Wednesday, October 6, 2010

ISO 9001: 2008 explained

Download Free Internal Audit Checklist template example

Exclusively for Iso Blog readers, here i attached download link for a free Internal Audit Checklist template example for your reference.It’s a complete Internal Audit checklist template which contained all related Internal Audit for Quality Management Systems and GAP analysis for ISO 9001:2008 standard.
So for a free ISO Internal Audit checklist, here’s the download link:


As for MONITORING AND MEASUREMENT – INTERNAL AUDIT it involves few procedures.Read it as follows.
1. The organization shall establish the system for internal audit to verify whether quality activities
a) Comply with planned arrangements and to determine the effectiveness of the quality system and requirements of the ISO9001:2008 Standard Requirement.
2. An Internal Lead Auditor shall be appointed and is responsible to select and train employees to become Internal Auditors, who shall be independent and non-bias in respective areas of audit. A selection criteria shall also be established by the Internal lead Auditor.
3. An Internal audit plan specifies that :
a) A yearly audit plan is maintain to ensure that all aspects of the quality system are audited (status and importance of processes). The audit criteria, scope, method, area and frequency are defined.
b) Good selection of auditors and placement.
c) All aspects of quality system are audited at least once a year.
d) Audit shall be carried out by using checklist.
e) Audits shall be carried out by trained personnel and not directly involved to the section / department that are being audited.
f) Auditor shall re-audit the deficient area to ensure that the corrective action taken is effective.
g) Result of Internal Audit Form an integral part of Management Review.
4. The Internal Lead auditor is responsible to schedule, conducting audit, review and audit findings, reporting result and maintaining records. Follow up actions shall be carried out in accordance to the documented procedures.
5. The head of department responsible for the area being audited shall take all necessary action without undue delay, to eliminate detected non-conformities and the causes. The follow up action shall include the verification of the action taken and reporting of the verification result.


Overall, the organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed
a) To demonstrate conformity of product
b) To ensure conformity of Quality Management System
c) To continually improve determination of applicable methods, statistical technique and extension of use

Measurement and Monitoring-Customer Satisfaction
The Company shall monitor information relating to customer perception, satisfaction and/or dissatisfaction as one of the measurements of performance of the Quality Management System and meeting to the customer requirement.
Methodologies for obtaining and using such information shall be determined and implemented.
Procedures shall be established for: -
a. The collection, recording, collating and analysis of information pertaining to Customer satisfaction
b. The collection, recording, collating and analysis of information pertaining to Customer dissatisfaction / complaint
c. Responsibilities and action to be initiated to correct or prevent any dissatisfaction or complaint.
d. Annual customer survey.
e. Customer requirement list paste at all department and understood by all employees.
f. Monthly Bulletin to highlight the customer satisfaction or dissatisfaction.


1. The organization shall establish the procedures and processes to control, calibrate and maintain inspection, monitoring, measuring and test equipment that are used to demonstrate the conformance of product to the specified requirements.
2. The ensure valid result, measuring equipment shall:
• Be calibrated or verified at specified intervals or prior to use against measurement standards traceable to international and national measurement standards, where no such standard exist, the basis used for calibration or verification shall be recorded.
• Be adjust or re-adjusted as necessary.
• Be identified to enable the calibration status to be determined.
• Be protected from damage and deterioration during handling, maintenance and storage.
• Faulty equipment is promptly removed and previous result is checked for validity.
• Calibration record is review, filed and properly labels.
• Where internal calibration is conducted, the employees are provided with the relevant training in calibration skills.
• Equipment is selected base on the precision capability and with known tolerance.
5. Organization shall assess and record the validity of the previous measuring result when the equipment is found not to conform to requirement and take appropriate action on the equipment or any product affected.
6. The ability of computer software or satisfy the intended application shall be conformed. This shall be undertaken prior to initial use and reconfirmed as necessary.

