This document provides guidance on assessing conformance to the ISO 9001:2015 quality management system standard. It includes an assessment checklist that mirrors the structure of the standard, an explanation of using a process approach in assessments, and sample assessment summary sheets to record results. The summary sheets are used to identify which processes were assessed and where any discrepancies were found for particular standard clauses.
The new ISO 9001:2015 committee draft is published and distributed. There are changes which affect organizations who applied this standard. As it is among most famous ISO standards, follow up the changes would be critical and it is time to consider changes which might affect organizations' management systems.
A brief Introduction to ISO 9001 2015-Quality Management SystemSARWAR SALAM
Introduction to Quality Management System ISO 9001-2015 as outlined in EDC Romfor's IMS. Preparation, role and resposibility allocation for Audit purposes.
ISO 9001 is defined as the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 series and the only standard in the series to which organizations can certify.
ISO 9001 was first published in 1987 by the International Organization for Standardization (ISO), an international agency composed of the national standards bodies of more than 160 countries. The current version of ISO 9001 was released in September 2015.
Quality Management System awareness for all ANUPAM RAY
I covered benefit and utilization ISO 9001:2015 standard, 8 quality principle, Root cause analysis, what is ISO, and basic auditing principle. Kindly comment and let me know how I can improve this.
The new ISO 9001:2015 committee draft is published and distributed. There are changes which affect organizations who applied this standard. As it is among most famous ISO standards, follow up the changes would be critical and it is time to consider changes which might affect organizations' management systems.
A brief Introduction to ISO 9001 2015-Quality Management SystemSARWAR SALAM
Introduction to Quality Management System ISO 9001-2015 as outlined in EDC Romfor's IMS. Preparation, role and resposibility allocation for Audit purposes.
ISO 9001 is defined as the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 series and the only standard in the series to which organizations can certify.
ISO 9001 was first published in 1987 by the International Organization for Standardization (ISO), an international agency composed of the national standards bodies of more than 160 countries. The current version of ISO 9001 was released in September 2015.
Quality Management System awareness for all ANUPAM RAY
I covered benefit and utilization ISO 9001:2015 standard, 8 quality principle, Root cause analysis, what is ISO, and basic auditing principle. Kindly comment and let me know how I can improve this.
ISO 9001-2015 Revision Training PresentationDQS Inc.
ISO 9001 is a great tool that is used for managing an organization and implementing continuous improvement. More than one million organizations worldwide are certified to ISO 9001 in order to help ensure that good quality products and services are provided to customers.
Get an in-depth overview of the upcoming changes to ISO 9001:2015, including:
- Revision timing and roll out
- Details on structure change
- In-depth review of changes including risk assessment
- Transitioning from ISO 9001:2008 to ISO 9001:2015 timing and requirements
- and more.
Use this ppt presentation to educate groups on what is ISO 9001:2015 standard, what are the requirements of ISO 9001:2015 certification, etc.
For more information visit: https://www.globalmanagergroup.com/
I made this one, and it is good to show how to address the new requirements -- Context of organization, interesting parties, SWOT, PEST Analysis, Risk evaluation. just want to share with someone who need it ...
Presented for ASQ India on 3/22/2016 7PM - 8PM IST (6.30 AM -7.30AM PST). Govind will briefly discuss key changes, new requirements and a high level transition plan. The new standard is more aligned with business than ever. However this new standard also bring challenges for auditing. As a QMS manager, auditor or even a practitioner you will be expected to apply this management system standard at work.
This presentation gives a bried overview of the various parts & purpose of the ISO 9001:2015 QMS.
It revolves around the PDCA Cycle and useful in Manufacture & construction Industry.
Introduction for ISO 9001 2015 Implementation. This is a very basic presentation with description of important points for consideration during implementation.
The Checklist contains explanations and recommendations that:
- Facilitate the audit;
- May serve as a guide in the transition to the new version of ISO 9001: 2015 using 'fill the gap' methodology;
- Allow for QMS self-assessment for compliance with ISO 9001: 2015;
- Facilitate learning and understanding of the new version of ISO 9001:2015 requirements
- User-friendly format and professional layout - reviewed and approved by experienced ISO 9001 quality auditors.
- 72 pages
ISO 9001-2015 Revision Training PresentationDQS Inc.
ISO 9001 is a great tool that is used for managing an organization and implementing continuous improvement. More than one million organizations worldwide are certified to ISO 9001 in order to help ensure that good quality products and services are provided to customers.
Get an in-depth overview of the upcoming changes to ISO 9001:2015, including:
- Revision timing and roll out
- Details on structure change
- In-depth review of changes including risk assessment
- Transitioning from ISO 9001:2008 to ISO 9001:2015 timing and requirements
- and more.
Use this ppt presentation to educate groups on what is ISO 9001:2015 standard, what are the requirements of ISO 9001:2015 certification, etc.
For more information visit: https://www.globalmanagergroup.com/
I made this one, and it is good to show how to address the new requirements -- Context of organization, interesting parties, SWOT, PEST Analysis, Risk evaluation. just want to share with someone who need it ...
Presented for ASQ India on 3/22/2016 7PM - 8PM IST (6.30 AM -7.30AM PST). Govind will briefly discuss key changes, new requirements and a high level transition plan. The new standard is more aligned with business than ever. However this new standard also bring challenges for auditing. As a QMS manager, auditor or even a practitioner you will be expected to apply this management system standard at work.
This presentation gives a bried overview of the various parts & purpose of the ISO 9001:2015 QMS.
It revolves around the PDCA Cycle and useful in Manufacture & construction Industry.
Introduction for ISO 9001 2015 Implementation. This is a very basic presentation with description of important points for consideration during implementation.
The Checklist contains explanations and recommendations that:
- Facilitate the audit;
- May serve as a guide in the transition to the new version of ISO 9001: 2015 using 'fill the gap' methodology;
- Allow for QMS self-assessment for compliance with ISO 9001: 2015;
- Facilitate learning and understanding of the new version of ISO 9001:2015 requirements
- User-friendly format and professional layout - reviewed and approved by experienced ISO 9001 quality auditors.
- 72 pages
QMS Effectiveness: Tracking and Trending Quality Data - OMTEC 2017April Bright
What measurements are useful, and which metrics’ baseline makes sense to show the effectiveness of your quality management system? This presentation takes an ISO 13485 and 21 CFR, Part 820 approach to deciding what measurements are important, how trending makes an impact on risk-based decision-making, and why management review is just one of the ways to discuss and document your Quality Data activities.
