What Does ISO9001 Help Achieve?

Companies who produce products? or deliver services that are supplied to customers, whether countrywide, or worldwide need to have standards by which they measure their products? oe services in order to ensure that quality is maintained at a level that is acceptable. Products and services need to consistently meet the requirements of the customers, and standards should be ever-improving. The ISO9001 standard addresses many important factors relating to quality management.

ISO 9001 is a guideline by which organisations can measure their quality standards. This is a standard which companies can obtain a certification in, although this is not really required. This standard can be implemented by any company, regardless of size or field of activity or industry.

This particular standard is based on various quality management principles. The focus lies predominantly on customer focus, the role of top management in motivating and implementing the standards, the actual process, as well as a need for continual improvement of standards.

By implementing the standard set out in ISO9001, companies can ensure that their customers receive consistently high standards and good products and services. By doing so, the company will reap the many business benefits on offer.

The Principles

The principles of ISO9001 are well-defined guidelines which assist any company in meeting the criteria and surpassing expectations. There are seven basic principles that should be adhered to. Customer focus, leadership, engagement of people, process of approach, improvement, evidence based decision making, and relationship management. Each of these principle carries with it benefits that are invaluable for any business.

Customer focus – The main aim of the standard is to meet and exceed customer expectations. By achieving this, your business will reap the rewards. Increased customer value, increased customer satisfaction, increased customer loyalty, enhanced repeat business, growth and enhancement of reputation of the business or organization, grow your customer base, and benefit from the increased revenue and market share.

Leadership – In order for any process to work in an organization, there needs to be direction and purpose. Good leadership will create unity, and conditions where the people involved are all motivated to achieve the company?s quality goals and objectives. A good leadership structure will ensure that there is an increased efficiency and effectiveness at achieving the quality objectives of the company, better co-ordination of the processes involved, improved communication between all levels within the business and a better understanding of the function of each, as well as increased development and improvement in the capability of the business and the staff to deliver the results that are desired.

Engagement of the people – The staff, as well as the management of an organisation are all required to work together in order to reach the desired quality standard results. An environment conducive to the enhancement of the company?s capability to produce and deliver quality and value. A company who has a staff and managment who are all geared towards the same end result will always perform more efficienctly, and reach objectives with effectiveness. Good communication will ensure that there is a better understanding of the company?s quality objectives as well as motivation to reach the goals set, a well-oiled machine headed in the same direction will ensure that involvement of all the staff to improve, each member of the team will have a desire to achieve and develop on a personal level, and trust will become a mutual factor between all members of staff regardless of designation. Team work is required to achieve the standards set out.

Process of Approach – Results will always be best achieved and with greater effectiveness and efficiency when the tasks being carried out are fully understood by all involved. Each activity needs to work together as a coherent system rather than individual tasks. Inter-related process is what the ISO 9001 quality management system is built around. By completely understanding how results can be achieved through the system is what gives the company the edge. Efforts are better directed at areas which are key to the process and where there is possibibility to improve on performance. Once implemented effectively and managed efficiently, resultscan become more easily predicted and consistent. This approach achieves best results when the objectives and goals of the process in clearly defined. Authority, responsibility and accountability for managing process must be established from the start. The necessary information required to properly operate the processes, monitor, analyse and evaluate them overall system must be readily available. Risk management is key to ISO 9001. Risks that can affect the process output and the results of the quality management system must be assessed and managed effectively.

Improvement – A company that is headed for success is one that is always focused on where improvement can be made. In order to maintain current levels of performance it is vital that a company focus on improvement at all times. Being prepared to adjust and react to change, whether internal or external, is a fundamental factor.

