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Audit Checklist

ISO 9001:2008

CMS ORGANIC FOOD PRODUCTS

E: evaluation: S= Satisfactory

NI= Need Improvement QMS 001-r03

US=Unsatisfactory

N.A.: not applicable Page 1 of 19

Audit Check list


ISO9001:2008

Chapter of standard: 4. Quality Management System


4.1 General requirements
Requirement / subject Obligation to establish andmaintain a QMS (s5.4.2)determination and application of quality system processes determination of sequence and interaction of these processes determination of process operations and control methods availability of resources and of informations required for process support and monitoring process monitoring, measurement and analysis implementation of necessary actions for continuous improvement of these processes (s.8.1+8.2.3) control of outsourced processes Documenta E tion Documents reviewed Audit notes E

S Quality Manual

S CMS/ QMS/ 01 S S

Documented processes/procedures and other applicable documents Process flow charts Management review Investment plans Action catalogs

The Basic Processes in the company has been determined along with their sequence and interactions.

The company adopts a PDCA S cycle to manage its QMS system. Quality management system manual, procedure, process flow chart , organisation chart verified. Quality manual issue dt20/02/2010 rev.00 men.00 are verifed byLEAD Auditor And taken by PROPRIETOR of the company ( Mohd. ADIL)

4.2 Documentation requirements


4.2.1 General Documentation must include: quality policy and quality objectives (s.5.3, 5.4.1) quality manual documents required for process control documented procedures required by this standard (s. 4.2.4) quality records S Quality Manual Documented procedures Commitment to continuous improvement On-going evaluation Communication within the organization Description of interactions Test plans Process flow charts Drawing Organizational charts DP Document control DP Control of quality records DP Control of internal audits DP Control of nonconforming product DP Control of corrective action DP Control of preventive action Order records Manufacturing records Minutes/records Checklists Test certificates Qualification certificates

CMS/ QMS/ 01

Quality Manual issued and Controlled. The Manual exhibits S and the clauses Of ISO 9001 with the justification of exemption which were found to be true. Quality policy and quality S objective approved by Mohd. ADIL

4.2.2 Quality Manual :

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NI= Need Improvement

US=Unsatisfactory N.A.: not applicable Page 2 of 19

Audit Check list


ISO9001:2008
Scope of QMS including justification of exclusions (s. 1.2) Descriptions of procedures and Interaction between quality system processes (cf. footnote to 4.1 in standard) S S Quality Manual Documented procedures Organizational charts Geographic or technical scope of application Justification for exclusions from requirements as per Chapter 7 S Process descriptions / flow charts

CMS/ QMS/ 01

Organization structure is found S satisfactory. Justification of excluded clause: S 7.3, is found satisfactory. Scope of company verified as per S work.

4.2.3 Control of document Review of adequacy prior to issue and approval Review, up-date and reapproval Identification of revision status and changes Steps taken to ensure that relevant documents are available at point of use Steps taken to ensure that documents are legible and readily identifiable Identification and controlled distribution of external documents that affects QMS Steps taken to ensure that the unintentional use of obsolete documents is prevented and that the latter are suitably identified

CMS/ QMS/ 01

S U S

DP Document control Quality Manual Approval documents Revision procedures Approval procedures Documented procedures Test plans Lists of revision state Distribution list Evidence of issue and receipt Review of external documents On-site review

Quality manual and procedure issued by Management S representative and approved by PROPRIETOR. Distribution list of the manual is verified and master copy hold by U the Management Representative S is defined in this list.

4.2.4 Control of records Controls must ensure Legibility Identification storage Protection from damage Retrievability Retention period disposition

CMS/ QMS/ 01

S S S

Quality Manual DP Control of records Sales and order records Manufacturing records Minutes/records Check lists Test certificates Documentation of internal audits Qualification certificates Purchase records Logistic records

Control of records Procedure S exists. The control defines regarding Legibility, Identification, S Storage, and Protection from damage, retrivability, retention period and disposition. Production And sales Record S Verified. All file maintained by the S respective deptt. Incharge

Chapter of standard: 5. Management responsibility


5.1 Management commitment

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NI= Need Improvement

US=Unsatisfactory N.A.: not applicable Page 3 of 19

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ISO9001:2008
Evidence of quality system effectiveness and continual improvement (s.8.4+8.5.1 ) Determination and communication of customer and statutory and regulatory requirements (s.5.2) Establishing of quality policy and quality objectives (s. 5.3 +5.4 ) Conduct of management reviews (s.5.6 ) Steps taken to ensure availability of resources (s.6) S S U S Management review Written quality policy Training schedules / evidence Employee information (notices, agenda of informative events) Manpower-development plans Quality plans Records of defined objectives Project plans Investment plans Plant agreements

CMS/ QMS/ 01

Management commitment in the S form of quality policy and objective and quality plans evident. PROPRIETOR is the chair person of the Management S Review Meeting. Output agenda was not evident in U management review meeting S report.

