This document provides a checklist for organizations to assess their readiness to transition to the new ISO 9001:2015 standard. It lists the requirements of each clause in ISO 9001:2015 and allows the organization to indicate whether they comply with each requirement and provide evidence. The checklist is a guide and completing it does not guarantee certification. The document also provides contact information for support and training from the certification body on transitioning to ISO 9001:2015.
• Lead a quality engineering team that supports all business units during component and finished device manufacturing transfers at suppliers around the world.
• Assess legacy specifications for compliance and work with R&D to update any required changes.
• Perform gap assessment, and facilitate gap closure with cross-functional team members, Enhance KPIs
• Provide expert guidance in interpreting governmental regulations, agency guidelines and PHF internal policies in general and specific to transfers to assure compliance.
• Understand all validation quality policy/system interfaces and dependencies between business partners and internal/external processes.
• Oversee the completion of projects through the development and approval of validation schedules, project plans, master plans, validation protocols and reports for systems to support the validation plan.
• Manages validation and qualification activities with Development, Manufacturing, and Engineering, Quality, Regulatory and other groups on projects.
• Manages the activities of assigned SMEs and contract personnel to ensure the quality of completed work.
• Provides technical assessment and approval for engineering and process changes.
• Reviews and approves protocols, reports and data tables generated by subordinates and contract personnel.
• Ensures solutions are consistent with organizational objectives.
• Support, mentor, train and educate suppliers in planning and executing the validation processes, best practices
• Support with metrics and reporting on critical aspects regarding the health of the overall project.
• Support the development and implementation of validation procedures, best practices, and training/education programs.
• Lead internal and external audits and inspections related to component and manufacturing transfers.
• Provide continuous and rigorous assessment of activities and documentation to assure compliance with FDA regulations, ISO 13485, and Corporate Policy through the review of qualification and/or validation records at critical phases.
• Uses full knowledge of cGMP, FDA CFR 820, Corporate Policy and industry best practices to ensure risk management, validation processes, acceptance and qualification processes, and documentation are efficient
• Lead a quality engineering team that supports all business units during component and finished device manufacturing transfers at suppliers around the world.
• Assess legacy specifications for compliance and work with R&D to update any required changes.
• Perform gap assessment, and facilitate gap closure with cross-functional team members, Enhance KPIs
• Provide expert guidance in interpreting governmental regulations, agency guidelines and PHF internal policies in general and specific to transfers to assure compliance.
• Understand all validation quality policy/system interfaces and dependencies between business partners and internal/external processes.
• Oversee the completion of projects through the development and approval of validation schedules, project plans, master plans, validation protocols and reports for systems to support the validation plan.
• Manages validation and qualification activities with Development, Manufacturing, and Engineering, Quality, Regulatory and other groups on projects.
• Manages the activities of assigned SMEs and contract personnel to ensure the quality of completed work.
• Provides technical assessment and approval for engineering and process changes.
• Reviews and approves protocols, reports and data tables generated by subordinates and contract personnel.
• Ensures solutions are consistent with organizational objectives.
• Support, mentor, train and educate suppliers in planning and executing the validation processes, best practices
• Support with metrics and reporting on critical aspects regarding the health of the overall project.
• Support the development and implementation of validation procedures, best practices, and training/education programs.
• Lead internal and external audits and inspections related to component and manufacturing transfers.
• Provide continuous and rigorous assessment of activities and documentation to assure compliance with FDA regulations, ISO 13485, and Corporate Policy through the review of qualification and/or validation records at critical phases.
• Uses full knowledge of cGMP, FDA CFR 820, Corporate Policy and industry best practices to ensure risk management, validation processes, acceptance and qualification processes, and documentation are efficient
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
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 ...
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.
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.
What is requirement of Risk based Thinking in ISO 9001:2015 & ISO 14001:2015 ?
What is Risk? How to identify? How to assess and control?
How to incorporate Risk based thinking in to QMS & EMS?
Join Joe Mansour, UL DQS Inc. Lead Auditor and ISO 9001:2015 Program Manager, as he gives an in-depth overview of the changes coming to ISO 9001:2015. Part 3 of the 5 part webinar concentrates on the review of questions received during part 2 and the review of sections 7 and 8 of the standard.
