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PURCHASING – ISO 9001 certification

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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.

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

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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.

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

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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.

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

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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.

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

ISO 9001 Quality Management system Principles

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Quality Management Principles are a set of fundamental beliefs, norms, rules and values that are accepted as a basis or foundation to guide an organization’s performance.

The new ISO 9001:2015 standard is based on seven Quality Management Principles. ISO 9001 Consultants should guide their clients about the importance and benefits of these principles and how to incorporate them into their businesses.

Customer focus

While implementing ISO 9001, the main focus of the organization should be to meet customer requirements and exceed customer satisfaction.

When an organization manages to attract and retain the confidence of its customers then it attains sustained success. Every instance of interaction with the customer provides an opportunity for the organization to deliver more value. When an organization evaluates current and future needs of its customer and interested parties then sustained success is ensured.

Benefits of Customer focus are and increase in customer value, customer satisfaction, customer loyalty, repeat business, better reputation, expansion is customer base and increase in revenue and market share.

You can focus on the needs of the Customer by linking your objectives to the customer needs and expectations, provide goods and services that meet customer needs and expectations, measure customer satisfaction, recognize direct and indirect customers.

Leadership

Unity of purpose is established at all levels by the leaders and they create conditions in which all employees work towards achieving organizational objectives.

The creation of unity of direction and purpose enables an organization to focus all its strategies and policies on the attainment of its objectives.

These result in increased effectiveness and efficiency in attainment of quality objectives and policies. This also results in better coordination of the organization’s business processes and in development of the capability of the organization to deliver desired outcomes.

You can take the steps of communicating the organizations’ mission, strategy, and processes throughout the organization, create shared values and ethical models for behavior and create a culture of integrity and trust.

Engagement of people

Engaged, competent and empowered people throughout the organization are mandatory to its capability to deliver value.

To manage an organization efficiently and effectively, it is necessary to involve all the people at all the levels and to give respect as individuals.

Benefits are increased motivation to achieve the quality objectives and increased involvement of the people in improvement activities.

Steps you can take to increase engagement are to communicate to the employees that you understand their importance to the organization and facilitate open discussion and the sharing of knowledge as well as experience. Empower people to undertake initiatives without fear.

Process approach

Predictable and consistent results are achieved more efficiently and effectively when activities are management and understood as a group of interrelated activities which function as an integrated and coherent system.

Understanding how the results are produced by a quality management system through its interrelated processes enables the organization to optimize its performance and system.

The benefits of process approach are a focus on key processes and predictable and consistent outcomes through aligned processes and optimized performance.

Actions you can take to adopt the process approach are defining objectives and processes necessary to achieve them. Also establishing authority and responsibility as well as accountability for each process. You can also determine process interdependence and analyze the effects of change to individual processes and to the whole system.

Improvement

Successful organizations everywhere have a continuous focus on improvement.

To maintain its current level of performance and to enhance it, the organization has to engage in improvement activities. Improvement is also essential for the organization to respond to its internal and external conditions and in the creation of new opportunities.

The benefits are an improvement in performance and focus on root cause investigation and corrective &preventive actions. The organization develops an ability to respond to internal and external changes as well as risks and opportunities. The organization also considers incremental and breakthrough change.

Steps one can take are establishment of improvement objectives at all levels and put in improvement considerations into development of new products, services and processes. Educate employees to apply basic improvement tools and methodologies.

Evidence-based decision making

When an organization makes decisions which are based on analysis and evaluation of data then it is more likely to lead to desired results.

It is vital for the leadership to understand cause-and-effect relationships as well as potential unintended consequences. Facts and data analysis leads to more objectivity and greater confidence in decision making.

The benefits of this approach are improved decision making processes and better assessment of process performance and ability to attain objectives. It also leads to better operational efficiency and effectiveness.

Steps you can take in this area are in determining, measuring and monitoring key indicators that demonstrate the organization’s performance. Ensure that data in accurate and make it available to the relevant personnel. Finally make decisions based on evidence and balance them with intuition and experience.

Relationship management

To achieve sustained results, the organization should manage its relationships with its interested parties like suppliers in a very good manner.

Interested parties influence the performance of the organization. Sustained results can be achieved when the relationships with all the interested parties are managed so that a positive impact is delivered on its performance.

Benefits of Relationship management are a supply chain which provides a continuous flow of goods and services. It also results in enhanced performance of the organization and the interested parties by better responding to the opportunities and constraints for each interested party.

Steps that the organization can take in this regard are determining the interested parties such as suppliers, customers, partners, employees, investors and their relationship to the organization. Determine relationships that need to be managed. Measure performance and provide feedback to interested parties so as to enhance performance. Share and pool information, expertise and resources for better outcomes.

More About The ISO9001 Certification in Melbourne

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ISO9001 need companies to meet certain requirements in order to qualify for the ISO 9001 certification. There are strict stipulations in place to be awarded the certificate. Only those organizations that act in accordance with the stringent quality guidelines in terms of business operations, products and services end up receiving this honor. The certificate is a way of showing the world that the organization’s commitment to quality is almost perfect in all regards.

In many ways, the certificate helps organizations stand apart from the crowd, function better, improve customer service and have a highly motivated staff. Qualified ISO 9001 Melbourne consultants are aware about the industry standards. So, they can help organizations set up an effective and productive system and staff to stay on top of the stringent requirements. Moreover, ISO9001 consulting Melbourne staff can perform periodic audits to test the effectiveness of the initiative. In this manner, an organization can be well prepared for the final audit conducted for the certification.

Quality management system is the key over here. Also, the system is not restricted to one department. All the departments must function properly and offer quality and productive service. Employees at all levels including the managerial staff play a role in the certification process since everybody is expected to be productive and efficient for the growth of an organization. The objectives and parameters have to be set and measured. All the employees should be aware of the governing processes and the quality requirements. They must be trained to follow all the guidelines to meet their objectives.

Regular assessment would also be needed to check on errors and to improve the system and process as and when needed. Conducting internal audits on regular basis will go a long way in deciding whether the company is ready for the certification or not. ISO9001 consultant can prove to be of great help for internal audits. The knowledge and expertise of a consultant in this field can end up being the deciding factor. Effective audits allow an organization to review the quality of the systems and processes across all departments. Deviations can be tracked as well and risk management along with recovery mechanics can be set in place too. Moreover, periodic audits will make way for ongoing improvements. When the internal audit report is submitted to the top management, ISO 9001 consultants review them and supply the company with useful suggestions on improvement in order to qualify for the final ISO 9001 certification.

Whether it’s a small or a big company, ISO 9001 certificate can benefit an organization in more than a few ways. It sets out clear targets, responsibilities and accountability. The deficiencies are taken care off and employees end up being more productive. Moreover, it encourages cost optimization and promotes continuous improvements through regular audits. All the benefits combined can improve company’s relationship with customers as well as suppliers.

ISO 9001 certification is not a one-time process. Therefore, hiring the services of ISO 9001 consultants can be of substantial help over here. Their in-depth knowledge and expertise can set a company right on the path of receiving ISO 9001 certification. While a company can get certification without the aid of an ISO 9001 consultant, the certification process can get delayed due to lack of experience and knowledge. On the other hand, the services of an ISO 9001 consultant can improve the company’s chances of getting certified in the quickest possible time.