5.2 Customer focus


Top Management shall ensure the determination of customer requirements and expectation (s.a. 7.2.1 +8.2.1 )

CMS/ QMS/ 01

Evaluation of customer surveys Market analyses Complaint documentation / analyses Product validation records Standards Customer-satisfaction analyses External quality costs ppm-statistics

Customer satisfaction analysis S through market survey.

5.3 Quality policy


Suitability for organization Commitment to continuous improvement (s.8.5.1 ) Definition and review of quality objectives Communication within the organization On-going review of suitability

CMS/ QMS/ 01

Quality Manual Corporate guidelines and principles Written quality policy Training schedules and evidence Employee information (notices, meetiING etc.) Management review Internal audits

Quality Policy communicates in the organization. Quality policy S training given to all employees.

5.4 Planning
5.4.1 Quality objectives Determination on the basis of data and parameters (s. 8.4+8.5.1) Alignment with quality policy Alignment with product requirements (s.7 .1a) S Quality Manual Internal/external target agreements (business plans, project plans, U quality assurance agreements) S company-related product-related customer-related general Employee information Records of employee interviews Trend analysis

CMS/ QMS/ 01

Plan to achieve objectives Verified. Quality objective measurable form.

Quality S is in S

5.4.2 Quality management system planning

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NI= Need Improvement

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ISO9001:2008
Steps taken to ensure that quality objectives and requirements outlined in 4.1 are satisfied Steps taken to ensure that changes to the QMS do not impair integrity Documentation S Quality Manual Documented procedures Investment plans Strategic plans Quality plans Production plans Resource plans / records Documented procedures / process descriptions Work and test plans

CMS/ QMS/ 01

QMS Plans along with objective planning and target for each & S every planning is determined.

5.5 Responsibility, authority and communication


5.5.1 Responsibility and authority Definition and communication of CMS/ responsibilities and QMS/ authorities Ensuring by top management 01 S U S Quality Manual Documented procedures (QM) Job / fuMIion profiles Requirement profiles

Responsibility authority are S defined in the manual A organization chart need to be displayed in the organization for U S better understanding.

5.5.2 Management representative


Appointment and announcement of an independent member of the management responsible for this task Tasks: Quality system establishment Reporting to top management Sensitization to customer requirements

CMS/ QMS/ 01

Quality Manual Organizational chart and organizational S structure QMR appointment letter QMR fuMIion profile QMR job profile Status report /Q analyses Internal audit reports Reports re quality situation Statistical evaluation

Proprietor himself appoint as a Management Representative. His S functions roles and responsibility verified.

5.5.3 Internal communication


Establishment of suitable communication processes within the organization (s,a, 7.2.3 ) Communication regarding quality system effectiveness

CMS/ QMS/ 01

S S

Minutes and reports of meeting Team training and other meeting Notice boards, internal magazines Audio-visual and electronic media Agenda of company events Circular letters Statistics Reports on quality system effectiveness

Internal communication system S through notice board, circular and phone

5.6 Management review


5.6.1 General

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NI= Need Improvement

US=Unsatisfactory N.A.: not applicable Page 5 of 19

Audit Check list


ISO9001:2008
Regular review of quality system Assessment of opportunities for improvements to quality policy and quality objectives Recording of the need for changes to the quality system

CMS/ QMS/ 01

Management-review report Monthly management reports Controlling reports Finance reports Q-reports Supplier evaluations Logistic reports

Six Monthly Plan is there for MRM. It has been planned after S every Internal Audit.

