ISO 9001 Quality Manuals

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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.

Some organisations use up huge resources setting up rigorous final product testing regimes to ensure that products meet the specification and customer requirements. The problem is that whilst this stops poor quality product from reaching the customer it actually is of little benefit to a business.

The real secret to a successful quality management system is to control the process. Some people call this quality assurance, in essence as a business you should concentrate your resource at stages where you can still take corrective action to produce a satisfactory product. Yes you need to confirm the final product meets specification but if you have control of the process then less resource is required at the final stage to confirm this.

The problem lies with figuring out what you should do to control the process. The easiest way to do this is to carry out a Quality HACCP analysis. This will indicate to you the key points in the process where you can apply controls. You may already have a HACCP which you can use as a template.

Principle 1 If you don’t already have one, prepare a flow diagram of the steps in the process. Conduct an analysis by identifying potential quality hazards.  Assess likelihood of occurrence of these defects and identify control  options.
Principle 2 Identify the Quality Control Points in the process using the same principles as the decision tree.
Principle 3 Establish quality limits, which must be met to ensure each Quality Control Point is under control.
Principle 4 Establish a monitoring system to ensure control of the Quality Control Point by scheduled testing or observations. Principle 5 Establish the corrective action to be taken when monitoring indicates that a particular Quality Control Point is moving out of control.
Principle 6 Establish procedures and records appropriate to the Quality Control Points and their application.
Principle 7 Verify that your Quality Control Point system is working effectively. This can be done in the normal way but also you should measure the difference in conforming final product.

I don’t really like to use the phrase Quality Control point as I much prefer to use the term quality assurance but what you should be generating in effect is Process Quality Control points which is different. Your system should increase the effectiveness of your process and also identify weaknesses and areas for improvement. For instance we went through this analysis and decided that one of the key quality control points in the filling process was capping and sealing. It wasn’t really a food safety hazard but it was really annoying if you were a customer and the stuff leaked all over your car. So to improve our performance we didn’t carry out more extensive tests to make sure less defective product got to the customer, what we did was put controls and checks in place to ensure a better capping and sealing performance. We put in place procedures to check capping torque settings prior to start up and checks on sealing head temperatures. There were many other things we implemented as well but the long and the short of it was that we reduced customer complaints and product wastage with the same resource.