To create a basic awareness about Quality Management System
(QMS) based on ISO 9001:2008 standard.
Content: Introduction Definitions Benefits of ISO 9001 Overview of ISO 9001:2008 Clause What is ISO ? Stands for, International Organization for Standardization (ISO) Founded in 1947 Independent, non-governmental organization Made up of member from the National Standard bodies of 163 countries and 3368 technical bodies. Central Secretariat in Geneva, Switzerland Published over 19, 500 international standards covering almost all aspects of Technology and Business NAME The International Organization for Standardization (ISO) would have different acronyms in different Language (IOS in English, OIN in French for Organization Internationale de Normalisation) Decided to give it short form ISO ISO is derived from the Greek word ISOS meaning Equal
ISO 9000:2005 QMS Fundamental and Vocabulary ISO 9001:2008 QMS Requirements (For Certification) ISO 9004:2009 Guideline (Beyond ISO 9001) ISO 19011:20011 For Auditing (Internal and External Audits) Family of related international standards and guidelines on Quality Management and Quality assurance. First published in 1987 (and continually updated) by the ISO Standards are not specific to any industry or product. This is a comprehensive set of standards and guideline for Quality Management Systems. ISO 9000 series of standards are developed by Technical Committee ISO/TC 176, Quality management and quality assurance. It is System-Based not Product Based. This is a distillation of Quality System that have been tried and proven by the industry.
Amount of money, time and paperwork required. Poor process selection and/or poor technical solutions might result in poor quality performance. (Garbage in and Garbage Out). Having concept that we just need to satisfy the Auditor. Prone to failure when a company is interested in certification before Quality. Mislead companies into thinking that certification means better Quality.
Organization Certification Bodies / Registrar Bureau Veritas, BSI Global, URS National Accreditation Bodies (NAB) UKAS( UK), ANAB(USA), JAS-ANZ (Australia) International Accreditation Forum (IAF) Certification is known in some countries as registration. It means that an independent, external body has audited an organization's management system and verified that it conforms to the requirements specified in the standard (ISO 9001). ISO does not carry out certification and does not issue or approve certificates, Certification bodies themselves operate under another quality standard, ISO/IEC 17021 Accreditation is like certification of the certification body. It means the formal approval by a specialized body - an accreditation body - that a certification body is competent to carry out ISO 9001:2008 certification in specified business sectors. Certificates issued by accredited certification bodies - and known as accredited certificates - may be perceived on the market as having increased credibility. ISO does not carry out or approve accreditation. Accreditation bodies operate under ISO/IEC 17011. A common sense way of ORGANIZING & MANAGING THE BUSINESS PROCESSES that affect the quality of our products and services
We gain a common understanding of how the important things get done We have a chance to capture our Best Practices Our Internal audit system ensures we stay on track Our Corrective Action system helps to fix problems Continual Improvement becomes a way of life A Quality Management System keeps us from moving backwards and losing important knowledge that we gain over time Changes are controlled
Documented QMS MARKET PRESSURE Tangible proof that the quality management system established by our organization meets the requirements of and internationally recognized standard. Provide marketing edge over competitors It enhanced customers satisfaction an loyalty; because it is assured that their requirements are met. Increased competitiveness and profitability as quality products are being delivered and operational cost are reduced. Once our system is developed and documented , all members of the organization should follow the procedures or rules and make improvements to the system. Document our work procedures / systems What we do Who does do it When we do it How we do it Ensure that the procedures are being followed in actual PRACTICE. Keep RECORDS, minutes of what you practice
Everyone is welcome! Improve your process Measure performance (see your procedure) Look for ways to improve efficiencies Look for ways to prevent errors Suggest changes to procedures and work instructions Help finding solutions to problems written in Corrective Action Requests and Preventive Action Requests
Say what youll do! Do what you say! (Disciplined Use of System) Prove It! Improve It! Everyone! Everywhere! Every Time! The Spirit of the QMS Way Do What You Say!!!!! Follow the established system (documented information) Ask for clarification if confusing Help other people to understand the system Improve your job, your process, the system! What Do You Do If a Process Is Wrong? Stop Get the process changed Participate in Quality Improvement Opportunities