5.6.2 Review input Management review must include: audit results customer feedback process performance and product conformity status of preventive and corrective action follow-up action from previous management reviews changes that could affect the quality system recommendations for improvement ( s. 8.1+8.2+8.4+8.5)

CMS/ QMS/ 01

Management-review report Customer-satisfaction analyses Process analyses Evidence of corrective and preventive action Resource deployment and application planning Benchmarking results Quality analyses Risk analyses (technical/economic) Internal audit reports Process audits Product audits / reports Action reports Investment planning

The Management Review meeting agendas cover more S points and agendas other than described as agenda in the standard.

5.6.3 Review output Decisions and actions shall include: improvement of the effectiveness of the QMS and its processes product improvements resources needs

CMS/ QMS/ 01

S U S

Management-review report Business plan Strategic plans Investment plans Human-resources plans New objectives Projects Action plans

Minutes of meeting is shown to S be prepared and verified. Output agenda was not evident in management review meeting U S report.

Chapter of standard: 6. Resource management


6.1 Provision of resources
Determination and provision of resources required for: implementing, maintaining and continually improving the quality system ensuring customer satisfaction

CMS/ QMS/ 01

Quality Manual S Investment plans relating to personnel relating to equipment relating to real estate Staffing schedules Other target plans

Proper Provision of Resources. Related to personnel like S computer, chair, phone, pen etc.

6.2 Human resources


6.2.1 General

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NI= Need Improvement

US=Unsatisfactory N.A.: not applicable Page 6 of 19

Audit Check list


ISO9001:2008
Personnel performing work affecting product quality must be competent based on: education training skills experience.

CMS/ QMS/ 01

S S

Quality Manual Job / fuMIion profiles Employment contracts Manpower-development plans Qualification documentation Records of employee interviews Employee certificates Qualification matrix

Competence matrix S (CMS/HR/01) verified List of employees verified.

Personnel file of the accountant S is found satisfactory

6.2.2 Competence, awareness and training Determination of training needs Provision of appropriate CMS/ training QMS/ Evaluation of training 01 effectiveness Actions of awarenessbuilding measures for the relevant activities and for the achievements of the objectives Maintaining of relevant records Ensure that necessary competency have been achieved

S S N I

Records of quality requirements Job / fuMIion profiles Induction plans Records of employee interviews Training schedules Training certificates Records on the evaluation of training effectiveness Training objectives Training benefits Training efficiency Company benefits Practice in the trained part

Competence Matrix is there. Proper Training records verified S covering training effectiveness.

Training Evaluation Method of ISO awareness training conducted on every six month Is Found Satisfactory In The Training Report. Increase the frequency of safety training in annual training calendar.

N I

6.3 Infrastructure
Determination, provision and maintenance of infrastructure, e.g.: building, workplace and associated utilities process equipment, hardware and software support services (such as transport or communication) Including information systems.

CMS/ QMS/ 01

Workplace investigations Investment plans Maintenance and servicing plans and S records Records of process capability studies Records of supplier evaluation S (including service providers)

Adequate Infrastructure is there in the company as per scope of certification. Proper maintenance records are there.

E: Evaluation: S= Satisfactory QMS 001-r02

NI= Need Improvement

US=Unsatisfactory N.A.: not applicable Page 7 of 19

Audit Check list


ISO9001:2008

6.4 Work environment


Definition and control of work-environment factors needed to achieve product conformity. It includes those conditions under which work is performed including physical, environmental & other factors(such as noise, humidity, temperature, lighting & weather).

CMS/ QMS/ 01

Evidence of instruction in occupational safety S Evidence of the satisfaction of statutory and regulatory requirements or conditions S Maintenance / servicing plans (records) Workplace investigations Benchmarking re work environment Employee -satisfaction analyses Analyses re labor turnover / absenteeism

work environment in the shop floor need to be improve smoke S and oil spillage found in Milling Section.
U

Fire Extinguisher is found empty S In Milling Section.

Chapter of standard: 7. Product realization

7.1 Planning of product realization


Planning and development of product-realization processes. Such planning must take the following points into account: quality objectives and product requirements the need to establish or provide product-specific processes, documents and resources product-specific verification, validation, monitoring, inspection and test activities and criteria for product acceptance appropriate records to provide documented evidence for the realizations of product and process (s.4.2.4 ) S S S Project-strategy approaches Specifications Quality plans Project-development plans Milestone plans Feasibility records Measurement and test strategies Logistic strategies Records relating to risk assessment and process evaluation (technical, economic) S FMEA Criteria for process release

CMS/ QMS/ 01

Quality plan, process flow chart, Course strategy & project plan S verified. Maintenance plan for equipment & tools verified all S

Measurement and test strategy of S all the process are verified Proper instruction related to manufacturing not displayed in S the ORGANISATION.

