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Iso 9002 International Standard

Iso 9002 International Standard

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11/17/2013

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ISO 9002 INTERNATIONAL STANDARD
 A BRIEF EXPLANATION OF THE TWENTY CLAUSES
Clause 4.1MANAGEMENT RESPONSIBILITYCLAUSE 4.1.1 "QUALITY POLICY"
 To comply with this requirement there must be a written Quality Policy for the organization. This Quality Policy document must be signed by the currentmanagement for the location or site in question. It must also be ensured that the Quality Policy, the objectives and the statement of intent are established andidentified in the Quality Manual.
The following criteria must be fulfilled:
 The company has a brief but comprehensive Quality Policy.This Quality Policy should be included in the Quality Manual as well as being on public display.Quality Objectives have been established by management and there is a statement outlining the intent to deliver against these objectives.
The company must ensure that:
 The Quality Policy is communicated throughout the organization.All employees, at all levels, receive the same message from management. All statements relating to quality that are in documents, training manuals,advertising literature, etc. must be consistent with the Quality Statement.Any changes must be issued in a controlled manner and must be properly communicated to all employees.It is now necessary for companies to clearly establish goals and appraise the needs and expectations of customers. As the goals will change and evolve thesecould be documented and expressed in a quality improvement plan which must be thoroughly examined at management reviews. (discussed below).
CLAUSE 4.1.2.1 "ORGANIZATION: RESPONSIBILITY AND AUTHORITY"
 
To satisfy this requirement the company must ensure that:
The Quality Manual contains an Organizational Chart.The Organizational Chart is current, authorized and issued as a controlled document.The management function responsible for quality is clearly identified.The responsibilities and authority of the Quality function are clearly defined.Responsibility and authority under this clause have been extended to cover product processes and quality system non-conformances. This now places greater emphasis on internal quality system activities such as internal quality audits, corrective/preventative actions and management review.
CLAUSE 4.1.2.2 "ORGANIZATION: RESOURCES"
 
The company must ensure that:
 Adequate resources are provided to allow the effective and efficient operation of the Quality Management system.All personnel involved in the verification of the quality of work have sufficient training and resources to allow them to carry out their duties.All operations involved in the verification of work are identified.Training records are maintained to provide evidence demonstrating that suitable training has been provided.Training records are treated as Quality Records and managed as such.Establish a clear division between the responsibility for the work and the responsibility for performing assessments. Until recently it was normal to have thesedifferent tasks carried by different groups reporting to different managers but there is no reason why self checking cannot be employed with the same person performing both roles but work must also be subjected to independent verification.Adequate training is provided to do both roles and keep the roles separate.
 Resources required must be adequately identified in the quality system: for example Human Resources will be identified under clause 4.18 (Training) and Calibration under clause (4.11)
 
CLAUSE 4.1.2.3 "MANAGEMENT REPRESENTATIVE"
 
The company needs to ensure that:
 A member of the management team is clearly identified as the person with responsibility for implementing and maintaining the requirements of ISO 9000.This authority is formally defined by some method such as job description, organizational chart or Quality Manual.
The management representative must be a member of the management team. A formal mechanism must exist to facilitate the management representative toreport to management on system, process or product failures with a view to continually improving the quality system. The standard suggests that theManagement Representative be the liaison person with external parties.
 
CLAUSE 4.1.3 "MANAGEMENT REVIEW"
 According to ISO 9002 management are required to assess the suitability and effectiveness of the quality system, at regular intervals, so that they may identifyareas where improvements can be made.It is suggested that:All affected groups are represented at management review meetings.The review process is described in the Quality Manual.Minutes of meetings are kept, to show what decisions were made and who was responsible for their implementation.Reviews are held at regular intervals (at least once per year).Evidence needs to be provided for external auditors to demonstrate that reviews are planned, effective and that corrective action decisions are made andimplemented. It should be noted that the last section of this particular ISO 9002 requirement specifies that records of management reviews are required.Management review records should be treated as quality records and managed at such.
The review must now, in addition to assessing the continuing suitability and effectiveness of the system, determine whether the stated quality objectives havebeen achieved. This can only be done by agreeing objective targets for quality system improvements and assessing if these have been achieved 
.
 
Clause 4.2QUALITY SYSTEM
Clause 4.2 covers the quality system of the organization and it's documentation. Initially the system organization is dealt with and recognized to be part of TQM (Total Quality Management). Output from each function or part must meet agreed customers' requirements, be they internal or external.The quality system is understood to be interrelated aspects of:Suppliers' needs and interests.Customers' needs and expectations.Therefore a well-planned and managed quality system has to be defined and documented, which are dealt with by quality plan and quality manual sub-clauses. The quality system and plans should be documented in enough detail so that suppliers and customers can understand it and audit the quality systemthemselves.This clause requires that the different parts of the company recognize that they are both customers of and suppliers to other parts of the organization as well asto external customers.
Sub-clause 4.2.1
now makes a Quality Manual an essential part of the quality system it also requires that other documented procedures are referenced fromthis document. This means that a Quality Manual is now mandatory and must reference all the operating procedures either directly from the text or through across reference matrix or table.
Sub-clause 4.2.2
requires that procedures are consistent with our Quality Policy and should reflect the complexity of the work/processes and skills/trainingrequired.
The documented procedures must be relevant to the stated quality policy. Where a company can demonstrate through adequate training or other records theacquisition of skills/training by all relevant personnel, detailed procedures are not mandatory; for example personnel who have achieved qualificationsthrough apprenticeship schemes may not require detailed procedures or work instructions.
 
