ISO 9001 :2015 Quality Management System

Upon completion of this module, you will be able to:

• Recognize the importance of managing organizational knowledge?
• Explain how organizational knowledge can be preserved
• Discuss how companies check their management system through internal audits
• Explain how internal auditors can audit the new requirements of the ISO 9001:2015
• Discuss how top management should be involved in Management System through Management reviews
• List the new inputs of management reviews??
• Explain how management reviews can be made effective in an organization
• Compare what has changed from previous version i.e. ISO 9001:2008 to new version ISO 9001:2015 regarding management reviews

The latest ISO 9001:2015 standard institutes the concept of “knowledge.”

As knowledge was not required by the former ISO 9001 standard, the concept of this topic and the method to it are newly introduced in the standard. ISO 9001:2015 explicates obligations for managing organizational knowledge in the following four phases, which are similar to the PDCA cycle:

• Identify?the knowledge which is mandatory for the implementation of processes and for acquiring conformity of products and services
• Keep knowledge?and make it accessible to the level needed.
• Be thoughtful?of the present organizational knowledge and measure it against contemporary requirements and trends.
• Gain?the required knowledge.

Knowledge Triangle: How data, information and analysis contributes to knowledge. And finally knowledge converts to wisdom.

Data

Data can be understood as “unordered facts and figures."

The fundamental part of information in an enterprise is in the shape of data. Organizations gather, assesses and analyses this data to recognize patterns and trends. Majority data thus gathered is linked with the main processes of the organization.

Data are particulars and statistics which reinforce something particular about a process, but data is not structured in any terms and it gives no further vision concerning trend, forecast and context, etc.?

Information

Each data unit is a fragment of a process transaction and does not give any information until these fragments are structured and ordered in concurrence with other data units. The collection of data into a meaningful context gives information. For data to be transformed to information, it must be connected with its background, grouped, formulated and compressed where necessary. Information therefore provides a larger picture; it is data with applicability and objective. It may transfer a behavior in the environment, or can refer a trend of sales for a timeline. Basically, information is revealed in responses to questions that start with words like what, who, when, where and how much.

Analysis

The information collected in the earlier phase provides much depth. Analysis provides more value by disconnecting or reorganizing this information. Simulations with systematic and logical processing give practitioners the capability to evaluate information and define process, trend, etc.

Knowledge

Knowledge is not identical to data, information or analysis. It is because knowledge can be generated from any source, or it can be founded on previous knowledge utilizing logical inferences.

Knowledge is related to performance and relates how to do and comprehension of a reality. The knowledge owned by each person is an output of one’s experience, and relies on the scale by which a person examines new inputs from his environment.

Knowledge can be determined as “an abstract mix of perceived experience, principles, socio-economic and political context, professional awareness, and the emotional elements."

All these elements give a surrounding and mechanism for assessing and adding new information and experiences. It initiates and is developed in the intellect of the one who knows. In companies, knowledge is frequently built within organizational culture, norms, routine activities along with its documentation.?

Wisdom

Wisdom is the use of gathered knowledge to build an increased comprehension of the reality and to optimize business functions.

How can you record the knowledge of your organization?

Every organization has significant knowledge that makes them gain a lead in the competition, but how is this recorded within your organization? When this knowledge resides with some employees and is not recorded, it is usually known as “tribal knowledge,” and if this can be a strength, it can be at risk of being forgotten when these personals leave the company.

So, how can you simply record the knowledge of your organization? Here are some ideas:

Work Instructions

Checklists

Training Packages

On-the-Job Training

Knowledge Database

Obviously, the best way to record this knowledge is with the help of instructions. If you have a process that needs to be done in a particular way in order to avoid problems, do so, and then this can be drafted easily for comprehension of new recruits.?

Taking Advantage of the Recorded Organizational Knowledge

When organizational knowledge is recorded, one should take advantage of this resource, particularly when bringing any changes.

Implementing quality checklists and work instructions can be met with resistance, but if all concerned personnel know how important this documentation is, implementation will be easier.

Similarly, the training requirements should be implemented as soon as they have been produced. Systems should be upgraded to incorporate the training for the implementation of work instructions and quality checklists. This incorporation will ensure that when a new person is recruited to the team, he/she will be provided with the most up-to-date training to start the job.