Key changes to ISO 9001:2015 and 7 steps of 7EpsilonMeghana Ransing
This presentation highlights key changes to the upcoming ISO 9001:2015 quality standard and describes how '7 steps of 7Epsilon' satisfy its various requirements on risk based thinking, organisational knowledge and management review.
CRJS466 – Psychopathology and CriminalityUnit 5 Individual Proje.docxfaithxdunce63732
CRJS466 – Psychopathology and Criminality
Unit 5 Individual Project Grading Criteria
(125 points)
Content (75 points):
Question 1 (20 points)
Question 2 (20 points)
Question 3 (15 points)
Question 4 (20 points)
Organization (25 points):
Clarity and conciseness of thought, minimum page length
APA Formatting (12.5 points):
Title page with Running head, page numbers, 12-pt. Times New Roman or
Arial font, 1” margins, spacing, in-text citations, and References (minimum of
three peer-reviewed, scholarly sources)
Mechanics (12.5 points):
Grammar, spelling/word usage, punctuation
______________________________________________________________________
For the Unit 5 IP, below are the specific questions and my expectations:
In a 3–5 page position paper, respond to the following:
(1) Articulate the mental disorder being considered by the court in the case that you selected, and why this disorder would make the defendant unfit for trial.
**Based on information and knowledge gathered from the DSM-IV-TR or DSM-5, course text, Live Chats, Learning Materials, and other peer-reviewed/scholarly sources, determine ONE possible mental disorder being considered. Discuss your rationale as to why you selected the diagnosis for this particular case. Before choosing a disorder, think about the defendant's mental status, including appearance, attitude, behavior, mood and affect, speech, thought process, thought content, perception, cognition, insight, and judgment.
(2) Explain the relationship between the actions and behavior that would cause the court to remand the defendant for a mental evaluation.
**Address the association between the actions or offenses of the defendant and the mental disorder associated with the offense.
(3) Evaluate the outcome of the case you selected in terms of the defendant, the victim, and the community.
**Identify the impact of the trial’s outcome on the community, the victim, and the defendant.
(4) Critique and assess the court’s decision in the case you selected. Choose ONE of the following:
(a) Support the court’s correct decision.
**Discuss why you support (agree with) the court's decision. Explain your rationale.
(b) Challenge the court’s decision with your supported reasons.
**Discuss why you challenge (disagree with) the court's decision. Explain your rationale.
SWE440-1402A-01
Software Project Management
Project Plan
27 April 2014
Content
Page
1)Project Description and Methodology
3-6
2)Project Plan Outline
7-8
3)ISO & IEEE Standard
9-11
4)Configuration Management
12-16
5)Defect Tracking
17
6)Risk Management
19-22
7) Final Project Report
23
8)References
24
Project Description and Methodology
The IT ecosystem of financial services institutions faces many challenges in aligning business needs with IT solutions which generally.
Core technology of Hyundai Motor Group's EV platform 'E-GMP'Hyundai Motor Group
What’s the force behind Hyundai Motor Group's EV performance and quality?
Maximized driving performance and quick charging time through high-density battery pack and fast charging technology and applicable to various vehicle types!
Discover more about Hyundai Motor Group’s EV platform ‘E-GMP’!
5 Warning Signs Your BMW's Intelligent Battery Sensor Needs AttentionBertini's German Motors
IBS monitors and manages your BMW’s battery performance. If it malfunctions, you will have to deal with an array of electrical issues in your vehicle. Recognize warning signs like dimming headlights, frequent battery replacements, and electrical malfunctions to address potential IBS issues promptly.
What Does the PARKTRONIC Inoperative, See Owner's Manual Message Mean for You...Autohaus Service and Sales
Learn what "PARKTRONIC Inoperative, See Owner's Manual" means for your Mercedes-Benz. This message indicates a malfunction in the parking assistance system, potentially due to sensor issues or electrical faults. Prompt attention is crucial to ensure safety and functionality. Follow steps outlined for diagnosis and repair in the owner's manual.
In this presentation, we have discussed a very important feature of BMW X5 cars… the Comfort Access. Things that can significantly limit its functionality. And things that you can try to restore the functionality of such a convenient feature of your vehicle.
Things to remember while upgrading the brakes of your carjennifermiller8137
Upgrading the brakes of your car? Keep these things in mind before doing so. Additionally, start using an OBD 2 GPS tracker so that you never miss a vehicle maintenance appointment. On top of this, a car GPS tracker will also let you master good driving habits that will let you increase the operational life of your car’s brakes.
Symptoms like intermittent starting and key recognition errors signal potential problems with your Mercedes’ EIS. Use diagnostic steps like error code checks and spare key tests. Professional diagnosis and solutions like EIS replacement ensure safe driving. Consult a qualified technician for accurate diagnosis and repair.
Why Is Your BMW X3 Hood Not Responding To Release CommandsDart Auto
Experiencing difficulty opening your BMW X3's hood? This guide explores potential issues like mechanical obstruction, hood release mechanism failure, electrical problems, and emergency release malfunctions. Troubleshooting tips include basic checks, clearing obstructions, applying pressure, and using the emergency release.
"Trans Failsafe Prog" on your BMW X5 indicates potential transmission issues requiring immediate action. This safety feature activates in response to abnormalities like low fluid levels, leaks, faulty sensors, electrical or mechanical failures, and overheating.
Comprehensive program for Agricultural Finance, the Automotive Sector, and Empowerment . We will define the full scope and provide a detailed two-week plan for identifying strategic partners in each area within Limpopo, including target areas.:
1. Agricultural : Supporting Primary and Secondary Agriculture
• Scope: Provide support solutions to enhance agricultural productivity and sustainability.
• Target Areas: Polokwane, Tzaneen, Thohoyandou, Makhado, and Giyani.
2. Automotive Sector: Partnerships with Mechanics and Panel Beater Shops
• Scope: Develop collaborations with automotive service providers to improve service quality and business operations.
• Target Areas: Polokwane, Lephalale, Mokopane, Phalaborwa, and Bela-Bela.
3. Empowerment : Focusing on Women Empowerment
• Scope: Provide business support support and training to women-owned businesses, promoting economic inclusion.
• Target Areas: Polokwane, Thohoyandou, Musina, Burgersfort, and Louis Trichardt.
We will also prioritize Industrial Economic Zone areas and their priorities.
Sign up on https://profilesmes.online/welcome/
To be eligible:
1. You must have a registered business and operate in Limpopo
2. Generate revenue
3. Sectors : Agriculture ( primary and secondary) and Automative
Women and Youth are encouraged to apply even if you don't fall in those sectors.
