Introduction to ISO9001:2008

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What is ISO?
• The International Organization for Standardization (ISO) was established in 1947 and is an association of 157 members, which each represent their own country. ISO employs a system of Technical Committees and Working Groups to develop International Standards. • British Standards Institute is the National Standards Body that represents the United Kingdom at ISO www.bsigroup.com
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What are the ISO 9000 standards?
• The ISO 9000 standards are a collection of formal International Standards, Technical Specifications, Technical Reports, Handbooks and web based documents on Quality Management. • There are 25 documents in the collection altogether

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What are the main ISO 9000 standards?
 ISO 9000:2005 Quality management systems – Fundamentals and vocabulary. Covers the basics of what quality management systems are and also contains the core language of the ISO 9000 series of standards. A guidance document used for reference to understand terms and vocabulary related to quality management systems.  ISO 9001:2008 Quality management systems – Requirements This is the only ISO9000 standard for which certification can be gained. Intended for use in any organization regardless of size, type or product including service. It provides a number of Quality Management System requirements which an organization needs to fulfil to achieve customer satisfaction. It includes a requirement for the continual improvement.  ISO 9004:2000 Quality management systems - Guidelines for performance improvements. Covers continual improvement. This gives you advice on what you could do to enhance a mature system. This standard very specifically states that it is not intended as a guide to implementation.
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What is the history of ISO 9001?
• ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing was for companies and organizations whose activities included the creation of new products. Had the same structure as the UK Standard BS 5750 unfortunately the emphasis tended to be placed on conformance with procedures rather than the overall process of management. • ISO 9001:2000 Combination of the three standards 9001, 9002, and 9003 into one, called 9001. Design and development procedures are required only if a company does engage in the creation of new products. Introduced the concept of process management. Required the involvement of Senior Management in order to integrate quality into the business system and avoid delegation of quality functions to junior staff. Required measurement of the effectiveness of tasks and activities. Expectations of continual process improvement and tracking customer satisfaction were defined.

• ISO 9001:2008 Introduces clarifications to the existing requirements of ISO 9001:2000 and some changes intended to improve consistency with Environmental Management Standard ISO 14001:2004. The standard is now practical and business improvement focused. It is completely different to the original standard which was discredited in some areas as a paper exercise.

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What are the ISO 9001 requirements for a Quality Management System? • The organisation needs to demonstrate its ability to consistently provide product that meets customer and regulatory requirements . • The organisation must aim to enhance customer satisfaction through the effective application of the quality management system. This includes processes for continual improvement of the system.
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What are the requirements of ISO 9001? The requirements in ISO 9001 include:  a set of procedures that cover all key processes in a business  monitoring processes to ensure they are effective  keeping adequate records  checking output for defects, with appropriate and corrective action where necessary  regularly reviewing individual processes and the quality system itself for effectiveness  Focus on continual improvement
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What are the ISO 9001:2008 Quality Management System requirements?
The ISO9001:2008 Standard consists of the following sections: Section 1: Scope Section 2: Normative Reference Section 3: Terms and definitions Section 4: Quality Management System Section 5: Management Responsibility Section 6: Resource Management Section 7: Product Realization Section 8: Measurement, analysis and improvement
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ISO 9001:2008 Quality Management System requirements: Section 4: Quality Management System from our Manual
Quality Management System Section 4 ISO9001:2008
ISO 9001:2008 Clause Our Document Number QM001 Our Procedure Quality Management System

4.1 Introduction
4.2 Documentation 4.3 Internal Document Control 4.4 External Document Control

QM002
QM003 QM004

QMS Manual Summary
Document Control

Customer, Statutory and Regulatory Conformance
Record Control

4.5 Quality System Records

QM005

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ISO 9001:2008 Quality Management System requirements: Section 5: Management Responsibility from our Manual
Management Responsibility Section 5 ISO9001:2008
ISO 9001:2008 Clause 5.1 Management Commitment
5.2 Customer Focus QM007 5.3 Quality Policy Quality Policy