The knowledge database is an exclusive idea in that it is a input mechanism into the design job, so one needs to update the system of design process to make sure that design engineers are able to take advantage from the lessons which have been incorporated into knowledge database to ensure that no one bypasses learning or improvement that has been recognized and recorded. Personnel should learn to utilize this system so that they may gradually progress in their jobs.

"Where is the knowledge we have lost in information?” - T. S. Eliot

Knowledge is often lost in information, especially when the given information is not analyzed and applied during work.

Some organizations make use of data by ordering and converting such data forms into information. Information provides insight about a process and the relation of data structures. But when this information is only utilized for reports without taking appropriate actions on processes based on this information, then a potential knowledge resource is lost.

Therefore knowledge is something beyond information that is applied to some process, machinery, procedure, and gives a comprehensive understanding of a process subject.

An Important Resource!

Considering organizational knowledge as a powerful resource can speed an organization into continual improvement, which can be crucial to the long-term success of an organization.

Frequently, organizations don’t understand what crucial knowledge they had until one key employee moves out and systems do not work properly anymore.

This can be a costly method for learning the lesson that it is important to record and regulate organizational knowledge. To avoid this, enterprises should take advantage of the ISO 9001:2015 requirements and opt for organizational knowledge recording by making it a strategic theme. The organization will receive the benefits of doing so.

Types of Knowledge

There are different types of organizational knowledge and these can be explained as:

• Tacit knowledge -?Knowledge that cannot be expressed and communicated
• Implicit knowledge -?Knowledge that can be expressed and communicated but it has never been?
• Explicit knowledge -?Knowledge that is expressed and communicated, mostly recorded in the structure of tables, text, relationship etc.
• Procedural knowledge -?Knowledge expresses itself in the form of doing some process.?
• Declarative knowledge -?Knowledge that comprises of methods, descriptions and things, and written procedures (declared and followed).
• Strategic knowledge -?Knowing the time of doing something with the reason of doing it.?

Business Knowledge and Resources

Business knowledge can be found on various different platforms, some are listed below:

Personal

Community

Structural

This is a type of knowledge found within an individual, it is mostly tacit knowledge. It can also be both implicit and explicit, but it must be personal in nature.?

Organizational Memory

Traditional memory is related to a person’s capability to obtain, retain, and retrieve knowledge.

Within organizations, this concept is stretched beyond the personal traditional memory, and organizational memory thus relates to the organization’s capability to obtain, retain and retrieve knowledge through information, analysis and proceedings.?

What is Organizational Memory?

It is defined as the memory in which all the types of repositories are set in, where a company may collect information.

This memory is comprised of the various official records, along with tacit and available knowledge in people, companies’ culture, and processes.?

Stage for Processing Knowledge Through Organizational Memory

Knowledge Addition: Organizational memory comprises of the obtained information concerning historic judgement. This information is not mainly warehoused in a central place, but instead it is divided across various storage units.

Each time a judgment is taken and the concerns are assessed, new information is supplemented to the memory of the organization.

Knowledge Retention: Knowledge in an organization is retained in five different knowledge storage areas:

• Personal:?The memories of the person who remember organizational events, decisions, and issues faced in the past.?
• Shared Values of an Organization:?The mode of communication and structures that are present in an organization and form the shared values of an organization.
• Developed Systems:?The developed standard procedures and official methods that the organization uses. These official methods imitate the company’s past experiences and are repositories for embedded knowledge.

The Role of Leadership

The role of a leader can never be underestimated in the development and effective management of organizational knowledge. Usually three leadership roles are identified as being important for the effective management of organizational knowledge.

These are explained as below:??

Lead Designer

Lead Teacher

Lead Steward

This type of leader can be described as the designer of a ship rather than just being a captain.

The key roles played by this leader include:

? To create a shared vision with the team having common values and purpose.

? To define the high level policy, plans, and business structures that transform ideas into effective decisions.

? To create beneficial learning methods; this will encourage the continual improvement of the policies, plans, and business structures.?

What is Internal Auditing?

Internal auditing is an internal process for facilitating organizations to meet their objectives. It is concerned with checking and improving the effectiveness of different management systems in an organization.

