2. What is management review?
• 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.
3. What is the Standard Mandated Management
Review Inputs?
• Although other inputs could be considered as needed by the company, ISO
9001:2015 mandates a minimum list required management review inputs that
top management must review.
• This can support the wellbeing of the QMS and can help in discovering regions
where correction is required or should brought in so as to fix the processes and
increase customer satisfaction.
4. Results of Audits
• As internal audits are conducted at planned intervals within organization,
external audits are conducted on annual basis as surveillance audit.
• What are the results of these audits?
• Are there any repetitive observations that are being highlighted in audits that
can potentially point to a bigger gap?
• What are the areas that management needs to support for improvement?
• These are the questions that will be asked when the results of audit are discussed
in management reviews.
5. What are the management review inputs?
Customer Satisfaction
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 reflected in
customer feedback reports.
• Customer feedback reports are usually collected by the Customer Services department.
• Besides, 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.
6. What are the management review inputs?
Process Performance and Product Conformity
Process performance and product conformity are actually indicated in the number of
non-conformities that are reported due to a process or on the product itself.
• For example, rejections and reworks of a process indicate that process performance is
declining.
• Then the question is whether the process is being fed with adequate resources or not.
• How are these processes and product non-conformities affecting customer
satisfaction?
• Which processes should be improved to ensure product conformity and what
resources should be provided to improve such processes?
7. What are the Required Management Review
Inputs? Status of Corrective Action
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.
8. What are the Required Management Review Inputs?
Follow-Up Actions from Previous Management Reviews
• This should occur at the beginning of a management review.
• The status of actions that have risen from the last management review meetings should be
addressed first.
• This also shows the effectiveness of the management review itself.
• If management decided upon some action plan during a previous management review,
management can then follow up on those actions and can decide whether the allocated
resources were effective in dealing with the issue and moving the organization forward.
• Management can see whether the actions taken have really solved the potential problems or
not.
9. What are the Required Management Review Inputs?
Changes that could affect the Quality Management
System (QMS)
• Sometimes changes occur due to a new legal requirement or any customer
requirement that may impact QMS.
• Management review provides a platform to plan for such changes earlier rather
than later, so that there will not be a rush to implement these changes upon the
enforcement of a new law.
10. What are the Required Management Review
Inputs? Performance of External Providers
• 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.
11. What are the Required Management Review Inputs?
Effectiveness of Actions Taken to Address Risks and
Opportunities
• Organizations as per ISO 9001:2015 are now required to manage risk and
opportunities.
For risk, management will take actions to mitigate the effects of risk. For opportunities,
management will take actions to maximize the returns for that opportunities.
• Management Reviews provide an opportunity to review the effectiveness of those
actions which are taken.
For actions that are not active, management can propose other actions in order to meet
the necessary objectives.
12. What are the Required Management Review
Inputs? Recommendations for Improvements
• Organizations receive recommendations for improvements from employees,
contractors, suppliers, customers etc.
• The management needs to see whether these recommendations are taken
seriously or just ignored.
• Management has to make the decision about which recommended areas for
improvement that the organization will work on in order to improve and gain
advantage in the market.
13. What are the Required Management Review
Inputs? Adequacy of Resources
• 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.
14. What are the Required Management Review
Inputs? Quality Policy
• Quality policy is a document that shows the commitment of top management to
a quality management system, as well as to the customer and other interested
parties.
• Although it is not a specific management review requirement as an input,
management is required to review its strategic direction regarding quality
management system and thus quality policy can also be reviewed to check if it is
aligned with strategic direction.
15. 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.
16. Improvement of the Effectiveness of the System
• 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.
17. Improvement of Product Related to Customer
Requirements
• Management should make decisions based on customer complaints or feedback
in order to improve the product.
• If the product is improved based upon an action derived from a management
review meeting, it offers management an opportunity to draw more customers.
• As the customer voice becomes in favor of the company, more customers will
yearn for the product.
18. Resources Needs
• Last but not the least, management should identify areas from the management
review which need more resources.
• Management should make the decision to hire competent resources to fill
potential gaps in the processes.
• This is how management review can be an effective tool for increasing the
performance of the quality management system and thus ensuring that the
customer is also satisfied with the company’s performance.
19. 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.
20. 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.
21. 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.
22. 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.
23. 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.
24. 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
25. 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.
26. 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.
27. Queries about Management Reviews:
Why Carry Out 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.
How Frequently Should an Organization Hold Management Reviews?
The standard requires that reviews should be carried out at “planned intervals”. This can be once-a-month, three-monthly or once a year. It is strongly
recommended that these should be conducted as per a defined plan on a regular basis. The schedule also needs to be shared with relevant stake holders in
order to hold management reviews appropriately.
Who Takes Part in Management Reviews?
The appointed personnel for managing management reviews is usually known as the management representative. He should chair the meeting with
concerned senior managers, line managers and top management representatives, like the CEO or members from the board of directors. Sometimes, vendors
are also invited to take part in reviews sessions regarding the performance of external providers.
28. 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: 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.
• Management Review Outputs: Minutes can also have the review output form. However, it can be managed separately as well. Outputs of
the management review is founded on judgments and proceedings concerning to:
Enhancement of the business / operations
Enhancement of the usefulness of the overall quality management system
Enhancement of product associated to customer requirements
Issuances of appropriate corrective actions, when needed
Decisions on Resource addition as per needs identified in review
29. 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
30. 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.
31. 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.
32. 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.
33. 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.
34. • 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.
35. • 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.