U S

Par day target need to fix against U sales, And displayed in notice S board in the ORGANISATION.

7.2 Customer-related processes


7.2.1 Determination of requirements related to the product

E: Evaluation: S= Satisfactory QMS 001-r02

NI= Need Improvement

US=Unsatisfactory N.A.: not applicable Page 8 of 19

Audit Check list


ISO9001:2008
Determination of: Order letter product requirements Customer inquiries S Records of consultations with customers including delivery and post- CMS/ delivery support such as Specifications QMS/ warranty, maintenance S drawiING services and supplementary 01 Trend analyses services such as recycling or Competitor analyses final disposition. Research re standards and statutory requirements not stated by requirements the customer but necessary for the use statutory and regulatory requirements all additional requirements laid down by the organization 7.2.2 Review of requirements related to the product Review of product Evidence of quotations, contracts, requirements prior to contract review commitment to supply product CMS/ Documentation of amendments to customer. The following Feasibility analysis records QMS/ must be ensured: S Feasibility studies 01 definition of product Confirmations of orders requirements calculations elimination of contradictions price lists contract review delivery schedules feasibility technical commercial qualitative documentation and understanding of amendments

Determination of requirement S through enquiry and mail Enquiry registers is properly S maintained in the organization. Order amendment details to be N enclosed in the order register I

Confirmation Verified

Of

Order

are S

7.2.3 Customer communication Determination and implementation of communication with CMS/ customers concerning: QMS/ product information 01 inquiries, contracts or order handling, including amendments customer feedback, including customer complaints

process description work instructions projects Customers' product specifications Inquiry documents Contracts Confirmation of order Advertising material Customer surveys and reports of customer visits Customer-satisfaction analyses Queries, complaints Complaint analyses Customer requests for changes

Customer communication S through customer feedback, enquiry on mail, order. And the records was not updated.

7.3 Design and development


7.3.1 Design and development planning

E: Evaluation: S= Satisfactory QMS 001-r02

NI= Need Improvement

US=Unsatisfactory N.A.: not applicable Page 9 of 19

Audit Check list


ISO9001:2008
Planning and controlling of design and development; in this context, the following aspects must be defined: design and development stages review, verification and validation process & are separate process. responsibilities and authorities actualization of plans interfaces and communication between the various groups involved Project plans Design and development plans and flow charts Milestone plans Measurement and test plans Verification and validation specifications Approval provisions Responsibility matrix Risk assessment

Not applicable

7.3.2 Design and development inputs Determination and recording of input relating to product requirements. This includes fuMIional and performance requirements applicable statutory and regulatory requirements previous design and development results obtained in connection with similar products other requirements (price, service life, recyclability) adequate, clear cut requirements

Specifications / terms of reference Statutory and/or regulatory implementing guidelines Result reports from previous similar design and development activities Evaluation of customer-requirement analyses Patent research Approval documents Trend in customer complaints Trends in ppm- statistics Garanties evaluations FMEAs

Not applicable

7.3.3 Design and development outputs

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NI= Need Improvement

US=Unsatisfactory N.A.: not applicable Page 10 of 19

Audit Check list


ISO9001:2008
Design and development output must: meet input requirements for design and development provide information for purchasing, production and service provision reference product acceptance criteria specify product characteristics essential for its safe and proper use product preservation (such as packaging) may be included for production and service provision 7.3.4 Design and development review Systematic review of design and development at suitable stages (s.7.3.1 ) to assess their ability to fulfill requirements to identify problems and propose necessary action The results of the review and the necessary action must be documented. (s. 4.2.4) drawing FE-calculations QM-plans Acceptance certificates Order documents containing specifications Risk analyses (e.g. FMEA) Test records (for production, verification and validation) Approval documents Sample test

Not applicable

Intermediate / final design and development reports Appropriate test records, e.g. of laboratory or field testing Minutes of meeting Milestone and phase reviews FMEA Models and simulations Approval documents

Not applicable

7.3.5 Design and development verification Design and development verification must ensure that: design and development outputs satisfy design and development input requirements (s. 7.3.1) follow-up action is defined verification results have been documented. (s. 4.2.4)

