Regular Management reviews should be conducted in order to assess the effectiveness of the Quality Management System and to continually improve. The management review should be a formal analysis and review of the quality policy, quality objectives and quality management system performance which generates plans for corrective action, preventative action or opportunities for improvement all of which should be documented in the management review minutes.

Clause 5.6.2 Management Review Input

The first item on the management review agenda really should be a review of the Quality Policy to confirm it is pertinent to the quality management system and organisation or if any changes are required. Similarly the Quality Objectives should be reviewed and updated as necessary. There should be a review of the Management Structure and any changes and confirmation that there is adequate quality management system resource.

The meeting should cover the minutes and follow-up actions from previous review meetings and confirm actions to improve the quality management system as a result of the review have been completed.

Findings of internal and external quality management system audits should be reviewed and outstanding non-conformances as a result of internal and external quality management system audits discussed. The Management Representative should conduct a trends analysis of the results of internal and external audits to present to the meeting. The management review team should also ensure that internal quality management system audits have been carried out as planned. Adverse trends such as an increased number of non-compliances should be identified and corrective action proposed. The results of third-party quality management system audits should be thoroughly scrutinised as these represent and independent view of the organisation.

The Quality Manager should present a trend analysis of Customer Complaints. This data should compare year on year performance especially when a product or service is seasonal. Volumes should be factored into the complaints analysis and so complaints should be presented taking this into consideration. Complaints are should also be categorise into critical and non-critical. Non-critical and total complaint analysis is useful for trends. Critical complaints should be closely analysed to determine if there is a common cause and if effective corrective action has been taken.

A standard format is to compare complaints per million units sold for each product. Industry standard complaint levels should be used for comparison. Again trends should be identified and if necessary plans for preventative action taken. Complaint analysis should also give an indication of opportunities for improvement of the quality management system. At this stage Safety incidents, recalls or withdrawals should also be reviewed. Corrective Action should have already been taken to deal with the causes of these incidents, the meeting should review the effectiveness of the quality management system in eliminating the cause of the incidents and also consider any common factor to the incidents in order to assess if preventative actions are required to improve the quality management system.

The meeting should review the quality management system Approved Supplier Register. A review of annual supplier performance should be presented normally by the Purchasing Manager. The report should include items such as percentage on time deliveries, percentage order completion, any non-conformances such as damaged deliveries or non-conforming products supplied plus any products rejected or accepted under concession. The report should also recognise exceptional supply performance and added value assistance received from suppliers as this should be factored into the quality management system when renegotiating contracts. Corrective Action plans should be formulated to deal with or change poor performing suppliers. Similarly to Customer Complaints, Supplier complaints should be analysed for trends.

The management review meeting should discuss quality management system process performance and confirm that the correct performance indicators are being monitored. Review and analysis of the quality management system Key Performance Indicator trends should be conducted to see if there is a visible improvement in performance. Sales levels should be one of the quality management system Key Performance Indicators as this will give an indication of company performance in the market place. Also the number and performance of new products successfully launched into the market place should be discussed. Again corrective action, preventative action and opportunities for improvement of the quality management system should be considered from the key performance indicator trend analysis.

The management review should cover the status of corrective and preventive action and compare numbers since the previous review and consider if the quality management system corrective and preventative actions are being completed in a timely fashion.

There should conduct a review of changes within the organisation and how this may have affected resource requirements including infrastructure, work environment, personnel and training requirements. At this stage proposed changes should be discussed and again quality management system resource requirements identified.

Review should also include Environmental performance and incidents,
and Health and Safety performance and accidents

Clause 5.6.3 Management Review Output

The Management Review outputs should include resource requirements corrective and preventative actions identified as a result of analysis of the quality management system review inputs, all of which should be clearly documented in the minutes.

There will also be opportunities for Improvement in quality management system effectiveness including product related customer requirements, change or elimination of non-productive elements, change or elimination of non-productive systems or procedures and supply of resource needed for improvement plans.

The results of the Management Review meetings should be documented in the minutes of the meeting and include a summary of all quality management system review inputs and outputs. The Management Representative should ensure the minutes of the Management Review meeting are distributed and effectively cascaded within the organisation.

Clause 4.1 requires an organization to

- determine the processes needed for the quality management system
- determine the sequence and interaction of these processes
- determine criteria and methods needed to ensure that both the operation and control of these processes are effective
- ensure the availability of resources and information to support the operation and monitoring of these processes
- monitor, measure, and analyse the processes
- implement actions necessary to achieve planned results and continual improvement

Clause 4.1 requires an organization to manage the processes in accordance with the requirements of the ISO 9001: 2008 standard.

Clause 4.1 requires that when an organization outsources any process that can affect product conformity to requirements, the organization shall ensure control over such processes. The type and extent of control to be applied to must be defined within the quality management system.

Quality management system processes should include management activities, provision of resources, product realization, measurement, analysis and improvement.

