Management Review as required by ISO 9001

Management review is a very important part of an organization’s quality management system based on ISO 9001:2015. It is the most important source for continuous improvements. It can be used to bring together all the elements of your quality program and bring cohesiveness to it. It allows the organization to focus on trends, objective evidences as well as data based decisions. It is used to assess the performance of the quality management system and find out opportunities for its improvement. It is held at-least once a year and is a platform for reviewing the quality policy and setting new quality objectives. It is important that the top management be involved in the management review.

The management review requires that a periodic review of the QMS shall be held so as to ensure it is suitable, adequate and effective. It is also required that the alignment of the Quality Management System with the organization’s strategic direction be checked. You should ask your ISO consultant to guide you one how to hold an effective management review.

Management review inputs

The management review process should ensure that all the necessary information is collected ahead of the time so as to allow management to complete this evaluation. Information review should includeand take into consideration

1. The status of actions decided in the previous management review.

2. Changes in the context or the external and internal issues that are relevant to the quality management system.

3. Information gathered on the performance and effectiveness of the quality management system and including the trends in

a. Customer satisfaction

b. Feedback from interested parties

c. The extent to which quality objectives have been met

d. Process performance

e. Conformity of products and services

f.  Nonconformities and corrective actions arising due to them

g. Monitoring and measurement results of processes, products and services

h. Audit results, both internal and external audits

i.  The performance of external providers or suppliers and outsourced processed

4. The adequacy of resources provided for the quality management system

5. The effectiveness of actions taken to address risks and opportunities

6. Opportunities for improvement

7. Suitability of possible changes in the QMS

8. New/proposed regulations or legislations

9. Advances in technology and science

10.Change in preference of buyers

11. New/modified products and services

For the management review to be effective, the attendees should come to the meeting prepared with data, and must have already drawn conclusions from the data.

Management review outputs

After analyzing the inputs given above, the management shall develop some outputs from it that should be in the form of decisions and actions that are related to

1. Opportunities for improvement which can be related to process improvement, quality management system improvement or product improvement

2. Any need for changes to the quality management system

3. Resource needs such as human, infrastructure, equipment or technology etc.

Records

The organization shall keep records of the management review such as minutes of the management review meeting. Observations as well as conclusions and also recommendations for further action from the management review must be recorded. If any corrective action is to be taken, then management must follow up on so as to ensure that the action has been implemented effectively.

The final objective of the management review should be continual improvement of the quality management system. As the QMS is made more effective and efficient, your organizational performance shall likewise improve.

Production and Service Provision as per ISO 9001

This is the main clause of ISO 9001 Quality management system which relates to the actual production process of a product or service.

Control of Production and Service

The standard requires the organization to undertake production and service under controlled conditions including delivery and post-delivery activities. These controlled conditions shall include:

• Documented information should be made available that define the characteristics of products and services.
• Documented information should be made available that define the activities that are to be performed and results that are to be achieved.
• Undertake monitoring and measuring activities for process and product and ensure acceptance criteria have been met.
• Suitable infrastructure and process environment is used.
• Ensure that suitable monitoring and measuring equipment are available and used.
• Competent and qualified personnel.
• Validation and re-validation of processes where the output that is resulting cannot be verified by subsequent measurement and monitoring.
• Implementation of actions to prevent any human error.
• Implementation of release, delivery and post-delivery activities for products and services.

Identification and Traceability

The organization shall use suitable means to identify process outputs, where necessary so as to ensure conformity of products and services.

It shall identify the current status of process outputs regarding monitoring and measurement requirements throughout the production process.

It shall control the unique identification of process outputs where traceability is required. Keep documented information or records required to maintain traceability.

Process outputs means the results of any activities which are ready for delivery to internal or external customer. They can include products, services, components or intermediate parts.

External Provider Property

External provider property can be equipment, tool, material or drawing etc. The organization shall take care of the external provider property while it is in its care so that there is no damage or deterioration.

The organization shall identify, verify, safeguard and protect external provider property given for incorporation or use in the products or services.

When the external provider property is lost, damaged or found unsuitable for use it shall be reported to the external provider and documented information is retained on what has happened.

Preservation

The organization shall ensure the preservation of process outputs during the production and service provision up to that extent required to maintain conformity of products and services.

Preservation includes identification, handling, packaging, storage, transmission or transportation and protection.

Post-Delivery Activities

The organization shall meet the requirements for post-delivery activities required for products and services. The organization shall consider the extent of post-delivery activities required for

• Risks or potential undesired consequences associated with the products or services.
• The nature, the use and the intended lifetime of products and services.
• Customer requirements.
• The customer feedback.
• The legal requirements.