Our Document Number QM006

Our Procedure Management Commitment

5.4 Planning
5.5 Responsibility & Authority

QM001
QM008

Quality Management System
Responsibility and Authority

5.6 Internal Communication

5.7 Management Review

QM009

Management Review

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ISO 9001:2008 Quality Management System requirements: Section 6: Resource Management from our Manual
Resource Management Section 6 ISO9001:2008
ISO 9001:2008 Clause 6.1 Resources QM010 6.2 Human Resources & Training Resources and Training Our Document Number Our Procedure

6.3 Infrastructure
QM011 6.4 Work Environment

Infrastructure and Work Environment

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ISO 9001:2008 Quality Management System requirements: Section 7: Product Realisation from our Manual
Product Realisation Section 7 ISO9001:2008
ISO 9001:2008 Clause 7.1 Planning 7.2 Customer Related Processes 7.3 Design and Development 7.4 Purchasing, Orders and Verification of Purchased Materials 7.5.1 Production 7.5.2 Validation of Processes QM012 QM013 Contract Review Design and Development Purchasing, Orders and Verification of Purchased Materials Our Document Number Our Procedure

QM014
7.5 Operational Control

QM015
QM016 QM017 QM018 QM019 QM020
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Production
Identification and Traceability Customer Property Preservation of Product Despatch and Distribution Maintenance
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7.5.3 Identification and Traceability 7.5.4 Customer Property
7.5.5 Preservation of Product
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ISO 9001:2008 Quality Management System requirements: Section 8: Measurement, Analysis and Improvement from our Manual
Measurement, Analysis and Improvement Section 8 ISO9001:2008
ISO 9001:2008 Clause 8.1 General 8.2 Monitoring and Measurement 8.2.1 Customer Satisfaction QM023 QM024 Measurement and Monitoring Customer Satisfaction Our Document Number Our Procedure

8.2.2 Internal Audit
8.2.3 Monitoring and Measuring QMS Processes 8.3 Control of Non-Conforming Product 8.4 Analysis of Data

QM025 QM026
QM027 QM026 QM028 QM029 QM030
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Internal Audit
Monitoring and Measuring QMS Processes, Analysis of Data Control of Non-Conforming Product Monitoring and Measuring QMS Processes, Analysis of Data Corrective Action, Preventive Action and Improvement Crisis Management Product Recall
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8.5 Corrective Action, Preventive Action and Improvement
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What are the ISO 9001:2008 Quality Management System document requirements?
ISO 9001:2008 refers specifically to only 6 documented procedures (See next Slide). Other documentation may be required by an organization in order to manage the processes that are necessary for the effective operation of the quality management system. This will vary depending on the size of the organization, the kind of activities in which it is involved and their complexity. Our small business manual covers all the basic clauses of ISO 9001:2008 with 9 procedures/documents our ISO9001:2008 is much more detailed and has 30 documents. Both include 14 records.
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What are the ISO 9001:2008 Quality Management System requirements?
The standard specifies six compulsory documents: • Control of Documents (4.2.3) • Control of Records (4.2.4) • Internal Audits (8.2.2) • Control of Nonconforming Product / Service (8.3) • Corrective Action (8.5.2) • Preventive Action (8.5.3) • In addition to these ISO 9001:2008 requires a Quality Policy and Quality Manual