Here is an easy to use checklist for the transition of ISO 9001 to the 2015 edition if you require any advise please call CAW Consultancy Business Solutions on 01772 932058 or our 24 hour hotline 07427535662
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
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 ...
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.
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.
What is requirement of Risk based Thinking in ISO 9001:2015 & ISO 14001:2015 ?
What is Risk? How to identify? How to assess and control?
How to incorporate Risk based thinking in to QMS & EMS?
Join Joe Mansour, UL DQS Inc. Lead Auditor and ISO 9001:2015 Program Manager, as he gives an in-depth overview of the changes coming to ISO 9001:2015. Part 3 of the 5 part webinar concentrates on the review of questions received during part 2 and the review of sections 7 and 8 of the standard.
Here is an easy to use checklist for the transition of ISO 9001 to the 2015 edition if you require any advise please call CAW Consultancy Business Solutions on 01772 932058 or our 24 hour hotline 07427535662
Sample of the first 8-9 pages of the manual. The manual is available online at https://www.complianceresourcelibrary.co.uk/product-category/certified-business-resources/qms-iso-9001_2015/
How to successfully implement ISO 9001:2015 with a minimal documents approachPECB
The webinar covers:
• Replacing the Quality Manual
• Replacing All Other Procedures
• Checking Yourself to Ensure You've Met All Requirements
Presenter:
This webinar was presented by Debra Hay Hampton, PECB Certified Trainer and Lead Auditor of Quality and Environmental Management Systems.
Link of the recorded session published on YouTube: https://youtu.be/PnCjPlGGb68
ISO 9001 ultimate guide to the core quality management standard.pdfFaiz Alkhawlani
This document describes the ultimate goals to quality control in medical laboratory and provide guidance for the accurately diagnosis of patients specimens ordered by the medical doctors
The role of the new ISO 9001:2015 leadership requirements in companiesPECB
In the ISO 9001:2015, this is an opportune time for managers, directors, and business owners to get up to speed on the new leadership requirements. The latest version, ISO 9001:2015, has 11 requirements that Top Management must demonstrate to show commitment to their Quality Management System.
Main points covered:
• The role Leaders plays in setting and achieving organizational objectives
• The impact Leadership can have on organizational communication
• How Leaders can share values, demonstrate fairness, and present an ethical role model
Presenter:
This webinar was presented by George Ogoti an MSC (Chemical Engineering) holder, also he is an International Auditor, Trainer and Consultant on SHEQFS and other systems . He has an excellent knowledge industry's standards having worked for over 34 years. He is also a PECB certified auditor, trainer and implementer and has extensive coverage in Africa and Middle East and Managing Director of MMCAFRICA.
Link of the recorded session published on YouTube: https://youtu.be/PBSQ9hxrSS8
Opendatabay - Open Data Marketplace.pptxOpendatabay
Opendatabay.com unlocks the power of data for everyone. Open Data Marketplace fosters a collaborative hub for data enthusiasts to explore, share, and contribute to a vast collection of datasets.
First ever open hub for data enthusiasts to collaborate and innovate. A platform to explore, share, and contribute to a vast collection of datasets. Through robust quality control and innovative technologies like blockchain verification, opendatabay ensures the authenticity and reliability of datasets, empowering users to make data-driven decisions with confidence. Leverage cutting-edge AI technologies to enhance the data exploration, analysis, and discovery experience.
From intelligent search and recommendations to automated data productisation and quotation, Opendatabay AI-driven features streamline the data workflow. Finding the data you need shouldn't be a complex. Opendatabay simplifies the data acquisition process with an intuitive interface and robust search tools. Effortlessly explore, discover, and access the data you need, allowing you to focus on extracting valuable insights. Opendatabay breaks new ground with a dedicated, AI-generated, synthetic datasets.
Leverage these privacy-preserving datasets for training and testing AI models without compromising sensitive information. Opendatabay prioritizes transparency by providing detailed metadata, provenance information, and usage guidelines for each dataset, ensuring users have a comprehensive understanding of the data they're working with. By leveraging a powerful combination of distributed ledger technology and rigorous third-party audits Opendatabay ensures the authenticity and reliability of every dataset. Security is at the core of Opendatabay. Marketplace implements stringent security measures, including encryption, access controls, and regular vulnerability assessments, to safeguard your data and protect your privacy.
