ISO 9001:2008 is a globally recognized standard for quality management system. This standard has been developed by ISO (International Organization for Standardization). This standard addresses all quality management related issues & can be adopted by any organization irrespective of its nature of business & size of organization.
ISO 9001 is by far the world’s most established quality framework, currently being used by over ¾ million organizations in 161 countries, and sets the standard not only for quality management systems, but management systems in general.What are the benefits of ISO 9001:2008 certification?
Some of the benefits to your organisation:
• Provides senior management with an efficient management process
• Sets out areas of responsibility across the organisation
• 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
Some of the benefits to your customers:
• Improved quality and service
• Delivery on time
• Right first time attitude
• Fewer returned products and complaints
• Independent audit demonstrates commitment to quality
What is in ISO 9001:2008 standard?
The Standard has 8 sections. The requirements are in sections 4 - 8:
· Section 4 is an 'overall' one for the system. It contains requirements applicable to the system throughout, including requirements to define processes, for documentation, and for records
· Section 5 is about the responsibility of management, particularly 'top management' - the decision-makers. It includes requirements for customer focus through quality policy, planning, defining responsibilities, setting objectives and reviewing performance
· Section 6 is about resources. Its aim is to ensure that people performing work affecting service/product quality are competent, and that suitable infrastructure (from facilities to tools & equipment) is provided.
· Section 7 is on service/product 'realisation' or core business activities – all the processes & activities involved in delivering your services or products. It contains the most requirements, from communicating with customers, and designing and/or developing products/services through to procurement, identification and controlling production/service delivery, etc.
· Section 8 covers measurement, analysis and improvement. It sets requirements for checking how you are performing, assessing performance, identifying and fixing various problems, and improving your system.
A simple overview of the ISO 9001 Standard
This is a 'nutshell' version of the requirements for quality management systems (ISO 9001:2008)
4 Overall Requirements for the System
4.1 Establish a quality management system: develop it, implement it and improve it.
4.2 Document the quality management system.
4.2.1 Create documents including a quality policy, objectives, manual, procedures and records
4.2.2 Have a quality manual
4.2.3 Control documents
4.2.4 Create and maintain records of your system to show that it works as described.
4.2.2 Have a quality manual
4.2.3 Control documents
4.2.4 Create and maintain records of your system to show that it works as described.
5 Requirements for Management
5.1 Demonstrate commitment to the quality management system
Communicate the importance of quality
Establish a quality policy and objectives.
Plan and do reviews of your system.
Make sure adequate resources are available.
Communicate the importance of quality
Establish a quality policy and objectives.
Plan and do reviews of your system.
Make sure adequate resources are available.
5.2 Focus on customers
Identify customer requirements.
Aim to enhance the satisfaction of your customers.
Identify customer requirements.
Aim to enhance the satisfaction of your customers.
5.3 Adopt and use a quality policy
Define a suitable quality policy.
Commit to meeting the system's requirements and to continual improvement.
Communicate and manage the quality policy.
Define a suitable quality policy.
Commit to meeting the system's requirements and to continual improvement.
Communicate and manage the quality policy.
5.4 Plan for quality
5.4.1 Set measurable objectives (aims/goals).
5.4.2 Have plans that are suitable to achieve the objectives
5.5 Define and communicate 'who does what'
5.5.1 Identify who has what responsibility and authority
5.5.2 Make a senior manager responsible for the quality system overall
5.5.3 Have effective means of communicating internally.
5.4.2 Have plans that are suitable to achieve the objectives
5.5 Define and communicate 'who does what'
5.5.1 Identify who has what responsibility and authority
5.5.2 Make a senior manager responsible for the quality system overall
5.5.3 Have effective means of communicating internally.
5.6 Review the quality management system (management review)
5.6.1 Review your system at planned intervals
5.6.2 I nclude reviews of customer feedback, performance including nonconformity, results of audits, status of actions, changes and improvements
5.6.3 Record outcomes from your reviews, including actions and decisions.
5.6.2 I nclude reviews of customer feedback, performance including nonconformity, results of audits, status of actions, changes and improvements
5.6.3 Record outcomes from your reviews, including actions and decisions.
6 Resource Requirements
6.1 Identify and provide the resources needed to implement, maintain and improve the system, and enhance customer satisfaction.
