D-121

Management - Laboratory

Section D — Laboratory Operations and Specifications Revision 0 26 pages

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1.0 Objective and Purpose 
 
 The objective of the Management process is to ensure the continuing suitability, adequacy, and
 
 effectiveness of the laboratory management system (LMS) in meeting objectives and in meeting
 the requirements of ISO 17025, the assessment of opportunities for improvement, and to review
 and set new policies and objectives as appropriate. Another objective of the Management process
 is to ensure that actions are taken to correct problems, to avoid potential problems, and to improve
 efficiencies and service to the customer, LMS processes, and the LMS as a whole.
 
 The purpose of this procedure is to describe how policies and objectives are established for LMS
 processes, and for the system of processes in place at Ion Labs. This procedure describes how
 performance against established objectives is measured or monitored, both as such information
 
 becomes available and on a periodic basis, and how management reviews and analyzes the
 outputs of such measuring and monitoring activities. This procedure describes how management
 reacts to analysis by making decisions and initiating actions to continually improve test services,
 LMS processes, as well as the LMS as a whole, including the policy and objectives themselves.
 
 This procedure also describes how any identified resource requirements are addressed, and how
 performance information is communicated internally. 
 
 2.0 Scope 
 
 This procedure is applicable to management of at Ion Labs, Inc laboratory activities.
 
 3.0 Responsibility 
 
 3.1 This procedure applies to Management who are responsible for establishing and reviewing
 quality objectives and performance metrics, for analyzing performance against those
 
 metrics, and for making decisions and taking actions to correct problems, prevent potential
 problems, and to improve the LMS processes and resulting services under the ISO 17025
 scope of accreditation. Responsibilities of Management are performed by the following
 members of Ion Labs staff: Lab Management. 
 
 3.2 This procedure also applies to personnel who are invitees to management review
 
 meetings, and those who are responsible for providing information and/or data for
 analysis. 
 
 3.3. Laboratory Management is responsible for being the point of contact for the accreditation
 
 
 

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 agency and arranging activities such as internal audits and management reviews.
 Laboratory Management is responsible for reporting LMS performance information and
 the need to improve the LMS to other members of Management. 
 
 3.4 Laboratory Management is responsible for implementing, maintaining, and improving the
 LMS, and ensuring the effectiveness of laboratory activities. 
 
 3.5 All Ion Labs personnel are responsible for supporting procedures, for performing
 laboratory activities accurately, for identifying deviations from the LMS, and notifying
 management when deviations are detected so correction and corrective action may be
 initiated. All Ion Labs personnel are authorized to initiate actions to prevent or minimize
 such deviations. 
 
 3.6 Laboratory Management is responsible for ensuring that this procedure is accurate,
 understood and implemented effectively. This procedure may not be changed without the
 authorization of Laboratory Management. 
 
 4.0 Definitions 
 
 4.1 Objective — Result to be achieved 
 
 4.2 Impartiality — the presence of objectivity. This means that the outcome or result of an
 activity is not compromised by a situation or action of a person. 
 
 4.3 Confidentiality- the protection of information to ensure that data is accessible only to
 authorized personnel and is not made available or disclosed to unauthorized individuals,
 
 entities, or processes. 
 
 5.0 References 
 
 5.1 C-502, SOP, Record Storage, Retention, and Destruction 
 
 5.2 LMS Planning Tools, see Attachments for examples 
 
 5.3 D-121-F1, Form, Management Review Meeting Minutes 
 
 5.4 QS-108, SOP, Corrective and Preventative Action procedure 
 
 5.5 A-113, SOP, Training procedure 
 
 6.0 General 
 
 6.1 Evidence of Management’s commitment to the development and implementation of the
 management system and continually improving its effectiveness is demonstrated through
 
 
 

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 Management’s involvement in decisions and actions related to the following:
 
 ® Establishing policies for the Lab’s expectations and performance,
 
 e Establishing objectives, 
 © Promoting the use of the processes described in LMS procedures,
 
 e Providing resources (personnel, facilities, equipment, systems, and support
 services) to implement, manage, perform, and improve LMS processes and
 laboratory activities, 
 
 ® Establishing methods of monitoring and measuring processes to achieve
 objectives, 
 
 e Participating in management review, 
 
 ® Communicating the effectiveness of the LMS to staff members, 
 @ Communicating the importance of meeting customer and other requirements to
 
 staff members, and the importance of conformance to ISO 17025 requirements,
 ® Taking steps to ensure impartiality and demonstrating commitment to impartiality
 by identifying and addressing risks to impartiality, 
 
 @ Identifying opportunities to improve LMS processes and providing resources to
 implement improvements. 
 
