ISO9001ChkDemo Process

8/6/2019 ISO9001ChkDemo Process

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INTERNAL AUDIT CHECKLIST

Issued by: QA Date: 00-00-00 Revision: A QF-82-02-3

ProductRea

lizationProcesses

PRP

QMS

PerformanceData

Product/

ProcessData

Policies &

Directions

Policies &Directions

Customer

ResourceNeeds

PROCESS MAP

PRP 08

PRP 02

Sales &

OrderProcessing

PRP 01

Inspection,

Test &Metrology

PRP 07

Receiving

PRP 03

InventoryMngmnt

PRP 04

Production

PRP 05

Delivery

PRP 06

ContinualImprovmnt

MRP 03

Resources

Resource Mngmnt Processes (RMP)

PersonnelCompetenceand Skills

RMP 01

Information,Doc. Cntrl &Inf. Tech

RMP 02

Facilities,Equipment &Work Envirmnt

RMP 03

Measurement, Analysisand Improvement Processes (MIP)

CustomerComplaints/Satisfaction

MIP 04

Control of

NC Product

Int. Audit &

Analysis of Data

MIP 02

C&P Action

MIP 03

MIP 01

Purchasing

Productionand QualityPlanning

Product

Design

PRP 09

This connection betweenPRP 01 andPRP09applies only when custom product designis included in contracts. Delete it if youspecify your own proprietary products.

If you are a subcontractor and neverdesign products deletePRP 09andmovePRP 08to its place. You need tokeep the connection betweenPRP 01and, the now moved, PRP 08only ifyour contracts typically requiredevelopment of special, new productionprocesses.

MngmntRespons

ibility

Processes(MR

P)Mngmnt

Review

MRP 01

MRP 02

Planning &Objectives

MarketResearch

RFQs, Quotes,Orders

Customer


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INTERNAL AUDIT CHECKLIST Doc: QF-82-02-3 Revision: A Pg. 3 of6

documented (not communicated in writing),confirm the requirements before acceptingthe order.

are these orders confirmed? How are such ordersconfirmed?Ask for records (copies) of the confirmations. Interview

personnel to find out whether they were consistentlytrained/instructed to confirm verbal orders.

7.2.2 When changing or amending orders, ensurethat relevant documents are amended andthat changes are communicated to relevantpersonnel.

How are change orders processed? Is there a systemfor amending documents? Are there writteninstructions, procedures and/or t raining? How isinformation about order changes communicated torelevant departments/personnel within the company?Review a sample of change orders to verify thatprocedures, instructions and/or t raining are beingfollowed. See if you can uncover any past problemscaused by mishandling of change orders.

7.2.3.a7.2.3.b

Determine and implement arrangements forcommunicating product information,handling enquiries, orders and change

orders.

Are processes for communicating with customersadequately defined, to include policies, assignment ofauthorities and responsibilities, and methods(procedures, instructions, training)? Are these processes consistently implemented?Verify that product brochures/specifications and otherproduct information (including the internet site) arecurrent.


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Product Realization Process PRP 02 Purchasing

ISO 9001 Requirements What to look for and how Comply Auditor notes and evidence

7.4.1 Control suppliers and the purchased productto ensure that the product conforms tospecified purchase requirements.

How are suppliers controlled: initial selectionevaluations, ongoing monitoring, audits of suppliersQMS and/or manufacturing processes, requests forcorrective actions?How is purchased product controlled: review of qualityrecords (SPC charts, inspection reports, lab testresults, etc.), receiving inspection? Who makes thesedecisions?

7.4.1 Evaluate and select suppliers based on theirability to supply products conforming tospecified requirements. Establish evaluationand selection criteria. Maintain records orsupplier evaluations and related actions.

Are suppliers evaluated and reviewed before they areapproved? What are the scope, extent and criteria forevaluating and approving suppliers? Who decides?How is the approval documented (an approved vendorlist)? Are there records of initial supplier evaluations?Select randomly and review a sample of supplierevaluation and monitoring files. Is their approval statusclearly authorized? Is their performance consistentlymonitored? In the event of nonconforming deliveries,are they required to implement corrective actions? Is

there a follow up?

7.4.2 In purchasing specifications include, whereappropriaterequirements for approval of product,

procedures, processes and equipment;requirements for approval of personnel,

andquality management system requirements.

Where appropriate, are there requirements forcertificates, inspection reports, SPC data, approval ofsamples, etc. included in purchasing documents? Arethere any requirements with regard to suppliers qualitymanagement system?Review a sample of purchase orders, especially thosewhere the product is expected to come with certificates.

7.4.2 Ensure adequacy of purchasingspecifications before they are forwarded tosuppliers.

How is adequacy of purchasing documents ensured?Are the documents reviewed before release? Are therestandard, pre-approved, specifications in the system?What other methods are used?See if you can uncover any past problems caused byerrors or omissions in purchasing documents.


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Product Realization Process PRP 03 Receiving

ISO 9001 Requirements What to look for and how Comply Auditor notes and evidence

7.4.3 Establish and implement activities forensuring that purchased products meetspecified purchase requirements.

What is being done to ensure purchased productconformity: certificates or inspection reports fromsupplier or independent labs, SPC records, Cpk or Ppkrequirements, in house receiving inspection, suppliersQMS certification?Select a sample of purchased product categories andinvestigate for each what activities or arrangements areplanned to ensure their conformity, how this plan is

documented and communicated, and whether it isconsistently implemented.

7.4.3 When intending to perform productverification at supplier premises, defineverification arrangements and methods inthe purchasing documents.

Is this relevant? If so, review a sample of purchaseorders or contracts to ascertain that product verificationand release methods are defined in the purchasingdocuments.

Checklists for the remaining 16 processes listed below are not included in the DEMO version of the software.

Product Realization Process PRP 04 Inventory Management

Product Realization Process PRP 05 Production

Product Realization Process PRP 06 Delivery

Product Realization Process PRP 07 Inspection, Test and Metrology

Product Realization Process PRP 08 Production and Quality Planning

Product Realization Process PRP 09 Product Design


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Measurement and Improvement Process MIP 01 Control of Nonconforming Product

Measurement and Improvement Process MIP 02 Internal Audits and Analysis of Data

Measurement and Improvement Process MIP 03 Corrective and Preventive Action

Measurement and Improvement Process MIP 04 Customer Complaints & Satisfaction

Management Responsibility Process MRP 01 Planning and Objectives

Management Responsibility Process MRP 02 Management Review

Management Responsibility Process MRP 03 Continual Improvement

Resource Management Process RMP 01 Personnel Competence and Skills

Resource Management Process RMP 02 Information, Document Control and IT

Resource Management Process RMP 03 Facilities, Equipment and Work Environment

Documents

ISO9001ChkDemo Process