ISO 9001:2008-Production and Service Operations

For Production and Service Operations portion there are a lot of things need attention.Below are the ideas for Production and Service Operations implementation on ISO 9001:2008.
1. The Company shall establish the necessary procedures for the following:
a. Operations Control
b. Identification and Traceability
c. Customer Property
d. Preservation of Product
e. Validation of Processes
2. Controls shall be established for production and service operations through: -
a. The availability of information that specifies the characteristics of the product
b. Ensuring the quality and characteristics of the product are maintained
c. The availability of Work Instructions where appropriate
d. Ensure the accuracy and performance of the equipment used for handling and measuring through preventive maintenance. This is to minimize equipment downtime.
e. Availability and use of measuring and monitoring devices
f. Implementation of monitoring activities
g. Implementation of defined processes for the release, delivery and applicable post-delivery activities
3. In general, the Process Controls shall be achieved by following:
? Establishing and implementing the Process Plan
Integrates all processes and sub-processes in sequence.
? Documented procedures
? Establishing workmanship / acceptable standards
? Ensuring use of trained and skilled employees
? Maintenance of equipment used for vehicle maintenance
? Use of correct parts/materials for maintenance of vehicles
? Recording accurate information
? Proper storage, handling, and preservation of products
? Ensuring effective transportation control, including obstacle control and
Contingency plan.
4. Identification and Traceability : The Company shall also: -
a. Identify the service or parts used during the whole process of service realization by suitable means
b. Identify the usability and conformance status of the parts
c. Provide proper control and records of the unique identification of the products kept or handled in the course of service provision for trace ability purposes
5. Customer Property : Where customer products are handled and / or received, the Company shall provide the relevant procedures for : -
a. The care and preservation of such property while within the premises and/or control of the Company
b. Identify, verify, protect and maintain the characteristics of such property for use or incorporation into the final product
c. Procedure for reporting and control of property in case of lost, damage or otherwise found not suitable for use or incorporation
6. Preservation of Product : Procedures shall be set to ensure the product is correctly / properly handled, stored, packaged, preserved and delivered without undue degradation in quality, contamination or damage. This shall be applicable to all goods in transit (goods during shipment / transportation until the intended destination) and in-storage products.
7. Procedures are documented to control the handling, storage, packaging, preservation and delivery of all materials,
a. To avoid damages and deterioration through proper storage
b. To ensure ease of identification, proper receipt, issue and delivery
8. Arrangement for process verification established in the Quality Plan shall include the following : -
a. Qualification of processes, equipment and personnel
b. Use of defined methodologies and procedures
c. Requirement for records and re-validation activities
9. Validation of processes for production and service provision (Clause 7.5.2 ISO9001:2008 Standard Requirement) is excluded.

ISO 9001:2008-Purchasing Procedure template

a) Ensure that purchase product conform the specified purchase requirements.
b) To establish a control method or inspection procedures to ensure product conformity.
c) Evaluate and select supplier base on their ability to supply product in accordance with the organization requirement.
d) Establish criteria of selection, evaluation and re-evaluation.
e) Record all result of evaluations and necessary action arising from the evaluation.
2. Purchasing information shall describe the product to be purchased including:
a) Requirement for approval of product, procedure, processes and equipment.
b) Requirement for qualification of personnel.
c) Quality Management System requirement.
3. These procedures have been set and made applicable to all purchasing activities, which includes qualifying new suppliers, sourcing, ordering and purchasing and monitoring supplier’s performance.
4. It is responsibilities of appointed Purchaser to ensure that suppliers satisfy the following basic requirements in Purchasing Control Procedure.
a) Able to supply service or parts of required quality consistently.
b) Able to deliver parts / goods within required time frame.
c) Able to supply parts / goods at reasonable prices.
d) Able to provide relevant information of material, such as specification, certificate of analysis, material safety data sheet (where applicable)
e) Purchasing data are correct and approved.
f) Supplier performance is monitored and evaluations recorded.
g) Approved supplier list is maintained.
h) Sub-contractor is selected based on ability to meet the above requirement.