What Does the Active Steering Malfunction Warning Mean for Your BMWTanner Motors
Discover the reasons why your BMW’s Active Steering malfunction warning might come on. From electrical glitches to mechanical failures and software anomalies, addressing these promptly with professional inspection and maintenance ensures continued safety and performance on the road, maintaining the integrity of your driving experience.
𝘼𝙣𝙩𝙞𝙦𝙪𝙚 𝙋𝙡𝙖𝙨𝙩𝙞𝙘 𝙏𝙧𝙖𝙙𝙚𝙧𝙨 𝙞𝙨 𝙫𝙚𝙧𝙮 𝙛𝙖𝙢𝙤𝙪𝙨 𝙛𝙤𝙧 𝙢𝙖𝙣𝙪𝙛𝙖𝙘𝙩𝙪𝙧𝙞𝙣𝙜 𝙩𝙝𝙚𝙞𝙧 𝙥𝙧𝙤𝙙𝙪𝙘𝙩𝙨. 𝙒𝙚 𝙝𝙖𝙫𝙚 𝙖𝙡𝙡 𝙩𝙝𝙚 𝙥𝙡𝙖𝙨𝙩𝙞𝙘 𝙜𝙧𝙖𝙣𝙪𝙡𝙚𝙨 𝙪𝙨𝙚𝙙 𝙞𝙣 𝙖𝙪𝙩𝙤𝙢𝙤𝙩𝙞𝙫𝙚 𝙖𝙣𝙙 𝙖𝙪𝙩𝙤 𝙥𝙖𝙧𝙩𝙨 𝙖𝙣𝙙 𝙖𝙡𝙡 𝙩𝙝𝙚 𝙛𝙖𝙢𝙤𝙪𝙨 𝙘𝙤𝙢𝙥𝙖𝙣𝙞𝙚𝙨 𝙗𝙪𝙮 𝙩𝙝𝙚 𝙜𝙧𝙖𝙣𝙪𝙡𝙚𝙨 𝙛𝙧𝙤𝙢 𝙪𝙨.
Over the 10 years, we have gained a strong foothold in the market due to our range's high quality, competitive prices, and time-lined delivery schedules.
What Exactly Is The Common Rail Direct Injection System & How Does It WorkMotor Cars International
Learn about Common Rail Direct Injection (CRDi) - the revolutionary technology that has made diesel engines more efficient. Explore its workings, advantages like enhanced fuel efficiency and increased power output, along with drawbacks such as complexity and higher initial cost. Compare CRDi with traditional diesel engines and discover why it's the preferred choice for modern engines.
What Exactly Is The Common Rail Direct Injection System & How Does It Work
Iso 9001 2015 checklist
1. RP-2 ISO 9001:2015 Issued: 9/18/15
DQS Inc. Revised: 5/12/17
ISO 9001:2015
Quality Management System
Assessment Checklist
RP-2
2. RP-2 ISO 9001:2015 Issued: 9/18/15
DQS Inc. Revised: 5/12/17
Table of Contents
Introduction ……………………………………………………………….…………………2
Assessment Summary Sheet - Sample………………………….………………..7
Assessment Summary Sheet ……………………………………….……………….10
4 – Context of the Organization ………………………………………………. 13
5 – Leadership …………………………………………………………………………. 14
6 – Planning for the Quality Management System …………………… 16
7—Support ……………………………………………………………………………... 17
8 – Operation ………………………………………………………………………….. 22
9 – Performance Evaluation …………………………………………………….. 33
10 – Improvement …………………………………………………………………… 36
3. RP-2 ISO 9001:2015 Issued: 9/18/15
DQS Inc. Revised: 5/12/17
The Quality System Checklist is intended to help you gain a better
understanding of the requirements of ISO 9001:2015. ISO
9001:2015 requires the adoption of the process approach which
extends to internal quality audits. This checklist follows the
structure of the standard, thus it is not process based. For this
reason it is not intended to be used as the only tool for internal
quality audits.
You can gain a better understanding of ISO 9001:2015 Standard as
it applies to your company by reviewing these questions. You may
wish to discuss them with your auditors to enhance everyone’s
understanding of the ISO 9001:2015 requirements and the
assessment process.
You should be aware that although the following questions include
most of the requirements of the ISO 9001:2015 standard, they do
not necessarily cover all aspects of the Standard. So, the use of this
checklist will give you only a sample of your organization’s
conformance to the ISO 9001:2015 standard.
4. RP-2 ISO 9001:2015 Issued: 9/18/15
DQS Inc. Revised: 5/12/17
Assessment Summary Sheet
The Assessment Summary Sheet may be used for visualizing the big picture:
what areas were checked and where discrepancies were found. You’ll see
from the sample Assessment Summary Sheet that assessment of the
Purchasing Process uncovered discrepancies for clauses 4.1, 5.3, 7.1.5, 8.1,
8.2, 8.3.1 and 8.5.3. This may be a sign of problems in that process, which
warrant planning and close monitoring of corrective actions. The Processes
Assessed column reveals that for clause 7.1.2 for Resource Requirements or
8.2 for Determination of requirements for products and services,
discrepancies were uncovered in all applicable areas. This may give
evidence of a system breakdown.
On the sample Assessment Summary Sheet, the circled numbers
correspond to the following:
The ISO 9001:2015 Assessment Standard correspond to the
ISO9001:2015 International Standard which your company has selected for
assessment.
The column Process Assessed lists the areas (i.e. process) where
compliance to given clauses will be evaluated.
These columns contain the list of clauses for the applicable ISO Standard
to which compliance is being sought. NOTE: All clauses of the ISO 9001
Standard must be addressed. See section 0.1. “Forward”, for further
information.
Use this grid to indicate where discrepancies are found by entering a “D”
into the corresponding boxes. Where no discrepancies are uncovered,
enter an “X” in the appropriate boxes.
5. RP-2 ISO 9001:2015 Issued: 9/18/15
DQS Inc. Revised: 5/12/17
0.2 Process Approach
ISO9001:2015 promotes the adoption of a process approach. As a first
step, all processes of the organization need to be identified and their
interrelation defined. A process is a set of activities that transform inputs
into outputs. The outputs of one process may be the input of another
process, or the finished product. Although a process map is not required,
it is an effective method for demonstrating process interrelation. Any other
method will equally meet the requirements of the standard as long as the
process interaction is somehow shown.
