ISO 9001:2008 Procedures Package
GENERAL INFORMATION ABOUT ISO 9001
The ISO 9000 is the world's most recognized quality management standard. The ISO 9000 family addresses various aspects of quality management and contains some of ISO’s best known standards. The standards provide guidance and tools for companies and organizations who want to ensure that their products and services consistently meet customer’s requirements, and that quality is consistently improved.
ISO 9001:2015
ISO 9001 is the world's most widely recognized Quality Management System (QMS). It belongs to the ISO 9000 family of quality management system standards and helps organizations to meet the expectations and needs of their customers, amongst other benefits.
An ISO 9001 quality management system will help you to continually monitor and manage quality across all operations, and outlines ways to achieve, as well as benchmark, consistent performance and service. Internationally, it is the quality system of choice.
ISO 9001:2015 sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity. In fact, there are over one million companies and organizations in over 170 countries certified to ISO 9001.
This standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. Using ISO 9001:2015 helps ensure that customers get consistent, good quality products and services, which in turn brings many business benefits.
As an ISO 9001 certified organization you will have implemented Quality Management System requirements for all areas of the business, including:
The process encompasses the entire organization and requires senior management buy-in, it is not just a function of the Quality Department. To achieve ISO 9001 certification your organization needs to demonstrate that it can meet the regulatory requirements and apply the system effectively to be of real benefit to your customers.
Sector-specific applications of ISO 9001
ISO has a range of standards for quality management systems that are based on ISO 9001 and adapted to specific sectors and industries. These include:
ISO 9001 Certification will provide maximum benefit to your organization if it approaches ISO 9001 implementation in a practical way. This will ensure that the Quality Management Systems that are adopted, work to improve the business and are not just a set of procedures that your employees will find hard to manage.
By adopting an approach that starts out to implement more efficient working practices and focuses on the business objectives of the organization, you will achieve a system that will help and support your staff, and improve your levels of customer satisfaction.
Whether you use an external assessor or allocate an internal resource to carry out the initial assessments, you will need to ensure that they have buy-in from senior management, so that all areas of the organization are aware of the importance of the ISO 9001 Certification process.
ISO 9001 Certification is not just suitable for large organizations but also small businesses that will benefit from adopting efficient Quality Management Systems that will save time and cost, improve efficiency and ultimately improve customer relationships.
Some of the benefits to your organization:
Checking that the system works is a vital part of ISO 9001:2015. It is recommended that an organization performs internal audits to check how its quality management system is working. An organization may decide to invite an independent certification body to verify that it is in conformity to the standard, but there is no requirement for this. Alternatively, it might invite its clients to audit the quality system for themselves.
Using ISO 9001 Procedures Package leads an organization to ISO 9001:2015 certification with confidence. Part of ISO 9001:2015-14001:2015 All in One Certification Package; the ISO 9001 Procedures Package also works for those companies that don’t plan to train their internal auditors, since it is tailored for them, as well.
These are some of the reasons for which some companies don’t need to train their internal auditor:
The ISO 9000 is the world's most recognized quality management standard. The ISO 9000 family addresses various aspects of quality management and contains some of ISO’s best known standards. The standards provide guidance and tools for companies and organizations who want to ensure that their products and services consistently meet customer’s requirements, and that quality is consistently improved.
ISO 9001:2015
ISO 9001 is the world's most widely recognized Quality Management System (QMS). It belongs to the ISO 9000 family of quality management system standards and helps organizations to meet the expectations and needs of their customers, amongst other benefits.
An ISO 9001 quality management system will help you to continually monitor and manage quality across all operations, and outlines ways to achieve, as well as benchmark, consistent performance and service. Internationally, it is the quality system of choice.
ISO 9001:2015 sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity. In fact, there are over one million companies and organizations in over 170 countries certified to ISO 9001.
This standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. Using ISO 9001:2015 helps ensure that customers get consistent, good quality products and services, which in turn brings many business benefits.
As an ISO 9001 certified organization you will have implemented Quality Management System requirements for all areas of the business, including:
- Facilities
- People
- Training
- Services
- Equipment
The process encompasses the entire organization and requires senior management buy-in, it is not just a function of the Quality Department. To achieve ISO 9001 certification your organization needs to demonstrate that it can meet the regulatory requirements and apply the system effectively to be of real benefit to your customers.
