DOCUMENTATION REQUIREMENTS

Based on ISO 9001:2008

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The quality management system documentation shall include the following.

Documented statements of a quality policy and quality objective.The quality policy ensures clear focus of quality across the organization and direct employee activities on quality, customer focus and continual improvement.

The quality objective ensures that customer requirements are met and also continually improve the performance of the organization through the quality management system. They will be set and they will be reviewed in management review meetings.

A quality manual. The quality manual shows the scope of quality management

system; incorporating details of justification for any exclusion (it shows functional organization structure)

Documented procedures and records required by the international standards.

Documents including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes.(quality manuals & quality procedures)

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The extent of quality management system documentation can differ/change from one organization to another due to the following factors- The size of organization and type of activities The complexity of processes and their interactions. The competence /ability of personnel/workers.

The quality manualThe organization shall establish and maintain a quality

manual that includes, The scope of the quality management system, including

details of and justification/explanation for any exclusion /leaving out.

The documented procedures established for quality management system, or reference to them.

A Description of interaction between the processes of the quality management system.

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Control of documentDocuments required by the quality management system shall be controlled, and documented procedures shall be established to define the controls needed.

To approve documents for adequacy prior to issueTo review and update as necessary and re-approve documentsTo ensure that changes and the current revision status of documents are identifiedTo ensure that relevant versions of applicable documents are available at points of use.To ensure that documents remain legible and readily identifiable.To ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled. To prevent the unintended use of obsolete documents and to apply suitable identifiable to them if they are retained for any purpose.

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Controls of recordsRecords established to provide evidence of conformity to requirements and of effective operation of the quality management system shall be controlled.

The organization shall establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention, and disposition of records.

Storage of records, Records shall be stored in either soft or hard copy.

Protection,All records shall be protected against damage; soft copy shall be protected from heat, dust, water and magnetic field. Hard copy records shall be protected from heat, dust, water, and kept in a safe place.

Records shall remain legible, readily identifiable and retrievable.

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EXTRA INFORMATION

DEMONSTRATING CONFORMITY WITH QMS STANDARD & OBJECTIVE EVIDENCE

It may be able to demonstrate conformity without the need for extensive documentation.

The organization has to be able to provide objective evidence of the effectiveness of its processes and its quality management system. Clause

3.8.1 of ISO 9000:2005 defines “objective evidence” as “data supporting the existence or variety of something” and notes that “objective evidence may be obtained through observation, measurement, test, or other means.”

Objective evidence does not necessarily depend on the existence of documented procedures, records or other documents, except where specifically mentioned in ISO 9001:2008. In some cases, (for example, in clause 7.1(d) Planning of product realization, and clause 8.2.4 Monitoring and measurement of product), it is up to the organization to determine what records are necessary in order to provide this objective evidence.  

Where the organization has no specific internal procedure for a particular activity, and this is not required by the standard, (for example, clause 5.6 Management Review), it is acceptable for this activity to be conducted using as a basis the relevant clause of ISO 9001:2008. In these situations, both internal and external audits may use the text of ISO 9001:2008 for conformity assessment purposes.

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OBJECTIVES OF DOCUMENTATION:a)   Communication of Information

as a tool for information transmission and communication. The type and extent of the documentation will depend on the nature of the organization’s products and processes, the degree of formality of communication systems and the level of communication skills within the organization, and the organizational culture.

b)   Evidence of conformity

provision of evidence that what was planned, has actually been done.

c)    Knowledge sharing

to disseminate and preserve the organization’s experiences. A typical example would be a technical specification, which can be used as a base for design and development of a new product.

Documents may be in any form or type of medium, examples: paper, magnetic electronic or optical computer disc , photograph, master sample 8

DOCUMENTATION the amount and detail of documentation required to be more relevant

to the desired results of the organization’s process activities.

the minimum amount of documentation needed in order to demonstrate the effective planning, operation and control of its processes and the implementation and continual improvement of the effectiveness of its QMS.

It is stressed that ISO 9001 requires (and always has required) a “Documented quality management system”, and not a “system of documents”.

Any documentation approach that you adopt should always provide value-added for the management of your quality system, not simply meet the auditor’s/ registrar's requirements.