 6.2 LMS Planning Tools are the control used to identify and monitor various aspects of our
 organization that are necessary to optimize the performance of the LMS and thereby
 ensuring optimal service to the customers. LMS Planning Tools consists of at least the
 
 following worksheets: Objectives, and Risks and Opportunities. 
 6.3. Any resource requirements relating to the operation or improvement of the LMS or its
 
 processes, are purchased per the Purchasing and Receiving procedure. Any human
 resource needs (including staffing level adjustments and/or training) are managed in
 accordance with SOP A-113 Training Procedure. 
 
 6.4 Laboratory Management, irrespective of other responsibilities, has the authority and
 resources needed to carry out duties including: 
 
 a) implementation, maintenance, and improvement of the LMS, 
 
 1. This is done through planning the Lab’s operations, ensuring the
 established processes are followed, maintaining the documentation that
 defines the processes, and identifying and implementing improvements to
 
 the infrastructure, processes, etc. 
 b) identification of deviations from the LMS or from the procedures for performing
 
 laboratory activities, 
 
 

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 1. This is done through recording the deviations, justifying the deviation, and
 authorizing the actions taken. This is documented in the Test reports.
 Cc) initiation of actions to prevent or minimize such deviations, 
 
 1. This is done through taking corrective actions in accordance with the QS-
 108 Corrective and Preventative Action procedure. 
 
 d) reporting to laboratory management on the performance of the LMS and any need
 for improvement, 
 
 1. This is done as the need arises and actions are taken as necessary. This is
 also completed during the Management Review Meeting (see below).
 
 e) ensuring the effectiveness of the Lab’s activities. 
 
 1. This done through monitoring daily activities and taking appropriate action
 as required when necessary. 
 6.5 Management designates a back-up to Laboratory Management to carry out his/her duties
 
 in case of his/her absence from the Laboratory. 
 
 7.0 Process Inputs 
 
 7.1 Inputs to the Management process include, but are not limited to: 
 
 s Service and process performance information 
 
 e Inputs for management review meetings and scheduled meetings 
 
 e Resource needs 
 
 8.0 Process Activities 
 
 8.1 Policies, Objectives, Performance Analysis, and Improvement 
 8.1.1 Management defines policies and objectives and ensures the objectives
 are measurable and are aligned with the established policies as
 
 appropriate. The policies and objectives address the competence,
 impartiality, and consistent operation of the laboratory. Performance
 against these objectives is monitored, measured, analyzed, and reacted to
 accordingly. Objectives are documented on the Metrics worksheet of the
 LMS Planning Tool. 
 
 8.1.2 | Management may also establish measurable objectives (e.g., goals or
 targets) for LMS processes (or functional levels) in support of the
 company objectives, where suitable and applicable. Suitable
 
 measurements are meaningful and add value to process effectiveness and
 
 
 

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 efficiency. 
 
 8.1.3 Data from quality assurance activities are included in objectives to
 measure competence and are analyzed and used to improve laboratory
 
 activities. If the results of this data analysis are found to not meet
 requirements, appropriate action is taken to prevent incorrect test results
 from being reported. Evidence of analysis and actions to improve
 laboratory activities will be documented in Management Review Meeting
 
 Minutes or corrective action records as appropriate. 
 8.1.4 Feedback from customers is received as described in the Sales procedure.
 
 The contents and nature of customer feedback will be as it is received for
 immediate response to the customer and will be analyzed during
 management review. The data analysis will be used as the basis for
 improving the LMS, laboratory activities, and customer service. Actions
 taken as a result of analyzing customer feedback will be documented in
 
 Management Review Meeting Minutes. 
 Opportunities to improve laboratory activities and the LMS are identified
 
 and selected based on the activities listed below. Depending on the
 source of the improvement opportunity and the actions required to
 implement improvements, records associated with specific improvements
 may be documented in corrective actions, Management Review Meeting
 Minutes, updated objectives, or changes to documented LMS procedures.
 
