FDA requirement: 21 CFR 820 and ISO 9001:2008

Compliance ISO 9001:2008 to requirement FDA: 21 CFR 820

21 CFR 820: Brief Description: ISO 9001:2008 clauses:
§ 820.1 – Scope.
§ 820.3 – Definitions.
§ 820.5 – Quality system.
General Provisions Scope: 1, 2, 3                                               4.1-General Requirement
§ 820.20 – Management responsibility.
§ 820.22 – Quality audit.
§ 820.25 – Personnel.
Quality System Requirements clause 5: Management Responsibilityclause 8.2.2: Internal Audit

clause 6.2 Human Resources

§ 820.30 – Design controls Design Controls clause  7.3 Design and Development
§ 820.40 – Document controls Document controls clause 4.2 Documentation Requirements
§ 820.50 – Purchasing controls. Purchasing controls. clause 7.4 Purchasing
§ 820.60 Identification.
§ 820.65 – Traceability.
Identification and Traceability clause 7.5.3 Identification and Traceability
§ 820.70 – Production and process controls.
§ 820.72 – Inspection, measuring, and test equipment.
§ 820.75 – Process validation.
Production and Process Controls clause 7.5 Production and service provision                                                  clause 7.6 Control of monitoring and measuring equipment
 § 820.80 – Receiving, in-process, and finished device acceptance.
§ 820.86 – Acceptance status.
Acceptance Activities clause 7.4.3 Verification of purchased product  clause 7.1 Product realization
§ 820.90 – Nonconforming product. Nonconforming product. clause 8.3 Control of noncoforming product
§ 820.100 – Corrective and preventive action. Corrective and preventive action. cluase 8.5.2 Corrective Actionclause 8.5.3 Preventive action
§ 820.120 – Device labeling.
§ 820.130 – Device packaging.
Labeling and Packaging Control

§ 820.140 – Handling.
§ 820.150 Storage.           § 820.160-Distribution

Handling, Storage, Distribution, and Installation 7.5.5 Preservation of product
§ 820.180 – General requirements.
§ 820.186 – Quality system record.
§ 820.198 – Complaint files.
Records clause 4.3 Control of records
§ 820.250 – Statistical techniques. Statistical Techniques clause 8.4 Analysis of data

Role of Quality Manager

  1. Quality Standards.  Documents and records are used all throughout the company.  Nobody should know more about quality, compliance and processes than the Quality Manager.  Your experience with Good Manufacturing Practices (GMP), ISO standards (i.e. ISO 9001), or 21 CFR 820 within a regulated industry are important to managing and controlling documents and records.
  2. Quality Project Management.  A Quality Manager is also a project manager managing corrective action, process improvement, and auditing projects.  One must have strong self-motivation, the ability to work independently, and within a team environment with strong follow up, organization and prioritization skills and excellent attention to detail helps too.  Perhaps most important of all is understanding the financial – risk-reward – trade-offs in good project management.
  3. Business Process Documentation.  A Quality Manager must be able to understand, comply, and improve established company policies and procedures.  Developing standard work, policies, procedures, job aids, and business process communications are a part of the job.  A Quality Manager is also a technical writer.  Familiarity with policy and procedure writing will help you to succeed.  Technical writing conveys technical information using active voice construction, instructional design, and desktop publishing methods to transfer information into understandable and useful information.
  4. Document Control.  As the Quality Manager, your Knowledge of the Quality documentation process, Document Control practices, and managing documents, records, forms, and work instructions is vital to maintaining your company’s compliance program.  A Quality Manager may be the Document Control Manager responsible for organizing documents into an easy to use and fast retrieval system.  Users need their policies and procedures to conform to requirements.  If they cannot find them, then they cannot follow them… Document control is an important priority.
  5. quality managerQuality Communications.  It might go without saying but explaining business process compliance to others is what a Quality Manager has to do.  Being able to understand a variety of instructions furnished in written, oral, diagram, or schedule form helps others to follow and conform to the established best practice.  Communicating compliance and conformance is done using software such as Microsoft Word and Excel, training using PowerPoint, process mapping using Visio, Statistical Process Control (SPC) using statistics, as well as document revision control software for policies and procedures management.
  6. People Management.  A Quality Manager should not be afraid of asking questions, collecting business process information, and working with others in a positive and collaborative manner.  Business processes include sensitive accounting and financial processes too.  So, you must be comfortable speaking effectively and communicating directly with all levels of personnel.
  7. Quality Auditing.  A Quality Manager performs some of the quality audits.  Supply chain audits, process audits, and may even lead ISO audits an act as a Lead Auditor managing teams of auditors.  Clearly understanding the compliance requirements, collecting objective evidence, and writing up audit reports ensure the quality management system is operating effectively.
  8. Problem Solving.  The Quality Manager solves problems, typically in situations where general standardization should exist, but may not be operating effectively.  Using process mapping techniques, lean, or Six Sigma process improvement methodology is essential to reducing waste and being effective in the Quality role.   A delicate balance exists between resolving problems yourself and identifying those situations that require management intervention for a solution.  Good political judgment is required where quality and compliance are concerned.
  9. Team Player.  The Quality Manager is involved in teams and meetings at every level of the organization.  Management reviews, material reviews, supplier reviews, corrective action reviews, process improvement teams, audits, customer visits and strategy discussions.  A good Quality Manager is involved with many areas of the company.
  10. Quality “Go To” Guy.  The Quality Manager is the person that everybody goes to to get answers about quality.  Product specifications, supplier requirements, testing, inspections, part verification, equipment calibration, corrective actions, non-conformances, workers compensation, benchmarking, voice of the customer, and on and on.  The buck stops here at Quality.


