ISO 9001 in a Nutshell
This is a simple summary of what the ISO 9001:2008 Standard for quality management systems says. To get certified to ISO 9001 you must meet all the applicable requirements.
4 General Requirements for the Management System
4.1 Establish a quality management system: develop it, use it, and continue to improve it.
4.2 Document your system.
4.2.1 Create whatever documents you need to describe, manage & operate your system. Must include a quality policy, objectives, procedures and records.
4.2.2 Have a quality manual
4.2.3 Have a systematic way to control your documents to make sure they are accurate and current.
4.2.4 Create and maintain records that show that your system does work.
5 Requirements for Management
5.1 Demonstrate commitment to your quality management system
Communicate how important quality is; have a policy on quality plus objectives you can measure.
Plan and do reviews of your system.
Make sure you provide adequate resources for the system: people, plant, equipment, tools, IT etc.
5.2 Focus on your customers
Identify their requirements. Aim to enhance their satisfaction.
5.3 Have and use a quality policy
Define a policy suitable for you. Include a commitment to meet all relevant requirements - ISO 9001, legal & statutory related to your services/products etc- and to continual improvement. Communicate your quality policy.
5.4 Plan for quality
5.4.1 Set measurable objectives (aims/goals) for your quality system and its services/products.
5.4.2 Plan for how to achieve them.
5.5 Define & communicate 'who does what'
5.5.1 Identify who has what responsibility and authority in our system
5.5.2 Have someone at senior management level be responsible for the quality system overall
5.5.3 Have effective methods for communicating internally, including about the quality system.
5.6 Review the quality management system (management review)
5.6.1 Schedule and do regular, periodic reviews
5.6.2 Include in your reviews: customer feedback, how your processes and services/products are performing, failures & weaknesses (nonconformity etc), results from quality audits, actions from previous reviews, changes (whether internal or external), improvements planned or suggested
5.6.3 Keep records from your reviews which include actions and decisions.
6 Resource Requirements
6.1 Decide what resources you need and provide them. Include the resources needed to operate your system, meet customer requirements, improve and enhance customer satisfaction.
6.2 Have competent people
6.2.1 Make sure whoever does work that affects the quality or conformity of yours services or products is competent for that work
6.2.2 Decide what competencies you need; make sure you get and maintain them
6.3 Provide whatever infrastructure you need: identify what you need, provide and maintain it.
6.4 Provide the work environment you need for you products/services to meet requirements.
7 Requirements for Services or Products (requirements for 'realization')
Plan and develop the processes needed for your services/products.
7.2 Have effective processes related to customers
7.2.1 Identify the requirements that apply to your products/services
7.2.2 Before promising to supply, make sure you can.
7.2.3 Have effective arrangements to communicate with customers.
7.3 Have effective processes for designing (if you 'do design') and for developing your products/services
7.3.1 Plan for design.
7.3.2 Define the inputs needed (includes all relevant requirements)
7.3.3 Have your 'design' (plan, model, prototype, etc) in a form that can be verified against its requirements (see 7.3.5)
7.3.4 Review your plan/design at suitable stages
7.3.5 Make sure the design meets the input 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; this includes outsourcing and subcontracting
7.4.1 Specify your requirements and make sure you get what you specified. Assess and monitor your suppliers.
7.4.2 Describe what you intend to purchase appropriately.
7.4.3 Verify that what you purchased met the requirements.
7.5 Control your operations
7.5.1 Have effective ways to control what you do, ie, your services/products
7.5.2 Validate production/service provision where required.
7.5.3 Identify and track your services or products where required and/or needed
7.5.4 Take care of any property supplied by customers, including confidential information
7.5.5 Look after your products/components during storage/delivery, etc.
7.6 Control measuring and monitoring equipment
Identify if you need monitoring/measuring equipment. If equipment is required, choose & use suitable equipment; ensure the results you get are valid and accurate.
8 Requirements for Analysis, Measurement and Improvement
8.1 Have processes that are suitable for ensuring your services or products meet requirements: of your customer, your quality management system including improvement, and any others that apply (eg, legal, statutory, contractual).
8.2 Monitor /measure to determine if you got the results you intended and planned for
8.2.1 Monitor the satisfaction of your customers satisfaction
8.2.2 Plan and implement a program of internal audit
8.2.3 Monitor and measure your processes appropriately
8.2.4 Monitor and measure your services/products at suitable stages, and only release your final service/product once requirements are met.
8.3 Control nonconformity
Have suitable method/s to identify and control product/service nonconformity; 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 that 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 from happening.
Note: the numbers correspond to the clause numbers of the Standard. They start at #4 since the requirements are set out in sections 4 to 8 of the Standard. 1-3 is the Introduction, Scope and References.
Disclaimer: This is a deliberately simplified summary for the current (2008) version. No representation or warranty is made for the accuracy or the completeness of the contents. We specifically disclaim any implied warranties or fitness for any particular purpose and will not be liable for any loss of profit or any other commercial damage as a result of your acting or relying upon any of this information.
Author: Jane Bennett