ISO 9001 Quality Manuals

Archive for July, 2009

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.

Food safety legislation changed on 1 January 2006. Regulation 852/2004 (EC) of the European Parliament and Council on the Hygiene of Food Stuffs now applies to all food businesses except primary producers. The Food Hygiene (England) Regulations 2006 has also come into force.
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). The HACCP principles referred to above consist of the following:
• Identifying any hazards that must be prevented, eliminated or reduced to acceptable levels
• Identifying the critical control points at the step or steps at which control is essential to prevent or eliminate a hazard or to reduce it to acceptable levels
• Establishing critical limits at critical control points that separate acceptability from unacceptability for the prevention, elimination or reduction of identified hazards
• Establishing and implementing effective monitoring procedures at critical control points
• Establishing corrective actions when monitoring indicates that a critical control point is not under control
• Establishing procedures, which shall be carried out regularly, to verify that the measures outlined in the above paragraphs
• Establishing documents and records commensurate with the nature and size of the food business to demonstrate the effective application of the measures outlined in the above paragraphs
When any modification is made in the product, process, or any step, food business operators shall review the procedure and make the necessary changes to it.

There are many different ways that companies go about formulating their HACCP plans but there are a few fundamentals:

Knowledgeable Staff
Staff involved in Hazard assessment should have a thorough knowledge of the process, what happens and what is likely to go wrong. In addition to this they need to have some understanding of food safety. This is where training is important; the HACCP team need to understand the range of potential hazards that can affect the process and how to assess the significance of these hazards. In addition the team leader should have expertise knowledge in acceptable standards for critical limits, suitable monitoring procedures and appropriate corrective actions.

Practical HACCP System
Many systems are over burdening in the amount of paper generated and how the analysis follows through. It can easier to use software based systems these days provided they are designed by people who understand food safety systems rather than being software writers.
We have designed a simple HACCP system that enables all of the Hazard Analysis and Critical Control Point Assessment documents to be held in one file we call the HACCP Calculator
Appropriate Monitoring Procedures, Records and Operator Training
While HACCP plans are being formulated sensible and appropriate procedures need to be established that are easy for the person carrying out the task to follow. Records need to be as simple as possible so that it is quite clear when a critical control point has been breached and the procedure should stipulate the corrective action required. It is then essential to train operators so that they thoroughly understand the procedures, how to complete the records, what the critical limits are and what corrective action to take.
Monitoring at critical control points should take into consideration the quantity of product likely to be affective and the risk. For instance if you only check something once a day you may have to quarantine a whole day’s production.