Test plans (verification requirements) Prototypes / test samples Test records / reports Records of alternative calculations /analyses Test / simulation reports Records of experiments / trials Description of follow-up measures Approval documents

Not applicable

7.3.6 Design and development validation

E: Evaluation: S= Satisfactory QMS 001-r02

NI= Need Improvement

US=Unsatisfactory N.A.: not applicable Page 11 of 19

Audit Check list


ISO9001:2008
Design and development validation must ensure: (s. 7.3.1) fitness for use partial validation, if applicable validation prior to product delivery, if possible documentation (s. 4.2.4) Test plans (validation requirements) Laboratory tests Environmental tests Results of pilot series / field testing Test records / reports (possibly from customers, too) Results of life testing Field testing Evaluation results from other bodies Validation approvals

Not applicable

7.3.7 Control of design and development changes This involves review of the following aspects: identification and documentation of changes review, verification, validation and approval prior to implementation review of effects of changes in design and development and of follow-up action on product documentation of review results(s.4.2.4 )

Documented requests for changes (e.g. by the customer, production, ...) New revision static of e.g. -specifications, drawiING, process descriptions, test procedures, measurement systems, Comments, test reports in connection with changes Approval documents in connection with implemented changes Communication of changes to customers, units Withdrawn documents History of changes

Not applicable

7.4 Purchasing
7.4.1 Purchasing process The purchased product must conform to product requirements. The supplier must be evaluated and criteria for such evaluation established. The following aspects must be considered in the purchasing process, e.g.: external product quality factors of influence supplier capability criteria for supplier selection, regular evaluation and re evaluation documentation of evaluation (s. 4.2.4) Product specifications Supplier's quality system S documentation Checklist Evidence of supplier evaluation List / database of approved suppliers S Evaluation criteria complaints ppn-statistics specifications

CMS/ QMS/ 01

List of approved supplier (CMS/ S PUR/01) verified Supplier performance evaluation to be done on the basis of S purchase frequency.

U S

7.4.2 Purchasing information

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NI= Need Improvement

US=Unsatisfactory N.A.: not applicable Page 12 of 19

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ISO9001:2008
Purchasing information must describe the product to be purchased. Such information must include, where appropriate, a description of the requirements pertaining to: product approval, procedures, processes, facilities and equipment personnel qualification the quality system. The adequacy of requirements must be ensured prior to their communication to the supplier N I Product specifications Order forms Purchasing specifications in EDP Order lists, piece lists Performance / delivery contracts Quality assurance agreements Order approval documents

CMS/ QMS/ 01

Purchase information system to U be improved S

7.4.3 Verification of purchased products In this context inspection/other activities must be established CMS/ and implemented which verify QMS/ product conformity with 01 requirements. For verification measures conducted at the supplier's premises, the intended verification measures and methods must be defined.

Acceptance criteria Verification plans Test regulations Regulations re approval under concession Test records of suppliers or of organization's own incoming inspection Certifications Incoming inspection

Incoming inspection system to be N improved I

7.5 Production and service provision


7.5.1 Control of production and service provision In this context:(s.a.7.1 ) product characteristics must S be defined, CMS/ work instructions, as QMS/ necessary, must be made 01 S available, suitable equipment must be used, monitoring and measuring devices must be made S available, activities must be monitored and measured release and delivery of products/services must be ensured post-delivery activities must be implemented Acceptance criteria Work instructions Test plans drawing Maintenance plans Installation plans Service contracts Operating instructions Process flow charts

Daily Production Report To Be N I Prepared In Analytical

Through board work instruction S of work displayed in ORGANISATION.

7.5.2 Validation of processes for production and service provision

E: Evaluation: S= Satisfactory QMS 001-r02

NI= Need Improvement

US=Unsatisfactory N.A.: not applicable Page 13 of 19

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ISO9001:2008
Validation must demonstrate process capability. In this context, the following must be taken into account: validation of all production processes where the resulting output cannot be verified by subsequent monitoring or measurement. This includes all processes where deficiencies become apparent only after the product has been delivered. Validation must include (where appropriate): criteria for review and approval approval of equipment and personnel qualification use of specific methods and procedures requirements pertaining to quality records (s. 4.2.4) possible necessity of renewed validation

CMS/ QMS/ 01

Evidence of machinery and process capability Process descriptions Data of process control Skills documentation and training certificates Qualification certificates Validation specifications

Work Instruction not display in Cutting Section. Final testing of the automobile parts doing by the customer.