The degree to which a set of inherent characteristic fulfills requirements. Fitness for the Purpose Conformance to Requirements Customer Satisfaction All activities of overall Management function that determine Quality Policy, Objectives & Responsibility, & Implement them by means of Quality Planning, Quality Control, Quality Assurance & Quality Improvement. A common sense way of ORGANIZING & MANAGING THE BUSINESS PROCESSES that affect the quality of our products and services Quality Assurance Quality Assurance is a set of activities intended to establish confidence that quality requirements will be met. Quality in Process Proactive in nature Example: Process checklists, Audits, Methodology etc. Quality Control Quality control is a set of activities intended to ensure that quality requirements are actually being met. Quality in Product Reactive in Nature Example: Inspection, Testing Process etc. Quality Management System Uses both Quality Assurance and Quality Control 8 Principle of Quality Management Organizations depend on their Customers and therefore should:
Understand current and future customer Needs; Meet customer Requirements and Strive to exceed customer Expectations. Leaders should:
Establish unity of purpose and Direction of the organization & Create and maintain the internal environment in which people can become fully Involved in achieving the organizations objectives. People at all levels are the essence of an organization and Their full involvement enables their abilities to be used for the organizations benefit. Organizations need to do more than simply monitor process outputs (typically through inspection activities): They must also control all process inputs, (people, facilities, equipment, material & methods) & They must establish appropriate controls over the transformation activities (if desired results are to be achieved consistently and efficiently). Process The Steps You Do to Accomplish Something Output Supplier Customer Input A Simple Process Model - Activity that transforms Input into Output Resources: People Facilities/Equipment Material Methods Result: Product Services Performance
Your Process Act Do Plan Check
Continual Improvement The Plan-do-Check-Act (PDCA) methodology applies to all processes Deploy and conform with plan Activities Controls Documentation Resources Objectives Analyze/review Decide/change Improve effectiveness Measure and monitor for conformity and effectiveness Organizations must understand a system is a set of interrelated processes, and the output of one process is the input to one or more subsequent processes, so ... It is critical to manage the white space (or interface) between processes to ensure that the overall system is effective Quality Management System is a key part of the entire business system Asset-creating Processes Finance Acquisition IT, Facilities, Equipment HR Customers Business Processes Core Processes (create customer value) Support Processes Maintenance Manage Information HR Maintenance Financial Transactions
Business System Sales Process Design Process Purchasing Process Receiving Process Delivery Process Production Process Process Combined to Make a System Process A Process C Input A O u t p u t
A
C o n t r o l
Output A C o n t r o l
Output C C o n t r o l
Process B Output B Input B Input C Continual improvement of the organizations overall performance should be a permanent objective; Improvement must be a planned activity if the organization desires to improve overall performance and capabilities. Effective decisions are:
Based on the analysis of data and information. An organization and its suppliers are truly inter-dependent and A mutually beneficial relationship enhances the ability of both to create value. 4. Quality Management System 6. Resource Management 7.Product Realization 8. Measurement Analysis & Improvement 5. Management Responsibility General Requirement Documentation Requirement Management Commitment Customer Focus Quality Policy Planning Responsibility, Authority & Communication Provision of Resources Human Resources Infrastructure Work Environment Planning Customer Related Processes Design and Development Purchasing Production and Service Provision General Monitoring and Measurement Control of NCP Analysis of Data Improvements Management Review Control of Measuring and Monitoring Equipment Thank you 1.1 General Applicable, where an organization: Needs to demonstrate its ability to provide product that meets customer and applicable statutory and regulatory requirements, and Aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to the customer and applicable regulatory requirements.
1.2 Application Tailoring permitted subject to following condition: Exclusions should not affect the organizations ability or responsibility, to provide product that fulfills customer and applicable regulatory requirements Exclusions permitted only in clause 7.
ISO 9000 : Quality management system - Fundamentals and Vocabulary
Terms and definitions given in ISO 9000 shall apply Product also means service
4.1. General Requirement Establish, document, implement and maintain quality management system and Continually improve the effectiveness of the quality management system.
4.1. General Requirement The organization shall: a) Identify the processes (Include processes related clause 5, 6, 7 and 8, consider clause 1.2) b) Determine the sequence and their interaction c) Determine criteria and methods required to ensure that both operation and control of these processes are effective.
