The management representative or designee is responsible for compiling the review output for management review meetings.

Distribute Management Review Output

The Management Representative retains copies of the management review output for his/her respective organizational level according to established record retention procedures and distributes at minimum copies according to the following:
Required Management Review Quorum or designees, the direct reports of the business head and anyone assigned an action item during the meeting (all other attendees/invitees upon request).
• Meeting minutes or equivalent.
• Action items from the meeting or documentation that no action items were identified during the meeting, as appropriate.

Next Level Management Representative:
• Meeting agenda or equivalent.
• Record of attendees.
• Meeting minutes or equivalent.
• Action items from the meeting or documentation that no action items were identified during the meeting, as appropriate.
• Management Review Certification or equivalent.
• Presentation (facility and /business unit reviews), if available.

The Management Review is considered to be a form of internal assessment and as such, only the Management Review Certification, Agenda and Attendees may be disclosed upon request by regulatory authorities. Additional disclosures require the pre-approval of Corporate Management Representative.

• Quality Trends and Metrics:
• Risk Management.
• Post Market Feedback:
• Complaint Management (e.g. product complaint trends and timeliness to closure).
• Vigilance Reports (e.g. MDRs, MDV, etc.).
• Field Corrective Actions (e.g. new and current status).
• Customer Feedback.
• Design Control (Product Development).
• CAPA (e.g. Timelines, closure, status, etc.).
• Non-conformances (e.g. timeliness, status, etc.).
• Quality Audits (internal and external).
• Supplier Management (e.g. Incoming Quality, Delivery, SCAR).
• Production and Process Controls: (as applicable Process Validations, Calibration,   Environmental Controls, Sterilization, Maintenance, etc.).
• Training.
• Change Management and Document (Records) Control.
• Regulatory findings (Notified Body audit observations, Competent Authority inspection observations (inc. FDA), etc.).
• Status of Notified Body/Competent Authority commitments that could have a significant impact on the business (e.g., FDA cWL, Notified Body, major non-conformances).
• New or revised regulatory requirements that could significantly impact Quality Systems or product lines (significant cost/time to comply and therefore needs executive awareness/commitment – e.g., 510(k) revisions, release/revision to  ISO 13485, ISO 14971, etc.).
• If appropriate, risks that may affect products, processes, the business and/or compliance.
• Evaluation of organizational structure and adequacy of staffing and resources.
• Other items defined by management at their discretion.
• Changes that could affect the Quality Management System.
• Recommendations for Improvement.

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Please refer below download link for Download Example/Template for Quality Management System File

Quality Management System template meeting minutes

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Food Safety Management System		RM	Mar	April	May
FSM1	HACCP Food Safety Management System	900			17-18
FSM4a	HACCP Internal Auditing	900	12-13
FSM8	Decoding & Applying the Malaysian Food Laws	550	26
FSM13	MS1514:2009 Good Manufacturing Practices (GMP) for Food	450			24
FSM14A	Food Safety Management for Food Service Organizations (BM)	900		9-10

ISO/TS 16949 : 2009 Quality Management System for Automotive Industry			RM	Mar	April	May
SMMT		ISO/TS 16949:2009 Lead Auditor Training for First and Second Party Auditors Certification	5500	12-16
SMMT1		ISO/TS 16949 Lead Auditor Re-Qualification Training for First and Second Party Auditors	2500	12-13
TS2		ISO/TS 16949 – A Strategy for Implementation	900		16-17
TS4		ISO/TS 16949 Process Based Internal Auditing	900			10-11
TS5		Quality Excellence Through Layered Process Audits (LPA)	600	5
VDA		VDA 6.3 Process Audit	650	27
ISO 13485:2003 Quality Management System for Medical Devices
MD1		Understanding ISO 13485:2003 Quality Management System for Medical Devices	900		9-10
MD2		Introduction to Risk Management for Medical Devices – ISO 14971	600	12
MD4		ISO 13485 Process Based Internal Auditing	900			3-4
FDA		Understanding of FDA 21 CFR Part 820	1100		16- 17
TL-9000 Quality Management System for Telecommunication Products & Services
TL1		Understanding TL-9000 Quality Management System for Telecommunication Products & Services	1100	28-29
TL4		TL-9000 Process Based Internal Auditing	1100		25-26
ISO 9001 Quality Management System			RM	Mar	April	May
C3-1	Understanding, Documenting & Implementing An ISO 9001:2008 Quality Management System		900	8-9	5-6	10-11
M3	Quality Management Systems Auditor/Lead Auditor Training Course (IRCA Reference: A17399)		3200	19-23	16-20	14-18
M4	ISO 9001 Process Based Internal Auditing		900	26-27	23-24	21-22
M8	Effective Implementation Of Document Control System		450		20
M9	Quality Management Representative Skills		900		12-13
M10	ISO 9004:2009 Sustaining the Organization’s Success		1100	19-22		3-4
M28	QMS Audit Report Writing		450	19-22
SAT	Supplier Auditing Training		900		18-19
ISO 14001:2004 Environmental Management System			RM	Mar	April	May
E01B	Understanding, Documenting & Implementing An ISO 14001 :2004 Environmental Management System		900		9-10
E03	ISO 14001 Environmental Impact Assessment		450	13
E04	ISO 14001 Process Based Internal Auditing		900			14-15
E06	Turning Waste Into Profit Through Effective Industrial Waste Management		450	14
E07	Decoding & Applying the Malaysian Environmental Laws		550			31
E09	Environmental Management Representative Skills		450	7
EA300	Environmental Management System Auditor Conversion Training Course (IRCA Reference: A17401)		2150		23-25
EA500	Environmental Management System Auditor/Lead Auditor Training Course (IRCA Reference A17400)		3200			21-25
OHSAS 18001:2007 Occupational Safety & Health			RM	Mar	April	May
HS500	Occupational Health & Safety Management System Auditor/Lead Auditor Training Course (IRCA Reference. A17436)		3200		9-13
HS1	Understanding, Documenting & Implementing Occupational Health & Safety Management System		900	26-27
HS3	Hazard Identification, Risk Assessment and Control (HIRAC)		450			30
HS4	Occupational Health & Safety (OH&S) Process Based Internal Auditing (CEP recognised)		900			8-9
HS9	Safety Leadership		450	2
HS10	Chemical Safety Data Sheet Awareness		450		17
HS11	Workplace Inspection for Safety and Health Committee		450			14
HS12	Essentials for the Safety & Health Committee		900	12-13
HS13	Incident Investigation For Safety & Health Committee		450		3

