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ISO 9001-Clause 8.2

ISO 9001-Clause 8.2 Monitoring and measurement

ISO 9001-Clause 8.2.1 Customer satisfaction

ISO 9001 Requirement

As one of the measurements of the performance of the quality management system, the organization shall monitor information relating to customer perception as to whether the organization has met customer requirements. The methods for obtaining and using this information shall be determined.

NOTE Monitoring customer perception can include obtaining input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, warranty claims and dealer reports.

Explanation:

Customers are primarily the end users of your product, but also include intermediaries such as assembler who may be internal or external and who integrate your product into theirs, and dealers and distributors who market and sell your product or the integrated product. You need to consider feedback from all these customers to determine whether or not you have met their specified and perceived requirements. Customer requirements may relate to the design, manufacture, delivery, servicing and support of product, QMS, communication and financial requirements, etc. you must have controls to identify and meet these requirements  Customer feedback or  satisfaction is the first tool required by this standard to gauge the health of your QMS. This clause requires you to gather and analyze information as to what extent you met these requirements, from the customers perspective. What is the customer’s evaluation of your performance with regard to their requirements?
You must continually gather information about these activities, in a manner capable of being analyzed and evaluated to determine how well you performed them. There are all kinds of performance indicators for design, manufacture, delivery, service and support, etc. Gather information on these indicators from both the customer as well from internal processes. There are many ways to monitor customer satisfaction feedback both positive as well as negative. These may include customer complaints, direct communications with customers, questionnaires and surveys, subcontracted collection and analysis of performance data, reports from consumer organizations, reports in various media, sector and industry studies. You are expected to have a process that defines your customer satisfaction indicators, frequency and method of data collection, summarization, review and evaluation of data, actions to improve, timeline, responsibility and follow-up. Many customers routinely provide feedback on some or all of the information indicated above.  You must continuously review this customer feedback to ensure you maintain and improve your customer satisfaction rating. You must monitor trends in customer satisfaction indicators and use these as a baseline for continual improvement. You should consider both external as well as internal customer satisfaction. Note that every internal process is either a customer or supplier of another process. You must identify and document the process addressing this clause as part of your QMS. For this process, you must also identify what specific documents, controls and resources are needed. You could use a documented procedure or other combination of specific practices, procedures, documents and methods. Look at the risks and benefits in determining the extent of documented controls you need to have.
Performance indicators to measure the effectiveness of processes that control customer satisfaction may include improvement in customer feedback ratings, reduction in customer complaints, increase in the number of customers providing feedback, increase in feedback that leads to QMS and product improvement opportunities.

ISO 9001-Clause 8.2.2 Internal audit

ISO 9001 Requirement

The organization shall conduct internal audits at planned intervals to determine whether the quality management system

a) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organization, and
b) is effectively implemented and maintained.

An audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. The selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work.

A documented procedure shall be established to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results.

Records of the audits and their results shall be maintained (see 4.2.4).

The management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes.

Follow-up activities shall include the verification of the actions taken and the reporting of verification results (see 8.5.2).

NOTE See ISO 19011 for guidance.
Explanation:

Internal audit is the second important tool required by this standard used to gauge the health of your QMS. How effective is it in meeting ISO 9001, your own QMS, customer and regulatory requirements. You must have a documented procedure for your internal audit process.
The scope of your internal audit program must cover the:

  • Audit of product realization processes to determine conformity of both product and product realization processes to customer and applicable regulatory requirements.
  • Audit of the QMS to determine conformity to the ISO 9001 standard.
  • Audit of the QMS to determine conformity to organizational requirements.
  • Audit of QMS processes and their interaction to determine if the QMS has been effectively implemented and maintained.

In determining the time frame for your audit program, you should consider organization size, complexity of product and processes, health of the QMS, customer, registrar and regulatory requirements, etc. The most common time frame is six months.
Consider adjusting the audit frequency and perhaps even the audit scope, of specific processes or group of processes, when:

  • You experience internal or external nonconformities.
  • Get customer complaints.
  • Have critical or high risk processes.
  • Have frequent or significant changes to processes and product.