4.1. General Requirement The organization shall: d) Ensure availability of resources and information to support their operation and monitoring e) Monitor, measure and analyze these processes f) Implement actions necessary to achieve planned results and continual improvement
Identify and ensure control over outsourced processes affecting product conformity, within Quality Management System
(In 2008 two notes are added to clarify outsourcing) DFC 4.1 Description of Interaction of Key QMS Processes Top Management / MR M a n a g e m e n t
R e s p o n s i b i l i t y Quality Production Purchase Marketing HRD Inf ormation Sy stem M e a s u r e m e n t ,
A n a l y s i s
a n d
I m p r o v e m e n t P r o d u c t
R e a l i z a t i o n R e s o u r c e M a n a g e m e n t Conduct Management Reviews DFC 5.6 Establish and Improve QMS QM Provide Resources Section 6.0 Conduct Internal Audits 8.2.2 (P-IQA) Plan and Maintain Facilities DFC 6.3 Qualifyand Train Workforce DFC 6.2 Maintain Documents and Records 4.2.3 (P-CD) 4.2.4 (P-CR) Initiate Corrective and Preventive Actions Section 8.5 (P-CPA) Analyze Internal Audit Data Monitor Customer satisfaction 8.2.1 (SOP 8.2.1) Analyze Customer Data Plan & Control Design SOP 7.3 Analyze Product Performance Data Design Identifyand ReviewProduct Requirements Manage Customer Communications (Inquiries, Orders, Amendments, Feedbacks including complaints) DFC 7.2 Design? Establish and Maintain Product Identification and Traceability SOP 7.5.3 Preserve Product and Control Customer Property (Purchased Product, In-Process and Finished Goods) SOP 7.5.4 and SOP 7.5.5 Section 8.4 (DFC 8.4) Analyze Supplier Performance Data Analyze Production Process Data Analyze Quality (QA/QC) Data Analyze Competency Data Analyze Documentation Control Nonconforming Product Section 8.3 (P-NCP) Monitor Production Processes Section 8.2.3 Monitor Product Quality (Receiv ing, In-process and Final Inspection) Section 8.2.4 Control Monitoring and Measuring Devices SOP 7.6 Assure Supplier Quality SOP 7.4.1 Purchase Product (Outsourced Products and Serv ices) SOP 7.4.2 Plan and Control Production DFC 7.1 (Producti Real izati on Cycl e) DFC 7.5.1 (Sequence of Producti on Processes) SOP 7.5.1 (Planni ng and support processes) Develop Product QualityPlans SOP 7.1 Validate Special Processes SOP 7.5.2 No Yes DFC 7.2 Quality Manual Name of organization Document ID: QM/ Rev . No.: 00/ Rev . Date: 01-04-2002/ Page 3 of 9 4.2.1 General Quality policy and its objectives ( See 5.3, 5.4.1) A quality manual (See 4.2.2) Documented procedures Documents required by the organization Quality records required by the standard
4.2.2 Quality Manual Standard requires organizations to prepare Quality Manual detailing: 1. Scope, exclusions (see 1.2) and their justification 2. Documented procedures or reference to them 3. Descriptions of interaction between the processes
4.2.3 Control of documents: Documented procedure is required for control of documents. Standard requires: 1. Approve documents for adequacy prior to issue 2. Review, update and re-approve 3. Identify changes and current revision status 4. Ensure availability of relevant versions at points of use 4.2.3 Control of documents: 6. Ensure that documents are legible and identifiable 7. identify and control distribution of documents of external origin 8. identify obsolete copies to prevent unintended use if retained.
4.2.4 Control of Records: 1. Documented procedure is required for Identification, Storage, Protection, Retrieval, Retention Time and Disposition of quality records. 2. Records should provide evidence of conformity 3. Records should evidence effectiveness of QMS. 4. Records should be legible, identifiable and retrievable. Legible: Clear, Comprehensive and Understandable (and not simply readable)
5.1 Management commitment: Top management to provide evidence of its commitment to the development, implementation and its continual improvement by: communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements (see 7.2.1) 5.1 Management commitment: Establishing Quality Policy (see 5.3), Ensuring that Quality Objectives are established (see 5.4.1 and 7.1a), Conducting management reviews (see 5.6), Ensuring the availability of resources (see 6.1)
Objective : Enhance Customer Satisfaction
What to do: Determine customer requirements. Fulfill customer requirements.