Data Centers - Striving Within A Narrow Range - Research Report - MCG - May 2...pchutichetpong
M Capital Group (“MCG”) expects to see demand and the changing evolution of supply, facilitated through institutional investment rotation out of offices and into work from home (“WFH”), while the ever-expanding need for data storage as global internet usage expands, with experts predicting 5.3 billion users by 2023. These market factors will be underpinned by technological changes, such as progressing cloud services and edge sites, allowing the industry to see strong expected annual growth of 13% over the next 4 years.
Whilst competitive headwinds remain, represented through the recent second bankruptcy filing of Sungard, which blames “COVID-19 and other macroeconomic trends including delayed customer spending decisions, insourcing and reductions in IT spending, energy inflation and reduction in demand for certain services”, the industry has seen key adjustments, where MCG believes that engineering cost management and technological innovation will be paramount to success.
MCG reports that the more favorable market conditions expected over the next few years, helped by the winding down of pandemic restrictions and a hybrid working environment will be driving market momentum forward. The continuous injection of capital by alternative investment firms, as well as the growing infrastructural investment from cloud service providers and social media companies, whose revenues are expected to grow over 3.6x larger by value in 2026, will likely help propel center provision and innovation. These factors paint a promising picture for the industry players that offset rising input costs and adapt to new technologies.
According to M Capital Group: “Specifically, the long-term cost-saving opportunities available from the rise of remote managing will likely aid value growth for the industry. Through margin optimization and further availability of capital for reinvestment, strong players will maintain their competitive foothold, while weaker players exit the market to balance supply and demand.”
Adjusting primitives for graph : SHORT REPORT / NOTESSubhajit Sahu
Graph algorithms, like PageRank Compressed Sparse Row (CSR) is an adjacency-list based graph representation that is
Multiply with different modes (map)
1. Performance of sequential execution based vs OpenMP based vector multiply.
2. Comparing various launch configs for CUDA based vector multiply.
Sum with different storage types (reduce)
1. Performance of vector element sum using float vs bfloat16 as the storage type.
Sum with different modes (reduce)
1. Performance of sequential execution based vs OpenMP based vector element sum.
2. Performance of memcpy vs in-place based CUDA based vector element sum.
3. Comparing various launch configs for CUDA based vector element sum (memcpy).
4. Comparing various launch configs for CUDA based vector element sum (in-place).
Sum with in-place strategies of CUDA mode (reduce)
1. Comparing various launch configs for CUDA based vector element sum (in-place).
Levelwise PageRank with Loop-Based Dead End Handling Strategy : SHORT REPORT ...Subhajit Sahu
Abstract — Levelwise PageRank is an alternative method of PageRank computation which decomposes the input graph into a directed acyclic block-graph of strongly connected components, and processes them in topological order, one level at a time. This enables calculation for ranks in a distributed fashion without per-iteration communication, unlike the standard method where all vertices are processed in each iteration. It however comes with a precondition of the absence of dead ends in the input graph. Here, the native non-distributed performance of Levelwise PageRank was compared against Monolithic PageRank on a CPU as well as a GPU. To ensure a fair comparison, Monolithic PageRank was also performed on a graph where vertices were split by components. Results indicate that Levelwise PageRank is about as fast as Monolithic PageRank on the CPU, but quite a bit slower on the GPU. Slowdown on the GPU is likely caused by a large submission of small workloads, and expected to be non-issue when the computation is performed on massive graphs.
06-04-2024 - NYC Tech Week - Discussion on Vector Databases, Unstructured Data and AI
Discussion on Vector Databases, Unstructured Data and AI
https://www.meetup.com/unstructured-data-meetup-new-york/
This meetup is for people working in unstructured data. Speakers will come present about related topics such as vector databases, LLMs, and managing data at scale. The intended audience of this group includes roles like machine learning engineers, data scientists, data engineers, software engineers, and PMs.This meetup was formerly Milvus Meetup, and is sponsored by Zilliz maintainers of Milvus.
