ISO 9001 Quality Manuals

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Clause 5.6.1 Management Review General

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 establish, document, implement and maintain a quality management system and continually improve the quality management system effectiveness.

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

A Quality Manual is a set of documents that describe an organization’s quality management system. Quality manuals include procedures for key elements of a quality management system with details of responsibilities and authorities for each element of the quality management system.

Typical contents of a Quality Manual include:

Quality Policy – A statement of intent from the organization with a commitment to providing a product or service to meet customer requirements

Quality Objectives – A set of defined, measureable goals that the organisation is committed to meeting in order to fulfil customer requirements

Top Level Procedures

Management Review – Describes the methods that senior management undertake to monitor and measure the performance of the organisation then take actions to improve performance

Control of documents – Describes the methods for ensuring that pertinent documents are available at their point of use

Control of records – Describes the methods for ensuring that pertinent records are available at their point of use

Internal audit – Describes the methods for auditing the quality management system to assess its effectiveness

Control of nonconforming product – Describes the methods for ensuring that product that does not meet requirements is prevented from delivery to the customer

Corrective action – Describes the methods for taking action to rectify non-conformances

Preventive action – Describes the methods for taking action to rectify potential non-conformances

Product Realization – Provides an overview of methods of manufacture or provision of service

Monitoring and Measuring – Describes the methods of measuring an organisation’s performance against customer requirements and company objectives

Purchasing – Describes the methods applied to ensure purchased goods meet requirements

Responsibility and Authority – Describes the organisational structure and chain of authority with responsibility of key personnel

Resource Management – Describes methods of managing resource to ensure the organization meets requirements in an efficient manner

Infrastructure and Work Environment – Describes an organization’s policy with regards to the prerequisite standards for infrastructure and work environment

The ISO 9001 Quality Manual includes a comprehensive set of documents, records, checklists and implementation guides making ISO 9001:2008 certification even easier.

The first step in the process of implementing a quality management system is to communicate with customers and potential customers and determine their expectations and requirements. Once this is completed confirm with the customers to ensure your understanding of their requirements is correct.

Senior management should decide which markets the company quality management system should address and develop relevant policies.

Based on these policies, management should then establish objectives for the company products, environmental performance, occupational health and safety performance

Example Quality Policy

The company’s quality policy is to provide competitive products and services of the highest standards of performance and reliability, satisfy the needs and expectations of its customers and achieve business success.This level of quality is achieved through adoption of a quality management system that reflects the competence of the Company to existing customers, potential customers, and independent authorities.

The next step is to determine the quality management system processes needed for achieving the policies and objectives. The Senior Management Team determines all the quality management system processes needed including Management Team Resources, Training & Competence Product Realization Design and Development Sales, Planning, Measurement, Analysis, Improvement, Suppliers, 
Audits, Management System and Customer Service

The Senior Management Team should use flowcharts to support the development of the quality management system process sequences and their interactions.

Senior Management should define individual roles and responsibilities for ensuring the implementation, maintenance and improvement of each quality management system process and its interactions. Establish a Process Management team that has an overview across all the quality management system processes, and which includes representatives (Process Owners) from each of the interacting processes.  

Determine the activities needed to achieve the objectives of the quality management system process. For example Product Realisation may require the following activities:
Planning, Processing, Production, Packing, Final Inspection and Storage

Assess each quality management system process and determine and the most appropriate way of managing them and if they are to be documented. Documentation is to enable the consistent and stable operation of the quality management system processes. Determine which quality management system processes are to be documented, on the basis of the: 

- size of your company and your activities
- complexity of the processes and their interactions
- criticality of the process
- availability of competent personnel

Different methods of documentation can be used. Decide which is best to represent and comprehend the quality management system process. Suitable documents include graphical representations, written instructions, checklists, flow charts, visual media and electronic methods

Determine the resources including Human resources, Infrastructure, Work environment, Information, Natural resources, Materials and Financial resources that are needed for the effective operation of each quality management system process.

For example for product realization resources required may be:
Human resources – Production Staff, Training & Competence
Infrastructure – buildings, workspace layout, process equipment, tools, supporting services and information systems
Work environment – layout of facilities, plant equipment, pest control, waste control, work wear, noise, temperature, humidity, lighting and weather.

Determine where and how monitoring and measuring should be applied both for control and improvement of the quality management system processes.
Develop a project for implementation that includes Communication, Awareness, Training, Change management, Management involvement, Review activities

Implement the quality management system processes and their activities as planned.

Measure or monitor to determine the effectiveness and efficiency of the quality management system process, taking into account such factors as Conformity with requirements, Customer satisfaction, Supplier performance, On time delivery, Waste, Process costs, Incident frequency, determine the need to record results

For example measurement criteria for measurement of customer satisfaction could be Complaint levels, % on time Deliveries, % Order Completion

Regularly analyze and evaluate quality management system information obtained from monitoring and measuring data in order to check your performance. Management Review is an ideal tool for this. 

Key Areas for Business and quality management system improvement should be identified during Management Review and could include: Complaint Levels, Production Efficiency, Process Simplification, Waste Reduction, Delivery Performance and Order Lead Time

Our Small Business ISO 9001 Manual contains the basic requirements of a quality management system and comes with implementation guides and implementation checklists.

ISO Certification normally refers to certification of your quality management system to ISO 9001. It is an internationally recognised standard for quality management system requirements. It is a certification that enhances your company reputation with your customer especially as it demonstrates your commitment to quality.
 
ISO 9001 was developed by ISO (International Organization for Standardisation), the world’s largest developer and publisher of International Standards. ISO is a network of 156 national standards bodies, based in Geneva, Switzerland. ISO is a non-governmental organisation that forms a bridge between the public and private sectors.
 
ISO 9001:2008 Quality Management Systems Requirements is the latest version of the standard and is intended for use in any organization regardless of size, type or product (including service). It provides a number of requirements which an organization needs to fulfil if it is to achieve customer satisfaction through consistent products and services which meet customer expectations. It includes a requirement for the continual improvement of the Quality Management System.

This is the only standard in the ISO 9000 series for which third-party auditors may grant certification.

ISO 9001:2008, the approval standard, has 5 main sections:

- Quality Management System
- Management Responsibility
- Resource Management
- Product Realization
- Measurement Analysis and Improvement

 
There are many other standards in the ISO series including the food safety related ISO 22000 standard. The ISO 22000 international standard specifies the requirements for a food safety management system that involves the following elements:

- interactive communication
- system management
- prerequisite programs
- HACCP principles