Your internal audit program should consider the following:

  • Input from audited area and related areas
  • Key customer oriented processes
  • Process and product performance results and expectations
  • Opportunities for continual improvement
  • Feedback from customers

Audit criteria, refers to the specific QMS policies, objectives, ISO requirements, documentation, customer and regulatory requirements, etc., that the audit is referenced to or conducted against. Audit criteria may relate to the whole audit program as well as each individual audit.
Audit methods refer to the specific techniques that auditors use to gather objective audit evidence that can be evaluated to determine conformity to audit criteria. Examples of audit methods include interview of personnel, observation of activities, review of documents and records, etc.
You must define the minimum qualification requirements for internal auditors. These requirements include knowledge of QMS processes and their interaction, related QMS controls, customer requirements, applicable regulatory requirements, the ISO 9001 standard, the audit process and audit techniques.
Internal auditors needs to be trained in the ISO 9001 standard as they generally audit for conformity to organizational requirements and also for conformity to ISO 9001 requirements. Additionally, the ISO 19011:2002 Guidelines for quality and environmental auditing says that auditors should have knowledge of quality management system standards and their application to the organization.
You must have appropriate resources for your annual audit program. These include having sufficient trained auditors available to conduct scheduled audits, sufficient time to perform audits, availability of department or process personnel to be audited, time and tools to prepare audit records and reports, etc. Auditor should be Independence. During the audit Auditors should ensure that the objectivity and impartiality of the audit is not compromised. Auditors cannot audit their own work. Auditor independence must be ensured when assigning personnel to specific audits.
Process owners must take timely corrective action on nonconformities found in their area. They should use the corrective action procedure to determine root cause, take appropriate action and follow-up to determine if results indicate that the root cause has been eliminated. Audit results must be summarized and reported for management review. The Management Representative must also report any opportunities for QMS improvement. The MR must analyze the results of each audit as well as the annual audit program to determine strengths and weaknesses in QMS processes, interactions, functions, products, etc., to identify and prioritize opportunities for improvement. Audit records include annual audit schedule, audit planning such as criteria, scope, frequency, methods, auditor selection and assignment, etc., auditor competence and training, audit checklists and forms, audit notes and other evidence gathered, audit findings, nonconformity reports, audit reports, corrective actions and follow-up of internal audit nonconformities, analysis of audit program performance indicators and trends, and identified improvement opportunities.
Performance indicators should be used to measure the effectiveness of your internal audit process and monitor trends in these indicators, to continually improve your audit program. Performance indicators may include reducing the number of – late or delayed audits, incomplete audits, incomplete audit records and late reports, auditor errors, auditee complaints, and use of untrained auditors, etc.
The output of your internal audit program may be used as performance indicators to:

  • Determine the degree of conformity of the QMS to ISO 9001, customer and regulatory requirements.
  • Determine the effectiveness of QMS implementation and maintenance.
  • Determine the degree of conformity of product to contractual and regulatory requirements.
  • Identify areas of the QMS that need improvement.

ISO 9001-Clause 8.2.3 Monitoring and measurement of processes

ISO 9001 Requirement

The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate.
NOTE When determining suitable methods, it is advisable that the organization consider the type and extent of monitoring or measurement appropriate to each of its processes in relation to their impact on the conformity to product requirements and on the effectiveness of the quality management system.

Explanation:

You must establish methods and indicators to monitor and measure your QMS processes to demonstrate process capability to achieve planned results and identify opportunities to improve the process. Use your organizations cross-functional knowledge of customer requirements, product, technology, manufacturing processes, etc., to determine process monitoring and measuring indicators and controls. Monitoring and measurement may be done manually or by automated means. Another way to identify useful methods and indicators is to review what problems could occur or have occurred within a particular process. Monitor and measure these occurrences and develop process controls to reduce or eliminate them. Problems or risks can occur with any of the variables in a process for e.g. materials, equipment, facility, methods, technology, personnel, computer hardware or software, etc. By using fishbone analysis or similar tools, you can develop very useful monitoring and measuring methods and process performance indicators.
Correction refers to action taken to eliminate a detected nonconformity, i.e. the symptom. Correction involves the containment, evaluation of the nonconformity and action that may result in rework, regrade, scrap, return of nonconforming material/work to supplier or outsourcer, or acceptance through a customer concession or deviation permit. Correction differs from corrective action. Corrective action is action taken to eliminate the cause of a detected nonconformity to prevent recurrence, whereas correction does not address cause. Managers or personnel responsible for corrective action must be promptly informed of product and process nonconformities.
You must monitor your processes:

  • First to determine and establish capability of new processes to conform to requirements.
  • And secondly, to monitor these processes over time to verify ngoing stability and capability to meet requirements.
  • And thirdly to determine and achieve levels of continual improvement

To achieve planned results, control methods used for monitoring and measurement should focus on achieving the performance indicators we have identified for each QMS process. The monitoring and measurement techniques, sampling plans, acceptance criteria may be documented or referenced in your quality plan, or you could use a combination of specific practices, procedures, documents and methods. Look at the risks and benefits in determining the extent of documented controls you need to have. Performance indicators are not needed for this clause as it provides direction for the application of monitoring and measurement performance indicators for all QMS processes. However the output of monitoring and measurement methods used within each QMS process provides useful performance indicators for determining the effective implementation and maintenance of QMS processes.

ISO 9001-Clause 8.2.4 Monitoring and  measurement of product

ISO 9001 Requirement

The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7.1). Evidence of conformity with the acceptance criteria shall be maintained.
Records shall indicate the person(s) authorizing release of product for delivery to the customer (see 4.2.4).
The release of product and delivery of service to the customer shall not proceed until the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer.

Explanation:

You must identify, monitor and measure product characteristics to verify conformity to requirements. Product characteristics may be dimensional, functional, performance, reliability, durability, maintainability, life, cost, etc. Requirements may come from your customer, your own organization, regulatory and industry sources. You must plan what product characteristic(s) to measure, type of measurements, what measurement device to use, how often to measure, sample size, acceptance criteria, and records needed for each product or product type. Use your product quality plan to document these controls.
Your product, project or contract quality plan must define the stages at which various monitoring and measurement will be carried out at incoming receipt of materials from suppliers or outsourced work, storage, internal production processes, finished product, packaging, at time of shipping, and post installation. Monitoring and measurement may be done by your personnel, subcontracted or outsourced labor or by the customer. You must ensure that all personnel performing monitoring and measurement of product are trained and competent.
If you plan on releasing during any stage of production or shipping finished product, where all planned inspections and measurements to that stage have not been completed, ensure that you obtain prior written approval/waiver from a relevant internal authority or the customer. Where practical, consider completing all missed planned inspections and measurements before product delivery. You must identify and document all product realization processes that may address this clause, as part of your QMS, e.g. receiving, production, shipping, etc. For such processes, you must also identify what specific documents are needed for effective planning, operation and control.
You could use a product quality plan, documented procedure or other combination of specific practices, procedures, documents and methods. Look at the risks related to your product, processes and resources in determining the extent of documented controls you need to have. Performance indicators to measure product conformity may include reduction in defect rates, PPM’s (defective parts per million), scrap rates, waste, rework, improvement in on time delivery, product returns from customer, etc. Performance indicators to measure the effectiveness of product realization processes in achieving product conformity include productivity, reduction of cycle time, errors, omissions and failures, etc.

Audit Checklist

For Clause 8.2.1:

  1. Are both a proactive and reactive approach used to obtain Customer feedback?
  2. How is feedback obtained from Customers? What is the structure/format that is used? Does it provide information on how Customers perceive the organization’s performance?
  3. Is more than one method or technique employed?
  4. How often is each method used (frequency)?
  5. How is this information communicated internally?
  6.  How is this information used to uncover ways to improve?

