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Are all audits the same?

There are three categories of audits; certification audits, surveillance audits and re-certification audits and three types of audits; first party, second party and third party audits.

ISO certified

Certification Audits or third party audits are conducted by an external third party to find out the conformance of the organization’s management to the international or national standard. As the ISO certificate is awarded for a period of three years, so the certification body or third party conducts a yearly surveillance audit to find out if the new system is being implemented correctly or not.

During the first or initial certification the external auditor will check to see if all the main elements of the management system are in place. All the SOP’s, Work Instructions, the Manual, Job Descriptions, Forms are in place. The auditor will check to see whether the processes are working as they are given in the documentation. The checking will be limited in its scope as only a few weeks or months may have passed since the new system has been put in place.

But on the other hand the ISO Certificate is issued for three years. For example if the certificate was awarded after audit in august 2015 and would be valid until August 2018. In this case the only way for the certification body to confirm that the system is being run as per the standard is to conduct yearly audits of the organization, for example in August 2016.   This audit is known as the Surveillance Audit and are conducted once or twice a year. If it is conducted once a year then it will be conducted next in August 2017. In August 2018 the certificate would expire and the company will have to go for a re-certification audit.

The main purpose of surveillance audit is to check whether your system really works in everyday operations or not. It focuses on things that the certification audit was not able to check. For example are all incidents recorded or all measurements are being recorded, or all corrective actions are being recorded and implemented, whether the top management supports the new system.

A surveillance audit or visit will also focus on areas that were deemed weak in previous surveillance audit or certification audit. These minor nonconformities as well as other areas where the auditor has made observations are followed through and checked for improvements.

First Party audits are called Internal Audits. This happens when a person conducts and audit of a process or set of processes to ensure that it meets the procedure that the company has documented. The person can be an employee of the organization or someone hired such as an ISO Consultant. These audits are deeper than other types of audits because they look for problems in the processes, areas where the processes are not in alignment and the effectiveness of the management system. These audits are one of the best ways in which an organization can improve itself.

Second party audit occurs when a company undertakes an audit of a supplier to make sure that it is meeting the contract requirements. These requirements can include traceability of parts (documenting which parts are used in which products), special control of certain processes such as welding, requirements for specific documentation or requirements for special cleanliness or any other requirements which may be of interest to the customer. This audit can be done on-site or off-site by reviewing the documents submitted by the supplier. The customer can audit a part of the contract or the whole contract wherever he sees a need. It should be clarified that the second party audit is between the supplier and the customer and is not linked to becoming ISO certified.

There was an opinion that second party audits would not be required once a company becomes ISO certified but that did not prove to be the case. Even if you are certified by a third party, your customers may still want to carry out an audit to look at elements of their contract especially if their contract elements are different from ISO 9001.

A third party audit occurs when a company decides that they want to create a management system that conforms to and international standard like ISO 9001 Quality management System, ISO 14001 Environmental Management System, Occupational Health & Safety Management System or Social Accountability Management System etc. In such a case the company has to hire an external certification body to perform an audit to verify that the company has succeeded in this challenge. These third parties or independent companies are called certification bodies or registrars. These certification bodies are in the business of doing audits to verify that the management system meets all the requirements of that particular standard and continues to meet the requirements on a continuous basis.

 

Benefits of ISO Certification

International standards ensure the quality and safety of the products that we use in everyday life. Without them we would be at the mercy of the claims of the advertising industry. International standards provide a surety and confidence to the consumer that the product or service he or she is purchasing is backed by an international quality and reliability certification. If a product conforms to international standards then the consumer is assured that the products, systems and organizations are reliable, safe and good for the environment. Thus ISO international standards are at the backbone of the society that we live in and the ISO Consultants play a key role in explaining and implementing these standards in our organizations.

ISO Certification

Many research studies have proved that standards give a boost to the economies and business. Due to the standards an estimated $ 81 billion has been put into the economy while in UK they are responsible for annual $ 8.2 billion growth in Gross Domestic Product or GDP.