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What are the ISO 9001:2008 Quality Management System requirements?
The standard specifies six compulsory documents: Control of Documents (4.2.3) • The ISO9001:2008 standard requires that an organization needs a documented procedure to control quality documents. All employees must have access to up-to-date documents and be aware of how to use them.
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What are the ISO 9001:2008 Quality Management System requirements?
The standard specifies six compulsory documents: Control of Records (4.2.4) • The ISO9001:2008 standard requires that Records are controlled in a similar way to documents. They should be retained to demonstrate conformity, show how products were processed and to allow products and problems to be traced to the source.
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What are the ISO 9001:2008 Quality Management System requirements?
The standard specifies six compulsory documents: Internal Audits (8.2.2)
• The ISO9001:2008 standard requires a documented procedure for internal audits. It is a requirement to regularly review performance through internal audits to determine whether the quality system is working and what improvements can be made. It is a requirement to keep records of these activities and the resulting decisions.
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What are the ISO 9001:2008 Quality Management System requirements?
The standard specifies six compulsory documents: Control of Nonconforming Product / Service (8.3)
• You need documented procedures for dealing with actual and potential non-conformances (problems involving suppliers or customers, or internal problems). The procedure should define how to isolate and quarantine product that does not meet requirements, how you decide what to do with this product and how you take action to deal with the root cause of the problem. You must also keep records of Non-Conforming Product to use as a tool to improve the system.
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What are the ISO 9001:2008 Quality Management System requirements?
The standard specifies six compulsory documents: Corrective Action (8.5.2) • The ISO9001:2008 standard requires that you take Corrective Action to rectify non-conformances. It is a requirement to keep records of these activities and monitor their effectiveness. Preventive Action (8.5.3) • The ISO9001:2008 standard requires that you need to take Preventative Action to eliminate potential causes of problems. It is a requirement to keep records of these activities and monitor their effectiveness.
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What are the ISO 9001:2008 Quality Management System requirements?
ISO 9001:2008 requires a Quality Policy and Quality Manual:
• The quality policy is a formal statement from management, closely linked to the business and marketing plan and to customer needs. The quality policy is understood and followed at all levels and by all employees. Each employee needs measurable objectives to work towards. • Your procedures will be maintained in your Quality Manual.
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What are the ISO 9001:2008 Quality Management System requirements?

• The ISO 9001:2008 standard requires that decisions about the quality system are made based on recorded data and the system is regularly audited and evaluated for conformance and effectiveness.

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What are the ISO 9001:2008 Quality Management System requirements?

• The ISO9001:2008 standard requires that to maintain the quality system and produce conforming product, you need to provide suitable infrastructure, resources, information, equipment, measuring and monitoring devices, and work environment.

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What are the ISO 9001:2008 Quality Management System requirements?

• The ISO9001:2008 standard requires that an organisation needs to map out all key processes in your company, control them by monitoring, measurement and analysis, and ensure that product quality objectives are met. • If you can’t monitor a process by measurement, then make sure the process is well enough defined that you can make adjustments if the product does not meet user needs.

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What are the ISO 9001:2008 Quality management systems requirements?
The ISO9001:2008 standard has an absolute requirement to maintain the following records: • Management Review Minutes • Training Record • Product Release Record • Design and Development Records - Results of the review of customer requirements - Design and development inputs relating to product requirements - Results of design and development reviews and actions - Results of design and development verification and actions - Results of design and development validation and actions - Results of the review of design and development changes • Supplier Assessment Record * All of these records are provided in our manual packs
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What are the ISO 9001:2008 Quality Management System requirements?
The ISO9001:2008 standard has an absolute requirement to maintain the following records: • Validation Record • Identification and Traceability Record • Register of Customer Property • Calibration Record
- Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist - Validity of the previous measuring results when the measuring equipment is found not to conform to requirements - Results of calibration and verification of measuring equipment

• Internal Audit Record • Records of Non-conforming Product • Corrective Action Request Form • Preventative Action Request Form * All of these records are provided in our manual packs
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What are the ISO 9001:2008 Quality Management System requirements? • The ISO9001:2008 standard requires that you establish quality objectives, plan processes, and document and measure results to use as a tool for improvement. • For each process it is important to determine what kind of procedural documentation is required

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What are the ISO 9001:2008 Quality Management System requirements?
• The ISO9001:2008 standard requires that you need to determine key points where each process requires monitoring and measurement, and ensure that all monitoring and measuring devices are properly maintained and calibrated. • The ISO9001:2008 standard requires that you need to have clear requirements for purchased product. • The ISO9001:2008 standard requires that you need to determine customer requirements and create systems for communicating with customers about product information, inquiries, contracts, orders, feedback and complaints.
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What are the ISO 9001:2008 Quality Management System requirements?

The ISO9001:2008 standard requires that when developing new products, you need to plan the stages of development, with appropriate testing at each stage. You need to test and document whether the product meets design requirements, regulatory requirements and user needs.
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What are the 8 Quality Management Principles?