Evidence-based decision making – Decisions made on solid analysis and evaluation of all the information on hand are the decisions most likely to produce results that are desired by the company. This principle benefits the company in many ways and in doing so allows ISO 9001 to become the useful asset that it is meant to be. Decision making processes are improved, assessment of process information and the ability to achieve objectives is enhanced. Operation effectiveness and efficiency shows vast improvement. In order to ensure that this principle is effective the company needs to determine and monitor the performance of the company, make all the relevant data and information accessible to the relevant people and it must be accurate, reliable and secure. Suitable methods should always be used to evaluate and analyse data. Decisions and actions must be based on evidence, experience and intuition.

Relationship Management – A company must manage its relationships with all interested parties at all times in order to maintain and sustain success. Interested parties such as suppliers influence the performance of any company. Maintaining these relationships ensures that the impact of said parties on performance is optimized. The interested parties must understand the goals and values of your organization so that they can better cater to the requirements. A chain of supply that is well-managed will always provide a stable influx of goods and services.

It becomes apparent that there is far more to a successful operation than simply putting out good products or services. Each and every link in the process in imperative to success and improvement. ISO 9001 certification allows every company the opporutnity to take advantage of what is right in front of them, and reaching for the top.

 

 

The value of ISO 9001 certification

What Is ISO Certified?

If a system is ISO certified it assures the people who have purchased the system that it is in fact reliable and of a high quality. The ISO 9001 system is one that carries many benefits and provides you with approval by many clients both local and international. The ISO 9001 quality management system is not only used by companies that produce products but also for companies that provide services. The management system is not a requirement and is completely voluntary to implement. The benefits of implementing such a system are invaluable to your business. Productivity will be increased and the efficiency and effectiveness of company operations will have far-reaching effects. The reasons for wanting to gain certification vary from wanting to motivate staff by setting clearly defined goals or it may simply be a requirement withing the context of their risk management program.

Who Certifies A Company?

A company can never be certified directly by ISO but rather by one of their accredited partners and private certification bodies. The certification may be stamped with the seal of ISO, however this does not mean it was issued by the institution. Certification is based on a Conformity Assessment which is evaluated by the Committee and they base this on many standards which are related to the certification process.

The Value of Audits

Audits are one of the most important parts of the ISO management process. These audits allow a company to understand whether they are on the right path to obtaining the official certification and if not, where do adjustments and changes need to be implemented. It must be remembered that although any company can implement the quality management system, obtaining certification will gain you good ground within the industry and the market. ISO 9001 certification ensures that waste and errors will become less and less and the quality of goods and services will improve drastically and consistently. ISO 9001 companies are more likely to attract investors both nationally and internationally. More confidence and trust is placed in companies that are ISO 9001 certified than those who are not.

Facts and Figures

  • 178 Countries are members
  • There are 3335 technical bodies responsible for the development of standards
  • 150 people work full time for ISO in Geneva, Switzerland
  • There are nearly 20000 individual ISO standards
  • There have been 1.1 million certificates issued across 178 countries
  • 42000 companies or organizations in North America are ISO 9001 certified
  • 29000 companies or organizations in the United States are ISO 9001 certified
  • Sections to ISO 9001 – Scope, normative reference, terms and definitions, quality management system, management responsibility, resource management, product realization and measurement, analysis and improvement
  • ISO 9001 organizations or businesses are paid more on average as they are deemed more competent and trustworthy
  • The increased benefits of becoming certified include higher demand for products and services, increased market share and improved company perception
  • Improved financial performance is noticeable after ISO 9001 certification
  • Better sales growth is registered in certified companies as opposed to those that are not certified

ISO is so much more than a set of guidelines to build your quality management? system around, this is your chance to improve the atmosphere in your work environment, share the responsibility and accountability, and create a dream team. By improving the team with which you work and becoming a partner rather than a boss to them you create an atmosphere where you become approachable. Once you become approachable you will find that suggestions and ideas begin to flow freely from every staff member, each committed to the cause.

The overall improvement in the product or service you produce will be more than enough to boost the confidence of your employees and encourage further productivity and change. Everybody will understand the goals and the path to those goals. Financial reward will be felt by all once the processes are streamlined the waste is reduced and let?s admit in this day and age, money talks loud and clear.? By rewarding, you encourage.

