ISO 9001 - 2008 Requirement

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ISO 9001 :2008 Quality Docume Quality policy ( Quality objectiv Documented Pro 4.2.3 Control of 4.2.4 Control of 8.2.2 Internal A 8.3 Control of n 8.5.2 Corrective 8.5.3 Preventive These documented Clause 4.2.3 Records requir Clause 5.6.1 6.2.2 (e) 7.1(d) 7.2.2 7.3.2 7.3.4 7.3.5 7.3.6 7.3.7 7.4.1 7.5.2 (d) 7.5.3 7.5.4 7.6 (a) 7.6 Quality manual (

description

ISO 9001 - 2008 Requirement

Transcript of ISO 9001 - 2008 Requirement

Page 1: ISO 9001 - 2008 Requirement

ISO 9001 :2008 Requred Documentation

Quality Documents :Quality policy (Clause 4.2.1 a )Quality objectives (Clause 4.2.1 a )

Documented Procedures :4.2.3 Control of documents4.2.4 Control of records8.2.2 Internal Audit8.3 Control of nonconforming product8.5.2 Corrective action8.5.3 Preventive action These documented procedured have to be controlled in accordance with the requirements of Clause 4.2.3

Records required by ISO 9001 : 2008Clause Record Required5.6.1 Management review6.2.2 (e) Education, training, skills and experience

Must maintain records of education, training, skills and experience ; there is a procedure

7.1(d) Evidence that the realization processes and resulting product fullfill requirements.records needed to provuded evidence that the realization (existing ) processeand resulting product (service) meet requirements.

7.2.2 Results of the reviwe of requirements related to the product and actions arising form the review.The organiztion shall review the customer requirements of the service. This review must be conducted prior to commitment to customer. Nedd records ofthe results of the review.

7.3.2 Design and development inputs relating to product requirements.7.3.4 Results of desing and development reviews and any necessary action.7.3.5 Results of desing and development verification and any necessary actions.7.3.6 Results of design and development validation and any necessary action.7.3.7 Results of the review of design and development changes and any necessry action.7.4.1 Results of supplier evaluations and any necessary actions arising from the evaluation

Records of evaluating suppliers must be maintained.7.5.2 (d) As required by the organization to demonstrate the validation of processes where the

resulting output cannot be varified by subsequent monitoring or measurement Need records to validate a process where you cannot monitor or measure easily.

7.5.3 The unique identification of the product, where traceability is a requirement.7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitaqble for use

Must maintain records re:customer property issues.7.6 (a) Basis used for calibration or verification of measuring equipment where no internatinal

or national measurement standards exist.7.6 Validity of the previous measuring results when the measuring equipment is found

not to conform to requirements.

Quality manual (Clause 4.2.1 b )

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7.6 Results of calibration and verification of measuring equipmen8.2.2 Internal audit results and follow-up actions8.2.4 Indication of the person(s) authorizing release of product.

Need a record of how service gets released (approved). This could includedaily inspection records, etc

8.3 Nature of the product nonconformities and any subsequent actions taken, includingconcessions obtained

8.5.2 Results of corrective action8.5.3 Results of preventive action

Documents which are not necessarily required but can be offered as supportingthe organization’s processes. This documentation should be minimized.• Process maps, process flow charts and/or process descriptions• Organization charts• Specifications• Work and/or test instructions• Documents containing internal communications• Production schedules• Approved supplier lists• Test and inspection plans• Quality plans

STEPS FOR ISO 9001: 2008 Registration Preparation:1. Perform Gap analysis on required procedures and quality manual, policy, and objectives.2. Write any procedures which are required3. Perform gap analysis on required records4. Work with staff to produce required records as necessary5. Perform a gap analysis on the process(es)6. Work with staff to ensure processes and work instructions are in place, up to date, used7. Work with staff to do an internal audit, and correct non-conformances

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PROCESS STAGE BASE CLAUSE RELATED CLAUSEDetermine the goal 5.3 Establish organization’s purpose 5.1 Management responsibility

5.1 Establish Quality policy 5.3 Quality policy

5.4.1 Establish Quality objectives 5.1 Management responsibility5.2 Customer focus7.1 Planning of product realization7.2.1 Determination of requirement related to the product7.3.2 Design and development inputs

Develop processes 4.1a Identify processes 5.4.2 QMS planningto achieve the goal 7.1 Planning of product realization

7.3.1 Design and development planning

4.1b Determine sequence and 7.1 Planning of product realizationinteraction of processes 7.3.1 Design and development planning

7.4.1 Purchasing process7.5.1 Control of production and service provision8.1 General

4.1c Develop criteria and methods 5.5.1 Responsibility and authority5.5.2 Management representative7.1 Planning of product realization7.4.1 Purchasing process7.5.1 Control of production and service provision7.5.3 Identification and traceability7.5.4 Customer property7.5.5 Preservation of product8.1 General8.3 Control of nonconforming product

4.1d Provide information 4.2.1 General documentation requirements4.2.2 Quality manual4.2.3 Control of documents