7.5.3 Identification and traceability Where appropriate, the product must be identified CMS/ throughout product QMS/ realization 01 -The product status must be identified with respect to monitoring and measurement requirements. Identification must be controlled and recorded, if traceability is required

N I

U S

Work instructions Accompanying documents, e.g. routing slips Production plans IT records Product identification Test certificates Segregation slips Approvals

Bin card to be used for countable S item for more controlling. Minimum order level is not S verified on stock

7.5.4 Customer property In this context, the following must be observed: careful handling (also where intellectual property & personal data is concerned) identification, verification, protection and maintenance procedure and documentation in cases involving damage or loss (notification of customer) 7.5.5 Preservation of product

CMS/ QMS/ 01

Inventory of customer property Identification (e.g. labels, stickers) Correspondence with customers Records on verification and maintenance conducted Incoming inspection

Customer Verified.

Property

Register S

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NI= Need Improvement

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ISO9001:2008
This refers to both internal processing and delivery and must include: preservation of product conformity identification handling packaging storage protection This also applies to the constituent parts of products. Regulations on packing, storage, preservation and delivery Piece lists S Inventory lists Stock-replenishment and -withdrawal plans U Regulations on storage periods and S segregation (where appropriate) Delivery labels Assembly / operating instructions

CMS/ QMS/ 01

Preservation improved

facility

to

be N
I

7.6 Control of monitoring and measuring equipments


Determination of required monitoring and measuring devices Determination of monitoring and measuring device ability Calibration and adjustment at regular intervals Identification of measuring equipment Identification of calibration status Steps to ensure protection and handling Documentation of calibration results Definition of corrective action Documentation If the equipment is found not to conform to calibration requirements, previous measuring results must be reassessed and documented. The capability of computer software must be confirmed. Capability must be confirmed prior to initial use and reconfirmed as necessary.

CMS/ QMS/ 01

Test certificates including acceptance criteria Evidence of capability of monitoring and measuring devices List or use of EDP for monitoring and measuring devices S Calibration instructions Calibration records U Gauging records S Calibration standards Calibration certificates Records on comparative measurements and inter-laboratory tests Records on software qualification testing S

List of measuring & monitoring S equipments verified. Calibration plan to be controlled N I and proper documented.

Chapter of standard: 8. Measurement, analysis and improvement


8.1 General

E: Evaluation: S= Satisfactory QMS 001-r02

NI= Need Improvement

US=Unsatisfactory N.A.: not applicable Page 15 of 19

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ISO9001:2008
Monitoring, measurement, analysis and continuous improvement processes must be defined planned implemented(s.a.4.1 ) to demonstrate conformity of the product and the quality system and improvement of quality system effectiveness. Determination of applicable requirements must include the use of suitable statistical techniques. S Design and development flow charts Design and development test plans Company data system Objectives and the actualization Improvement schemes Statistics Progress reports Information boards Inputs for continual improvements

CMS/ QMS/ 01

Process flow chart and progress N report not verified. I

8.2 Monitoring and measurement


8.2.1 Customer satisfaction Customer perception must be monitored. Methods of obtaining and using this information must be determined. (s. a . 5.2) Eg. Customer satisfaction survey, customer data on delivered product quality, user opinion survey, lost business analysis, compliments, warranty claims, dealer reports 8.2.2 Internal audit Conducting of internal audits to the planed arrangements (s.7.1) at planned intervals planning execution documentation evaluation definition and implementation of corrective action surveillance The results of previous audits must be taken into account. The objectivity and impartiality of auditors must be ensured. s Action catalogs Customer-satisfaction analyses Benchmarking Checklists Evaluation of mailing and telephone initiatives Evaluation records (general) Records of target requirement review

CMS/ QMS/ 01

Customer satisfaction analysis S through Customer Feedback.

CMS/ QMS/ 01

N I U S

DP internal audits Audit plans Audit reports Nonconformance reports Action catalogs for the establishment of corrective action Test records etc. Management reviews Reports on effectiveness of corrective action Evidence of auditor qualification

Include all deptt in the internal N I audit report Result of previous audit is also S reviewed.