Source: www.bizmanualz.com

Requirements of Quality Management System

What are Requirements of ISO 9001 Quality Management Systems?

audited image1The ISO offers one among the known management systems within the world. Overall, the systems are enforced by quite one million organizations in many countries. The ISO 9001 certified company follows tips set by the organization. The standards represent the foremost comprehensive existing nowadays, and are a tried and tested framework for firms to higher make sure that they’re meeting the wants of their several purchasers.

Requirements – Documentation

In order to be ISO 9001 compliant, an authorized company giving services or product should be in possession of documented statements of a top quality policy that delineates the standard objectives.

Quality Manual

A company seeking ISO 9001 certification should possess a top ISO 9001 quality manual that sets forth the scope of the standard management system and documented procedures for addressing quality problems.

Control of Documentation

Documentation should be controlled therefore on make sure the documents are approved before being issued. Additionally, all documentation should be unbroken up-to-date. Revisions should be resubmitted for approval once an amendment is formed.

Management Responsibility

Although the ISO 9001 produces the management standards, it’s the responsibility of the corporate to self-audit. Additionally, the corporate might permit customers to perform an audit likewise. To be certified as compliant, businesses management practices should be reviewed by a freelance ISO 9001 quality system certification company.

Measurement and Analysis

Per Section eight of the ISO standards, an organization should set up and implement “the watching, measure, analysis and improvement processes” that are required to demonstrate conformity to product necessities, guarantee conformity of the standard management system, and to supply continual improvement of the standard management necessities.

Continual Improvement

In order to stay compliant with the ISO standards, an organization should frequently develop and improve its own tips to make sure corrective and preventative measures are in situ to contend with any nonconformity that will arise.

source: qms9001certificationprocedures.wordpress.com

ISO 9001:2008 to ISO/DIS 9001 Correlation Matrix

What to expect in new revision of ISO 9001? ISO 9001

ISO 9001:2008 to ISO/DIS 9001 (rev.2015) Correlation Matrix

ISO 9001:2008 ISO/DIS 9001
4        Quality management system 4         Quality management system
4.1     General requirements 4.4     Quality management system and its processes
4.2     Documentation requirements 7.5     Documented information
4.2.1  General 7.5.1  General
4.2.2  Quality manual 4.3     Determining the scope of the quality management system

7.5.1  General

4.4     Quality management system and its Processes

4.2.3  Control of documents 7.5.2  Creating and updating

7.5.3  Control of documented Information

4.2.4  Control of records 7.5.2  Creating and updating

7.5.3  Control of documented Information

5         Management responsibility 5        Leadership
5.1      Management commitment 5.1     Leadership and commitment

5.1.1  Leadership and commitment for the    quality management system

5.2      Customer focus 5.1.2  Customer focus
5.3      Quality policy 5.2     Quality policy
5.4      Planning 6        Planning for the quality management system
5.4.1  Quality objectives 6.2     Quality objectives and planning to achieve them
5.4.2  Quality management system planning 6        Planning for the quality management system

6.1     Actions to address risks and opportunities

6.3     Planning of changes

5.5      Responsibility, authority and communication 5        Leadership
5.5.1   Responsibility and authority 5.3     Organizational roles, responsibilities and  authorities
5.5.2   Management representative           Title removed

5.3     Organizational roles, responsibilities and  authorities

5.5.3   Internal communication 7.4     Communication
5.6      Management review 9.3     Management review
5.6.1   General 9.3.1  Management review
5.6.2   Review input 9.3.1  Management review
5.6.3   Review output 9.3.2  Management review
6         Resource management 7.1     Resources
6.1      Provision of resources 7.1.1  General