What is auditing? Auditing is defined in international standard ISO 19011:2011—Guidelines for auditing management systems as a “systematic, independent and documented process for obtaining audit evidence [records, statements of fact or other information which are relevant and verifiable] and evaluating it objectively to determine the extent to which the audit criteria [set of policies, procedures or requirements] are fulfilled.”

The Concept Behind Internal Auditing

An audit can be termed as a type of inspection and testing, except that in this case the product being inspected is the management system itself.

Similar to a product or process inspection, an audit compares “how things really are” to “how they are supposed to be”.

Audits attempt to reveal areas that should be given attention and areas that are veiled during routine activities; audits look at the whole process with fresh eyes, which can detect such shortcomings. Although it is such a constructive tool in the management system, audits often evoke a level of stress that is equivalent to the stress of completing an exam.

An positive external audit carries a lot of weight, so it is natural that there is some concern and worry from the auditee. However, a robust internal audit cycle can minimize the stress, as an audit might reveal the problems within department and perhaps even solve them before an external audit ever begins.

Comparing the Old and New ISO 9001 Standard

All types of management standards need audits to observe and present findings on the efficiency of the management system.?

A comparison of the internal audit between the old ISO 9001:2008 and the new ISO 9001:2015 is shared below:??

ISO 9001:2008

ISO 9001:2015

This internal audit process is required in one of the documented procedures mandated by ISO 9001:2008, which explicates that companies will implement a documented procedure with defined tasks owners. The procedure should also state how internal audits will be planned, conducted and results reported. The records should also be kept.?

Phases of an Audit

There are four phases of an audit program. Click on the following tabs to learn more:

Audit Preparation

Audit Proceedings

Audit Reporting

Audit Follow-Up and Closure

Audit preparation contains all steps that are made in advance by concerned parties ( such as the lead auditor, the auditee, and the audit program manager) to make sure that the audit acts in accordance with the client’s objective. The preparation part of an audit starts with the decision to perform the audit. Preparation finishes when the audit starts.?

First, Second and Third Party Audits

First Party Audit

Second Party Audit

Third Party Audit

A first party audit is also known as internal auditing.

It is conducted within an organization to gauge strengths and flaws for an organizations own procedures, work instruction, or external standards like ISO 9001, which are voluntarily adopted or mandated by a regulatory body.

A first party audit is performed by auditors who are part of the organization being reviewed but who have no interest in the falsification of audit results.

Types of Audit

Product Audit

Process Audit

System Audit

This type of audit is carried out on a particular product or service to observe whether or not these products and services conform to specifications and customer requirements.?

Internal Audit Planning

Internal audit planning is one of the most important activity of internal audit process:??

• Internal Audits should be planned at scheduled intervals to verify that the management system fulfills requirements and that the effectiveness of the system is maintained. 'Requirements' comprise of the standard itself, along with the organizational requirements (such as the organization’s procedures and policies).
• One does not need to audit an entire organization at any given time. The external audit (third party audit) can cover the complete scope of organization, but internal audits can be done by flexible means with different departments audited at different point of times.?
• The standard does not mandate a mandatory audit frequency. Instead, it endorses making your plan on the basis of importance of the processes, their associated risks, their former past issues, and the associated quality objectives. One can set different audit frequencies for different processes.?
• If an organization is applying a new management system (such as ISO 9001:2015), then all processes and departments covered under the management system scope should be internally audited at least one time before third party external audit.?

Who Will Perform Internal Audit?

There are a number of things that should be considered before selecting an internal auditor.

Moreover, there are different approaches to perform internal audit. Some things that should be considered before selecting internal auditors for a process include:

• An auditor should be unbiased and independent. One cannot audit processes that he/she organize or has any stakes involved in it.?
• Auditors should be competent with the auditing process itself.
• Internal auditors should be aware of the requirements of ISO 9001:2015 and organizational procedures.

Approaches to internal auditing used by organizations include:??

• Organizations can use consultants to carry out internal audits to implement a management system.
• Some organizations employ full-time, permanent, internal auditors.
• Big organizations may utilize a team of internal auditors.
• Cross-function internal audits are also popular. These internal auditors are trained by various departments and are allocated to audit other departments as per designated plan.