8.2.3 Monitoring and measurement of processes

E: Evaluation: S= Satisfactory QMS 001-r02

NI= Need Improvement

US=Unsatisfactory N.A.: not applicable Page 16 of 19

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ISO9001:2008
Suitable methods for monitoring and measurement of quality system processes must be determined based on product conformity, applied, reviewed and corrective and preventive action implemented, where appropriate. (s. 7.1+5.1) S Company data Process data Controlling data Statistic analysis Quality data SPC-data and evaluations Work instructions Risk analysis records (FMEA) Maintenance and servicing plans and implementation measures Quality records Test plans Test records

CMS/ QMS/ 01

Inprocess Inspection Plan And S Test Certificate Of The Major Product Is Verified.

8.2.4 Monitoring and measurement of product Product characteristics: monitoring S CMS/ measuring verification QMS/ documentation 01 at appropriate stages of product realization.(s. 7.1) Products or service may only be approved after conformity has been established. The responsible person for release must be identified in each case. Release of product is to the customer and not next in process stage

Test plans Test instructions Test records Sampling plans (attributive und variable) Checklists Comparative samples Q records Approval under concession by the customer or an authority (where appropriate)

Monitoring and measurement of S the process through test report.

8.3 Control of nonconforming product


Nonconforming products must be: identified separated controlled corrected re-verified documented corrected nonconforming products must be: re-verified, approval by customer under concession, where appropriate CoCMSquences of nonconformances, also for products in use must be: determined and action taken records of concessions shall be maintained

CMS/ QMS/ 01

S U S

DP control of nonconforming product Nonconformance records Test regulations Test certificates Customer information Additional test plans, where appropriate Approval records Expert opinions Approval under concession Identification requirements

Control Of Nonconforming S Through Expert Opinion

8.4 Analysis of data

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NI= Need Improvement

US=Unsatisfactory N.A.: not applicable Page 17 of 19

Audit Check list


ISO9001:2008
Appropriate data to demonstrate quality system suitability and effectiveness must be: determined collected analyzed to provide information relating to customer satisfaction/ dis -satisfaction (s. 8.2.1) conformity of product requirements (s. 7.2.1 process and product characteristics (s. 8.2.3 +8 .2.4) suppliers (s. 7.4.1) for the purpose of continuous improvement of the effectiveness of the quality management system N I Measurement and test records Nonconformance records Records of customer complaints Customer-satisfaction analyses Audit reports Q reports Records relating to field experience Target/performance comparison reports

CMS/ QMS/ 01

Sales comparison report to be N prepared in measurable form I such as graphical

8.5 Improvement
8.5.1 Continuous improvement Continuous improvement must be made possible through the use of the quality policy quality objectives audit results data analysis corrective and preventive action management review. (s. 4.1) 8.5.2 Corrective action To prevent the recurrence of nonconformances , the documented procedure must cover the following aspects: reviewing noncon-formities (incl. Customer complaints) determination of the causes of nonconformities required measures to prevent recurrence action / corrective action monitoring and evaluation of corrective action documentation S Quality management plans Project plans Documentation of target requirements Progress reports Management reviews Corrective-action catalogs Preventive-action catalogs Inputs for continual improvements

CMS/ QMS/ 01

Management Review Conducted S On Regular Interval i.e. three month basis. Agenda points not evident.

CMS/ QMS/ 01

DP Control of corrective action Nonconformance records D-reports Statistical evaluations Test / result records Instructions re corrective action Training plans Training certificates Complaints analyses Amended delivery contracts (where appropriate), Q agreements Investment plans Documentation of reviews

CA procedure is there. Justified the records Of CA

S S

8.5.3 Preventive action

E: Evaluation: S= Satisfactory QMS 001-r02

NI= Need Improvement

US=Unsatisfactory N.A.: not applicable Page 18 of 19

Audit Check list


ISO9001:2008
To eliminate the causes of potential nonconformances, the documented procedure must cover the following aspects: determination of potential nonconformances planning of preventive action implementation of preventive action evaluation of preventive action taken documentation S DP Control of preventive action Risk analyses (economic / technical) Nonconformance records D-reports Analyses records Test records Action catalogs Training plans Training certificates Amended delivery contracts Q agreements Investment plans Trend analysis Cost evaluations Inputs for continuous improvement

CMS/ QMS/ 01

PA procedure is there.
Verified the records Of PA

S S

E: Evaluation: S= Satisfactory QMS 001-r02

NI= Need Improvement

US=Unsatisfactory N.A.: not applicable Page 19 of 19

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