Chatty Kathy - UNC Bootcamp Final Project Presentation - Final Version - 5.23...John Andrews
SlideShare Description for "Chatty Kathy - UNC Bootcamp Final Project Presentation"
Title: Chatty Kathy: Enhancing Physical Activity Among Older Adults
Description:
Discover how Chatty Kathy, an innovative project developed at the UNC Bootcamp, aims to tackle the challenge of low physical activity among older adults. Our AI-driven solution uses peer interaction to boost and sustain exercise levels, significantly improving health outcomes. This presentation covers our problem statement, the rationale behind Chatty Kathy, synthetic data and persona creation, model performance metrics, a visual demonstration of the project, and potential future developments. Join us for an insightful Q&A session to explore the potential of this groundbreaking project.
Project Team: Jay Requarth, Jana Avery, John Andrews, Dr. Dick Davis II, Nee Buntoum, Nam Yeongjin & Mat Nicholas
Chatty Kathy - UNC Bootcamp Final Project Presentation - Final Version - 5.23...
Iso 9001-client-transition-checklist (1)
1. Page 1 of 8 www.alcumusgroup.com Issue001 Sept 15
ISO 9001:2015 - Client Transition Checklist
How to use this document: It is not mandatory to use this document. It is a guide to give you an indication of your readiness for audit
against ISO 9001:2015. It may be useful to use this as an indication of how close to compliance you are and to give you confidence when
applying for the standard upgrade. Our auditors will not ask for this as evidence of compliance as they will be using their own audit
procedures. Please be aware that this does not guarantee that you will be recommended for certification to ISO 9001:2015 and you will also
need to obtain a copy of the published standard as the clauses are not covered in their entirety by this document.
ISO 9001:2015 Clause New
requirement
Complies
(Yes/No)
Evidence
4 Context of the organization
4.1 Understanding the organization
and its context
The organization shall determine
external andinternal issues that are
relevant to its purpose and its strategic
direction and that affect its abilityto
achieve the intendedresult(s) ofits
qualitymanagement system. The
organizationshall monitor andreview
the informationabout these external
and internal issues
Yes
4.2 Understanding the needs and
expectations of interested parties
Due to their impact or potential impact
on the organizations abilityto
consistentlyprovide products and
services that meet customer and
applicable statutoryandregulatory
requirements, the organizationshall
determine:
The interested partiesthat are relevant
to the qualitymanagement system
The requirements of these interested
parties that are relevant to the quality
management system;the organization
shallmonitor and reviewthe
informationabout these interested
parties and their relevant requirements
Yes
4.3 Determining the scope of the
quality management system
The organization shall determine the
boundaries andapplicabilityof the
qualitymanagement systemto
establishits scope
Yes
4.4 Quality management system
The organization shall establish,
implement, maintainandcontinually
improve a qualitymanagement system,
includingthe processes neededand
their interactions
Yes
For support regarding your transition, please contact us:
General enquiries: 0161 865 3699
To book a transition training course: 01296 678484
To book a transitiontraining courses:01296678484
2. Page 2 of 8 www.alcumusgroup.com Issue001 Sept 15
ISO 9001:2015 Clause New
requirement
Complies
(Yes/No)
Evidence
5 Leadership
5.1 Leadership and commitment
5.1.1 General
Top management shall demonstrate
leadershipandcommitment with
respect to the qualitymanagement
systemby:
Taking accountabilityof the
effectivenessof the QMS
Ensuring that the qualitypolicyand
objectives are establishedfor the QMS
and are compatible withthe context
and strategic direction oforganization
Ensuring the integrationof the QMS
requirements intothe organization’s
business processes
Promotingthe use of the process
approachandrisk based thinking
Ensuring that the resources needed for
the QMS are available
Communicating the importance of
effective qualitymanagement andof
conformingto the QMS requirements
Ensuring that the QMS achieves its
intendedresults
Engaging, directing and supporting
persons to contribute to the
effectivenessof the QMS
Promotingcontinual improvement
Supporting other relevant
management roles to demonstrate
their leadershipas it applies to their
areas of responsibility
5.1.2 Customer Focus
Top management shall demonstrate
leadershipandcommitment with
respect to customer focus byensuring:
a) Customer and applicable
statutoryandregulatory
requirements are
determined, understoodand
consistentlymet
b) The risks and opportunities
that can effect conformityof
products andservices and
the abilityto enhance
customer satisfaction are
determinedandaddressed
c) The focus onenhancing
customer satisfaction is
maintained
Yes
5.2 – Policy
5.2.1 Developing the Quality Policy
Top management shall establish,
review andmaintaina qualitypolicy
that:
Is appropriate to the purpose and
context of the organization.