Requirements for Each Audit

Audit requirements should be well studied by internal auditors before going into the audit process. Some methodologies include:

• The internal audit plan should have previously recognized the region that one will audit. Now the auditor needs to recognize what criteria he/she will audit. At times this will be done with a formal checklist that has a list of relevant questions. One can also consider the procedure and identify check points. Internal auditors will check those records to verify.?
• Findings from previous internal audits, or external audits can also help internal auditors to identify weak areas and thus can re-audit those point to check whether follow-up actions were effective or not.?
• The criteria for internal audits should be communicated to the auditee before audit. It is a good practice to communicate to the auditee to arrange required documents before the audit to save time.
• Last but not the least, the use of observation and listening skills during the questioning of the audit helps to identify gaps within the systems.

Perform the Internal Audit

Performing an internal audit should follow a series of steps that are based on international protocols. These steps should be followed while conducting an internal audit:

Step 1

Step 2

Step 3

Step 4

Step 5

An audit normally begins with an opening meeting where the auditor interacts the auditee(s), states the projected schedule, and informs the auditee about how the audit will be performed.?

Audit Findings Kept as Documented Information

Audit findings should be maintained as documented information. An external third party auditor will give an official written report on the external audit to management a few days after the audit and some companies do the same internal audits. However, there is no obligation in the ISO 9001:2015 standard for an official internal audit report. Internal auditors should make sure that the findings are documented and communicated to top management.

Auditor can just record the findings and their particulars in an organization’s non-conformance form and the associated register.?

Auditors should keep records of the audit which will normally be available in following forms:??

• Filled-in internal audit checklists
• Observations against procedures
• Minutes on objective evidence observed, and employees cross-examined
• Audit findings which can be referenced to your non-conformance report and register
• A formal audit report
• Non-conformance report on a software managed through the cloud or the organization's local server

Process Improvement Through Internal Audits

Internal audits can serve as a vital tool to maintain the effectiveness of the system and can act as the “Check” part of the PDCA cycle. Through internal audits, organizations highlight the failures within management system that develops over time of the implementation and thus can address such gaps. Through internal audits process owners can also see underlying gaps in their processes which are camouflaged as part of the process. This provides them the opportunity to fill those gaps which they are not able to perceive due to routine work cycles.

Organizations can make a culture of process improvement by internal audits by carrying out the following steps:

Step 1

Step 2

Step 3

Awareness by process owners that internal audits help them to improve their processes and that audits add value to the process. They should value the cycle of internal audits.?

Internal Audits for Risk Management System

ISO 9001:2015 focuses on risk management of organizational processes. The organization is required to identify risks and opportunities for its business processes as well as for internal processes.

An internal auditor will have to check following:??

• Has the process owner identified its associated risks and opportunities?
• Has the process owner has identified the acceptable risks and opportunities which require no further action??
• Have they indentified significant risks and opportunities for which a plan must be made to mitigate the negative impact of the risk and maximize the positive impact of the opportunity??
• Are the plans for risk mitigation or opportunity optimized to ensure they are achieved?
• Are the plans implemented and residual risk is acceptable?
• Does the process owner reassess the process risk if there is a change in workforce, machinery, material, or the process after a shutdown activity begins?
• Has the internal auditor verified that the process of risk management is being implemented?

Internal Audit for the Context of an Organization

ISO 9001:2015 requires organizations to identify its context. The organization should highlight internal and external issues. The organizations should identify a list of interested parties.

The organizations should also identify needs and expectations of the interested parties. When an internal auditor audits management representatives or top management for clauses related to top management responsibilities, all requirements can be audited there.

However when auditing a process owner, following the requirements of context of organization can be addressed:

• Process owner should understand how his/her process is linked with the organization’s goals and the context in which it operates.
• What are the external issues that influence that process (such as the material supply of that process)???
• What are the internal issues that influence the process (such as the work force, support activities from other departments, machinery, internal software applications, etc.)
• How are the issues related to the processes managed?
• How the need and expectations of interested parties are fulfilled. For example, the employee running the process is an internal party and they expect to be rewarded for their hard work. Annual appraisal programs in their organization provides incentives for their hard work.?