An outsourced process is a process which the organization chooses to have performed by an external party but is still a part of the quality management system. The organization still assumes responsibility of conformity to all customer, statutory and regulatory requirements for all outsourced processes. The control applied to the outsourced process can be influenced by the potential impact of the outsourced process on the organization’s capability to provide product that conforms to requirements, the degree to which the control for the process is shared, and the capability of achieving the necessary control through the application of purchasing procedures

All of our manual packages come with our comprehensive guide to the process of implementing an ISO 9001 compliant Quality Management System

Stage 1: Understanding of ISO 9001:2008

ISO 9001:2008 is an international standard for quality management systems. Our introduction to ISO 9001:2008 presentation guides you through the whole standard. We recommend that you obtain the actual ISO 9001:2008 standard for reference purposes.
Use our Introduction to ISO 9001:2008 and Benefits of an ISO9001:2008 compliant Quality Management System Presentation to brief Senior Management. You should ensure that the Senior Management Team completely support the ISO 9001 system. The presentation will help you to explain to them the advantages an ISO 9001:2008 compliant will bring to your organisation including:
Competitive advantage
Improves business performance
Enhanced reputation
Saves you money
Streamlines operations and reduces waste
Encourages internal communication and raises morale
Increases customer satisfaction

Stage 2 Quality Management System Initial Development

Senior Management Input
The start of developing a Quality Management System requires Senior Management to assess Customer, Potential Customer and other interested parties requirements and as a result of that review establish policies and objectives. We include an ISO 9001 Senior Management Implementation Checklist for Customer Requirements and establishing policies and objectives which will guide you through this process.
At this stage the Senior Management team should appoint a Management Representative. This is normally a quality manager or senior manager of your company, it needs to be somebody who has sufficient authority to change the way that the company works. This person is responsible for the ISO 9001 quality management system implementation. This person will need to have a thorough understanding of the principles of the standard so will have to be qualified and/or trained.
You should also brief all employees using our Introduction to ISO 9001:2008 Quality Management System Presentation

Stage 3 Documenting your Quality Management System Quality Manual, Quality Policy, Quality Objectives, Procedures and Records Implementation

Using a sample of good ISO 9001:2008 documentation is an excellent training tool. The procedures and records provided in our manual are excellent templates. We also highly recommend you see our Guide to the Process of Implementing an ISO9001 Compliant Quality Manual.
Developing the various documents required by ISO 9001:2008 is for most companies the most difficult part of the ISO 9001:2008 implementation. These documents have to meet the requirements of the ISO 9001:2008 standard and it is not always clear exactly what is required, so this represents the biggest hurdle for an organisation.
With our Manual packages it couldn’t be easier:
We have made this task simple and straightforward as we provide the entire compulsory documentation required by ISO 9001:2008 in our Manual packages.
Our Small Business manual contains all the Documents required by ISO9001:2008:

QMD 001 Quality Manual
QMD 002 Quality Policy
QMD 003 Quality Objectives
QMD 004 Control of Documents
QMD 005 Control of Records
QMD 006 Internal Audit
QMD 007 Control of Non-Conforming product
QMD 008 Corrective Action
QMD 009 Preventive Action

Our Small Business manual contains all the Records required by ISO9001:2008:

QMR 001 Management Review Minutes     
QMR 002 Training Record
QMR 003 Product Release Record 
QMR 004 Design and Development Records
QMR 005 Supplier Assessment Record
QMR 006 Validation Record
QMR 007 Identification and Traceability Record
QMR 008 Register of Customer Property
QMR 009 Calibration Record
QMR 010 Internal Audit Record
QMR 011 Records of Non-conforming Product
QMR 012 Corrective Action Request Form
QMR 013 Preventative Action Request Form

We also include our ISO 9001  implementation checklist for using your quality manual, procedures and records using the useful procedures and records included in the Manual Package, all of which you can use as templates. These templates are easily edited to suit your organisation.
You can now complete this crucial step quickly and easily
Once you have established you quality manual and procedures you will need to brief all the staff and train staff in those procedures and records pertinent to their areas. Identify the training needs for all employees and set up a training plan. Nominate qualified trainers to carry out the training.
Stage 4: Confirm you Quality Management system works

Take Corrective Actions and Preventative Actions
You will need to implement corrective actions and preventative actions and review these actions to ensure they are effective
Carry out a Management Review using our QMR 001 Management Review Minutes templates as a guide and Analyze your data and make improvements
Carry out Internal Audits
Internal audits need to be scheduled and performed. Ensure you have enough qualified resource to carry out the audits as per the schedule. Training of internal auditors may be required. The role of the auditor is to verify that your company meets the requirements of ISO 9001 as they are described in your Quality Manual. You can use QMR 010 Quality System audit form for this.
Once you have performed a complete internal audit schedule that didn’t uncover any significant gaps in your system or major non-compliances, you are probably ready for the certification audit

Stage 5: Certification

We would recommend using a well recognised certification body as they will issue your certificate and this will only enhance your quality management system credibility with your customers. After all they will want to see a copy of your certificate.
Once you successfully passed the certification audit, you can use your certification freely in marketing your organisation. You may want to prepare a press release and print your certification mark on business cards and letterheads.
Our final words: Your ISO 9001 quality management system is designed to continually improve your performance, maintain your system and continue your internal audits, and we are convinced you’ll see a continual improvement in performance.