7.1.2  People

6.2      Human resources           Title removed

7.2     Competence

6.2.1   General 7.2     Competence
6.2.2  Competence, training and awareness 7.2      Competence

7.3      Awareness

6.3      Infrastructure 7.1.3  Infrastructure
6.4      Work environment 7.1.4  Environment for the operation of processes
7         Product realization 8         Operation
7.1      Planning of product realization 8.1      Operational planning and control
7.2      Customer-related processes 8.2      Determination of requirements for products and services
7.2.1  Determination of requirements related to the product 8.2.2  Determination of requirements related to products and services
7.2.2  Review of requirements related to the product 8.2.3  Review of requirements related to the products and services
7.2.3  Customer communication 8.2.1  Customer communication
7.3      Design and development 8.5      Production and service provision
7.3.1  Design and development planning 8.3      Design and development of products and services

8.3.1  General

8.3.2  Design and development planning

7.3.2  Design and development inputs 8.3.3  Design and development Inputs
7.3.3  Design and development outputs 8.3.5  Design and development outputs
7.3.4  Design and development review 8.3.4  Design and development controls
7.3.5  Design and development verification 8.3.4  Design and development controls
7.3.6  Design and development validation 8.3.4  Design and development controls
7.3.7  Control of design and development changes 8.3.6  Design and development changes
7.4      Purchasing 8.4      Control of externally provided products and services
7.4.1  Purchasing process 8.4.1  General

8.4.2  Type and extent of control of external provision

7.4.2  Purchasing information 8.4.3  Information for external providers
7.4.3  Verification of purchased product 8.6      Release of products and services
7.5      Production and service provision 8.5      Production and service provision
7.5.1  Control of production and service provision 8.5.1  Control of production and service provision

8.5.5  Post-delivery activities

7.5.2  Validation of processes for production and service provision 8.5.1  Control of production and service provision
7.5.3  Identification and traceability 8.5.2  Identification and traceability
7.5.4  Customer property 8.5.3  Property belonging to customers or external providers
7.5.5  Preservation of product 8.5.4  Preservation
7.6      Control of monitoring and measuring equipment 7.1.5  Monitoring and measuring resources
8.0      Measurement, analysis and improvement 9.1      Monitoring, measurement, analysis and evaluation
8.1      General 9.1.1  General
8.2      Monitoring and measurement 9.1      Monitoring, measurement, analysis and evaluation
8.2.1  Customer satisfaction 9.1.2  Customer satisfaction
8.2.2  Internal audit 9.2      Internal audit
8.2.3  Monitoring and measurement of processes 9.1.1  General
8.2.4  Monitoring and measurement of product 8.6      Release of products and services
8.3      Control of nonconforming product 8.7      Control of nonconforming process outputs, products and services
8.4      Analysis of data 9.1.3  Analysis and evaluation
8.5      Improvement 10       Improvement
8.5.1  Continual improvement 10.1   General

10.3   Continual Improvement

8.5.2  Corrective action 10.2   Nonconformity and corrective action
8.5.3  Preventive action            Clause removed

6.1       Actions to address risks and opportunities (see 6.1.1, 6.1.2)

ISO 9001 Revision 2015 Is Coming

The ISO 9001 Revision 2015 timetable for development is as follows:

July 2015 – Final Draft International Standard ballot opens
August 2015 –  Final Draft International Standard ballot closes
9 September 2015 – ISO 9001:2015 International Standard is published
 According to the draft design specification, the revised ISO 9001:2015 standard should:
  • Provide a stable core set of requirements for the next 10 years or moreISO
  • Remain generic, and relevant to all sizes and types of organization operating in any sector
  • Maintain the current focus on effective process management to produce desired outcomes
  • Take account of changes in quality management systems practices and technology since the last major revision in 2000
  • Reflect changes in the increasingly complex, demanding and dynamic environments in which organizations operate
  • Enhance compatibility and alignment with other ISO management system standards
  • Facilitate effective organizational implementation and effective conformity assessment by first, second and third parties
  • Use simplified language and writing styles to aid understanding and consistent interpretations of its requirements

Seven Significant Changes in ISO 9001 Revision 2015 Committee Draft

  1. The term „product” has been replaced by „goods and services”.
  2. Two new clauses related to the context of the organization:
    4.1 Understanding the organization and its context
    4.2 Understanding the needs and expectations of interested parties.
  3. The requirement to use the „process approach” has been more explicit by adding a new clause.
    4.4.2 Process approach
  4. The standard does not include a specific clause for „Preventive Actions”.
  5. The terms „document” and „records” have been replaced with the term „documented information”.
  6. of external provision of goods and services address all forms of external provisions.
  7. The term „continual improvement” has been replaced with „improvement”.