An example of a typical process map is noted on the next page. Please note
that a process map is not a process flow diagram, but merely highlights the
main processes of the organization that are needed to be effectively
monitored to ensure “consistent and predictable results”. Also, the
processes noted are not the names of the functions within the
organization, but value added activities within the organization that may
involve sub-processes that will have to be further defined.
7. RP-2 ISO 9001:2015 Issued: 9/18/15
DQS Inc. Revised: 5/12/17
Assessment Summary Sheet – SAMPLE
ISO 9001:2015 Processes of the Organization
Quality Management
Systems:
Requirements Management
Sales
Engineering
Cust.Sat.
Purchasing
Production1
Production2
Test
Pack&Ship
HR
Maintenance
Doc.Control
Quality
CAR/CI
InternalAudits
Mgt.Review
Accounting
Discrepancy Reference
Number
Clause
Number
Clause
Description
4.1 Understanding the organization
and its context
X X
4.2 Needs and Expectations of the
Interested Parties
X X X X X X X X X X X X X X X X
4.3 Determining the scope of the
quality management system
X
4.4 Quality Management System
and its processes
X
5.1 Leadership and commitment X X
5.2 Quality Policy X X X X X X X X X X X X X X X X X
5.3 Organizational roles,
responsibilities and authorities
X X X X D X X X X X X X X X X X X
6.1 Actions to address risks and
opportunities
X X X X X X X X X X X X X X X X X
6.2 Quality objectives and planning
to achieve them
X X X X X X X X X X X X X X X X X
6.3 Planning of changes D X
7.1 Resources X X X X X X X X X X X X X X X X X
7.1.1 General X
7..1.2 People D D D D D D D D D D D
7.1.3 Infrastructure X X X X X X X X
7.1.4 Environment for the operation
of processes
X X X X X X X X X
7.1.5 Monitoring and Measuring X D X X X X
7.1.6 Organizational Knowledge X X X X X X X X X X X X X X X X X
7.2 Competence X X X X X X X X X X X X X X X X X
7.3 Awareness X X X X X X X X X X X X X X X X X
7.4 Communication X X X X
8. RP-2 ISO 9001:2015 Issued: 9/18/15
DQS Inc. Revised: 5/12/17
ISO 9001:2015 Processes of the Organization
Quality Management
Systems:
Requirements
Management
Sales
Engineering
Cust.Sat.
Purchasing
Production1
Production2
Test
Pack&Ship
HR
Maintenance
Doc.Control
Quality
CAR/CI
InternalAudits
Mgt.Review
Accounting
Discrepancy Reference
Number
Clause
Number
Clause
Description
7.5 Documented Information X X X X X X X X D X X X X X X X X
7.5.1 General X
7.5.2 Creating and updating X X
7.5.3 Control of documented
Information
X X
8.1 Operational planning and
control
X X X X D X X X X
8.2 Determination of requirements D D D D D D D D D
8.2.1 Customer communication X X X
8.2.2 Determination of requirements
related to products and services
x X
8.2.3 Review of requirements related
to products and services
X
8.2.4 Changes to requirements X
8.3 Design and Development X X X X X X
8.3.1 General X X X X D X X X X
8.3.2 Design and development
planning
X X
8.3.3 Design and development inputs X X
8.3.4 Design and development
controls.
D X X
8.3.5 Design and development
Outputs
X X
8.3.6 Design and development
changes
X X
8.4.2 Type and extent of control of
external provision
X
8.4.3 Information for external
providers
X
8.5.1 Control of production and
Service
X X
9. RP-2 ISO 9001:2015 Issued: 9/18/15
DQS Inc. Revised: 5/12/17
ISO 9001:2015 Processes of the Organization
Quality Management
Systems:
Requirements
Management
Sales
Engineering
Cust.Sat.
Purchasing
Production1
Production2
Test
Pack&Ship
HR
Maintenance
Doc.Control
Quality
CAR/CI
InternalAudits
Mgt.Review
Accounting
Discrepancy Reference
Number
Clause
Number
Clause
Description
8.5.2 Identification and traceability X X X X X
8.5.3 Property belonging to
customers or external providers
D
8.5.4 Preservation X X X X X
8.5.5 Post-delivery activities X X X X
8.5.6 Control of changes X X X
8.6 Release of products and
services
X X X
8.7 Control of nonconforming
products
X X X D X X
9.1.1 Monitoring, measurement,
analysis
X X X X X X X X D X X X X X X X
9.1.2 Customer Satisfaction X X X
9.1.3 Analysis and evaluation X X X X X X X X D X X X X X X X
9..2 Internal Audits X X
9.3 Management Review X X
10.1 Improvement – General X X X X X X X X D X X X X X X X
10.2 Nonconformity/Corrective
Action
X X X D X X
10.3 Continual improvement X X X X X X X X D X X X X X X X
* Use an “X” to indicate that the clause was assessed in the area described.
Use a “D” to indicate that a discrepancy was found.
10. RP-2 ISO 9001:2015 Issued: 9/18/15
DQS Inc. Revised: 5/12/17
Assessment Summary Sheet
ISO 9001:2015 Processes of the Organization
Quality Management
Systems:
Requirements
Discrepancy Reference
Number
Clause
Number
Clause
Description
4.1 Understanding the organization
and its context
4.2 Needs and Expectations of the
Interested Parties
4.3 Determining the scope of the
quality management system
4.4 Quality Management System
and its processes
5.1 Leadership and commitment
5.2 Quality Policy
5.3 Organizational roles,
responsibilities and authorities
6.1 Actions to address risks and
opportunities
6.2 Quality objectives and planning
to achieve them
6.3 Planning of changes
7.1 Resources
7.1.1 General
7..1.2 People
7.1.3 Infrastructure
7.1.4 Environment for the operation
of processes
7.1.5 Monitoring and Measuring
7.1.6 Organizational Knowledge
7.2 Competence
7.3 Awareness
7.4 Communication
11. RP-2 ISO 9001:2015 Issued: 9/18/15
DQS Inc. Revised: 5/12/17
ISO 9001:2015 Processes of the Organization
Quality Management
Systems:
Requirements
Discrepancy Reference
Number
Clause
Number
Clause
Description
7.5 Documented Information
7.5.1 General
7.5.2 Creating and updating
7.5.3 Control of documented
Information
8.1 Operational planning and
control
8.2 Determination of requirements
8.2.1 Customer communication
8.2.2 Determination of requirements
related to products and services
8.2.3 Review of requirements related
to products and services
8.2.4 Changes to requirements
8.3 Design and Development
8.3.1 General
8.3.2 Design and development
planning
8.3.3 Design and development inputs
8.3.4 Design and development
controls.