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4.2.4 Control of records5.1 Management commitment5.5.3 Internal communication7.1 Planning of product realization7.2.3 Customer communication7.3.3 Design and development outputs7.4.2 Purchasing information

4.1d Provide resources 6.1 Provision of resources6.2 Human resources6.3 Infrastructure6.4 Work environment7.1 Planning of product realization

Operate and 4.1 Implement and maintain QMS 4.2.2 Quality manualmaintain processes 4.2.3 Control of documents

5.1 Management commitment5.4.2 Quality management system planning5.5.2 Management representative6.3 Infrastructure7.2.3 Customer communication7.5.1 Control of product and service provision

Establish that goal 8.2.4 Monitor and measure product 7.2.2 Review of requirements related to the productis being achieved 7.3.4 Design and development review

7.3.5 Design and development verification7.3.6 Design and development validation7.4.3 Verification of purchased product7.5.1 Control of production and service provision7.6 Control of monitoring and measuring devices8.1 General8.2.1 Customer satisfaction8.2.2 Internal audit

Establish that goal 8.4 Analyse product 8.1 Generalis being achieved 8.5.2 Corrective action

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(continued) 8.5.3 Preventive action8.3 Control of nonconforming product

4.1f Implement actions to 5.6 Management reviewachieve planned results 7.3.7 Control of design and development changes

8.1 General8.2.3 Monitoring and measurement of processes8.5.1 Continual improvement8.5.2 Corrective action8.5.3 Preventive action

Establish goal is 4.1e Monitor and measure 5.6 Management reviewachieved in the best processes 7.5.2 Validation of processes for production and service provisionway 7.6 Control of monitoring and measuring devices

8.1 General8.2.2 Internal audit8.2.3 Monitoring and measurement of processes

4.1e Analyse processes 8.1 General8.4 Analysis of data

4.1f Continually improve 8.1 Generalprocesse 8.5.1 Continual improvement

Establish if it’s the 8.4 Analyse suitability, 5.6.2 Review inputright goal adequacy and effectiveness 7.6 Control of monitoring and measuring devices

5.6.1 Review system effectiveness 5.6 Management review

4.1f Continually improve 8.5.1 Continual improvementprocesses

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QUALITY POLICY

To meet our commitment, we must;

QUALITY POLICYExpectations with those of our suppliers, employees, investors and society andendeavour to give full satisfaction to all parties.

QUALITY POLICYOn continual improvementWe will provide an environment in which every person is motivated tocontinually improve the efficiency and effectiveness of our products, processes andour management system.

Quality Policy Quality ObjectiveWe are committed to providing products 98% on time delivery s measured by thethat we are delivered on time. customerand meet customer requirements. 99.9% of monthly output to be defect free

as measured by customer returnswhile yielding a profit 5% profict on annual salesand increasing sales 25% increase in annual sales volumeWe accomplish this through product and 20% of out product reange will contain new process innovation, product and 50 improvement teams will

be set up to seek process improvementCost reduction activities. 15% reduction in cost of poor quality as

a precentage of sales

JP Engg. is committed to providing superior quality products and services by adhering to a quality management system that benefits our customers & employees.

V alue our Customers through open communication, timely responses and continual improvement.

A ppreciate and foster an environment of trust, integrity, challenge and reward that attracts and retains the best employees in all positions throughout the company.

L everage efficient technology applied to all business processes in order to maintain a competitive advantage.

U nderstand that our ultimate purpose is customer satisfaction.

E nsure that our Quality Management System serves our customers’ needs.

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JP Engg. Will provide products and services to global markets that will meet or exceed customer expectations through people, teamwork, and continuous improvement.

We are committed for an entire satisfaction of each & every customer by supplying consistent Quality Product by way at continual improvement in process / technology &in time delivery.

Quality Objectives1) Timely Delivery2) Minimize Customer Complaint3) Increase Turnover

QUALITY POLICY"JP Engg. Is dedicated to Customer Satisfaction by providing Quality Products in a Timely Manner through Teamwork and a commitment to continual Improvement.".

JP Quality Management System Objectives for quality are to…..strive to be the supplier of choice for JP customers.(External PPM, customer quality concerns, on time PPAP, first time PPAP approval, customer surveys, internal and external quality audits. )

……..establish zero defects as the goal of procudtion.(Internal PPM, scrap as a precentage of production.)

……meet customer expectations for on-time delivery.(Ford SIM, GM Report, Chrysler EBSC, premium freight)

….avoid waste and excessive cost without jeopardizing quality.(WOW, Cost of Poor Quality)

…….provide a safe environment for employees.(Reduction or turnover, elimination of accidents)

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To meet our commitment, we must;

JP Engg. is committed to providing superior quality products and services by adhering to a quality management system

alue our Customers through open communication, timely responses and continual improvement.

ppreciate and foster an environment of trust, integrity, challenge and reward that attracts and retains the best

everage efficient technology applied to all business processes in order to maintain a competitive advantage.

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We are committed for an entire satisfaction of each & every customer by supplying consistent Quality Product by way at continual improvement in process / technology &in time delivery.