9.1 Monitoring, measurement, analysis, and evaluation
The organization should determine what needs to be monitored and measured. It must also determine the methods for monitoring, measurement, analysis, and evaluation needed to ensure valid results. When the monitoring and measuring must be performed. Also when the results from monitoring and measurement must be analyzed and evaluated. The organization should also evaluate the performance and effectiveness of the quality management system. It must retain appropriate documented information as evidence of the results.
- Show how does the organization determines what needs to be monitored and measured?
- Show how does the organization determines what methods for monitoring, measurement, analysis, and evaluation to ensure valid results?
- Show how does the organization determines what to perform monitoring and measuring?
- Show how does the organization determines what results shall be analyzed and evaluated?
- What documented information can you show that monitoring and measurement activities have been implemented in accordance with determining requirements?
- Show how the organization evaluates the quality performance and the effectiveness of the QMS.
- The organization must plan and implement processes that monitor, measure, analyze and evaluate the health of your QMS. The focus of these processes must be on product/service conformity, process conformity, and improving QMS effectiveness.
- You must monitor your processes:
a) First to determine and establish the capability of new processes to conform to requirements.
b) And secondly, to monitor these processes over time to verify ongoing stability and capability to meet requirements.
c) And thirdly to determine and achieve levels of continual improvement
- The monitoring and measurement techniques, sampling plans, acceptance criteria should be documented or referenced in your quality plan, or you could use a combination of specific practices, procedures, documents and methods.
9.1.2 Customer Satisfaction
The organization should monitor customer perceptions of the degree to which their needs and expectations have been fulfilled and must determine the methods for obtaining, monitoring, and using this information. Some of the methods by which monitoring of customer perceptions can include customer surveys, customer feedback on delivered products or services, meetings with customers, market-share analysis, compliments, warranty claims, and dealer reports.
- How does the organization monitor customer perception of the degree to which requirements have been met?
- How does the organization obtain information relating to customer views and opinions of products and services?
- What are the methods for obtaining and using this information?
- Information related to customer views can include customer satisfaction or opinion surveys, customer data on delivered products or services quality, market share analysis, compliments, warranty claims, and dealer reports.
- Customer requirements may relate to the design, manufacture, delivery, servicing, and support of the product, QMS, communication, and financial requirements, etc.
- The organization should consider both external as well as internal customer satisfaction. The organization must monitor trends in customer satisfaction indicators and use these as a baseline for continual improvement.
9.1.3 Analysis and Evaluation
The organization should analyze and evaluate appropriate data and information arising from monitoring and measurement. Use the results of the analysis to evaluate the conformity of products and services, the degree of customer satisfaction, the performance and effectiveness of the quality management system. The organization must also evaluate if planning has been effectively implemented and the effectiveness of actions taken to address risks and opportunities. The performance of external providers and the need for improvements within the quality management system must also be evaluated. Methods to analyze data can include statistical techniques.
- Show how does the organization analyze and evaluates data and information arising from monitoring, measurement, and other sources.
- Show how the output of analysis and evaluation is used to:
a) Demonstrate conformity of products and services to requirements?
b) Assess and enhance customer satisfaction?
c) Ensure conformity and effectiveness of the QMS?
d) Demonstrate that planning has been successfully implemented?
e) Assess process performance?
f) Assess the performance of external providers?
g) Determine the need or opportunities for improvements within the QMS?
- Show me where the results of analysis and evaluation are used to provide inputs to management review.
- You must collect and analyze QMS data that relate to the performance, effectiveness, and efficiency of products, services, QMS processes, production output, external provider (supplier) performance, use of resources, cost of poor quality, customer satisfaction, etc.
- You must sort and summarize the data you collect into things gone right and things that have gone wrong and present them separately. Management can then focus on continual improvement of things gone right and take corrective action on things gone wrong.
- A summary of QMS performance data must be included in your periodic management review.
9.2 Internal Audit
The organization should conduct internal audits at planned intervals to provide information on whether the quality management system conforms to the organization’s own requirements, the requirement of ISO 9001:2015 standards and is effectively implemented and maintained
The organization must plan, establish, implement, and maintain an audit program, which must include frequency, methods, and responsibilities, planning requirements, and reporting. While making an audit program, consideration must be given to the importance of concerned processes, changes impacting the organization, and the results of previous audits. It must define audit criteria and scope for each audit. It must select auditors and conduct audits for the impartial and objective audit process. It must ensure the results of audits are reported to relevant management. it must take necessary correction and corrective actions without undue delay. It must retain evidence of audit program implementation and audit results.