For Clause 8.2.2:

  1. Is there a procedure in place for auditing? Does it cover the  requirements in ISO 9001 and ISO 19011? How is the audit schedule prepared/approved each year? What approach was used to audit a process based system?
  2. How were individual processes audited? Was a process auditing technique used? How was this done?
  3. How is effectiveness of the QMS assessed/verified?
  4. What were the results from last Internal/External audits? Were  corrective actions implemented? For those that are closed, how was cause investigated? How were they followed up on and verified?
  5. Any audit findings still open/unresolved? Why?
  6. How are Auditors trained? How is independence of Auditors ensured?How are resource needs identified and provided, for all areas of the quality management system? Is there only one way to get resources?

For Clause 8.2.3:

  1. Are all identified processes being monitored and measured? Are both product and service processes covered?
  2.  How is monitoring and measurement being done? Are same approach used for each process?
  3. How often is the data collected? Who looks at it? How is it analysed?
  4.  Are process targets defined? Do they link to higher level objectives? How is this communicated?
  5.  What are the results showing? If process performance is below targets, what actions are taken? Who decides? Who takes the action?
  6.  Did the actions taken work? How do you know they worked? Are there any repeat problems occurring in the process?How does the organization identify a need to add to the current  infrastructure? (i.e. new buildings or additions, new or replacement process hardware or software, enhanced support services such as new or upgraded information technology)

For Clause 8.2.4:

  1. Is there a procedure or program or plan in place to monitor and measure the product/service being supplied to the Customer?
  2.  Has the entire plan or procedure been followed? (check product examples as well as service examples) Is it consistent in all cases? Is the same approach used for each product or service?
  3. Will the monitoring and measurement methods show whether the  product/service has met Customer requirements?
  4. How often is the data collected? Who looks at it? How is it analysed?
  5.  Are there targets defined? How is this communicated?
  6.  What are the results showing? If performance is below targets, what actions are taken? Who decides? Who takes the action?
  7.  Did the actions taken work? How do you know they worked? Are there any repeat problems occurring?


Mandatory Procedure :
For Clause 8.2.2: Procedure for Internal audit

pdf Example of Procedure for Internal Audit

Mandatory record:
For Clause 8.2.1 : Not applicable
For Clause 8.2.2 : Internal audit report

pdf Example of form of Internal Audit Observation Sheet
pdf Example of form of Internal Audit Summary Sheet

For Clause 8.2.3 : Not applicable
For Clause 8.2.4 : Product acceptance/release report

pdf Example of format for Pre Delivery Inspection Report

Evidence/ Implementation document ( Not mandatory but helps in fulfillment of requirement):
For Clause 8.2.1:

  1. Customer satisfaction survey
  2. Customer complaints
  3. Analysis of lost business
  4. Warranty claims
  5. Phone in log
  6. Customer satisfaction (feedback) is the first tool. Customer complaints, direct communications with customers, questionnaires and surveys, subcontracted collection and analysis of performance data , reports from consumer organizations, reports in various media, sector and industry studies
pdf Example of format for Customer Complain Register
pdf Example of format for Customer Satisfaction Survey

For Clause 8.2.2:

  1. Annual audit schedule
  2. Audit findings record
  3. Training records
  4. Corrective action report
  5. Audit records include – annual audit schedule, audit planning- (criteria, scope, frequency, methods, auditor selection and assignment, etc), auditor competence and training, audit checklists and forms, audit notes and other evidence gathered, audit findings, nonconformity reports, audit reports, corrective actions and follow-up of internal audit nonconformities, analysis of audit program performance indicators and trends, and identified improvement opportunities.
pdf Example of Format of List of Internal Auditors
pdf Example of formats for Audit Schedule and Audit Plan
pdf Example of Format of Audit Checklist
pdf Example of Format of Internal Audit corrective action report

For Clause 8.2.3:

  • Check lists
  • Process input / output flow
  • Control charts
  • fish-bone analysis
  • Monitoring of Quality objectives
pdf Example of format for Analysis of Quality Objectives
pdf Example of format for Fish Bone Analysis

For Clause 8.2.4:

  • Product acceptance criteria
  • Drawing inspection
  • Final release checklist
  • Sample audit

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