 ® Evaluation of performance data presented during management
 review, 
 
 ® Review of performance against objectives and the quality
 policy, 
 
 8 Feedback (both positive and negative) received from
 customers, 
 
 @ Determination and review of risks and opportunities,
 
 ® Review of findings presented during internal audits or
 assessments from external bodies, 
 
 ® Evaluation of the results of corrective actions, 
 ® Suggestions from staff members who participate in the LMS,
 
 ® Results of quality assurance activities, 
 
 ® Proficiency testing results. 
 
 
 

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 8.2 Monitoring and Measurement of Processes 
 
 8.2.1 All LMS processes (and the LMS as a whole), are monitored by internal audits to
 assess their continuing suitability and effectiveness in meeting their respective
 
 objectives, as well as their effectiveness in meeting the requirements of ISO
 17025. See the H-101 Internal Audits procedure. 
 
 8.2.2 Management is responsible for establishing any suitable measurable objectives for
 processes as deemed necessary. Where such objectives exist, they will be
 reviewed during management reviews and monitored/measured, reported,
 analyzed, and acted upon accordingly (see below). Reported performance
 information from personnel will also be reviewed to determine process adequacy.
 
 8.3 Impartiality 
 8.3.1 Management ensures actions are taken to safeguard impartiality. Actions include
 training activities, reviewing orders, reviewing reports and results as necessary,
 
 and reinforcing impartiality when deemed necessary. Training involves all Ion
 Labs personnel interfacing with the Laboratory and focuses on the need to ensure
 test results are not swayed in any way. The structure and management of
 laboratory activities are established and implemented in LMS procedures to ensure
 
 impartiality is always practiced. Potential compromises to impartiality may
 include commercial, financial, relationships to other organizations, relationships of
 Ion Labs staff, or other pressures. Management will be responsible for taking
 action to prevent pressures from compromising impartiality. 
 
 8.3.2 Risks to impartiality will be identified and documented on the Risks and
 Opportunities worksheet of the LMS Planning Tool. Risks to impartiality will be
 reviewed during management review. If changes to known risks or additional risks
 
 are identified prior to planned management review activities, Management will add
 to or revise the identified risks. 
 8.3.3 Complaint investigations will determine if impartiality contributed to the Lab’s
 
 performance that instigated the complaint. Management will take appropriate
 action immediately if it is determined that impartiality caused a complaint or an
 inaccurate test result. Feedback information will also be reviewed during the
 management review to assess incidents that occurred during the review period.
 
 8.3.4 Actions to eliminate or minimize risks to impartiality will be documented on the
 Risks and Opportunities worksheet of the LMS Planning Tool. As necessary, a
 corrective action will be completed per the QS-108 Corrective and Preventative
 
 Action procedure. 
 
 8.4 Risks and Opportunities 
 8.4.1 Management determines risks and opportunities associated with laboratory
 
 
 

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 activities that need to be addressed in order to give assurance that the LMS can
 
 achieve its intended results, enhance opportunities to achieve the purpose and
 objectives of Ion Labs, prevent or reduce undesired impacts and potential failures
 in laboratory activities, and achieve improvement. 
 
 8.4.2 Opportunities (situations favorable for achieving an intended result) may arise
 through various means including, but not limited to, requests for new services,
 ideas for new services generated during research activities, new technologies, new
 
 practices, new partnerships, changes to infrastructure, an effect of addressing risks,
 LMS changes, etc. 
 8.4.3 Risks and Opportunities are documented on the Risks and Opportunities worksheet
 
 in the LMS Planning Tool. 
 8.4.4 Management determines and plans actions to reduce or mitigate risks and works
 
 toward pursuing opportunities proportional to the potential impact on the validity
 of laboratory results. Actions to address risks and opportunities, including plans
 for integrating and implementing actions into the LMS are documented on the
 Risks and Opportunities worksheet of the LMS Planning Tool. 
 
 8.4.5 The risks that have been determined and the actions taken to address the risks are
 evaluated during management reviews. A record of the review is documented in
 the Management Review Meeting Minutes. The Risk and Opportunities worksheet
 
 of the LMS Planning Tool is updated as necessary when new risks and
 opportunities are identified or when changes are made to existing actions that
 address current risks. 
 
 8.4.6 The Risk and Opportunities worksheet is updated as necessary when new
 opportunities are identified, as opportunities are fulfilled or deemed no longer
 active, or when other existing information is no longer current.
 