In the ISO 9001 management process there is a huge emphasis placed on the consumer or customer. This process is directed at meeting the needs, expectations and requirements of those that purchase your products. Customer satisfaction is paramount in the pursuit of increased market share, confidence and sales increases.

If your expectations of what you can achieve from the ISO 9001 process are still on shaky ground you can simply implement the processes to see if there are improvements in production, consistency , waste reduction and staff morale before you take the step to becoming certified. A tremendous part of the ISO 9001 process is documentation. This paperwork has to be in order, up to date and available as? this is the means by which you measure improvements or realise where changes need to be implemented. This documented evidence is what will be used during any form of auditing process.

Bear in mind if you are considering this for of quality management process, gone are the days of you, the boss, dictating, you have to adjust to become part of a team. You have to be prepared to take the good with the bad, dish out commendations when necessary but also reprimand but, you yourself cannot expect to receive all the praise for a system operated by the people as a team. I think for many this is one of the greatest obstacles to achieve but one that is well-worth getting past. The sooner that line is abolished, the sooner your team will become one. It is time to make the change, see improvements and put your business on the map.

?ISO 9001 certification can?assist you on your path to consistent quality products and services, gaining trust from your client base, attracting new investors and opening the horizons to the international market. Your team will get you there but you need to ensure they have all the tools readily available and the confidence from you to drive them forwards.

PURCHASING ? ISO 9001 certification

Purchasing is one of the most important processes of the Quality Management System based on ISO 9001?certification?standard. The inputs to the Purchasing or the Purchasing Information comes from the Design & Development Process. Design specifies the parts and materials and their grades and qualities that are going to become part of the product. If this step is not correct then the purchased part will not meet the requirement of the Design and hence the Production will not be done correctly.

ISO 9001 certification

The organization shall develop the criteria for the evaluation and selection of External providers (Suppliers). The organization shall monitor the performance of the external providers and periodically re-evaluate them based on their ability to meet requirements for products and processes. The organization shall maintain documented information of these activities and any actions arising from the evaluations. The organization may develop an External Provider Audit Checklist and evaluate External Providers based on that criteria.?Calibration is done through measuring a standard .

The main objective of Purchasing is making sure that the purchased product conforms to what you asked for. So the control you place one the Supplier will be based on the effect it will have on the production process and the final product. For example if you bought a nail with a damaged head then you can easily put it aside and replace it with another nail with a good head. There is no need to place a strict control on the supplier.

You have to make sure that the supplier can provide the quantity and quality of products that you require. You also have to look into the financial strength and market reputation of suppliers.

Controls

The organization shall determine the controls to be applied to externally provided processes, products and services when products and services from external provider are intended for incorporation into the organization?s own products and services or products and services are directly provided by the external provider to the customer on behalf of the organization or a process or part of a process is provided by the external provider as a result of a decision by the organization.

Types and extent of control

The organization shall make sure that the externally provided products or services do not negatively affect its ability of providing consistent quality products and services to its customers.

The organization shall make sure that externally provided products and services remain within the control of its Quality Management System.

The organization shall also determine the control?s that it plans to apply to the external provider and to the product.

The organization shall also take into consideration the potential impact of externally provided products and services on its ability to consistently meet customer and applicable legal requirements,

The organization shall also take into consideration whether the controls applied by the external provider are adequate or not.

The organization shall also determine the Verification and other activities required to ensure that the externally provided products and services meet requirements.

Purchasing Information

Information in the Purchase order is the most important information in the purchasing process. You should describe the product being purchased, and if appropriate then add the approval requirements for the product, process, procedure or equipment to be accepted. If you require a specific piece of equipment to be used then this should be included in the Purchase Order. Finally you should check the adequacy of purchasing information before sending the purchase order to the supplier. If the supplier does not have adequate information then it is your fault.