One key finding is that standards can be utilized to streamline the internal processes of an organization. For example by decreasing the time required to execute specific activities in various business processes, decreasing the level of waste, reducing the procurement costs and enhancing productivity. It has been found out that the standards contribution to the gross profit of companies ranges between 0.15 % and 5 % of annual sales revenue.

As the business is better organized by adopting standards, it helps the business to innovate easily. Case studies have shown that organizations are better able to expand their offerings by introducing and innovating in new products in their distribution network. The standards also help in mitigation of risks associated with introducing new products. Furthermore the standards help in the organization with adding more suppliers to their network.

Standards have been used by organizations as the basis for new product development, entering new domestic and international markets and supporting the market demand of the products. The standards are helpful even in creating new markets. In some extreme cases, companies have far exceeded their profit margins from the figures given above to the level of 33% of their annual revenue. This also helped the companies in positioning themselves as market leaders in their field over a period of time.

WikaBeton, an Indonesian conglomerate active in construction, real estate and trading businesses, used ISO 9001, OHSAS 18001 and various technical quality standards. They developed a unified management system allowing for high quality operations which resulted in increased customer confidence.

The major benefits of using standards allowed the organization to improve its selection and evaluation of suppliers, save resources in research and development, optimize the transfer of information through unified specifications and standard information capture, high quality supplies, optimization of production process and obtain benefits in sales negotiations.

NTUC Fairprice is the largest supermarket chain in Singapore with a market share of over 50%. It uses Cold Chain standards for milk and frozen meat as well as Bar code standard and ISO 9001 and well as HACCP.

The benefits to NTUC of the standards were in doubling the volume of goods handled while having the same number of employees, improving process efficiency, extending the supplier network, raising and maintaining the product level of quality and increasing the level of customer loyalty and confidence.

The benefits were translated into annual saving of approximately USD 3.2 million and also helped nurture a culture of continuous improvement in the organization.

Gefor is a Colombian multinational company which is active in the plastics and synthetic fibers sector in the petrochemical industry. It uses over 200 standards, both national and international ones. The benefits to it were in continual improvement in operations and production, sales and marketing by creating market access allowing it to expand rapidly in the domestic market, and accessing international markets by meeting market entry requirements and conditionsin the design of new products, quality inspections of supplies. The economic benefits of the standards is USD 8 051 919 which is 77% of the company revenues. The company has introduces ISO 9001, ISO 14001 and OHSAS 18001which have helped in streamlining its processes and increasing its quality and reliability.

Danper, founded in 1994, is one of the largest agro-exporter in Peru dealing mainly in Asparagus and Artichokes. Its business comprises of preserved goods (77% of sales), fresh products (21 % of sales) and frozen products (2% of sales). It is certified to ISO 9001 and ISO 14001 and National Peruvian Standards as well as HACCP, OHSAS 18001 and SA 8000 and finally Global GAP and US GAP.

It has benefited by USD 648 158 annually from the standards which amounts to 0.73 % of sales revenue. Using standards has allowed Danper to continuously improve its skills and implement an efficient and reliable production process, manage the cold chain in a highly efficient way and ensuring product quality requirements are met in overseas markets and demonstrate through its certifications to its overseas customers, its ability to produce and deliver safe and high quality products and to qualify as a supplier for them.

 

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.

Quality management system: The most important points we often neglect

Quality management is a management methodology. We often forget the basic management functions and principles, while adopting and implementing quality management system in an organization. Basic functions of management include goal setting, organizing, staffing, planning, coordinating, monitoring and controlling.

Quality Management system

Effective managerial leadership process also involves supervising and directing, motivating, problem solving and communicating with employees for ensuring that the company accomplishes the planned objectives and goals.

Planning and coordinating to ensure quality

The planning function creates process, activity and task schedules, along with resource allocation such as manpower as well as equipment, information and knowledge support, enabling the organization to operate successfully, for achieving its goals. What is often forgotten is the need to update and modify plans based on changes in customer requirements, changes in environment, progress in plan implementation and new constraints on resources?

