Iso 9001: 2008 Gap.Analysis Report

ISO 9001: 2008 Gap AnalysisSECT NO.ISO 9001:2008 FORMATQUALITY MANAGEMENT SYSTEM REQUIREMENTSQM/FORM NO.Procedure/ Page #Y/N

General Requirements

1.2Organization has identified all exclusions that apply to the QMS

4.1Organization shall control all processes that are outsourced (7.4)

Documentation

4.2.1Documentation includes: a) statement of quality policy and quality objectives

b) quality manual

c) documented procedures and records

d) those determined necessary to ensure planning, operation and control of its processes

4.2.2 Quality Manual includes: a) scope of QMS and exclusions (with justifications)

b) documented procedures or reference to them

c) description of interaction between the processes of the QMS

4.2.3Documented Procedure established and maintained for control of documentsa) Approve documents for adequacy prior to issue

b) Review and update as necessary and re-approve documents

c) Changes to current revisions are identified

d) Relevant revisions of documents available at points of use

e) Ensure documents remain legible and readily identifiable

f) Ensure documents of external origin are identified and distribution controlled

g) Prevent unintended use of obsolete documents

4.2.4Documented Procedure for the identification, storage, protection, retrieval, retention and disposition of records

Management Responsibility

5.1Top Management commitment to develop and implement QMS and continually improve effectiveness

5.2Focus on the customer - requirements are determined and met with aim of enhancing customer satisfaction

5.3Quality Policy: (b) includes commitment to comply and continually improve QMS

(c) provides a framework for establishing quality objectives

(d) is communicated and understood within the organization

(e) is reviewed periodically (MR)

5.4.1Top Management establishes quality objectives that are measurable and consistent with quality policy

SECT NO.ISO 9001:2008 FORMATQUALITY MANAGEMENT SYSTEM REQUIREMENTSQM/FORM NO.Procedure/ Page #Y/N

5.4.2Planning of QMS carried out to meet requirements of quality objectives

5.5.1Responsibilities and authorities are defined

5.5.2Management representative:a/ b) is identified and has authority to ensure that quality system is implemented and maintained

c) Promotes awareness of customer requirements throughout organization

5.5.3Top Management commits to establishing communication within the organization (internal communications)

5.6.1

Management Review of QMS conducted

Records of management reviews are maintained

5.6.2Management review includes: a) results of internal audits

b) customer feedback

c) process performance (to include product nonconformity)

d) status of corrective and preventive actions

e) follow-up actions from last management reviews

f) changes that could affect the QMS (to include oil/gas industry standards)

g) recommendations for improvement

5.6.2Management review output includes: a) Improvement of effectiveness of QMS

b) improvement of product to meet customer needs

c) resource needs

Resource Management

6.2.1Human Resources: Personnel shall be competent on the basis of education, training, skills and experience

6.2.2Human Resources: a) Determine necessary competence (requirements) for personnel performing work affecting conformity

b) Provide training

c) Evaluate effectiveness of actions taken

d) Ensure personnel are aware of importance of their work with respect to QMS

e) Maintain records of education, training, skills and experience


6.3Provide and maintain the infrastructure (equipment, buildings, etc.) needed to achieve conformity to product requirements

6.4Determine and manage work environment needed to achieve conformity to product requirements

Customer Related Processes- Contract Review

7.1aThe organization shall determine the quality objectives and requirements for the product

7.1bThe need to establish processes and documents, and to provide resources specific to the product

7.1cThe organization shall determine verification, validation, monitoring, measurement, inspection and test activities

7.1dRecords needed to provide evidence that the realization processes and resulting product meet requirements (4.2.4)

7.2.1Customer Related Processes: Determination of Requirements Related to the Product

7.2.2Contract review ensure that:a) product requirements are defined

b) requirements differing from those previously expressed are resolved

c) organization has ability to meet defined requirements

Records of the results of reviews shall be maintained

Organization shall ensure amendments are made and transferred to proper function

7.2.3Determine and implement arrangements for communication with customers

Design and Development

7.3.1Organization shall manage the interfaces between different groups involved in design and development

Design output updated as the design and development progresses

7.3.2Input includes: a) functional and performance requirements

b) applicable statutory and regulatory requirements

7.3.3Output shall: a) meet the input requirements

b) provide information for purchasing, production and service

c) contain or reference product acceptance criteria

d) specify the characteristics of the product that are essential for the safe and proper use

7.3.4Review shall occur at suitable stages to evaluate design as it meets requirements

Participants of review shall include representatives of functions concerned with design and development

Records of review shall be maintained

7.3.5Verification shall be performed

7.3.5Verification results shall be recorded


7.3.6Validation shall be performed

Validation results shall be recorded

7.3.7Changes shall be identified, reviewed, verified, validated and records maintained