The adequacy of purchasing information shall be ensured prior to its communication to the supplier.

The organization shall communicate to the external providers its requirements for the products, processes or services to be provided. It shall communicate the requirements for approval of products and services, methods, processes and equipment and the methods for release of products and services. It shall communicate the competence requirements of supplier personnel, the requirements for external provider?s interaction with the organization, the control and monitoring of external providers performance to be applied by the organization and the verification or validation that the organization intends to apply at the premises of the external provider.

When the organization receives the products, then it needs to verify that it had got what it ordered. The products are first placed in the Quality Check Area in the store and they are checked for acceptable quality. If they pass the checking then they are placed in the store in designated area. Entry is made in the store register for the product or part. After that they are forwarded to the production area when the requirement arises and the Store Issue Requisition is given to the Store Personnel by the Production Personnel. Any product or part failing the quality check is placed in the Quarantine Area and the Store Manager in consultation with the Production Manager decides what to do. He has the option of using it under concession if the defect is slight. He also has the option of sending it back to the supplier or scrapping it with the supplier?s permission.?Calibration is a process through which you confirm that the measurements you have taken are true.

 

CALIBRATION ? ISO 9001 certification

Calibration is a process through which you confirm that the measurements you have taken are true. The measurements can be of the components, final product or your process parameters. Calibration is done through measuring a standard e.g. a measuring device and ensuring that the error is within the required limits.

calibration

For example a measuring scale is being calibrated. You place a known weight of 10 KG on it. Your measurement reading is 10.05 Kilograms. This means that the error is 0.05 grams. Depending on the level of accuracy required in your organization, this may mean a pass or a fail.? If your required tolerance limit is +/- 0.03 grams then your scale has failed calibration test. A tolerance of +/- 0.10 grams means that your scale has passed the test. Tolerance of the measuring equipment is usually set by the manufacturer but it is also determined by your process or customer requirements.? A real calibration shall test the measuring equipment over a range of measurements which can be either the range over which it is to be used or the full range.

Reference material is a material answering to the definition of material having the quality of being sufficiently homogenous and stable with reference to specified properties which has been established to be fit for its intended use in measurement or in examination of normal properties. Reference material accompanied by documentation issued by an authoritative body is called Certified Reference Material. You use reference material to find out the trueness of your measuring equipment as a true standard against which your equipment is measured.

Your measuring equipment degrades over time and must be re-calibrated. There are calibration companies which will calibrate your measuring equipment such as weighing and measuring equipment or pressure and heat gauges against known national or international standards and provide you a Calibration Certificate which is valid over a specified period of time.

Suppose you have an on-off gauge which determines the conformance of an item. Over time the gauge will wear out and it can show more components as good or vice versa. It shall appear through its flawed measurement that the production is improving when the gauge is simply out of calibration.

The time interval between calibrations is dependent on a number of factors which are the manufacturer?s guidelines, the operating environment in your organization, the accuracy requirements and the historical data of the length of time the instrument gives true readings.

All companies do not require calibration and those that do are not required to calibrate everything. For example if you have a manpower company dealing in labour then you do not need to calibrate and can claim an exception to this part of the ISO 9001 standard. To find out which equipment requires Calibration you have to keep in mind a number of factors:

Is the calibration required by the customer?

Is the calibration required by the product specifications? If your measurements should be within tolerances then you are required to calibrate your measuring equipment to make sure that your measurements are correct.

What are the consequences of the equipment?s giving wrong measurements? E.g. processing returns, accepting bad components, rejecting good components, reworkand unhappy customers. You will find out that these costs exceed the costs of calibration.

The cost of replacement compared to the cost of calibration. You will still need to calibrate and monitor the new equipment so as to know when it is not serviceable.

The equipment not requiring calibration should be marked as such.