Internal Audits for Organization Knowledge

ISO 9001:2015 also requires organization to manage knowledge. Each process owner has an adequate amount of knowledge regarding their processes.

During an internal audit, the auditor can examine whether the knowledge possessed within that process are documented in checklists, work instructions, or some documents related knowledge management. Internal audit can provide a continual way for organizations to document knowledge within those processes which are not yet documented.

Thus, the reliance of organizations on old employees possessing the knowledge about processes is reduced to a level manageable by the organization. Therefore, internal audits can serve as a tool for improving the organizational knowledge by documenting it and reduces the dependency of an organization on just a few individuals.

Therefore, the risk of organizational knowledge being lost when the old employees leave the company is taken care of. Internal audit will act as the "check phase" of the whole knowledge management cycle.?

Management Review

Click on the following tabs to learn about management review:??

What is management review?

What is the Standard Mandated Management Review Inputs?

Results of Audits

Management review is a process in which top management reviews the performance of management system. In the case of ISO 9001:2015, it is the quality management system that should be reviewed by top management. The standard defines some requirements for management reviews. It is again the “Check” part of the PDCA cycle for quality management system.?

What are the management review inputs?

Click on the following tabs to learn more:??

Customer Satisfaction

Process Performance and Product Conformity

Customer satisfaction is one of the most important management review inputs. As a Quality Management System focuses on customer satisfaction, the voice of the customer is actually reflected in customer feedback reports.

Customer feedback reports are usually collected by the Customer Services?department. Moreover, customer complaints are also considered customer feedback.

There are number of things that management should consider in customer feedback review. Is customer feedback in the form of complaint occurring less often and positive feedback becoming more frequent? Are customer complaints handled speedily to ensure that customer satisfaction is not affected? Last but not the least, when analyzing the data, management should ask what changes must be made to the processes to avoid a complaint and/or to reduce the frequency of any complaint.?

What are the Required Management Review Inputs?

Click on the following tabs to learn more:??

Status of Corrective Action

Follow-Up Actions from Previous Management Reviews

Changes that could affect the Quality Management System (QMS)

ISO 9001:2015 mandates a protocol for corrective actions in processes. Corrective action request is issued when a non-conformity has occurred.

Management needs to observe when these actions do not occur within the given timeline. What has delayed corrective actions and why? Are there suitable resources assigned to the most serious issues?

Management should intervene during the review to complete the critical corrective actions for their processes. This is how management review meetings can address the status of corrective actions.?

What are the Required Management Review Inputs?

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Performance of External Providers

Effectiveness of Actions Taken to Address Risks and Opportunities

Recommendations for Improvements

Management must also review the performance of their external providers such as their suppliers, contractors, vendors and other service providers.

The performance is reviewed on the basis of service or product quality, timely delivery, and the extent to which the organizational requirements are being met. Based on this review, management can also take decisions.

For example, if a supplier is not performing well, is providing bad quality raw material, and as a result a company is facing difficulties in meeting its quality objectives, then management can make decisions to connect with another supplier who can provide a quality raw material.

Even if the cost will increase, it will be better compared to the cost incurred in product rejections, utilities and resource utilization during reworks etc.??

What are the Required Management Review Inputs?

Click on the following tabs to learn more:??

Adequacy of Resources

Quality Policy

Management must also review the resources that are allocated for the effectiveness of quality management system as a whole. It is possible that due to changes in processes or the addition of other products in the product manufacturing line, the resources requirements may have increased. But the management cannot address such issues in daily routine.

Management review provides management with an opportunity to provide adequate resources for such processes which have been neglected for any reason in the past. This will ensure the effectiveness of the process and will help the management to achieve its goals.? ?

What are the Required Management Review Outputs?

The three points discussed below are the compulsory outputs of Management Review.

Proceedings of the inputs need to be kept to display that management review has effectively addressed them and produced the required outputs for the QMS. The records maintained can differ and these records are reliant on how the management review is planned and completed. These records are imperative not only to show to an auditor, but to record decisions for betterment of the company, what decisions were made, and why.

Improvement of the Effectiveness of the System

Improvement of Product Related to Customer Requirements

Resources Needs

Management should make decisions as to what actions are needed to improve the effectiveness of the system. A management review is not only meant for reviewing things without acting. A management review means that management must make decisions for the improvement of the system. This is similarly mandated by ISO 9001:2015.