 8.5 Management Review 
 
 8.5.1 Management reviews the performance of the LMS on an annual basis at minimum
 to ensure its continuing suitability, adequacy, and effectiveness in meeting the
 requirements of Jon Labs stated policies, objectives, and conformity with ISO
 
 17025. Management review meetings will be conducted according to the agenda
 in the Management Review Meeting Minutes form D-121-F1, which identifies the
 inputs for review and analysis and serves as a record of the results. Additional
 personnel may be invited to attend and provide input as deemed appropriate by
 Management. Attendees will be recorded on the agenda/minutes. The meeting
 
 may be held in one session or may occur over several meetings at the
 Management’s discretion. 
 8.5.2 In preparation for the meeting, responsible personnel generate any reports and
 
 collect and/or summarize information required by the agenda in the Management
 
 

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 Review Meeting Minutes form. 
 
 8.5.3 During management review meetings, management reviews each agenda item. For
 each item, consideration will be given to events occurring since the previous
 
 review, any changes in the organization or in the market, as well as current
 performance levels relative to any established objectives. Notes regarding
 information presented and issues considered/discussed will be recorded in the
 minutes. Though items may be added to or removed from the agenda at the
 
 discretion of management, the agenda items will include at least the following:
 
 Status of actions from previous management reviews, 
 
 Fulfillment of objectives, 
 Suitability of policies and procedures, 
 
 Changes in internal and external issues that are relevant to the Lab,
 
 Customer communications and feedback including complaints,
 
 Ion Labs personnel feedback regarding the LMS and performance in their
 areas, 
 Results of quality assurance activities (validity of results) including
 
 proficiency testing, 
 Results of monitoring activities and training, 
 
 Performance of external providers (suppliers, vendors), 
 
 Results of recent audits including internal audits and assessments by
 external bodies, 
 
 Status of corrective actions, 
 
 Effectiveness of implemented improvements, 
 Changes in the volume and type of work or in the range of laboratory
 
 activities, 
 Results of risk identification (including risks to impartiality),
 
 Adequacy of resources (human, infrastructure, facilities), 
 
 Resource needs, 
 
 Recommendations for improvement, 
 LMS performance, adequacy, suitability, and effectiveness,
 
 Any need for change, 
 
 
 

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 ® Date of next meeting. 
 
 8.5.4 Outputs of management review will be recorded and will include decisions and
 actions to improve processes and services relative to customer and Ion Labs’
 requirements. Management review outputs will include the following decisions
 
 and actions at a minimum: 
 
 @ Improvements to the effectiveness of the management systems and its
 processes, 
 
 & Improvement of laboratory activities related to the fulfilment of the
 requirements of ISO 17025, 
 
 @ Changes or additions to resources required to perform laboratory activities,
 
 @ Any other changes necessary to support the LMS. 
 
 8.5.5 Decided action items will be recorded in the Management Review Meeting
 Minutes form. Persons responsible for completing such actions will be recorded,
 and target dates for completion will be determined and recorded. Where
 appropriate, a corrective action will be initiated to implement actions and to track
 
 completion and effectiveness in accordance with the QS-108 Corrective and
 Preventative Action procedure. 
 
 8.5.6 Where changes to the LMS will be implemented as an output of management
 review, management will ensure that such changes occur in a controlled manner to
 maintain the integrity of the LMS, and that process effectiveness and test services
 will not be compromised during or after the change. Such planning will include
 considerations appearing in the Changes to the LMS and Planning section of the
 
 Management Review Meeting Minutes form. 
 8.5.7 New objectives and changes to the laboratory policies may result as performance
 
 levels and/or service quality improves. Management will ensure changes to the
 policy and/or objectives will be documented and implemented under controlled
 conditions. 
 
 8.5.8 The agenda, when complete, serves as the record of management review and is
 retained according to the SOP C-502 Record Storage, Retention, and Destruction.
 
 8.5.9 Upon completion of management review activities, resulting performance
 information is summarized and reported to employees, as appropriate. Such
 information may be presented in meetings, on an individual basis, and/or it may be
 posted in conspicuous locations in the facility. 
 
 
 

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 8.6 Resources 
 
 8.6.1 Management ensures the personnel, facilities, equipment, systems, and support
 services necessary to manage the LMS and the test services provided are available.
 
 Resources are identified and allocated as described in LMS procedures and
 monitored through the management review process. 
 
 8.6.2 Management ensures personnel with responsibilities for managing the LMS have
 the authority and resources necessary to carry out their duties. Formal
 identification of authority is described in the process procedures where the
 decision-making and responsibilities occur. Training requirements for authorities
 and responsibilities is described in the A-113 Training procedure.
 