Sub-clause 4.2.3
requires a company to undertake quality planning as appropriate to the organization and that this should be defines and documented.
Clause 4.3CONTRACT REVIEWThis is the clause that the majority of companies have most difficulty with. Some make the mistake of assuming that this clause applies to therelationship between the company and it's vendors when in fact it applies to the relationship between the organization's front end andclients/customers.
 The 1994 version of ISO 9002 places a much greater emphasis on Contract Review.Where the sales of product and services are covered by contracts there must be clear evidence of a review of terms and conditions.
Attention should be paid to the following:
 Ensuring requirements are agreed and clearly understood by all involved parties.Checking that all parties have the necessary resources, organization and facilities.
VERBAL CONTRACTS
 
Verbal contracts must be agreed before acceptance implying that some positive confirmation of order requirements must be made. In practice this could beachieved using fax confirmation messages or logging verbal orders and confirming them back to customers over the phone.
 
AMENDMENT TO A CONTRACT
 This is a new addition to the ISO 9002 requirement for contract review. The company must have a mechanism for internal communication of all contractamendments ... this could be achieved by reviewing ongoing contracts at the daily production meetings by putting a system in place whereby Scheduling,Planning and Production would be alerted to all changes.
Clause 4.4DESIGN CONTROLClause 4.5DOCUMENT AND DATA CONTROL
This requirement has been updated in the 1994 version (operational since 1 March, 1995.)
DOCUMENT AND DATA CONTROL
 
Clause 4.5
deals with how documentation should be treated. All documents in must be checked before issue or re-issue after revision. Documents must be positioned so that all persons concerned have easy access to them. A master record file has to be kept.People responsible for revision and issuing of documentation must be identified.
Sub-clause 4.5.1
clause requires that documents of external origin such as standards and customer drawings are controlled.Sub-clause 4.5.2 requires that all obsolete documents be adequately identified and that all such documents which are held for reference purposes should besuitably identified. NOTE 10 of ISO 9002 states that documents can be in the form of any type of media such as hard copy or electronic media. If the system is totally electronicthen there has to be sufficient availability of hardware (terminals, etc.) to facilitate personnel in accessing procedures, work instruction and records.The procedure for document control must clearly identify who has authority to authorize read and / or write access to controlled documents.All electronic document and data systems must have adequate security / backup procedures.
 
 
Clause 4.6PURCHASINGClause 4.6
deals with purchasing. In the procurement of materials or external services, quality need to be assessed in respect to agreed specifications.Assessment of subcontractors (i.e. vendors or suppliers), ensures that all have the capability of supplying materials or services of the required quality. Aformal assessment of capability is needed, possibly through an audit of a subcontractor's quality or by way of other evidence. Documented evidence on formalassessments is required.Purchasing data when placing orders should amount to a formal procedure that ensures all necessary information is given to a vendor. Communication linksare a central here and a record of performances is needed.
Sub-clause 4.6.4.1 "Supplier Verification at Subcontractor's Premises"
 This sub-clause requires that all details in relation to product verification and the method of product release by the supplier at the subcontractor's premises isdescribed on the purchasing documents.
Clause 4.7CONTROL OF CUSTOMER-SUPPLIED PRODUCTControl of Customer-Supplied Product
 Clause 4.7 deals with purchaser supplies. Here, purchaser means our external customers. In manufacturing the external customer may make "Free Issue",which is where they provide materials for incorporation in products they ultimately buy back.The onus is on the issuer to check quality, but this does not absolve us from knowingly incorporating poor quality components into finished product..
Clause 4.8PRODUCT IDENTIFICATION AND TRACEABILITYPRODUCT IDENTIFICATION AND TRACEABILITY
 This clause deals with product identification and traceability. A manufactured product must be traced through the various stages of its production and delivery.This is crucial to help identify the stage and hence the cause of any product failure. Where different products are similar or identical they must be identifiedusing a method of labeling or coding. Note: In the case of a mail-order/telesales business this clause may apply to mail, checks, registration forms, etc.
Clause 4.9PROCESS CONTROL
The company must be able to demonstrate that the overall process (sales right through to delivery to the end user) is in control.There are many significantly different processes in both the manufacturing and service sectors. Accordingly only principles are set out in
Clause 4.9
, detailshaving to be put in place by each organization.The main point is that process steps need to be identified and a plan to implement needs to be declared and documented.The process must be carried out in a controlled way, so that plans / procedures / instructions are to hand, equipment and personnel used are adequate and thatthe general conditions are amenable to achieving the plans.To ensure that a process is carried out in a controlled manner the process must be well documented and the staff well trained.
Clause 4.10INSPECTION AND TESTINGMany changes have been made in the 1994 version of ISO 9002
 This clause addresses inspection and testing for incoming goods, in-process and final inspection.Inspection of incoming materials must be directed by a sampling plan which details the selection of materials for inspection / testing from each received batch. Results must be documented, describing material inspected, number of rejects, reasons for rejection and corrective action.In-process inspection similarly needs to be dealt with, tying in with
clause 4.8
"Product Identification and Traceability".Upon completion all products must undergo clearly specified final inspection. NOTE:
Sub-clause 4.10.2.2
is a new addition and reads as follows... "In determining the amount and nature of receiving inspection, consideration shall be given tothe amount of control exercised at the subcontractor's premises and the recorded evidence of conformance provided". This deals with the practice of ship-to-stock based on certificates of conformance or other recorded evidence of conformance of product or service.

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