6.2 Make sure people are suitably competent
6.2.1 Anyone whose work affects product/service conformity must be competent
6.2.2 Decide what competencies are required, provide and maintain them
6.2.2 Decide what competencies are required, provide and maintain them
6.3 Provide infrastructure: Identify what you need, provide and maintain it.
6.4 Provide the work environment you need for product/service conformity.
7 Requirements for Products or Services
7.1 Plan
Plan and develop the processes you need for your products/services.
Plan and develop the processes you need for your products/services.
7.2 Have effective customer-related processes
7.2.1 Identify requirements that apply to your products/services
7.2.2 Ensure you can supply or deliver before accepting an order
7.2.3 Have effective arrangements to communicate with customers.
7.2.2 Ensure you can supply or deliver before accepting an order
7.2.3 Have effective arrangements to communicate with customers.
7.3 Have effective processes for designing & developing your products/services
7.3.1 Plan design/development.
7.3.2 Define what inputs are needed to design/create/develop
7.3.3 Have a 'design' or plan in a form that enables you to verify the output against it (see 7.3.5)
7.3.4 Review the design/plan at suitable points
7.3.5 Make sure the result meets the agreed & defined requirements (verification)
7.3.6 Validate design (where practicable).
7.3.7 If changes to design occur, manage them.
7.3.2 Define what inputs are needed to design/create/develop
7.3.3 Have a 'design' or plan in a form that enables you to verify the output against it (see 7.3.5)
7.3.4 Review the design/plan at suitable points
7.3.5 Make sure the result meets the agreed & defined requirements (verification)
7.3.6 Validate design (where practicable).
7.3.7 If changes to design occur, manage them.
7.4 Control any purchasing of goods, materials or services that affects product/service conformity; 'purchasing' includes outsourcing and subcontracting
7.4.1 Make sure what you buy meets the requirements you specified; assess and monitor the suppliers you use.
7.4.2 Describe what you intend to purchase adequately.
7.4.3 Verify that what was purchased did meet the requirements you set
7.4.2 Describe what you intend to purchase adequately.
7.4.3 Verify that what was purchased did meet the requirements you set
7.5 Control operations
7.5.1 Have effective ways to control what you do (providing products/ services)
7.5.2 Validate production/service provision where required.
7.5.3 Identify and track services/products where appropriate
7.5.4 Take care of any property supplied by customers
7.5.5 Care for products/components during storage/delivery, etc.to make sure they stay in good condition
7.5.2 Validate production/service provision where required.
7.5.3 Identify and track services/products where appropriate
7.5.4 Take care of any property supplied by customers
7.5.5 Care for products/components during storage/delivery, etc.to make sure they stay in good condition
7.6 Control measuring and monitoring equipment
Identify what monitoring/measuring equipment and processes your need for valid measurement results. If equipment is required, choose & use equipment that is suitable equipment. Make sure results are and remain accurate.
Identify what monitoring/measuring equipment and processes your need for valid measurement results. If equipment is required, choose & use equipment that is suitable equipment. Make sure results are and remain accurate.
8 Requirements for Analysis and Improvement
8.1 Have processes suitable to ensure your services/products conform to requirements and to your quality management system; include improvement.
8.2 Monitor and measure (as necessary) to work out if you achieved the results you planned to
8.2.1 Monitor customer satisfaction.
8.2.2 Plan and implement a program of internal audit
8.2.3 Have appropriate ways to monitor and measure your processes
8.2.2 Plan and implement a program of internal audit
8.2.3 Have appropriate ways to monitor and measure your processes
8.2.4 Monitor and measure products/services at suitable points.
Release final product/service only after requirements have been met.
Release final product/service only after requirements have been met.
8.3 Control nonconformity (services/products not meeting requirements)
Identify and control nonconformity suitably; includes written procedure.
Identify and control nonconformity suitably; includes written procedure.
8.4 Analyse information from your system
Define the information needed to show your system is working and to improve.
Collect, analyse and use the information.
Define the information needed to show your system is working and to improve.
Collect, analyse and use the information.
8.5 Continually improve.
8.5.1 Improve your system.
8.5.2 Have a systematic approach to fix nonconformity and stop it recurring.
8.5.3 Have a systematic approach to prevent potential nonconformity or failures happening
8.5.2 Have a systematic approach to fix nonconformity and stop it recurring.
8.5.3 Have a systematic approach to prevent potential nonconformity or failures happening
ISO 9001 standard mandatory procedures:
ISO 9001 quality system documentation requirements:
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