ISO 9001:2008 requires a “Documented quality management system”, and not a “system of documents”.

The main objectives of your documentation should be:

- Communication of Information – as a tool for information transmission and communication.

- Evidence of conformity – provision of evidence that what was planned, has actually been done.  

- Knowledge sharing – to share and preserve the organization’s experiences. An example would be a technical specification, which can be used as a base for design and development of a new product.

ISO 9001:2008 clause 4.2 Documentation requirements documents may be in any form or type of medium, and the definition of “document” in ISO 9000:2005 clause 3.7.2 gives the following examples:

- paper
- magnetic
- electronic or optical computer disc 
- photograph
- master sample

ISO 9001:2008 clause 4.1 General requirements requires an organization to “establish, document, implement, and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard”

Clause 4.2.1 General explains that the quality management system documentation shall include:

- Quality policy (clause 4.2.1.a)
- Quality objectives (clause 4.2.1.a)
- Quality manual (clause 4.2.1.b)
- documented procedures required by the Standard* See Clause 4.2.2 below
- documents needed by the organization to ensure the effective planning, operation and control of its processes, and records required by the Standard

Clause 4.2 makes it clear that where the standard specifically requires a “documented procedure”, the procedure has to be established, documented, implemented and maintained. It also emphasizes that the extent of the quality management system documentation may differ due to:
- the size of organization and type of activities;
- the complexity of  processes and their interactions, and
- the competence of personnel.

All the documents that form part of the Quality Management System have to be controlled in accordance with clause 4.2.3 of ISO 9001:2008, or, for the particular case of records, according to clause 4.2.4

Clause 4.2.2 of ISO 9001:2008 specifies the minimum content for a quality manual. ISO 9001:2008 specifically requires the organization to have “documented procedures” for the following six activities:

- 4.2.3  Control of documents
- 4.2.4  Control of records
- 8.2.2  Internal audit
- 8.3  Control of nonconforming product
- 8.5.2 Corrective action
- 8.5.3  Preventive action
These documented procedures have to be controlled in accordance with the requirements of clause 4.2.3.
It is sometimes convenient to combine the procedure for several activities into a single documented procedure for example we have combined corrective action and preventive action.

Larger organizations or those with more complex processes will almost certainly require additional documented procedures particularly those relating to product realization processes.

In order to demonstrate compliance with ISO 9001:2008, you need to be able to provide objective evidence, although not necessarily documented, that your quality management system has been effectively implemented.

In order to demonstrate the effective implementation of your quality management system, it may be necessary to develop documents other than documented procedures.

There are several requirements of ISO 9001:2008 where you could add value to your quality management system and demonstrate conformity by the preparation of other documents, even though the standard does not specifically require them. Types of documents that can be useful:

Process maps, process flow charts and/or process descriptions
Organization charts
Specifications
Work and/or test instructions
Documents containing internal communications
Production schedules
Approved supplier lists
Test and inspection plans
Quality plans
Record Requirements

Records specifically required by ISO 9001:2008 are listed below:

Management Review       
- Clause 5.6.1

Education, training, skills and experience  
- Clause 6.2.2 e)

Evidence that the realization processes and resulting product fulfill requirements
- Clause 7.1 d)

Results of the review of customer requirements prior to supply related to the product and actions arising from the review
- Clause 7.2.2

Design and development inputs relating to product requirements
- Clause 7.3.2

Results of design and development reviews and any necessary actions
- Clause 7.3.4

Results of design and development verification and any necessary actions         
- Clause 7.3.5

Results of design and development validation and any necessary actions
- Clause 7.3.6

Results of the review of design and development changes and any necessary actions
- Clause 7.3.7

Results of supplier evaluations and any necessary actions arising from the evaluations
- Clause 7.4.1

As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement
- Clause 7.5.2 d)

The unique identification of the product, where traceability is a requirement
- Clause 7.5.3

Customer property that is lost, damaged or otherwise found to be unsuitable for use
- Clause 7.5.4
Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist
- Clause 7.6 a)

Validity of the previous measuring results when the measuring equipment is found not to conform to requirements
- Clause 7.6

Results of calibration and verification of measuring equipment
- Clause 7.6

Internal audit results and follow-up actions
- Clause 8.2.2

Indication of the person(s) authorizing release of product
- Clause 8.2.4

Nature of the product nonconformities and any subsequent actions taken, including concessions obtained
- Clause 8.3

Results of corrective action
- Clause 8.5.2 e)

Results of preventative action
- Clause 8.5.3 d)

Other records will almost certainly be needed to demonstrate conformity of your processes, products and quality management system. Requirements for the control of records are described in clause 4.2.4 of ISO 9001:2008.