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Some definitions on Data Analysis and Trending Requirements Policy

Corrective Action: Steps that are taken to remove the causes of an existing nonconformance or to make quality improvements. Corrective actions address actual problems.

Data Source: The output of a process that is analyzed and trended.

Preventive Action: Steps that are taken to remove the causes of potential nonconformities or to make quality improvements. Preventive actions address potential problems, ones that haven’t yet occurred.

Significant Event: Significant issues that result in substantial impact on customer satisfaction, events that result in patient compromise,, events that are likely to recur and that require healthcare professional intervention, or issues that have a major impact on product safety or efficacy or major impact on quality systems.

Threshold: The point at which the recurrence of a nonconformance or result from data analysis or trend is escalated to a CAPA.

PROCEDURE/REQUIREMENTS: Facilities will implement procedures that provide for the periodic analysis and review of product and quality data to identify trends that may indicate action is warranted to correct existing product or quality issues and to develop actions to prevent their recurrence.

Data Sources: Consideration should be given to the following internal and external sources of data and included in the procedure if relevant.
• Complaints.
• Returned products analysis.
• Medical Device Reports and Vigilance Reports.
• Reports of system, process or product non-conformances.
• Acceptance Data (Incoming, in-process and final).
• Process performance.
• Equipment, preventive maintenance, and calibration data.
• Facility systems data.
• Scrap or rework records.
• Yield Data, Production efficiencies.
• Internal, external supplier and third party audits.
• FDA 483s and Warning Letters.
• Corrective and preventive actions.
• Service or Repair records.
• Delivery Timeliness.
• Customer Feedback.
• Management Reviews.

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Basic things to include inside CERTIFICATE OF CONFORMITY(COC) including which customer we want to sent out,traceability such as packing List No. / Invoice No. and Packing List Date.Statement such as inspection criteria, shelf-life, and expiry date based on customer’s request.Simple example/tempalte you can refer below:

CERTIFICATE OF CONFORMITY

Customer :

Packing List No. / Invoice No. :

Packing List Date :

This document certifies that the above referenced products have been subjected to Quality
Assurance procedural testing and conform to Company xyz product specifications and the
results of these evaluations are available for your inspection for a period of five (5) years from the
date of manufacture.

____ ______________________________
Date
Quality Assurance

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1.1 To provide training for all new and existing employees who perform activities that are documented within the scope of the Company x y z0 1 Quality Management System.

2.0 Scope

2.1 All Employees who perform activities within the scope of the Company x y z0 1 Quality Management System and in some instances 0 wide training initiatives will be trained and competent to the requirements of the Quality Management System prior to executing these activities.

3.0 Responsibilities

Quality Department
This programme and the scheduling of training will be the responsibility of the Quality Department and all other departments as applicable operating within the 1 Quality Management System.

HR Department
The HR Department is responsible for the maintenance of personnel files including curriculum vitae, job descriptions and evidence of education.

Employee
It is the responsibility of the employee to ensure that their Training File is maintained and that they are appropriately trained in accordance with – Training Matrix.

Change Order Originator
– It is the responsibility of the change order originator to complete – Training/COF Tracker when releasing a change order through Document Control.
– It is the responsibility of the change order originator to complete the required training.
– It is the responsibility of the change order originator to provide a list of outstanding trainees to Document Control and to follow-up on training records for same until 100% completion rate has been reached.

4.0 Reference Documents

Change Control
Induction Training
Change Control Form (COF)
Induction Training Log
Training Effectivity Record
Quality System Training Plan
General Training Record
Training Matrix
Training/COF Tracker
Company x y zTraining requirements (Corporate)

5.0 Procedure

5.1 Guidelines – New Employees

Assessment of training needs will be performed by the employee’s Manager, based on the following:
a. Job requirement /description.
b. Employee’s prior training, experience or educational background.
c. Initial hire and or transfer.
d. As the job requirements change.