When it comes to conformation sometimes customer tend to request document to verify it.One of it which a lot of us encountered as QA Engineer was COC a short term for Certificate of Compliance (COC) or some people would prefer it as Certificate of Conformance (COC).
Bare in mind no matter which Certificate of Compliance (COC) or Certificate of Compliance Certificate of Conformance (COC) requested, it depends solely on customer.They need clarification so they request COC as a gurantee letter on behalf of the supplier to customer.These also include what content to include into the COC, what key item needed to attached with it.So, asked your customer the sample or format if they have any.If not then you have create one for them based on what they need us to declare on that COC.
However below is one example of sample/template of COC regarding RoHS requirement for your understanding and reference.
Customer: Company XYZ
Customer Reference: COC-WD001
Issue Date: July 15, 2010
Products supplied to Company XYZ:
1) 1230
2) 3450
3) 3440
4) 0900
5) 0999
This document is to certify that all products produced by (Your company name) comply to the
allowed limits of “banned” substances, currently set by Company XYZ Restricted/Prohibited
Material List (Doc. No. 0010 -Rev2)
This document certifies that all the information stated above is accurate to the best of our
Signature :
Name :
Title/Designation :
Date :
Basically these are the basic things customer want to know from its supplier when it comes to product supplied to them.You may add up according to your customer request.If you have anything to add up or have your own sample, feel free to share with us so we can paste into this entry.Thanks!

Customer Related Processes-Part 2

1. Customer contracts / purchasing orders are reviewed and recorded prior to the confirmation to service to ensure that Company is able to fulfil and meet obligations in contract and / or booking schedule. Contracts / orders are reviewed to ensure:
? Correct and defined service requirement
? Available resources (vehicle, driver and other facilities) to supply such services
? Delivery date is defined
? Quotation / Service price is correct
2. Responsibilities are defined and communicated to ensure timely deliveries. The requirements include:
? Customer’s address / data
? Item or model product to be delivered
? Quantity and dimension (length, thickness, specification, etc.)
? Delivery dates & Destination
? Customer feedback, including customer complaints.
3. Record of any changes to the contract/order shall be:
• Accepted and approved by the customer
• By the Head of Sales Department or F/Manger and/or Managing Director
• Communicated to the relevant departments

Customer Related Processes

1. The Company shall determine customer requirements including: -
a) Requirements specified by the customer, including the requirements for manufacturing, delivery and support.
b) Additional requirements not specified by the customer but necessary for intended or specified use.
c) Obligations related to service, including both regulatory and legal requirement.
2. The company shall review the requirement related to product and shall ensure that.
a) Product requirement are define.
b) Contract or order requirement differing from those previously expressed and resolved
c) Organization ability to meet defined requirement

Planning of Product Realization

1. The Management shall ensure that the planning of product realization processes shall be consistent with the other requirements of the organization’s Quality and Environmental Management System.
2. In the process of such planning, the Company shall define: -
a. The Quality and Environmental objectives for the service or contract,
b. The need to establish processes and documentation, and to provide resources and facilities specific to the product.
c. Verification, validation, monitoring, Inspection and test activities specific to the product and the criteria for product acceptance.
d. The records that is necessary to provide confidence of conformity and meeting the requirement of the process and product.
3. The Quality and Environmental Plan are also generated to integrate all Quality and Environmental activities and processes of the business.
4. COMPANY, through the efforts of the Environmental Committee and the Environmental Aspects and Impacts procedure, identifies and plans those operations that are associated with COMPANY’s identified significant environmental aspects consistent with its environmental policy, objectives and targets. This process ensures that these activities are carried out under specified conditions, by
a. Establishing, implementing and maintaining documented procedures to control situations where their absence could lead to deviation from the environmental policy, objectives and targets
b. Stipulating the operating criteria in these procedures
c. Establishing, implementing and maintaining procedures related to the identified significant environmental aspects of goods and services used by the organization and communicating applicable procedures and requirements to suppliers, including contractors. Suppliers are required to provide appropriate environmental, health & safety information about their products (i.e. MSDS sheets) as part of the order. These are maintained in MSDS binders available to all employees. Significant aspects associated with new materials are identified as described in the Environmental Aspects and Impacts procedure and appropriate operational controls established.
5. Subcontractors involved in work that could have a significant environmental impact (e.g. construction, demolition, etc.) are requested to describe their processes, materials and wastes. Only certified and/or licensed environmental subcontractors (e.g. environmental compliance consultants, waste haulers) are used for specific environmental services. COMPANY’s environmental policy and appropriate requirements are communicated to environmental subcontractors prior to the start of any work. Specific instructions for the communication with suppliers and contractors are provided in the Environmental Briefing Form