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ISO 9001:2008
E: evaluation: S= Satisfactory
US=Unsatisfactory
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)
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
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
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.
CMS/ QMS/ 01
Evaluation of customer surveys Market analyses Complaint documentation / analyses Product validation records Standards Customer-satisfaction analyses External quality costs ppm-statistics
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
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Quality S is in S
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QMS Plans along with objective planning and target for each & S every planning is determined.
Responsibility authority are S defined in the manual A organization chart need to be displayed in the organization for U S better understanding.
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.
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
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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)
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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.
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.
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
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.
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
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.
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.
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
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
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
CMS/ QMS/ 01
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
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
CMS/ QMS/ 01
Preservation improved
facility
to
be N
I
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.
CMS/ QMS/ 01
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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.
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)
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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
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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.
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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
S S
CMS/ QMS/ 01
PA procedure is there.
Verified the records Of PA
S S