8.3.5 Design and development
Outputs
8.3.6 Design and development
changes
8.4.2 Type and extent of control of
external provision
8.4.3 Information for external
providers
8.5.1 Control of production and
Service
12. RP-2 ISO 9001:2015 Issued: 9/18/15
DQS Inc. Revised: 5/12/17
ISO 9001:2015 Processes of the Organization
Quality Management
Systems:
Requirements
Discrepancy Reference
Number
Clause
Number
Clause
Description
8.5.2 Identification and traceability
8.5.3 Property belonging to
customers or external providers
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of changes
8.6 Release of products and
services
8.7 Control of nonconforming
products
9.1.1 Monitoring, measurement,
analysis
9.1.2 Customer Satisfaction
9.1.3 Analysis and evaluation
9..2 Internal Audits
9.3 Management Review
10.1 Improvement – General
10.2 Nonconformity/Corrective
Action
10.3 Continual improvement
* Use an “X” to indicate that the clause was assessed in the area described.
Use a “D” to indicate that a discrepancy was found.
On the following pages, indicates new/significantly changed
requirements.
13. RP-2 ISO 9001:2015 Issued: 9/18/15
DQS Inc. Revised: 5/12/17
Quality Management System Checklist
ISO9001:2015
Clause #
Quality Management System
Requirements
Documented
Information
Reference
Explanatory Notes and
Comments
4 Context of the organization
4.1 Understanding the organization and its context
4.1
Has the organization identified all external and
internal issues relevant to its purpose and
direction?
4.1
What is the process for monitoring and review of
the external and internal issues?
4.2 Understanding the needs and expectations of interested parties
4.2
Has the organization identified all relevant
interested party requirements that are relevant to
the quality management system? How is the
information monitored?
4.3 Determining the scope of the Quality Management System
4.3 Is the scope of the quality management system,
including products and services provided and
justification for any exclusion, defined?
4.3 Is the scope of the quality management system
maintained as documented information?
4.3 Are the following considered when determining
the scope?
• External and Internal Issues
• Requirements of relevant interested
parties
• The products and services provided.
4.3 Is there assurance that all requirements of the
standard that can be applied, have been applied
by the organization and those determined non-
applicable do not affect the organization’s ability
or responsibility to ensure conformity?
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Explanatory Notes and
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4.4 Quality Management System and its processes
4.4
Have the processes of the organization been
identified?
• Inputs and Outputs
• Sequence and interaction
• Criteria, method and performance
indicators
• Resources needed
• Defined responsibility and authority for all
personnel.
• Risks and Opportunities
• Method for monitoring and change to
ensure intended results
• Opportunities for improvement of the
processes
4.4
Has the organization defined
• Needed documented information to
support the operation of its processes?
• Documented information to be retained as
evidence that the processes are being
carried out as planned?
5 Leadership
5.1.1
Has top management demonstrated leadership by
• Taking accountability of the process?
• Establishing the Quality Policy and
Objectives?
• Communicating the Policy?
• Ensuring QMS Requirements are
integrated into the processes?
• Making available adequate resources?
• Communicating QMS effectiveness?
• Ensuring achievement of results?
• Engaging/directing/supporting process
effectiveness?
• Promoting continual improvement?
• Supporting other management roles
within the organization to do the same?
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Requirements
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Information
Reference
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Comments
5.1.1
Can top management demonstrate evidence of
commitment to the development, implementation
and improvement of the effectiveness of the
quality management system by:
• Communicating to the organization the
importance of meeting customer requirements?
• Establishing the quality policy?
• Ensuring that quality objectives are
established?
• Conducting management reviews?
• Ensuring the availability of resources?
5.1.2 Customer Focus
5.1.2
Has top management demonstrated leadership by
• Identifying customer requirements?
• Identifying regulatory requirements?
• Identifying statutory requirements?
• Risks and Opportunities determined and
addressed?
• Focus to consistently provide
products/services that meet customer
requirements?
• Enhancing customer satisfaction?
5.2 Quality Policy
5.2.1
Has top management established a quality policy
that
• Is appropriate to the organization?
• Allows for review of process indicators
and objectives?
• Includes a commitment to satisfy
applicable requirements?
• Includes a commitment to continual
improvement?
• Is communicated and understood
throughout the organization
• Is reviewed for continuing suitability?
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Reference
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5.2.1 Are the quality objectives measurable and
consistent with the quality policy?
5.2.2
Is the quality policy
• Documented?
• Communicated and understood?
• Available to relevant interested
parties?
5.3 Organizational roles, responsibilities and authorities
5.3
Has top management defined
• Responsibility and authority for all
personnel affecting quality?
• Ensuring that the processes are effective
and delivering their intended results?
• Reporting on the performance of the QMS
and opportunities?
• Ensuring Customer Focus throughout the
organization?
• Maintaining the integrity of QMS when
changes are implemented?
6 Planning for the Quality Management System
6.1.1
Has the organization considered risks and
opportunities noted in 4.1 and 4.2 and have
assurances that QMS
• Can achieve its intended results?
• Mitigate Risk by prevention or reduction
of undesired effects?
• Enhance desirable effects?
• Achieve improvements?
6.1.2
Does the organization plan
• Actions needed to address risks and
opportunities?
• Integrate actions into its QMS processes?
• Evaluate the effectiveness of actions?
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Comments
6.2.1
Has the organization established Quality
objectives that are:
• Consistent with the Quality Policy?
• Are measurable?
• Considered applicable requirements?
• Relevant?
• Monitored?
• Communicated?
• Updated?
6.2.2
Has the organization planned how to achieve its
quality objectives by
• Identifying what has to be done?
• Identifying the needed resources?
• Identifying the responsibility for
achievement?
• Due date for achievement?
• Evaluation of the results?
6.3
For changes to the QMS, has the organization
proceeded in a planned and systemic manner by
• Identifying the changes and their
consequence?
• The integrity of the QMS?
• Availability of resources?
• Allocation or reallocation of
responsibilities and authorities?
7 Support
7.1.1
Has the organization determined the needed
resources while considering
• Limitations of internal resources?
• What has to be obtained from external
providers?
7.1.2 People
7.1.2
Are adequate human resources in place to ensure
compliance with the customer and applicable
regulatory and statutory requirements?
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Explanatory Notes and
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7.1.3 Infrastructure
7.1.3
Has the organization identified the infrastructure
needed for effective operation of the QMS, ,
including
• Maintenance of equipment?
• Buildings and associated utilities?
• Transportation?