Note : See 7.2.1 Product related requirements See 8.2.1 Customer satisfaction
Responsibility : Top management
Top management should ensure that Quality Policy: is appropriate to purpose of organization includes a commitment to comply with requirements and for continual improvement of effectiveness of processes of quality management system.
Responsibility : Top management provides a framework for establishing and reviewing quality objectives is communicated and understood within the organization, and is reviewed for its continuing suitability.
5.4.1 Quality Objectives Quality Objectives are required: at relevant functions and levels to be measurable (not necessarily quantifiable) to be consistent with quality policy to include product requirements (See 7.1a)
5.4.2 Quality Management System Planning Planning of QMS to meet the requirements given in clause 4.1 Establish, document, implement and maintain quality management system, and Continually improve the effectiveness of the quality management system. Integrity of QMS should be maintained, when changes are planned and implemented.
5.5.1 Responsibility and authority Define and communicate : Responsibilities Authorities Interrelations between various authorities within the organization
Appoint a Management Representative for : Ensuring that processes of QMS are established, implemented and maintained. Reporting to top management on performance and need for improvement. Ensuring the promotion of awareness of customer requirements throughout the organization.
1. Processes to be established for communication within the organization. 2. Internal communication may be documented, verbal or through electronic media. For example : a. Amendment in customer requirements, b. Purchasing information.
5.6.1 General By top management, maintain records (See 4.2.4): 1. QMS should be reviewed at planned intervals 2. Verify continuing suitability of QMS 3. Verify adequacy of QMS 4. Verify effectiveness of QMS 5. Evaluate need for changes in QMS
5.6.2 Review input Management review inputs should include: 1. Results of audits (internal quality audits, customer audits and third party audits). 2. Customer feedback (including customer complaints) . 3. Process performance and product conformity. 4. Status of corrective and preventive actions. 5. Follow-up actions from previous management reviews. 6. Planned changes that could affect QMS 7. Recommendations for improvement
5.6.2 Review input Notes: 1. Define periodicity of some or all the inputs. 2. Based on need, short reviews can be conducted for just one or two points. 3. MR should submit report of performance of QMS and suggestions for improvement prior to review. 4. Trends of process performance and product conformity should form a part of review.
5.6.3 Review Output Record (see 4.2.4) the decisions and actions finalized during review. It may be relating to: 1. improvement of QMS and its processes. 2. improvement of product related to customer requirements 3. resource needs Note : Record actions and follow-ups.
6.1 Provision of resources Determine and provide the resources needed. To implement and maintain QMS and continually improve effectiveness of QMS
Enhance customer satisfaction by meeting customer requirements.
6.2.1 General Personnel performing work affecting conformity to product requirement shall be competent on the basis of: 1. Education 2. Training 3. Skills 4. Experience
The organization should: Determine the necessary competence for personnel performing work affecting product quality Provide training or take other actions to satisfy these needs Evaluate the effectiveness of actions taken Ensure that employees are aware of the relevance and importance of their activities and how they contribute to achievement of quality objectives. Maintain appropriate records of education, training, skills and experience (see 4.2.4).
Determine, provide and maintain infrastructure required to achieve product conformity.
What to consider: Buildings, workspace and associated utilities. Process equipment (hardware and software). Supporting services (transportation, communication, information system etc.)
Determine and manage work environment required to achieve product conformity.
What to consider: Ambient temperature of workspace Availability of fresh air Lighting, etc.
7.1 Planning of product realization Process: An activity that transforms inputs into outputs.
Product realization: Sequence of processes and sub-processes required to achieve the product is called product realization.
A document which describes how the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract, can be referred as quality plan.
Organization should determine followings Quality objectives and requirements for the product, Need to establish processes Documentation required Resources needed Verification and validation requirement Monitoring, inspection and test requirements Criteria for product acceptance Records necessary to provide evidence of conformity of realization processes and conformity of product (See 4.2.4)
7.2.1 Determination of requirements related to the product a) Specified by customer (including delivery and post delivery activities) b) Not specified by the customer but necessary for specified use or known and intended use.
* Post delivery includes recycling, final disposal
7.2.1 Determination of requirements related to the product c) Statutory and regulatory requirements related to the product and d) any additional requirement determined by the organization.
