ISO 9001 Quality Manuals

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.

HACCP is the acronym for Hazard Analysis Critical Control Point.  The concept was originally developed in the 1960’s by NASA to ensure food safety for the manned space programme. The Pillsbury Food Company in association with NASA developed the first HACCP programme for astronaut food. Pillsbury presented it at the first American National Conference for Food Protection in 1971. The Food and Drug Administration (FDA) in the US liked the HACCP programme and had Pillsbury assist them with it – it was first applied to low-acid tinned food in 1973. HACCP has gradually made its way around the globe since then. HACCP is managed globally by Codex Alimentarius. Its primary aim is to prevent food safety problems and effectively control food borne disease. The principles of HACCP can be used for all product and hazard types.

The Hazard Analysis Critical Control Point (HACCP) system is internationally recognised as the most effective method of ensuring food safety. 

HACCP is a system, which identifies specific hazards and implements measures for their control.  HACCP’s systems are developed using the seven basic principles detailed below:

Principle 1
Prepare a flow diagram of the steps in the process.  Conduct a hazard analysis by identifying potential hazards.  Assess likelihood of occurrence of these hazards and identify control options

Principle 2
Identify the Critical Control Points in the process using the decision tree

Principle 3
Establish critical limits, which must be met to ensure each Critical Control Point is under control

Principle 4
Establish a monitoring system to ensure control of the Critical Control Point by scheduled testing or observations

Principle 5
Establish the corrective action to be taken when monitoring indicates that a particular Critical Control Point is moving out of control

Principle 6
Establish documentation concerning all procedures and records appropriate to these principles and their application

Principle 7
Verify that HACCP is working effectively

On the 29 April 2004, the European Parliament and the Council issued Regulation (EC) No 852/2004 on the hygiene of foodstuffs.
Article 5 states that: Food business operators shall put into place, implement and maintain a permanent procedure based on the principles of hazard analysis critical control points (HACCP).

At www.9001manual.com we have completely simplified the process of developing HACCP system by offering the unique © HACCP Calculator with our “off the shelf” HACCP manuals.

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

Simplify your ISO 9001 certification by following our 5 stage process.
Follow the five stages below and use our guaranteed ISO 9001:2008 package and you will be surprised how simple the ISO 9001:2008 implementation can be.

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.