After calibration your calibration provider usually affixes a sticker on the equipment stating that the piece is calibrated and the time period for the calibration to stay effective. The Calibration provider also issues a certificate to this effect which you need to store in the calibration file so that you can show it at the time of the ISO 9001 certification audit and for your own records.

It is a nonconformance under ISO 9001 when your measuring equipment fails calibration. All the measurements that you have taken since the last calibration are suspect now. The effects of this depend on how critical this equipment is? How much out of tolerance is the equipment? And how much time has passed since the last calibration? The action required may be corrective action like re-measurement, product recall or rework.

You should make sure that your measuring equipment is safeguarded from adjustments, damage or deterioration that would nullify the calibration status and subsequent measurement results.

You should maintain documented information of the measurement as evidence of the fitness for purpose of the monitoring and measurement equipment.

The difference between calibration and verification is that a calibration provides the error of the instrument and compensates for any lack of trueness through applying a correction. A verification on the other hand indicates that a measurement error is smaller than the maximum permissible error. The maximum permissible error is defined by the user as the largest error he or she is prepared to accept.

 

 

CORRECTIVE ACTION ? ISO 9001 certification

A correction is that when a problem and you fix it immediately. For example if a machine is making bad parts because the alignment is wrong and you fix it then it is a Correction. But if you look deeper and find out that the machine has to be aligned after every 4 hours and develop a schedule for it then it is called a Corrective Action.

ISO 9001 certification

As ISO 9001 certification looks at production / service in terms of a Process Approach. If there is some problem or a fault then it is a fault in one of the processes. A process is defined as a way in which work gets done. It is a series of steps that if followed consistently delivers the expected output. For example Engineering has a process which results in designs, Manufacturing has a process which results in finished product. Purchasing has a process which results in quality inputs. Sales has a process which results in new orders. Also service companies have their own processes.

A process has to follow a few basic principles to succeed:

  • The process must be defined by the planner of the work
  • The Process must be understood by the operators
  • Process must be easy to carry out
  • Process must be measured in order to make a sense of its results

For any process to succeed these four rules must be followed. If any one of these rules is broken then problems arise in the output of the concerned process.

If the process has not been defined in a proper way then it is up to the operator to get it done. Meaning that the process will be done in a different way by each operator.

If the process has not been fully understood then it will cause the operators to develop their own understanding based on trial and error and educated guesses.

If the process is difficult in following because of problems with equipment, schedules, materials, instructions etc. the operators will be forced to work around the system to get the job done which will produces different results for different operators.

If there is no reliable data coming out of the process then nobody will know how well the process is performing and should changes be made to the process or not.

Problems occur when a process goes wrong. For example one time problem occurs due to a single breakdown of a process. When a process consistently breaks one or more of the four rules then recurring problems occur. There are a few basic questions that will guide you is resolving one time or recurring problems. This is known as investigating the Root Cause.

Some questions are as follows:

  • Where the process has been formally defined?
  • Can the operators demonstrate complete understanding of the said process?
  • Can you observe any obstacles to the correct and consistent adherence to the process?
  • Is the process consistently meeting requirements as shown by the measurement results?

These four questions are a powerful tool in finding the root cause if you know which process has failed. However as the processes are linked and interconnected, problem occurring in one process may have a root cause in another process. So you have to ask the WHY question repeatedly to arrive at the real root cause.

The Corrective action to undertake is also based on the four questions:

  • If the process has not been properly defined then update or create documentation.
  • Provide training if the process has not been fully understood.
  • Identify and remove problems if there are obstacles to the process
  • If the measurements show that the process is incapable of meeting requirements, then re-design the process.

Below is a step by step methodology for Root Cause Analysis and Corrective Action:

First define the problem. You have to make sure that it is not a perceived problem but a real one. You can verify this by writing the problem on a sheet of paper and identify the problem as ?Should be? as compared to ?is? statement. E.g. parts should be chromed, parts were received with golden plating.

Secondly you should define the scope of the problem. Is it just a problem in a particular day?s production or is it a recurring problem.