7.2.2 Review of requirements related to product Ensure that Product requirements are defined. Contract or order requirements differing from those previously expressed are resolved, and Organization has ability to meet the requirements. When: submitting tender or quotation, accepting contract or order, accepting changes to orders
7.2.2 Review of requirements related to product Ensure that Record results of the review and actions arising from the review. In case of amendments (changes) in the requirements, amend relevant documents inform relevant personnel Confirm, in case of verbal communication
7.2.3 Customer communication Effective arrangements for communication required with customer on following matters Product Information Enquiries, contracts or order handling, amendments to orders Customer feedback, including customer complaints
7.3.1 Design and development planning Plan and control to determine: Stages of design and development Requirement of review, verification and validation as appropriate to each stage Responsibilities and Authorities Manage interfaces between different groups involved in design and development to ensure communication (see 5.5.3) and clear assignment of responsibility (see 5.5.1) Update planning output document, as appropriate, with progress in design and development
7.3.2 Design and development inputs Objective : To determine inputs relating to product requirements. Determine and maintain records (See. 4.2.4) to be reviewed for adequacy to be complete and unambiguous should not conflict with each other
7.3.2 Design and development inputs Inputs should include a) Functional and performance requirements b) Applicable statutory and regulatory requirements. c) Information derived from previous similar designs d) Other essential requirements.
7.3.2 Design and development outputs Objective a) To meet input requirements b) Provide appropriate information for purchasing, production and for service provision c) Provide product acceptance criteria d) Specify characteristics essential for its safe and proper use, preservation. e) Outputs Shall be approved prior to release
7.3.4 Design and development review Objective a) To evaluate the ability of the results to fulfill requirements, and b) To identify any problems and propose necessary actions
7.3.4 Design and development review When and How ? At suitable stages, in a systematic manner Review team to include functions concerned with stage of being reviewed Record result of review and actions (see 4.2.4)
7.3.5 Design and development Verification Objective: Verification To Verify that output satisfies input requirement Requirement: Records result of verification and necessary action (see 4.2.4)
7.3.6 Design and development Verification Objective: Validation To ensure product capability to meet specified or known intended use How and When ? 1. To be planned (see 7.3.1) 2. Prior to delivery or prior to implementation 3. Record result of validation and necessary actions.
7.3.7 Design and development Changes Objective 1. To identified and recorded (See 4.2.4) 2. To be reviewed, verified and validated (see 7.3.6) 3. To be approved before implementation 4. To include evaluation of effect of changes on constituent parts and delivered products 5. Record result of review of changes and necessary actions (See 4.2.4)
7.4.1 Purchasing process 1. Ensure that purchased product conforms to specified purchase requirements. 2. Select suppliers based on their ability 3. Document criteria for selection, evaluation and re- evaluation. 4. Define type and extent of control on supplier.
7.4.1 Purchasing process Type and extent of control exercised on supplier should depend on effect of purchased product on next process (see 7.1) or final product Results of evaluation and necessary actions arising from evaluation to be recorded (See 4.2.4).
7.4.2 Purchasing process Purchasing information normally consists of: a) Requirement of approval of product, procedures, processes and equipment, as appropriate. b) Requirement of qualification of personnel, if required. c) Quality management system requirements. d) Product verification arrangements (see 7.4.3)
7.4.3 Verification of purchased product Establish and implement arrangements (inspection etc.) for verification of purchased product. This may consists of : 1. Total verification after receipt of product 2. Partial or total verification at suppliers premises by organization or its customer.
7.5.1 Control of production and service provision Plan and carry out under controlled conditions, that includes: a) Availability of information that describes the characteristics of product, b) Availability of work instructions, (Refer clause 4.2.1, Note 2)
7.5.1 Control of Production and service provision Controlled Condition c) use of suitable equipment, d) availability and use of measuring and monitoring equipment, e) Implementation of monitoring and measurement processes f) Implementing release, delivery and post-delivery activity.
7.5.2 Validation of processes for production and service provision Applicable only on those processes where : Quality of output can not be verified by subsequent monitoring and measurement. Deficiency will become apparent only when product is in use or service is delivered.
7.5.2 Validation of processes for production and service provision The Validation should demonstrate Ability to provide conforming product Evidence of consistency in result Achieve planned result Criteria to decide about a process to be considered as Special process depends on resources availability in an organization.
