ISO 9001 is one of the most popular standards among all ISO certification standards. This is the standard to which the maximum of number of organizations have been certified the world over.
The reason for its popularity & acceptability is hidden in its name only, "Quality". All organizations, irrespective of their size, whether a manufacturer or service provider, aim to provide quality products/services to their end customers. Therefore, due to its huge scope, this standard is far way ahead of other ISO standards.
In order to achieve ISO 9001 certification, an organization needs to effectively implement the requirements of this standard. Once the organization is fully convinced that it has an effective management system in place, it can apply for ISO 9001 certification with an accredited registrar/certification body. The certification body, after the succesful audit, will grant the ISO 9001 certifiucation, which is valid for 3 years.
The 5 major requirements of ISO 9001 standard can be summarized as given below -
4. Overall Requirements for the System
4.1 Set up your quality management system: develop, use and improve it.
4.2 Document your system to say how it should work.
4.2.1 Write documents including a quality policy, objectives, manual, procedures and records; decide what procedures you need for your system; must include those listed below
4.2.2 Have a quality manual
4.2.3 Control your documents to make sure they are accurate and suitable, including a procedure
4.2.4 Manage your records (which show your system works as you say it does) suitably, including a procedure.
5 Requirements for Management
5.1 Demonstrate your commitment to the quality management system by
- communicating to personnel how important quality is
- setting a quality policy and objectives for your system.
- providing adequate resources (people, plant, equipment, IT etc.).
- ensuring there is adequate planning
- reviewing how the system performs.
5.2 Focus on customers
Identify their requirements and aim to enhance their satisfaction.
5.3 Write a quality policy. Use it.
Commit to meeting requirements of the quality system and ISO 9001, including continual improvement.
Make sure you communicate this policy and that it's understood.
5.4 Plan for quality
5.4.1 Set objectives (aims/goals) that you can measure.
5.4.2 Have suitable plans to achieve these objectives
5.5 Define and communicate 'who does what'
5.5.1 Identify who has what responsibility and authority
5.5.2 Give a senior manager responsibility for the quality system overall
5.5.3 Have effective methods of internal communication.
5.6 Review your quality management system (management review) at regular intervals
5.6.1 Review the system and performance.
5.6.2 Include consideration of: customer feedback, performance, nonconformity, audits, actions raised, changes and any need to improve
5.6.3 Keep records of outcomes from your reviews; include decisions and actions.
6 Resource Requirements
6.1 Decide what resources are need for the system, and to enhance customer satisfaction. Provide them.
6.2 Make sure people are competent:
6.2.1 Include this for anyone whose work affects whether your services/products meet requirements
6.2.2 Decide what competencies are needed; provide and maintain them
6.3 Infrastructure: Decide what you need (to meet requirements). Provide it and maintain it.
6.4 Work environment: provide what you need so that your services/products meet requirements.
7 Requirements for Products or Services
Plan and develop the processes needed for your products/services.
7.2 Have effective 'customer-related' processes:
7.2.1 Know what requirements apply to your products/services
7.2.2 Make sure you can meet them (or don't take the order)
7.2.3 Have effective ways to communicate with your customers.
7.3 Have effective processes for designing & developing products/services
7.3.1 Plan design/development.
7.3.2 Define what inputs are needed to design/create/develop
7.3.3 Do the 'design' /plan in some form that enables you to verify the output (see 7.3.5?)
7.3.4 Review the design/plan at suitable stages
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 happen during design, manage them.
7.4 Control what you buy, outsource or subcontract (goods, materials or services) if it affects your services or products
7.4.1 Make sure what you buy meets the requirements you specified; assess and monitor your suppliers/supply chain.
7.4.2 Describe what you plan to purchase.
7.4.3 Make sure it meets requirements.
7.5 Manage your operations
7.5.1 Have effective ways to control what you do (providing products/ services)
7.5.2 Validate production/service provision (if required).
7.5.3 Identify and track services/products (when appropriate)
7.5.4 Take care of any property supplied by your customers, including IP and confidential information
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
When measuring, make sure your results are valid. Identify what equipment and processes you need for this. Choose suitable equipment or instruments. Make sure the results are and stay accurate.
8 Requirements for Analysis and Improvement
8.1 Have processes suitable to ensure your services/products meet all relevant requirements (customer, yours, contractual, legal, etc.). Include improvement.
8.2 Monitor and measure processes and services/products (as necessary) to check you got the results you wanted:
8.2.1 Monitor customer perception of satisfaction.
8.2.2 Plan and implement a suitable program of internal system audits, including a procedure
8.2.3 Have suitable methods to monitor / measure your processes.
8.2.4 Monitor and measure products/services at suitable stages. Release the final only when all requirements are met.
8.3 Control nonconformity (services/products not meeting requirements) in suitable ways, including a written procedure.
8.4 Collect and analyses information
Decide what information is needed to tell you how your system is working and for improvement.
Collect, analyses and use it.
8.5 Continually improve.
8.5.1 Improve your system.
8.5.2 Have a systematic approach to fix nonconformity and stop it recurring, including a procedure.
8.5.3 Have a systematic approach to prevent potential nonconformity or failures happening, including a procedure.