ISO 9001/2/3 standards series first published in 1987 and then revised in 1994.
Major revision in 2000 with publication of ISO 9001:2000 QMS Standard on 15 December 2000
Fourth edition – ISO 9001:2008 QMS Standard published on 15 November 2008
Overview
Clause 1 deals with scope including application
Clause 2 deals with references
Clause 3 deals with terms and definitions
Clause 4 to 8 deal with requirements of QMS
Clause 4 – Quality Management System
Clause 5 – Management Responsibility
Clause 6 – Resource management
Clause 7 – Product realization
Clause 8 – Measurement, analysis and improvement
Scope
ISO 9001:2008 QMS Standard specifies requirements for a QMS
Generic standard applicable to all organization regardless of its type, size and product
Exclusions are limited to requirements within clause 7 only.
References
Normative reference document
ISO 9000:2005, Quality management systems – Fundamental and vocabulary
Terms and definition
Terms and definitions as mentioned in ISO 9000 apply
Product include service
Quality Management System
General concept – Plan-Do-Check-Act (PDCA)
Determine processes, their application, sequence and interaction
Determine criteria and methods needed to ensure processes are effective
Provide necessary resources
Monitor, measure and analyze processes
Implement actions necessary to achieve planned results
Have continual improvement
Manage processes in accordance with requirements of ISO 9001:2008 QMS standard
Ensure control over outsourced processes
Quality Management System … Documentation
Remember – Say what you do, do what you say
Purpose – Effective planning, operation and control of QMS
Need documented quality policy
Need documented quality objectives
Need a quality manual
Need six documented procedures required by ISO 9001:2008 QMS standard
Need documents (procedures, work instructions etc.) determined by the organization
Maintain records required by ISO 9001:2008 QMS standard
Maintain records determined by the organization
Six documented procedures required by the Standard
- Control of documents
- Control of records
- Control of nonconforming product
- Internal audit
- Corrective action
- Preventive action
Management responsibility
Responsibility – Top management
Provide vision and commitment to quality
Communicate importance of meeting requirements (customer as well as legal)
Establish quality policy
Establish quality objectives
Conduct management reviews at planned intervals
Ensure availability of resources
Maintain customer focus
Ensure enhancement of customer satisfaction
Define duties and responsibilities
Assign someone from your management as management representative
Establish and use appropriate internal communication processes
Management responsibility …. Review the QMS
At planned (defined) intervals
Inputs to include from previous audits, customer, previous management reviews and information on process performance, product conformity, preventive action, corrective action, changes and recommendations in QMS
Output to cover decisions and actions on resource needs and improvement in QMS, processes and product.
Keep review records
Resource Management
Determine and provide resources (human and infrastructure including necessary equipment, tools and supporting services)
Engage competent work force
Determine necessary competence
Provide training or take other actions to achieve competence
Evaluate effectiveness of the training or action taken
Maintain records of education, training, skills and experience of your work force
Manage proper work environment
Product realization
Do proper planning
Determine and define – Product specifications, processes, documents and provide resources
Determine and define – Processes for verification, validation, monitoring, measurement, inspection and test activities for the product and product acceptance criteria
Determine and keep records needed
Product realization …
Determine what customer wants
Determine customer requirements, including requirements for delivery and after sales activities
Determine requirements not stated by customer but necessary for specified or intended use
Determine legal requirements applicable to the product and any additional requirements that you consider necessary
Make contract review that you can meet what customer wants
Keep contract review records
Determine and implement effective arrangements for customer communication
Product realization ….
Design and development of the product
Determine a design and development plan
Determine (define) design and development input requirements and maintain records
Verify that input requirements are met
Ensure that design and development output provide information on purchasing, production and service
Ensure that design and development outputs have product acceptance criteria and characteristics of the product for safe and proper use
Review the design and development process at suitable stages and keep records
Verify that design and development outputs meet design and development inputs and keep records
Validate the design and development process and keep records
Control changes to design and development and keep records
Product realization …
Purchasing activity
Purchase and use good product
Define what you want to purchase
Evaluate and select suppliers.
Maintain records of evaluation.
Communicate to your supplier what you want to purchase
Verify your purchase against what you ordered
Product realization …
Control your production and service activities
Plan and carry out production and service activities under controlled conditions
Validate processes where resulting output can’t be verified by subsequent monitoring or measurement
Identify product throughout product realization process
Where traceability is a requirement, control unique identification of the product and maintain records
If you use customer property, exercise due care. Report where customer property is lost, damaged or found unsuitable for use and maintain records.
Preserve the product during product realization and delivery to intended destination
Product realization …
Check the monitoring and measuring equipment
Determine the equipment
Control the equipment
Make sure the equipment is calibrated or verified
Keep records of calibration and verification
Measurement, analysis and improvement
Plan and implement monitoring, measurement, analysis and improvement processes to ensure product conformity with requirements, conformity of the QMS and improvement of the effectiveness of the QMS
Monitor information relating to customer perception
Carry out Internal audit at planned intervals and keep records of audits
Monitor and measure internal processes
Monitor and measure product
Control nonconforming product to prevent unintended use or delivery. Keep appropriate records of nonconformities and actions taken
Collect and analyze appropriate data and analyze
Continually improve the QMS effectiveness.
Take corrective and preventive actions and keep records of results of action taken
Suggested to refer to ISO 9001:2008 QMS and ISO 9000:2005 Standards
Thanks,
Keshav Ram Singhal
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