Yes
3. Page 3 of 8 www.alcumusgroup.com Issue001 Sept 15
Provides a framework for setting and
reviewing qualityobjectives
Includesa commitment to satisfy
applicable requirements
It shouldcommunicatedand
understood andbe available to
relevant interestedparties as
appropriate
5.2.2 Communicating the Quality
Policy
The qualitypolicyshall:
a) Be available and be
maintained as documented
information
b) Be communicated,
understood andapplied
within the organisation
c) Be available to relevant
interestedparties, as
appropriate
5.3 Organizational roles,
responsibilities and authorities
Top management shall ensure that the
responsibilitiesandauthorities for
relevant roles are assigned,
communicatedandunderstood within
the organization
No
6 Planning
6.1 Actions to address risk and
opportunities
When planning for the QMS the
organizationshall consider the issues
referredto 4.1 and the requirements
referredto in4.2 anddetermine the
risks andopportunities that needto be
addressedto:
a)give assurance that the QMS can
achieve the intendedresults
b) enhance desirable effects
c) prevent or reduce, undesired
effects
d) achieve improvement
Yes
6.1.2 The organizationshall plan:
a) actions to address these risks and
opportunities
b) how to:
1) Integrate andimplement the
actions into its QMS
2) Evaluate the effectiveness of
these actions
Yes
6.2 Quality objectives and planning to
achieve them
6.2.1 The organisation shall establish
qualityobjectives at relevant functions,
levels and processesneeded for the
QMS
Yes
4. Page 4 of 8 www.alcumusgroup.com Issue001 Sept 15
ISO 9001:2015 Clause New
requirement
Complies
(Yes/No)
Evidence
6.2.2 When planning actions to achieve
qualityobjectives the organizationshall
determine:
What willbe done, what resourceswill
be required, whowillbe responsible,
when will it be completed, howwill the
results be evaluated
Yes
6.3 Planning of changes
When the organisationdeterminesthe
need for changes to the QMS, the
changes shall be carried out ina
planned manner:
The purpose of the change and any
potential consequences, the integrity
of the QMS, the availabilityof
resources, the allocationor re-
allocationof responsibilities and
authorities
No
7 Support
7.1 Resources
The organization shall determine and
provide the resourcesneededfor the
establishment, implementation,
maintenance andcontinual
improvement of the quality
management system
No
7.2 Competence
The organisation shall:
Determine the necessarycompetence
of persons doingwork under its control
that affects the performance and
effectivenessof the QMS
Ensure that these persons are
competent onthe basis of appropriate
education, trainingor experience
Where applicable take actions to
acquire the necessarycompetence and
evaluate the effectiveness of the
actions taken
Retainappropriate documented
informationas evidence ofcompetence
7. 3 Awareness
Persons doingwork under the
organization’s control shallbe aware
of:
The qualitypolicyand relevant quality
objectives
Their contributionto the effectiveness
of the QMS, includingthe benefits of
improvedperformance
The implications of not conforming
with the QMS requirements
Yes
5. Page 5 of 8 www.alcumusgroup.com Issue001 Sept 15
ISO 9001:2015 Clause New
requirement
Complies
(Yes/No)
Evidence
7.4 Communication
The organization shall determine
internal andexternal communications
relevant to the QMS
What it will communicate?
When to communicate?
With whomto communicate?
How to communicate?
Yes
7.5 Documented information
7.5.1 General
The organizations QMS shall include:
Documentedinformationrequired by
this international standard and
determinedbythe organizationas
being necessaryfor the effectiveness of
the QMS
7.5.2 Creating and updating
When creating and updating
documentedinformationthe
organizationshall ensure appropriate:
Identificationanddescription (e.g. a
title, date, author, or reference
number);
format (e.g. language, software
version, graphics) andmedia (e.g.
paper, electronic);
review andapprovalfor suitabilityand
adequacy.