• Information and Communication
Technology?
7.1.4 Environment for the operation of processes
7.1.4
How will it be demonstrated that the organization
determines and manages the work environment
needed to achieve conformity to product and
service requirements?
7.1.5 Monitoring and measuring resources
7.1.5 Has the organization determined the monitoring
and measurement to be undertaken, and the
monitoring and measurement resources needed
to provide evidence of conformity to determined
requirements?
7.1.5
Are suitable monitoring and measuring resources
available to ensure valid and reliable results,
including
• Ensuring suitable resources?
• Resources are maintained to ensure their
continued fitness for their purpose?
• Maintaining documented information as
evidence of fitness of the monitoring and
measuring resources?
• Determining suitability of the specific type
of monitoring and measurement
activities?
7.1.5 Have all monitoring and measuring activities
determined?
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Reference
Explanatory Notes and
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7.1.5 Are monitoring and measuring resources
• Suitability maintained?
7.1.5 What documented information is maintained as
evidence of fitness for the monitoring and
measurement resources?
7.1.5 • Is measuring equipment calibrated or
verified, or both, at specified intervals or
prior to use against traceable international
or national measurement standards? (If
international or national measurement
standards are not available, the basis for
calibration or verification shall be defined)
• Identified in order to determine its
calibration status?
• Safeguarded from adjustments that would
invalidate the measurement result?
• Protected from damage and deterioration
during handling, maintenance and
storage?
7.1.5 How will it be demonstrated that:
• The validity of previous measuring results are
assessed by the organization when equipment is
found not to conform to requirements?
• Appropriate action is taken on the equipment
and any affected product?
7.1.6 Organizational Knowledge
7.1.6 What evidence is available to ensure that the
organization has determined the knowledge
necessary for effective operation of its processes?
7.1.6
Is the knowledge necessary for the operation of
the various processes determined, maintained,
and made available, if needed?
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Reference
Explanatory Notes and
Comments
7.2 Competence
7.2 Has the necessary competence for personnel
performing work affecting conformity to product
requirements been determined?
• Appropriate documented information for
education, training, skills and experience are
maintained?
7.2 Where applicable, is the Training provided or
other actions taken evaluated for effectiveness in
meeting the necessary competence?
7.2 Are Personnel aware of the relevance and
importance of their activities and how they
contribute to the achievement of the quality
objectives?
7.2 Are documented information maintained to
demonstrate competency achievements thru
education, training, skills and experience?
7.3 Awareness
7.3
Are methods in place to ensure understanding of
the following by all affected personnel:
• The quality policy?
• Relevant Quality Objectives?
• Contributions to the effectiveness of the
quality management system?
• Benefits of improved quality
performance?
• Implications of not conforming with the
quality management system
requirements?
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Reference
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7.4 Communication
7.4
Have the following been addressed for all internal
and external communication channels?
• Subject of Communication?
• When to communicate?
• With whom?
• How?
• Who?
7.4 Is Leadership able to demonstrate how they
ensure that appropriate communication processes
are established within the organization, and that
communication takes place regarding the
effectiveness of the quality management system?
7.5 Documented Information
7.5.1
Does the organization’s quality management
system include
• Documented information required by
ISO9001:2015?
• Documented information determined by
the organization to be necessary for the
effectiveness of the quality management
system?
7.5.2
Are all documented information
• Properly identified (e.g. title, date, author
or reference)?
• In defined format – language, software
version, graphics, media?
• Reviewed and approved for adequacy?
7.5.3.1
Are all documented information controlled to
ensure
• Its suitability and availability?
• Adequately protected from use or
improper use?
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Documented
Information
Reference
Explanatory Notes and
Comments
7.5.3.2
Have the following issues addressed for control of
Documented Information;
• Distribution, control, access, retrieval and
use?
• Storage and preservation, including
legibility?
• Control of changes (version control)?
• Retention and disposition?
• Identification and control of documents of
external origin?
8 Operation
8.1
Are adequate actions in place to ensure effective
planning, implementation and control of the
processes, including, the methods needed to
ensure
• Adequate identification of requirements
for products and services?
• Establishment of criteria for products and
services?
• Determination of needed resources?
• Implementation of the processes in
accordance with the noted criteria?
• Retention of documented information to
show process effectiveness, and to
demonstrate conformity of products and
services to requirements?
8.1
• How are the consequences of unintended
changes controlled, and how are actions
take to mitigate their adverse effects?
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8.2 Determination of requirements for products and services
8.2.1
Is there a process in place for communicating with
customers in relation to:
• Information related to products and
services?
• Handling of enquiries, contracts, including
changes?
• Obtaining customer views and
perceptions, including customer
complaints?
• Handling customer supplied property?
• Requirements of actions for
contingencies?
8.2.2
Have the processes been implemented for
• Identification of product requirements,
including applicable statutory and
regulatory requirements?
• Ability to meet the defined requirements
and substantiate the claims for the
products or services?
8.2.3 How are the following requirements determined?
• Customer specified requirements
including delivery and post-delivery.
• Requirements not stated by the customer
but necessary for specified or intended
use when known.
• Statutory and regulatory requirements
applicable to the product.
• Any additional requirements considered
necessary by the organization.
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Information
Reference
Explanatory Notes and
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8.2.3
Is there a process in place to
• Review requirements specified by the
customer?
• Consider requirements not stated by the
customer, but necessary?
• Identify the applicable statutory and
regulatory requirements for the products
or services?
• Handle order changes?
• Review of customer orders prior to order
acceptance?
Also, are documented information maintained as a
result of the review and handling of change
orders.
8.2.3
Are Requirements related to the product
reviewed prior to the commitment to supply a
product to the customer?
8.2.3
Does the review activity ensure:
• Product requirements are defined?
• Contract or order requirements differing from
those previously expressed are resolved?
• The organization’s ability to meet defined
requirements?
8.2.3
How will it be demonstrated that
the organization confirms customer requirements
when no documented statement of requirement is
provided by the customer?
8.2.4
How will the relevant documented information
amended, and persons made aware of the
changes, when the requirements are changed?
8.3 Design and development of products and services
8.3.2
Is evidence available that the organization plans
and controls the design and development of
products and services, considering the nature,
duration and complexity of the design activities?
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Reference
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Comments
8.3.2
Is the following determined during design and
development planning?
• The design and development stages
• The review, verification and validation
appropriate to each design and development
stage.
• The responsibilities and authorities for design
and development.
8.3.2
Are the interfaces between different groups
involved in design and development managed to
ensure effective communication and clear
assignment of responsibility, including
involvement of customer and/or user groups?