Steps involved in ISO9001:2008 Certification

Steps involved in ISO9001:2008 Certification 

ISO 9001
The steps involved in any ISO9000 certification project are the following:

  • Gap Analysis: Assessment of existing quality management practices vis-a-vis ISO9001 requirements.
  • Orientation Training: Top/Senior Management orientation on ISO9001 requirements and action plans.
  • System Documentation: Preparation of quality manuals and design of quality record formats.
  • System Implementation: Implementation of quality system as per the quality manuals.
  • Company-wide Training: Training on ISO9000 clauses, Statistical Quality Control Techniques, and Quality Audit.
  • Internal Quality Audits: Periodic assessment of quality system implementation and corrective actions.
  • Pre assessment: Initial audit by Certifying agency, and, implementation of corrective actions.
  • Final Assessment: Certification audit by the Certifying agency and recommendation for certification

Continuous Improvement – Way of Developing New Products

Continuous Improvement – Way of Developing New Products

Many companies pursuing lean transformation and continuous improvement are focusing on the customer fulfillment operations to improve quality and delivery while reducing costs.


Organizations are working to reduce lead time, improve quality, and make their manufacturing and distribution operations more efficient in an effort to cut costs. While these improvements are important, they are not sufficient in today’s globally competitive manufacturing world.

In many companies today, direct labor is a single-digit percentage of the cost of goods sold (COGS), with purchased materials and overhead burden making up over 90% of their COGS. Even with these cost breakdowns, many continuous improvement efforts still focus on trying to eliminate waste in the manufacturing process to use labor more efficiently to reduce labor content. These efforts will produce some small incremental improvements in the COGS, but a much better opportunity exists early in the new product design cycle.

It is estimated by some product development experts that 80% of the final cost of a new product is determined in the first 20% of the design cycle where the product concept and initial design philosophy are chosen. If you involve your manufacturing organization and your suppliers at these very early stages of the cycle and form a concurrent engineering design team, you have the opportunity to design products for manufacturing and assembly, both at your suppliers and in your own operations as well as using their expertise in your designs. Using such design-for-manufacturing techniques as reduced parts count, substitution of molded plastics or pressed and sintered powdered metal parts for machined metal and poka-yoke designs to eliminate assembly errors, your new products can be developed with a radically lower final cost of goods sold.

People from your manufacturing operations are a great resource to use with your product design teams to offer suggestions on how designs can be manufactured and how costs can be reduced by making products easier to assemble, with less chance for quality issues and their resultant scrap and rework costs. Manufacturing engineers can plan how to produce a new product while it’s still in design when options for processing methods and equipment are still available. Operators can evaluate their ability to assemble new products and can offer suggestions on visibility and accessibility of components before designs are frozen.

Manufacturing personnel who are familiar with existing products can suggest part substitutions to increase commonality of parts rather than having all unique components. A unique fastener that is out of stock will shut down a product operation just as surely as a custom casting or machined component, but common fasteners can often be designed in from the start.

Your suppliers, working with your product development teams, can suggest design alternatives that often reduce a product’s material cost by up to 50%. Rather than just giving them a component specification to quote, use their expertise to suggest alternate materials, design options, different fabrication techniques, and tolerances that really matter to reduce your product’s component costs. Too often, suppliers are not trusted and not involved until the design is complete and your organization has lost the opportunity to exploit the supplier’s expertise to minimize component costs by being involved with the design team from the very beginning.

There are a number of organizations utilizing concurrent engineering design teams today to incorporate the knowledge and unique experience of suppliers, manufacturing engineers, quality professionals, production and distribution personnel, accounting/finance folks and marketing/sales people to bring increased knowledge and expertise to the team to get better designs at a lower product cost. These teams are part of the design process from the very beginning, at the ideation phase, to develop new products that are better quality and lower cost than those designed exclusively behind the curtain of new-product engineering. Don’t forget to involve your suppliers and operations organization in your new product-development process at the very start.

source: http://www.industryweek.com

Manufacturing Trends in 2015

Manufacturing Trends that will Shape the Market in 2015

Greater automation and investment driven by accelerated production cycles, advanced technology and changing labor demographics will continue to revolutionize the industry


As 2015 approaches it’s time to look ahead at emerging trends that will impact 21stcentury manufacturing around the globe.

The entire supply chain ecosystem — encompassing manufacturers, distributors and retailers — is undergoing a business transformation. This is in response to changing dynamics involving shifting consumer expectations, time to market and intense global competition that is being dictated by the rising Internet and mobile economies.