Can Management Review be Done Without Holding a Meeting?

While management review meeting scripts are easier for the external auditor to analyze, it is not the concern of company management to make things comprehensible for the auditor. Rather, management reviews are in place to ensure that their organization works well.

Many organizations conduct reviews by means of a management review meeting and generally do so on an yearly, biannually or quarterly in an year. The standard simply mandates management review, not a management review meeting, therefore it is up to the organization how the management review is conducted.

For example, a customer complaint needs to be reviewed. However, if this review only occurs on a bi-annual or annual basis in a meeting, a timely response may not be provided on customer issues.

Therefore management might review it on quarterly basis as well. Management must conduct reviews, but how these reviews are to be done is up to management to decide. The only thing that is required is that reviews should be effective in providing an accurate picture of a QMS and improving the QMS, so as to achieve increased customer satisfaction.

Management Review can be a Key Driver of Improvement

Management Review is all about reviewing the presented review inputs to make sure that sufficient resources are available so as to have customer satisfaction and increase the efficiency of the QMS and to increase the quality of product. This is done to confirm that resources are producing the right outputs.?

How Do Auditors Verify Management Reviews During an Audit?

External and internal auditors will try to verify the requirements of ISO 9001:2015, which are almost the same to that of ISO 9001:2008, except with few changes.

The auditors will check how the management review inputs are prepared for the review. The auditor will try to establish evidence that the organization has conducted a review on the inputs of management review. They will also check the outputs of the management review.

ISO 9001:2015 Transition??

• Auditors are being counselled to ensure that planned management reviews are establishing that the management system association is aligned with organization's strategic themes. The particular requirements added in the latest version of ISO is concerned with the context in which the organization operates and the related actions to address risks, which will also be checked by auditor as Management Review inputs.
• The bigger emphasis in the 2015 edition of ISO is on top management’s involvement with the management system. This will certainly lead to the amplified inspection of the management review process, which will authenticate its incorporation into an organization's business processes.?
• The auditor can also verify the depth of review, suitably scheduled frequency of reviews, timeliness of conducting reviews, suitable attendance and results worked on. Auditor can verify these elements of management review by checking records and interviewing the top management.

Changes Between the Old and New Version of Standard

As the ISO 9001:2008 called for the evaluation of the quality objectives and their appropriateness to the quality management system in the management review, the ISO 9001:2015 entails an evaluation on changes in the industrial environment and how these elements of change might disturb the strategy of the business.

The ISO 9001:2008 asks in simple terms:

• Kindly demonstrate changes and improvements that have happened
• How they associate with the Quality Management System
• How the management reacts to changes

The ISO 9001:2015 wants organizations to demonstrate in below terms:? ?

• Please show evaluation (in management reviews) of business strategy to attain organizational quality objectives in the environment where your business operates
• Please show how changes in this business environment are evaluated in management reviews
• Please show evaluation in reviews regarding these changes impacting QMS?
• And if changes impacts QMS what actions are taken in management reviews

Now, Standard relies upon how strong or old-standard oriented the external auditor is; if he is tenacious and updated, he might need to evaluate the business environment, how company’s strategy is relevant to it, and its association with the QMS.

Management Review Relation with PDCA

Performance Evaluation is a necessary part of ISO 9001:2015. The “Check” phase of the PDCA cycle relates to Performance Evaluation. Performance Evaluation comprises of management review, internal audits and monitoring, measurement analysis.

Queries about Management Reviews

Click on the following tabs to learn more:??

Why Carry Out Management Reviews?

How Frequently Should an Organization Hold Management Reviews?

Who Takes Part in Management Reviews?

Management reviews are carried out in order to ensure that the requirements of the management system and its effectiveness are evaluated. The reviews need to evaluate present management performance statistics and make sure that improvement opportunities have been identified and taken care of.?

Records for Management Reviews

Records of management reviews can be kept in various forms. As the standard says to maintain documented information, it means the requirements of standard can be attained with the help of any format that has got the provisions to address standard requirements.

Normally management review records are available in following forms and can also be maintained to fulfill standard requirements:??