7.5.2 Validation of process for production and service provision Process Validation may include 1. Defined criteria for review and approval of processes 2. Approval of equipment and qualification of personnel 3. Use of specific methods and procedures 4. Process parameters and other details to be recorded (see 4.2.4) 5. Re-validation (Frequency of validation)
7.5.3 Identification and Traceability Identify the product (See 7.5.1) Identify status with respect to monitoring and measurement requirements (i.e. inspection and test status) Control and record the identification of product, if traceability is a requirement (See 4.2.4).
What is customer property ? Any product received from the customer or made available by the customer to the organization or its representative for production and service provision. What is customer property ? Any product received from the customer or made available by the customer to the organization or its representative for production and service provision. What is customer property ? Products to be incorporated in to the final product. Products to enable processing or delivery of final product. Tools and equipment provided by the customer. Products received from customer for post delivery service operation. What is customer property ? Products (including tools) provided by customer at customer premises to enable delivery of final product or post-delivery operation. Any type of intellectual property including concepts, designs (or drawings) provided by customer. (Personal data) 1. Identifying, Verifying, Protecting and Safe guarding customer property. 2. Recording the occurrence of lost, damage or otherwise finding un-suitability of use (See 4.2.4) 3. Reporting to customer, occurrence of lost, damage or otherwise finding un-suitability of use 1. Apply suitable techniques for preserving the conformity of product. 2. Also applicable to constituent parts of the product, 3. Requirement covers product identification, handling, packaging, storage and protection.
What are monitoring and measurement equipment: Physical Software Question paper, Checklist or questionnaire used for measurement of competence of personnel, customer satisfaction, effectiveness of QMS, used during internal audit, etc.
Determine monitoring and measurements to be undertaken. Determine monitoring and measurement devices needed. Determine calibration (or verification) requirements based on use, Calibrate, traceable to national or international standards if such standards exists, else record basis used for calibration or verification. (See 4.2.4)
Identify calibration status. Safeguard the devices from adjustments that could invalidate the result. Protect the devices from damage and deterioration during handling, maintenance and storage. Record the results Validate conformity of previous results if device is found out of calibration and take appropriate action on the equipment and product affected.
8.1 General What to do 1. Plan and implement monitoring, measurement, analysis and improvement processes needed. 2. Include applicable methods and extent of their use.
8.1 General Objective: 1. To demonstrate conformity of product 2. To ensure conformity of QMS, and 3. To continually improve the effectiveness of quality management system.
8.2.1 Customer Satisfaction 1. An objective of QMS 2. One of the measurement of performance of QMS. 3. Monitor customer perception regarding fulfillment of requirements. 4. Determine the methods for obtaining and using the information on customer satisfaction.
8.2.2 Internal Audit Objective 1. QMS conforms to planned arrangements (see7.1) 2. QMS conforms to the requirement of the standard 3. QMS conforms to the requirements of the organization 4. QMS: Effectively implemented and maintained
8.2.2 Internal Audit Requirement: 1. Ensure objectivity and impartiality of audit. 2. Auditors shall not audit their own work. 3. Actions to be taken without undue delay. 4. Follow-up actions to verify actions taken and report verification results (See 8.5.2). 5. Results of audit to be reported for management review (See 5.6).
a. Audit Planning b. Audit criteria c. Audit scope d. Audit frequency e. Audit method f. Responsibilities g. Reporting results h. Maintain records (4.2.4)
DOCUMENTED PROCEDURE IS REQUIRED TO DEFINE a. status of processes b. importance of processes c. results of previous audits. 8.2.2 INTERNAL AUDIT 8.2.3 Monitoring and Measuring of processes:
Objective: Monitor and Measure Process 1. Apply suitable methods for monitoring and, where applicable, for measurement. 2. Demonstrate ability of processes to achieve planned results. 3. Make corrections, if required. 4. Take corrective action, if required, 5. Applicable to all the processes (see 4.1 & 7.1)
8.2.4 Monitoring and Measurement of Product Monitor and measure product characteristics 1. At appropriate stages of product realization (7.1) 2. Record evidence of conformity against acceptance criteria. 3. Records to indicate authority responsible for release. 4. Product release and service delivery to proceed only when all specified activities (see 7.1) have been completed, else approval is required by relevant authority or customer.
