We start presenting in our blog details and the interpretation for all requirements of ISO 9001:2008 Standard. In some cases we will publish tools in Excel, Power Point, sample of applicable documents or videos to complement the information and explanation about this Quality Management Standard. If you don´t wanna lose our articles you can subscribe our content using your email adress. It´s free, safe and advantageous, the service is provided by Google Feedburner.
I hope to help you in establishing, documenting, implementing, and maintaining a quality management system (QMS) based in ISO 9001:2008 Standard.
Index of Requirements for ISO 9001 Standard
4. Quality Management System
4.1 General Requirements
4.2 Documentation Requirements
4.2.1 Documentation Requirements - General
4.2.2 Quality Manual
4.2.3 Control of Documents
4.2.4 Control of Records
5. Management Responsibility
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning
5.4.1 Quality Objectives
5.4.2 Quality Management System Planning
5.5 Responsibility, Authority and Communication
5.5.1 Responsibility and Authority
5.5.2 Management Representative
5.5.3 Internal Communication
5.6 Management Review
5.6.1 General
5.6.2 Review Input
5.6.3 Review Output
6 Resource Management
6.1 Provision of resources
6.2 Human Resources
6.2.1 General
6.2.2 Competence, Training and Awareness
6.3 Infrastructure
6.4 Work Environment
7. Product Realization
7.1 Planning of Product Realization
7.2 Customer-Related Processes
7.2.1 Determination of Requirements Related to the Product
7.2.2 Review of requirements related to the product
7.2.3 Customer Communication
7.3 Design and Development
7.3.1 Design and Development Planning
7.3.2 Design and Development Inputs
7.3.3 Design and Development Outputs
7.3.4 Design and Development Review
7.3.5 Deisgn and Development Verification
7.3.6 Design and Development Validation
7.3.7 Control of Design and Development Changes
7.4 Purchasing
7.4.1 Purchasing Process
7.4.2 Purchasing Information
7.4.3 Verification of Purchased Product
7.5 Production and Service Provision
7.5.1 Control of production and Service Provision
7.5.2 Validation of Processes for Production and Service Provision
7.5.3 Identification and Traceability
7.5.4 Customer Property
7.5.5 Preservation of Product
7.6 Control of Measuring and Monitoring Equipment
8. Measurement, Analysis, and Improvement
8.1 General
8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction
8.2.2 Internal Audit
8.2.3 Monitoring and Measurement of Processes
8.2.4 Monitoring and Measurement of Product
8.3 Control of Nonconforming Product
8.4 Analysis of Data
8.5 Improvement
8.5.1 Continual Improvement
8.5.2 Corrective Action
8.5.3 Preventive Action
5.4 - Planning - 5.4.1 Quality Objectives
The Quality Objectives:
Quality Objectives are the purposes of an organization in quality management. They need to be measurables and a principal way is using KPI (Key Performance Indicators). In our example in the last article about ISO 9001 Requirements - 5.3 Quality Policy we can establish the following objectives through this Policy:
"The STJGM Consulting and Engineering promotes the continuous improvement of its Quality Management System ensuring customer satisfaction through Projects in Steel Structures that are provided in accordance with the specifications and deadlines for their customers.".
Objective 1 - the continuous improvement of its Quality Management System;
Objective 2 - Ensure customer satisfaction;
Objective 3 - Offers Projects in Steel Structure in correct time.
Now we need to develop indicators to measure its compliance.
For example: Customer Satisfaction, Number of nonconformities per services, number of clients claim, lead time of service, percentual of compliance in products.
Look now a framework of Quality Policy - Quality Objective - Key Performance Indicators.
The principal content of a Key Performance Indicator is:
5.4 - Planning - 5.4.1 Quality Objectives
The Quality Objectives:
- Must be measurable in a quantitative way;
- Can change over time and should be reviewed periodically;
- Should be set with the aim of improving the effectiveness of the QMS.
Quality Objectives are the purposes of an organization in quality management. They need to be measurables and a principal way is using KPI (Key Performance Indicators). In our example in the last article about ISO 9001 Requirements - 5.3 Quality Policy we can establish the following objectives through this Policy:
"The STJGM Consulting and Engineering promotes the continuous improvement of its Quality Management System ensuring customer satisfaction through Projects in Steel Structures that are provided in accordance with the specifications and deadlines for their customers.".
Objective 1 - the continuous improvement of its Quality Management System;
Objective 2 - Ensure customer satisfaction;
Objective 3 - Offers Projects in Steel Structure in correct time.
Now we need to develop indicators to measure its compliance.
For example: Customer Satisfaction, Number of nonconformities per services, number of clients claim, lead time of service, percentual of compliance in products.
Look now a framework of Quality Policy - Quality Objective - Key Performance Indicators.
The principal content of a Key Performance Indicator is:
- Measure (name) - Leadtime customer service;
- Purpose - Ensure that clients will be meet in controled times;
- Refers - Communication;
- Target - 24 hours;
- Formula - Sum of number complaints / Sum of time to answer;
- Frequency - Monthly;
- Who measures - Central Customer Service;
- Sources of Data - CRM or ERP Software Company;
- Who acts on the data? - All sectors involved;
- What possible actions - Increase number of functions in Central Customer Service, improve productions quality, etc;
- Notes and Comments