The coordinating function has to interface with planning, organizing, as well as controlling functions, in line with goals of the organization which are driven by customer requirements. Coordinating is usually a weak link in the quality system and higher management must constantly monitor the coordination function.

Organizing and staffing

 Organizing involves allocating responsibilities and tasks to teams and individuals based on specific skill sets needed to complete the tasks. Agile organizations are able to respond fast to changing customer demands. Organizing also involves reporting and line of command. Organizing and staffing together involves complete talent management function involving sourcing and retention of talent and performance management. Non availability of the necessary skills in time can mean risks to the output of the processes and outcome of businesses. This aspect is normally neglected in quality system. Development of skills and monitoring of skill development could be a critical success factor for business organizations.

Motivating teams and involving people in improvement activities are other critical factors related to organizing and staffing.

Strategy for fulfilling quality objectives: role of ISO 9001 consultants

Organization’s strategic plans must take into account resources needed, including expertise, knowledge, updated information and skill requirements, and how to source the critical resources. Sourcing strategy for the critical resources is a major challenge for every organization. But this aspect is usually neglected and companies are often operating in the firefighting mode. ISO 9001 consultants can help you solve such issues and put in place the strategies for sourcing critical resources. 

Evaluating, Controlling and monitoring

The monitoring and controlling function acts as eye and ears of the management. This is to ensure that all the necessary functions of the business organization are operating as planned. Controls are exercised on the basis of process control criteria and other standards of performance and targets set for teams. Any deviations from control criteria must be investigated and risks to final outcome of the company must be evaluated. Measurement of process parameters and product and service characteristics must be utilized for statistical analysis to obtain trends of non-conformity. Impact of non-conformity on other related processes must be analyzed. Necessary corrective actions must be planned across the entire organization, so that learning action from failure can be initiated.

Based on the changes in customer expectations, as well as regulatory changes,   the process acceptance criteria must be changed and process owners trained on the new criteria.

Evaluating and controlling includes monitoring the status and measuring the attributes of a process as well as the output (product or service) and taking appropriate actions based on data and observations. Manager’s wakeup to the need to monitor only when there is a crisis.  If  process evaluation  is done even   when everything appears to be running smoothly, sales are growing along with profits, customers are happy,  then you are going to prevent an impending crisis due to customer complaints, by taking preventive actions.

Voice of the customer

 Top managements of the companies are unable to respond quickly to the changes in customer requirements and latest customer perceptions about company’s products and services. Employees as well as managers across the organization must listen directly to the voice of the customer. Changes in resources and processes required   to meet new expectations of customers and other interested parties, must be analyzed and evaluated. New strategic plans should incorporate necessary changes in processes and process criteria based on changes in customer needs. Risks and opportunities arising out of the voice of the customer must be assessed regularly.  Changes in market place occurring due to competitors coming up with new offerings of products and services need to be assessed.

Thus by following some of the management principles and functions, and listening to the voice of the customer, we can make the quality management system more effective.

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

How is Systems Thinking as per ISO 9001 connected to Product Management?

Product management is a coordinating role that deals with design, planning, production, forecasting, marketing and sales of product during all stages of the product’s life cycle. As people and processes from different departments come together to form a product, so Systems Thinking as per ISO 9001 Quality management system which views the Organization as a combination of interacting processes which affect one another is a great tool to understand this complexity. The barriers across different departments have to be brought down to develop a product. Systems thinking greatly helps in achieving this objective.

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Don Norman says. “No product is an island. A product is more than the product. It is a cohesive, integrated set of experiences. Think through all of the stages of a product or service. Make them all work together seamlessly. That’s systems thinking.”

To develop a product, the product managers have to listen to the voice of the customer, the offerings of the competitors, technological change. The design team has its own considerations that take a product from a drawing to a prototype and a launch. Purchases have to be made and storage and production have to be organized and controlled. Selling of the product and market reaction and customer reaction have to be taken into account. How the customer experiences the product through its life cycle has to be observed. A television is more than a product, it is an experience and a family get together social phenomenon.