Thirdly, while you find out a fix for the problem make sure that you have installed checks or stop gap measures to detect the problem if it occurs again.

Fourthly find the root cause of the problem. This can be done by asking the WHY question repeatedly five times and arriving at the real cause of the problem.You can also use the Fish bone Diagram or Ishikawa Diagram for this purpose.

Then you have to plan a Corrective Action to remove the problem and also identify the cost and return on investment. And get the approval for the corrective action from the concerned authority.

Sixthly, you have to implement the corrective action. This can be preventive maintenance of a piece of machinery etc.

Seventhly, after you have made the changes, you have to observe the process again to see if the problem is removed and the real root cause has been removed.

Minimum Documented Information To Be Maintained For Achieving ISO 9001 Certification

Business organizations use documented information to train employees, for ensuring products and services produced are of consistent quality. It also provides evidence of compliance to various requirements.? As per clause 3.8.5 of ISO 9000 the minimum documented information required for achieving ISO 9001 certification is: a document can be based on magnetic, optical, electronic computer disc, a sample, a photograph or paper.

ISO 9001 Certification

According to requirements of ISO 9001:2015, the overall documented information to be maintained and retained will depend on the risk of nonconformity inherent in the processes or activities of a particular business organization. ?Risk evaluation should include the likely impact of the risk, likelihood of non-conformity and interaction of the processes among one another as well as the type of controls required. (To maintain documented information means to have procedures, flowcharts as means of telling the methods and to retain documented information means records to be retained as evidence)

Minimum documented information to be maintained by the company is discussed below. (Based on the risk profile of the processes, products and services, more documented information may be required in many cases.)

Defining the scope of the QMS: role of ISO 9001 consultants

Scope should include details of the services, products and activities covered by Quality Management System. If some clauses of ISO 9001 cannot be applied to the company because of the nature of the business, the justification for excluding the requirements of relevant clauses should be furnished. ISO 9001 consultants can provide guidance on defining the scope and planning for documented information to be maintained. Scope will be part of documented information

QMS and its Process requirement (Clause 4.4.2A)

Documented information must be maintained as support for operation of the processes required for the QMS. Documented information may ??cover

  • determination ?of the ?processes needed for the QMS,
  • process inputs, interaction? of processes? and?? their? sequence,
  • how to address ?risk of non-conformity, resource availability
  • process control and criteria for effective operation,
  • Evaluation and improvement of processes.

QUALITY POLICY (5.2.2)

Top management must establish and maintain Quality policy for the organization, which may be maintained as documented information.

QUALITY OBJECTIVES (6.2.1)

Organization must maintain the documented info about the quality objectives

Quality objectives will be a part of product/service realization planning and include:

  • What is to be achieved,
  • who will achieve it,
  • how to achieve it,
  • What are resources required and planned?
  • When will the objectives be achieved?
  • How will it be measured?

Thus status of attaining of quality objectives will be part of evaluation process.

Clause 7.5 explains that documented information to be maintained as support for operation of processes.

There is need to control all the documented information, but documented procedure is not mandatory. Control may include usage as well as the access of the information.

Claus 8.5.1?? documented info for control of production processes and service provision

This is the basic Information that clarifies and defines product characteristics, and attributes of services, characteristics of activities and tasks to be performed, as well as the outputs as well as the results to be achieved.

Additional process specific documented info

Process specific documented information may be maintained separately by each process owner as support for individual activity, process or task, which could add value to QMS.

Such information could be in the form of

  • Flow charts,
  • Organization charts
  • Task ?maps,
  • process ?flow descriptions
  • work ?Procedures
  • instructions
  • purchase Specifications
  • Departmental or corporate ( internal) communications
  • Operation ?schedules
  • Authorized vendor lists
  • Test ?plans
  • Detail ?inspection plans
  • Quality control ?plans
  • manuals
  • Strategic plans
  • Standard Forms