Mutually beneficial supplier relationships

Customer focus Leadership

Factual approach to decision making

Quality Management Principles

Involvement of people

Continual improvement System approach to management

Process approach

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Why is customer satisfaction included in ISO 9001? "Customer satisfaction" is one of the main driving criteria for any organization. In order to evaluate if a product meets customer needs and expectations, it is necessary to monitor and measure customer satisfaction. Improvements can be made by taking action to address any identified issues and concerns. Your customers will gain confidence that your products will meet their needs and increase their satisfaction.
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What is Continual Improvement?

Continual improvement is the process focused on continually increasing the effectiveness and/or efficiency of the organization to fulfil its policies and objectives.

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ISO 9001:2008 Process Approach to Management

The ISO9001:2008 standard requires that an organisation needs to map out all key processes in your company, control them by monitoring, measurement and analysis, and ensure that product quality objectives are met.

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ISO 9001:2008 Process Approach to Management What is a process? • An activity which receives inputs and converts them to outputs is a process. • Almost all activities and operations involved in generating a product or providing a service are processes.

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ISO 9001:2008 Process Approach to Management

What is a “process approach”?
• The systematic identification and management of the processes within an organization and the interactions between the processes is known as a process approach to management. • The process approach is a key element of the ISO 9000 standards.

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ISO 9001:2008 Process Approach to Management

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ISO 9001:2008 Process Approach to Management
What are the benefits “process approach”?  The integration and alignment of its processes to enable the achievement of its planned results.  An ability to focus effort on process effectiveness and efficiency.  Transparency of operations within the organization.  Lower costs and shorter cycle times through effective and efficient use of resources.  The encouragement and involvement of people, and the clarification of their responsibilities.  The elimination of barriers between different functional units and the unification of their focus to the objectives of the organization.  Improved management of process interfaces.
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ISO 9001:2008 Process Approach to Management - How do you measure a process?
Typical factors that are useful to consider when identifying measures of process control and process performance include:
• • • • • • • • • Product Conformity with requirements Customer satisfaction Supplier performance On time delivery Lead times Incident numbers and Failure rates Percentage Waste Process costs Order completion
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ISO 9001:2008 Process Approach to Management
What is the difference between a process and a procedure?
• A process may be explained as a set of interacting or interrelated activities, which are employed to add value. A procedure is a method of describing the way or in which all or part of that process activities should be performed. • ISO 9000:2005 defines a procedure as a "specified way to carry out an activity or a process", which does not necessarily have to be documented.

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What is the PDCA cycle?
The PDCA cycle is an established, logical, method that can be used to improve a process. This requires:
 (P) planning (what to do and how to do it),  (D) executing the plan (do what was planned),  (C) checking the results (did things happened according to plan) and  (A) act to improve the process (how to improve next time). The PDCA cycle can be applied within an individual process, or across a group of processes.
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PDCA Cycle

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What do you need to do to comply with ISO 9001:2008?
When initially starting to use ISO 9001, you should familiarize yourself with the Quality Management System standards, especially ISO 9000, ISO 9001 and ISO 9004, and consider their requirements.

If you wish to proceed to certification, you should follow our guides and checklists and implement the procedures and records in our manual pack then use Gap Analysis Checklist to determine if your system meets the requirements of ISO 9001. Developing and implement additional procedures or processes to address any shortfalls.
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What are the requirements for consultants?

• As a minimum, quality management system consultants should understand the requirements of ISO 9001:2008, and also with the content of ISO 9000:2005, ISO 9004 and the Quality Management Principles. • Consultants should understand their client’s activities and processes.