Sector-specific applications of ISO 9001
ISO has a range of standards for quality management systems that are based on ISO 9001 and adapted to specific sectors and industries. These include:
- ISO/TS 29001 – Petroleum, petrochemical and natural gas industries
- ISO 13485 – Medical devices
- ISO/IEC 90003 – Software engineering
- ISO 17582 – Electoral organizations at all levels of government
- ISO 18091 - Local government
ISO 9001 Certification will provide maximum benefit to your organization if it approaches ISO 9001 implementation in a practical way. This will ensure that the Quality Management Systems that are adopted, work to improve the business and are not just a set of procedures that your employees will find hard to manage.
By adopting an approach that starts out to implement more efficient working practices and focuses on the business objectives of the organization, you will achieve a system that will help and support your staff, and improve your levels of customer satisfaction.
Whether you use an external assessor or allocate an internal resource to carry out the initial assessments, you will need to ensure that they have buy-in from senior management, so that all areas of the organization are aware of the importance of the ISO 9001 Certification process.
ISO 9001 Certification is not just suitable for large organizations but also small businesses that will benefit from adopting efficient Quality Management Systems that will save time and cost, improve efficiency and ultimately improve customer relationships.
Some of the benefits to your organization:
- Provides senior management with an efficient management process
- Sets out areas of responsibility across the organization
- Mandatory if you want to tender for some public sector work
- Communicates a positive message to staff and customers
- Identifies and encourages more efficient and time saving processes
- Highlights deficiencies
- Reduces your costs
- Provides continuous assessment and improvement
- Marketing opportunities
- Improved quality and service
- Delivery on time
- Right first time attitude
- Fewer returned products and complaints
- Independent audit demonstrates commitment to quality
Checking that the system works is a vital part of ISO 9001:2015. It is recommended that an organization performs internal audits to check how its quality management system is working. An organization may decide to invite an independent certification body to verify that it is in conformity to the standard, but there is no requirement for this. Alternatively, it might invite its clients to audit the quality system for themselves.
Using ISO 9001 Procedures Package leads an organization to ISO 9001:2015 certification with confidence. Part of ISO 9001:2015-14001:2015 All in One Certification Package; the ISO 9001 Procedures Package also works for those companies that don’t plan to train their internal auditors, since it is tailored for them, as well.
These are some of the reasons for which some companies don’t need to train their internal auditor:
- There are trained auditors on staff
- They will be trained elsewhere
- An outside consultant will perform the audits, at least for the first year
- There are not enough employees to perform internal audits (NOTE: These standards do not allow someone to audit their own work)
- Package has been used by companies across the globe
- Has never failed an audit
- Comes with efficient and effective design
- Highly recommended by Registrars
- Many Procedures & Forms are fully written and ready for you to customize. They contain guidance so you know what to edit and examples are provided.
- No need to hire consultants to develop your system or to train your employees.
- Training of requirements of the standard on how to implement them.
It contains the following areas:
AP-500-A
Management Responsibility
1.0 PURPOSE
2.0 RESPONSIBILITIES
3.0 DEFINITIONS
4.0 EQUIPMENT/SOFTWARE
5.0 INSTRUCTIONS
5.1 Top Management has established a Quality Policy, and reviews it for continuing suitability during Management Review meetings.
5.2 Top Management communicates the Quality Policy and the importance of meeting regulatory, statutory and customer requirements in employee orientation training and during company and department meetings and functions.
5.3. Top Management identifies the Key Processes included in the QMS
5.4 Identifying data required for review of the QMS Processes
5.5 Identifying data required for review of Product Realization Processes
5.6 Identifying data required for review of customer feedback
5.7 Management Review
6.0 FORMS AND RECORDS
7.0 ATTACHMENTS
8.0 RELATED DOCUMENTS
9.0 REFERENCES
AP-500-A
Management Responsibility
1.0 PURPOSE
2.0 RESPONSIBILITIES
3.0 DEFINITIONS
4.0 EQUIPMENT/SOFTWARE
5.0 INSTRUCTIONS
5.1 Top Management has established a Quality Policy, and reviews it for continuing suitability during Management Review meetings.
5.2 Top Management communicates the Quality Policy and the importance of meeting regulatory, statutory and customer requirements in employee orientation training and during company and department meetings and functions.
5.3. Top Management identifies the Key Processes included in the QMS
5.4 Identifying data required for review of the QMS Processes
5.5 Identifying data required for review of Product Realization Processes
5.6 Identifying data required for review of customer feedback
5.7 Management Review
6.0 FORMS AND RECORDS
7.0 ATTACHMENTS
8.0 RELATED DOCUMENTS
9.0 REFERENCES