8.3 Control of Nonconforming Product Objective 1. To prevent unintended use or delivery of products which does not conform to requirements. 2. To take appropriate action on consequences if non conformity is detected after delivery.
8.3 Control of Nonconforming Product Disposition could be: a) To eliminate the detected nonconformity b) Use, release or acceptance under concession (to be authorized by relevant authority and, where applicable, by customer) c) Preclude its original intended use
8.3 Control of Nonconforming Product Documented Procedure should cover: 1. Identifying nonconforming product 2. Recording the nature of nonconformities and subsequent actions taken (See 4.2.4) 3. Responsibilities and authorities 4. Re-verification, when non-conformity is corrected, as per specified requirements (see 8.2.4)
8.3 Control of Nonconforming Product Documented Procedure should cover: 5. Allowing concessions 6. Obtaining concessions from the customer 7. Actions needed when nonconformity is detected after delivery (these actions should be appropriate to the effects, or potential effects of nonconformity)
8.3 Analysis of Data Objective To determine suitability and effectiveness of QMS To identify areas of improvements and opportunities for preventive action. Requirement: Determine, Collect and Analyze data
8.3 Analysis of Data Area of Application ( not exhaustive list) Customer satisfaction (see 8.2.1) Conformance to product requirements (See 7.2.1) Characteristics and trends of processes and products Suppliers
8.4 Analysis of Data Area of Application ( not exhaustive list) Customer satisfaction (see 8.2.1) Conformance to product requirements (See 7.2.1) Characteristics and trends of processes and products Suppliers
8.5 Improvement 8.5.1 Continual Improvement 1. Quality Policy (see 5.3) 2. Quality Objectives (see 5.4.1) 3. Audit results (see 8.2.2) 4. Analysis of data (see 8.4) 5. corrective action (see 8.5.2) 6. Preventive action (see 8.5.3) 7. Management review (see 5.6)
Correction: Elimination of nonconformities. Corrective action: Actions taken to prevent the recurrence of nonconformities. Preventive action: Actions taken to prevent the potential occurrence of nonconformities. Review non conformities (including customer complaints), Determine the causes of non conformity, Evaluate the need for actions to prevent recurrence of nonconformities, Determining and implementing the actions needed (appropriate to their effects) Recording results of action taken (see 4.2.4) Reviewing the effectiveness of action taken
1. Determine potential non conformities 2. Determine the causes 3. Evaluate the need for action to prevent occurrence of nonconformities. 4. Determining and implementing the actions needed (appropriate to their effects) 5. Recording results of action taken (see 4.2.4) 6. Reviewing the effectiveness of action taken
Only six documented procedures are Mandatory 1. Control of documents (See 4.2.3) 2. Control of quality records (See 4.2.4) 3. Internal quality audit (See 8.2.2) 4. Control of nonconforming product (See 8.3) 5. Corrective action (See 8.5.2) 6. Preventive action (See 8.5.3)
Management review (clause 5.6.1) Education, training, skills and experience (clause 6.2.2 e) Evidence that the realization processes and resulting product fulfill requirements (clause 7.1 d) Results of the review of product requirements and actions arising from the review (clause 7.2.2) Design and development inputs (clause 7.3.2)
Result of design and development review and any necessary actions (clause 7.3.4) Result of design and development verification and any necessary actions (clause 7.3.5) Result of design and development validation and any necessary actions (clause 7.3.6) Result of design and development changes and any necessary actions (clause 7.3.7)
Results of supplier evaluations and actions arising from the evaluations (clause 7.4.1) Validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement (clause 7.5.2 d) The unique identification of the product, where traceability is a requirement (clause 7.5.3) Customer property that is lost, damaged or otherwise found to be unsuitable for use (clause 7.5.4) Standards used for calibration or verification of measuring equipment where no international or national measurement standards exist (clause 7.6a) Validity of previous results when measuring equipment is found not to conform with its requirements (clause 7.6)
Results of calibration and verification of measuring equipment (clause 7.6) Internal audit results (clause 8.2.2) Evidence of product conformity with the acceptance criteria and indication of the authority responsible for the release of the product (clause 8.2.4)
Nature of the product nonconformities and any subsequent actions taken, including concessions obtained (clause 8.3) Results of corrective action (clause 8.5.2) Results of preventive actions (clause 8.5.3)