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What are the requirements for auditors?
The standards require that auditors are able to understand the organization's activities and processes and appropriately audit against the requirements of the ISO 9001 in relation to the organization's objectives. Auditors should be able to demonstrate competency in:  Quality Management Systems.  The requirements of the ISO 9001:2008.  A general understanding of ISO 9000:2005 and ISO 9004.  Auditing techniques.
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What is certification to ISO9001:2008?
Organizations have their quality management system certified to ISO 9001:2008:  When an organization seeks to certify (sometimes referred to as register) it’s quality management system to ISO 9001:2008, it is required to agree a "scope of certification" with its certification body (sometimes called registrar).  This will define the products to which the organization's quality management system is applicable, and against which it will be assessed. An organization is not obliged to include within its "scope of certification" all the products that it provides but may be selective about those that are included. All applicable requirements of ISO 9001:2008 will need to be addressed by the organization's quality management system that covers those products that are included in the "scope of certification".
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What is ISO 9001 certification?
A company or organization that has been independently audited and certified to be in conformance with ISO 9001 may publicly state that it is "ISO 9001 certified" or "ISO 9001 registered". Certification to an ISO 9001 standard does not guarantee any quality of end products, it certifies that approved business processes are being applied. Although the standards originated in manufacturing, they are now employed across several types of organizations. A "product" in ISO vocabulary can mean a physical object or services.
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What are the main benefits to be derived from implementing an ISO 9000 quality management system?
• The ISO 9000 standards give organizations the discipline to focus their activities and to continually improve their performance. • The standards require implementation of a quality management system which manages the processes within an organisation.

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What are the benefits of using the ISO 9001 standard?
The management of an organization should be able to view the adoption of the ISO9001 Quality Management System standards as a profitable business investment, not just as a required certification issue:

 The discipline of the standard drives the connection of quality management systems to organizational processes  The disciplines involved give improved organizational performance, via: - Using the 8 Quality Management Principles - Using a "process approach" - Commitment from senior management - Using measurable objectives - Focus "continual improvement" and "customer satisfaction" - Measurement of the quality management system effectiveness - Assessing resource requirements

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How will the implementation of the ISO9001:2008 standard help us?

• ISO 9001:2008 aims at guaranteeing the effectiveness of the organization • Further progress can be made by using ISO 9004 in addition to ISO 9001:2008. The ISO 9004 guiding quality management principles are intended to assist an organization in continual improvement

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How will the implementation of the ISO9001:2008 standard help us?

It gives you a Competitive advantage: • ISO 9001 is senior management led so ensuring a strategic approach to your management systems. • The certification process ensures that your business policies and objectives drive your processes and working practices to ensure you maximise the return from your resources.

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How will the implementation of the ISO9001:2008 standard help us?

It Improves performance : • ISO 9001 helps your employees to raise the organization’s performance above and beyond competitors who aren’t using structured management systems. Certification also makes it easier to measure performance and improve the way you manage your business.

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How will the implementation of the ISO9001:2008 standard help us?

It enhances Company reputation:
• Certification to ISO 9001 will boost your company’s reputation and can be a useful promotional and marketing tool. It sends a clear message to all interested parties that this is a company committed to high standards and continual improvement.

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How will the implementation of the ISO9001:2008 standard help us?
It saves you money:
• Evidence shows that the financial benefits for companies that have invested in and certified their quality management systems to ISO 9001 include operational efficiencies, increased sales, higher return on assets and greater profitability.

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How will the implementation of the ISO9001:2008 standard help us?

Improves Efficiency and Streamlines operations:
• Your quality management system focuses on your objectives and operating processes. This encourages you to improve the efficiency of your business, the quality of your products, the service you provide and helps to reduce your waste and customer complaints levels.

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How will the implementation of the ISO9001:2008 standard help us?
It increases customer satisfaction:
• The structure of ISO 9001 ensures that the needs of the customer are being considered and met and your company focus is on constantly increasing customer satisfaction. • "Customer satisfaction" is one of the main driving criteria for any organization. In order to evaluate if a product meets customer needs and expectations, it is necessary to monitor and measure customer satisfaction. Improvements can be made by taking action to address any identified issues and concerns. Your customers will gain confidence that your products will meet their needs and increase their satisfaction.
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How will the implementation of the ISO9001:2008 standard help us?

It encourages internal communication, raises morale and employee ownership: • ISO 9001 ensures that employees feel more involved through improved communication and training they will understand and take ownership of the company policies and objectives.

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What is the next stage for us?

View our Guide to the process of Implementing an ISO9001:2008 compliant manual at www.9001manual.com

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