 8.6.3 Any resource requirements which will be provided by external sources relating to
 the operation or improvement of the LMS or its processes, including those needed
 
 to meet customer requirements for the test services provided, will be arranged by
 Management according to the Purchasing and Receiving procedure. Any
 identified staff training needs will be provided as described in the A-113 Training
 procedure. 
 
 8.7. Record Management 
 
 8.7.1 Records are maintained per SOP C-502 Record Storage, Retention, and
 
 Destruction. 
 
 8.8 Process Outputs 
 
 8.8.1 Outputs from the Management process include, but are not limited to:
 
 e completed, and updated as needed, LMS Planning Tool, 
 
 8 decisions and actions to improve LMS processes and the LMS as a whole,
 
 ® improvements to service, 
 ® identification of resource needs, 
 
 ® records of completed management reviews 
 
 
 

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 8.0 Revision History 

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 11/04/21 | New. N/A J. Sassman | - | - |

 9.0 Attachments 
 
 9.1 Attachment 1 - LMS Planning Tool 
 
 9.2 Attachment 2— LMS Planning Tool Objectives 
 
 9.3 Attachment 3 —- LMS Risks and Opportunities 
 
 
 

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[SOP 

 IANLABS Management Review Meeting Minutes 
 Form: D-121-F1 CCR No. N/A Revision: 0 
 
 Status of Actions from Previous Meetings 
 Open action items 
 
 Management 
 Suitability and monitoring of policies, objectives, and procedures, internal communications, internal and
 external issues, risks and opportunities, changes and LMS planning 
 Sales 
 Process Effectiveness — customer and personnel feedback and complaints 
 
 Purchasing and Receiving 
 Process Effectiveness - supplier performance 
 Test Items 
 Test items, sample and retains preparation, and identification as well as environmental monitoring
 
 Laboratory Operations 
 Process Effectiveness —nonconforming work, quality control activities, measurement uncertainty, test
 method validations, software validations 
 
 Calibration and Equipment Control 
 Equipment adequacy 
 Resources and Training 
 Changes in the volume or type of work, infrastructure, environment, staffing levels, training needs
 
 Audits and Assessments 
 Internal audit results and plan, accreditation assessment results 
 Corrective Actions 
 Status of open actions, timeliness 
 
 Improvements 
 Improvements completed and effectiveness, improvements planned 
 LMS Adequacy, Suitability and Effectiveness 
 
 Overall assessment of the LMS 
 Date of Next Meeting 
 
 
 

[SOP 

 IAN LABS Management Review Meeting Minutes 
 Form° D-121-F1 CCR No. N/A ReviSion 0 
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[SOP 

 IAN LABS Management Review Meeting Minutes 
 Form: D-121-F] CCR No. N/A Revision: 0 
 
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 Is the Lab’s policy for competence of personnel suitable 
 adequate and still appropriate? 
 If not, describe necessary changes. 
 Is the Lab’s policy for confidentiality and impartiality 
 suitable and adequate? 
 If not, describe changes. 
 Is the Lab’s policy for consistent operation of the Lab 
 suitable and adequate? 
 
 If not, describe necessary changes. 
 State how policies are known and followed. 
 Is it necessary to change any policies? If yes, describe 
 plan. 
 State how procedures are known and followed. 
 Do procedures accurately describe current practices and 
 conform to ISO 17025 requirements? 
 Is it necessary to change any procedures? If yes, 
 describe plan. 
 
 Fulfillment of Objectives (review the Objectives worksheet in the LMS Planning Tool)
 Measurable Objective: Current Level Goal Positive or Negative Trend?
 
 Other Objectives (non-measurable) Fulfillment Status 
 
 Where objectives are not being achieved, describe 
 necessary plans or corrective actions: 
 Internal Communications 
 Describe methods used for internal communications. 
 Are performance results communicated adequately? If 
 not, describe necessary actions. 
 Are the current methods adequate? If not, describe 
 necessary actions. 
 
 External and Internal Issues (review the Issues section of the LMS Overview worksheet in the LMS Planning
 Tool) 
 
 Are there any known external issues that could impact 
 the company? (e.g., competition, technology, etc.) 
 Are there any internal issues that could impact the LMS? 
 (e.g., changes in staffing levels, facility, equipment, 
 layout moves, etc.) 
 