Advances in technology — coupled with changing labor demographics — are proving to be the lynchpin shaping this new business model. To remain economically viable, retailers must sell products faster and at competitive prices which sends a ripple effect down the supply chain. For example, manufacturers must accelerate production cycles and distributors must shorten delivery times.

Stakeholders throughout the supply chain have no choice but to adjust their business models to meet consumer demand and increase profits. However, technology is helping businesses stay relevant in these changing times. Let’s take a look at five manufacturing trends that will impact the industry in 2015:

  1. ‚SMAC Stack’ adoption to gain speed.A manufacturing comeback is being driven by SMAC — social, mobile, analytics and cloud. The SMAC Stack is becoming an essential technology tool kit for enterprises and represents the next wave for driving higher customer engagement and growth opportunities. The need to innovate is forcing cultural change within a historically conservative „if it’s not broke don’t fix it” industry, and SMAC is helping early adopters in the manufacturing market increase efficiencies and change.
  2. Social media to further impact business model innovation. According to an IDC white paper, „The Future of Manufacturing,” sponsored by Infor, social media is forcing manufacturers to become more customer-centric. The traditional business-to-business model is becoming outdated because today’s connected consumers are better informed and expect products on-demand. Consumers compare, select or buy multiple products with a tap of their smartphone or tablet, and social media has become their preferred communication platform. This consumer purchasing style is not only having an impact on brand-oriented value chains, but is transforming traditional B2B to B2B2C models.
  3. Internet of Things (IoT) will increase automation and job opportunities.A renewed focus on science and engineering education is cultivating a manufacturing workforce that can manage highly technical systems and allow for greater automation. This frees up employees to put their talents to work on R&D which is helping to redefine what it means to have a career in manufacturing. In addition, IoT allows for condition-based maintenance which is driving efficiencies as businesses save on labor and service costs.
  4. Greater capital investment.Though the slow economic recovery continues to hinder expansion and growth opportunities, recent government and industry reports show an uptick in capital investment funding. As manufacturers become focused on capturing value through innovation, original design and speed to market, they are increasing spend for upgrading plant, equipment and technologies.
  5. The emergence of „Next-Shoring.”The rise of a more technical labor force to manage supply chain operations — combined with rising wages in Asia, higher shipping costs and the need to accelerate time to market to meet retailer and consumer demands — has led to more companies shifting their manufacturing strategies from outsourcing overseas to developing products closer to where they will be sold. „Next-shoring,” as this tactic has been dubbed, allows manufacturers to increase the speed at which product is replenished on store shelves. The faster inventory can be moved to the consumer, the sooner the costs to warehouse, ship and dock goods can be freed up.

These are a few of the game-changing trends expected to impact manufacturing in 2015 and it will be exciting to watch which take off as the industry continues to evolve.

source: http://www.industryweek.com

Revised ISO 9001 Standard Moves Closer to Completion

Revised ISO 9001 Standard Moves Closer to Completion

The revised standard will retain its strong focus on a process-based approach to quality management systems.

quality management

There is change afoot with respect to the ISO 9001 standard on quality management systems.

It is not unexpected change. All ISO standards are reviewed every three to five years to determine whether revisions are needed to keep the standards current and relevant in the marketplace, according to the International Organization for Standardization.

ISO 9001 is in the late stages of the revision process, with a new edition expected in 2015.

There are several changes outlined in the ISO 9001: 2015 edition, although the standard will retain its strong focus on a process-based approach to produce desired outcomes, explained Nigel Croft, chair of the ISO subcommittee revising the standard, in a Web update. „…which in the case of a quality management systems means, of course, consistent products and services consistently meeting customer needs and expectations.”

The changes focus on three concepts:

  1. The process approach will strongly emphasize that the quality management system has to be woven into and fully aligned with an organization’s strategic direction.
  2. Superimposed on the system of processes is the PDCA (plan-do-check-act) methodology, which will apply both to individual processes as well as the quality management system as a whole.
  3. An overall focus on risk-based thinking aimed at „preventing undesirable outcomes,” such as non-conforming products and services.

A recent vote approved the latest draft of the revised ISO 9001 standard, which has since moved to the next stage – Final Draft International Standard. In his update, Croft explained that the subcommittee will review comments that came in during the last vote and produce a final draft, which then will be voted on.

While ISO itself does not certify organizations to ISO standards, Croft noted that there would be a three-year transition period for companies to migrate to the updated standard once the new edition is published.

He also suggested that organizations may want to review the draft rather than wait until the new edition of the standard is published.


Source: http://www.industryweek.com
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