Evaluation of design changes on constituent parts and delivered product

Purchasing

7.4.1Organization establish the criteria for evaluation/selection of a supplier ability to supply product in accord with requirements

Receiving Inspection performed on all incoming materials

Quality records of acceptable suppliers maintained

7.4.2Purchasing documents includes: a) products, procedures, processes, equipment, personnel and QMS requirements

Organization shall ensure adequacy of specified purchase requirements prior to communication to the supplier

7.4.3Organization established & implemented controls to ensure purchased product meets specified purchasing requirements

Organization has implemented controls for verification of product at suppliers premises (by itself or its customers)

Control of Production and Service Provision

7.5.1Controlled conditions include: a) information that describes the characteristics of the product

b) availability of work instructions

c) use of suitable equipment

d) Availability and use of monitoring and measuring equipment

e) Implementation of monitoring and measurement

f) Implementation of product release, delivery and post-delivery activities

Validation of Processes for Production and Service Provision

7.5.2The Organization shall demonstrate ability of these processes to achieve planned results: a) Define criteria for review and approval of processes where resulting output cannot be verified

b) Approval of equipment and qualification of personnel

c) Use of specified methods and procedures

d) Requirements for records

e) Revalidation

Identification and Traceability

7.5.3Organization shall identify product by suitable means throughout product realization

Where traceability is requirement, organization shall control and maintain records

Organization shall identify the product status with respect to monitoring and measurement requirements


Customer Property

7.5.4Control of customer property while under organizations control

Preservation of Product

7.5.5Preservation of product during handling

Preservation of product during packaging

Preservation of product during storage

Control of Monitoring and Measuring Devices

7.6Determine the monitoring and measurements required and obtain the required equipment

Equipment shall be: a) calibrated against standards traceable to international or national standards

b) adjusted or re-adjusted as necessary

c) identified to determine calibration status

d) safeguarded from adjustments that would invalidate the measurement results

e) protected from damage and deterioration during handling, maintenance and storage

Assess and record the validity of previous measuring results when the equipment is found not to conform to requirements

Action taken on monitoring and measurement equipment when found to be out of calibration

Calibration records of equipment maintained

Measurement, Analysis and Improvement

8.1Plan and implement the monitoring, measurement, analysis, and improvement processes needed to: a) demonstrate conformity to the product requirements

b) ensure conformity of the QMS

c) continually improve the effectiveness of the QMS

8.2.1Customer Satisfaction - monitor info relating to customer perception whether organization met customer requirements

8.2.2Procedure includes responsibilities for planning and conducting audits, establishing records and reporting results

Internal audits (RECORD): Consider the results of previous audits

Auditors shall not audit their own work

Audit criteria, scope, frequency and methods shall be defined

Management responsible shall ensure that any actions are taken to eliminate nonconformities

Follow up includes verification of action taken and reporting results

8.2.3Apply suitable methods of monitoring and measurement of QMS conformity


8.2.4Monitor characteristics of product to verify it meets requirements

Monitoring carried out at appropriate stages of product realization process

Evidence of product conformity maintained

Records indicate the person(s) authorizing release of product for delivery

Product release and delivery to customer shall not proceed until planned arrangements have been completed

Control of Nonconforming Product

8.3Documented procedure established for dealing with nonconforming product

Nonconforming product controlled by taking action to eliminate nonconformity; acceptance under concession; or by taking action to preclude its intended use or application

Organization shall take appropriate action when nonconformity is detected after delivery or use

Responsibility for review and disposition defined

Records of nonconformities and any subsequent actions maintained

When nonconformity is corrected, it shall be re-verified to demonstrate conformity to requirements

Analysis of Data

8.4Determine, collect & analyze data to demonstrate the suitability & effectiveness of QMS & evaluate continual improvement

Data provided relating to customer satisfaction, product conformity, process/product trends, supplier information

Improvement

8.5.1Continually improve the effectiveness of the QMS

Corrective Action

8.5.2Documented procedure required to take action to eliminate the causes of nonconformities to prevent recurrence

Corrective action established and include: a) reviewing nonconformities (including customer complaints)

b) determining the cause of nonconformities

c) evaluating the need for action to ensure that nonconformities do not re-occur

d) determining and implementing action to eliminate nonconformity

e) records of results taken

f) reviewing the effectiveness of corrective action taken

Preventive Action

8.5.3Documented procedure required to take action to eliminate the cause of potential nonconformities to prevent occurrence

Preventive action established: a) to determine potential nonconformities and their causes

b) evaluating the need for action to prevent nonconformities

c) determining and implementing action needed

d) records of results taken

e) reviewing the effectiveness of preventive action taken

Date: Page 5 of 6

Documents

Iso 9001: 2008 Gap.Analysis Report