 
 

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 ION LABS Management Review Meeting Minutes 
 Form: D-121-F1 N/A Revision: 0 
 
 Risks (review the Risks and Opportunities worksheet in the LMS Planning Tool) 
 Review the identified risks and determine if they are 
 current. Indicate new risks or those that have changed 
 since the last review. 
 Verify the worksheet is updated. 
 Review the actions taken to address risks. Have the 
 actions been effective? If not, describe necessary 
 
 changes. 
 Opportunities (review the Risks and Opportunities worksheet in the LMS Planning Tool)
 Review the identified opportunities and determine if they 
 are current. Indicate new opportunities or those that have 
 changed since the last review. Verify the worksheet is 
 updated. 
 If the opportunities have been pursued, were the actions 
 taken effective at improving the LMS and/or the overall 
 performance of the Lab? If not, describe necessary 
 changes. 
 
 LMS changes and planning 
 List potential changes to the LMS and the necessary 
 planning to implement them (include revisions to ISO 
 17025, internal issues, external issues, or other 
 influences): 
 Determine how the integrity of the LMS will be 
 maintained during such changing circumstances. 
 What roles, responsibilities and/or authorities will require 
 
 changes? 
 What resources will need to be applied? 
 What additional training is required? 
 Other comments, suggestions: 
 
 
 

[SOP 

 IANLABS Management Review Meeting Minutes 
 Form: D-121-F1 CCR No. N/A Revision: 0 
 
 Sales process effectiveness 
 Describe the planned results for the Sales 
 
 process. 
 Describe whether or not the process is 
 achieving planned results (reports from 
 Managerial personnel) 
 If not, what actions are being taken or are 
 necessary? 
 How has the process improved? 
 Other comments, suggestions: 
 Customer and personnel complaints andfeedback (review Customer Feedback Log) 
 What complaints have been received? 
 
 (summarize and list) 
 
 Are corrective actions necessary or initiated? 
 Have we received positive feedback? 
 (summarize and list) 
 
 What is the overall perception internal 
 customers have of the Lab and its 
 performance? 
 
 
 

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 IAN LABS Management Review Meeting Minutes 
 Form: D-121-F1 CCR No. N/A Revision: 0 
 
 Purchased Services and Supplies process effectiveness 
 Describe the planned results for the Purchasing 
 process. 
 Describe whether or not the process is 
 achieving planned results (reports from 
 Managerial personnel). 
 If not, what actions are being taken or are 
 
 necessary? 
 How has the process improved? 
 
 Other comments, suggestions: 
 
 Review information regarding supplier and vendor (external provider) performance
 
 List suppliers (including service providers, 
 subcontractors, technicians, laboratories) with 
 inadequate performance and describe issue(s): 
 
 Should the status of any suppliers or vendors 
 change as the result of their performance 
 analysis? 
 Verify the accreditation status of any suppliers 
 or service providers who are required to 
 maintain their accreditation to ISO 17025 (or 
 ISO 17034 if appropriate) is current. Identify 
 those who are not current and the plan to ensure 
 they are current or obtain an alternate source. 
 List any other actions that should be taken to 
 ensure proper supplier and vendor performance. 
 
 Receiving process effectiveness 
 Describe the planned results for the Receiving 
 process. 
 Describe whether or not the process is 
 achieving planned results (reports from 
 Managerial personnel). 
 If not, what actions are being taken or are 
 necessary? 
 
 How has the process improved? 
 
 
 

[SOP 

 IAN LABS Management Review Meeting Minutes 
 Form: D-121-F1 CCR No. N/A Revision: 0 
 
 Other comments, suggestions: 
 oF eee i Piecboliieeret ee! 
 
 Samples process effectiveness 
 Are test items samples properly 
 prepared and labeled? 
 
 Are storage and identification 
 requirements for test items and retains 
 adequate? 
 
 Are storage requirements for test items 
 and retains properly monitored? 
 Other comments, suggestions: 
 
 
 

[SOP 

 IANLABS Management Review Meeting Minutes 
 Form: D-121-F1 CCR No. N/A Revision: 0 
 
 ess effectiveness 
 Describe the planned results for the Laboratory 
 Operations process. 
 Describe whether or not the process is achieving 
 planned results (reports from Managerial 
 personnel). 
 If not, what actions are being taken or are 
 
 necessary? 
 How has the process improved? 
 Other comments, suggestions: 
 Nonconforming Work (review Lab Nonconformity Log) 
 Review Lab testing service nonconformities 
 issued (trend data or specific incidents). 
 Does the data indicate that competence or 
 verification points and methods of 
 verification/review are inadequate? 
 