The product managers have to understand the eco-system in which a product exists, the peoples who shall interact with it and its life cycle. Product management is about working with and understanding, explaining and interpreting and fine tuning different sub-systems. Product management is about managing systems that become more complex and dynamic with evolution.

Systems thinking brings together all these discordant elements together in a whole and makes the different parts understandable to those dealing with product management. Product managers have to understand the whole of the product as well as its parts. Frequently, the design will change a component such as a processor of a Lap top or a hard drive or put in a screen with a new technology. Product management has to understand how the change in the part affects the whole and also the effect on the market response to the innovations and changes.

Systems thinking is important for Product Managers to fully understand the different stakeholders and other variables that affect the business of the product. How is the product discovered by the buyer, how is it purchased, first use, continued usage, returns and upgrades are functions handled by different parts of a company. But the product management is tasked with overseeing all these activities, and Systems thinking provides them with the tools to achieve them.

The Systems thinking is a great model for enabling Product management through product design, development, prototyping, development and launch. It is also used to understand competition or market reaction. ISO 9001 Consultants play an important role in creating awareness about Systems Thinking to their clients for its use in Product Development.

 

Core Principles of Systems Thinking as per ISO9001

Systems Thinking is at the base of the ISO 9001 Quality Management System. A system has been defined as “A collection of interrelated, interdependent components or processes that act in concert to turn inputs into some kind of output in pursuit of some goals. Systems influence and are influenced by their external environment”

A single process is defined as actions on inputs in a controlled manner which are transformed into outputs. The organization is a collection or system of interrelating processes which are glued by many input –output relationships.

ISO 9001

ISO 9001 states that “Identifying, understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objectives.”

System thinking is opposite to the normal form of analysis. Analyze comes from the root “to break into constituent parts” Instead of isolating smaller and smaller parts of the system being studied, in systems thinking the view is expanded to look at larger and larger interactions. It focuses on how the thing being studied interacts with other constituents of the system. A system is a set of elements that interact to produce behavior, of which it is a part. The systems thinking results in sometimes different conclusions from the traditional form of analysis.

Examples of situations in which systems thinking has proved its use are

  • Complex problems that require helping many actors see the big picture and not their part in it.
  • Recurring problems or those problems that have been made worse by past attempts.
  • Where the action influences the environment surrounding the issue.
  • Problems in which the solution is not obvious.

Systems have been organized into four categories:

  • The whole
  • The goals
  • The internal workings
  • The long term results

Once we observe and understand the relationship between the system and behavior, we can understand how the system works. What makes it deliver poor results and how to shift it into better behavior patterns? Processes that cover the organization are managed and results are the outputs or outcomes of the organization which must satisfy all stakeholders and should lead to sustained success.

Feedback is an important element of the systems thinking. In the case of a quality management system, feedback is received from interested parties like vendors, customers, regulators, employees.

External boundary of the system may be set and the interaction with outside parties noted and how it effects the organization also understood.

A quality management system is made up of three sub systems, a social, a technical and a management sub-system.

  • Social Subsystem

Requires a change in organizational culture (values, attitudes, norms and role expectations, communications (level of relationship between individual s and groups, symbols of power and reward structure) and behavioral attributes. It encapsulates customer satisfaction, respect for people, continuous improvement and management based on facts.

  • Technical Subsystem

Includes a transformation process as an interaction among inputs, resources and outputs and all the tools, techniques, machinery and quantitative aspects of quality.

  • Managerial Subsystem

Includes the framework for policies, practices, procedures and leadership in the organization. Includes the organizational structure, mission, vision, and goals of the organization as well as administrative activities like planning, directing, organizing, coordinating and controlling activities

The System approach enables the organization to meet customer requirements and achieve continual improvement by finding a cause and effect relationship in its processes and their interrelationship.

ISO 9001 Quality Management system Principles

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.

ISO 9001

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.