No
7.5.3 Control of documented
information
Documentedinformationrequired by
the QMS and bythis International
Standardshall be controlledto ensure:
it is available andsuitable for use,
where andwhenit is needed it is
adequatelyprotected
No
7.5.3.2
For control ofdocumentedinformation
the organizationshall address the
following activities where applicable:
Distribution, access, retrieval and use
Storage and preservation
Control of changes
Retentionanddisposition
Documentedinformationof external
originshall be identifiedas appropriate
and controlled
6. Page 6 of 8 www.alcumusgroup.com Issue001 Sept 15
ISO 9001:2015 Clause New
requirement
Complies
(Yes/No)
Evidence
8 Operation
8.1 Operational planning and control
The organization shall plan, implement
and control the processes neededto
meet requirements for the provision
of products andservices, and to
implement the actions determinedin
6.0 by:
Determining requirements for the
products andservices
Establishing criteriafor the processes
and for the acceptance of products and
services
Determining the resources needed to
achieve conformityto product and
service requirements
Implementingcontrol of the processes
in accordance withthe criteria
Determining andkeeping documented
informationto the extent necessaryto
have confidence that the processes
have been carried out as planned and
to demonstrate conformityof products
and services to requirements
The organisation shall control planned
changes andreviewthe consequences
of unintendedchanges takingactionto
mitigate anyadverse effects as
necessary
The organisation shall ensure that
outsourced processes are controlled in
accordance with8.4
Yes
8.2 Requirements for products and
services
8.2.1 Customer communication
Communication withcustomers shall
include:
Providing information relating to
products andservices
Handlingenquiries, contracts or orders
includingchanges
Obtaining customer feedback,
includingcustomer complaints
The handling or controllingcustomer
property
Establishing specific requirements for
contingencyactions when relevant
No
7. Page 7 of 8 www.alcumusgroup.com Issue001 Sept 15
ISO 9001:2015 Clause New
requirement
Complies
(Yes/No)
Evidence
8.2.2 Determining requirements
related to products or services No
8.2.3 Review of requirements related
to products and services
No
8.2.4 Changes to requirements for
products and services No
No
8.3 Designand development No
8.3.1 General
The organisation shall establish,
implement andmaintaina designand
development process that is
appropriate to ensure the subsequent
provisionof products andservices
No
8.3.2 Design and development
planning
No
8.3.3 Design and development inputs No
8.3.4 Design and development
controls
No
8.3.5 Design and development outputs No
8.3.6 Design and development
changes
No
8.4 Control of externally provided
services
No
8.5 Production and service provision No
8.6 Release of products and services No
8.7 Control of nonconforming process
outputs
No
9 Performance evaluation
9.1 Monitoring, measurement,
analysis and evaluation
9.1.1 General
The organization shall determine:
what needs to be monitoredand
measured, the methods ofmonitoring
measurement, analysisandevaluation
as applicable to ensure validresults
when monitoring andmeasuring will be
performed and whenresults from
monitoringandmeasurement shallbe
analysedandevaluated
The organisation shall evaluate the
qualityperformance andeffectiveness
of the QMS
No
9.1.2 Customer Satisfaction No
9.1.3 Analysis and evaluation No
9.2 Internal Audit
9.2.1
The organization shall conduct internal
audits at planned intervalsto provide
information onwhether the QMS
conforms to the organisations own
requirements for its QMS andto this
international standardandis
effectivelyimplementedand
maintained
New clause
but not really
any new
requirements
8. Page 8 of 8 www.alcumusgroup.com Issue001 Sept 15
ISO 9001:2015 Clause New
requirement
Complies
(Yes/No)
Evidence
9.3 Management Review
Top management shall review the
organization's QMS, at planned
intervals, to ensure its continuing
suitability, adequacyandeffectiveness
New clause
but not really
any new
requirements
10 Improvement
10.1 General
10.2 Nonconformity and corrective
action
When a nonconformityoccurs,
includingthose arising from
complaints, the organizationshall react
to the nonconformity
New clause
but not really
any new
requirements
10.3 Continual improvement
The organization shall continually
improve the suitability, adequacyand
effectivenessof the QMS
New clause
but not really
any new
requirements