  Create an implementation plan based on opportunities for improvement found in Step 4. The plan should be thorough and specific. Document each change in the process flowchart. If you already have documentation supporting your processes, use it. However, if you identify an area which lacks documentation, this should be viewed as an opportunity. Documentation is the lifeblood of continuous improvement. If you don’t already have one, create a documentation control system which manages the creation, approval, distribution, storage and disposal of documents.

6.  Report out on improvements, create metrics to track improvements and repeat the process. ISO 9001 Standard is about continuous process improvements, and the success of the program is a function of both commitment and the achievement of this goal.

The International Organization for Standardization, ISO, is a non-governmental agency that publishes and develops standards for the public and private sectors. From mechanical engineering and technology to agriculture, the ISO 9000 Standards establishes benchmarks and guidelines for quality products and services. ISO 9001 quality standards are a highly regarded and internationally recognized set of standards that are used in businesses, nonprofit groups and government organizations.

Since 1947, the ISO has published more than 17,500 standards. Many of these standards are specific for a product or process. In 1979, the ISO established the quality management and quality assurance committee. This committee established international quality management guidelines. The first guidelines published in 1986 were referred to as ISO 8402. These standards were updated and replaced with the ISO 9000 family of quality management systems standards. The latest round of quality standards fall under the ISO 9001:2008 title.

ISO quality standards include technical requirements, customer service levels, continual improvement requirements and documentation of key systems and processes. Quality is assured through strict process monitoring, checking for defects and routine internal and external reviews. Conformance with the rules and regulations of the ISO standards results in a company being publicly labeled as ISO 9001 certified or ISO 9001 registered.

Companies and organizations that adopt ISO quality standards increase their visibility as a quality-focused company. The public recognition as an ISO 9001 certified company could lead to increased access to contracts, especially for the government and to higher prestige in an industry. For some businesses, ISO 9001 certification is seen as a competitive advantage, while in other industries compliance is a requirement for continued operation.

The ISO claims that implementation of ISO standards increases a company’s return on investment, increases market share and profits and improves operational results. Societal benefits are improved health and safety, corporate compliance with legal requirements and reduced environmental impact.

The ISO quality standards and audits confirm compliance with the processes and business framework for a company to produce quality goods and services. Audits and reviews do not certify the actual products or services provided by a company, only the business methodology and quality systems that are designed to ensure quality. It is also a misconception that the ISO standards for quality only apply to manufacturing and physical goods. The ISO standards are also applicable to the service industry.

History Of ISO 9001 Standards

Pre ISO 9000
During World War II, there were quality problems in many British industries such as munitions, where bombs were exploding in factories during assembly. The solution adopted to address these quality problems required factories to document their manufacturing procedures and to prove by record-keeping that the procedures were being followed. The standard was BS 5750, and it was known as a management standard because it specified not what to manufacture, but how the manufacturing process was to be managed. In 1987, the British Government persuaded the International Organization for Standardization (ISO) to adopt BS 5750 as an international standard. The international standard was named ISO 9000.

ISO 9000: 1987 Version
ISO 9000:1987 had the same structure as the British Standard BS 5750, with three ‘models’ for quality management systems, the selection of which was based on the scope of activities of the organisation:
• ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing was for companies and organisations whose activities included the creation of new products
•ISO 9002:1987 Model for quality assurance in production, installation, and servicing had basically the same material as ISO 9001 but without covering the creation of new products.
•ISO 9003:1987 Model for quality assurance in final inspection and test covered only the final inspection of finished product, with no concern for how the product was produced.
ISO 9000:1987 was also influenced by existing U.S. and other Defense Standards (MIL SPECS), and so was well-suited to manufacturing. The emphasis tended to be placed on conformance with procedures rather than the overall process of management—which was likely the actual intent.

Useful Aids To Implement ISO 9001 Standards

Many companies implement ISO 9001 without using all the available tools. As a result, some companies may not fully optimize their implementation. This issue could be manifested as confusion over terms, misunderstanding about requirements, and perplexity concerning intention.
ISO, the International Organization for Standardization, based in Geneva Switzerland issues thousands of standards, but we limit our scope to ISO 9001:2008 and its immediate “family”.
This includes ISO 9000:2005 and ISO 9004:20002. ISO 9001 is a general industry standard for quality management, but ISO also issues industry specific standards. Many of these standards, such as ISO 13485 for medical devices, are based on ISO 9001 and can also utilize these available tools.

In addition to the information discussed below, ISO also issues standards related to specific activities that may arises in a quality management system. The following lists these supporting documents.

Automotive ISO/TS 16949:2002
Education IWA 2:2007
Energy PC 242, ISO 50001
Food safety ISO 22000:2005
Information security ISO/IEC 27001:2005
Health care IWA 1:2005
Local government IWA 4:2005
Medical devices ISO 13485:2003
Petroleum and gas ISO 29001:2003
Ship recycling ISO/PAS 30000:2008
Supply chain security ISO 28000:2007