ISO 9001 Quality Manuals

Archive for the ‘Quality Management Systems’ Category

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.

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

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.

The new revision of the ISO 9001 standard has been simplified so that it is equally applicable to small as well as medium and large organizations and that the amount and detail of documentation required to be more relevant to the your  activities. ISO 9001:2008 allows flexibility in the way you document your quality management system. This enables you to develop the minimum amount of documentation needed in order to demonstrate the effective planning, operation and control of your processes and the implementation and continual improvement of the effectiveness of your quality management system.

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.