8.3.2
Are documented information maintained to
demonstrate that the design and development
requirements have been met?
8.3.3 Design and development Inputs
8.3.3
Are inputs relating to product requirements
determined and documented information
maintained relating to:
• Functional and performance requirements?
• Applicable statutory and regulatory
requirements?
• Applicable information from previous similar
designs?
• Other requirements essential for design and
development?
• Level of control by customers and other
relevant interested parties.
8.3.3
What evidence is available to indicate that
• Design and development inputs are reviewed
for adequacy?
• Requirements are complete, unambiguous
and not in conflict with each other?
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Reference
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8.3.4 Design and development controls
8.3.4
Are controls in place to ensure
• The results to be achieved are clearly
defined?
• Design and Development reviews are
planned and conducted?
• Verification activities are conducted to
ensure all inputs are met?
• Validation is conducted to ensure
suitability for the intended use?
8.3.4
Is verification performed to ensure that design and
development outputs have satisfied the design
and development input requirements?
8.3.4
Is design and development validation conducted
to ensure that the resulting product is capable of
fulfilling the requirements for the specified or
known intended use or application?
8.3.5 Design and development outputs
8.3.5
Are controls in place to ensure
• Input requirements have been met?
• Outputs are adequate for the subsequent
processes of the provision of products and
services?
• Identification of monitoring and
measuring requirements, and the
acceptance criteria?
• Designed products are fit for intended
purpose and their safe and proper use?
8.3.5
Are documented information maintained for the
design and development activities?
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8.3.6 Design and development changes
8.3.6
Are design and development changes:
• Controlled during, and after, the design and
development process?
• Identified?
• Reviewed?
• Verified and validated as appropriate?
• Evaluated for effect on constituent parts and
delivered products?
• Approved before implementation?
• Considered to have no adverse impact on
conformity to requirements
8.3.6
Are documented information on results of
changes and any necessary actions maintained?
8.4 Control of externally provided products and services
8.4.1
What processes exist to ensure that externally
provided processes, products and services
conform to specified purchase requirements?
8.4.1
Are the requirements in 8.4.2 applied to all
suppliers who
• Provide products for incorporation in the
products
• Provide products directly to the customers
• Provide full or partial outsourced process to
the organization.
8.4.1
Are external providers evaluated and selected,
monitored for performance and re-evaluated
based upon their ability to supply product in
accordance with the organization requirements?
8.4.1
Are documented information of the results of
supplier evaluations and any necessary actions
arising from evaluations maintained?
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8.4.2 Type and extent of control
8.4.2
Does the external provider monitoring process
take into consideration:
• The type and extent of controls to be applied?
• The potential impact of the externally
provided processes, products and services on
the ability to meet applicable statutory and
regulatory requirements?
• The perceived effectiveness of the controls
applied by the external provider?
8.4.2
Have necessary verification processes been
implemented to ensure the externally provided
processes, products and services do not adversely
affect the organization’s ability to meet customer
requirements?
8.4.2
Are controls of outsourced processes and
functions remain within the scope of the
organization’s quality management system?
8.4.2 Are documented information maintained as a
result of evaluation, monitoring and re-evaluation
of external providers?
8.4.2 Have inspection or other activities necessary for
ensuring that purchased product meets specified
purchase requirements been established and
implemented?
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Reference
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8.4.3 Information for external providers
8.4.3 Does the organization ensure communication to
external providers concerning:
• Products and services to be provided or
provided on behalf of organization?
• Approval of products and services, methods,
processes or equipment?
• Competence of personnel, including needed
qualification?
• Interactions with the organization’s quality
management system?
• Control and monitoring of the external
provider’s performance?
• Notification of verification activities to be
conducted by the organization at the external
provider’s premises?
8.4.3
Is the adequacy of specified purchase
requirements ensured prior to their
communication to the supplier?
8.5 Production and Service provision
8.5.1 Control of production and service provision
8.5.1
Are production and service operations carried out
under controlled conditions?
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8.5.1
What evidence is available to demonstrate that
controlled conditions include the following, as
applicable?
• The availability of information that describes
the characteristics of the product.
• The availability of the required documented
information.
• The use of suitable equipment.
• The availability and use of monitoring and
measurement resources.
• The implementation of monitoring and
measurement.
• The implementation of release, delivery and
post-delivery activities.
• The competency requirements or qualification
of personnel.
• The implementation of products and services
release, delivery and post-delivery activities.
8.5.1 Can it be demonstrated that measurement and
monitoring of the product is carried out at various
stages of the product realization process in
accordance with planned arrangements?
8.5.1 Are production and service processes validated,
and periodically revalidated, where the resulting
output cannot be verified by subsequent
monitoring or measurement?
8.5.2 Identification and traceability
8.5.2
Are process outputs identified, as appropriate, by
suitable means throughout the product/service
realization process?
8.5.2
Is product status identified with respect to
measuring and monitoring requirements
throughout product realization?
8.5.2
Is traceability a specified requirement? If so, is
unique identification of the product outputs
controlled and documented information
maintained to ensure adequate traceability?
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8.5.3 Property belonging to customers or external providers
8.5.3
Is customer property provided for the use or
incorporation into the product under the control
or use of the organization? If so, does a process
exist which ensures that care is provided for
customer or external provider property?
8.5.3
Is the organization reporting to the customer or
external provider, when their property is
incorrectly used, lost, damaged or otherwise
found to be unsuitable for use?
8.5.3 How will it be demonstrated that customer
property is:
Identified?
Verified?
Protected?
Safeguarded?
8.5.3 Is lost, damaged, or unsuitable product reported
to the customer?
8.5.4 Preservation
8.5.4
How will it be demonstrated that product, and
constituent parts of the product, are preserved
during internal processing and delivery to the
intended destination in order to maintain
conformity to requirements?
8.5.4 As applicable, are product preservation methods
established, as appropriate, for:
• Identification?
• Handling?
• Packaging?
• Storage?
• Protection?
8.5.5 Post-delivery activities
8.5.5
Is the organization meeting requirements for post-
delivery activities?
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8.5.5
With respect to post-delivery activities, are the
following considered?
• The risks associated
• The nature, use and intended lifetime of the
products and services
• Customer feedback
• Statutory and regulatory requirements
8.5.6 Control of changes
8.5.6
Are documented information maintained describing the
results of the review of the changes, the personnel
authorizing the change, and the necessary actions?
8.6 Release of products and services
8.6
Are planned arrangements in place to ensure
achievement of the product and service
requirements?