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TERMS AND DEFINITIONS RELATING TO DOCUMENTS

Document - Information and its supporting medium

Procedure - Specified way to carry out an activity or a process  (Note: Procedures can be documented or not)

Quality Manual - Document specifying the quality management system of an organization

Quality Plan - Document specifying which procedures and associated resources shall be applied by whom and when to a specific project, product, process or contract

Record - Document stating results achieved or providing evidence of activities performed

Specification - Document stating requirements 10

QMS- DOCUMENTATIONDocumentation requirement

– Systematic and orderly– Written policies and procedures– Ensure common understanding– Shall include provision for:

• Identification• Distribution• Collection• Update• Withdrawal• Archiving

• Retention/retrieval

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DOCUMENTS REQUIRED The quality management system documentation shall include:

documented statements of a quality policy and quality objectives; a quality manual documented procedures required by this International Standard

4.2.3 Control of documents 4.2.4 Control of records 8.2.2 Internal audit 8.3 Control of nonconforming product 8.5.2 Corrective action 8.5.3 Preventive action

documents needed by the organization to ensure the effective planning, operation and control of its processes, and

records required by this International Standard; All the documents that form part of the QMS have to be controlled

in accordance with clause 4.2.3 of ISO 9001:2008, or, for the particular case of records, according to clause 4.2.4. 12

ADDITIONAL DOCUMENTS TO ADD VALUE An organization could add value to its QMS and demonstrate

conformity by the preparation of other documents, even though the standard does not specifically require them. Examples may include:

- Process maps, process flow charts and/or process descriptions

- Organization charts- Specifications - Work and/or test instructions - Documents containing internal communications- Production schedules- Approved supplier lists- Test and inspection plans- Quality plans

All such documents have to be controlled in accordance with the requirements of clause 4.2.3 and/or 4.2.4, as applicable13

RECORDS REQUIRED BY ISO 9001:2008

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CLAUSE RECORD REQUIRED

5.6.1 Management reviews

6.2.2(e) Education, training, skills and experience

7.1(d) Evidence that the realization processes and resulting product fulfil requirements

7.2.2 Results of the review of requirements related to the product and actions arising from the review

7.3.2 Design and development inputs relating to product requirements

7.3.4 Results of design and development reviews and any necessary actions

7.3.5 Results of design and development verification and any necessary actions

7.3.6 Results of design and development validation and any necessary actions

7.3.7 Results of the review of design and development changes and any necessary actions

7.4.1 Results of supplier evaluations and any necessary actions arising from the evaluations

7.5.2(d) As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement

7.5.3 The unique identification of the product, where traceability is a requirement

7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable for use

7.6(a) Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist

7.6 Validity of the previous measuring results when the measuring equipment is found not to conform to requirements

7.6 Results of calibration and verification of measuring equipment

8.2.2 Internal audit results and follow-up actions

8.2.4 Indication of the person(s) authorizing release of product.

8.3 Nature of the product nonconformities and any subsequent actions taken, including concessions obtained

8.5.2(e) Results of corrective action

8.5.3(d) Results of preventive action

QMS- DOCUMENTATION HIERARCHY

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I Level Policy What do we do?Why?

Policy ObjectivesStated once

II Level Procedures Who?When?Where?

CalibrationQA ProceduresAudit Processes

III Level Work Instructions or Practices, Technical Data

How? Work Instructions,Inspection Instructions, Standard Operating Practices, Drawings, Specifications, Standards

IV Level Records or Proof

Evidence-;all the records and forms which are generated by the working system. 4

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RBS - Quality Management

Systems

Requirements for service quality by public service organisations.

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DOCUMENTATION REQUIREMENTS

GeneralThe organization shall document the following:

• Service quality manual;

• Citizens’ charter;

• Any other document needed by the organization for effective planning, operation and control of its service and service delivery processes; and

• Records required by this standard (see 4.4).

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Service Quality ManualThe organization shall establish and maintain a service quality manual which includes:

• Scope of service quality management system;

• Service quality policy;

• Service quality objectives;

• Complaints handling objectives;

• Responsibility and authority of personnel at relevant levels within the scope of this standard;

• Documented procedures required by this standard;

• Other documents, needed by the organization for effective planning, operation and control of its service and service delivery processes, or reference to them; and

• Description of service processes including service delivery processes at the customer interface and those needed to directly support them (see 7.2).

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Control of DocumentsAll the documents required by this standard shall be

• approved for adequacy prior to issue;

• reviewed periodically, updated as necessary and re-approved. The changes made shall be identified; and

• legible and identifiable indicating their current revision status.

The organization shall• maintain a master list of all documents related to the scope of this

standard which also identifies their current revision status;

• maintain distribution list of all such documents;

• ensure that the current versions of applicable documents are available at points of use;

• ensure that obsolete documents, if retained for any purpose, are suitably identified to prevent their unintended use; and

• ensure that the documents of external origin are identified and their distribution controlled.

A documented procedure shall be established to define the controls needed for the above.

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Control of Records:Records (including files) shall be established and maintained to provide evidence of conformity to requirements and for the effective operation of the management system for service quality.

The records shall remain • legible, • readily identifiable and • easily retrievable.

The method of • identification, • storage, • protection,• disposition of each record, • their retention time and • responsibility

for each of these activities shall be established in a documented procedure.

PREPARED BY

Note: All the above companies are ISO certified

BRALIRWA NAKUMATT RWANDA

SULFO RWANDA

INDUSTRIES

THANK YOU !