 Is corrective action necessary? 
 If not, why? 
 Is additional training or monitoring necessary? If 
 yes, list. 
 
 Quality Control Activities (review Quality Control Activities Schedule and Results)
 Describe the results of inter-laboratory 
 comparisons or proficiency testing. 
 Review results and outcomes from other quality 
 
 assurance activities. Describe whether or not the 
 current activities are adequate to ensure valid 
 results. 
 Does the data indicate that current methods or 
 techniques are inadequate? If yes, describe 
 necessary actions. 
 Does that data indicate that additional monitoring 
 is necessary? If yes, describe plan. 
 Measurement Uncertainty 
 Are Measurement Uncertainty Budgets current for the tests 
 performed and the measurement equipment used? If not, 
 describe plan to update. 
 Test Method Validations 
 Have any changes occurred that would affect 
 existing validations of test methods? If yes, 
 describe plan. 
 
 
 

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 IANLABS Management Review Meeting Minutes 
 Form: D-121-Fl CCR No. N/A Revision: 0 
 
 Have new lab-developed or non-standard test 
 methods been introduced requiring test method 
 validation? If yes, describe plan. 
 Software Validations 
 Have any changes occurred that would affect 
 existing software validations? If yes, describe 
 plan. 
 
 Has any new software been added that requires 
 software validation? If yes, describe plan. 
 
 Calibration process effectiveness 
 
 Is current calibration status of measurement and 
 test equipment being maintained as required? 
 If not, what actions are being taken or are 
 necessary? 
 
 Other comments, suggestions: 
 
 Equipment Maintenance process effectiveness 
 Is equipment being maintained in proper 
 working order through required preventive 
 maintenance activities? 
 
 If not, what actions are being taken or are 
 necessary? 
 
 
 

[SOP 

 IAN LABS Management Review Meeting Minutes 
 Form: D-121-F1l CCR No. N/A Revision: 0 
 
 Changes in volume or type of work 
 Describe known changes in volume or type of 
 work and the plans to address the changes. 
 
 Include when the change is expected. 
 Is the infrastructure adequate? 
 
 (Facilities, proper equipment, equipment 
 capacity, layout, hardware, software, etc.) 
 List what infrastructure changes are needed: 
 
 Is the work environment adequate and adequately 
 controlled? 
 
 (Temperature control, Humidity Control, lighting, 
 etc.) 
 List what work environment changes are needed: 
 
 Are staffing levels / resources adequate to support 
 the LMS and service to customers? 
 
 What processes and/or testing services are 
 experiencing delays or problems due to lack of 
 resources? 
 Are adequate controls in place for access into and 
 use of the Lab areas which affect laboratory 
 activities? If not, describe actions that will be 
 
 taken to improve controls. 
 Are adequate controls in place to prevent 
 contamination, interference, or adverse influences 
 on laboratory activities? If not, describe actions 
 that will be taken to improve controls. 
 
 Does the facility layout and physical 
 configuration provide effective separation 
 between areas with incompatible laboratory 
 activities? If not, describe actions that will be 
 taken to improve controls. 
 Training needs (list): 
 
 Comments, suggestions: 
 
 
 

[SOP 

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 LMS Internal Audit results 
 
 Necessary actions 
 Plan for next LMS Internal Audit: 
 
 Technical Internal Audit resultse 
 e 
 Necessary actions 
 Accreditation Assessment results 
 
 Necessary actions 
 Comments, suggestions for all audit 
 results 
 
 Open Actions (list CA Seq Ref # and 
 discuss) 
 
 Time|ieness oOf act1*0nS initi ted: 
 
 Time|iness ofie mplemented act10Nns: 
 Plans for improving responsiveness (if 
 necessary) 
 
 Comments, Suggestionse 
 ° 
 
 
 

[SOP 

 IANLABS Management Review Meeting Minutes 
 Form. D-121-F1 CCR No. N/A Rev1S«i0n 0 
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 Conclusion regarding the current 
 state/performance of the LMS 
 Does our LMS allow us to meet customer and ISO 
 
 17025 requiremen ts as well as meet the needs of 
 the business? 
 
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 ASODments