Management Review Meeting Minutes

Management Review Outputs

This should comprise of particulars of attendees, summarized notes of the conversations or review proceedings, as well as action managers and offered action due dates for completion.??

Three Steps to More Effective Management Reviews

Following are the three steps required for the effectiveness of management reviews:

• Top management involvement
• Speak in their terms
• Distribute the responsibility

Top Management Involvement

The top management (chief operating officer, chief executive officer, managing director, general manager and chief financial officer) are all concerned about the organizational financial and accounting management system and all believe that the performance of the financial system is vital for company’s growth and success.?

Similarly, the quality management system should also be taken into the same spirit, where all among the top management should believe that quality is an integral part of organizational success. This belief will drive the top management involvement which is needed to accelerate the business processes.?

In the same way, top management must understand and behave as though quality is an essential element in the organization’s victory. Furthermore, they must believe that every single manager and member of organization has a role in the success of quality management systems.?

Therefore, quality should be taken as a critical business activity. Management reviews are imperative to meet the goals of an organization and all participants of top management must and should show ownership and engagement in the system to make it effective.?

Speak in their terms

One of the best methods for getting top management enthusiastically involved in management reviews is to speak in their terms, which is in business linguistics. It means convincing them that bad management system can increase the cost of running the business and an effective quality management system can save internal inaccuracies in the processes that can result in profitability of the business.

What have the quality management systems supported to the organization outside audits, inspections, and system certificates placed on the wall? Quality managers and management representatives must speak in the language understood by top management, similar to that of finance and accounting managers when discussing the company’s monetary achievements.

Top management should be provided with eyes to see how the organization’s economic activity and the effectiveness of its management systems are connected. The management review is an ideal method for validating the business value that quality management systems have given to the organization.

For example, if the organization has improved its market share following the application of its quality management system, it is reasonable to attribute this success to the quality management system. This attribution follows the cause-and-effect principle.

For example: before the quality management system was applied, the business had “X’ of the market share, but three years after its implementation, the company has expanded with “1.5 X” percent of the market share. This means that the company has grown in three years and the implementation of the quality management system is one of the key reason for this expansion.?

Three Steps to More Effective Management Reviews

Distribute the Responsibility

It is common for the quality manager to have impressions that they are only accountable for the company’s management systems. However, quality is the concern of every executive and member of organization, even if it occurs on different levels. It is agreed that the quality manager is responsible for the whole routine operation of the quality management system, but all executives, members and their teams are also liable for system to be operational.?

Thus it is wisely said, “quality is every one’s responsibility”.?

?Quality managers must exert efforts to transfer responsibilities to the appropriate department managers, that way responsibility can be shared

The main points from this module are as follows:

ISO 9001:2015 introduced a new concept to Quality Management System. The concept speaks about the management of organizational knowledge.

The standard mandates that complying organizations must:

• recognize the knowledge areas that are necessary for the effective operations of processes and the conformity of product/service;
• ?maintain this knowledge and keep it accessible where necessary;
• recognize the changing trends for knowledge and compare it with current organizational knowledge;
• and attain the required knowledge if necessary.?

The knowledge triangle involves: the collection of data, the grouping of data to create information, the analysis of information, which then creates knowledge for the organization. Following this, repeatedly applying knowledge to improving processes will result in wisdom.

Organizational knowledge is recorded in work instructions, checklists, training packages, on-the-job training, and knowledge databases.

The organization uses the knowledge sources to create advantage in their processes.

Knowledge is often lost in information if information is not analyzed and worked upon.

Knowledge should be considered as an important resource. Some types of knowledge are tactic, implicit, explicit, procedural, declarative, and strategic.

Business knowledge exists among personnel, organizational communities, and the structure of an organization.

Processing of knowledge from organizational memory comprises of knowledge addition, retention, and retrieval.?

Internal auditing is the inspection of a management system itself.

Phases of an audit comprise of audit preparation, audit proceedings, audit reporting, and audit follow-up and closure.

An audit is done by first party (internal audits), second party (customer audits) and third party (external certification audits).

Types of audit are product audit, process audit and management system audit. Internal audit against ISO 9001:2015 is a management system audit.

Following the revision of ISO 9001, internal audits will now be conducted to assess risk management systems, context of organization, and organizational knowledge.?