Post-delivery activities can include the following

Actions to be taken under warranty.The contractual obligations e.g. maintenance.The supplementary services e.g. recycling or the final disposal.

Control of Changes

The organization shall review and control changes that are unplanned that are essential for production and service to the level required to ensure conformity with the specified requirements.

The organization shall retain information that describes

• The result of review of changes.
• The person who is authorizing the changes.
• Any necessary action resulting from review.

ISO 9001 certification

Organisation are looking to achieve ISO 9001 Certification for several reasons eg: getting pre qualified for tenders, Customer request, etc,. To develop and Implement systems quickly and have systems that add value to your organisation you may need the services of specialist ISO 9001 Consultants who can guide you through the requirements of the ISO 9001 Quality management system in relation to production and service provision.

ISO 9001 Do You Even Need To Become Certified

A number of establishments throughout the world have the feeling, whether they even have a need to become ISO 9001 compliant. They could have different reasons for this feeling. Most of the establishments we are talking about are working in an industry that is highly regulated and have regular audits carried out for every step the industry is involved in. When looking forward to getting certified for ISO 9001 establishments will have to comply with certain regulations that will look difficult, but they are in no way compelled to implement the guidelines required unless they are prepared to do so. Industries that are highly regulated for any reason can easily begin to feel they can give up on the certificate for ISO 9001 because they are required to comply with other regulations that are specific to the business they are involved in. It is these reasons which give some establishments the feeling they no longer have to be involved in matters like getting certified or maintaining the standards of ISO.

Industries which now believe they no longer require certification from ISO 9001 or decide to give up on the certification they earned after becoming compliant with the regulations will have a decision to make because while the certification would have given their businesses, several advantages also have been an optional requirement. They would not have been compelled to become certified just because they had been involved in industry offering goods and services that were sensitive and required quality measures of the highest kind. They would be required to pay for the annual audits, which are carried out by the third-party body and therefore, could get the feeling; they should no longer be spending their resources on such matters. It is also possible they may not have hired the services of ISO 9001 certification consultants to understand how they could continue reaping the benefits of their efforts. Things would certainly be different if they had ISO consultants of repute to make them understand why they should not be looking forward to giving up after getting the certificate they wanted. While there are costs involved with remaining compliant with ISO 9001 guidelines industries have no obligation to continue remaining compliant and can easily give up on their certification without the inclusion of any further costs. The fact that other bodies constantly regulate them could perhaps give them the feeling that they no longer need to indulge in extra expenditure and therefore, conclude they should not be getting involved in such matters.

Most ISO certification consultants will hesitate to offer the complete information about how or why establishments will benefit after they are certified for ISO 9001. They will generally be concerned about holding on to their client's keeping in mind the revenue they can generate from the establishment. However, this will not be the case with consultants of repute because they will not hesitate to give appropriate information to the establishments making it clear why they should be looking forward to staying compliant with the regulations for ISO 9001 forwarding them on details about the benefits they can look forward to.

Companies and establishments generally do not understand the reasons why they should continue maintaining the approval from ISO and the onus of forwarding the correct information to them will rest upon ISO certification consultants who they hire for getting them certified. Moreover, this is one regulatory body that is constantly looking forward to making improvements for the benefit of businesses in the industry of goods and services. Therefore, the ISO consultant will be required to keep his or her client regularly updated about the changes to make them compliant with the regulations regardless of what type of industry they may be working in. ISO consultants must be in a position to convince their clients about the need to maintain the certificate of approval the regulatory body gave them. They must emphasize the importance of the certificate making it clear to the clients concerned why it has better benefits for them than any other regulations they are required to comply with.

Coming to the matter about whether a company or an establishment even needs to become ISO compliant will certainly depend upon the kind of industry they are involved in. There are no compulsions on an industry to follow the terms and conditions laid down by ISO. However, information is also available to show why getting certified and deciding to continue remaining compliant will make it easier for the industries concerned to continue with their business unobstructed within their country and in international markets is a matter which will have to be discussed with them by ISO certification consultants that are assisting them.

Establishments that have decided to retain the services of Anitech Consulting will not come across these problems because this is an agency of repute and will make an effort to provide all information about why the establishment should continue remaining compliant with the regulations set forth by ISO. Establishments can contact this agency by sending an email to get all the information they need about how they can remain in line with the requirements of ISO. Establishments can contact the agency on http://www.anitechconsulting.com.au with the knowledge that they will soon receive a response that will make it easier for them to decide about how they should be looking ahead.