The Training Plan will be documented and approved by the employee’s Manager on 9, Quality System Training Plan.

5.2 Training Programme Types – New Employees

Induction Programme:
New employees will undertake an induction-training programme within 15 days of joining the company. This programme is outlined in the Induction Training procedure.

5.3 Position Specific Training – New Employees

Training requirements will be based on a specific position operating within the 1 Quality Management System / Departments. This applies to both temporary/contract and permanent staff. It is the responsibility of the employees Functional Manager to identify and provide the required training for certain specific job roles and document it on Form Quality System Training Plan. It is the responsibility of the Functional Manager to identify the required training and complete the Training Matrix –

The Functional Manager assigns the type of training as follows:

Key Type of Training Required Description Training Form Required
C Core Employee is actively carrying out function. If first time training on procedure complete
OR
If Group training or procedure has been upreved and FRM0008 has already been completed, complete

RU Read & Understand Employee is not carrying out function and only needs to be aware that the procedure exists. In the case where this status changes and the employee switches to actively carrying out the function they should complete Core training as described above. Complete

NR Not Required Not required No form required.

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Business Process Improvement Through 7 Management Tools
Date: 5-6 January 2012
These 7 Management tools make it possible for managers to plan wide-ranging and detailed total quality objectives throughout the entire organization. Some of these tools are borrowed from other disciplines and others are developed specifically for quality management.

Failure Mode & Effect Analysis (FMEA)
Date: 9 January 2012
FMEA is focused on prevention; a well-developed and comprehensive FMEA can greatly reduce the cost of poor quality. As new information emerges and/or when change is encountered, updating the FMEA will continually improve the quality and reliability of a process or product design.

Advanced Product Quality Planning (APQP), Control Plan & Production Part Approval Process (PPAP)
Date: 10 January
APQP focuses on the utilization of various techniques to identify and resolve problems before a product goes into full production while PPAP is a structured approach to ensure that customer requirements are understood and the manufacturing processes have the potential to produce parts that meet the customer’s requirements during actual production.

Quick Changeover for Operational Flexibility and Responsiveness (confirmed)
Date: 10 January
This training will equip participants with the practical knowledge to reduce set-up time reduction and thereby, enhance the organisation’s flexibility and responsiveness to meet customers’ demands. As a result, small batch scheduling and production, as well as mix production, can be practiced effectively and efficiently.

Total Productive Maintenance (TPM): Key to Production Effectiveness (confirmed)
Date: 11 January
This training will provide participants with a good overview of the concepts and practical approaches in implementing an effective TPM program. It takes participants through in details the 8 Pillars of TPM and the TPM implementation roadmap.

Zero Defects Through Poka Yoke (confirmed)
Date: 12 January
This compact course will help participants to get started on developing and implementing a mistake-proofing system for their organizations.

Measurement System Analysis (MSA)
Date: 16-17 January
In Measurement System Analysis (MSA), you will learn how to identify and analyze the source of measurement system variation and how to improve the measurement error to achieve high accuracy and high precision.

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2. In the process of such planning, the Company shall define: -

a. The Quality and Environmental objectives for the service or contract,
b. The need to establish processes and documentation, and to provide resources and facilities specific to the product.
c. Verification, validation, monitoring, Inspection and test activities specific to the product and the criteria for product acceptance.
d. The records that is necessary to provide confidence of conformity and meeting the requirement of the process and product.

3. The Quality and Environmental Plan are also generated to integrate all Quality and Environmental activities and processes of the business.

4. COMPANY, through the efforts of the Environmental Committee and the Environmental Aspects and Impacts procedure, identifies and plans those operations that are associated with COMPANY’s identified significant environmental aspects consistent with its environmental policy, objectives and targets. This process ensures that these activities are carried out under specified conditions, by

a. Establishing, implementing and maintaining documented procedures to control situations where their absence could lead to deviation from the environmental policy, objectives and targets

b. Stipulating the operating criteria in these procedures

c. Establishing, implementing and maintaining procedures related to the identified significant environmental aspects of goods and services used by the organization and communicating applicable procedures and requirements to suppliers, including contractors. Suppliers are required to provide appropriate environmental, health & safety information about their products (i.e. MSDS sheets) as part of the order. These are maintained in MSDS binders available to all employees. Significant aspects associated with new materials are identified as described in the Environmental Aspects and Impacts procedure and appropriate operational controls established.

5. Subcontractors involved in work that could have a significant environmental impact (e.g. construction, demolition, etc.) are requested to describe their processes, materials and wastes. Only certified and/or licensed environmental subcontractors (e.g. environmental compliance consultants, waste haulers) are used for specific environmental services. COMPANY’s environmental policy and appropriate requirements are communicated to environmental subcontractors prior to the start of any work. Specific instructions for the communication with suppliers and contractors are provided in the Environmental Briefing Form

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