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ISO 9001 in a Nutshell

A simple overview of what's in the ISO 9001:2008 Standard for quality management systems. 

4 General Requirements for the Management System

4.1 Establish a quality management system: develop it, make it a 'happening thing' and continually improve it.

4.2 Document the system.

4.2.1 Create the documents you need to describe and operate your system.  This 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 documents.
4.2.4 Create and maintain records that show your system works.

5 Requirements for Management

5.1 Demonstrate commitment to the quality management system
Communicate the importance of quality and set up a quality policy and objectives you can measure.
Plan and do reviews of the system.
Make sure you have sufficient resources (people, plant, equipment, tools, IT etc).

5.2 Focus on customers
Identify customer requirements.  Work to increase customer satisfaction.

5.3 Adopt and use a quality policy
Define a suitable policy. Commit to meeting all relevant requirements (ISO 9001, legal & statutory related to your services/products + any others you need) and continual improvement. Communicate and manage the quality policy.

5.4 Do planning for quality

5.4.1 Set measurable objectives (aims/goals).
5.4.2 Have plans for achieving your objectives

5.5 Define & communicate 'who does what'

5.5.1 Identify who has what responsibility and authority
5.5.2 Make someone responsible overall for the quality system at senior management level
5.5.3 Have effective ways to communicate internally.

5.6 Review the quality management system (management review)

5.6.1 Do reviews at planned intervals
5.6.2 Include at least:  customer feedback, performance of processes and products/services, failures & weaknesses (nonconformity etc), audit results, actions, changes, improvements
5.6.3 Records of the reviews must exist and include actions and decisions.

6 Resource Requirements

6.1 Decide what resources you need to operate your system and increase customer satisfaction (including maintaining and improving).  Provide them.

6.2 Have competent people

6.2.1 Anyone whose work affects product/service conformity must be competent for their work
6.2.2 Decide the competencies you need; make sure you get and maintain them

6.3 Provide infrastructure: Identify what you need, provide and maintain it.

6.4 Provide the work environment needed to ensure your products/services meet requirements. 

7 Requirements for Products or Services ("Realization' Requirements)

7.1 Plan
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 & developing your products/services

7.3.1 Plan.
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 enables you to verify it (see 7.3.5)
7.3.4 Review the design/plan at suitable points
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; 'purchasing' includes outsourcing and subcontracting

7.4.1 Make sure what you purchase 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 is purchased met the requirements.

7.5 Control your 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 products/services where appropriate
7.5.4 Take care of any property supplied by customers
7.5.5 Look after products/components during storage/delivery, etc.

7.6 Control measuring and monitoring equipment
Identify what monitoring/measuring equipment and processes are needed to obtain valid results.  If equipment is required, choose & use suitable equipment and ensure the results are and remain accurate.

8 Requirements for Analysis and Improvement

8.1 Have processes that are suitable for ensuring conformity of products/services and the quality management system, including improvement.

8.2 Monitor and measure to establish whether you achieved the results you planned

8.2.1 Monitor customer satisfaction.
8.2.2 Plan and implement a program of internal audit
8.2.3 Monitor and measure processes appropriately
8.2.4 Monitor and measure products/services at suitable points.
Release final product/service only after requirements have been met.

8.3 Control nonconformity
Identify and control product/service nonconformity with suitable methods, including a 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.

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 themselves are set out in sections 4 to 8 of the Standard.

Disclaimer:  This is a simplified summary only, from 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.

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