- Are internal audits being conducted at planned intervals? Do they determine whether the QMS conforms to the requirements of ISO 9001 and to the other requirements established by Organization? (Review records to demonstrate conformance)
- Do they determine whether the QMS is effectively implemented and maintained? (Review records)
- Can you show audit programme(s) that takes into consideration the quality objectives, importance of the processes, customer feedback, changes impacting the organization, and the results of previous audits?
- What are the audit criteria and scope for the audit?
- Can you demonstrate that selection of auditors and the conduct of audits are objective and impartial and that auditors don’t audit their own work?
- How are audit results reported to relevant management?
- Can you demonstrate that necessary correction and corrective actions are taken without undue delay?
- Can you show documented information about the audit program and the audit results?
- The audit process must address the responsibilities for conducting the audits, ensuring independence, recording results, and reporting to management.
- Audits obtain objective evidence of conformity with requirements. The evidence must be based on fact and may be obtained through observation, measurement, test, or by other means. Evaluating the extent to which audit criteria are fulfilled involves an assessment of both implementation and effectiveness.
- The scope of your internal audit program must cover the
a) Audit of operation processes to determine conformity of product/services and their processes to customer and applicable regulatory requirements.
b) Audit of the QMS to determine conformity to the ISO 9001 standard and organizational requirements.
c) 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, the complexity of product and processes, the 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:
a) You experience internal or external nonconformities.
b) Get customer complaints.
c) Have critical or high-risk processes.
d) Have frequent or significant changes to processes and products.
- During the audit, auditors should ensure that the objectivity and impartiality of the audit are not compromised. Auditors cannot audit their own work.
9.3 Management Review
The Top Management of the organization should review the Organization’s QMS at planned intervals to ensure its continuing suitability, adequacy, effectiveness and it should be aligned with the strategic direction of the organization.
9.3.2 Management review inputs
Plan and carry out management review considering the status of actions from previous management reviews, changes in external and internal issues relevant to QMS, the adequacy of resources, opportunities for improvement, and the effectiveness of actions taken to address risks and opportunities as explained in clause 6.1. The organization must also consider information on quality performance and effectiveness, including trends in non-conformities and corrective actions, customer satisfaction and feedback from relevant interested parties, Monitoring and measurement results, Audit results, the extent to which quality objectives have been met, process performance, conformity of product and services, the performance of external providers
9.3.3 Management review outputs
Outputs from the management review must include decisions and actions related to opportunities for improvement, any need for changes to QMS, and resource needs. The organization should retain documented information as evidence of the results of management reviews.
- What is the frequency that top management reviews the organization’s QMS? How is the QMS deemed suitable, adequate, and effective?
- What kinds of information are reviewed in management reviews? Do they include:
a) actions status of previous reviews;
b) changes to internal/external issues relevant to the QMS;
c) issues that affect strategy;
d) KPIs for nonconformities and corrective actions;
e) monitor and measurement of results;
f) audit results;
g) customer satisfaction;
h) issues concerning external providers;
i) issues concerning other relevant parties;
j) adequacy of resources and effectiveness of QMS;
k) process performance;
l) conformity of products and services;
m) actions are taken to address risks and opportunities and their effectiveness;
n) new potential opportunities for continual improvement.
- Show that management reviews include decisions and actions relating to:
a) Continual improvement opportunities;
b) The need for changes to the QMS including resource needs.
- Show what documented information you have as evidence of management reviews.
- Though not required by the standard, there should be a procedure for management review as it has specific requirements for management review inputs, value-adding review activities, and outputs. The procedure should address the frequency, schedule, quorum, and agenda for review meetings to be attended by top management.
- For the management review process itself to be effective, top management must plan the review of all agenda items with some regularity and take timely action to change or improve any part of it, including the quality policy and objectives.
- The Top Management can incorporate QMS agenda items into regular monthly or quarterly operational meetings.
- Management review input should preferably be in summary form, showing QMS and operational performance measured against the business and quality plans, customer and regulatory objectives, and goals.
- Review decisions and actions must relate to improving products and processes or even creating new ones, providing more resources or perhaps improving the efficiency of existing resources, improving QMS controls, objectives, improving overall QMS effectiveness and customer satisfaction.
- Responsibilities and timelines should accompany these decisions and actions.
- The performance of these actions must be followed up at subsequent management review meetings.
- You must also identify what specific documents are needed for effective planning, operation, and control of this process. These documents may include – a documented information, review on, schedule, agenda, and action forms, etc., combined with unwritten practices, procedures, and methods.
- Management review records must include topics discussed, decisions, responsibilities for corrective or improvement actions and related timelines, provision of resources, and follow-up actions from previous management reviews.