8.6
Are documented information maintained as
evidence of conformity with the acceptance
criteria?
8.6 Are controls in place to ensure that release of
product and delivery of service to the customer do
not proceed until all planned arrangements are
satisfactorily completed? Do documented
information identify the person authorizing the
release?
8.7 Control of nonconforming outputs
8.7
Are products and services that do not conform to the
requirements, identified and controlled to prevent their
unintended use or delivery?
8.7
Do the dispositions include any of the following?
• Correction
• Segregation, containment
• Informing the customer
• Obtaining authorization for use “as-is”,
continuation or acceptance under concession.
8.7
Are documented information maintained as evidence of
conformity with the acceptance criteria?
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8.7
Are corrected nonconforming products and
services verified for compliance after rework?
9 Performance Evaluation
9.1.1
Has the organization identified
• What has to be monitored
• The methods for monitoring,
measurement, analysis, evaluation
• When the monitoring to be performed
• When the results to be analyzed.
9.1.1
Is documented information maintained to ensure
that the monitoring and measurement activities
are implemented in accordance with the above
requirements?
9.1.1
Does this evaluation include review of the quality
performance data to ensure effectiveness of the
quality management system?
9.1.2 Customer Satisfaction
9.1.2 Is information relating to customer perception to
whether the organization has fulfilled customer
requirements monitored?
9.1.2
Is information obtained related to customer views
and opinions of the organization and its products
and services?
9.1.2
Is the method for obtaining and using the
customer satisfaction information determined?
9.1.3 Analysis and evaluation
9.1.3 Does the organization analyze and evaluate the
data arising from monitoring and measurement
activities?
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9.1.3
Is the organization using the sources of data to
• Demonstrate conformity of products and
services to requirements?
• Assess and enhance customer
satisfaction?
• Ensure conformity of effectiveness of the
quality management system?
• Demonstrate that planning has been
successfully implemented?
• Assess the performance of processes?
• Assess the performance of external
providers?
• Determine the need or opportunities for
improvement within the quality
management system?
9.1.3
Are the results of the above analysis provided as
input to management review?
9.2 Internal Audits
9.2.1
Does the internal quality audit activity determine
whether the quality management system:
• Conforms to planned arrangements?
• Conforms to ISO 9001:2015?
• Conforms to quality management system
requirements established by the organization?
• Is effectively implemented and maintained?
9.2.2
Is evidence available to confirm that internal
audits are conducted at planned intervals based
upon:
• The status and importance of the processes
and areas to be audited?
• The results of previous audits?
• Customer feedback?
• Changes impacting the organization?
9.2.2
Have audit criteria, scope, frequency and methods
been defined?
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9.2.2
Is evidence available to confirm that internal
auditors do not audit their own work, and are
objective and impartial of the audit process?
9.2.2
Does the management responsible for the area
being audited ensure that any necessary
corrections and corrective actions are taken
without undue delay to eliminate detected
nonconformities and their causes?
9.2.2
Are documented information maintained as
evidence of the implementation of the audit
program and the audit results?
9.3 Management Review
9.3.1
Does top management review the quality
management system at planned intervals to
ensure its continuing suitability, adequacy and
effectiveness?
9.3.1
Does management review evaluate the need for
changes to the quality management system,
including the quality policy and quality objectives?
9.3.1 Is documented information maintained as the
result of management reviews?
9.3.2
Do the inputs to management review include
information on the following (including quality
indicators (if any):
• Results of audits
• Customer Satisfaction
• Nonconformities and Corrective Actions
• Monitoring and measurement results
• Issues concerning external providers and other
relevant interested parties
• Adequacy of resources
• Process performance and conformity of
products and services
• Effectiveness of actions taken to address risks
and opportunities.
• Performance of external suppliers.
36. RP-2 ISO 9001:2015 Issued: 9/18/15
DQS Inc. Revised: 5/12/17
ISO9001:2015
Clause #
Quality Management System
Requirements
Documented
Information
Reference
Explanatory Notes and
Comments
9.3.3
Do the outputs from management review
include decisions and actions related to:
• Improvement of the effectiveness of the
quality management system and its processes?
• Improvement of product related to customer
requirements?
• Resource needs?
9.3.3
Are documented information maintained as
evidence of management reviews?
9.3.3 Does management review evaluate the need for
changes to the quality management system,
including the quality policy and quality objectives?
10.1 Improvement
10.1
Is the organization selecting opportunities for
improvement and implementing necessary actions
to meet customer requirements?
10.1
Is the organization taking actions to prevent
nonconformities, improve products and services,
and improve the overall quality management
system results?
10.2 Nonconformity and corrective action
10.2
In the presence of a nonconformity, does the
organization
• React to the nonconformity by taking
actions to control and correct it, and
dealing with its consequences?
• Evaluate the need for action to eliminate
the cause?
• Implement any action needed?
• Review the effective of any corrective
action?
• Make change to the quality management
system?
10.2
In the presence of a nonconformity, does the
organization react to the nonconformity by taking
actions to control and correct it, and dealing with
its consequences?
37. RP-2 ISO 9001:2015 Issued: 9/18/15
DQS Inc. Revised: 5/12/17
ISO9001:2015
Clause #
Quality Management System
Requirements
Documented
Information
Reference
Explanatory Notes and
Comments
10.2
Are actions taken appropriate to the effects, or
potential effects of the nonconformity?
10.2
Are corrective actions taken appropriate to the
effects of the nonconformities encountered?
10.2 Is action taken to eliminate the causes of
nonconformities in order to prevent recurrence?
10.2
Is documented information maintained to show
the nature of the nonconformity and any
subsequent actions taken, and the results of any
corrective action taken?
10.3 Continual Improvement
10.3
Is the organization continually improving the
suitability, adequacy and effectiveness of the
quality management system?
10.3
Are the outputs of analysis and evaluation, and
the outputs from the management review process
used to identify the areas of underperformances?
10.3
Are specialized tools and methodologies used for
investigation of the causes of underperformance?
10.3 How is it demonstrated that the effectiveness of
the quality management system is being
continually improved?
38. RP-2 ISO 9001:2015 Issued: 9/18/15
DQS Inc. Revised: 5/12/17
How to contact DQS Inc.
If you have additional questions or would like more information on how to
proceed, please feel free to contact DQS Inc. at: 1-800-285-4476 from North
America.
You can also access DQS Inc.'s website at www.dqsus.com for more
information.
Questions concerning any aspect of this document may be sent to
ISO9001_2015_Questions@dqsus.com